Alaunos Therapeutics (TCRT) 10-Q 2019 Q2 Quarterly report

Exhibit 10.3

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE ZIOPHARM ONCOLOGY, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO ENTEROME S.A. IF PUBLICLY DISCLOSED.

PUBLIC HEALTH SERVICE

PATENT LICENSE AGREEMENT –EXCLUSIVE

ThisAgreement is based on the model Patent License Exclusive Agreement adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are agencies of thePHS within the Department of Health and Human Services (“HHS”).

This Cover Page identifies the Parties to thisAgreement:

The U.S. Department of Health and Human Services, as represented by

National Cancer Institute

an Institute or Center (hereinafter referred to as the “IC”) of the

NIH

and

Ziopharm Oncology, Inc.,

hereinafter referred to as the “Licensee”,

having offices at One First Avenue, Parris Building #34, Navy Yard Plaza, Boston, MA 02129,

created and operating under the laws of Delaware.

Tax ID No.:841475642

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For theIC internal use only:

License Number:L-190-2019-0

License Application Number:A-085-2019

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Cooperative Research and Development Agreement (CRADA) Number (if a subject invention): 03111

Additional Remarks: N/A

Public Benefit(s): New therapeutics options for the treatment of advanced cancers.

This Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this Cover Page, an attachedAgreement, a Signature Page, Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties), Appendix D (Benchmarks and Performance), Appendix E (Commercial Development Plan), Appendix F (Example Royalty Report), and Appendix G (Royalty Payment Options).

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TheIC and theLicensee agree as follows:

1. BACKGROUND

1.1 In the course of conducting biomedical and behavioral research, theIC investigators made inventions that may have commercial applicability.

1.2 By assignment of rights fromIC employees and other inventors,HHS, on behalf of theGovernment, owns intellectual property rights claimed in any United States or foreign patent applications or patents corresponding to the assigned inventions.HHS also owns any tangible embodiments of these inventions actually reduced to practice by theIC.

1.3 The Secretary ofHHS has delegated to theIC the authority to enter into thisAgreement for the licensing of rights to these inventions.

1.4 TheIC desires to transfer these inventions to the private sector through commercialization licenses to facilitate the commercial development of products and processes for public use and benefit.

1.5 TheLicensee desires to acquire commercialization rights to certain of these inventions in order to develop processes, methods, or marketable products for public use and benefit.

2. DEFINITIONS

2.1 “Affiliate(s)” means a corporation or other business entity, which directly or indirectly is controlled by or controls, or is under common control with theLicensee. For this purpose, the term “control” shall mean ownership of more than fifty percent (50%) of the voting stock or other ownership interest of the corporation or other business entity, or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the corporation or other business entity. Notwithstanding the foregoing, Eden BioCell Limited shall be deemed anAffiliate ofLicensee.

2.2 “Additional T Cell Receptor(s)” means an isolated human, murine or human-murine hybrid T cell receptor restricted by any major histocompatibility complex class molecule, which immunologically recognizes a mutated epidermal growth factor receptor (EGFR), KRAS or P53 tumor antigen.

2.3 “Benchmarks” mean the performance milestones that are set forth in Appendix D.

2.4 “Combination Product” means a product that (a) contains aLicensed Product(s) or utilizes aLicensed Process(es), and (b) contains at least one other active therapeutic component or device other than aLicensed Product(s).

2.5 “Commercial Development Plan” means the written commercialization plan attached as Appendix E.

2.6 “CRADA”means a Cooperative Research and Development Agreement. For purposes of thisAgreement, the specificCRADAbetweenIC andLicensee bearsIC reference number 03111.

2.7 “FDA” means the Food and Drug Administration of the United States of America.

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2.8 “First Commercial Sale” means the initial transfer by or on behalf of theLicensee, its Affiliates or sublicensees of theLicensed Productsor the initial practice of aLicensed Process by or on behalf of theLicensee, itsAffiliatesor sublicensees in a country, in each case, after all applicable marketing and pricing approvals (if any) have been granted by the applicable governing regulatory authority in such country, in exchange for cash or some equivalent consideration to which value can be assigned for the purpose of determiningNet Sales. In addition, sales of a Product by and between theLicensee and itsAffiliates and sublicensees shall not constitute aFirst Commercial Sale.

2.9 “Government” means the Government of the United States of America.

2.10 “Licensed Fields of Use” means the fields of use identified in Appendix B.

2.11 “Licensed Patent Rights” shall mean:

(a) Patent applications (including provisional patent applications and PCT patent applications) or patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from these applications, divisions, and continuations, and any reissues, reexaminations, and extensions of these patents;

(b) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.11(a):

(i) continuations-in-part of 2.11(a);

(ii) all divisions and continuations of thesecontinuations-in-part;

(iii) all patents issuing from thesecontinuations-in-part, divisions, and continuations;

(iv) priority patent application(s) of 2.11(a); and

(v) any reissues, reexaminations, and extensions of these patents;

(c) to the extent that the following contain one or more claims directed to the invention or inventions disclosed in 2.11(a): all counterpart foreign and U.S. patent applications and patents to 2.11(a) and 2.11(b), including those listed in Appendix A; and

(d) Licensed Patent Rights shallnot include claims included in patents or applications identified in 2.11(b) or 2.11(c) to the extent that such claims are directed to new matter which is not the subject matter disclosed in 2.11(a).

2.12 “Licensed Processes” means processes which, in the course of being practiced, would be within the scope of one or moreValid Claims of theLicensed Patent Rightsin the country in which such processes are practiced.

2.13 “Licensed Products” means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or moreValid Claims of theLicensed Patent Rightsin the country of such manufacture, use, sale, or import, as applicable.

2.14 “Licensed Territory” means the geographical area identified in Appendix B.

2.15 “Net Sales” means [***];

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2.16 “Phase 1 Clinical Study” shall mean the initial introduction of an investigational new drug into humans, the principal purpose of which is to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness, in compliance with 21 C.F.R. §312(a) or foreign equivalen0074.

2.17 “Phase 2 Clinical Study” shall mean controlled human clinical studies conducted to evaluate the effectiveness of a drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug in compliance with 21 C.F.R. §312(b) or foreign equivalent, and shall include any clinical study that leads to a conditional regulatory approval, that is followed by a confirmatoryPhase 3 Clinical Trial.

2.18 “Phase 3 Clinical Study” shall mean expanded controlled and uncontrolled human clinical trials pursuant to a randomized study with endpoints agreed upon by regulatory bodies for regulatory approval performed afterPhase 2 Clinical Trial evidence suggesting effectiveness of a drug has been obtained, and is intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a drug and to provide an adequate basis for regulatory approval and physician labeling, as in compliance with 21 C.F.R. §312 or foreign equivalent, and shall include a confirmatory study that is conducted following conditional regulatory approval.

