Exhibit 4.34

 

***Certain portions of this exhibit have been omitted based on a request for confidential treatment pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. The omitted portions have been filed separately with the Securities and Exchange Commission.

 

PRIVATE & CONFIDENTIAL

 

AGREEMENT

 

BETWEEN:

 

ADAPTIMMUNE LIMITED (1)

 

and

 

UNIVERSAL CELLS, INC. (2)

 

 

 

 

 

RESEARCH COLLABORATION AND LICENCE

AGREEMENT RELATING TO GENE EDITING AND

HLA-ENGINEERING TECHNOLOGY

 

 

 

 

 



 

TABLE OF CONTENTS

 

1.

Definitions

 

1

 

 

 

 

2.

Research Program

 

10

 

 

 

 

3.

Management of Research Program

 

13

 

 

 

 

4.

Reports and Audits relating to the Research Program

 

15

 

 

 

 

5.

Grant of Rights

 

16

 

 

 

 

6.

Consideration

 

17

 

 

 

 

7.

Ownership of Intellectual Property

 

24

 

 

 

 

8.

Prosecution and Maintenance of patents

 

26

 

 

 

 

9.

Enforcement of Patents

 

27

 

 

 

 

10.

Potential Third Party Actions

 

28

 

 

 

 

11.

Confidentiality and Non-Disclosure

 

29

 

 

 

 

12.

Trademarks

 

33

 

 

 

 

13.

Representations, Warranties and Covenants

 

33

 

 

 

 

14.

Indemnity

 

34

 

 

 

 

15.

Term and Termination of Agreement

 

36

 

 

 

 

16.

Anti-Corruption Laws

 

39

 

 

 

 

17.

Assignment

 

40

 

 

 

 

18.

Severability

 

40

 

 

 

 

19.

Governing Law, Jurisdiction, Venue

 

41

 



 

20.

Dispute Resolution

 

41

 

 

 

 

21.

Notices

 

42

 

 

 

 

22.

Relationship of the Parties

 

42

 

 

 

 

23.

Entire Agreement

 

43

 

 

 

 

24.

English Language

 

43

 

 

 

 

25.

Amendment

 

43

 

 

 

 

26.

Waiver and Non-Exclusion of Remedies

 

43

 

 

 

 

27.

Further Assurance

 

43

 

 

 

 

28.

Expenses

 

44

 

 

 

 

29.

Counterparts

 

44

 

 

 

 

Schedule 1 — Outline of Research Program

 

46

 

 

 

Schedule 2 — Sublicense under AAV/HLA-engineering Licence

 

56

 

 

 

Schedule 3 — Sublicense under Elf Licence

 

57

 

 

 

Schedule 4 — Universal Pre-existing Patents

 

58

 

 

 

Schedule 5 — AAV/HLA-engineering Licence

 

61

 

 

 

Schedule 6 — Elf Licence

 

44

 



 

This RESEARCH COLLABORATION AND LICENCE AGREEMENT (the “Agreement”) is made as of the 25th day of November 2015 (the “Effective Date”) by and between:

 

(1)                                 ADAPTIMMUNE LIMITED, a company incorporated in England and Wales with its registered address at 101 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY (“Adaptimmune”);

 

and

 

(2)                                 UNIVERSAL CELLS, INC., a company incorporated in the State of Washington with its principal address at 720 Broadway, Seattle, WA 98122 (“Universal”).

 

Background

 

(A)                               WHEREAS Universal has taken a licence from the University of Washington in relation to certain Intellectual Property Rights for Gene Editing Technology, HLA Engineering Technology and a cell line (defined further below) and has certain related know-how;

 

(B)                               WHEREAS Adaptimmune is a clinical-stage biopharmaceutical company focussed on immunotherapy products based on its T-cell receptor platform;

 

(C)                               WHEREAS Universal has experience and related know-how for the development of a ‘universal’ cell line;

 

(D)                               WHEREAS the parties wish to conduct certain collaborative development activities;

 

(E)                                WHEREAS Adaptimmune wishes to acquire exclusive rights to certain work product and intellectual property rights arising from collaborative development activities together with certain pre-existing intellectual property rights; and

 

(F)                                 WHEREAS the parties have agreed to collaborate on the terms and conditions set out below.

 

Agreement

 

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Universal and Adaptimmune intending to be legally bound, agree as follows:

 

1.                                     Definitions

 

Unless otherwise specifically provided herein, the following terms, when used with a capital letter at the beginning, shall have the following meanings:

 

1.1.                           AAV/HLA-engineering Licence” means the Licence and Material Transfer Agreement between Universal and the University of Washington dated 27 June 2014 and attached as Schedule 5;

 

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1.2.                           Adaptimmune Technology” means the gene sequence provided by Adaptimmune encoding the affinity engineered TCR intended for expression in any transduced T-cell and the resulting amino-acid sequence transcribed from such gene sequence.

 

1.3.                           Affiliate” means, with respect to a Person, any Person that directly, or indirectly through one or more intermediaries, Controls, is Controlled by or is under common Control with such first Person.

 

1.4.                           Anti-Corruption Laws” means the US Foreign Corrupt Practices Act 1977, the UK Bribery Act 2010 and any other Applicable Laws for the prevention of fraud, corruption, racketeering, money laundering or terrorism.

 

1.5.                           Applicable Law” means the applicable laws, rules and regulations in the world, including any rules, regulations, guidelines or other requirements of the Governmental Authorities that may be in effect from time to time and in each case to the extent they apply to a party’s performance of its obligations under this Agreement. Applicable Law shall include compliance with GMP.

 

1.6.                           Arising IP” means any Intellectual Property Rights first conceived, first generated or reduced to practice (excluding any inventions first conceived outside of the performance of the Research Program) in the performance of the Research Program by or on behalf of either Party including performance by any contractors or sub-contractors or Affiliates of either Party.

 

1.7.                           Breaching Party” has the meaning set forth in Section 15.3.

 

1.8.                           Business Day” means a day other than Saturday or Sunday or a public holiday in the United States of America and England.

 

1.9.                           Change in Control” means a transaction pursuant to which Third Parties (a) that did not have Control prior to the applicable transaction acquire (whether by merger, consolidation or transfer or issuance of capital stock or otherwise) the Control of such Person, or (b) acquire assets constituting all or substantially all of the assets of such Person or in the case of Universal, assets constituting all or substantially all of either the Universal Technology or rights under the Universal Patents; other than (i) the initial public offering of the common stock of a Person in a public market; or (ii) any sale or transfer of the capital stock owned or controlled by the majority stockholder or stockholders of a Person to trusts or comparable entities for the primary benefit of such stockholders or their family members or to the estate, heirs or devisees of any such stockholder in the event of his or her death; or (iii) any transaction in which a Person reincorporates in another jurisdiction or engages in other internal reorganization or changes in corporate structure but where there is no change in Control of such Person or change in ownership of any assets.

 

1.10.                    Commercially Reasonable Efforts” means with respect to the research, development, manufacture or commercialisation of a Product, at least the same efforts and resources used by a biopharmaceutical company for similar products with similar commercial and scientific potential at a similar stage in their development or lifecycle

 

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or in a similar therapeutic area taking into consideration their safety and efficacy, their cost to develop, the competitiveness of alternative products and the nature and extent of their market exclusivity (including Patent coverage and regulatory exclusivity), the likelihood of Regulatory Approval, and their expected profitability and level of pricing and reimbursement, including the amounts of marketing and promotional expenditures with respect to the Products and generic products.  Commercially Reasonable Efforts shall be determined based on the world as a whole and without reference to specific markets or group of markets.

 

1.11.                    Competitor” means any Person which Exploits products or therapies for immunotherapy and wherein such product or therapy incorporates a genetically engineered T-cell including where such Person is listed as a competitor or having a competitive offering in Adaptimmune’s publicly available filings with the Securities Exchange Commission including its 20-F as filed at the Effective Date.

 

1.12.                    Complaining Party” has the meaning set forth in Section 15.3.

 

1.13.                    Confidential Information” means, subject to Section 11.3, any and all confidential data, results, know-how, plans, business information and other Information, whether oral or in writing or in any other form, disclosed before, on or after the date of this Agreement by one Party or its Affiliates to another Party or its Affiliates or sub-contractors, including the terms and existence of this Agreement.

 

1.14.                    Control” means, with respect to any item of Information, Patent or Intellectual Property Right, possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to assign, or grant a license, sublicense or other right to or under, such Information, Patent or Intellectual Property Right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party and without owing any payment to a Third Party in relation to such assignment, grant, license, sublicense or other right. “Control” with respect to any Person and for the purposes of clauses 1.3 and 1.9 means (a) the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, resolution, regulation or otherwise; or (b) to own directly or indirectly 50% or more of the outstanding voting securities or other ownership interest of such Person. The terms “Controlled by” and “under common Control with” shall be interpreted accordingly.

 

1.15.                    Cover” means, with respect to a particular Patent or patent application and with reference to a specific product, service or process, that the use, manufacture, sale, offer to sale, supply or import of such product, service or process would infringe a claim of such Patent or patent application.

 

1.16.                    Deliverable” means any tangible deliverable provided to Adaptimmune by Universal during the course of the Research Program and specified as a Deliverable in such Research Program including for clarity any cell bank or cell line provided by Universal.

 

1.17.                    Development Milestone” shall have the meaning provided in Section 6.2.

 

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1.18.                    Disclosing Party” has the meaning set forth in Section 11.1.

 

1.19.                    Effective Date” has the meaning set forth in the preamble to this Agreement.

 

1.20.                    Elf Licence” means the Non-exclusive License Agreement between Universal and the University of Washington dated 22 October 2014 and attached as Schedule 6.

 

1.21.                    EMA” means the European Medicines Agency and its successors.

 

1.22.                    Exploit” means to keep, make, have made, import, use, sell, or offer for sale, including to research, develop, register, modify, enhance, improve, manufacture, have manufactured, hold/keep (whether for disposal or otherwise), formulate, optimise, have used, export, transport, distribute, promote, market or have sold or otherwise dispose or offer to dispose of, a product or process. Exploiting shall be interpreted accordingly.

 

1.23.                    Exploitation” means the act of Exploiting a product or process.

 

1.24.                    FDA” means the United States Food and Drug Administration and any successor agency thereto.

 

1.25.                    Field” means immunotherapy and wherein the administered product or therapy incorporates a form of T-cells including, but without limitation, genetically engineered T-cells or stem cell derived T-cells.

 

1.26.                    First Commercial Sale” means the first sale for monetary value of a Product in any country after Regulatory Approval in such country.  For the avoidance of doubt, sales prior to receipt of the required Regulatory Approval, on a country-by-country basis required to commence regular commercial sales, such as so-called “treatment IND sales”, “named patient sales” and “compassionate use sales”, shall not be construed as a First Commercial Sale.

 

1.27.                    First Multi-Indication Product” means the first Product for which Adaptimmune applies for an IND in more than one Indication.

 

1.28.                    Gene Editing Technology” means the recombinant adeno-associated virus (rAAV)-mediated genome editing technology for the introduction, removal and disruption of chromosomal genes (including associated processes) developed by Universal prior to the Effective Date of this Agreement or by Universal outside of the performance of this Agreement.

 

1.29.                    GMP” means the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.

 

1.30.                    Governmental Authority” means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of Products.

 

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1.31.                    Government Official” means any individual person employed by or acting on behalf of a government, government-controlled entity (including any government hospitals or academic institutions) or public international organization; any political party, party official or candidate; any individual person who holds or performs the duties of an appointment, office or position created by custom or convention; and any individual person who holds himself or herself out to be the authorized intermediary of any of the foregoing.

 

1.32.                    HLA Engineering Technology” means the use of the Gene Editing Technology to disrupt or prevent expression of HLA class I and HLA class II via disruption to the B2M gene and RFXANK gene and to cause the expression of a single chain HLA-E protein via insertion of a gene into the B2M gene (including associated processes) and in each case as developed prior to the Effective Date of this Agreement by Universal or outside of the performance of this Agreement by Universal

 

1.33.                    IND” means an investigational new drug application filed with the FDA for authorisation to commence human clinical trials in the U.S., and/or its equivalent in other countries or regulatory jurisdictions in the world.

 

1.34.                    Indication” means a disease, treatment area or therapeutic indication in relation to which any Product has obtained Regulatory Approval.

 

1.35.                    Indemnified Party” means a Party, its Affiliates or its or their respective directors, officers and employees, seeking to recover a Loss under Section 14.1, 14.2.

 

1.36.                    Indemnifying Party” means Universal or Adaptimmune from whom recovery of a Loss is sought under Sections 14.1 or 14.2.

 

1.37.                    Indirect Taxes” means value added taxes and sales taxes.

 

1.38.                    Information” means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results, laboratory notes and notebooks, and other material, including: high-throughput screening, gene expression, genomics, proteomics and other drug discovery and development technology; biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols; assays and biological methodology; manufacturing and quality control procedures and data, including test procedures; and synthesis, purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and any products, apparatuses, cultures, biological materials and other materials and compositions.

 

1.39.                    Infringement Suit” has the meaning set forth in Section 10.3.

 

1.40.                    Intellectual Property Rights” means trademarks, service marks, trade secrets, trade names, registered designs, design rights, copyrights (including rights in computer

 

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software), domain names, database rights and any rights or property similar to any of the foregoing (excluding Patents) in any part of the world, whether registered or not, together with the right to apply for the registration of any such rights.

 

1.41.                    JSC” shall have the meaning provided in Section 3.1.

 

1.42.                    Losses” means any and all direct liabilities, damages, losses or expenses, including interest, penalties, and reasonable lawyers’ fees and disbursements.  In calculating Losses, the legal duty to mitigate on the part of the Party suffering the Loss shall be taken into account. “Loss” shall be construed accordingly.

 

1.43.                    Major Territory” means the United States, Germany, China, Japan, France or the UK.

 

1.44.                    Manufacturing Price” means the cost of manufacture and supply of any Product as accounted for by Adaptimmune in accordance with its internal accounting policies (consistently applied) and including the following:

 

a)                           cost of raw materials and intermediate materials including vector constructs;

 

b)                           third party manufacture (including associated manufacturing and quality services) and supply costs for manufacture, quality control, distribution, release testing, packaging and supply of vector and Product;

 

c)                            cost of any Third Party materials used in the manufacture or supply of product;

 

d)                           payments made to Third Parties under any licences or consents and specific to manufacture, sale or supply of the relevant product;

 

e)                            any taxes or charges payable (including customs charges or other charges) in relation to the shipping, import, export and supply of product or any intermediate materials or product required for manufacture of end product.

 

f)                             Cost of patient administration including associated clinical care and any pre-conditioning or pre-treatment regimen required by patients; and

 

g)                            Cost of any patient follow-up or other treatment occasioned as a result of treatment using product.

 

1.45.                    Materials” means samples or other materials provided by a Party to another Party under this Agreement.

 

1.46.                    Material Anti-Corruption Law Violation” means a violation of an Anti-Corruption Law relating to the subject matter of this Agreement which would if it were publically known have a material adverse effect on a Party or on the reputation of a Party because of its relationship with the other Party.

 

1.47.                    Mean Average Cost of Supply” shall mean the mean average of the Manufacturing Price in the applicable twelve (12) month period.

 

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1.48.                    Net Sales” means the gross invoiced amount on sales of the Products by Adaptimmune and its Affiliates and their respective sublicensees to Third Parties after deduction of the following that are specific for Products:

 

a)                          normal and customary trade, quantity or prompt settlement discounts (including chargebacks and allowances) actually allowed and taken;

 

b)                           normal and customary amounts repaid or credited by reason of rejection, returns or recalls of goods, rebates or bona fide price reductions determined by Adaptimmune or its Affiliates and sublicensees in good faith;

 

c)                            normal and customary rebates and similar payments made with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, Federal or state Medicaid, Medicare or similar state program in the United States or equivalent governmental program in any other country;

 

d)                           any invoiced amounts which are not collected by Adaptimmune or its Affiliates or licensees and which are not recovered under an insurance policy and which are written off by Adaptimmune as part of its accounting processes;

 

e)                            excise taxes, Indirect Taxes, customs duties, customs levies and import fees imposed on the sale, importation, use or distribution of the Products; and

 

f)                             any other similar and customary deductions that are consistent with generally accepted accounting principles.

 

Net Sales shall be calculated using Adaptimmune’s internal audited systems used to report such sales as adjusted for any of items (a) to (f) above not taken into account in such systems.  All amounts shall be determined from the books and records of Adaptimmune and its Affiliates and sublicensees, maintained in accordance with IFRS (or equivalent system) and consistently applied.

 

Sales between Adaptimmune and its Affiliates will not be Net Sales unless the sale is to an end user (other than for the purposes of research, development and manufacture) and there is no onward sale or supply. The transfer of Products for sampling purposes without monetary consideration shall be disregarded for the purposes of calculating Net Sales.  Any free of charge disposal or use of a Product for regulatory or marketing purposes such as compassionate use or indigent patient programs, will not be deemed a sale or disposition for calculating Net Sales.

 

1.49.                    Notice Period” has the meaning set forth in Section 15.3.

 

1.50.                    Party” means Universal or Adaptimmune and “Parties” means both of Universal and Adaptimmune.

 

1.51.                    Patents” means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an

 

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application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)), and (e) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent applications and patents.

 

1.52.                    Payments” shall mean the payments and royalties to be paid by Adaptimmune to Universal in accordance with Section 6 of this Agreement.

 

1.53.                    Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organisation, including a government or political subdivision, department or agency of a government.

 

1.54.                    Phase” means a phase of the Research Program as summarised in Schedule 1.

 

1.55.                    Product Milestone” shall have the meaning given in Section 6.5.

 

1.56.                    Products” means any pharmaceutical product, service or therapy that contains, incorporates or uses any Deliverable provided by Universal under the Research Program.

 

1.57.                    Receiving Party” has the meaning set forth in Section 11.1.

 

1.58.                    Regulatory Approval” means an approval for a Product from a Governmental Authority necessary for the sale of a Product.

 

1.59.                    Regulatory Documentation” means all applications, registrations, licenses, authorisations and approvals, all correspondence submitted to or received from Governmental Authorities (including minutes and official contact reports relating to any communications with any Governmental Authority) and all supporting documents and all clinical studies and tests, in each case relating to any Products, and all data contained in any of the foregoing, including all investigational new drug applications, Regulatory Approvals, regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

 

1.60.                    Research Activities” means all those tests, studies and other activities described in the Research Plan, as such plan may be amended in accordance with Section 2.4 .

 

1.61.                    Research Documentation” means any and all documents, records, accounts, notes, reports and other data documenting Research Activities, whether in written, electronic, video or other form.

 

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1.62.                    Research Plan” means a detailed research plan, describing the Research Activities to be performed, timelines to be adhered to and setting out in more detail the roles and responsibilities of each Party in connection with the Research Program, as may be amended pursuant to Section 2.4. The Research Plan shall include the activities outlined in Schedule 1. The Research Plan shall contain success criteria to be achieved and Deliverables to be provided for each Phase.

 

1.63.                    Research Program” means the collective set of Research Activities to be conducted by the Parties in accordance with the Research Plan.

 

1.64.                    Results” means any ideas, inventions, discoveries, know-how, data, documentation, reports, materials, work product, writings, designs, computer software, processes, principles, methods, techniques and other information, recorded in any form, that are identified, invented, discovered, conceived or reduced to practice in the conduct of the Research Program.

 

1.65.                    Sublicenses” shall mean the sublicenses executed between the Parties and in the agreed form set out in Schedules 2 and 3.

 

1.66.                    Sublicensed IP” means the Intellectual Property Rights sub-licensed to Adaptimmune under the Sublicenses.

 

1.67.                    TCR” means T-cell receptor.

 

1.68.                    Term” has the meaning set forth in Section 15.1.

 

1.69.                    Third Party” means any Person not including any of Universal or Adaptimmune or any of their respective Affiliates.

 

1.70.                    Third Party Claim” has the meaning set forth in Section 14.1.

 

1.71.                    Trademark” means any word, name, symbol, colour, designation or device or any combination thereof for use in the course of trade, including any domain name, trademark, trade dress, brand mark, trade name, brand name, logo or business symbol used by Adaptimmune and/or its Affiliates in connection with the Products.

 

1.72.                    Universal IP” shall mean the Universal Know-How and Universal Patent(s).

 

1.73.                    Universal Know-How” means all Information owned or Controlled by Universal at the Effective Date or during the term of this Agreement which may be necessary and/or useful for either (a) performance of the Research Program; or (b) use of any Work Product resulting from the Research Program.

 

1.74.                    Universal Material” means Materials provided by Universal to Adaptimmune for use in the performance of the Research Program.

 

1.75.                    Universal Patent(s)” means any Patents or other Intellectual Property Rights owned or Controlled by Universal at the Effective Date or during the term of this Agreement which may be necessary and/or useful for either (a) performance of the Research Program; or (b) use of any Results resulting from the Research Program. The Universal

 

9



 

Patents shall include those patents and patent applications listed in Schedule 4 (“Universal Pre-existing Patents”).

 

1.76.                    Universal Technology” means Universal’s rights to Gene Editing Technology and HLA Engineering Technology existing prior to the Effective Date or first conceived or first generated or first reduced to practice outside of the performance of the Research Program together with any improvements or developments to such technology made by Universal in the course of the Research Program, in each case which is used or incorporated in the Research Program (including any process used for manufacture or development of any work product).

