Document:

EX-10.17

 Exhibit 10.17 

***Text Omitted and Filed Separately 

with the Securities and Exchange Commission. 

Confidential Treatment Requested 

Under 17 C.F.R. Section 200.80(b)(4) and Rule 406 of the 

Securities Act of 1933, as amended. 

THE NATIONAL INSTITUTES OF HEALTH 

PATENT LICENSE AGREEMENT — EXCLUSIVE/CO-EXCLUSIVE 

COVER PAGE 
 For the NIH internal use
only: 
 License Number: L-068-2013/0 

License Application Number: A-294-2011 

Serial Number(s) of Licensed Patent(s) or Patent Application(s): 
  

	 	1.	[...***...] 

  

	 	2.	PCT Patent Application No. PCT/US2011/051537 filed September 21, 2011 [HHS Ref. No. E-269- 2010/0-PCT-02] 

  

	 	3.	[...***...] 

  

	 	4.	PCT Patent Application No. PCT/US2012/029861 filed March 21, 2012 [HHS Ref. No. E-148-2011/0- PCT-02] 

Licensee: Kite Pharma, Inc. 

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

Additional Remarks: 

Public Benefit(s): Clinical data from NCI Surgery Branch and other academic centers has demonstrated that patient’s
engineered T cells engineered with T cell receptors (TCRs) or chimeric antigen receptors (CARs), when administered back to the patient, can traffic to the tumor, become activated upon engagement with the tumor antigen and selectively
eradicate the tumors. This Autologous Cell Therapy (ACT) approach has shown the potential to result in a significant and durable clinical benefit to patients with advanced, metastatic tumors. Synovial sarcoma breakpoint X-2 (SSX2) and epidermal
growth factor receptor variant III (EGFRvIII) tumor antigens are attractive targets for application of the engineered ACT technology due to their expression in different tumor types and lack of expression in vital normal tissues. Therefore,
development of the ACT TCR product directed to SSX2 and the ACT CAR product directed to EGFRvIII by the Licensee, in partnership with the NIH, has the potential to generate new efficacious and safe therapies for patients that have not
responded to all other therapies. The relevant cancer indications include those with critical unmet needs such as hepatocellular carcinoma, glioblastoma, melanoma, sarcoma and caners of the prostate, head and neck, ovary, breast and colon. 

  
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 This Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this
Cover Page, an attached Agreement, 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). The Parties to this Agreement are: 
  

	 	1)	The National Institutes of Health (“NIH”) an agency of the United States Public Health Service within the Department of Health and Human Services (“HHS”); and 

 

	 	2)	The person, corporation, or institution identified above or on the Signature Page, having offices at the address indicated on the Signature Page, hereinafter referred to as the “Licensee”.

  
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 The NIH and the Licensee agree as follows: 

 

	1.	BACKGROUND 

  

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

 

	 	1.2	By assignment of rights from NIH or FDA employees and other inventors, HHS, on behalf of the Government, 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 the NIH or the FDA. 

 

	 	1.3	The Secretary of HHS has delegated to the NIH the authority to enter into this Agreement for the licensing of rights to these inventions. 

 

	 	1.4	The NIH 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	The Licensee 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 the Licensee. 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. 

  

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

  

	 	2.3	“Combination Product” means a product that contains a Licensed Product(s) and at least one other active therapeutic component or device other than a Licensed Product(s) that is not claimed
or covered by the Licensed Patent Rights. 

  

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

  

	 	2.5	“FDA” means the United States Food and Drug Administration or its successor. 

  

	 	2.6	“First Commercial Sale” means the initial transfer by or on behalf of the Licensee, its Affiliates, or sublicensees of Licensed Products or the initial practice of a Licensed
Process by or on behalf of the Licensee, its Affiliates, or 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 determining Net Sales. 

  

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

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

  

	 	2.9	“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 2.9(a): 

  

	 	(i)	continuations-in-part of 2.9(a); 

  

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

  

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

  

	 	(iv)	priority patent application(s) of 2.9(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 2.9(a): all counterpart foreign and U.S. patent applications and patents to 2.9(a) and 2.9(b), including
those listed in Appendix A; and 

  

	 	(d)	Licensed Patent Rights shall not include 2.9(b) or 2.9(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.9(a). 

 

	 	2.10	“Licensed Processes” means processes which, in the course of being practiced, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable,
invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. 

  

	 	2.11	“Licensed Products” means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that
have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. 

  

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

  

	 	2.13	“Net Sales” means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of the Licensee, its Affiliates, or sublicensees
and from leasing, renting, or otherwise making Licensed Products available to others without sale or other dispositions, whether invoiced or not, less [...***...]. 

  
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 [...***...] No deductions shall be made for [...***...]. If the Licensee, its
Affiliates or sublicensees sell a Combined Product, the Net Sales [...***...]. If the Licensed Product is not sold separately, then Net Sales for such Combined Product [...***...]. 

 

	 	2.14	“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 or Government regulations available to the public on reasonable terms. 

 

	 	2.15	“Research License” means a nontransferable, nonexclusive license to make and to use Licensed Products or Licensed Processes as defined by the Licensed Patent Rights solely for
purposes of internal research and not for any commercial purposes or distribution in lieu of purchase. 

  

	3.	GRANT OF RIGHTS 

  

	 	3.1	The NIH hereby grants and the Licensee accepts, subject to the terms and conditions of this Agreement, an exclusive license under the Licensed Patent Rights in the Licensed Territory
to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use (a) — (b) in Appendix B and to practice and have practiced any
Licensed Processes in the Licensed Fields of Use (a) — (b) in Appendix B. 

  

	 	3.2	The NIH hereby grants and the Licensee accepts, subject to the terms and conditions of this Agreement, a co-exclusive license under the Licensed Patent Rights in the Licensed Territory
to make and have made, to use and have used, to sell and have sold, to offer to sell, and to import any Licensed Products in the Licensed Fields of Use (c)— (d) in Appendix B and to practice and have practiced any Licensed
Processes in the Licensed Fields of Use (c)— (d) in Appendix B. For purposes of this Agreement “co-exclusive” shall mean that at any time only the Licensee and its Affiliates, on the one hand, and
one (1) other Licensee and its Affiliates, on the other hand, shall at any time have a license or other right from the NIH under the Licensed Patent Rights in the Licensed Territory in the Licensed Fields
of Use. 

  

	 	3.3	This Agreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of the NIH other than the Licensed Patent Rights regardless of whether
these patents are dominant or subordinate to the Licensed Patent Rights. 