2.19 “Practical Application” means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case, under these conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law orGovernment regulations available to the public on reasonable terms.

2.20 “Research License” means a nontransferable, nonexclusive license to make and to use theLicensed Products or theLicensed Processes as defined by theLicensed Patent Rights for purposes of research within theLicensed Fields of Use and not for any commercial purposes or distribution or in lieu of purchase.

2.21 “Sublicense Revenue” means [***].

2.22 “Valid Claim” means (a) a claim of any issued and unexpired patent within theLicensed Patent Rights; or (b) a claim of a pending patent application within theLicensed Patent Rights and, in each case has not been (i) permanently revoked or held unpatentable, invalid or unenforceable by a final decision of a court or governmental agency of competent jurisdiction, which decision can no longer be appealed or was not appealed within the time allowed, (ii) rendered unenforceable through disclaimer or otherwise, (iii) abandoned or (iv) permanently lost through an interference or opposition proceeding without any right of appeal or review;provided, however, that if a claim of a pending patent application within theLicensed Patent Rights shall not have issued within [***] after the first official office action on its merits, such claim shall not constitute aValid Claim for the purposes of thisAgreement unless and until a patent issues with such claim (from and after which time the same would be deemed aValid Claim).

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3. GRANT OF RIGHTS

3.1 TheIC hereby grants and theLicensee accepts, subject to the terms and conditions of thisAgreement, an exclusive license under theLicensed Patent RightsGroups A, B, C, D and E in theLicensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import anyLicensed Products in theLicensed Fields of Use and to practice and have practiced anyLicensed Process(es) in theLicensed Fields of Use. For clarity:Licensed Field of Use 1 applies toLicensed Patent Rights Group A only;Licensed Field of Use 2 applies toLicensed Patent Rights Group B only;Licensed Field of Use 3 applies toLicensed Patent Rights Group C only;Licensed Field of Use 4 applies toLicensed Patent Rights Group D only; andLicensed Field of Use 5 applies toLicensed Patent Rights Group E only.

3.2 The IC hereby grants and theLicensee accepts, subject to the terms and conditions of thisAgreement, a nonexclusive license underLicensed Patent RightsGroup F in theLicensed Territory to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import anyLicensed Products in theLicensed Fields of Use6 and to practice and have practiced anyLicensed Processes in theLicensed Fields of Use6.

3.3 ThisAgreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of theIC other than theLicensed Patent Rights regardless of whether these patents are dominant or subordinate to theLicensed Patent Rights.

4. SUBLICENSING

4.1 Upon written approval, which shall include prior review of any sublicense agreement by theIC and which shall not be unreasonably withheld, theLicensee may enter into sublicensing agreements under theLicensed Patent Rights.If, within [***] ofIC’s receipt of a proposed sublicense fromLicensee,IC has not providedLicensee with a written notice of rejection thereof, thenIC shall be deemed to have given its approval of such sublicense agreement andLicenseeshall be free to enter into such sublicense agreement under theLicensed Patent Rights,subject to the further requirements of Paragraphs4.2-4.4 of thisAgreement.However,Licensed Patent Rights Group F may only be sublicensed in combination withLicensee’s proprietary intellectual property,in-licensed intellectual property rights received from a third party, or other exclusivelyin-licensed intellectual property rights received from theIC. For the avoidance of doubt, theLicensee does not have the right to solely sublicenseLicensed Patent RightsGroup F.

4.2 TheLicensee agrees that any sublicenses granted by it shall provide that the obligations to theIC of Paragraphs5.1-5.4, 8.1, 10.1, 10.2, 12.5, and13.8-13.10 of thisAgreement shall be binding upon the sublicensee as if it were a party to thisAgreement. TheLicensee further agrees to attach copies of these Paragraphs to all sublicense agreements.

4.3 Any sublicenses granted by theLicensee shall provide for the termination of the sublicense, or the conversion to a license directly between the sublicensees and theIC, at the option of the sublicensee, upon termination of thisAgreement under Article 13. This conversion is subject to theIC approval and contingent upon acceptance by the sublicensee of the remaining provisions of thisAgreement.

4.4 TheLicensee agrees to forward to theIC a complete copy of each fully executed sublicense agreement postmarked within [***] of the execution of the agreement. To the extent permitted by law, theIC agrees to maintain each sublicense agreement in confidence.

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5. STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS

5.1         (a) TheIC reserves on behalf of theGovernment an irrevocable, nonexclusive, nontransferable,royalty-free license for the practice of all inventions licensed under theLicensed Patent Rights throughout the world by or on behalf of theGovernment and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which theGovernment is a signatory. Prior to theFirst Commercial Sale, theLicensee agrees to provide theIC with reasonable quantities of theLicensed Products or materials made through theLicensed Processes forIC research use. Given the nature of the envisionedLicensed Products as personalized autologous cell therapy products, if anyLicensed Products and/or materials made through theLicensed Processes are not available in reasonable quantities forIC research use, they shall not be subject to the foregoing obligation; and

(b) In the event that theLicensed Patent Rights are Subject Inventions made underCRADA, theLicensee grants to theGovernment, pursuant to15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable,paid-up license to practice theLicensed Patent Rights or have theLicensed Patent Rights practiced throughout the world by or on behalf of theGovernment. In the exercise of this license, theGovernment shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from anon-Federal party. Prior to theFirst Commercial Sale, theLicensee agrees to provide theIC with reasonable quantities of theLicensed Products or materials made through theLicensed Processes forIC research use. Given the nature of the envisionedLicensed Products as personalized autologous cell therapy products, if anyLicensed Products and/or materials made through theLicensed Processes are not available in reasonable quantities forIC research use, they shall not be subject to the foregoing obligation.

5.2 TheLicensee agrees that products used or sold in the United States embodying theLicensed Products or produced through use of theLicensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from theIC, which written waiver will not be unreasonably withheld or denied.

5.3 TheLicensee acknowledges that theIC may enter into futureCRADAs under theFederal Technology Transfer Act of 1986 that relate to the subject matter of thisAgreement. TheLicensee agrees not to unreasonably deny requests for aResearch License from future collaborators with theIC when acquiring these rights is necessary in order to make aCRADA project feasible. TheLicensee may request an opportunity to join as a party to the proposedCRADA.