 

1.77.                    Valid Claim” means a claim of an issued and unexpired patent or patent application within the Universal Patents or Universal Know-How (including any Arising IP solely owned by Universal but excluding other Arising IP) to the extent that such claim in any patent or patent application has not lapsed, been withdrawn or been disclaimed, denied or admitted to be invalid in any court of competent jurisdiction or patent office in a non-appealable judgment or otherwise rendered invalid or unenforceable through reissue, disclaimer or otherwise or otherwise been cancelled or abandoned or dedicated to the public.

 

2.                                     Research Program

 

2.1.                           Research Plan. The Parties shall agree the Research Activities for each Phase of the Research Plan as outlined in Schedule 1.  Within a period of sixty (60) days from the Effective Date, the JSC shall approve Phase 1 of the Research Plan. The parties shall collaborate in good faith to facilitate such approval. Remaining Phases of the Research Plan shall be agreed in writing between the parties and approved by the JSC within forty-five (45) days of Adaptimmune confirming in writing that either (a) the requirements for completion of the preceding Phase have been successfully met and Adaptimmune wishes to proceed to the next Phase; or (b) where the requirements for completion of any Phase have not successfully been met that it wishes to continue to the next Phase of the Research Plan.  Adaptimmune shall provide written notice of its decision in relation to whether or not to start the next Phase of the Research Plan within (a) thirty (30) days following completion of the prior Phase where no characterisation or testing is required by Adaptimmune under the agreed delivery criteria; or (b) where any delivery criteria agreed for any deliverable require characterisation of such deliverable by Adaptimmune or performance of testing on any such deliverable, as soon as reasonably possible and in any event within ninety (90) days following completion of the prior Phase.  If Adaptimmune notifies Universal that Adaptimmune does not wish to proceed to the next Phase, then either party may serve thirty (30) days written notice of termination and unless the parties agree otherwise such termination shall occur at the end of the relevant thirty (30) day notice period.

 

2.2.                           Research Activities. Adaptimmune and Universal shall collaboratively conduct the Research Activities in accordance with the Research Plan. Notwithstanding the foregoing, each Party shall be responsible for performance of any Research Activities allocated to it under the Research Plan.

 

2.3.                           Time for performance. Both Parties shall use commercially reasonable efforts to perform their Research Activities in accordance with any timescales set out in the

 

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Research Plan. In addition Universal shall use commercially reasonable efforts to facilitate timely completion or performance of Research Activities where subcontracted to Third Parties and shall not prioritise the resourcing of other programs of work or research at Universal over the performance of the Research Program. Where any Research Activities are specified to be performed by Universal in the Research Plan and Universal is either unable to perform such Research Activities or alternatively is delayed in the start of performance of such Research Activities by over ninety (90) days, in addition to any other remedies available to it, Adaptimmune may ***

 

 

                                                                                                                                                             .  If, after any such inability to perform, Universal is able to perform, then Universal shall have the right to resume carrying out such Research Activities save to the extent such Research Activities ***

 

 

                                            .

 

2.4.                           Research Plan amendments. The JSC shall review, revise as necessary and approve the initial Research Plan within forty five (45) days after the Effective Date. The Research Plan may only be amended through the JSC.

 

2.5.                           Conduct of Research Activities.  Each Party shall diligently perform or cause to be performed its Research Activities in good scientific manner and in compliance in all material respects with all Applicable Laws, including good laboratory practice and good clinical practices to the extent applicable.

 

2.6.                           Laboratory Notebooks.  Universal shall use all reasonable endeavours to procure that its employees and any of its Third Party subcontractors shall keep and securely retain laboratory notebooks recording all Results. Such laboratory notebooks should reflect the chronological events and be witnessed. No attempt shall be made to falsify, amend or otherwise change notebooks that would in any way distort or change such record.  Universal shall make all relevant pages of laboratory notebooks available at reasonable times upon reasonable notice for review, analysis and use by or on behalf of Adaptimmune during the performance of the Research Program and for a period of 6 years after expiry or completion of the Research Program or earlier termination of this Agreement. If Adaptimmune requires access to the whole laboratory notebooks for any reason, including in relation to litigation, then Universal shall make such notebooks available and the Parties will agree reasonable steps to preserve the confidentiality of their contents and in particular in respect of any records or laboratory notebooks created prior to the Effective Date, preservation of any confidential information owned or Controlled by any Third Party.

 

2.7.                           Research Results.  During the Term, Universal shall promptly provide Adaptimmune with a copy of any Results and all raw data and other information that it has obtained in the conduct of the Research Program, in sufficient written detail to permit Adaptimmune to analyze such Results and employ them in its own Research Activities, for Exploitation of any Product or associated research, development and clinical programs. Adaptimmune will also share the Results it obtains during the conduct of the Research Program as required for the performance of the Research Program and

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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otherwise by providing a project summary of its Research Activities to JSC meetings and Universal may request reasonable further clarification on the Results described in such project summary. Adaptimmune will own all Results excluding any Arising IP in such Results which shall be owned by the Parties in accordance with the provisions of Section 7 below; provided that Universal shall have the right to use and disclose the Results as subject to Section 11 below. In addition, in the event of the commencement of a bankruptcy proceeding by or against Universal under the U.S. Bankruptcy Code, and in the event this Agreement is rejected by or on behalf of Universal in such proceeding, notwithstanding the provisions of this Section and in addition to the provision of Section 15.7 below, Adaptimmune shall have the right, at its expense, to a complete duplicate of (or complete access to, as appropriate) all Results and Laboratory Notebooks in Universal’s control reasonably necessary or useful for Adaptimmune to comply with its obligations under Applicable Law (including filing obligations in relation to any regulatory approvals required for any Product) to the extent not already in Adaptimmune’s possession.

 

2.8.                           Electronic records. The Parties will share and provide access to Results and where practicable Deliverables through the use of a secure electronic system or facility. Adaptimmune shall be responsible for the set-up and maintenance of such system. The Parties will provide the Results and Deliverables in a format suitable for uploading into the relevant electronic system or facility. Universal will maintain any passwords or passcodes provided by Adaptimmune to facilitate access to electronic facility as Confidential Information of Adaptimmune and shall not provide such passwords or passcodes to Third Parties or to employees who do not require access to the electronic facility for the purposes of the performance of the Research Program.

 

2.9.                           Commercialisation Responsibilities. Adaptimmune shall be solely responsible for:

 

2.9.1                              Following completion of the Research Program, the further development of Products and clinical trials in respect of them; and

 

2.9.2                              formulating regulatory strategy and for preparing, filing, obtaining and maintaining Regulatory Documentation, and all Regulatory Approvals including, where applicable: (a) pricing or reimbursement approvals; (b) pre- and post-approval marketing authorisations (including any prerequisite manufacturing approval or authorisation related thereto); (c) labelling approvals; and (d) technical, medical and scientific licenses for Products.  Adaptimmune shall be the holder of all Regulatory Approvals for Products and shall have responsibility for interactions with Governmental Authorities with respect to Products.

 

2.10.                    Debarment.  Universal agrees to inform Adaptimmune in writing immediately if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the United States Federal Food, Drug and Cosmetic Act, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to Universal’s or its Affiliates’ knowledge, is threatened, relating to the debarment or conviction of Universal or any Person performing services hereunder on behalf of Universal.

 

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2.11.                    Subcontracting. Universal will not subcontract any performance of its Research Activities or the Research Program to any Third Parties (including Third Party manufacturers, suppliers or research institutions) without the prior written consent of Adaptimmune, which consent shall not be unreasonably withheld, conditioned or delayed.  Adaptimmune may require such Third Parties to agree specific terms relevant to such subcontracting prior to such subcontractor being approved by Adaptimmune. In particular, no facilities, resources or employees of ***                                          or any other state funded organisation or Institution (“together “State Resources”) will be used in the performance of any Research Activities without the explicit prior written consent of Adaptimmune, except with respect to any fee-based services provided by the ***                             that are identified in the Research Plan and agreed to by Adaptimmune.  Universal confirms and represents that any use of fee-based services from the ***                                                          in the performance of the Research Plan do not require the assignment or licensing of any Intellectual Property Rights first conceived in the performance of the Research Plan to the ***                                                             . Where such State Resources are agreed by Adaptimmune to be used, Adaptimmune reserves the right to negotiate any required agreement for the use of such State Resources directly with the relevant Third Party. Universal and Adaptimmune will cooperate and work together to agree any subcontracting terms with Third Parties, to the extent requested by Adaptimmune.

 

2.12.                    Third Party provision of Materials or Information. Where any part of the Research Program by Universal requires Universal to provide or facilitate access to any Third Party Information or Third Party Materials (including cell lines or cell materials or manufacturing services), such Third Parties shall be specified in the Research Plan and Adaptimmune shall be entitled, at its request, to be involved in discussions and negotiations with such Third Party. Any contractual obligations with such Third Party will be pre-approved by Adaptimmune and at Adaptimmune’s request, Adaptimmune may take over the negotiation of such relationship with Third Party. Where Adaptimmune does take over such negotiations, Universal approval (such approval not to be unreasonably withheld) shall be required for any term or provision which would require Universal to perform any obligation or make any payment to such Third Party or otherwise incur any liability.

 

3.                                     Management of Research Program

 

3.1.                           Formation of Joint Steering Committee. The Parties shall establish a “Joint Steering Committee” or “JSC” (the “JSC”) to oversee the Research Program.  Each Party shall initially appoint three (3) representatives of such Party or its Affiliates to the JSC. The JSC may change its size from time to time by mutual consent of its members, provided that the JSC shall consist at all times of an equal number of representatives of each of Universal and Adaptimmune. Each Party may replace its JSC representatives at any time upon written notice to the other Party or may delegate performance to an alternative representative by written notice to the other Party where any representative cannot attend meetings or is unable to vote.  The JSC may invite non-members (including consultants and advisors of a Party who are under an obligation of confidentiality consistent with this Agreement), but with a maximum of three (3) per Party, to participate in the discussions and meetings of the JSC, provided that such participants shall have no voting authority at the JSC.  The JSC shall have a chairperson

 


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who shall be selected by Adaptimmune.  The role of the chairperson shall be to convene and preside at meetings of the JSC, to prepare and circulate agendas and to ensure the preparation of minutes, but shall have no additional powers or rights beyond those held by the other JSC representatives. Attendance of representatives of a Party at meetings (including any associated travel or accommodation costs) of the JSC shall be at the cost and expense of the relevant Party.

 

3.2.                           Meetings. The JSC shall meet every three calendar months during performance of the Research Program unless the Parties mutually agree in writing to a different frequency for such meetings or as reasonably necessary.  Meetings may be held in person or by telephone as agreed by the JSC. The JSC shall cease following completion of the Research Program.

 

3.3.                           Specific Responsibilities of the JSC.  The JSC shall be responsible for overseeing the activities of the Parties under the Research Program. In addition to its general responsibilities, the JSC shall in particular, without limitations:

 

(i)                                   approve the Research Plan;

 

(ii)                                oversee the implementation of the Research Plan;

 

(iii)                             oversee the conduct of research according to the Research Plan;

 

(iv)                            decide on discontinuation of studies in the Research Plan;

 

(v)                               decide on possible additional studies in the Research Plan;

 

(vi)                            decide on possible amendment of scope of the Research Plan;

 

(vii)                        resolve possible non-scientific issues (e.g. logistics and financial) directly relating to the Research Plan;

 

(viii)                     facilitate the flow of Information between the Parties in relation to the Research Plan; and

 

(ix)                           perform such additional functions in relation to the Research Program as the Parties may jointly agree from time to time.

 

The JSC shall not have any authority to amend the terms of this Agreement or to amend the level of any Development Milestone or Product Milestone or to expand the Research Plan beyond the Field.

 

3.4.                           Decision-Making of JSC. The JSC shall act by consensus.  The representatives from each of (a) Universal and (b) Adaptimmune, will have, collectively, one (1) vote.  If the JSC cannot reach consensus on an issue that comes before the JSC, then the Parties shall refer such matter to the CEO of Adaptimmune and the CEO of Universal (collectively, “the Senior Officers”). The Senior Officers shall use reasonable efforts to resolve such issue within thirty (30) days of the issue being referred to them. In the event that the Senior Officers cannot reach agreement, Adaptimmune shall have the casting vote to resolve such issue save where such issue would result in any of the following: (a) an increase in capital commitment for Universal which is not reimbursed by Adaptimmune; or (b) a material increase in resource commitment or financial commitment by Universal which is not reimbursed by Adaptimmune.  Adaptimmune shall not use its decision-making authority to unreasonably increase the scope of the Research Plan.  Notwithstanding the foregoing, if there is a dispute as to whether a

 

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particular Phase of the Research Plan has been achieved (including without limitation for purposes of a Development Milestone being due), then Adaptimmune will not have the decision-making right and the Parties shall submit the dispute to an independent, neutral expert (mutually agreed in good faith) with biopharmaceutical expertise to determine whether the Phase or Development Milestone has been achieved.  The Parties shall be bound by any such expert determination in the absence of manifest fraud and the non-prevailing Party shall pay the reasonable costs of such expert.

 

3.5.                           Project Committee. Day to day management of the Research Plan shall be carried out by a project committee comprised of at least one (1) project manager from each party. The Project Committee is a non-voting committee intended to facilitate collaboration between the parties and to manage performance of the Research Plan as against timescales set out in the Research Plan. The Project Committee shall meet on a regular basis at least monthly or as often as necessary to ensure management of the Research Program.

 

3.6.                           Other Sub-committees. Other sub-committees may be set up by the Parties from time to time during the Term in order to facilitate any particular Research Activities. The composition and scope of such sub-committees will be agreed by the JSC.

 

4.                                     Reports and Audits relating to the Research Program

 

4.1.                           Recordkeeping.  Universal shall prepare and maintain complete, current, accurate, organized and legible records of all Research Documentation in a manner reasonably acceptable to Adaptimmune as necessary for patent and regulatory purposes and in full compliance with applicable UK and US law. All laboratory notebooks recording the Research Activities shall be dedicated to the Research Activities and not include any other research. Universal shall retain all Research Documentation and store such research Documentation securely for at least *** years from completion of such Research Documentation. Universal shall make all Research Documentation available at reasonable times upon reasonable notice for review by Adaptimmune, providing that such review shall be no more often than once per year. To the extent Adaptimmune requires access to the Research Documentation after termination of this Agreement in order to comply with its obligations under Applicable Law, such access right shall continue to apply after termination of this Agreement. In other cases the right of access shall cease on termination of this Agreement. Universal shall notify Adaptimmune prior to any destruction of any Research Documentation and afford Adaptimmune the opportunity to take over storage of such Research Documentation.

 

4.2.                           Audits. To the extent required for Adaptimmune to satisfy its obligations under Applicable Law, Adaptimmune may audit Universal, no more than once in any calendar year, for compliance with Applicable laws. Adaptimmune shall provide at least 20 Business Days’ notice of such requirement to audit. Universal will enable Adaptimmune or its designated Third Party inspector to carry out such audit including making all Research Documentation available, providing access to facilities used in the performance of the Research Program and providing access to relevant personnel in each case to the extent necessary for Adaptimmune to satisfy its obligations under Applicable Law. Universal will procure similar rights of access and audit from any Third Party sub-contractors it uses in the performance of the Research Program. To the extent Adaptimmune requires any audit after termination of this Agreement in order to

 


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comply with its obligations under Applicable Law, such audit right shall continue to apply after termination of this Agreement. In other cases the right of audit shall cease on termination of this Agreement.

 

4.3.                           Governmental Authority inspection. Universal will also permit any Governmental Authority to inspect its facilities and processes to the extent such Governmental Authority requires such inspection in relation to the performance of the Research Program or later supply and manufacture of Product by Adaptimmune. Universal will notify Adaptimmune if it receives any request for inspection by any Governmental Authority and provide Adaptimmune the opportunity to attend such inspection to the extent reasonable possible and in each case to the extent relevant to the Research Program or facilities used in the performance of the Research Program by Universal.

 

4.4.                           Non-conformance. Should any inspection (whether under Section 4.2 or 4.3) identify any non-conformance with Applicable Laws or other requirement, Universal shall promptly correct such non-conformance and shall keep Adaptimmune informed of the progress of such correction. Adaptimmune may carry out further inspections to assess the progress of such correction and to verify that any non-conformance has been corrected.

 

5.                                     Grant of Rights

 

5.1.                           Licence Grants to Adaptimmune.  Universal hereby grants to Adaptimmune an exclusive, sub-licenseable, worldwide right and licence in the Field, with the right to grant sublicences, under the Universal Patents (excluding the Sublicensed IP) and Universal Know-how to use, sell, supply, manufacture (including to have manufactured), import, research, develop (including to have developed) and distribute (through multiple distribution levels) the Products. For clarity, the foregoing license does not transfer any ownership of the Universal Patents, Universal Materials and Universal Know-how to Adaptimmune.

 

5.2.                           Diligence Obligations. Other than as provided under the Research Plan or explicitly otherwise provided in this Agreement, Adaptimmune shall be solely responsible for the Exploitation of the Products in its sole discretion. Adaptimmune shall use Commercially Reasonable Efforts to further develop and to seek Regulatory Approval and to commercialise at least one Product.  Save as explicitly provided in this Section, Universal acknowledges and agrees that nothing in this Section 5.2 is intended, or shall be construed, to require Adaptimmune to Exploit a specific Product providing that if Adaptimmune decides to discontinue the development of one Product in favour of another Product its obligations under Section 5.2 shall cease with respect to such discontinued Product in favour of such other Product.  Save as provided in Section 5.2, Adaptimmune shall have no other obligation, express or implied, to Exploit the Products.  Notwithstanding the foregoing, if Adaptimmune (a) makes any decision to cease working on the development or Exploitation of any Product; or (b) has no good faith intent to further develop or Exploit any Product and ceases actively working on the development or Exploitation of any Product for a period of ***  (***) consecutive ***, then upon written notice Universal shall have the right to terminate this Agreement.

 

5.3.                           Limitation on Adaptimmune diligence obligations. Universal acknowledges that Adaptimmune is in the business of developing, manufacturing and selling

 


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pharmaceutical products and nothing in this Agreement shall be construed as restricting such business or imposing on Adaptimmune a duty to market and/or sell and exploit the Products to the exclusion of, or in preference to, any other product or process, or in any way other than in accordance with its normal commercial practices and those of its Affiliates.

 

5.4.                           Sublicences. Adaptimmune and Universal agree to enter in to the Sublicenses, approved versions of which are attached in Schedules 2 and 3. Both Parties shall execute such Sublicenses on the Effective Date.

 

5.5.                           Licence Grant to Universal. Adaptimmune grants to Universal a non-exclusive, non-transferable licence in the Field, without the right to grant sublicenses, under its Intellectual Property Rights to the extent necessary for Universal to perform its obligations under the Research Program. The licence granted under this clause will terminate on completion of all Research Activities delegated to Universal under the Research Plan.

 

6.                                     Consideration

 

6.1.                           Effective Date Payment.  In partial consideration of the licenses and other rights granted by Universal to Adaptimmune herein and subject to the terms and conditions of this Agreement, Adaptimmune shall pay the sum of two and a half million US Dollars (US$2,500,000) to Universal within ten (10) Business Days of the Effective Date subject to receipt of an invoice from Universal.

 

6.2.                           Development Milestones. On achievement of the milestones set out below (“Development Milestones”), Adaptimmune shall pay the following payments to Universal, whether such milestones are first achieved by Universal or Adaptimmune:

 

(1) Approval of Phase 1 of the Research Plan by the JSC and completion of first project committee meeting:

 

US$3,000,000

 

 

 

(2) ***

 

US$***

:

 

 

 

 

 

(3) ***

 

 

:

 

US$***

 

 

 

(4) ***

 

US$***

 


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(5) ***

 

 

 

 

 

.

 

US$***

 

 

 

(6) ***

 

US$***

 

 

 

(7) ***

 

US$***

 

If any of the Development Milestones require a decision by the JSC or Adaptimmune, the JSC or Adaptimmune (as applicable) shall provide their decision within either (a) where any delivery criteria agreed for any deliverable require characterisation of such deliverable by Adaptimmune or performance of testing on any such deliverable, as soon as reasonably possible and in any event within ninety (90) days following applicable event first coming up for consideration; or (b) where no characterisation or testing is required, thirty (30) days after the applicable event first comes up for consideration.  If the JSC or Adaptimmune (as applicable) does not decide to move to the next Phase or does not provide its approval or acceptance, then upon Universal providing thirty (30) days written notice and unless there is mutual agreement by the Parties otherwise this Agreement shall terminate.  For the purposes of interpreting the Development Milestones above: “***              

 

 

 

                                                                                                                  .

 

6.3.                           Modifications to Development Milestones. The Parties accept that the above milestones are based on the Research Program as outlined in Schedule 1 and reflect reimbursement of the anticipated development expenses undertaken by Universal.  Where the scope of such Research Program materially changes or requires Universal to take on a materially higher resource or financial burden, the Parties shall negotiate adjustment to the above Development Milestones in good faith to reflect such increased scope, resource or financial burden.

 


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6.4.                           Adjustments to Development Milestones. Where any Research Activities are specified to be performed by Universal in the Research Plan and Universal is unable to perform such Research Activities or alternatively is delayed in the start of performance of such Research Activities and in accordance with Section 2.3 Adaptimmune takes over the performance of such Research Activities or appoints a Third Party to carry out such Research Activities, the Development Milestone will be reduced on a pro-rated basis to reflect the reduction in work activities being conducted by Universal. Where a Third Party is used by Adaptimmune to perform such Research Activities the reduction shall additionally cover the costs of such Third Party performing the Research Activities where greater than the pro-rated reduction in level of Development Milestone.  Where no activities are performed by Universal under a Development Milestone as a result of an inability to perform by Universal, no Development Milestone shall become due and owing on achievement of such milestone by Adaptimmune.