  

	4.	SUBLICENSING 

  

	 	4.1	Upon written approval, which shall include prior review of a copy of any sublicense agreement by the NIH and which shall not be unreasonably withheld, the Licensee may enter into sublicensing agreements
under the Licensed Patent Rights. With respect to any proposed sublicense agreement, if the NIH does not provide the Licensee with written rejection thereof within [...***...] after the date the NIH receives a copy
thereof from the Licensee, the NIH shall be deemed to have given its approval of such sublicense agreement and the Licensee shall have the right to enter into such sublicense agreement. 

  
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	 	4.2	The Licensee agrees that any sublicenses granted by it shall provide that the obligations to the NIH of Paragraphs 5.1-5.4, 8.1, 10.1, 10.2, 12.5, and 13.8-13.10 of this Agreement shall be binding
upon the sublicensee as if it were a party to this Agreement. The Licensee further agrees to attach copies of these Paragraphs to all sublicense agreements. 

 

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

 

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

  

	 	4.5	The Licensee’s right to grant sublicenses hereunder is further subject to the limitation that there shall not exist, at any time in any country, (i) more than [...***...] sublicense then in effect
for the Licensed Fields of Use (a) and/or (c) in Appendix B; and/or (ii) more than [...***...] sublicense then in effect for the Licensed Fields of Use (b) and/or (d) in Appendix B. 

 

	5.	STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS 

  

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

  

	 	(b)	In the event that the Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement (“CRADA”), the Licensee grants to the
Government, pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable, paid-up license to practice Licensed Patent Rights or have Licensed Patent Rights practiced throughout the
world by or on behalf of the Government In the exercise of this license, the Government 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 a non-Federal party. Prior to the First Commercial Sale, the Licensee agrees to provide the NIH reasonable quantities of
Licensed Products or materials made through the Licensed Processes for the NIH research use. Given the nature of the envisioned Licensed Products as personalized autologous cell therapy products, if any Licensed
Products and/or materials made through the Licensed Processes are not available in reasonable quantities for NIH research use, they shall not be subject to the foregoing obligation. 

  
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	 	5.2	The Licensee agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United
States, unless a written waiver is obtained in advance from the NIH. 

  

	 	5.3	The Licensee acknowledges that the NIH may enter into future CRADAs under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement. The
Licensee agrees not to unreasonably deny requests for a Research License from future collaborators with the NIH when acquiring these rights is necessary in order to make a CRADA project feasible. The Licensee may
request an opportunity to join as a party to the proposed CRADA. 

  

					
	5.4	    	(a)	    	In addition to the reserved license of Paragraph 5.1, the NIH reserves the right to grant Research Licenses directly or to require the Licensee to grant Research Licenses on reasonable terms. In
the exercise of this reserved right, the NIH 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 a non-Federal party. The purpose of these Research Licenses is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent
Rights, however, before granting to commercial entities a Research License or providing to them research samples of materials made through the Licensed Processes, (i) the NIH shall give to the Licensee advance
written notice of any commercial party to which the NIH proposes to grant a Research License, (ii) the NIH shall provide the Licensee reasonable opportunity to raise objections thereto and comment thereon, and
(iii) the NIH shall consult with the Licensee to consider in good faith the objections and comments of the Licensee; and

  

	 	(b)	In exceptional circumstances, and in the event that Licensed Patent Rights are Subject Inventions made under a CRADA, the Government, pursuant to 15 U.S.C. §3710a(b)(1)(B),
retains the right to require the Licensee to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the Licensed Patent Rights in the Licensed Field of Use on terms that are
reasonable under the circumstances, or if the Licensee fails to grant this license, the Government retains the right to grant the license itself. The exercise of these rights by the Government shall only be in exceptional
circumstances and only if the Government determines: 

  

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

  

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

 

	 	(iii)	the Licensee has failed to comply with an agreement containing provisions described in 15 U.S.C. §3710a(c)(4)(B); and 

 

	 	(c)	The determination made by the Government under this Paragraph 5.4 is subject to administrative appeal and judicial review under 35 U.S.C. §203(b); and 

  
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	 	(d)	The NIH acknowledges and agrees that a Research License or other right granted pursuant to this Paragraph 5.4 shall only pertain to the Licensed Patent Rights and shall not include a right or
license to any patent or other intellectual property right solely owned or solely controlled by the Licensee or its Affiliates other than the Licensed Patent Rights. Without limiting the foregoing, except as expressly provided
herein, nothing contained in this Agreement shall be construed as granting, by implication, estoppel or otherwise, any licenses or rights under any patents or other intellectual property rights other than the Licensed Patent Rights.

  

	 	5.5	Notwithstanding anything to the contrary set forth in this Agreement, except with respect to a co-exclusive licensee as set forth in Section 3.2, or as set forth in Section 5.4(b), the NIH shall
not grant any rights under the Licensed Patent Rights within the Licensed Fields of Use and shall not provide any Licensed Products or materials made through the Licensed Processes to any third party for any commercial
purpose within the Licensed Fields of Use. 

  

	6.	ROYALTIES AND REIMBURSEMENT 

  

	 	6.1	The Licensee agrees to pay the NIH a noncreditable, nonrefundable license issue royalty as set forth in Appendix C. 

 

	 	6.2	The Licensee agrees to pay the NIH a nonrefundable, fully creditable (against earned royalties due for sales made in that specific year under Paragraph 6.3, below) minimum annual royalty as set forth in
Appendix C. 

  

	 	6.3	The Licensee agrees to pay the NIH earned royalties as set forth in Appendix C. 

  

	 	6.4	The Licensee agrees to pay the NIH benchmark royalties as set forth in Appendix C. 

  

	 	6.5	The Licensee agrees to pay the NIH sublicensing royalties as set forth in Appendix C. 

  

	 	6.6	A patent or patent application licensed under this Agreement shall cease to fall within the Licensed Patent Rights for the purpose of computing earned royalty payments in any given country on the earliest
of the dates that: 

  

	 	(a)	the application has been abandoned and not continued; 

  

	 	(b)	the patent expires or irrevocably lapses, or 

  

	 	(c)	the patent has been held to be invalid or unenforceable by an unappealed or unappealable decision of a court of competent jurisdiction or administrative agency. 

 

	 	6.7	No multiple royalties shall be payable because any Licensed Products or Licensed Processes are covered by more than one of the Licensed Patent Rights. 

 

	 	6.8	On sales of Licensed Products by the Licensee to its Affiliates or sublicensees, or on sales made in other than an arms-length transaction, the value of the Net Sales attributed under
this Article 6 to this transaction shall be that which would have been received in an arms-length transaction, based on sales of like quantity and quality products on or about the time of this transaction. 