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(a) In addition to the reserved license of Paragraph 5.1, theIC reserves the right to grantResearch Licenses directly or to require theLicensee to grantResearch Licenses on reasonable terms. In the exercise of this reserved right, theIC shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from anon-Federal party. The purpose of theseResearch Licenses is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard theLicensed Patent Rights, however, (i) theIC shall consult with theLicensee before granting to commercial entities aResearch License or providing to them research samples of materials made through theLicensed Processes; (ii) theIC shall give to theLicensee advance written notice of any commercial party to which theIC proposes to grant aResearch License; (iii) theIC shall provide theLicensee reasonable opportunity to raise objections thereto and comment thereon, such objection(s) and comment(s) to be provided within fifteen (15) days; and (iv) theIC shall consult with theLicensee to consider in good faith the objections and comments of theLicensee; and

(b) In exceptional circumstances, and in the event that theLicensed Patent Rights are Subject Inventions made under aCRADA, theGovernment, pursuant to15 U.S.C. §3710a(b)(1)(B), retains the right to require theLicensee to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use theLicensed Patent Rights in theLicensed Field of Useon terms that are reasonable under the circumstances, or if theLicensee fails to grant this license, theGovernment retains the right to grant the license itself. The exercise of these rights by theGovernment shall only be in exceptional circumstances and only if theGovernment determines:

(i) the action is necessary to meet health or safety needs that are not reasonably satisfied by theLicensee;

(ii) the action is necessary to meet requirements for public use specified by Federal regulations, and these requirements are not reasonably satisfied by theLicensee; or

(iii) theLicensee has failed to comply with an agreement containing provisions described in15 U.S.C. §3710a(c)(4)(B).

(c) The determination made by theGovernment under this Paragraph 5.3 is subject to administrative appeal and judicial review under35 U.S.C. §203(b).

(d) TheIC acknowledges and agrees that aResearch License or other right granted pursuant to this Paragraph 5.3 shall only pertain to theLicensed Patent Rights and shall not include a right or license to any patent or other intellectual property right owned or controlled by theLicensee or itsAffiliates other than theLicensed Patent Rights. Without limiting the foregoing, except as expressly provided herein, nothing contained in thisAgreement shall be construed as granting, by implication, estoppel or otherwise, any licenses or rights under any patents or other intellectual property rights other than theLicensed Patent Rights.

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5.4 Notwithstanding anything to the contrary set forth in thisAgreement, except as set forth in Paragraph 5.3(b), theIC shall not grant any rights under theLicensed Patent Rights within theLicensed Field of Use and shall not provide anyLicensed Products or materials made through theLicensed Processes to any third party for any commercial purpose within theLicensed Field of Use.

6. ROYALTIES AND REIMBURSEMENT

6.1 TheLicensee agrees to pay theIC anon-creditable,non-refundable license issue royalty as set forth in Appendix C.

6.2 TheLicensee agrees to pay theIC anon-refundable, fully creditable (against earned royalties due for sales under Paragraph 6.3 below) minimum annual royalty as set forth in Appendix C.

6.3 TheLicensee agrees to pay theIC earned royalties as set forth in Appendix C.

6.4 TheLicensee agrees to pay theIC benchmark royalties as set forth in Appendix C.

6.5 TheLicensee agrees to pay theIC sublicensing royalties as set forth in Appendix C.

6.6 A patent or patent application licensed under thisAgreement shall cease to fall within theLicensed Patent Rights for the purpose of computing earned royalty payments in any given country on the earliest date that aValid Claim no longer exists. For the avoidance of doubt, if a patent application pending for more than [***] from the first official office action on its merits later issues as a patent,Licensee shall thereafter pay any royalties payable with respect thereto.

6.7 On sales of theLicensed Products by theLicensee to sublicensees or on sales made in other than anarm’s-length transaction, the value of theNet Sales attributed under this Article 6 to this transaction shall be that which would have been received in anarm’s-length transaction, based on sales of like quantity and quality products on or about the time of this transaction.

6.8 With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included withinLicensed Patent RightsGroups C and E and paid by theIC prior to the effective date of thisAgreement, theLicensee shall pay theIC, as an additional royalty, within sixty (60) days of theIC’s submission of a statement and request for payment to theLicensee, an amount equivalent to these unreimbursed expenses previously paid by theIC. A good faith estimate of the unreimbursed expenses previously paid by theIC is set forth in Appendix C.

Pursuant to Article 14.4, for amendments adding additional patent applications or patents to theLicensed Patent Rights,the royalty due under this Article 6.8 solely for the additional patent applications or patents added by the amendment shall be calculated as of the date of execution of the amendment.

6.9 With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within theLicensed Patent Rights and paid by theIC on or after the effective date of thisAgreement, theIC, at its sole option, may require theLicensee:

(a) [***]

(b) [***]; or

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(c) in limited circumstances, theLicensee may be given the right to assume responsibility for the preparation, filing, prosecution, or maintenance of any patent application or patent included with theLicensed Patent Rights. In that event, theLicensee shall directly pay the attorneys or agents engaged to prepare, file, prosecute, or maintain these patent applications or patents and shall provide theIC with copies of each invoice associated with these services as well as documentation that these invoices have been paid.

6.10 TheIC agrees, upon written request, to provide theLicensee with summaries of patent prosecution invoices for which theIC has requested payment from theLicensee under Paragraphs 6.8 and 6.9. TheLicensee agrees that all information provided by theIC related to patent prosecution costs shall be treated as confidential commercial information and shall not be released to a third party except as required by law or a court of competent jurisdiction.

6.11 TheLicensee may elect to surrender its rights in any country of theLicensed Territory under any of theLicensed Patent Rights upon ninety (90) days written notice to theIC and owe no payment obligation under Paragraph 6.9 for patent-related expenses paid in that country after ninety (90) days of the effective date of the written notice.

7. PATENT FILING, PROSECUTION, AND MAINTENANCE

7.1 Except as otherwise provided in this Article 7, theIC agrees to take responsibility for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in theLicensed Patent Rights. ICshall further consult with theLicensee in the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included inLicensed Patent Rights Groups A, B, C, D and E and shall, on an ongoing basis, furnish copies of relevantpatent-related documents from these groups to theLicensee.

7.2 Upon theIC’s written request, theLicensee shall have the right to assume the responsibility for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in theLicensed Patent Rights and shall, on an ongoing basis, promptly furnish copies of allpatent-related documents to theIC. In this event, theLicensee shall, subject to the prior approval of theIC, select registered patent attorneys or patent agents to provide these services on behalf of theLicensee and theIC. TheIC shall provide appropriate powers of attorney and other documents necessary to undertake this action to the patent attorneys or patent agents providing these services. TheLicensee and its attorneys or agents shall consult with theIC in all aspects of the preparation, filing, prosecution and maintenance of patent applications and patents included within theLicensed Patent Rights and shall provide theIC sufficient opportunity to comment on any document that theLicensee intends to file or to cause to be filed with the relevant intellectual property or patent office.