 

6.5.                           Product Milestones.  Adaptimmune shall pay the following product milestone payments on the first Product to achieve each of the following milestones (“Product Milestones”):

 

(1) ***

 

 

.

 

US$***

 

 

 

(2) ***

 

 

 

:

 

US$***

 

 

 

(3) ***

 

 

:

 

US$***

 

In this Section: (a) a “Pre-Existing Adaptimmune Product” shall mean a Product which comprises a sequence for a TCR and in relation to which Adaptimmune has previously received Regulatory Approval for a product comprising the same TCR sequence or a non-material variant of such TCR sequence; (b) a “New Adaptimmune Product” shall mean a Product comprising a sequence for a TCR and in relation to which Adaptimmune has not previously received Regulatory Approval or filed an IND (or foreign equivalent) for a product comprising the same TCR sequence or a non-material variant of such TCR sequence.

 

6.6.                           Notice.  Adaptimmune shall give Universal written notice within twenty (20) Business Days of the first achievement of each milestone event set forth in Sections 6.2 (to the extent Universal is not already aware of achievement) and 6.5 above.  After receiving such written notice, Universal shall submit an invoice to Adaptimmune for the amount

 


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of such milestone payment, and Adaptimmune will pay Universal the applicable milestone payment within thirty (30) days after receipt of an invoice from Universal.

 

6.7.                           One-Time Payments.  Each individual milestone payment (whether a Development Milestone or Product Milestone) is payable one time only regardless of the number of Products developed and/or commercialized and regardless of the number of times any of the applicable events occurs with respect to any Product.  Where any milestone event is not achieved the relevant Product Milestone or Development Milestone shall not be due and owing.

 

6.8.                           No Additional Milestones.  In addition and for the avoidance of doubt, Adaptimmune will not be obligated to make any other payments in respect of the above milestone events to Universal and/or Third Parties.

 

6.9.                           Profit Share. Following expiry of the first ***    (***) *** period after First Commercial Sale of the First Multi-Indication Product by Adaptimmune its Affiliate or sublicensee, Adaptimmune will calculate the profit share due to Universal in relation to the commercialisation of such First Multi-Indication Product. The profit share for such ***      (***) ***  period, and each consecutive ***       (***) ***  period (each a “Profit Share ***”) until expiration of the last Valid Claim, shall be calculated as follows:

 

***

 

***

 

***

 

The New Mean Average Cost of Supply shall be the ***                                        over the ***                         of sale for the ***                                                      sold by Adaptimmune or its Affiliate or sublicensee, the first month starting on date of First Commercial Sale of such Product.

 

The Old Mean Average Cost of Supply shall be the ***                                                for the product sold by Adaptimmune or its Affiliate or sublicensee ***                                                                                                                         as used in the ***                                                          as calculated using the ***                  immediately preceding date of First Commercial Sale of the First Multi-Indication Product. ***

 

 

.

 

The Profit share due and payable shall be calculated in US dollars. Where any calculation of Mean Average Cost of Supply requires conversion from a currency other than US dollars, Adaptimmune shall carry out such conversion using Adaptimmune’s customary and standard internal exchange rates. Where the Old Mean Average Cost of

 


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Supply is lower than the New Mean Average Cost of Supply, no profit share shall be payable.

 

If the Profit Share Amount is negative, then the First Multi-Indication Product shall be subject to the royalty under Section 6.12 and no further Profit Share shall be payable or owing from Adaptimmune.

 

6.10.                    Valid Patent limitation. The profit share payable in accordance with Section 6.9 above shall only be payable on Products which are Covered by a Valid Claim. Once the last Valid Claim to Cover the First Multi-Indication Product expires, any obligation to pay the profit share in relation to such Product shall cease.  Except as set forth in the last paragraph of Section 6.9, for clarity no royalty shall be payable on the sale of a First Multi-Indication Product.

 

6.11.                    Profit Share report.  Adaptimmune will deliver to Universal a report detailing the profit share due to Universal and calculated in accordance with Section 6.9 within sixty (60) calendar days of the expiry of each Profit Share *** . Adaptimmune will pay the relevant profit share to Universal following receipt of invoice from Universal and within 30 days of receipt of such invoice.

 

6.12.                    Royalties. In addition to the profit share payable under Section 6.9, on a country by country and Product by Product basis and for all Products other than the First Multi-Indication Product (unless subject to a royalty pursuant to the last paragraph of Section 6.9), Adaptimmune shall pay to Universal a royalty of *** % of Net Sales. Adaptimmune’s obligation to pay royalty with respect to any Product shall commence upon the First Commercial Sale of a Product in a country and shall expire on the earlier of (i) the expiration of the last Valid Claim to Cover such Product; and (ii) the date that is *** (***) years from the First Commercial Sale of such Product in a country (“Royalty Term”). On expiration of the Royalty Term in relation to any Product, no further royalties shall be due or payable in relation to the sale of such Product.

 

6.13.                    Currency Conversion for Net Sales. With respect to sales of Product in US dollars, the Net Sales shall be expressed in US dollars. With respect to sales of Products in a currency other than US dollars, the Net Sales shall be reported in US dollars and converted using Adaptimmune’s customary and standard internal exchange rates. The basis of any conversion shall be specified in the relevant Royalty Report.

 

6.14.                    Royalty Reports. Following First Commercial Sale of a Product other than the First Multi-Indication Product, Adaptimmune shall provide a report to Universal within sixty (60) days of each calendar quarter (“Royalty Report”), the first such report being due within sixty (60) days after expiry of the calendar quarter in which the First Commercial Sale of a Product (excluding the First Multi-Indication Product unless subject to a royalty pursuant to the last paragraph of Section 6.9) is made. The Royalty Report shall include (a) the total Net Sales for each Product worldwide; and (b) calculation of the royalty due to Universal under Section 6.12 above. On receipt of such Royalty Report, Universal will provide an invoice for the royalty and Adaptimmune shall pay such royalty within 30 days of receipt of invoice.

 


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6.15.                    Interest. Payments which are not made when due may bear interest as of the due date until the date the amount is effectively received on the account of Universal, at a rate of EURIBOR (12 months) plus ***% calculated on a weekly basis for every week that the payment is due but unpaid. Universal shall notify Adaptimmune prior to making any interest charge on any overdue payment, providing at least 5 Business Days prior notice.

 

6.16.                    Mode of Payment.  All payments set forth in this Section 6 shall be remitted by wire transfer to the following bank account of Universal or such other account as Universal may designate in writing to Adaptimmune:

 

ACCOUNT HOLDER —  Universal Cells, Inc

 

BANK ACCOUNT NUMBER: ***

 

BANK DETAILS: ***

 

SWIFT CODE: ***

 

ABA Routing code: ***

 

6.17.                    Currency.  All payments required under this Section 6 shall be made in U.S. Dollars.

 

6.18.                    Taxes.

 

6.18.1                                General. Universal alone shall be responsible for paying any and all taxes (other than withholding taxes required by Applicable Law to be paid by Adaptimmune) levied on account of, or measured in whole or in part by reference to, any Payments it receives.  Adaptimmune shall deduct or withhold from the Payments any taxes that it is required by Applicable Law to deduct or withhold and shall reasonably assist Universal in obtaining any such deductions.

 

6.18.2                                Indirect Taxes.  All amounts payable by Adaptimmune under this Agreement are stated exclusive of any Indirect Taxes, which Universal may be obliged to charge.  If any Indirect Taxes are chargeable in respect of any Payments, Adaptimmune shall pay such Indirect Taxes at the applicable rate in respect of such Payments following receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by Universal in respect of those Payments.  The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes.  If such amounts of Indirect Taxes are refunded by the applicable Governmental Authority or other fiscal authority to Universal subsequent to payment, the Party receiving such refund will transfer such amount to the paying Party within sixty (60) days of receipt. The Parties agree to reasonably cooperate to provide any information required by the Party pursuing a refund of Indirect Taxes paid.

 


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6.19.                    Operating Licences. Each Party is solely responsible for payment required under any operating licences or permits including any required to perform its Research Activities in accordance with Applicable Laws.

 

6.20.                    Records. Adaptimmune shall keep and maintain records of its sales of Products in sufficient detail to enable Universal to verify the accuracy of Payments due from Adaptimmune and pursuant to an inspection under Section 6.21. Adaptimmune shall keep such records for a period of five (5) years from the end of the calendar year in which the relevant Product sales were made.

 

6.21.                    Inspections. Universal shall be entitled to appoint an independent third party qualified accountant or a person possessing similar professional status and associated with an independent accounting firm acceptable to the Parties to verify the level of Net Sales accounted for by Adaptimmune in accordance with Section 6.12 and the basis for the calculation of profit share in accordance with Section 6.9.  Adaptimmune shall make its records available as set forth in this Section.  The accounting firm shall enter into appropriate obligations with Adaptimmune to treat all information it receives during its inspection in confidence.  Such audit right shall apply no more than once in any calendar year and shall only relate to the previous three (3) calendar year’s records (to the extent not previously audited by Universal). The independent third party shall only be entitled to report to Universal as to whether or not the Net Sales of any Product or the calculation of Profit Share are materially accurate. Where any inspection identifies any shortfall in the Payments required to Universal, Adaptimmune shall make up such shortfall within 30 days of receiving notice of such shortfall. Where any inspection identifies an overpayment in the Payments required to Universal, Adaptimmune shall be entitled to deduct the amount of such overpayment from the next Payment or Payments made to Universal. Universal shall pay the cost of any inspection unless such inspection identifies a shortfall in payments in the preceding calendar year in excess of five (5) percent in which case Adaptimmune shall pay the reasonable costs of the Third Party carrying out such inspection.

 

6.22.                    Investment. In addition to the above Payments, Universal shall provide Adaptimmune with the right to participate in the next two (2) Qualified Equity Investment Events that occur after the date hereof, on the following terms:

 

6.22.1              If Universal proposes to conduct a Qualified Equity Investment Event, then it will provide Adaptimmune with as much notice as reasonably possible and in any event at least twenty (20) Business Days prior written notice of the estimated initial closing of such Qualified Equity Investment Event (a “Financing Notice”), which Financing Notice will also describe the principal terms of the Qualified Equity Investment Event.

 

6.22.2                    If Adaptimmune wishes to participate in such Qualified Equity Investment Event, it must notify Universal within ten Business Days after delivery of the Financing Notice, in which case:

 

6.22.2.1.                                                 Universal will allow Adaptimmune to participate in the initial closing of the Qualified Equity Investment Event;

 

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6.22.2.2.                                                 Universal will permit Adaptimmune to review the initial closing, such stock purchase agreement, investors’ rights agreement, co-sale agreement, voting agreement and/or other agreements as are entered into by the investors in the Qualified Equity Investment Event generally (“Investment Documents”) and both Universal and Adaptimmune will negotiate in good faith and on a timely basis any changes required by Adaptimmune to such Investment Documents; and

 

6.22.2.3.                                                 Adaptimmune will execute and deliver to Universal at the initial closing, theagreed Investment Documents.

 

Qualified Equity Investment Events” means a transaction or series of related transactions, conducted primarily for the purpose of raising additional working capital, in which Universal sells shares of its preferred stock to new or existing investors, other than to a Universal licensee or collaborator in connection with the grant of a license or entering into a collaboration.

 

Adaptimmune’s rights and Universal’s obligations under this Section 6.22 shall terminate on the earliest to occur of (a) the initial closing of the second Qualified Equity Investment Event occurring after the date of this Agreement, (ii) a Change of Control of Universal, or (iii) an initial public offering of Universal’s common stock pursuant to a registration statement under the Securities Act of 1933, as amended.

 

Adaptimmune’s agreement to participate in any such financing or investment shall be entirely at its discretion. The exact level of any contribution or financing shall be agreed as part of any financing round.

 

7.                                     Ownership of Intellectual Property

 

7.1.                           Background Intellectual Property. Nothing in this Agreement will affect the ownership of any Intellectual Property Rights and Patents Controlled by either Party prior to the Effective Date of this Agreement or arising outside of the performance of this Agreement or the Research Program.

 

7.2.                           Ownership of Arising IP. Any Intellectual Property Rights arising from the performance of the Research Program shall be owned as follows:

 

7.2.1                                       All Arising IP which relates solely to the differentiation of T-cells or to any process relating to such differentiation or which is specific to the Field shall be solely owned by Adaptimmune.

 

7.2.2                                       All Arising IP which is solely created or reduced to practice by Adaptimmune employees or employees of its Affiliates or by Third Parties on behalf of Adaptimmune or its Affiliates shall be solely owned by Adaptimmune.

 

7.2.3                                       Excluding any Arising IP which is owned by Adaptimmune in accordance with Clauses 7.2.1 and 7.2.2 above, any Arising IP which constitutes an improvement to or development of Gene Editing Technology or HLA Engineering Technology shall be solely owned by Universal.

 

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7.2.4                                       Any Arising IP other than that owned in accordance with Clauses 7.2.1 — 7.2.3 shall be jointly owned by Universal and Adaptimmune in equal undivided shares.

 

7.3.                           Assignment. At the request of Adaptimmune, Universal shall and shall procure that any of its employees, agents and contractors shall do all acts and things (including making declarations, oaths and providing assistance in relation to the supply of information for any patent applications) and execute all documents that may be reasonably necessary under the laws of any country for ensuring that all rights in Arising IP owned by Adaptimmune under Clause 7.2.1 above are assigned to Adaptimmune together with the right to sue for past infringement and to recover damages. At the request of the other Party, each Party shall and shall procure that any of its employees, agents and contractors shall do all acts and things (including making declarations, oaths and providing assistance in relation to the supply of information for any patent applications) and execute all documents that may be reasonably necessary under the laws of any country for ensuring that all rights in Arising IP co-owned by it under Clause 7.2.4 are vested in it in accordance with clause 7.2.4. Universal shall ensure that it has in place with all Third Party subcontractors agreements assigning or requiring the assignment of any Arising IP to Universal sufficient to vest title to Arising IP in the relevant Party in accordance with Section 7.2 above.  At the request of Universal, Adaptimmune shall and shall procure that any of its employees, agents and contractors shall do all acts and things (including making declarations, oaths and providing assistance in relation to the supply of information for any patent applications) and execute all documents that may be reasonably necessary under the laws of any country for ensuring that all rights in Arising IP owned by Universal under Clause 7.2.3 above are assigned to Universal together with the right to sue for past infringement and to recover damages. Adaptimmune shall ensure that it has in place with all Third Party subcontractors, agreements assigning or requiring the assignment of any Arising IP to Adaptimmune sufficient to vest title to Arising IP in the relevant Party in accordance with Section 7.2 above.

 

7.4.                           Jointly-owned IP.  To the extent that any Arising IP is jointly owned by the Parties under Clause 7.2.4, then save as provided under Section 7.1, both Parties shall be entitled to use such jointly owned Arising IP without restriction.  Neither Party shall be entitled to assign its interest in such jointly owned Arising IP without the consent of the other Party save that either Party shall be entitled to assign its interest to an Affiliate or to an assignee to this Agreement (in accordance with Section 17). Both Parties shall be entitled to sub-license their interest in such jointly owned Arising IP without the requirement of consent from the other Party and in each case subject to the licences granted under Section 7.1.

 

7.5.                           Sublicensed IP. The Sublicensed IP will be licensed to Adaptimmune in accordance with the terms of the Sublicenses. Universal agrees that it shall notify Adaptimmune prior to any amendments to the terms of the AAC/HLA-engineering Licence or the Elf Licence. Such notification shall include the detail of the amendment proposed. Universal shall not agree any amendment that would adversely affect Adaptimmune’s rights unless Adaptimmune provides its prior written consent to such amendment.

 

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8.                                     Prosecution and Maintenance of patents

 

8.1.                           Pre-existing Intellectual Property Rights. Nothing in this Agreement will affect the prosecution and maintenance of any Intellectual Property Rights and Patents Controlled by either Party prior to the Effective Date of this Agreement or arising outside of the performance of this Agreement or the Research Program unless explicitly otherwise provided.

 

8.2.                           Prosecution of Arising IP. Adaptimmune shall be entitled in its sole discretion to control and take decisions in relation to the filing, prosecution, maintenance and obtaining, (including carrying out any interferences, reissue proceedings and re-examinations), throughout the world of any patent application Covering any Arising IP solely or jointly owned by Adaptimmune and all Patents granted therefrom at its expense. Adaptimmune shall keep Universal reasonably informed through the JSC (to the extent still in existence or otherwise by notice in writing) of any filings of patent applications Covering any such Arising IP and the progress of such patent applications. Universal shall provide all necessary powers of attorney to Adaptimmune to allow Adaptimmune to carry out such prosecution and maintenance.  Universal shall be entitled in its sole discretion to control and take decisions in relation to the filing, prosecution, maintenance and obtaining, (including carrying out any interferences, reissue proceedings and re-examinations), throughout the world of any patent application Covering any Arising IP solely owned by Universal and all Patents granted therefrom at its expense.

 

8.3.                           Support. Universal shall provide reasonable support in relation to Adaptimmune’s prosecution and maintenance of any patent applications or Patents Covering the Arising IP solely or jointly owned by Adaptimmune, subject to reimbursement of out of pocket expenses that Universal necessarily incurs in providing such support.  Adaptimmune shall provide Universal with updates (at the JSC or on the occurrence of any material event in relation to any Patent) in relation to the progress of any patent application or Patent claiming any such Arising IP.

 

8.4.                           Election not to Prosecute.  If, Adaptimmune or Universal (each a “Prosecuting Party”) elects not to pursue or continue the filing, prosecution (including any interferences, reissue proceedings and re-examinations) or maintenance of any Patent Covering any Arising IP solely or jointly owned by Adaptimmune or Universal respectively in any Major Territory, the relevant Prosecuting Party shall so notify the other Party promptly in writing in sufficient time (usually 45 days but may be a shorter period depending on the notice given to Prosecuting Party by the relevant patent office) in advance to enable other Party to meet any deadlines by which an action must be taken to establish or preserve any such rights in such notified Patent.  Upon receipt of any such notice from Prosecuting Party and to the extent possible under any Third Party agreement existing as at the Effective Date, the non-Prosecuting Party shall have the right, but not the obligation, to pursue the filing or registration, or support the continued prosecution (but excluding any interferences, reissue proceedings and re-examinations) or maintenance, of such notified Patent, at its expense in such country. The non-Prosecuting Party will keep the Prosecuting Party reasonably informed with regard to the current status of any Patent for which non-Prosecuting Party takes over responsibility for under this Section

 

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8.4, including providing copies of any material correspondence with relevant patent offices.

 

8.5.                           CREATE Act.  Notwithstanding anything to the contrary in this Section 8 no Party shall have the right to make an election under the Cooperative Research and  Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the “CREATE Act”) when exercising its rights under this Section 8 without the prior written consent of the other Party. With respect to any such permitted election, the Parties shall use reasonable efforts to cooperate and coordinate their activities with respect to any submissions, filings or other activities in support thereof.  The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in the CREATE Act.

 

9.                                     Enforcement of Patents

 

9.1.                           Rights and Procedures. In the event that a Party is notified that a Third Party may be infringing any of the Arising IP, Universal Patents or Universal Know-How, such Party shall promptly notify the other Party in writing, identifying the alleged infringer (to the extent not in breach of any Third Party obligation of confidence) and the alleged infringement complained of and furnishing the information of which it has been notified.

 

(a)                                          In relation to any infringement or alleged infringement of any Universal IP and subject to Section 9.3, and where any alleged infringement occurs within the Field or relates to a Third Party which is in the process of development and/or Exploiting products or therapies within the Field, Adaptimmune may, in its sole discretion and in its own name but after notifying Universal, through counsel of its choosing, take any measures it deems appropriate to stop such infringing activities by such Third Party in any part of the Territory. Where Adaptimmune wishes to grant any Third Party a license under the Universal IP in the context of any infringement or alleged infringement of any Universal IP, Adaptimmune and Universal will use good faith efforts to agree the terms of such Third Party license, in each case to the extent permitted by any Third Party agreement. Any such license will require the prior written consent of Universal. Should Adaptimmune determine that it does not wish to enforce or to take any steps to enforce any Universal IP against a Third Party under this Clause 9.1(b) in any Major Territory, it shall notify Universal in writing ninety (90) days after first notice of the infringement. Universal shall then have the option to in its sole discretion and in its own name, through counsel of its choosing, take any measures it deems appropriate to stop such infringing activities in the relevant Major Territory by such Third Party, save that it shall have no right to grant any licenses under the Universal IP within the Field without Adaptimmune’s prior written consent.

 

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(b)                                          Save as provided in Clauses 9.1(a) and (b) above and subject to Section 9.3 below, in relation to any other infringement or alleged infringement of the Universal IP, Universal may, in its sole discretion and in its own name, through counsel of its choosing, take any measures it deems appropriate to stop such infringing activities by such Third Party in any part of the Territory or to grant to the infringing Third Party adequate rights and licenses necessary for continuing such activities. Any licences granted to any Third Party shall not restrict or conflict with the licences and rights granted to Adaptimmune under this Agreement.

 

(c)                                           Upon reasonable request by the enforcing Party and at the enforcing Party’s cost and expense, the other Party shall provide all reasonable information and assistance, including allowing access to files and documents and to personnel who may have possession of relevant information and, if necessary for prosecution of any legal action, joining in the legal action.

 

9.2.                           Recovery. Any amounts recovered by an enforcing Party pursuant to Sections 9.1(a) or (b) (expressly excluding subclause (c)), whether by settlement or judgment, shall be shared as follows:  the enforcing Party shall first reimburse its costs and expenses for the infringement action and retain ***           percent (***%) of the remainder and provide the non-enforcing Party with the remaining ***             percent (***%) of the remainder.