  
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	 	6.9	With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights and paid by the
NIH prior to the effective date of this Agreement, the Licensee shall pay the NIH, as an additional royalty, an amount equivalent to these unreimbursed expenses previously paid by the NIH in accordance with the
following schedule: 

  

	 	(a)	[...***...] percent ([...***...]%) of these unreimbursed expenses will be paid by the Licensee to the NIH within [...***...] of the
NIH’s submission of a statement and request for payment to the Licensee; and 

  

	 	(b)	[...***...] percent ([...***...]%) of these unreimbursed expenses will be paid by the Licensee to the NIH on or before the [...***...] anniversary of the effective date of this
Agreement or upon termination of this Agreement, whichever occurs sooner. 

  

	 	(c)	A good faith estimate of the unreimbursed expenses previously paid by the NIH is set forth in Appendix C. 

  

	 	6.10	With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights and paid by the
NIH on or after the effective date of this Agreement, the NIH, at its sole option, may require the Licensee: 

  

	 	(a)	to pay the NIH on an annual basis, within [...***...] of the NIH’s submission of a statement and request for payment, a royalty amount equivalent to these unreimbursed expenses paid during the
previous calendar year(s) provided, however, that if the NIH grants a commercialization license under the Licensed Patent Rights to one or more third parties, then the Licensee shall pay the NIH a pro-rated portion of
such unreimbursed expenses calculated by dividing the total patent costs paid during the previous calendar year(s) by the number of commercialization Licensees of record whose licenses have a Licensed Field of Use which
includes the development of therapeutic or diagnostic products and falls within the scope of the Licensed Patent Rights as of the date of this statement. For avoidance of doubt, if the Licensee is the only commercialization
Licensee of record whose license has a Licensed Field of Use which includes the development of therapeutic or diagnostic products and falls within the scope of the Licensed Patent Rights as of the date of this statement, the
Licensee shall pay NIH a royalty amount equivalent to [...***...] percent ([...***...]%) of these unreimbursed expenses paid during the previous calendar year(s); 

 

	 	(b)	to pay these unreimbursed expenses directly to the law firm employed by the NIH to handle these functions. However, in this event, the NIH and not the Licensee shall be the client of the law firm;
or 

  

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

  
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	 	6.11	The NIH agrees, upon written request, to provide the Licensee with summaries of patent prosecution invoices for which the NIH has requested payment from the Licensee under Paragraphs 6.9 and
6.10. The Licensee agrees that all information provided by the NIH 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. 

  

	 	6.12	The Licensee may elect to surrender its rights in any country of the Licensed Territory under any of the Licensed Patent Rights upon
[...***...] written notice to the NIH and owe no payment obligation under Paragraph 6.10 for patent-related expenses paid in that country after [...***...] of the effective date
of the written notice. 

  

	7.	PATENT FILING, PROSECUTION, AND MAINTENANCE 

  

	 	7.1	Except as otherwise provided in this Article 7, the NIH agrees to take responsibility for, but to consult with, the Licensee in the preparation, filing, prosecution, and maintenance of any and all patent
applications or patents included in the Licensed Patent Rights and shall, on an ongoing basis, furnish copies of relevant patent-related documents to the Licensee. 

 

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

  

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

 

	 	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 the Licensed 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 Licensed Patent Rights, which comments and suggestions shall be considered in good
faith by the other party. 

  

	8.	RECORD KEEPING 

  

	 	8.1	 The Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed
Processes practiced under this Agreement appropriate to determine the 

  
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amount of royalties due to the NIH. These records shall be retained for at least [...***...] following a given reporting period
and shall be available during normal business hours, but not more than once in any [...***...] period, for inspection, at the expense of the NIH, by an accountant or other designated auditor selected by the NIH 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, unless NIH determines that there is just cause for an
additional audit, and shall only disclose to the NIH information relating to the accuracy of reports and royalty payments made under this Agreement. If an inspection shows an underreporting or underpayment in excess of [...***...]
([...***...]%) for any [...***...] period, then the Licensee shall reimburse the NIH for the cost of the inspection at the time the Licensee 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 [...***...] of the date the NIH provides the Licensee notice of the payment due. The Licensee shall have the right to require that any accountant or auditor, prior to
conducting an audit under this Paragraph 8.1, enter into an appropriate non-disclosure Agreement with the Licensee regarding such financial information. 

  

	9.	REPORTS ON PROGRESS BENCHMARKS SALES AND PAYMENTS 

  

	 	9.1	Prior to signing this Agreement, the Licensee has provided the NIH with the Commercial Development Plan in Appendix E, under which the Licensee intends to bring the subject matter of
the Licensed Patent Rights to the point of Practical Application. This Commercial Development Plan is hereby incorporated by reference into this Agreement. Based on this plan, performance Benchmarks are determined
as specified in Appendix D. 

  

	 	9.2	The Licensee shall provide written summary annual reports on its product development progress or efforts to commercialize under the Commercial Development Plan for each of the Licensed Fields of Use
within [...***...] after December 31 of each calendar year. These progress reports shall include, but not be limited to: progress on research and development, status of applications for regulatory approvals, establishment of manufacturing
sites for Licensed Product(s), and status of sublicensing, marketing, importing, and sales during the preceding calendar year, as well as, plans for the present calendar year. The NIH also encourages these reports to include
information on any of the Licensee’s public service activities that relate to the Licensed Patent Rights. If reported progress differs from that projected in the Commercial Development Plan and Benchmarks, the
Licensee shall explain the reasons for these differences. In the annual report, the Licensee may propose amendments to the Commercial Development Plan, acceptance of which by the NIH may not be denied unreasonably. The
Licensee agrees to provide any additional information reasonably required by the NIH to evaluate the Licensee’s performance under this Agreement. The Licensee may amend the Benchmarks at any time upon
written approval by the NIH, which approval shall not be unreasonably withheld. The NEB shall not unreasonably withhold approval of any request of the Licensee to extend the time periods of this schedule if the request is supported by
a reasonable showing by the Licensee of diligence in its performance under the Commercial Development Plan and toward bringing the Licensed Products to the point of Practical Application as defined in 37 C.F.R.
§404.3(d). The Licensee shall amend the Commercial Development Plan and Benchmarks at the request of the NIH to address any Licensed Fields of Use not specifically addressed in the plan originally
submitted. 

  

	 	9.3	The Licensee shall report to the NIH the dates for achieving Benchmarks specified in Appendix D and the First Commercial Sale in each country in the Licensed Territory within
[...***...] of such occurrences. 