7.3 At any time, theIC may provide theLicensee with written notice that theIC wishes to assume control of the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in theLicensed Patent Rights. If theIC elects to reassume these responsibilities, theLicensee agrees to cooperate fully with theIC, its attorneys, and agents in the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in theLicensed Patent Rights and to provide theIC with complete copies of any and all documents or other materials that theIC deems necessary to undertake such responsibilities. TheLicensee shall be responsible for all costs associated with transferring patent prosecution responsibilities to an attorney or agent of theIC’s choice.

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7.4 Each party shall promptly inform the other as to all matters that come to its attention that may affect the preparation, filing, prosecution, or maintenance of theLicensed Patent Rights and provide sufficient opportunity, when possible, to the other party to provide comments and suggestions with respect to the preparation, filing, prosecution, and maintenance of theLicensed Patent Rights, which comments and suggestions shall be considered by the other party.

8. RECORD KEEPING

8.1 TheLicensee agrees to keep accurate and correct records of theLicensed Products made, used, sold, or imported and theLicensed Processes practiced under thisAgreement appropriate to determine the amount of royalties due theIC. These records shall be retained for at least five (5) years following a given reporting period and shall be available during normal business hours, but not more than once in anyone-year period, for inspection, at the expense of theIC, by an accountant or other designated auditor selected by theIC for the sole purpose of verifying reports and royalty payments hereunder. The accountant or auditor shall only have the right to audit those records that have not previously been audited pursuant to this Paragraph 8.1, unlessIC determines that there is just cause for an additional audit, and shall only disclose to theIC information relating to the accuracy of reports and royalty payments made under thisAgreement. If an inspection shows an underreporting or underpayment in excess of five percent (5%) for any twelve (12) month period, then theLicensee shall reimburse theIC for the cost of the inspection at the time theLicensee pays the unreported royalties, including any additional royalties as required by Paragraph 9.8. All royalty payments required under this Paragraph shall be due within sixty (60) days of the date theIC provides to theLicensee notice of the payment due. TheLicensee shall have the right to require that any accountant or auditor, prior to conducting an audit under this Paragraph 8.1, enter into an appropriatenon-disclosure agreement with theLicensee regarding such financial information.

9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS

9.1 Prior to signing thisAgreement, theLicensee has provided theIC with theCommercial Development Plan in Appendix E, under which theLicensee intends to bring the subject matter of theLicensed Patent Rights to the point ofPractical Application. ThisCommercial Development Plan is hereby incorporated by reference into thisAgreement. Based on this plan, performanceBenchmarks are determined as specified in Appendix D.

9.2 TheLicensee shall provide written summary annual reports on its product development progress or efforts to commercialize under theCommercial Development Plan for each of theLicensed Fields of Use within [***] days after December 31 of each calendar year. These progress reports shall include, but not be limited to: [***]. TheIC also encourages these reports to include information on any of theLicensee’s public service activities that relate to theLicensed Patent Rights. [***], theLicensee shall [***]. In the annual report, theLicensee [***]. TheLicensee agrees to provide any additional information reasonably required by theIC to evaluate theLicensee’s performance under thisAgreement. TheLicensee may [***]. TheIC shall not unreasonably withhold approval of any request of theLicensee to [***].

9.3 TheLicensee shall report to theIC the dates for achievingBenchmarks specified in Appendix D and theFirst Commercial Sale in each country in theLicensed Territory within [***] of such occurrences.

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9.4 TheLicensee shall submit to theIC, within [***] after each calendarhalf-year ending June 30 and December 31, a royalty report, as described in the example in Appendix F, setting forth for the precedinghalf-year period the amount of theLicensed Products sold orLicensed Processes practiced by or on behalf of theLicensee in each country within theLicensed Territory, theNet Sales, and the amount of royalty accordingly due. With each royalty report, theLicensee shall submit payment of earned royalties due. If no earned royalties are due to theIC for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of theLicensee [***]. The royalty report shall also identify the site of manufacture for theLicensed Product(s) sold in the United States.

9.5 TheLicensee agrees to forwardsemi-annually to theIC a copy of these reports received by theLicensee from its sublicensees during the precedinghalf-year period as shall be pertinent to a royalty accounting to theIC by theLicensee for activities under the sublicense.

9.6 Royalties due under Article 6 shall be paid in U.S. dollars and payment options are listed in Appendix G. [***]. The royalty report required by Paragraph 9.4 shall be mailed to theIC at its address forAgreement Notices indicated on the Signature Page.

9.7 [***].

9.8 [***] may be assessed by theIC on any payment that is more than ninety (90) days overdue at the rate of [***]. [***] rate may be applied retroactively from the original due date until the date of receipt by theIC of the overdue payment and additional royalties. The payment of any additional royalties shall not prevent theIC from exercising any other rights it may have as a consequence of the lateness of any payment.

9.9 All plans and reports required by this Article 9 and marked “confidential” by theLicensee shall, to the extent permitted by law, be treated by theIC as commercial and financial information obtained from a person and as privileged and confidential, and any proposed disclosure of these records by theIC under the Freedom of Information Act (FOIA),5 U.S.C. §552 shall be subject to the predisclosure notification requirements of45 C.F.R. §5.65(d).

10. PERFORMANCE

10.1 TheLicensee shall use its reasonable commercial efforts to bring theLicensed Products and theLicensed Processes toPractical Application. “Reasonable commercial efforts” for the purposes of this provision shall include adherence to theCommercial Development Plan in Appendix E and performance of theBenchmarks in Appendix D. The efforts of a sublicensee shall be considered the efforts of theLicensee.

10.2 Upon theFirst Commercial Sale, until the expiration or termination of thisAgreement, theLicensee shall use its reasonable commercial efforts to make theLicensed Products and theLicensed Processes reasonably accessible to the United States public. The efforts ofLicensee’s Affiliates or sublicensees shall be considered the efforts of theLicensee for purposes of this Paragraph 10.2.

10.3 TheLicenseeagrees, after itsFirst Commercial Saleand as part of its marketing and product promotion, to develop educational materials (e.g., brochures, website, etc.) directed to patients and physicians detailing theLicensed Products or medical aspects of the prophylactic and therapeutic uses of theLicensed Products.

10.4 TheLicensee agrees to supply, to the Mailing Address forAgreementNotices indicated on the Signature Page, the Office of Technology Transfer,NIH with inert samples of theLicensed Products or theLicensed Processesor their packaging for educational and display purposes only.

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11. INFRINGEMENT AND PATENT ENFORCEMENT

11.1 The IC and theLicensee agree to notify each other promptly of each infringement or possible infringement of theLicensed Patent Rights, as well as, any facts which may affect the validity, scope, or enforceability of theLicensed Patent Rights of which either party becomes aware.