 

9.3.                           Enforcement of Sublicensed IP. Any enforcement of any Sublicensed IP shall be subject to the terms of the Sublicenses.

 

10.                              Potential Third Party Actions

 

10.1.                    Third Party Licenses.  If, in the opinion of Adaptimmune, the Exploitation of the Products by Adaptimmune, its Affiliates or any of their licensees infringes or misappropriates any Patent or any Intellectual Property Right of a Third Party in any country, then, Adaptimmune shall have the right, but not the obligation to negotiate and obtain a license from such Third Party as necessary for Adaptimmune and its Affiliates and licensees to Exploit the Products in such country.  Adaptimmune will be responsible for the performance of any license agreement it executes with such Third Party. Adaptimmune understands and accepts that it shall be responsible for negotiation of any agreements with Third Parties required for the commercial use of any Third Party cell lines or cell banks required for commercial manufacture and sale of Product (excluding any use for research and development or clinical trials).

 

10.2.                    Invalidity or Unenforceability Defences or Actions.

 

10.2.1                                In the event that a Third Party asserts, as a defence or as a counterclaim in any infringement action, that any Universal Patent (excluding any Arising IP) or any Arising IP solely owned by Universal is invalid or unenforceable, then Universal shall have the right, but not the obligation, through counsel of its choosing to respond to such defence or defend against such counterclaim (as applicable), including the right to settle or otherwise compromise such claim.

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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10.2.2                                Similarly, if a Third Party asserts, in a declaratory judgment action or similar action or claim filed by such Third Party, that any Patent within the Arising  IP solely or jointly owned by Adaptimmune is invalid or unenforceable, then Adaptimmune shall have the right, but not the obligation, through counsel of its choosing to defend against such action or claim.

 

10.3.                    Third Party Litigation.  In the event of any actual or threatened suit against Adaptimmune or Universal alleging that the Exploitation of Products by or on behalf of Adaptimmune under this Agreement infringes the Patent or Intellectual Property Rights of any Person (an “Infringement Suit”), the Party first becoming aware of such Infringement Suit shall promptly give written notice to the other Party.  In relation to any Products, Adaptimmune shall have the right, but not the obligation, through counsel of its choosing, to assume direction and control of the defence of claims arising therefrom (including the right to settle such claims in its sole discretion).

 

10.4.                    Cooperation.  Each Party will provide to the other Party all reasonable assistance requested by such Party in connection with any action, claim or suit under Section 10.2 or 10.3, including allowing such Party access to the other Party ‘s files and documents and to the other Party ‘s personnel who may have possession of relevant information. The requesting Party shall pay the other Party’s reasonable out of pocket expenses in relation thereto. In particular the other Party will promptly make available to the requesting Party, all information in its possession or control that it is aware will assist such Party in responding to any such action, claim or suit under Section 10.2 or 10.3.

 

11.                              Confidentiality and Non-Disclosure

 

11.1.                    Confidentiality.  At all times during the term of this Agreement and for a period of *** years following termination or expiration hereof, each Party (the “Receiving Party”) shall, and shall cause its officers, directors, employees, agents, Affiliates and sub-licensees to, keep confidential and not publish or otherwise disclose and not use, directly or indirectly, for any purpose, any Confidential Information of the other Party (the “Disclosing Party”), except to the extent such disclosure or use is otherwise expressly permitted or licensed by the terms of this Agreement.

 

11.2.                    Permitted Disclosures.  Each Party may disclose Confidential Information  to the extent that such disclosure is:

 

11.2.1                                made in response to a valid order of a court of competent jurisdiction or other competent authority; provided, however, that the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash any such order or obtain a protective order requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or authority or, if disclosed, be used only for the purpose for which the order was issued; and provided further that if such order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order shall be limited to that information that is legally required to be disclosed in response to such court or governmental order;

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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11.2.2                                made by Adaptimmune or its Affiliates or its licensees to a Governmental Authority as may be necessary or useful in connection with any filing, application or request for a Regulatory Approval and or pricing or reimbursement approval, pre- and post-approval marketing authorisations (including any prerequisite manufacturing approval or authorisation related thereto), labelling approval and technical, medical and scientific licenses; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available;

 

11.2.3                                made by a Party to a patent authority as may be necessary or useful for purposes of obtaining or enforcing a Patent (consistent with the terms and conditions of Section 8); provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available;

 

11.2.4                                otherwise required by Applicable Law or by stock exchange or other financial authority requirement;

 

11.2.5                                made by Adaptimmune or its Affiliates or its licensees to Third Parties as may be necessary or useful in connection with the Exploitation of Products, including subcontracting or sublicensing transactions in connection therewith and in each case subject to such Third Parties, where reasonably possible, agreeing confidentiality obligations substantially equivalent to those set out in this Agreement ; or

 

11.2.6                                made by Universal or its Affiliates to actual or prospective investors or acquirers to the extent necessary for the purposes of such investment or acquisition and provided that in each such case investors or acquirers are subject to written obligations of confidentiality substantially equivalent to those set out in this Agreement.

 

Notwithstanding the foregoing, in the event that Adaptimmune or any of its Affiliates is required by Applicable Law or the requirements of a national securities exchange or another similar regulatory body to disclose this Agreement, in whole or in part, the Parties shall reasonably agree on a redacted version of this Agreement as necessary to protect the Confidential Information of Universal prior to making such disclosure.

 

11.3.                    Exclusions.  Notwithstanding the foregoing, Confidential Information shall not include any information that:

 

11.3.1                                is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the Receiving Party;

 

11.3.2                                can be demonstrated by documentation or other competent proof to have been in the Receiving Party’s or its Affiliates’ possession prior to disclosure by the Disclosing Party;

 

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11.3.3                                is subsequently received by the Receiving Party or its Affiliates from a Third Party who is not bound by any obligation of confidentiality with respect to said information;

 

11.3.4                                is generally made available to Third Parties by the Disclosing Party without restriction on disclosure; or

 

11.3.5                                is independently developed by or for the Receiving Party or its Affiliates without reference to the Disclosing Party’s Confidential Information.

 

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party.  Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.

 

11.4.                    Results.                                             Universal and Adaptimmune shall each keep the Results confidential as if such Results were Confidential Information of the other Party, save:

 

11.4.1                                To the extent such disclosure is permitted for Confidential Information under Section 11.2 above;

 

11.4.2                                to the extent such Results need to be disclosed to Third Parties (i) in the case of Universal for the further development of the Universal Technology outside of the Field provided that if the Results to be disclosed would include information regarding the Field, then where reasonably possible subject to such Third Party agreeing to obligations of confidentiality substantially equivalent to those set out in this Agreement; and (ii) in the case of Adaptimmune for the further development and Exploitation of Products within the Field and where reasonably possible subject to such Third Party agreeing to obligations of confidentiality substantially equivalent to those set out in this Agreement;

 

11.4.3                                to the extent such Results are published under Section 11.5;

 

11.4.4                                to the extent the Results satisfy any of the exclusions under Section 11.3.

 

11.5.                    Publications and Presentations.  The Parties acknowledge that scientific publications must be strictly monitored to prevent any adverse effect from premature publication of results of the research and development activities hereunder.  Accordingly Universal shall not publish, present or otherwise disclose Confidential Information of Adaptimmune without the prior written consent of Adaptimmune which can be withheld in its absolute discretion.  Where either Party wishes to publish any Results (“Publishing Party”), it shall provide the other Party with prior written notice of such, where reasonably possible such notice being provided at least 30 days prior to any deadline for

 

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submission of such publication. The non-Publishing Party shall be entitled to review and comment on the publication and to request removal of any Results which it considers would (a) place it in breach or non-conformance with any Applicable Law or any requirement of any stock exchange rules or requirements; (b) would invalidate or prevent the filing of any patent application or the prosecution of any existing patent application; or (c) would materially affect its commercial interests, ongoing development programs or development of its products or programs.  The Publishing Party shall incorporate any reasonable comments made by the non-Publishing Party and shall remove any Results which non-Publishing Party requests removed pursuant to this Section. In relation to any Results which are specific to the Field or which relate to any clinical trial which Adaptimmune is controlling or sponsoring, Adaptimmune shall be entitled to decline the publication of any such Results in its sole discretion. In relation to any Results which do not relate to the Field, Universal shall be entitled to decline the publication of any Results in its sole discretion.

 

11.6.                    Use of Name.  Neither Party, nor its Affiliates shall mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of another Party or its Affiliates in any publication, press release, promotional material or other form of publicity without the prior written consent of such other Party.  The restrictions imposed by this Section 11.5 shall not prohibit a Party from making any disclosure identifying another Party that is required by Applicable Law or the requirements of a national securities exchange or another similar regulatory body, provided that any such disclosure shall be governed by this Section 11.  Further, the restrictions imposed on each Party under this Section 11.5 are not intended, and shall not be construed, to prohibit a Party from identifying the other Party in its internal business communications, provided that any Confidential Information in such communications remains subject to this Section 11.

 

11.7.                    Public Announcements. No public announcement concerning this Agreement, its subject matter or the transactions described herein shall be made, either directly or indirectly, by Adaptimmune or Universal or their respective Affiliates, except as may be legally required by Applicable Laws, regulations, judicial order, or required by stock exchange or quotation system rule without first obtaining the approval of the other Party and agreement upon the nature, text and timing of such announcement, which approval and agreement shall not be unreasonably withheld or delayed.  The Party desiring to make any such voluntary public announcement shall provide the other Party with a written copy of the proposed announcement in reasonably sufficient time prior to public release to allow such other Party to comment upon such announcement, prior to public release.  In the case of press releases or other public communications legally required, or required by stock exchange or quotation system rule, to be made, the Party making such press release or public announcement shall provide to the other Party a copy of the proposed press release or public announcement in written or electronic form upon such advance notice as is practicable under the circumstances for the purpose of allowing the notified Party to review and comment upon such press release or public announcement.  Under such circumstances, the releasing Party shall not be obligated to delay making any such press release or public communication beyond the time when the same is required to be made in order to facilitate review and comment by the receiving Party.

 

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12.                              Trademarks

 

12.1.                    Adaptimmune shall have the sole right to select the Trademarks for the marketing and sale of the Products; provided the Trademark is not a trade mark registered by Universal. Adaptimmune shall own such Trademarks and all Intellectual Property Rights and other rights and goodwill with respect thereto.  Universal shall not, and shall not permit its Affiliates to, use any trademark that is the same as or confusingly similar to, misleading or deceptive with respect to or that dilutes any registered Trademark.

 

13.                              Representations, Warranties and Covenants

 

13.1.                    Universal represents and warrants to Adaptimmune as at the Effective Date that:

 

13.1.1                                To its knowledge the University of Washington is the sole legal and beneficial owner of the Universal Pre-existing Patents and to its knowledge has obtained written assignments of all right, title and interest from the inventors named on the Universal Pre-existing Patents; ;

 

13.1.2                                It is the sole and beneficial owner of any Universal Materials (excluding any intellectual property rights) or alternatively that it has the unencumbered right to provide any Universal Materials for use in the Research Program and in each case save as explicitly otherwise communicated in writing to Adaptimmune;

 

13.1.3                                It will have in place binding legal agreements with all of its employees and sub-contractors which assign and require the assignment of any Arising IP created or reduced to practice by employees or consultants of Universal or sub-contractors acting on behalf of Universal, to Universal;

 

13.1.4                                To its knowledge, the performance of the Research Plan will not infringe any Patent or other Intellectual Property Right or proprietary right of any Person.

 

13.1.5                                It is not aware of any other individual who has made an inventive contribution to any of the inventions disclosed and claimed in the Universal Pre-Existing Patents other than those inventors named as inventors in the filing of such Universal Pre-Existing Patents.

 

13.1.6                                The conception, development and reduction to practice of the Universal  Know-How and Universal Patents has not, to Universal’s knowledge, constituted or involved the misappropriation of trade secrets or other rights or property of any Person.

 

13.1.7                                No claim or litigation has been brought or threatened as of the Effective Date by any Person alleging, and Universal is not aware of any possible claim, whether or not asserted, that Adaptimmune’s use the Universal Patents and Universal Know-How would violate, infringe or otherwise conflict or interfere with any intellectual property or proprietary right of any Person.

 

13.1.8                                Universal has not previously entered into any agreement, whether written or oral, with respect to, or otherwise assigned, transferred, licensed, conveyed or

 

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otherwise encumbered its right, title or interest in or to the Universal Patents or Universal Know-How in the Field.

 

13.1.9                                As of the Effective Date, and except with respect to amendments provided to Adaptimmune, no amendments have been agreed between Universal and the University of Washington to the terms of the Elf Licence or the AAV/HLA-engineering Licence.

 

13.1.10                         Universal is not in breach of any of the terms of the AAV/HLA-engineering Licence or the Elf Licence, it has not received notice of any breach from the University of Washington and is not aware of any circumstances which would put it in breach of any term of the AAV/HLA-engineering Licence or the Elf Licence.

 

13.1.11                         Universal has not entered into any agreement with any Third Party (whether oral or written) which would conflict with or restrict the rights and licences granted to Adaptimmune under this Agreement, save for the AAV/HLA-engineering Licence and the Elf Licence.

 

13.2.                    Each Party represents and warrants to the other Party that:

 

13.2.1                                it has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

 

13.2.2                                it has full legal power to grant the rights and licenses granted to the other under this Agreement; and

 

13.2.3                                it has taken all necessary action on its part required to authorise the execution and delivery of this Agreement.

 

13.3.                    DISCLAIMER OF WARRANTY.  EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN IN THIS AGREEMENT NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

14.                              Indemnity and Limitation

 

14.1.                    Indemnification of Adaptimmune by Universal.  In addition to any other remedy available to Adaptimmune, Universal shall indemnify, defend and hold harmless Adaptimmune, its Affiliates and their respective directors, officers and employees, from and against any and all Losses incurred by them to the extent resulting from or arising out of or in connection with any claims made or suits brought by a Third Party (collectively, “Third Party Claims”) against Adaptimmune, its Affiliates or their

 

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respective directors, officers or employees that  arise or result from (i) any claim that any use of the Universal Technology within the Field infringes the rights of any Third Party; or (ii) any claim that the use of the Universal Technology as part of or comprised within or used for the manufacture of any Product within the Field infringes the rights of any Third Party; or (iii) breach of any of the terms of this Agreement by Universal (or any Third Party acting on behalf of Universal); or (iv) breach of any Applicable Laws by Universal (or any Third Party acting on behalf of Universal) except for (x) any Loss for which Adaptimmune has an obligation to indemnify Universal and its Affiliates pursuant to Section 14.2 , as to which Loss each Party shall indemnify the other to the extent of their respective liability for such Loss; or (y) caused by the gross negligence or wilful misconduct of Adaptimmune or its Affiliates; or (z) any use of the Universal Technology by Adaptimmune outside of the Field or within the Field in a manner or form differently from that provided for use in or used in the performance of the Research Program.

 

14.2.                    Indemnification of Universal by Adaptimmune.  In addition to any other remedy available to Universal, Adaptimmune shall indemnify, defend and hold harmless Universal, its Affiliates, and its and their respective directors, officers and employees, from and against any and all Losses incurred by them to the extent resulting from or arising out of or in connection with any Third Party Claims against Universal its Affiliates or its or their respective directors, officers or employees that arise or result from (i) any claim that use of the Adaptimmune Technology or any Adaptimmune Material by Universal in the performance of the Research Program infringes the rights of any Third Party; (ii) any breach of Applicable Laws by Adaptimmune or its Affiliates or (iii) the development or commercialization of any Product by Adaptimmune, its Affiliates or sublicensees, except for any Loss (x) for which Universal has an obligation to Indemnify Adaptimmune and its Affiliates pursuant to Section 14.1, as to which Loss each Party shall indemnify the other to the extent of their respective liability for such Loss or (y) caused by the gross negligence or wilful misconduct of Universal.

 

14.3.                    Indemnification Procedure.  Should the Indemnified Party intend to claim indemnification hereunder from the Indemnifying Party the Indemnified Party shall promptly notify the Indemnifying Party in writing of any Losses in respect of which the Indemnified Party intends to claim such indemnification and the Indemnifying Party shall be entitled, but not obligated, to assume the defence of any Third Party Claim thereof with counsel selected by it.  The Indemnified Party, including its Affiliates, directors, officers and employees, shall co-operate fully, at the Indemnifying Party’s expense, with the Indemnifying Party and its legal representatives in the investigation and defence of any Third Party Claim covered by this indemnification.  The indemnification shall not apply to amounts paid in settlement of any Third Party Claim if such settlement is effected without the consent of the Indemnifying Party which consent will not be unreasonably withheld.

 

14.4.                    LIMITATION ON DAMAGES. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE, DEATH OR PERSONAL INJURY CAUSED BY THE NEGLIGENCE OF EITHER PARTY, OR FRAUD BY A PARTY OR ITS AFFILIATES, NO PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES,

 

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INCLUDING INDIRECT LOST PROFITS, WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE. EACH PARTY’S TOTAL AGGREGATE LIABILITY UNDER ANY INDEMNITY PROVIDED UNDER SECTION 14 OF THIS AGREEMENT SHALL BE LIMITED TO THE GREATER OF: (A) ***

 

                                                                                                                                                                ; AND (B) ***

                                         .

 

14.5.                    Additional Limitation. Universal shall not be responsible for any Losses under the indemnity in Section 14.1 to the extent that any Third Party Claims (a) arise as a result of the commercial use of any cell line for which Adaptimmune has entered into an Agreement with a Third Party provider of such cell line for such commercial use; (b) arise as a result of any use by Adaptimmune of the Universal Technology outside of the scope of any licence agreement negotiated between Adaptimmune and the relevant Third Party or between Universal and the relevant Third Party (provided in the latter case Adaptimmune has reviewed and approved the terms of such Third Party license); or (c) relates to any part of the Product or part of the manufacturing process other than the Universal Technology.

 

14.6.                    Insurance.  Each Party shall have and maintain such type and amounts of liability insurance covering its liabilities under this Agreement as is normal and customary in the industry generally. The requirement to maintain insurance under this clause shall not limit the liability of a Party under this Agreement.

 

15.                              Term and Termination of Agreement

 

15.1.                    Term.  The term of this Agreement shall become effective as of the Effective Date and unless terminated earlier as provided herein (including pursuant to Sections 2.1 or 5.2 or 6.2) shall continue until the last to expire of any Patent or other Intellectual Property Rights within the Universal Patents (the “Term”).

 

15.2.                    Termination by Adaptimmune.  Adaptimmune shall have the right, in its sole discretion, to terminate this Agreement by giving thirty (30) days’ prior written notice to Universal (a) for safety or scientific reasons; (b) if a Third Party Patent is identified which would Cover any Product and a licence or alternative development route is not commercially feasible in Adaptimmune’s sole discretion; or (c) in the event it does not wish to proceed with the next Phase of the Research Plan, based on the outcome of any previous Phase.

 

15.3.                    Termination for Material Breach.  If either Party is in material breach of the Agreement (a “Breaching Party”), in addition to any other right and remedy the other Party (the “Complaining Party”) may have, the Complaining Party may terminate this Agreement in its entirety by ninety (90) days prior written notice (the “Notice Period”) to the Breaching Party, specifying the breach and its claim of right to terminate, provided always that the termination shall not become effective at the end of the Notice Period if the Breaching Party cures the breach complained about during the Notice Period (or, if such default cannot be cured within such ninety (90) day period, if the

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

36



 

Breaching Party commences actions to cure such default within the Notice Period and thereafter diligently continues such actions).

 

15.4.                    Termination for Insolvency. Either Party may (without limiting any other remedy it may have), terminate this Agreement with immediate effect if the other Party becomes insolvent, is unable to pay its debts, or if an order is made or a resolution is passed for its winding up (except voluntarily for the purpose of a solvent amalgamation or reconstruction), or if an administrator, administrative receiver or receiver is appointed over the whole or any part of the other Party’s assets, or if the other Party makes any arrangement with its creditors or ceases to carry on business or does or suffers any similar or analogous act existing under the laws of any country.

 

15.5.                    Consequences of Termination

 

15.5.1                                Termination of Rights. In the event of termination or expiry of this Agreement and save as otherwise explicitly provided all rights and licences granted to Universal and to Adaptimmune under this Agreement shall terminate and each Party shall return all data, files, records and other materials in its possession or control containing or comprising the other Party’s Information or other Confidential Information to which such first Party does not retain rights hereunder (except one copy of which may be retained by the returning Party’s General Counsel or external law firm solely for archival purposes).

 

15.5.2                                Licence of Adaptimmune Know How. On expiry of the Term but not termination, Universal shall grant Adaptimmune a non-exclusive, royalty free, fully paid up, perpetual, irrevocable, worldwide, assignable right and licence in the Field, with the right to grant sublicences through multiple tiers, under the Universal Know How to Exploit and further develop the Products.

 

15.5.3                                Return of Materials.  On termination but not expiry (a) each Party will return any Materials of the other Party to that other Party promptly on termination, and (b) Adaptimmune and its Affiliates and sublicensees shall cease all use of the Deliverables (to the extent such Deliverables cannot be used without a licence under any of Universal’s Intellectual Property Rights).

 

15.5.4                                Remedies.  Early termination of this Agreement by a Party shall in no way affect or limit such Party’s right to claim against any of Universal, or Adaptimmune for any damages arising out of the breach of this Agreement.