  
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	 	9.4	The Licensee shall submit to the NIH, within [...***...] after each calendar half-year ending June 30 and December 31, a royalty report,
as described in the example in Appendix F, setting forth for the preceding half-year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of the Licensee in each country within the
Licensed Territory, the Net Sales, and the amount of royalty accordingly due. With each royalty report, the Licensee shall submit payment of earned royalties due. If no earned royalties are due to the NIH for any
reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer of the Licensee and shall include a detailed listing of all deductions made under Paragraph 2.11 to determine
Net Sales made under Article 6 to determine royalties due. The royalty report shall also identify the site of manufacture for Licensed Product(s) sold in the United States. 

 

	 	9.5	The Licensee agrees to forward [...***...] to the NIH a copy of these reports received by the Licensee from its sublicensees during the preceding half-year period as shall be pertinent to a
royalty accounting to the NIH by the Licensee 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 United States dollar equivalent shall be calculated using the average of the exchange rate (local currency
per US$1) published in The Wall Street Journal, Western Edition, under the heading “Currency Trading” on the last business day of each month during the applicable half-year. Any loss of exchange, value, taxes, or other expenses
incurred in the transfer or conversion to U.S. dollars shall be paid entirely by the Licensee. The royalty report required by Paragraph 9.4 shall be mailed to the NIH at its address for Agreement notices indicated on the
Signature Page. 

  

	 	9.7	The Licensee shall be solely responsible for determining if any tax on royalty income is owed outside the United States and shall pay the tax and be responsible for all filings with appropriate agencies of
foreign governments. 

  

	 	9.8	Additional royalties may be assessed by the NIH on any payment that is more than [...***...] overdue at the rate of [...***...] percent ([...***...]%) per month. This [...***...] percent
([...***...]%) per month rate may be applied retroactively from the original due date until the date of receipt by the NIH of the overdue payment and additional royalties. The payment of any additional royalties shall not prevent the
NIH 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 the Licensee shall, to the extent permitted by law, be treated by the NIH as commercial and financial information
obtained from a person and as privileged and confidential, and any proposed disclosure of these records by the NIH under the Freedom of Information Act (FOIA), 5 U.S.C. §552 shall be subject to the predisclosure notification
requirements of 45 C.F.R. §5.65(d). 

  

	10.	PERFORMANCE 

  

	 	10.1	The Licensee shall use its reasonable commercial efforts to bring the Licensed Products and Licensed Processes to Practical Application. “Reasonable commercial efforts” for the purposes of
this provision shall include adherence to the Commercial Development Plan in Appendix E and performance of the Benchmarks in Appendix D. The efforts of a sublicensee shall be considered the efforts of the Licensee.

  
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	 	10.2	Upon the First Commercial Sale, until the expiration or termination of this Agreement, the Licensee shall use its reasonable commercial efforts to make Licensed Products and Licensed
Processes reasonably accessible to the United States public. 

  

	 	10.3	The Licensee agrees, after its First Commercial Sale and as part of its marketing and product promotion, to develop reasonable educational materials (e.g., brochures, website, etc.) directed to patients
and physicians reasonably detailing the Licensed Products or medical aspects of the prophylactic and therapeutic uses of the Licensed Products. 

  

	 	10.4	The Licensee agrees to supply, to the Mailing Address for Agreement notices indicated on the Signature Page, the Office of Technology Transfer, NIH with inert samples of the Licensed Products
or Licensed Processes or their packaging for educational and display purposes only. 

  

	11.	INFRINGEMENT AND PATENT ENFORCEMENT 

  

	 	11.1	The NIH and the Licensee agree to notify each other promptly of each infringement or possible infringement of the Licensed Patent Rights, as well as, any facts which may affect the validity, scope,
or enforceability of the Licensed Patent Rights to the extent a party becomes aware of such infringement or facts. 

  

	 	11.2	Pursuant to this Agreement and the provisions of 35 U.S.C. Part 29, the Licensee may: 

  

	 	(a)	bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in the Licensed 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 the Licensed Patent Rights provided, however, that the NIH and appropriate Government authorities shall have the first right to take such actions; and

  

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

  
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	 	11.3	In the event that a declaratory judgment action alleging invalidity or non-infringement of any of the Licensed Patent Rights shall be brought against the Licensee or raised by way of counterclaim or
affirmative defense in an infringement suit brought by the Licensee under Paragraph 11.2, pursuant to this Agreement and the provisions of 35 U.S.C. Part 29 or other statutes, the Licensee may: 

 

	 	(a)	defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in the Licensed 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 the Licensed Patent Rights provided, however, that the NIH and appropriate Government authorities shall have a continuing right to
intervene in the suit at its own expense; and 

  

	 	(d)	If the NIH does not notify the Licensee of its intent to respond to the legal action within a reasonable time, the Licensee shall be free to do so. The Licensee shall take no action to compel
the Government either to initiate or to join in any declaratory judgment action. The Licensee may request the Government to initiate or to join any suit if necessary to avoid dismissal of the suit. Should the Government
be made a party to any suit by motion or any other action brought by the Licensee, the Licensee shall reimburse the Government for any costs, expenses, or fees, which the Government incurs as a result of the motion or
other action. If the Licensee elects not to defend against the declaratory judgment action, the NIH, at its option, may do so at its own expense. In all cases, the Licensee agrees to keep the NIH reasonably apprised of
the status and progress of any litigation. Before the Licensee commences an infringement action, the Licensee shall notify the NIH and give careful consideration to the views of the NIH 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 Licensee. The value of any recovery made
by the Licensee through court judgment or settlement, after first reimbursing the Licensee for such expenses paid by the Licensee, shall be treated as Net Sales and subject to earned royalties. 

 

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

  

	12.	NEGATION OF WARRANTIES AND INDEMNIFICATION 

  

	 	12.1	The NIH offers no warranties other than those specified in Article 1. 

  

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

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

  

	 	12.4	The NIH does not represent that it shall commence legal actions against third parties infringing the Licensed Patent Rights. 

 

	 	12.5	The Licensee shall indemnify and hold the NIH, 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 to the extent arising out of any suit or proceeding brought by a third party for: 

  

	 	(a)	the use by or on behalf of the Licensee, its sublicensees, Affiliates, or their respective directors, employees, or third parties (on behalf of the Licensee, its sublicensees or Affiliates)
of any Licensed Patent Rights; or 

  

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

  

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

  

	13.	TERM, TERMINATION, AND MODIFICATION OF RIGHTS 

  

	 	13.1	This Agreement 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 the Licensed Patent Rights
unless sooner terminated as provided in this Article 13. 