11.2 Pursuant to thisAgreement and the provisions of35 U.S.C. Chapter 29, theLicensee may:

(a) bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in theLicensed Patent Rights;

(b) in any suit, enjoin infringement and collect for its use, damages, profits, and awards of whatever nature recoverable for the infringement; or

(c) settle any claim or suit for infringement of theLicensed Patent Rights provided, however, that theIC and appropriateGovernment authorities shall have the first right to take such actions; and

(d) if theLicensee desires to initiate a suit for patent infringement, theLicensee shall notify theIC in writing. If theIC does not notify theLicensee of its intent to pursue legal action within [***], theLicensee shall be free to initiate suit. TheIC shall have a continuing right to intervene in the suit at its own expense. TheLicensee shall take no action to compel theGovernment either to initiate or to join in any suit for patent infringement; provided, however, that theGovernment will participate in the suit if, and only if, required for legal standing purposes. TheLicensee may request theGovernment to initiate or join in any suit if necessary to avoid dismissal of the suit. Should theGovernment be made a party to any suit, theLicensee shall reimburse theGovernment for any costs, expenses, or fees which theGovernment incurs as a result of the motion or other action, including all costs incurred by theGovernment in opposing the motion or other action. In all cases, theLicensee agrees to keep theIC reasonably apprised of the status and progress of any litigation. Before theLicensee commences an infringement action, theLicensee shall notify theIC and give careful consideration to the views of theIC and to any potential effects of the litigation on the public health in deciding whether to bring suit.

11.3 In the event that a declaratory judgment action alleging invalidity ornon-infringement of any of theLicensed Patent Rights shall be brought against theLicensee or raised by way of counterclaim or affirmative defense in an infringement suit brought by theLicensee under Paragraph 11.2, pursuant to thisAgreement and the provisions of35 U.S.C. Chapter 29 or other statutes, theLicensee may:

(a) defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in theLicensed Patent Rights;

(b) in any suit, ultimately to enjoin infringement and to collect for its use, damages, profits, and awards of whatever nature recoverable for the infringement; and

(c) settle any claim or suit for declaratory judgment involving theLicensed Patent Rights-provided, however, that theIC and appropriateGovernment authorities shall have the first right to take these actions and shall have a continuing right to intervene in the suit at its own expense; and

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(d) if theIC does not notify theLicensee of its intent to respond to the legal action within a reasonable time, theLicensee shall be free to do so. TheLicensee shall take no action to compel theGovernment either to initiate or to join in any declaratory judgment action. TheLicensee may request theGovernment to initiate or to join any suit if necessary to avoid dismissal of the suit. Should theGovernment be made a party to any suit by motion or any other action of theLicensee, theLicensee shall reimburse theGovernment for any costs, expenses, or fees, which theGovernment incurs as a result of the motion or other action. If theLicensee elects not to defend against the declaratory judgment action, theIC, at its option, may do so at its own expense. In all cases, theLicensee agrees to keep theIC reasonably apprised of the status and progress of any litigation. Before theLicensee commences an infringement action, theLicensee shall notify theIC and give careful consideration to the views of theIC and to any potential effects of the litigation on the public health in deciding whether to bring suit.

11.4 Except as otherwise set forth above, in any action under Paragraphs 11.2 or 11.3 the expenses including costs, fees, attorney fees, and disbursements, shall be paid by [***]. The value of any recovery made by theLicensee through court judgment or settlement, after first reimbursing theLicensee for such expenses paid by theLicensee, [***].

11.5 TheIC shall cooperate fully with theLicensee in connection with any action under Paragraphs 11.2 or 11.3. TheIC agrees promptly to provide access to all necessary documents and to render reasonable assistance in response to a request by theLicensee.

12. NEGATION OF WARRANTIES AND INDEMNIFICATION

12.1 TheIC offers no other warranties than those specified in Article 1: (i)HHS, by assignment of rights fromNIH employees, on behalf of theGovernment, owns all intellectual property rights claimed in the United States and foreign patent applications and patents in theLicensed Patent Rights, (ii) HHS owns tangible embodiments of inventions actually reduced to practice, and (iii) IC has the authority, by delegation from the Secretary ofHHS, to enter into thisAgreement.

12.2 TheIC does not warrant the validity of theLicensed Patent Rights and makes no representations whatsoever with regard to the scope of theLicensed Patent Rights, or that theLicensed Patent Rights may be exploited without infringing other patents or other intellectual property rights of third parties.

12.3 THEIC MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THELICENSED PATENT RIGHTS OR TANGIBLE MATERIALS RELATED THERETO.

12.4 TheIC does not represent that it shall commence legal actions against third parties infringing theLicensed Patent Rights.

12.5 TheLicensee shall indemnify and hold theIC, its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage (“Losses”) to the extent arising out of any suit or proceeding brought by a third party for:

(a) the use by or on behalf of theLicensee, its sublicensees, directors, employees, or third parties of anyLicensed Patent Rights; or

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(b) the design, manufacture, distribution, or use of anyLicensed Products,Licensed Processes or materials by theLicensee, or other products or processes developed by or on behalf of the Licensee in connection with or arising out of theLicensed Patent Rights.

Notwithstanding the foregoing,Licensee shall have no obligation under this Paragraph 12.5 to the extent any suchLosses were the result of the willful misconduct or gross negligence ofIC.

12.6 TheLicensee agrees to maintain a liability insurance program consistent with sound business practice.

13. TERM, TERMINATION, AND MODIFICATION OF RIGHTS

13.1 ThisAgreement is effective when signed by all parties, unless the provisions of Paragraph 14.16 are not fulfilled, and shall extend to the expiration of the last to expire of theLicensed Patent Rights unless sooner terminated as provided in this Article 13.

13.2 In the event that theLicensee is in default in the performance of any material obligations under thisAgreement, including but not limited to the obligations listed in Paragraph 13.5, and if the default has not been remedied within ninety (90) days after the date of notice in writing of the default, theIC may terminate thisAgreement by written notice and pursue outstanding royalties owed through procedures provided by theFederal Debt Collection Act.

13.3 In the event that theLicensee files a petition in bankruptcy, has such a petition filed against it, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, theLicensee shall immediately notify theIC in writing. To the extent allowed under applicable law, theIC shall have the right to terminate thisAgreement immediately upon theLicensee’s receipt of written notice. However, with respect to any petition(s) filed against theLicensee,Licenseeshall have [***] to resolve or obtain the dismissal of such petition. If resolution or dismissal of the petition(s) is not achieved in the allotted period,IC shall have the right to immediately terminate thisAgreement.