 

15.6.                    Change of Control. Universal shall notify Adaptimmune of any Change in Control of Universal in advance of such Change in Control where possible or in any event within five (5) Business Days following such Change in Control.  If the Change in Control occurs prior to completion of the Research Program, then when Adaptimmune receives notice of such Change in Control, if the surviving entity (excluding any Competitor) does not also provide a written notice within five (5) Business Days of such Change of Control that the surviving entity will assume the obligations of Universal and complete the Research Program, then: (a) Adaptimmune will have the option to terminate this

 

37



 

Agreement immediately on written notice and the provisions of Section 15.5 above shall apply to such termination; or (b) Adaptimmune may elect by provision of notice in writing to Universal, in its sole discretion to perform additional parts of the Research Plan previously reserved to Universal.  Where any Development Milestone was attributed to completion of such additional parts, such Development Milestone shall cease to be payable where Adaptimmune takes over performance of the relevant Research Activities. Where any part of the Research Plan or Phase of the Research Plan was part performed, following Adaptimmune taking over performance of such part or Phase of the Research Plan the Development Milestone for such part or Phase will be pro-rated accordingly based on the Research Activities performed prior to receipt by Universal of notification from Adaptimmune. Universal will cooperate with Adaptimmune to ensure that any handover of Materials and Information required for Adaptimmune to take over performance of Research Activities occurs promptly and Universal will make relevant personnel available to ensure a smooth transition in such Research Activities. In the event of a Change in Control and Adaptimmune electing to take over the Research Plan in accordance with Section 15.6 (b) or in the event of a Change in Control in favour of a Competitor the following shall apply:

 

15.6.1                                The licences and rights granted by Adaptimmune to Universal shall immediately terminate save to the extent required to ensure a smooth transition of the Research Activities to Adaptimmune;

 

15.6.2                                Any reporting obligations from Adaptimmune to Universal shall cease and save as necessary under Section 6 for the purposes of payment of the Development Milestones and Product Milestones, for the reporting and payment of Profit Share and Royalty. Adaptimmune shall be under no further obligation to continue to report on the progress of the Research Program or to share any results or development of any Deliverable or Product with Universal.

 

15.6.3                                Universal shall immediately (a) provide to Adaptimmune all Results generated to date including any Deliverables (even if not in final form) or otherwise provide access to such Results and Deliverables (in the case of cell lines, cell banks or other cell based deliverables or materials); and (b) to the extent any Research Activities are provided by a Third Party, provide access to such Third Party and facilitate an ongoing relationship between such Third Party and Adaptimmune to enable Adaptimmune to complete the Research Program in its sole discretion.

 

15.6.4                                The licence rights and access reports granted to Adaptimmune shall continue in full force and effect for the Term. The diligence obligations under Section 5.2 shall continue to apply but for clarity, Adaptimmune shall be under no obligation to provide any reports on progress or any detailed reports on Product sales, nature of Product, manufacturing process for Product or timelines for Exploitation of any Product.

 

38



 

15.6.5                                The JSC shall immediately cease as shall any project or other sub-committees save where such committees are required to facilitate transition of the Research Activities to Adaptimmune.

 

15.6.6                                Other terms of the Agreement shall remain in full force and effect.

 

Pending notice of Change in Control under this Clause 15.6 with a Competitor and termination or transfer of Research Program to Adaptimmune in accordance with this Clause 15.6, Universal will not permit the Third Party Competitor (or any of its employees) in respect of which the relevant Change in Control has occurred to have access to any Confidential Information of Adaptimmune (other than Confidential Information permitted to be provided in accordance with Section 10 above).

 

15.7.                    Application of US Bankruptcy Code. The Parties agree that the license rights granted under this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code and similar laws and regulations outside of the United States, licenses of rights to “intellectual property” as defined under Section 101 of the Bankruptcy Code or such other laws and regulations. The Parties shall retain and may fully exercise all of their respective rights and elections under Section 365(n) of the Bankruptcy Code or similar laws and regulations outside of the United States. During the duration of the Research Program, Universal agrees to provide to Adaptimmune a copy of its audited accounts (or if not audited, its annual accounts or financial statements) within 30 days of finalisation, or alternatively the CEO of Universal will telephone the CEO of Adaptimmune within 30 days of annual accounts being finalised to discuss the contents of the annual accounts and in particular financial status of Universal.

 

15.8.                    Accrued Rights; Surviving Obligations.

 

15.8.1                                Survival.  The termination of this Agreement shall not relieve any of Universal or Adaptimmune from performing any obligations accrued prior to the date this Agreement terminates.  Subject to the foregoing, each of Universal or Adaptimmune obligations under Section 1 (to the extent necessary for interpretation of other surviving Sections), Sections 2.6, 2.7, 4.1, 4.2, 7, 8, 11, 12, 13, 14, 15. 17, 18, 19, 20, 21 - 29 shall survive the termination or expiration of this Agreement.

 

16.                               Anti-Corruption Laws

 

16.1.                    Both Parties shall ensure that in connection with its obligations under this Agreement, they shall conduct their activities in a manner that is consistent with the Anti-Corruption Laws.  Each Party further undertakes that none of its or its Affiliates’ employees, directors or officers shall, directly or indirectly, engage in any activities that violate any Anti-Corruption Law (a) in order to influence official action of any Government Official, or (b) with the intention of or as a condition to inducing any person to carry out a duty or function improperly or to reach a favourable decision on an improper basis, in each case in connection with the activities contemplated under this Agreement.

 

39



 

16.2.                    Universal shall promptly provide Adaptimmune with written notice of (a) becoming aware of a Material Anti-Corruption Law Violation by it or any of its employees, directors or officers with respect to the subject matter of this Agreement, or (b) upon receiving a formal notification that it or any of its employees, directors or officers is the target of a formal investigation by any Governmental Authority for a Material Anti-Corruption Law Violation.

 

16.3.                    Universal acknowledges that its undertakings given in this Section 16 are material to Adaptimmune in entering into this Agreement.  Notwithstanding any other provision of this Agreement, if Adaptimmune becomes aware of what it determines, acting reasonably, to be a breach of these undertakings, then Adaptimmune shall be entitled to terminate this Agreement in its entirety, and any other agreement among the Parties, on notice with immediate effect.  Subject to the accrued rights of the Parties pursuant to termination, Adaptimmune shall have no liability to Universal for any fees, reimbursements or other compensation or for any loss, cost, claim or damage resulting, directly or indirectly, from such termination.  At the sole discretion of Adaptimmune, any breach of a Universal obligation with respect to its obligation in this Section 16 may be cured (if capable of being cured) within a reasonable period of time after learning of such material breach or Material Anti-Corruption Law Violation.

 

17.                              Assignment

 

17.1.                    Neither Party may assign its rights or except as otherwise explicitly provided, delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written consent of the other Party, which consent shall not be unreasonably withheld, except that a Party shall always have the right, without such consent: (a) to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any of its Affiliates or licensees; and (b) assign any or all of its rights and delegate any or all of its obligations hereunder to any of its Affiliates or, subject to the terms of Section 15.6 to any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of the business to which this Agreement relates, provided that such Party shall provide written notice to the other Party within ninety (90) days after such assignment or delegation.  All validly assigned rights of any of Universal or Adaptimmune shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such party shall be binding on and be enforceable against, the permitted successors and assigns of such party. Any attempted assignment or delegation in violation of this Section 17 shall be void.

 

18.                              Severability

 

To the fullest extent permitted by Applicable Law, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect.  If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by any of the Parties and shall not form part of this Agreement.  To the fullest extent permitted by Applicable Law and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement shall remain in full force and effect, and each Party

 

40



 

shall use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Law and achieves, as nearly as possible, the original intention of each of the Parties.

 

19.                              Governing Law, Jurisdiction, Venue

 

19.1.                    Governing Law.  This Agreement and any dispute or claim arising out of or in connection with it (whether contractual or non-contractual in nature such as claims in tort, from breach of statute or regulation or otherwise) shall be governed by and construed in accordance with the laws of England excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.  The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.

 

19.2.                    Arbitration.  Save for any dispute relating to ownership of Intellectual Property Rights or validity of any Intellectual Property Rights which shall be dealt with by the appropriate court of competent jurisdiction, any dispute or claim arising out of or in connection with this Agreement, including any question regarding its existence, validity or termination shall be referred to and finally resolved by arbitration under the rules of the International Chamber of Commerce which only are deemed incorporated into this Section 19.2.  The place of arbitration shall be London, if the dispute is brought by Universal, and San Francisco, California if the dispute is brought by Adaptimmune.  The language to be used in the arbitration procedures shall be English.  The arbitration proceedings including any outcome shall be confidential.  Nothing in this Section 19.2 will preclude any of the Parties from seeking equitable interim or provisional relief from a court of competent jurisdiction including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such party or to preserve the status quo pending the arbitration proceeding.

 

19.3.                    Number of Arbitrators. The number of arbitrators shall be three (3) of which Adaptimmune and Universal shall appoint one (1), the arbitrators so appointed will select the third and final arbitrator. The arbitrators shall have experience of pharmaceutical licensing disputes.

 

20.                              Dispute Resolution

 

20.1.                    If a dispute arises between the Parties relating to the existence, negotiation, validity, formation, interpretation, breach, performance or application of this Agreement, the Parties shall use the following non-binding procedure in good faith prior to any Party pursuing judicial remedies provided that this shall not prevent any Party pursuing interim remedies to protect their rights.

 

20.2.                    Each Party shall notify the other Party of the dispute in accordance with this Section 20.  The Parties shall use good faith efforts to resolve such dispute within thirty (30) days after delivery of such notice, which good faith efforts shall include at least one in-person meeting between representatives of each Party having decision-making

 

41



 

authority. For Universal the representatives shall be the [insert] or their designee. For Adaptimmune the representative shall be the Chief Executive Officer. All discussions under this Section 20 are confidential and shall be treated as compromise and settlement negotiations for purposes of applicable rules of evidence.

 

20.3.                    If Universal or Adaptimmune are unable to resolve the dispute in accordance with this Section 20, any Party may initiate arbitration in accordance with Section 19.

 

21.                              Notices

 

21.1.                    Notice Requirements.  Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or electronic mail, or by internationally recognised overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 21.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 21.  Such notice shall be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or electronic mail, or on the second Business Day (at the place of delivery) after deposit with an internationally recognised overnight delivery service. Any notice delivered by facsimile or electronic mail shall be confirmed by a hard copy delivered as soon as practicable thereafter.  This Section 21 is not intended to govern the day-to-day business communications necessary between any parties in performing their obligations under the terms of this Agreement.

 

21.2.                    Address for Notice.

 

For :

 

Universal

Address:

 

Attn: Claudia Mitchell, CEO

 

 

720 Broadway

 

 

Seattle, WA 98122

 

 

Email: ***

 

 

 

For:

 

Adaptimmune

Address:

 

as for registered office

Facsimile:

 

N/A

For the attention of:

 

COO and General Counsel

 

22.                              Relationship of the Parties

 

The status of any party under this Agreement shall be that of an independent contractor.  Nothing contained in this Agreement shall be construed as creating a partnership, joint venture or agency relationship between any of the parties or, except as otherwise expressly provided in this Agreement, as granting any Party the authority to bind or contract any obligation in the name of or on the account of another party or to make any statements, representations, warranties or commitments on behalf of another Party.  All persons employed by a Party shall be employees of such Party and not of another Party

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

42



 

and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such party.

 

23.                              Entire Agreement

 

This Agreement together with the Sublicenses constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement.  This Agreement together with the Sublicenses supersedes all prior agreements, whether written or oral, with respect to the subject matter of the Agreement. Each Party confirms that it is not relying on any statements, representations, misrepresentation, warranties or covenants of any person (whether a party to this Agreement or not) except as specifically set out in this Agreement or in the Sublicenses.  Nothing in this Agreement is intended to limit or exclude any liability for fraud.  All Schedules referred to in this Agreement are intended to be and are hereby specifically incorporated into and made a part of this Agreement.  In the event of any inconsistency between any such Schedules and this Agreement, the terms of this Agreement shall govern save that in relation to any licence to the Sublicensed IP, to the extent there is any conflict between the provisions of this Agreement and the terms of such Sublicenses, the terms of the Sublicenses shall prevail.

 

24.                              English Language

 

This Agreement is written and executed in the English language.  Any translation into any other language shall not be an official version of this Agreement and in the event of any conflict in interpretation between the English version and such translation, the English version shall prevail.

 

25.                              Amendment

 

Any amendment or modification of this Agreement must be in writing and signed by authorised representatives of each Party.

 

26.                              Waiver and Non-Exclusion of Remedies

 

Any failure of a Party to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy shall not constitute a waiver of that provision, right or remedy or prevent such Party from enforcing any or all provisions of this Agreement and exercising any rights or remedies.  To be effective any waiver must be in writing.  The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available, except as expressly set forth herein.

 

27.                              Further Assurance

 

Each Party agrees to do and perform all such further acts and things and will execute and deliver such other agreements, certificates, instruments and documents necessary or that any other party may reasonably request in order to carry out the intent and accomplish the

 

43



 

purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.

 

28.                              Expenses

 

Except as otherwise expressly provided in this Agreement, each Party shall pay the fees and expenses of its respective lawyers and other experts and all other expenses and costs incurred by such party incidental to the negotiation, preparation, execution and delivery of this Agreement.

 

29.                              Counterparts

 

This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same instrument.  An executed signature page of this Agreement delivered by facsimile transmission or by electronic mail in “portable document format” (“.pdf”) shall be as effective as an original executed signature page.

 

44



 

THIS AGREEMENT IS EXECUTED by the authorised representatives of the parties as of the date first written above.

 

SIGNED for and on behalf of UNIVERSAL CELLS, INC.

 

SIGNED for and on behalf of ADAPTIMMUNE LIMITED

 

 

 

/s/ Claudia Mitchell

 

/s/ James Noble

Signature

 

Signature

 

 

 

Name:

Claudia Mitchell CEO

 

Name:

James Noble

 

 

 

 

 

Title:

Authorised Signatory

 

Title:

CEO

 

45



 

PRIVATE & CONFIDENTIAL

 

Schedule 1 — Outline of Research Program

 

46



 

RESEARCH PLAN FOR UNIVERSAL CELLS AND ADAPTIMMUNE

 

Background:

 

***

 

 

 

 

 

 

 

 

 

 

 

 

.

 

Phase

 

Workstream(s) #

 

Summary

1

 

1, 2, 3

 

· ***
· ***

· ***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

47



 

2

 

4,5

 

· ***
· ***

3

 

6

 

· ***

4

 

7, 8

 

· ***
· ***

 

1.             Define and evaluate ***

 

.

 

 

·                  ***                                                                                       .

 

·                  ***                                                                 .

 

·                  ***                                                                                                                                          .

 

·                  ***

 

 

.

 

·                  ***                                         .

 

·                  ***                                                                                                                                                     :

 

·                  ***

 

·                  ***

 

·                  ***

 

·                  ***

 

·                  ***                                     .

 

1.1.    Timeline:

 

All aspects done concurrently with completion within ***            .

 

1.2.    Milestone(s):

 

***

 

 

 

 

.

 

2.              Generate a ***

 

***

 

.

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

48



 

·                  ***

 

·                  ***

 

.

·                  ***

 

.

 

·                  ***                                                                                                                                       .

·                  ***

 

.

 

·                  ***

 

.

 

·                  ***

 

.

 

·                  ***

 

.

 

·                  ***

 

.

 

2.1.    Timeline:

 

***                                                                                                                              .

 

***

 

 

.

 

2.2.    Milestone(s):

 

***

 

.

 

3.              Establish ***                                                                                                        .

 

·                  ***

 

.

 

·                  ***                                                                                                                  .

 

·                  ***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

49



 

3.1.    Timeline:

 

 

Total time taken approximately ***            .

 

***

 

 

.

 

***

 

 

.

 

3.2.    Milestone(s):

 

***

 

 

.

 

 

4.              ***

 

***

 

.

 

·                  ***

 

 

 

.

 

·                  ***

 

 

.

 

·                  ***

 

.

 

·                  ***                                                                                                                                                                          .

 

4.1.    Timeline:

 

***

 

 

 

.

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

50



 

4.2.    Milestone(s):

 

***

 

 

.

 

 

5.              Establish ***

 

·                  ***                                                                                                                                                          .

 

·                  ***

 

.

 

·                  ***                                                                                                                                                          .

 

·                  ***

 

.

 

5.1.    Timeline:

 

Finalize plan for creating ***                within ***                  .

 

***

 

.

 

5.2.    Milestone(s):

 

***

 

 

 

 

.

 

 

6.              Establish protocol for ***

 

***

 

 

 

.

 

·                  ***

 

.

 

·                  ***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

51



 

.

 

·                  ***

.

 

·                  ***

 

.

 

·                  ***                                                                                                                                            .

 

·                  ***                                                                                                                 .

 

6.1.    Timeline:

 

***                                                                                                                                                                                    .

 

***

 

.

 

***                                                                                                                                                    .

 

6.2.    Milestone(s):

 

***                                                                                                                                 .

 

***

 

.

 

***                                                                                                               .

 

***                                                                                                                                                                          ..

 

7.              ***                         Creation

 

***

 

.

 

8.              Pre-clinical / Clinical

 

***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

52



 

.

 

***

 

.

 

Milestones

 

#

 

Milestone

 

Trigger

 

Amount
(US$)

1

 

Project Initiation

 

Approval of Phase 1 of the Research Plan by the JSC and completion of the first project committee meeting

 

3,000,000

2

 

***

 

***

 

 

                                                           :

 

· ***
· ***


· ***

· ***                                  .

 

***

3

 

***

 

***


:
· ***

· ***

· ***
· ***

 

***

 


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53



 

#

 

Milestone

 

Trigger

 

Amount
(US$)

 

 

 

 

 

 

 

4

 

***

 

***

 

***

5

 

***

 

***

 

                                                                 .

 

***

 

 

 

***

6

 

***

 

***




 

 

.

 

***

7

 

***

 

***

 

 

 

 

***

8

 

***

 

***

 

 

 

 

 

 

***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

54



 

Example timeline:

 

***

 

 

 

 

 

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

55



 

Schedule 2 — Sublicense under AAV/HLA-engineering Licence

 

56



 

PRIVATE & CONFIDENTIAL

 

AGREEMENT

 

BETWEEN:

 

ADAPTIMMUNE LIMITED (1)

 

and

 

UNIVERSAL CELLS, INC. (2)

 


 

HLA/AAV Sub-Licence

 


 

57



 

This HLA/AAV Sublicence AGREEMENT (the “Sub-Licence”) is made as of the 25th day of November 2015 (the “Effective Date”) by and between:

 

(1)           ADAPTIMMUNE LIMITED, a company incorporated in England and Wales with its registered address at 101 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY (“Adaptimmune”);

 

and

 

(2)           UNIVERSAL CELLS, INC., a company incorporated in the State of Washington with principal office at 720 Broadway, Seattle, WA 98122 (“Universal”).

 

Background

 

(A)          WHEREAS Universal has taken a licence from the University of Washington in relation to certain Intellectual Property Rights for Gene Editing Technology, HLA Engineering Technology and a cell line (defined further below) and has certain related know-how (defined below as the AAV/HLA-Engineering Licence);

 

(B)          WHEREAS Universal and Adaptimmune have entered into a Research and Collaboration Licence Agreement on or about the Effective Date which provides for entry into a sub-licence under the AAV/HLA-Engineering Licence; and

 

(C)          WHEREAS the parties have agreed to a sublicence under the AAV/HLA-Engineering Licence on the terms and conditions set out below.

 

Agreement

 

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Universal and Adaptimmune intending to be legally bound, agree as follows:

 

1.             Definitions.

 

For purposes of interpreting this Agreement, the following terms have the following meanings ascribed to them:

 

1.1. Confidential Information” means any information or materials (biological, chemical, or otherwise) disclosed by University and not generally known to the public, including any information comprised of those materials, and including without limitation the inventions covered by the Licensed Patents and in each case provided under the AAV/HLA-Engineering Licence. Confidential Information does not include any information that:

 

1.1.1.      is or becomes part of the public domain through no fault of receiving Party;

 

1.1.2.      is known to receiving Party prior to the disclosure by the disclosing Party, as evidenced by documentation;

 

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1.1.3.      is publicly released as authorized under this Agreement by University, its employees or agents;

 

1.1.4.      is subsequently obtained by a Party from a Third Party who is authorized to have such information; or

 

1.1.5.      is independently developed by a Party without reliance on any portion of the Confidential Information received from the disclosing Party and without any breach of this Agreement as evidenced by documentation.

 

1.2.         Event of Force Majeure” means an unforeseeable act that wholly prevents a Party from performing one or more of its material duties under this Agreement and that is outside of the reasonable control of the Party.  An Event of Force Majeure includes acts of war or of Nature, insurrection and riot, and labor strikes.  An Event of Force Majeure does not mean a Party’s inability to obtain a Third Party’s consent to any act or omission.

 

1.3.         Group 2 Scope” means co-exclusive for the construction, sale and use of cell lines derived from Stem Cells using Group 2 Licensed Patents specifically for: i) in vitro discovery and development of pharmaceutical agents; ii) in vitro discovery, development and validation of diagnostic targets; and iii) in vitro development of engineered cell lines for bioproduction of pharmaceutical agents; exclusive for the development and use of therapeutic products where the construction or manufacture of the therapeutic product itself utilized Group 2 Licensed Patents and in each case within the Fields of Use.

 

1.4.         AAV/HLA-engineering Licence” means the Licence and Material Transfer Agreement between Universal and the University dated 27 June 2014 and attached as Schedule 5;

 

1.5.         Product Family 1” means Licensed Products that are vectors or cell lines for research and development purposes. “Product Family 2” means Licensed Products in a therapeutic.