  

	 	13.2	In the event that the Licensee is in default in the performance of any material obligations under this Agreement, 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, the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the
Federal Debt Collection Act. 

  

	 	13.3	In the event that the Licensee, files a petition in bankruptcy, or has such a petition filed against it, the Licensee shall immediately notify the NIH in writing. Furthermore, to the extent allowed
under applicable law, the NIH shall have the right to terminate this Agreement immediately upon the Licensee’s receipt of written notice; provided, however, that with respect to any petition filed against the
Licensee, the NIH shall not have the right to terminate this Agreement if the Licensee is able to resolve or obtain the dismissal of such petition within
[...***...] following the date of such notice. 

  

	 	13.4	The Licensee shall have a unilateral right to terminate this Agreement or any licenses in any Licensed Field of Use as specified in Appendix B in any country or territory by giving the NIH
sixty (60) days written notice to that effect. 

  

	 	13.5	The NIH shall specifically have the right to terminate or modify, at its option, this Agreement by written notice to the Licensee, if the NIH determines in good faith that the
Licensee: 

  
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	 	(a)	is not executing the Commercial Development Plan submitted with its request for a license and the Licensee cannot otherwise demonstrate to the NIH’ satisfaction that the Licensee has
taken, or can be expected to take within a reasonable time, effective steps to achieve Practical Application of the Licensed Products or Licensed Processes; 

 

	 	(b)	has not achieved the Benchmarks 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 this Agreement; 

 

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

 

	 	(e)	is not keeping Licensed Products or Licensed 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, the NIH 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 the Licensee under Paragraph 9.2. Prior to invoking termination or modification of this Agreement under Paragraph 13.5, the NIH shall give written notice to the Licensee
providing the Licensee specific notice of, and a ninety (90) day opportunity to respond to remedy the items referenced in Paragraphs 13.5(a)-13.5(g). If the Licensee fails to alleviate the NIH’s concerns as to the
items referenced in Paragraphs 13.5(a)-13.5(g) within ninety (90) days following written notice from the NIH or otherwise fails to initiate corrective action to the NIH’s satisfaction, the NIH may terminate this
Agreement upon written notice to the Licensee. 

  

	 	13.7	When the public health and safety so require and after written notice to the Licensee providing the Licensee a sixty (60) day opportunity to respond, the NIH shall have the right to require the
Licensee to grant sublicenses to responsible applicants, on reasonable terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless the Licensee can reasonably demonstrate that the granting of the
sublicense would not materially increase the availability to the public of the subject matter of the Licensed Patent Rights. The NIH shall not require the granting of a sublicense unless the responsible applicant has first negotiated
in good faith with the Licensee. 

  

	 	13.8	The NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate or modify this Agreement upon written notice to the Licensee if 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 the Licensee within ninety (90) days following written notice from the
NIH. 

  

	 	13.9	Within thirty (30) days after receipt of written notice of the NIH’s unilateral decision to modify or terminate this Agreement, the Licensee may, consistent with the provisions of 37
C.F.R. §404.11, appeal the decision by written submission to the designated NIH official. The decision of the designated NIH official shall be the final agency decision. The Licensee may thereafter exercise any and all
administrative or judicial remedies that may be available. 

  
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	 	13.10	Within [...***...] after expiration or termination of this Agreement under this Article 13, a final report shall be submitted by the Licensee. Any
royalty payments, including those incurred but not yet paid (such as the full minimum annual royalty), and those related to patent expense, due to the NIH 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 the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement, upon termination of this
Agreement, the Licensee shall have the right to offer for sale and sell any existing inventory of Licensed Products for [...***...] following the effective termination date of this Agreement, subject to the royalty
obligations as set forth in Appendix C. After this [...***...] period, the Licensee shall return all remaining Licensed Products or other materials included within the Licensed Patent Rights to the NIH or provide
the NIH with certification of the destruction thereof. The Licensee may not be granted additional NIH licenses if the final reporting requirement is not fulfilled. 

 

	14.	GENERAL PROVISIONS 

  

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

 

	 	14.2	This Agreement constitutes the entire agreement between the parties relating to the subject matter of the Licensed Patent Rights, Licensed Products and Licensed Processes, and all prior
negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this Agreement. 

  

	 	14.3	The provisions of this Agreement are severable, and in the event that any provision of this Agreement 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 this Agreement. 

  

	 	14.4	If either party desires a modification to this Agreement, 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 this Agreement or their designees. 

 

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

 

	 	14.6	All Agreement notices required or permitted by this Agreement 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	 This Agreement 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) without the prior written consent or approval of the NIH 

  
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except to the Licensee’s Affiliate(s) or in connection with the transfer or sale of all or substantially all of its business (including without limitation by means of merger,
consolidation or change of control) relating to operations which concern this Agreement. The Licensee shall notify NIH within [...***...] of any assignment of this
Agreement. 

  

	 	14.8	The Licensee agrees in its use of any NIH-supplied materials to comply with all applicable statutes, regulations, and guidelines, including the NIH and HHS regulations and guidelines. The
Licensee agrees not to use the materials for research involving use of the Licensed Products in human subjects (including clinical trials) in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part
46. The Licensee agrees not to use the materials for research involving use of the Licensed Products in human subjects (including clinical trials) outside of the United States without notifying the NIH, in writing, of the
research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to the NIH 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	The Licensee acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms 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 the Licensee that it shall not export these items to certain foreign countries without prior approval of this agency. The NIH neither represents that a license is or is not required or that, if required, it shall be
issued. 

  

	 	14.10	The Licensee agrees to mark the Licensed Products or their packaging or containers in accordance with the applicable patent marking laws. 

 

	 	14.11	By entering into this Agreement, the NIH does not directly or indirectly endorse any product or service provided, or to be provided, by the Licensee whether directly or indirectly related to this
Agreement. The Licensee shall not state or imply that this Agreement is an endorsement by the Government, the NIH, any other Government organizational unit, or any Government employee, Additionally,
the Licensee shall not use the names of NIH, FDA, the NIH, or HHS or the Government or their employees in any advertising, promotional, or sales literature in connection with this Agreement or
the Licensed Patent Rights without the prior written approval of the NIH. 

  

	 	14.12	The parties agree to attempt to settle amicably any controversy or claim arising under this Agreement or a breach of this Agreement, except for appeals of modifications or termination decisions provided
for in Article 13. The Licensee agrees first to appeal any unsettled claims or controversies to the designated NIH official, or designee, whose decision shall be considered the final agency decision. Thereafter, the Licensee may
exercise any administrative or judicial remedies that may be available. Notwithstanding anything to the contrary in this Agreement, the Licensee shall have the right, without waiving any right or remedy available under this
Agreement 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 the Licensee, 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 to 37 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. 