13.4 TheLicensee shall have a unilateral right to terminate thisAgreement or any licenses in any country or territory by giving theIC sixty (60) days written notice to that effect.

13.5 TheIC shall specifically have the right to terminate or modify, at its option, thisAgreementby written notice to theLicensee, if theIC determines in good faith that theLicensee:

(a) is not executing theCommercial Development Plan submitted with its request for a license and theLicensee cannot otherwise demonstrate to theIC’s reasonable satisfaction that theLicensee has taken, or can be expected to take within a reasonable time, effective steps to achieve thePractical Application of theLicensed Products or theLicensed Processes;

(b) has not achieved theBenchmarks as may be modified under Paragraph 9.2;

(c) has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by thisAgreement;

(d) has committed a material breach of a covenant or agreement contained in thisAgreement that has not been remedied within the ninety (90) day period set forth in Paragraph 13.2 above;

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(e) is not keeping theLicensed Products or theLicensed Processes reasonably available to the public after commercial use commences; or

(f) cannot reasonably justify a failure to comply with the domestic production requirement of Paragraph 5.2 unless waived.

13.6 In making the determination referenced in Paragraph 13.5, theIC shall take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment and the annual reports submitted by theLicensee under Paragraph 9.2. Prior to invoking termination or modification of thisAgreement under Paragraph 13.5, theIC shall give written notice to theLicensee providing theLicensee specific notice of, and a [***] opportunity to respond to, theIC’sconcerns as to the items referenced in13.5(a)-13.5(f). If theLicensee fails to alleviate theIC’s concerns as to the items referenced in13.5(a)-13.5(f) within [***] following written notice from theIC or fails to initiate corrective action to theIC’s reasonable satisfaction, theIC may terminate thisAgreement upon written notice to theLicensee.

13.7 When the public health and safety so require, and after written notice to theLicensee providing theLicensee a [***] opportunity to respond, theIC shall have the right to require theLicensee to grant sublicenses to responsible applicants, on reasonable terms, in anyLicensed Fields of Use under theLicensed Patent Rights, unless theLicensee can reasonably demonstrate that the granting of the sublicense would not materially increase the availability to the public of the subject matter of theLicensed Patent Rights. TheIC shall not require the granting of a sublicense unless the responsible applicant has first negotiated in good faith with theLicensee.

13.8 TheIC reserves the right according to35 U.S.C. §209(d)(3) to terminate or modify thisAgreement if upon written notice to theLicensee it is determined that this action is necessary to meet the requirements for public use specified by federal regulations issued after the date of the license and these requirements are not reasonably satisfied by theLicenseewithin [***] following written notice from theIC.

13.9 Within [***] of receipt of written notice of theIC’s unilateral decision to modify or terminate thisAgreement, theLicensee may, consistent with the provisions of37 C.F.R. §404.11, appeal the decision by written submission to the designatedIC official or designee. The decision of the designatedIC official or designee shall be the final agency decision. TheLicensee may thereafter exercise any and all administrative or judicial remedies that may be accessible.

13.10 Within [***] of expiration or termination of thisAgreement under this Article 13, a final report shall be submitted by theLicensee. Any royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expenses, due to theIC shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with theIC pursuant to Paragraph 4.3. Unless otherwise specifically provided for under thisAgreement, upon termination or expiration of thisAgreement, theLicensee shall have the right to offer for sale and sell any existing inventory ofLicensed Products for [***] following the effective termination date of thisAgreement, subject to the royalty obligations as set forth in Appendix C. After this [***] period, theLicensee shall return all remainingLicensed Products or other materials included within theLicensed Patent Rights to theIC or provide theIC with certification of the destruction thereof. TheLicensee may not be granted additionalIC licenses if the final reporting requirement is not fulfilled.

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14. GENERAL PROVISIONS

14.1 Neither party may waive or release any of its rights or interests in thisAgreement except in writing. The failure of a party to assert a right hereunder or to insist upon compliance with any term or condition of thisAgreement shall not constitute a waiver of that right by such party or excuse a similar subsequent failure to perform any of these terms or conditions by the other party.

14.2 ThisAgreement constitutes the entire agreement between the parties relating to the subject matter of theLicensed Patent Rights, theLicensed Productsand theLicensed Processes, and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by thisAgreement.

14.3 The provisions of thisAgreement are severable, and in the event that any provision of thisAgreement shall be determined to be invalid or unenforceable under any controlling body of law, this determination shall not in any way affect the validity or enforceability of the remaining provisions of thisAgreement.

14.4 If either party desires a modification to thisAgreement, the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of the modification. No modification shall be effective until a written amendment is signed by the signatories to thisAgreement or their designees.

For clarity, the parties intend to amend thisAgreement to include new patent applications as they are filed by theICwhich claimAdditional T Cell Receptor(s) not presently a part of theLicensed Patent Rights. ShouldIC andLicensee agree to such written amendment, it will include an amendment issue royalty as described in Appendix C, Paragraph VII of thisAgreement.

14.5 The construction, validity, performance, and effect of thisAgreement shall be governed by Federal law as applied by the Federal courts in the District of Columbia.

14.6 AllAgreement notices required or permitted by thisAgreement shall be given by prepaid, first class, registered or certified mail or by an express/overnight delivery service provided by a commercial carrier, properly addressed to the other party at the address designated on the following Signature Page, or to another address as may be designated in writing by the other party.Agreement notices shall be considered timely if the notices are received on or before the established deadline date or sent on or before the deadline date as verifiable by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should request a legibly dated U.S. Postal Service postmark or obtain a dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.

14.7 ThisAgreement shall not be assigned or otherwise transferred (including any transfer by legal process or by operation of law, and any transfer in bankruptcy or insolvency, or in any other compulsory procedure or order of court), except to theLicensee’s Affiliate(s), without the prior written consent of theIC, which will not be unreasonably denied.

If, within [***] ofIC’s receipt of a proposed assignment fromLicensee,IC has not providedLicensee with a written notice of rejection thereof, thenIC shall be deemed to have given its approval of such assignment of thisAgreement. In the event of any such assignment (other than toLicensee’s Affiliate),theLicensee shall pay theIC, as an additional royalty, [***]. For clarity, no royalty shall be due under this Paragraph 14.7 for an assignment of thisAgreement toLicensee’sAffiliate(s).

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14.8 TheLicensee agrees in its use of anyIC-supplied materials to comply with all applicable statutes, regulations, and guidelines, includingNIH andHHS regulations and guidelines. TheLicensee agrees not to use the materials for research involving use of theLicensed Products in human subjects or clinical trials in the United States without complying with21 C.F.R. Part 50 and45 C.F.R. Part 46. TheLicensee agrees not to use the materials for research involving use of theLicensed Products in human subjects (including clinical trials) outside of the United States without notifying theIC, in writing, of the research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to theIC of such research involving human subjects or clinical trials outside of the United States shall be given no later than [***] prior to commencement of the research or trials.