 

1.6.         Fields of Use” means immunotherapy and wherein the administered product or therapy incorporates a form of T-cells including, but without limitation, genetically engineered T-cells or stem cell derived T-cells.

 

1.7.         Licensed Materials” means the materials provided by Universal to Company, which were originally provided by University under the AAV/HLA-engineering licence (including those listed in Exhibit B), and includes any Licensed Materials contained within materials derived by Adaptimmune or Universal under the Research and Collaboration Agreement from such Licensed Materials.

 

1.8.         Licensed Patents” means the patents and patent applications (including all provisional, nonprovisional, and PCT patent applications, and all national stage and foreign equivalents of the foregoing, accordingly) listed in Section A1 “Licensed Patents” of attached Exhibit A “Patent License Schedule”, all divisionals and continuations of these patent applications, all patents issuing from these applications, divisionals, and continuations and any reissues, reexaminations and extensions of these patents including any foreign equivalents of

 

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such listed patent applications and patents or patent applications claiming priority from such listed patent applications.  Claims in continuations-in-part applications are included in Licensed Patents only to the extent such claims are supported by a patent or patent application set forth in Section A1 “Licensed Patents” of Exhibit A “Patent License Schedule” to benefit from the priority date of such patent or patent application and to the extent such claims are not encumbered by Third Party rights.

 

1.9.         Licensed Product” means “Products” as defined under the Research and Collaboration Agreement.

 

1.10.       Research and Collaboration Agreement” means the agreement between the parties of date on or around the Effective Date and entitled “RESEARCH COLLABORATION AND LICENCE AGREEMENT RELATING TO GENE EDITING AND HLA-ENGINEERING TECHNOLOGY”

 

1.11.       Territory” means worldwide.

 

1.12.       Third Party” means an individual or entity other than Adaptimmune and Universal.

 

1.13.       Valid Claim” means (i) a claim in an issued and unexpired patent included in the Licensed Patents that: (a) has not been  held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, and not subject to appeal, (b) has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, (c) has not been lost through an interference, re-examination, or reissue proceeding; or (ii) a pending claim of a pending patent application included in the Licensed Patents.

 

2.             Term.

 

The term of this Sub-licence will commence on the Effective Date and, unless terminated earlier as provided in Article 8 “Termination”, will expire on the date on which no Valid Claim in a Licensed Patent is pending or subsisting in any country in the Territory.

 

3.             Grant of License.

 

3.1.         Adaptimmune’s Rights.

 

3.1.1.      License Grant for Group 1 Licensed Patents.  Subject to the terms and conditions of this Agreement, Universal hereby grants to Adaptimmune, and Adaptimmune hereby accepts, a non-exclusive sub-license under Universal’s rights in Group 1 Licensed Patents to make, have made on Adaptimmune’s behalf, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products in the Territory in the Field of Use.

 

3.1.2.      License Grant for Group 2 Licensed Patents.  Subject to the terms and conditions of this Agreement, Universal hereby grants to Adaptimmune, and Adaptimmune hereby accepts, a sub-license with scope restricted co-exclusivity and scope restricted exclusivity as defined in Group 2 Scope, under Universal’s rights in Group 2 Licensed Patents to make, have made on Adaptimmune’s behalf, use, offer to sell or sell, offer to lease or lease, import,

 

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or otherwise offer to dispose or dispose of Licensed Products in the Territory in the Field of Use.  Universal will not grant to any Third Party any sub-license under the Group 2 Licensed Patents for the use, offering to sell, sale, disposal or making of any products within the Field of Use.

 

3.1.3.      License Grant for Group 3 Licensed Patents.  Subject to the terms and conditions of this Agreement, Universal hereby grants to Adaptimmune, and Adaptimmune hereby accepts, an exclusive sub-license under Universal’s rights in Group 3 Licensed Patents to make, have made on Adaptimmune’s behalf, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products in the Territory in the Field of Use.  Universal will not grant to any Third Party any sub-license under the Group 3 Licensed Patents for the use, offering to sell, sale, disposal or making of any products within the Field of Use.

 

3.1.4.      License Grant for Licensed Materials.  Subject to the terms and conditions of this Agreement, Universal hereby grants to Adaptimmune,and Adaptimmune hereby accepts, a non-exclusive sub-license under Universal’s rights in Licensed Materials to use the Licensed Materials in research and development activities related to the Licensed Products, and in the creation of Licensed Products.  For avoidance of doubt, Adaptimmune is not granted the right to use Licensed Materials other than in the development of Licensed Product, or in the construction or manufacture of Licensed Product.

 

3.1.5.      Sublicenses.  Adaptimmune may sublicense its rights under this Sublicense to its Affiliates without any need for prior consent from Universal and provided that such Affiliates agree to substantially the same terms as contained in this Sub-licence and Adaptimmune remains responsible for the compliance and performance of such Affiliates with the terms of this Sub-licence.

 

3.1.6.      Provision of Agreement to University. Adaptimmune agrees that a copy of this Agreement may be provided to the University as required by the terms of the AAV/HLA-engineering licence. Universal will use reasonable efforts to ensure that the University keeps the terms of this Agreement confidential.

 

3.1.7.      The license granted in this Agreement is limited to the inventions that are expressly claimed in the Licensed Patents.  No provision of this Agreement grants Adaptimmune, by implication, estoppel or otherwise, any rights other than the rights expressly granted it in this Agreement to the Licensed Patents, Licensed Materials, or to any other University-owned technology, materials, patent applications, or patents.

 

3.2.         The United States Government’s Rights.  The inventions covered in the Licensed Patents arose, in whole or in part, from federally supported research and the federal government of the United States of America has certain rights in and to the Licensed Patents as those rights are described in Chapter 18, Title 35 of the United States Code and accounting regulations, including Part 401, Chapter 37 of the Code of Federal Regulation. The Parties’ rights and obligations under this Agreement to any government-funded inventions, including the grant of sub-license set forth in Subsection 3.1.1, are subject to the applicable terms of the aforementioned United States laws.

 

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3.3.         University’s Reservation of Rights.  To the extent required by the University under the AAV/HLA-engineering Licence, Universal retains for itself an irrevocable, nonexclusive license to make, have made, and use products, processes, and other subject matter covered by the Licensed Patents or Licensed Materials in the Field of Use for academic research, medical, instructional, or any other academic purpose.  Expressly included within this University reservation of rights is the right (i) to use the Licensed Patents in sponsored research or collaborative research with any Third Party but only to the extent no such Third Party is granted any rights to the Licensed Patents or to commercialize Licensed Products, (ii) to grant material transfer agreements to materials whose composition of matter is covered by the Licensed Patents where the use of such materials is restricted to academic research, medical, instructional, or any other academic purpose, and (iii) to publish any information included in the Licensed Patents or any other information that may result from University’s research. Universal will use reasonable efforts to (a) within a reasonable period of time after the Effective Date, request from the University prior notice of any sponsored research or collaborative research with any commercial Third Party and obtain University’s agreement to such provision; (b) ensure that any publication (to the extent University provides notice of such publication to Universal) does not impact on the ability of the University to obtain patent protection in relation to any of the Licensed Patents.

 

3.4.         Mandatory Sublicensing.

 

3.4.1.      Under the AAV/HLA-engineering licence, the University has the right to request mandatory sublicensing in certain fields. Universal will use reasonable efforts to obtain from the University as soon as reasonably possible after the Effective Date a written confirmation that such mandatory sublicensing shall not apply in relation to mandatory sublicensing in the Fields of Use during the term of the Research and Collaboration Agreement provided Adaptimmune is complying with the terms of the Research and Collaboration Agreement.

 

3.4.2.      If Universal receives notice under the AAV/HLA-engineering licence that the University has been solicited by a Third Party who wishes to license Licensed Patents for any field within the Field of Use that Adaptimmune or Universal is not diligently pursuing (hereinafter “Third Party Field”), Universal shall so notify Adaptimmune, and Adaptimmune shall be entitled to be actively involved in any notifications made to University in relation to such Third Party Field notification from University.  Universal and Adaptimmune shall discuss which of the following options should be exercised in response to such University’s notification:

 

3.4.2.1.           Development Plan. Provide University with a reasonable rationale as to why offering a sublicense in Third Party Field would be competitive with market opportunity Adaptimmune or Universal is either actively pursuing, or planning on pursuing; or

 

3.4.2.2.           Direct Grant. Universal to grant a sublicense to the said soliciting Third Party in the Third Party Field on commercially reasonable licence terms, such terms being subject to review and approval by Adaptimmune. Adaptimmune will not unreasonably withhold or delay its review and approval of such terms, but will be involved in discussions relating to the scope of any sublicense granted and the terms applicable to such grant.

 

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3.4.3.      University Direct Grant.  Adaptimmune understands that if Universal has not proceeded under either Subsection 3.4.2.1 or 3.4.2.2 within ninety (90) days of notification to Universal by University under AAV/HLA-engineering licence, University may directly grant a license to such Third Party in the Third Party Field for the benefit of University exclusive of any benefit to Adaptimmune. Universal and Adaptimmune will work together to ensure that one of the options under 3.4.2.1 or 3.4.2.2 is taken within the ninety (90) day period.

 

4.             Applications and Patents.

 

4.1.         Patent Application Filings during the Term of this Agreement.

 

4.1.1.      University Prosecutes Patents.  Adaptimmune understands that the University retains the sole and exclusive right to file or otherwise prosecute Licensed Patents.  Universal shall use reasonable efforts to copy Adaptimmune on any material correspondence, material filings or other material communications relating to the prosecution of the Licensed Patents to the extent relevant to the Fields of Use and in each case (a) which relate to the filing or not filing of any patent application or patent, the lapse of any patent or patent application, in which the scope of any claims are restricted or narrowed, any third party observations or oppositions or any communication where any patent office indicates any claim is invalid or insufficient for any reason and any response to such patent office communication; and (b) to the extent possible under the AAV/HLA-engineering Licence will provide Adaptimmune with an opportunity to comment on any proposed response, including the countries in which any patent application or patent is filed.

 

4.1.2.      University’s Independent Patent Filings.  Universal shall immediately notify Adaptimmune where University wishes to file, prosecute or maintain any Licensed Patents in a country that Universal does not wish the University to file in.

 

4.2.         Maintenance of Licensed Patents.  Universal shall notify Adaptimmune on a timely basis of any failure on its part to comply with any reimbursement or other payment obligation under the AAV/HLA-engineering licence or other default which may cause or result in any Licensed Patent to cease to fall within the Sub-licence or which might result in any Licensed Patent lapsing or ceasing to be filed, prosecuted or maintained. Such notice shall where possible be provided in sufficient time for Adaptimmune to correct any non-payment or reimbursement obligation of Universal. Any correction made by Adaptimmune shall be reimbursed in full by Universal.

 

4.3.         Ownership of the Licensed Patents.  No provision of this Agreement grants Adaptimmune any rights, titles, or interests (except for the grant of license in Subsection 3.1.1 “License Grant” of this Agreement) in the Licensed Patents.

 

5.             Commercialization.

 

5.1.         Covenants Regarding the Manufacture of Licensed Products.  Adaptimmune hereby covenants and agrees that the manufacture, use, sale, or transfer of Licensed Products will comply with all applicable federal and state laws, including all federal export laws and regulations.  Adaptimmune understands that there is a requirement under the AAV/HLA-engineering licence requiring that all products embodying or produced through the use of an

 

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invention that is subject to the rights of the federal government of the United States of America shall be substantially manufactured in the United States of America. Due to the nature of the product concerned, Universal understand that this may not always be commercially feasible and hence Universal agrees to work with Adaptimmune and to approach the University on a timely basis during the performance of the Research Plan (as defined in the Research and Collaboration Agreement)  to obtain waiver from the University in relation to such manufacture and as permitted in accordance with 35 United States Code Section 204.

 

5.2.         Use of University’s Name and Trademarks or the Names of University Faculty, Staff, or Students.  No provision of this Agreement grants Adaptimmune or any of its Sublicensees any right or license to use the name or trademarks of University or the names or identities of any member of the faculty, staff, or student body of University.  Adaptimmune shall not use, and shall not permit a Sublicensee to use, any such trademarks, names, or identities without University’s and, as the case may be, such member’s prior written approval.

 

5.3.         Records Retention and Audit Rights.

 

5.3.1.      Records Retained.  Throughout the term of this Agreement and for 5 years thereafter, Adaptimmune, at its expense, shall keep and maintain and shall cause each Sublicensee to keep and maintain complete and accurate records of all sales, leases, and other dispositions of Licensed Products during the term of this Agreement and all other records related to this Agreement.

 

5.3.2.      Auditing Rights.  Adaptimmune shall permit, at the request of University, one or more accountants selected exclusively by the University (“Accountants”) to have access to Adaptimmune’s records and books of account pertaining to this Agreement, but not more than once per calendar year.  Accountants’ access will be during ordinary working hours to audit Adaptimmune’s records for any payment period ending prior to such request, the correctness of any report or payment made by Universal under this Agreement, or to obtain information as to the payments due for any period in the case of failure of Adaptimmune to report pursuant to the terms of this Agreement. Any such inspection shall be subject to Accountants signing confidentiality agreements with Adaptimmune to ensure the confidentiality of Adaptimmune’s information. Access under this clause shall only be provided to records relating to sales of Licensed Products and not to any other products or services. The cost of any audit under this clause shall be at the cost of the University.

 

5.3.3.      Scope of Disclosure.  Accountants shall not disclose to University any information relating to the business of Adaptimmune except that which is necessary to inform University of: the accuracy or inaccuracy of Adaptimmune’s reports provided to Universal under this Agreement (and which Universal subsequently provides to University under the AAV/HLA-engineering licence); and the extent of any inaccuracy or noncompliance.

 

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6.             Infringement.

 

6.1.         Third-Party Infringement of a Licensed Patent.

 

6.1.1.      Notice of Third Party’s Infringement.  If a Party learns of substantial, credible evidence that a Third Party is infringing a Licensed Patent in the Field of Use in the Territory, that Party will promptly deliver written notice of the possible infringement to the other Party, describing in detail all relevant information to which that Party has access or control suggesting infringement of the Licensed Patent. Adaptimmune understands that under the terms of the AAV/HLA-engineering licence, Universal is not able to grant a right to Adaptimmune to enforce the Licensed Patents. Universal will work with Adaptimmune in relation to the exercise of Universal’s rights to enforce and prosecute an infringement or potential infringement action under the AAV/HLA-engineering licence and to the extent permitted by the University, will permit Adaptimmune to be present at any court hearings, material meeting or other actions taken in relation to enforcement of the Licensed Patents to the extent in each case relevant to the Fields of Use or scope of Research and Collaboration Agreement. To the extent Universal proposes to settle any action for infringement or potential infringement, Universal will discuss and obtain Adaptimmune’s approval to such settlement, such approval not to be unreasonably withheld or delayed. To the extent the University has control of any infringement suit or action under the AAV/HLA-engineering licence, Universal will to the extent permitted by University keep Adaptimmune informed of the progress of such infringement suit or action and permit Adaptimmune to be actively involved in such infringement suit or action including the terms of any sublicense proposed to be granted by the University. Any involvement of Adaptimmune shall be at Adaptimmune’s cost and expense save where University requests any assistance from Adaptimmune, in which case University shall pay for any direct associated expenses related to provision of such assistance.

 

7.             Patent Validity.

 

7.1.         Notice and Investigation of Third Party Challenges.  If any Third Party challenges the validity or enforceability of any of the Licensed Patents, the Party having such information shall immediately notify the other Party. Universal shall keep Adaptimmune informed of the status of any defense of any claim challenging validity or enforceability, where the University assumes control and defense of the claim in accordance with the terms of the AAV/HLA-engineering licence. Where Universal assumes the defense of any such claim, Universal will cooperate with Adaptimmune and enable Adaptimmune to be actively involved in the defense of such claim and any decisions taken in relation to such claim at Adaptimmune’s cost and expense.

 

7.2.         Enforceability of Licensed Patents.  Notwithstanding challenge by any Third Party, any Licensed Patent will be enforceable under this Agreement until such Licensed Patent is determined to be invalid.

 

8.             Termination.

 

8.1.         By Universal.

 

8.1.1.      Breach by Adaptimmune.  If Adaptimmune breaches or fails to perform one or more of its material duties under this Agreement, Universal may deliver to Adaptimmune a written notice of default.  Universal may terminate this Agreement by delivering to

 

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Adaptimmune a written notice of termination if the default has not cured in full within 60 days of the delivery to Adaptimmune of the notice of default.

 

8.1.2.      Events of Default.  Universal may terminate this Agreement by delivering to Adaptimmune a written notice of termination at least 10 days prior to the date of termination if Adaptimmune (i) becomes insolvent; (ii) voluntarily files or has filed against it a petition under applicable bankruptcy or insolvency laws that Adaptimmune fails to have released within 30 days after filing; (iii) proposes any dissolution, composition, or financial reorganization with creditors or if a receiver, trustee, custodian, or similar agent is appointed;  (iv) makes a general assignment for the benefit of creditors; or (v) if Adaptimmune challenges the validity of the Licensed Patents.

 

8.2.         By Adaptimmune.  Adaptimmune may terminate this Agreement at any time by delivering to University a written notice of termination at least 60 days prior to the effective date of termination.

 

8.3.         Automatic termination. This Agreement shall automatically terminate on termination of the Research and Collaboration Agreement.

 

8.4.         Effect of Termination.

 

8.4.1.      License Terminated.  After termination of this Agreement, Adaptimmune shall destroy Licensed Materials, and Adaptimmune shall not make, have made, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products.

 

8.5.         Right to continue licence on termination of AAV/HLA-engineering licence.  Universal shall notify Adaptimmune immediately if it receives any notice of termination of the AAV/HLA-engineering licence and of any actual termination of the AAV/HLA-engineering licence. At any time within 30 days following termination of the AAV/HLA-engineering licence, Adaptimmune may notify University and Universal that it wishes to enter into a direct license with University in order to retain its rights to the Licensed Patents and/or Licensed Materials granted to it under its Sublicense (such 30-day period following termination, the “Initial Notice Period”).  Following receipt of such notice, Universal shall procure (to the extent necessary under the AAV/HLA-engineering licence) that University and Adaptimmune shall enter into a license agreement the terms of which shall be substantially similar to the terms of the AAV/HLA-engineering licence; and the scope of such direct license, the licensed territory or the duration of the license grant shall be comparable to the corresponding terms granted under this Agreement; provided that Adaptimmune will be granted at least the same scope of rights as it obtained from Adaptimmune under this Agreement.  For the sake of clarity, the financial terms, including without limitation, the running royalty rate and milestone payments, shall be identical to the corresponding financial terms set forth in the AAV/HLA-engineering licence.  Notwithstanding the foregoing, Adaptimmune understands that its right to enter into such direct license shall be conditioned upon:

 

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8.5.1.      Written Notification to University.  Adaptimmune informing University in writing, pursuant to Article 21 “Notices” of the AAV/HLA-engineering licence, that it wishes to enter into such direct license with University, within the Initial Notice Period;

 

8.5.2.      Good Standing.  Adaptimmune being in good standing with Universal under this Agreement, and this Agreement not being the subject of a dispute between Universal and Adaptimmune, or between Universal and University under the AAV/HLA-engineering licence;

 

8.5.3.      Valid Sublicense.  This Agreement having been validly entered into by Adaptimmune and Sublicensee pursuant to the terms of Section 3.1.5 “Sublicenses” of the AAV/HLA-engineering licence;

 

8.5.4.      Sublicensee Certification that Conditions Satisfied.  Adaptimmune using reasonable efforts to certify or otherwise demonstrate that the conditions set forth in this Section 8.5 have been met within 30 days of expiration of the Initial Notice Period (or within such longer period of time as University agrees is reasonable under the circumstances, based on the nature and extent of any documentation reasonably requested by University); and

 

8.5.5.      Time Limitations.  Such negotiations for a direct license not exceeding 90 days from the end of the 30-day (or longer, if applicable) period described in subsection 8.5.4 “Sublicensee Certification that Conditions Satisfied” (subject to extension of said 90-day period by mutual written agreement of University and Sublicensee).

 

University may, at its sole discretion, waive any of the above requirements.  Adaptimmune understands and Universal confirms that if all of the conditions set forth in this Section 8.5 are met, then Adaptimmune will be granted such direct license by University.  If any condition set forth in this Section 8.5 is not met, then after expiration of any time period granted to Adaptimmune with respect to meeting such condition , Adaptimmune shall not make, have made, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products and University shall be free to license or not license Licensed Patents to Adaptimmune according to its sole discretion.

 

9.             Release, Indemnification, and Insurance.

 

9.1.         Adaptimmune’s Release.  For itself and its employees, Adaptimmune hereby releases University and its regents, employees, and agents forever from any suits, actions, claims, liabilities, demands, damages, losses, or expenses (including reasonable attorneys’ and investigative expenses) relating to or arising out of (i) the manufacture, use, lease, sale, or other disposition of a Licensed Product or Licensed Material; or (ii) the assigning or sublicensing of Adaptimmune’s rights under this Agreement.

 

9.2.         Adaptimmune’s Indemnification.  Throughout the term of this Agreement and thereafter, Adaptimmune shall indemnify, defend, and hold University and its regents, employees, and agents harmless from all suits, actions, claims, liabilities, demands, damages, losses, or expenses (including reasonable attorneys’ and investigative expenses), relating to or arising out of the manufacture, use, lease, sale, or other disposition of a Licensed Product or Licensed Materials, including, without limitation, personal injury, property damage, breach of

 

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contract and warranty and products-liability claims relating to a Licensed Product or Licensed Materials and claims brought by a sublicensee of Adaptimmune.