  
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	 	14.14	Any formal recordation of this Agreement required by the laws of any Licensed Territory as a prerequisite to enforceability of the Agreement in the courts of any foreign jurisdiction or for other
reasons shall be carried out by the Licensee at its expense, and appropriately verified proof of recordation shall be promptly furnished to the NIH. 

 

	 	14.15	Paragraphs 4.3, 8.1, 9.5-9.7, 12.1-12.5, 13.9, 13.10, 14.12 and 14.15 of this Agreement shall survive termination of this Agreement. 

 

	 	14.16	The terms and conditions of this Agreement shall, at the NIH’s sole option, be considered by the NIH to be withdrawn from the Licensee’s consideration and the terms and conditions
of this Agreement, and the Agreement itself to be null and void, unless this Agreement is executed by the Licensee and a fully executed original is received by the NIH within [...***...] from the date of the NIH signature found at the Signature Page. 

SIGNATURES BEGIN ON NEXT PAGE 

  
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 NIH PATENT LICENSE AGREEMENT —EXCLUSIVE/CO-EXCLUSIVE 

SIGNATURE PAGE 
 For the NIH: 

 

							
	 /s/ Richard U. Rodriguez
	 		  	  4-11-13
	  	
	Richard U. Rodriguez	 		  	Date	  	
	Director, Division of Technology Development and Transfer	 		  		  	
	Office of Technology Transfer	 		  		  	
	National Institutes of Health	 		  		  	

 Mailing Address or E-mail Address for Agreement notices and reports: 

Chief, Monitoring & Enforcement Branch 
 Office of
Technology Transfer 
 National Institutes of Health 
 6411
Executive Boulevard, Suite 325 
 Rockville, Maryland 20852-3804 U.S.A. 

E-mail: LicenseNotices_Reports@mail.nih.gov 
  

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

 

									
	 /s/ Aya Jakobovits
	 		  	  4-11-13
	  	
	Signature of Authorized Official	 		 		  	Date	  	
					
	 Aya Jakobovits
	 		 		  		  	
	Printed Name	 		 		  		  	
					
	 President and Chief Executive Officer
	 		 		  		  	
	Title	 		 		  		  	

  

	 	I.	Official and Mailing Address for Agreement notices: 

  

			
	 Aya Jakobovits
	 	
	Name	 	
		
	 President and Chief Executive Officer
	 	
	Title	 	
		
	Mailing Address	 	

  
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	 Kite Pharma, Inc.
	  		  	
			
	 10924 Le Conte Avenue
	  		  	
			
	 Los Angeles CA 90024
	  		  	
			
	Email Address:  	  	 ajakobovits@kitepharma.com
	  	
			
	Phone:	  	 310-824-9999 x201
	  	
			
	Fax:	  	 310-824-9994
	  	

  
  

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

  

							
	 Aya Jakobovits
	  		  	
	Name	  		  	
			
	 President and Chief Executive Officer
	  		  	
	Title	  		  	
			
	Mailing Address	  		  	
			
	 Kite Pharma, Inc.
	  		  	
			
	 10924 Le Conte Avenue
	  		  	
			
	 Los Angeles CA 90024
	  		  	
			
	Email Address:  	  	 ajakobovits@kitepharma.com
	  	
			
	Phone:	  	 310-824-9999 x201
	  	
			
	Fax:	  	 310-824-9994
	  	

 Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions,
under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 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): 
  

	I.	[...***...] 

  

	II.	PCT Patent Application No. PCT/US2011/051537 filed September 14, 2011 [HHS Ref. No. E-269-2010/0-PCT-02] 

  

	III.	[...***...] 

  

	IV.	PCT Patent Application No. PCT/US2012/029861 filed March 21, 2012 [HHS Ref. No. E-148-2011/0-PCT-02] 

  
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 APPENDIX B — LICENSED FIELDS OF USE AND TERRITORY 

 

	I.	Licensed Fields of Use: 

  

	 	(a)	Development and manufacture of synovial sarcoma breakpoint X-2 (SSX-2) T cell receptor (TCR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment
of head and neck cancer, hepatocellular carcinoma, melanoma, prostate cancer, and sarcoma. 

  

	 	(b)	Development and manufacture of epidermal growth factor receptor variant III (EGFRvIII) chimeric antigen receptor (CAR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent
Rights for the treatment of brain cancer, head and neck cancer, and melanoma. 

  

	 	(c)	Development and manufacture of synovial sarcoma breakpoint X-2 (SSX-2) T cell receptor (TCR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent Rights for the treatment
of breast cancer, ovarian cancer, and colorectal cancer. 

  

	 	(d)	Development and manufacture of epidermal growth factor receptor variant III (EGFRvIII) chimeric antigen receptor (CAR)-based autologous peripheral blood T cell therapy products as set forth in the Licensed Patent
Rights for the treatment of breast cancer, ovarian cancer, and colorectal cancer. 

 For purposes of the Agreement,
“autologous peripheral blood T cell therapy products” shall mean T cell or precursor products and compositions derived from blood, bone marrow, lymph nodes and thymus and, for the avoidance of doubt, shall exclude tumor-infiltrating
lymphocytes (TILs). 
  

	II.	Licensed Territory: 

 Worldwide 

  
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 APPENDIX C — ROYALTIES 

Royalties: 
  

	I.	The Licensee agrees to pay to the NIH a noncreditable, nonrefundable license issue royalty in the amount of two hundred thousand dollars ($200,000.00) in two installments as follows: 

 

	 	(a)	The first installment of one hundred thirty three thousand three hundred thirty three dollars and thirty three cents ($133,333.33) shall be payable within sixty (60) days from the effective date of the
Agreement; and 

  

	 	(b)	The second installment of sixty six thousand six hundred sixty six dollars and sixty seven cents ($66,666.67) shall be payable (i) on or before the eighteen (18) month anniversary of the effective date of this
Agreement or (ii) on or before the termination date of the Agreement, whichever occurs sooner. 