14.9 TheLicensee acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including theExport Administration Act of 1979 andArms Export Control Act) controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of these items may require a license from the appropriate agency of the U.S.Government or written assurances by theLicensee that it shall not export these items to certain foreign countries without prior approval of this agency. TheIC neither represents that a license is or is not required or that, if required, it shall be issued.

14.10 TheLicensee agrees to mark theLicensed Products or their packaging sold in the United States with all applicable U.S. patent numbers. All theLicensed Products manufactured in, shipped to, or sold in other countries shall be marked in a manner to preserve theIC’s patent rights in those countries.

14.11 By entering into thisAgreement, theIC does not directly or indirectly endorse any product or service provided, or to be provided, by theLicensee whether directly or indirectly related to thisAgreement. TheLicensee shall not state or imply that thisAgreement is an endorsement by theGovernment, theIC, any otherGovernment organizational unit, or anyGovernment employee. Additionally, theLicensee shall not use the names of theIC, theFDA or theHHS or theGovernment or their employees in any advertising, promotional, or sales literature in connection with thisAgreement without the prior written approval of theIC.

14.12 The parties agree to attempt to settle amicably any controversy or claim arising under thisAgreement or a breach of thisAgreement, except for appeals of modifications or termination decisions provided for in Article 13. TheLicensee agrees first to appeal any unsettled claims or controversies to the designatedIC official, or designee, whose decision shall be considered the final agency decision. Thereafter, theLicensee may exercise any administrative or judicial remedies that may be available. Notwithstanding anything to the contrary in thisAgreement, theLicensee shall have the right, without waiving any right or remedy available under thisAgreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of theLicensee, pending any such settlement or the determination of any such appeal.

14.13 Nothing relating to the grant of a license, nor the grant itself, shall be construed to confer upon any person any immunity from or defenses under the antitrust laws or from a charge of patent misuse, and the acquisition and use of rights pursuant to37 C.F.R. Part 404 shall not be immunized from the operation of state or Federal law by reason of the source of the grant.

14.14 Any formal recordation of thisAgreement required by the laws of anyLicensed Territoryas a prerequisite to enforceability of theAgreement in the courts of any foreign jurisdiction or for other reasons shall be carried out by theLicensee at its expense, and appropriately verified proof of recordation shall be promptly furnished to theIC.

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14.15 Paragraphs 4.3, 8.1,9.5-9.8,12.1-12.5, 13.9, 13.10, 14.12 and 14.15 of thisAgreement shall survive termination of thisAgreement.

14.16 The terms and conditions of thisAgreement shall, at theIC’s sole option, be considered by theIC to be withdrawnfrom theLicensee’s consideration and the terms and conditions of thisAgreement,and theAgreementitself to be null and void,unless thisAgreement is executedby theLicensee and a fully executed original is received by theIC within sixty (60) days from the date of theIC’s signature found at the Signature Page.

SIGNATURES BEGIN ON NEXT PAGE

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NIH PATENT LICENSE AGREEMENT –EXCLUSIVE

SIGNATURE PAGE

For theIC:

/s/ Richard U. Rodriguez	May 28, 2019
Richard U. Rodriguez, MBA	Date
Associate Director
Technology Transfer Center, National Cancer Institute
National Institutes of Health

Mailing Address orE-mail Address forAgreement notices and reports:

License Compliance and Administration

Monitoring & Enforcement

Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

Rockville, Maryland 20852-3804 U.S.A.

E-mail:                                                                     

For theLicensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of theLicensee made or referred to in this document are truthful and accurate.):

by:
/s/ Robert Hadfield	May 28, 2019
Signature of Authorized Official	Date
Robert Hadfield
Printed Name
General Counsel
Title

I. Official and Mailing Address forAgreement notices:

Robert Hadfield

Name

General Counsel

Title

Mailing Address

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One First Avenue, Parris Building #34

Navy Yard Plaza

Boston, MA 02129

Email Address:

Phone:

Fax:

II. Official and Mailing Address for Financial notices (theLicensee’s contact person for royalty payments)

Eshane Dupre

Name

Accounts Payable

Title

Mailing Address:

One First Avenue, Parris Building #34

Navy Yard Plaza

Boston, MA 02129

Email Address:

Phone:

Fax:

Any false or misleading statements made, presented, or submitted to theGovernment, including any relevant omissions, under thisAgreement and during the course of negotiation of thisAgreement are subject to all applicable civil and criminal statutes including Federal statutes31 U.S.C. §§3801-3812 (civil liability) and18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).

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APPENDIX A – PATENT(S) OR PATENT APPLICATION(S)

Patent(s) or Patent Application(s):

Group A

1. [***];

2. [***];

3. [***];

4. [***];

5. [***];

6. [***];

7. [***];

8. [***];

9. [***];

10. [***];

11. [***];

12. [***];

13. [***];

14. [***];

15. [***];

16. [***];

17. [***];

18. [***];

19. [***];

20. [***];

21. [***];

22. [***];

23. [***];

24. [***];

25. [***];

26. [***];

27. [***];

28. [***];

29. [***];

30. [***];

31. [***];

32. [***];

33. [***];

34. [***];

35. [***];

36. [***];

37. [***];

38. [***];

39. [***];

40. [***];

41. [***];

42. [***];

43. [***];

44. [***];

45. [***];

46. [***];

47. [***];

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48. [***]; and

49. [***].

Group B

1. [***]; and

2. [***].

Group C

1. [***]; and

2. [***].

Group D

1. [***]; and

2. [***].

Group E

1. [***]; and

2. [***].

Group F

1. [***];

2. [***];

3. [***];

4. [***];

5. [***];

6. [***];

7. [***];

8. [***]; and

9. [***].

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APPENDIX B – LICENSED FIELDS OF USE AND TERRITORY

I. Licensed Fields of Use:

1. Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by transposon-mediated gene transfer to express T cell receptors reactive to mutated KRAS, as claimed in the Group ALicensed Patent Rights, for the treatment of human cancers. [***].

2. Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by transposon-mediated gene transfer to express T cell receptors reactive to mutated P53, as claimed in the Group BLicensed Patent Rights, for the treatment of human cancers. [***].

3. Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by transposon-mediated gene transfer to express T cell receptors reactive to mutated EGFR, as claimed in the Group CLicensed Patent Rights, for the treatment of human cancers.

4. Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered by transposon-mediated gene transfer to express T cell receptors reactive to mutated P53, isolated as claimed in the Group DLicensed Patent Rights, for the treatment of human cancers. [***].

5. Development, manufacture and commercialization of autologous, peripheral bloodT-cell therapy products engineered bynon-viral gene transfer to express T cell receptors, as claimed in the Group ELicensed Patent Rights, for the treatment of human cancers.

6. Development, manufacture and commercialization of autologous, peripheral blood T cell therapy products engineered to express T cell receptors, as claimed in the Group FLicensed Patent Rights, for the treatment of human cancers.

For the avoidance of doubt, “autologous peripheral blood T cell therapy products” included inField of Use1-6 may include autologous and/or allogeneicT-cell receptors obtained from [***].

[***]:

1) [***]; and

2) [***].

IfIC receives a license application with a complete commercial development plan from a third partyfor commercial development of aLicensed Product(s) or Licensed Processes, as they pertain toLicensed Patent Rights for which the proposed commercial development is not reasonably addressed inLicensee’s then-currentCommercial Development Plan,IC shall notifyLicensee, in writing, of the existence of the third party’s license application, identifying the scientific, clinical or technical basis for its belief that such commercial development should occur. Upon receipt of such written notice,Licensee shall either: (a) within [***] amend itsCommercial Development Plan in a manner reasonably acceptable toIC to include a clinical research and development program for the proposed third party’s commercial development of saidLicensed Product(s) or Licensed Processes including revisedBenchmarks, acceptance of said amendment to saidCommercial Development Plan byIC shall take into accountLicensee’s ongoing efforts and normal drug development standards for obtainingFDA approval for multiple indication prophylactic and therapeutic products; or (b) amend itsCommercial Development Plan within [***] in a manner reasonably acceptable toIC to include an offer to enter into a commercially reasonable and customary jointpre-clinical research and development program with the third party for the proposed third party’s commercial

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development of saidLicensed Product(s) or Licensed Processes; or (c) within [***] offer to grant a sublicense under commercially reasonable and customary terms to said third party underLicensed Patent Rights; or both (b) and (c). IfLicensee does not (a) amend itsCommercial Development Plan in a manner reasonably acceptable toIC to include a clinical research and development program for the proposed commercial development of saidLicensed Product(s) or Licensed Processes of such third party including revisedBenchmarks; or (b) amend itsCommercial Development Plan in a manner reasonably acceptable toIC to include a jointpre-clinical research and development program with the third party for the proposed commercial development of saidLicensed Product(s) or Licensed Processes; or (c) grant a sublicense within [***] under commercially reasonable terms to said third party underLicensed Patent Rights,for such commercial development; or both (b) and (c),IC shall remove saidLicensed Product(s) or Licensed ProcessesfromLicensed Fields of Use in thisAgreement,IC shall be free to license saidLicensed Product(s)or Licensed Processes to said third party solely for the unaddressed indication(s) that were the subject of such license application, andLicensee’sLicensed Product(s) or Licensed ProcessesfromLicensed Fields of Use shall be limited to the remaining indications.

II. Licensed Territory:

Worldwide

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APPENDIX C – ROYALTIES

Royalties:

I. TheLicensee agrees to pay to theIC anon-creditable, nonrefundable license issue royalty in the amount of one million five hundred thousand dollars ($1,500,000.00) in three (3) installments according to the following schedule:

1. Five hundred thousand dollars ($500,000.00) within sixty (60) days of the effective date of thisAgreement;

2. Five hundred thousand dollars ($500,000.00) on the six (6) month anniversary of the effective date of thisAgreement; and

3. Five hundred thousand dollars ($500,000.00) on the twelve (12) month anniversary of the effective date of thisAgreement.

[***]

II. The Licensee agrees to pay to theIC anon-refundable minimum annual royalty as follows:

1. The first minimum annual royalty payment of two hundred fifty thousand dollars ($250,000.00) is due on the eighteen (18) month anniversary of the effective date of thisAgreement and [***];

2. Subsequent minimum annual royalty payments of two hundred fifty thousand dollars ($250,000.00 are due and payable on January 1 of each calendar year and [***];

3. After aggregate minimum annual royalty payments received byIC under thisAgreement reach one million five hundred thousand dollars ($1,500,000.00), subsequent minimum annual royalty payments shall be reduced to one hundred thousand dollars ($100,000.00) and shall be due [***].

III. The Licensee agrees to pay theIC earned royalties as follows:

1. [***];

2. [***]; and

3. [***].

4. [***].

5. [***].

IV. The Licensee agrees to pay theICBenchmark royalties within [***] of achieving eachBenchmark:

1. One hundred thousand dollars ($100,000.00) upon initiation of the firstLicensee-sponsoredPhase 1 Clinical Studyof aLicensed Product orLicensed ProcessinLicensed Fields of Use1-5;

2. [***];

3. [***];

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4. [***];

5. [***];

6. [***];

7. [***];

8. [***]; and

9. [***].

[***]

V. TheLicensee agrees to pay theIC the following sublicense royalties onSublicense Revenue received for granting each sublicense within [***] of the execution of each sublicense:

1. [***].

2. [***].

3. [***].

4. [***].

5. [***].

VI. As of May 10, 2019, the estimated amount of the royalty due under Paragraph 6.8 is forty-five thousand seven hundred eleven dollars ($45,711.00). This is only a good faith estimate andLicensee will be responsible for reimbursement of all unreimbursed expenses as stipulated in Paragraph 6.8.

VII. Subject to Paragraph 14.4 of thisAgreement, for eachAdditional T Cell Receptoradded by written amendment, thenon-creditable,non-refundable amendment issue royalty shall be [***] for suchAdditional T Cell Receptor. In addition, for eachAdditional T Cell Receptor added by written amendment,Licensee shall pay the same earned royalty, benchmark royalty and sublicensing royalty rates that are applicable to [***].

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APPENDIX D – BENCHMARKS AND PERFORMANCE

TheLicensee agrees to the followingBenchmarks for its performance under thisAgreement and, within thirty (30) days of achieving aBenchmark, shall notify theIC that theBenchmark has been achieved.

Benchmark		Deadline
I.	[***]	[***]
II.	[***]	[***]
III.	[***]	[***]
IV.	[***]	[***]
V.	[***]	[***]
VI.	[***]	[***]
VII.	[***]	[***]

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APPENDIX E – COMMERCIAL DEVELOPMENT PLAN

[***]

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APPENDIX F – EXAMPLE ROYALTY REPORT

[***]

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APPENDIX G – ROYALTY PAYMENT OPTIONS

New Payment Options Effective March 2018

The License Number MUST appear on payments, reports and correspondence.

[*** 3 PAGES OMITTED ***]

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