 

9.3.         Universal’s Indemnification. Throughout the term of this Agreement and thereafter, Universal shall indemnify, defend and hold Adaptimmune and its employees and agents harmless from all suits, actions, claims, liabilities, demands, damages, losses or expenses (including reasonable attorneys’ and investigative expenses), relating to or arising out of any breach by Universal (or any of its agents or employees) of the terms of the AAV/HLA-engineering licence.  Such indemnification shall not cover any suits, actions, claims, liabilities, demands, damages, losses or expenses to the extent arising as a result of Adaptimmune’s breach of the terms of this Agreement or failure to comply with Section 8.5 above.

 

9.4.         Adaptimmune’s Insurance.

 

9.4.1.      General Insurance Requirement.  Throughout the term of this Agreement, or during such period as the Parties shall agree in writing, Adaptimmune shall maintain in full force and effect commercial general liability (CGL) insurance, with single claim limits consistent with industry standards.  Such insurance policy will include coverage for claims arising under Section 9.2 above.

 

9.4.2.      Clinical Trial Liability Insurance.  Within thirty (30) days prior to the initiation of human clinical trials with respect to Licensed Product(s), Adaptimmune shall provide to Universal copies of certificates evidencing the existence and amount of clinical trials liability insurance following request from Universal for copies of such certificates.

 

10.          Warranties.

 

10.1.       Authority.  Each Party represents and warrants to the other Party that it has full corporate power and authority to execute, deliver, and perform this Agreement, and that no other corporate proceedings by such Party are necessary to authorize the Party’s execution or delivery of this Agreement.

 

11.2 Universal Representation and Warranty.  Universal represents and warrants that:

 

11.2.1 it has sufficient rights, title and interests of the Licensed Patents and Licensed Materials to grant the licenses to Adaptimmune as purported to be granted pursuant to this Agreement;

 

11.2.2 as at the Effective Date it is not in breach of any of the terms of the AAV/HLA-engineering Licence including any failure to perform or cause to happen or be performed any performance milestones specified in the AAV/HLA-engineering Licence.

 

10.2.       Disclaimers.

 

10.2.1.            General Disclaimers.  EXCEPT FOR THE EXPRESS WARRANTY SET FORTH IN SECTION 11.1 “Authority” OF THIS AGREEMENT, UNIVERSAL AND ADAPTIMMUNE DISCLAIM AND EXCLUDE ALL WARRANTIES, EXPRESS AND IMPLIED, CONCERNING EACH LICENSED PATENT AND EACH LICENSED PRODUCT, INCLUDING, WITHOUT LIMITATION, WARRANTIES

 

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OF NON-INFRINGEMENT AND THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

10.2.2.    Patent Disclaimers.  Adaptimmune understands that the University expressly disclaims any warranties concerning and makes no representations:

 

10.2.2.1.        Patent Issuance.  That the Licensed Patent(s) will be approved or will issue;

 

10.2.2.2.        Licensed Patent Validity/Scope.  Concerning the validity or scope of any Licensed Patent; or

 

10.2.2.3.        Non-Infringement.  That the manufacture, use, sale, lease or other disposition of a Licensed Product or Licensed Material will not infringe a Third Party’s patent or violate a Third Party’s intellectual property rights.

 

11.          Damages.

 

11.1.       Remedy LimitationEVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, IN NO EVENT SHALL UNIVERITY BE LIABLE FOR (A) PERSONAL INJURY OR PROPERTY DAMAGES ARISING IN CONNECTION WITH THE ACTIVITIES CONTEMPLATED IN THIS AGREEMENT AND (B) AND IN NO EVENT SHALL EITHER PARTY OR THE UNIVERSITY BE LIABLE FOR LOST PROFITS (OTHER THAN IN THE CASE OF THE PARTIES DIRECT LOSS OF PROFITS ARISING AS A RESULT OF A BREACH OF CONFIDENTIALITY), LOST BUSINESS OPPORTUNITY, INVENTORY LOSS, WORK STOPPAGE, LOST DATA OR ANY OTHER RELIANCE OR EXPECTANCY, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OF ANY KIND.

 

11.2.               Damage CapIN NO EVENT WILL UNIVERSITY’S TOTAL LIABILITY FOR THE BREACH OR NONPERFORMANCE OF THIS AGREEMENT EXCEED THE AMOUNT OF PAYMENTS PAID TO UNIVERSITY BY UNIVERSAL UNDER THE AAV/HLA-ENGINEERING LICENCE.  THIS LIMITATION WILL APPLY TO CONTRACT, TORT, AND ANY OTHER CLAIM OF WHATEVER NATURE.

 

12.          Amendment and Waiver.

 

This Agreement may be amended from time to time only by a written instrument signed by the Parties.  No term or provision of this Agreement will be waived and no breach excused unless such waiver or consent will be in writing and signed by the Party claimed to have waived or consented.  No waiver of a breach will be deemed to be a waiver of a different or subsequent breach.

 

13.          Assignment.

 

The rights and licenses granted by Universal in this Agreement are personal to Adaptimmune and Adaptimmune shall not assign its interest or delegate its duties under this Agreement without the written consent of Universal; any such assignment or delegation made

 

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without written consent of Universal will not release Adaptimmune from its obligations under this Agreement. The preceding sentence notwithstanding, Adaptimmune, without the prior approval of Universal, may assign all, but no less than all, its rights and delegate all, but no less than all, its duties under this Agreement to a Third Party provided that:

 

(i)            the assignment is made to such Third Party as a part of and in connection with (a) the sale by Adaptimmune of all but no less than all of its assets to the Third Party, (b) the sale, transfer, or exchange by the shareholders, partners, or equity owners of Adaptimmune of a majority interest in Adaptimmune to the Third Party, or (c) the merger of Adaptimmune into the Third Party (each of the events described in part (a), (b) or (c) of this paragraph, an “Acquisition”),

 

(ii)           Adaptimmune obtains from such Third Party written agreement to honor all obligations under this Agreement accrued by Adaptimmune before Acquisition and all obligations under this Agreement to accrue by such Third Party assignee after Acquisition, including any and all financial obligations, and

 

(iii)          no later than 10 days after the close of the transaction pursuant to which such Acquisition is made, Adaptimmune shall provide written notice to Universal of the Acquisition, as well as a substitution of parties document, in which such Third Party assignee assumes responsibility for all of Adaptimmune’s outstanding and future obligations relating to this Agreement.  Any assignment made in violation of this Article will be void and will, without further act, cause the immediate termination of this Agreement, effective retroactively to the date of the Acquisition.

 

This Agreement will inure to the benefit of Adaptimmune and Universal and their respective permitted assignees and trustees.

 

14.          Confidentiality.

 

14.1.       Form of transfer.  Confidential Information may be conveyed in tangible or intangible form.    Disclosing Party must clearly mark its Confidential Information “confidential.”  If disclosing Party communicates Confidential Information in non-written form, it shall reduce such communications to writing, clearly mark it “confidential”, and provide a copy to receiving Party within 30 days of original communication at the address in Article 21 “Notices”.

 

14.2.               No Unauthorized Disclosure of Confidential Information.  Beginning on the Effective Date and continuing throughout the term of this Agreement and thereafter for a period of 5 years, receiving Party shall not disclose or otherwise make known or available to any Third Party any disclosing Party Confidential Information, without the express prior written consent of disclosing Party.  Notwithstanding the foregoing, receiving Party shall be permitted to disclose disclosing Party Confidential Information to (i) actual or potential investors, lenders, consultants, collaborators, sublicensees, or development partners, which disclosure will be made under conditions of confidentiality and limited use and (ii) its attorney or agent as reasonably required. In no event shall receiving Party incorporate or otherwise use disclosing Party’s Confidential Information in connection with any patent application filed by or on behalf of receiving Party.

 

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Receiving Party shall restrict the use of disclosing Party’s Confidential Information exclusively to the terms of this Agreement.  Receiving Party shall use reasonable procedures to safeguard disclosing Party’s Confidential Information.

 

14.3.               Access to University Information.  University is an agency of the state of Washington and is subject to the Washington Public Records Act, RCW 42.56 et seq., (“Act”).  If University receives a request for public records under the Act for documents containing Adaptimmune Confidential Information, and if University concludes that the documents are not otherwise exempt from public disclosure, University will provide Universal notice of the request before releasing such documents.  Universal will provide such notice to Adaptimmune. Such notice will be provided in a timely manner to afford Adaptimmune sufficient time to review such documents and/or seek a protective order to the extent agreed as necessary with Universal in good faith and utilizing the procedures described in RCW 42.56.540

 

14.4.               Disclosure as Required by Law.  Either Party shall have the right to disclose the other Party’s Confidential Information as required by law or valid court order, provided that such Party shall inform the Party who owns such Confidential Information prior to such disclosure and shall limit the scope and recipient of disclosure to the extent required by such law or court order.

 

15.          Consent and Approvals.

 

Except as otherwise expressly provided, all consents or approvals required under the terms of this Agreement must be in writing and will not be unreasonably withheld or delayed.

 

16.          Construction.

 

The headings preceding and labeling the sections of this Agreement are for the purpose of identification only and will not in any event be employed or used for the purpose of construction or interpretation of any portion of this Agreement.  As used herein and where necessary, the singular includes the plural and vice versa, and masculine, feminine, and neuter expressions are interchangeable.

 

17.          Enforceability.

 

If a court of competent jurisdiction adjudges a provision of this Agreement unenforceable, invalid, or void, such determination will not impair the enforceability of any of the remaining provisions hereof and the provisions will remain in full force and effect.

 

18.          No Third-Party Beneficiaries.

 

No provision of this Agreement, express or implied, confers upon any person other than the Parties to this Agreement and the University any rights, remedies, obligations, or liabilities hereunder.

 

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19.          Language.

 

Unless otherwise expressly provided in this Agreement, all notices, reports, and other documents and instruments that a Party hereto elects or is required by the terms of this Agreement to deliver to the other Party hereto will be in English.

 

20.          Notices.

 

All notices, requests, and other communications that a Party is required or elects to deliver will be in writing and will be delivered personally, or by facsimile or electronic mail (provided such delivery is confirmed), or by a recognized overnight courier service or by United States mail, first-class, certified or registered, postage prepaid, return receipt requested, to the other Party at its address set forth below or to another address as a Party may designate by notice given pursuant to this article:

 

If to Universal:

Universal Cells, Inc

 

 

 

Attn: Claudia Mitchell, CEO

 

 

 

720 Broadway

 

 

 

Seattle, WA 98122

 

 

 

Email: ***

 

 

If to Adaptimmune:

Adaptimmune Limited

 

 

 

Attn: Helen Tayton-Martin, COO

 

 

 

101 Park Drive, Milton Park, Abingdon

 

 

 

Oxfordshire, OX14 4RY

 

 

 

E-mail: *** with a copy to legal@adaptimmune.com

 

21.          Patent Marking.

 

Adaptimmune shall mark all material forms of Licensed Product(s)  or packaging pertaining thereto made and sold by Adaptimmune in the United States with patent marking conforming to 35 U.S.C. §287(a), as amended from time to time.  Such marking shall further identify the pendency of any U.S. patent application and/or any issued U.S. or foreign patent forming any part of the Licensed Patents.  All Licensed Product(s) shipped to or sold in other countries will be marked in such a manner as to provide notice to potential infringers pursuant to the patent law and practice of the country of manufacture or sale.

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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22.          Publicity.

 

The Parties will cooperate with one another to review and respond to any press release or similar communication proposed by the other Party regarding the non-confidential subject matter of this Agreement. The specific content and timing of such press releases or similar communication is subject to mutual agreement by the Parties, which will not be unreasonably withheld.

 

23.          Relationship of Parties.

 

In entering into, and performing their duties under, this Agreement, the Parties are acting as independent contractors and independent employers.  No provision of this Agreement shall create or be construed as creating a partnership, joint venture, or agency relationship between the Parties.  No Party shall have the authority to act for or bind the other Party in any respect.

 

24.          Survival.

 

Immediately upon the termination or expiration of this Agreement all Company’s rights under this Agreement will terminate; provided, however, Company’s obligations that have accrued prior to the effective date of termination or expiration of this Agreement (e.g., the obligation to report and make payments on sales, leases, or dispositions of Licensed Products and to reimburse University for costs) and the obligations specified in Sections 6.1 “Payments” and 6.4 “Sales Reports” will survive.  The obligations and rights set forth in Sections 6.5 “Records Retention and Audit Rights” and 9.3 “Effect of Termination” and Articles 10 “Release, Indemnification, and Insurance”, 11 “Warranties”, 12 “Damages”, 15 “Confidentiality”, 29 “Applicable Law” and 30 “Forum Selection” will survive the termination or expiration of this Agreement.

 

25.          Collection Costs and Attorneys’ Fees.

 

If a Party fails to perform an obligation or otherwise breaches one or more of the terms of this Agreement, the other Party may recover from the non-performing breaching Party all its costs (including actual attorneys’ and investigative fees) to enforce the terms of this Agreement.

 

26.          Applicable Law.

 

The internal laws of the state of Washington will govern the validity, construction, and enforceability of this Agreement, without giving effect to the conflict of laws principles thereof.

 

27.          Forum Selection.

 

A suit, claim, or other action to enforce the terms of this Agreement will be brought exclusively in the state and federal courts of King County, Washington.

 

28.          Entire Agreement.

 

This Agreement (including all attachments, exhibits, and amendments) is the final and complete understanding between the Parties concerning licensing the Licensed Patents.  This Agreement supersedes any and all prior or contemporaneous negotiations, representations, and agreements, whether written or oral, concerning the Licensed Patents. This Agreement may not

 

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be modified in any manner, except by written agreement signed by an authorized representative of both Parties. Nothing in this Section excludes or limits any liability for fraud or fraudulent misrepresentation.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed by their respective authorized representatives.

 

 

Adaptimmune Limited

 

Universal Cells Inc

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

 

By:

 

 

 

 

 

 

Name:

 

 

Name:

 

 

 

 

 

 

Title:

 

 

Title:

 

 

 

 

 

 

Date:

 

 

Date:

 

 

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Exhibit A

 

Patent License Schedule

 

A1.          Licensed Patents:

 

A1.1               Group 1 Licensed Patents: Non-exclusive grant

 

UW#

 

IP#

 

Short Title

 

Status

 

Application
Number

 

Filing Date

 

Grant

41571

 

41571.01US2

 

AAV Isolates and AAV Vectors

 

Issued/Granted

 

08/873,168

 

6/11/1997

 

Non-exclusive

 

A1.2               Group 2 Licensed Patents

 

UW#

 

IP#

 

Short Title

 

Status

 

Application
Number

 

Filing Date

 

Grant

41754

 

41754.01US1

 

Targeted Gene Modification by Parvoviral Vectors

 

Converted

 

60/044,789

 

4/24/1997

 

Group 2 Licensed Patents Scope

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.02WO2

 

Targeted Gene Modification by Parvoviral Vectors

 

Nationalized

 

PCT/US98/07964

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.03US1

 

Targeted Gene Modification by Parvoviral Vectors

 

Converted

 

60/106,191

 

10/28/1998

 

 

 

75



 

 

 

41754.04AU2

 

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

72521/98

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.05CA2

 

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

2,289,277

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.06EP2

 

Targeted Gene Modification by Parvoviral Vectors

 

Validated

 

98919818.9

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.10WO2

 

Targeted Gene Modification by Parvoviral Vectors

 

Nationalized

 

PCT/US99/25462

 

10/27/1999

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.18US4

 

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

10/423,604

 

4/24/2003

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.20FR2

 

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.21DE2

 

Targeted Gene Modification by

 

Issued/Granted

 

98919818.9

 

4/20/1998

 

 

 

76



 

 

 

 

 

Parvoviral Vectors

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.22CH2

 

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.23IE2

 

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.24GB2

 

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.25US5

 

Targeted Gene Modification by Parvoviral Vectors

 

Pending

 

13/114,117

 

5/24/2011

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

41754.26CA3

 

Targeted Gene Modification by Parvoviral Vectors

 

Pending

 

2,797,661

 

4/20/1998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45039

 

45039.01GB2

 

Methods for Improving the Efficiency of Gene Targeting

 

Pending

 

1301125.9

 

1/22/2013

 

Jointly owned with third party

 

77



 

 

 

45039.02WO2

 

Methods for Improving the Efficiency of Gene Targeting

 

Pending

 

PCT/GB2014/050173

 

1/22/2014

 

Jointly owned with third party

 

A1.3               Group 3 Licensed Patents

 

UW#

 

IP#

 

Short Title

 

Status

 

Application
Number

 

Filing Date

 

Grant

 

 

 

 

 

 

 

 

 

 

 

 

 

43950

 

43950.01US1

 

HLA Homozygous Cells and Methods of Use Thereof

 

Converted

 

60/905,966

 

3/9/2007

 

Exclusive all fields

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

43950.02US2

 

HLA Homozygous Cells and Methods of Use Thereof

 

Issued/Granted

 

12/044,471

 

3/7/2008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

43950.03US4

 

HLA Homozygous Cells

 

Issued/Granted

 

13/333,010

 

12/21/2011

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45038

 

N/A

 

***

 

Not Filed Yet

 

N/A

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45365

 

45365.01US1

 

B2M-deficient human cells

 

Converted

 

61/477,474

 

4/20/2011

 

Exclusive all fields

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

78



 

 

 

45365.02WO2

 

B2M-deficient human cells

 

Nationalized

 

PCT/US2012/034051

 

4/18/2012

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45365.03US2

 

B2M-deficient human cells

 

Pending

 

14/111,837

 

10/15/2013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45365.04CA2

 

B2M-deficient human cells

 

Pending

 

2,833,173

 

4/18/2012

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45365.05EP2

 

B2M-deficient human cells

 

Pending

 

12720040.0

 

4/18/2012

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45365.06JP2

 

B2M-deficient human cells

 

Pending

 

Not available

 

4/18/2012

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45826

 

45826.01US1

 

HLA Class II Deficient Cells

 

Converted

 

61/625,314

 

4/17/2012

 

Exclusive all fields

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

45826.02WO2

 

HLA Class II Deficient Cells

 

Pending

 

PCT/US2013/032058

 

3/15/2013

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

46825

 

N/A

 

***

 

Not Filed Yet

 

N/A

 

N/A

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

46895

 

N/A

 

***

 

Not Filed Yet

 

N/A

 

N/A

 

 

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

79



 

Licensed Patents includes University rights in any patent application that may be filed by University solely on the technology specified in invention disclosures listed above where the patent status is “Not Yet Filed”

 

80



 

Exhibit B

 

Licensed Materials

 

UW Materials to Transfer to Universal Cells

 

Cell lines

 

***

 

***

 

***

 

***

***

***

***

***

***

 

AAV Vector stocks

 

***

***

***

***

***

***

***

***

 

***

***

***

***

***

 

***

***

***

***

***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

81



 

***

***

 

***

***

 

***

***

 

Plasmids

 

***

***

***

***

 

***

***

***

***

***

 

***

***

***

***

***

***

***

***

 

***

 

***

***

***

 

***

***

 

***

***

***

***

***

***

***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

82



 

***

***

***

***

***

***

***

 

Foamy Vectors and Plasmids

 

Foamy vectors

 

***

 

Foamy helper plasmids

 

***

***

***

***

***

***

 

Foamy backbones

 

***

 

***

 

***

 

Foamy vector plasmids

 

***

 

***

 

***

 

***

 

***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

83



 

Foamy reprogramming plasmids

 

***

 

***

 

***

 

***

 

Single chain construct plasmids

 

***

 

***

 

***

 

***

 

***

 

***

 

***

 

***

 

***

 

 

***

 

***

 

***

 

***

 

***

 

***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

84



 

***

 

***

 

***

 

***

 

 

***

 

***

 

***

 

***

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

85



 

Schedule 3 — Sublicense under Elf Licence

 

86



 

 

November 25, 2015

 

NON-EXCLUSIVE SUB-LICENSE AGREEMENT

 

THIS AGREEMENT (“Agreement”) is dated and effective as of the date of last signature (“Effective Date”), and is made by and between Universal and Adaptimmune Limited, an English Adaptimmune with principal offices at 101 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY (“Adaptimmune”), and Universal Cells, a Corporation under the laws of the state of Washington (“Universal”) with principal offices at 720 Broadway, Seattle, WA 98122, agree as follows:

 

1.                                      BACKGROUND

 

1.1                               Universal has certain rights to Biological Material known as New naive human embryonic stem cell line - Elf1 (as defined in Section 2.1), developed in the laboratory of ***                 and licensed from the University under a Non-Exclusive License Agreement dated 22 October 2014 (“Elf Licence”).

 

1.2                               Adaptimmune and Universal have entered in to a Research Collaboration and Licence Agreement relating to gene editing and HLA-Engineering on or about the date of this Agreement (“Collaboration Agreement”), under which the parties agreed to enter into this Agreement.

 

1.3                               Universal and University have previously entered into an exclusive license agreement with University for inventions and materials related to or useful for Adeno-associated virus (AAV)-mediated gene targeting and HLA engineering, UW Ref # 34243A on June 27, 2014 “AAV/HLA-engineering Licence”. Adaptimmune and Universal have also entered into an exclusive sub-licence agreement under the AAV/HLA-engineering Licence on or about the Effective Date (“Exclusive Agreement”).

 

2.                                      DEFINITIONS

 

2.1                               “Biological Material” means New naive human embryonic stem cell line - Elf1 (with a University Reference UW # 45910).