  

	II.	The Licensee agrees to pay to the NIH a nonrefundable minimum annual royalty in the amount of twenty thousand dollars ($20,000.00) as follows: 

 

	 	(a)	The first minimum annual royalty is due within sixty (60) days following the expiration date of Cooperative Research and Development Agreement (CRADA) Ref. No. C-064-2012/0 (NCI Ref. No. 02716) between the
National Cancer Institute (NCI) and the Licensee that includes further research and development of technologies related to the Licensed Patent Rights. This first minimum annual royalty may be prorated according to the fraction of the
calendar year remaining between the expiration date of the aforementioned CRADA and the next subsequent January 1; and 

  

	 	(b)	Subsequent minimum annual royalty payments are due and payable on January 1 of each calendar year and may be credited against any earned royalties due for sales made in that year. 

 

	III.	The Licensee agrees to pay the NIH earned royalties of [...***...] percent ([...***...]%) on Net Sales by or on behalf of the
Licensee and its sublicensees, subject to the following adjustment: 

  

	 	(a)	The Licensee shall be entitled to a credit of [...***...] percent ([...***...]) against the earned royalty rate for each percent point in excess of [...***...] percent ([...***...]%) that
the Licensee must pay to an unaffiliated licensor for the manufacture, use, offer for sale, sale or import of Licensed Product(s). Said credit, however, shall not reduce the earned royalty due to NIH for Licensed
Product(s) below [...***...] percent ([...***...]%). 

  

	IV.	The Licensee agrees to pay the NIH Benchmark royalties within [...***...] of achieving each Benchmark: 

 

	 	(a)	Fifty thousand dollars ($50,000.00) upon commencement of the first human clinical study for the first indication in each of Licensed Field of Use (a) or (c) and (b) or (d) from Appendix B.

  

	 	(b)	[...***...] dollars ($[...***...]) for [...***...]. 

  

	 	(c)	[...***...] dollars ($[...***...] for [...***...]. 

  
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	 	(d)	[...***...] dollars ($[...***...]) for [...***...]. 

  

	 	(e)	[...***...] dollars ($[...***...]) for [...***...]. 

  

	 	(f)	[...***...] dollars ($[...***...]) upon FDA approval or foreign equivalent for a Licensed Product or Licensed Process for the first indication in each of Licensed Field of Use
(a) or (c) and (b) or (d) from Appendix B. A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China), or the Ministry of Health and Welfare
(India). 

  

	 	(g)	[...***...] dollars ($[...***...]) upon [...***...]. A foreign equivalent to the FDA (United States) shall mean the EMEA (Europe), Japanese Ministry of Health and Welfare (Japan), SFDA (China),
or the Ministry of Health and Welfare (India). 

  

	 	(h)	The first time the aggregate Net Sales of all Licensed Products achieve the following thresholds, the Licensee pays the following one-time Benchmark royalties: 

 

	 	(1)	[...***...] dollars ($[...***...]) when the aggregate Net Sales of all Licensed Products reaches [...***...] dollars ($[...***...]. 

 

	 	(2)	[...***...] dollars ($[...***...] when the aggregate Net Sales of all Licensed Products reaches [...***...] dollars ($[...***...]. 

 

	 	(3)	[...***...] dollars ($[...***...] when the aggregate Net Sales of all Licensed Products reaches one billion dollars ($1,000,000,000.00). 

 

	V.	The Licensee agrees to pay the NIH the following additional sublicensing royalties on the fair market value of any consideration received for granting each sublicense, in accordance with Article 4 of the
Agreement, within [...***...] of the execution of each sublicense: 

  

	 	(a)	[...***...] percent ([...***...]%) for a sublicense granted [...***...]. 

  

	 	(b)	[...***...] percent ([...***...]%) for a sublicense granted [...***...]. 

  

	 	(c)	[...***...] percent ([...***...]%) for a sublicense granted [...***...]. 

  

	 	(d)	[...***...] percent ([...***...]%) for a sublicense granted [...***...]. 

Such sublicense royalties are in lieu of, and not in addition to, the Benchmark royalties and earned royalties on Net Sales above. 

 

	VI.	 The estimated amount of the royalty due under Paragraph 6.9 is [...***...] ($[...***...]) as of January 18, 2013. This is only a good
faith estimate and 

  
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 APPENDIX D — BENCHMARK AND PERFORMANCE 

 

	 	Licensee will be responsible for reimbursement of all unreimbursed expenses as stipulated in Paragraph 6.9. 

The Licensee agrees to the following Benchmarks for its performance under this Agreement and, within [*...***...] of achieving a Benchmark, shall notify the NIH that the Benchmark has been achieved. 

The Licensee will initiate its first Phase 2 clinical study for the first Licensed Product for the first cancer indication
within the Licensed Fields of Use from Appendix B within [...***...] after demonstration by the National Cancer Institute’s Surgery Branch within the NIH of the proof-of-concept of the first Licensed Product in such
cancer indication from the Licensed Fields of Use listed in Appendix B, and the National Cancer Institute’s Surgery Branch within the NIH delivers to the Licensee the final clinical study report and all clinical data for
the applicable clinical study demonstrating proof of concept. 
 The Licensee will initiate its first Phase 2 clinical study for the
first Licensed Product for any additional cancer indication (after the first cancer indication) within the Licensed Fields of Use from Appendix B within [...***...] to [...***...] after demonstration by the National Cancer
Institute’s Surgery Branch within the NIH of the proof-of-concept of the first Licensed Product in such cancer indication from the Licensed Fields of Use listed in Appendix B, and the National Cancer Institute’s
Surgery Branch within the NIH delivers to the Licensee the final clinical study report and all clinical data for the applicable clinical study demonstrating proof of concept. 

 

	 	(a)	The Licensee will initiate its first Phase 3 clinical study for the first Licensed Product for the first cancer indication within the Licensed Fields of Use from Appendix B within [...***...]
after successful completion of a Licensee Phase 2 clinical study for the first Licensed Product in such cancer indication from the Licensed Fields of Use from Appendix B. 

 

	 	(b)	The Licensee will initiate its first Phase 3 clinical study for the first Licensed Product for any additional cancer indication (after the first cancer indication) within the Licensed Fields of Use
from Appendix B within [...***...] to [...***...] after successful completion of a Licensee Phase 2 clinical study for the first Licensed Product in such cancer indication from the Licensed Fields of Use from
Appendix B. 