 

2.2                               “Internal Research Field of Use” means internal research. Internal Research Field of Use specifically excludes any use which requires regulatory approval, including any in vitro and in vivo diagnostic or therapeutic applications.

 

2.3                               “Product Field of Use” means in vivo therapeutics excluding any therapeutic agent for cardiac regeneration and cardiovascular disease.

 

2.4                               “Licensed Product” means a Product as defined in the Collaboration Agreement.

 

2.5                               “Licensed Territory” means worldwide.

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

87



 

2.6                               “Modifications” means any derivatives or modifications of Biological Material that, but for the rights granted under Exclusive Agreement, would otherwise infringe a Valid Claim of Groups 2 and 3 Licensed Patents as defined in Exclusive Agreement.

 

2.7                               “Service Partner” means a legal entity that is a Third Party with whom Adaptimmune has contracted to provide services within the Internal Research Field of Use and Product Field of Use.  For clarity, a legal entity is only a Service Partner for so long as the definition remains true.  If such entity terminates its contractual obligation with Adaptimmune, it thereafter is an arm-length Third Party for the purposes of this Agreement.

 

2.8                               “Third-Party” means any individual or entity other than Universal and Adaptimmune or their respective affilliates.

 

2.9                               “University” means the University of Washington a public institution of higher education and an agency of the State of Washington acting through its administrative offices at UW CoMotion, 4311 Eleventh Avenue NE, Suite 500, Seattle, WA 98105

 

3.                                      GRANT

 

3.1                               Universal hereby grants, and Adaptimmune accepts, a nonexclusive license in the (i) Product Field of Use and Licensed Territory to make, use, offer, and sell Licensed Product(s) for Product Family 2 and (ii) make, use, offer, and sell Licensed Products in the Internal Research Field of Use for Product Family 1. Such license does not include the right for Adaptimmune to transfer any Licensed Products to any Third Parties or affiliates for resale other than as incorporated in a therapeutic product. Such licence shall not include any right to Biological Material.

 

3.2                               Service Partners of Adaptimmune shall have the right to transfer Modifications to Service Partners working on behalf of Adaptimmune solely for the purpose of carrying out services in direct connection with using the Modifications in the Internal Field of Use and Product Field of Use.  Any such transfer of Modifications to such Service Partner shall be under a written agreement between Adaptimmune and such Service Partner which (a) shall be in writing, (b) shall be subject to, subordinate to, and consistent with, the terms and conditions of this Agreement, (c) shall not adversely affect the rights of University or Universal or limit the obligations of Adaptimmune under this Agreement, (d) shall contain terms substantially similar to those contained in this Agreement, and (e) shall expressly provide that the Service Partner has no rights to use the Modifications for any purpose other than to perform the services in direct connection with the Licensed Field of Use, and that such Service Partner shall not transfer the Modifications to any Third-Party.  Adaptimmune will be responsible for the performance of all Service Partner in compliance with all obligations of Adaptimmune under this Agreement.

 

3.3                               The term of this Agreement shall commence as of the Effective Date and shall expire on termination of the Collaboration Agreement or at such point as a decision is taken by both parties under the Collaboration Agreement that the Biological Material and any Modifications are no longer required for use under the Collaboration Agreement.

 

88



 

3.4                               Nothing in this Agreement shall be construed as granting by implication, estoppel, or otherwise any licenses or rights under patents or patent applications of Universal.

 

4.                                      NEGATION OF WARRANTIES

 

Except as expressly set forth in this Agreement, NEITHER UNIVERSAL OR ADAPTIMMUNE MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTIBILITY, FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF BIOLOGICAL MATERIAL, MODIFICATIONS, AND/OR LICENSED PRODUCT(S) WILL NOT INFRINGE ANY PATENT, COPYRIGHT, OR TRADEMARK, OR OTHER RIGHTS OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.

 

5.                                      Release, Indemnification, and Insurance

 

5.1                               Adaptimmune’s Release.  For itself and its employees, Adaptimmune hereby releases University and its regents, employees, and agents forever from any suits, actions, claims, liabilities, demands, damages, losses, or expenses (including reasonable attorneys’ and investigative expenses) relating to or arising out of (i) the manufacture, use, lease, sale, or other disposition of a Licensed Product; (ii) the assigning or sublicensing of Adaptimmune’s rights under this Agreement; or (iii) manufacture or use of Modifications and/or Licensed Products by Service Partners.

 

5.2                               Adaptimmune’s Indemnification.  Throughout the term of this Agreement and thereafter, Adaptimmune shall indemnify, defend, and hold University and its regents, employees, and agents harmless from all suits, actions, claims, liabilities, demands, damages, losses, or expenses (including reasonable attorneys’ and investigative expenses), relating to or arising out of the manufacture, use, lease, sale, or other disposition of Biological Materials, Modifications, and/or Licensed Product(s), including, without limitation, personal injury, property damage, breach of contract and warranty and products-liability claims relating to a Licensed Product and claims brought by a SubAdaptimmune or Service Partner.

 

5.3                               Adaptimmune’s Insurance.

 

5.3.1       General Insurance Requirement.  Throughout the term of this Agreement, or during such period as the Parties shall agree in writing, Adaptimmune shall maintain, and shall cause each Sub-Licensee to maintain, in full force and effect commercial general liability (CGL) insurance, with single claim limits consistent with industry standards.  Such insurance policy will include coverage for claims that may be asserted by Universal against Adaptimmune under section 6.2 “Adaptimmune’s Indemnification”.  Adaptimmune shall deliver to Universal a copy of the certificate of insurance for such policy following receipt of written request for such.

 

5.3.2       Clinical Trial Liability Insurance.  On initiation of human clinical trials with respect to Licensed Product(s), Adaptimmune shall provide to Universal certificates evidencing the existence and amount of clinical trials liability insurance, following receipt of request from Universal.    Adaptimmune shall further provide Universal, at least annually, proof of continued coverage to the extent such clinical trials are continuing and following receipt of request from Universal.

 

89



 

6.                                      Warranties.

 

6.1                               Authority.  Each Party represents and warrants to the other Party that it has full corporate power and authority to execute, deliver, and perform this Agreement, and that no other corporate proceedings by such Party are necessary to authorize the Party’s execution or delivery of this Agreement.

 

6.2                               Disclaimers.

 

6.2.1       General Disclaimers.  EXCEPT FOR THE EXPRESS WARRANTY SET FORTH IN SECTION 11.1 “Authority” OF THIS AGREEMENT, UNIVERSAL DISCLAIMS AND EXCLUDES ALL WARRANTIES, EXPRESS AND IMPLIED, CONCERNING EACH BIOLOGICAL MATERIAL AND MODIFICATIONS AND EACH LICENSED PRODUCT, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT AND THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

 

7.                                      Damages.

 

7.1                               Remedy LimitationEVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, IN NO EVENT SHALL UNIVERSITY BE LIABLE FOR (A) PERSONAL INJURY OR PROPERTY DAMAGES ARISING IN CONNECTION WITH THE ACTIVITIES CONTEMPLATED IN THIS AGREEMENT OR (B) LOST PROFITS, LOST BUSINESS OPPORTUNITY, INVENTORY LOSS, WORK STOPPAGE, LOST DATA OR ANY OTHER RELIANCE OR EXPECTANCY, INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OF ANY KIND.

 

7.2                               Damage CapIN NO EVENT WILL UNIVERSITY’S TOTAL LIABILITY FOR THE BREACH OR NONPERFORMANCE OF THIS AGREEMENT EXCEED ***                                                                                                                                                                                                          .  THIS LIMITATION WILL APPLY TO CONTRACT, TORT, AND ANY OTHER CLAIM OF WHATEVER NATURE.

 

8.                                      NAMES AND MARKS

 

Nothing contained in this Agreement shall be construed as conferring any right to use any name, trade name, trademark, service mark, symbol or other designation of the other party, or the name of any faculty member, employee, or student of the other party, without prior written consent of that party, unless such listing is required under local laws or regulations, provided that either party may state the existence of this Agreement.  For any use other than the foregoing, the parties hereby expressly agree not to use the other party’s name or the University’s name or any contraction, abbreviation, or simulation thereof without prior written approval from an authorized representative of the relevant entity.

 

9.                                      TERMINATION

 

9.1                               Adaptimmune may terminate this Agreement by giving Universal notice in writing at least 30 days in advance of the effective termination date provided that Adaptimmune, Sublicencees, and Service Partners shall thereupon cease use and sale of Biological Material and any Licensed Product(s).

 


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9.2                               Effect of Termination

 

9.2.1       Licensed Terminated - After termination of this Agreement, Adaptimmune shall not make, have made, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products.

 

9.2.2       Concurrent with notice of termination by either Adaptimmune or Universal, Adaptimmune and Service Partners shall destroy all Modifications, and Licensed Product(s) in their possession, and shall provide written evidence of said destruction. If Adaptimmune enters into a direct license with Universal to retain rights in the Modifications under Section 10.2.3

 

9.2.3       “Termination of Elf Licence.  ”, Adaptimmune may retain Modifications and Licensed Product(s) in its possession during the Initial Notice Period and negotiation period. At any time within 30 days following termination of the Elf Licence (notification of which to be immediately provided by Universal to Adaptimmune), Adaptimmune may notify Universal and University that it wishes to enter into a direct license with University in order to retain its rights to the Modifications granted to it under this Agreement (such 30-day period following termination, the “Initial Notice Period”).  Following receipt of such notice, University and Adaptimmune (and to the extent required Universal shall facilitate such negotiations and finalization) shall enter into a license agreement the terms of which shall be substantially similar to the terms of the Elf Licence; and the scope of such direct license, the licensed territory or the duration of the license grant shall be comparable to the corresponding terms granted to Adaptimmune under this Agreement; provided that Adaptimmune will be granted at least the same scope of rights as it obtained from Universal under this Agreement.  For the sake of clarity, the financial terms, including without limitation, the running royalty rate and milestone payments, shall be identical to the corresponding financial terms set forth in the Elf Licence. Universal shall keep Adaptimmune informed of all material changes to the Elf Licence, including changes to the financial terms that Adaptimmune would be required to accept under this Section. Notwithstanding the foregoing, each Adaptimmune’s right to enter into such direct license shall be conditioned upon:

 

10.2.3.1                         Written Notification to University.  Adaptimmune informing Universal and University in writing, pursuant to Article 11.4 “Notices”, that it wishes to enter into such direct license with University, within the Initial Notice Period;

 

10.2.3.2                         Adaptimmune Good Standing.  Adaptimmune being in good standing with Universal under this Agreement, and this Agreement not being the subject of a dispute between Adaptimmune and Universal, or between Universal and University under the Elf Licence (in which case Universal shall have notified Adaptimmune of such dispute);

 

10.2.3.3                         Valid Sublicense.  This Agreement having been validly entered into by Adaptimmune and Universal pursuant to the terms of the Elf Licence and the parties confirm and agree that this Agreeent has been validly entered into pursuant to the terms of the Elf Licence;

 

10.2.3.4                         Certification that Conditions Satisfied.  Adaptimmune using reasonable efforts to certify or otherwise demonstrate that the conditions set forth in the above subsections subsections  have been met within 30 days of expiration of the Initial Notice Period (or within such longer period of time as University agrees is reasonable under the

 

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circumstances, based on the nature and extent of any documentation reasonably requested by University); and

 

10.2.3.5                         Time Limitations.  Such negotiations for a direct license not exceeding 90 days from the end of the 30-day (or longer, if applicable) period described in subsection 9.2.3.2 “Adaptimmune Certification that Conditions Satisfied” (subject to extension of said 90-day period by mutual written agreement of University and Adaptimmune).  University may, at its sole discretion, waive any of these requirements.  If all of the conditions set forth in this Subsection 9.2.3 “Termination of Sublicenses” are met, then Adaptimmune will be granted such direct license by University.  If any condition set forth in this Section 10.2.3 “Termination of Sublicenses” is not met, then after expiration of any time period granted to Adaptimmune with respect to meeting such condition, Adaptimmune shall not make, have made, use, offer to sell or sell, offer to lease or lease, import, or otherwise offer to dispose or dispose of Licensed Products and University shall be free to license or not license Licensed Patents to such Adaptimmune according to its sole discretion. Adaptimmune shall destroy all Modifications and Licensed Product(s) in their possession, and shall provide written evidence of said destruction.

 

9.3                               Breach by Adaptimmune. Universal may terminate this Agreement if Adaptimmune is in breach of any provision hereof and Adaptimmune fails to remedy any such breach no later than 60 days after written notice thereof by Universal.

 

9.4                               Survival. Immediately upon the termination of this Agreement all Adaptimmune’s rights under this Agreement will terminate; provided, however, That the obligations and rights set forth in Sections 11.7 “Records Retention”, 11.8 “Audit Rights” and 10.2 “Effect of Termination” and Articles 6 “Release, Indemnification, and Insurance”, 7 “Warranties”, 8 “Damages”, 11.2 “Public Records Act”, 11.6 “Law and Venue” will survive the termination of this Agreement.

 

10.                               MISCELLANEOUS

 

10.1                        Adaptimmune Compliance With All Laws - Adaptimmune shall comply and ensure that any Service Partners shall comply with all applicable laws, statutes, regulations, guidelines and reporting requirements in all applicable jurisdictions in its use, storage, disposal, handling, transferring and selling of Biological Material and/or Licensed Product(s).

 

10.2                        Assignment Adaptimmune shall not assign this Agreement to a Third Party without the express written consent of Universal, except that Adaptimmune may assign or otherwise transfer this Agreement and the license granted hereby and the rights acquired by it hereunder so long as such assignment or transfer is accompanied by a sale or other transfer of Adaptimmune’s entire business or of the entirety of that part of Adaptimmune’s business to which the license granted hereby relates, including a change of control. Adaptimmune shall provide written notice to Universal of such assignment and transfer no later than 10 days after the close of the transaction pursuant to which such assignement is made.  Upon such assignment or transfer, the term “Adaptimmune” as used in this Agreement will include such assignee or transferee and this Agreement will be binding upon Adaptimmune’s permitted successors and assigns.  Any

 

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attempted assignment, transfer or delegation in breach of this provision will be deemed void and will entitle Universal to terminate this Agreement upon written notice to Adaptimmune.

 

10.3                        Notices - All notices under this Agreement will be deemed to have been fully given when done in writing and deposited in the United States mail, registered or certified, and addressed as follows:

 

If to University:

UW Center for Commercialization

 

Attn: Director, Technology Licensing

 

4311 11th Avenue NE, Suite 500

 

Seattle, WA 98105-4608

 

Facsimile No.: 206-685-4767 (Universal shall keep Adaptimmune informed of any changes to notification address for University)

 

 

If to Universal:

Attn: Claudia Mitchell, CEO

 

Universal Cells, Inc

 

720 Broadway

 

Seattle, WA 98122

 

E-mail: ***

 

 

If to Adaptimmune:

Attn: Helen Tayton-Martin, COO

 

 

 

Adaptimmune Limited, 101 Park Drive, Milton Park

 

Abingdon, Oxford, OX14 4RY

 

E-mail: *** with a copy to legal@adaptimmune.com.

 

Either party may change its address upon written notice to the other party.

 

10.4                        Waiver and Severability - None of the terms of this Agreement can be waived except by the written consent of the party waiving compliance. If any provision of this Agreement is held illegal, void, or unenforceable, the remaining portions will remain in full force and effect.

 

10.5                        Law and Venue - The laws of the state of Washington will govern the validity, construction, and enforceability of this Agreement, without giving effect to the conflict of laws principles thereof. Any claim related in any manner to this Agreement will be instituted and commenced in, and venue will be either King County, Washington or the United States District Court for the Western District of Washington.

 

10.6                        Record Retention- Throughout the term of this Agreement and for 5 years thereafter, Adaptimmune, at its expense, shall keep and maintain complete and accurate records of all sales, leases, and other dispositions of Licensed Products during the term of this Agreement and all other records related to this Agreement.

 

10.7                        Audit Rights - Adaptimmune shall, at the request of Universal, permit one or more accountants selected exclusively by University to have access to Adaptimmune’s records and books of

 


***         Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

 

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account pertaining to this Agreement during ordinary working hours to audit with respect to any payment period ending prior to such request, the correctness of any report or payment made under this Agreement.

 

The accountant will not disclose to University or Universal any information relating to the business of Adaptimmune except that which is necessary to inform University of: the accuracy or inaccuracy of Adaptimmune’s reports and payments; compliance or noncompliance by Adaptimmune with the terms and conditions of this Agreement; and the extent of any inaccuracy or noncompliance.

 

University will bear the costs of any audit initiated by Universal.

 

10.8                        Export Controls - Adaptimmune shall abide by all U.S. export laws and regulations. Accordingly, Adaptimmune is solely responsible for securing any necessary permissions or licenses to exercise its rights under this Agreement.

 

10.9                        Entire Agreement - No Third Party Beneficiaries. This Agreement (including all attachments, exhibits, and amendments hereto) is intended by the parties as the final and binding expression of their contract and agreement and as the complete and exclusive statement of the terms thereof. This Agreement cancels, supersedes, and revokes all prior negotiations, representations and agreements among the parties, whether oral or written, relating to the subject matter of this Agreement.

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate originals by their duly authorized officers or representatives.

 

 

Adaptimmune

Universal Cells

 

 

By:

 

 

By:

 

 

 

 

 

 

Name:

 

 

Name:

 

 

 

 

 

 

Title:

 

 

Title:

 

 

 

 

 

 

Date:

 

 

Date:

 

 

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Schedule 4 — Universal Pre-existing Patents

 

Title

 

Status

 

Application
Number

 

Country

 

Filing Date

Adeno-Associated Viruses (AAV) Isolates and AAV Vectors Derived Therefrom

 

Issued/Granted

 

08/873,168

 

US

 

6/11/1997

Targeted Gene Modification by Parvoviral Vectors

 

Converted

 

60/044,789

 

US

 

4/24/1997

Targeted Gene Modification by Parvoviral Vectors

 

Nationalized

 

PCT/US98/07964

 

WO

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Converted

 

60/106,191

 

US

 

10/28/1998

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

72521/98

 

AU

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

2,289,277

 

CA

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Validated

 

98919818.9

 

EP

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Nationalized

 

PCT/US99/25462

 

WO

 

10/27/1999

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

10/423,604

 

US

 

4/24/2003

 

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Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

FR

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

DE

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

CH

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

IE

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Issued/Granted

 

98919818.9

 

GB

 

4/20/1998

Targeted Gene Modification by Parvoviral Vectors

 

Pending

 

13/114,117

 

US

 

5/24/2011

TARGETED GENE MODIFICATION BY PARVOVIRAL VECTORS

 

Pending

 

2,797,661

 

CA

 

4/20/1998

HLA Homozygous Cells and Methods of Use Thereof

 

Converted

 

60/905,966

 

US

 

3/9/2007

HLA Homozygous Cells and Methods of Use Thereof

 

Issued/Granted

 

12/044,471

 

US

 

3/7/2008

HLA HOMOZYGOUS CELLS

 

Issued/Granted

 

13/333,010

 

US

 

12/21/2011

METHODS FOR IMPROVING THE EFFICIENCY OF GENE TARGETING

 

Pending

 

1301125.9

 

GB

 

1/22/2013

 

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Methods for Improving the Efficiency of Gene Targeting

 

Pending

 

PCT/GB2014/050173

 

WO

 

1/22/2014

Beta-2 microglobulin-deficient human cells

 

Converted

 

61/477,474

 

US

 

4/20/2011

BETA-2 MICROGLOBULIN-DEFICIENT CELLS

 

Nationalized

 

PCT/US2012/034051

 

WO

 

4/18/2012

BETA-2 MICROGLOBULIN-DEFICIENT CELLS

 

Pending

 

14/111,837

 

US

 

10/15/2013

BETA-2 MICROGLOBULIN-DEFICIENT CELLS

 

Pending

 

2,833,173

 

CA

 

4/18/2012

BETA-2 MICROGLOBULIN-DEFICIENT CELLS

 

Pending

 

12720040.0

 

EP

 

4/18/2012

Beta-2 microglobulin-deificient human cells

 

Pending

 

Not available

 

JP

 

4/18/2012

HLA CLASS II DEFICIENT CELLS

 

Converted

 

61/625,314

 

US

 

4/17/2012

HLA CLASS II DIFICIENT CELLS, HLA CLASS I DEFICIENT CELLS CAPABLE OF EXPRESSING HLA CLASS II PROTEINS, AND USES THEREOF

 

Pending

 

PCT/US2013/032058

 

WO

 

3/15/2013

Controlling stem cell potential

 

Converted

 

62/012,539

 

US

 

6/16/2014

 

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Schedule 5 — AAV/HLA-engineering Licence

 

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EXCLUSIVE PATENT LICENSE AND MATERIAL TRANSFER AGREEMENT

 

BETWEEN

 

UNIVERSAL CELLS

 

AND

 

UNIVERSITY OF WASHINGTON

 

FOR

 

INVENTIONS AND MATERIALS RELATED TO OR USEFUL FOR ADENO-ASSOCIATED VIRUS (AAV)-MEDIATED GENE TARGETING AND HLA ENGINEERING

 

UW REF. 34243A

 



 

CONFIDENTIAL

 

Table of Contents

 

Background

1

1.

Definitions

1

2.

Term

4

3.

Grant of License

5

4.

Applications and Patents

7

5.

Commercialization

8

6.

Payments, Reimbursements, Reports, and Records

9

7.

Infringement

10

8.

Patent Validity

12

9.

Termination

12

10.

Release, Indemnification, and Insurance