 For purposes of the Agreement, “initiate” shall mean (i) with respect to a Phase 2
clinical study, the Licensee, its Affiliate or sublicensee having filed a company sponsored IND necessary to commence such Phase 2 clinical study, and (ii) with respect to a Phase 3 clinical study, the Licensee, its
Affiliate or sublicensee having submitted to the FDA a pivotal clinical trial protocol for such Phase 3 clinical study. 
 For purposes of
the Agreement, “proof-of-concept” shall mean, with respect to a specified construct, formulation and dose of a specified Licensed Product for the treatment of a specified cancer indication, the demonstration in a Phase
1/Phase 2A or Phase 2A clinical study of safety and efficacy, sufficient to enable the Licensee to commence multi-center Phase 2 clinical studies without further studies, for such specified construct, formulation and dose of such specified
Licensed Product for the treatment of such specified cancer indication. 
 For purposes of the Agreement, “successful
completion of a Licensee Phase 2 clinical study” shall mean, with respect to for a specified construct, formulation and dose of a specified Licensed Product in a specified cancer indication, the statistical demonstration in
multi-center Phase 2 clinical studies of safety and efficacy, sufficient to enable the Licensee to commence pivotal Phase 3 clinical studies without further studies, for such specified construct, formulation and dose of such specified
Licensed Product for the treatment of such specified cancer indication. 

  
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 APPENDIX E — COMMERCIAL DEVELOPMENT PLAN 

[...***...] 

  
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 APPENDIX F — EXAMPLE ROYALTY REPORT 

Required royalty report information includes: 
  

	•	 	OTT license reference number (L-XXX-200X/0) 

	•	 	Reporting period 

	•	 	Catalog number and units sold of each Licensed Product (domestic and foreign) 

	•	 	Gross Sales per catalog number per country 

	•	 	Total Gross Sales 

	•	 	Itemized deductions from Gross Sales 

	•	 	Total Net Sales 

	•	 	Earned Royalty Rate and associated calculations 

	•	 	Gross Earned Royalty 

	•	 	Adjustments for Minimum Annual Royalty (MAR) and other creditable payments made 

	•	 	Net Earned Royalty due 

   Example 

									
	Catalog Number	  	Product Name	  	Country	  	Units Sold	  	Gross Sales
(US$)
	
1
	  	A	  	US	  	250	  	62,500
	
1
	  	A	  	UK	  	32	  	16,500
	
1
	  	A	  	France	  	25	  	15,625
	
2
	  	B	  	US	  	0	  	0
	
3
	  	C	  	US	  	57	  	57,125
	
4
	  	D	  	US	  	12	  	1,500

  

									
		 	Total Gross Sales	 		 	 	153,250	  
		 	 Less Deductions:             
	 		 			
		 	 [...***...]
	 		 	 	3,000	  
		 	 [...***...]
	 		 	 	7,000	  
		 	 Total Net Sales
	 		 	 	143,250	  
				
		 	 Royalty Rate
	 		 	 	[...***...]%	  
		 	 Royalty Due
	 		 	 	[...***...]	  
		 	 Less Creditable Payments
	 		 	 	[...***...]	  
		 	 Net Royalty Due
	 		 	 	[...***...]	  

  
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 APPENDIX G — ROYALTY PAYMENT OPTIONS 

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

Automated Clearing House (ACH) for payments through U.S. banks only 

The NIH encourages our licensees to submit electronic funds transfer payments through the Automated Clearing House (ACH). Submit your ACH
payment through the U.S. Treasury web site located at: https://www.pay.gov. Locate the “NIH Agency Form” through the Pay.gov “Agency List”. 

Electronic Funds Wire Transfers 
 The following
account information is provided for wire payments. In order to process payment via Electronic Funds Wire Transfer sender MUST supply the following information within the transmission: 

Drawn on a U.S. bank account via FEDWIRE should be sent directly to the following account: 

 

					
	Beneficiary Account:	 	[...***...]	  	
	Bank:	 	[...***...]	  	
	ABA#	 	[...***...]	  	
	Account Number:	 	[...***...]	  	
	Bank Address:	 	[...***...]	  	
	Payment Details:	 	[...***...]	  	
		 	[...***...]	  	

 Drawn on a foreign bank account should be sent directly to the following account. Payment must be sent
in U.S. Dollars (USD) using the following instructions: 
  

					
	Beneficiary Account:	 	[...***...]	  	
	Bank:	 	[...***...]	  	
	SWIFT Code:	 	[...***...]	  	
	Account Number:	 	[...***...]	  	
	Bank Address:	 	[...***...]	  	
	Payment Details (Line 70):	 	[...***...]	  	
		 	[...***...]	  	
		 	[...***...]	  	
	Detail of Charges (line 71a):	 	[...***...]	  	

  
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 Checks 

All checks should be made payable to “NIH Patent Licensing” 

Checks drawn on a U.S. bank account and sent by US Postal Service should be sent directly to the following address: 

National Institutes of Health (NIH) 

P.O. Box 979071 
 St. Louis, MO
63197-9000 
 Checks drawn on a U.S. bank account and sent by overnight or courier should be sent to the following address:

 US Bank 
 Government Lockbox
SL-MO-C2GL 
 1005 Convention Plaza 

St. Louis, MO 63101 
 Phone:
314-418-4087 
 Checks drawn on a foreign bank account should be sent directly to the following address: 

National Institutes of Health (NIH) 

Office of Technology Transfer 

Royalties Administration Unit 

6011 Executive Boulevard 
 Suite
325, MSC 7660 
 Rockville, Maryland 20852 

  
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Page 31 of 30    [FINAL]  [Kite Pharma, Inc]  [April 11, 2013]EX-10.18

 Exhibit 10.18 

***Text Omitted and Filed Separately 

with the Securities and Exchange Commission. 

Confidential Treatment Requested 

Under 17 C.F.R. Section 200.80(b)(4) and Rule 406 of the 

Securities Act of 1933, as amended. 

PUBLIC HEALTH SERVICE 

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT 

FOR INTRAMURAL-PHS CLINICAL RESEARCH 
 This
Agreement is based on the model Cooperative Research and Development Agreement (“CRADA”) 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 the PHS within the Department of Health and Human Services (“HHS”).

 This Cover Page identifies the Parties to this CRADA: 

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

National Cancer Institute 

an Institute, Center, or Division (hereinafter referred to as the “ICD”) of the 

National Institutes of Health 

and 
 Kite Pharma, Inc.

 hereinafter referred to as the “Collaborator”, 

having offices at 10924 Le Conte Avenue, Los Angeles, CA 90024 

created and operating under the laws of Delaware. 

  

					
	PHS ICT-CRADA	 	Case Ref. No.               	 	MODEL ADOPTED June 18, 2009
	Page 1 of 52	 		 	

 COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT 

FOR INTRAMURAL-PHS CLINICAL RESEARCH 
  

	Article 1.	Introduction 

 This CRADA between ICD and Collaborator will be effective when signed by the Parties,
which are identified on both the Cover Page and the Signature Page (page 21). The official contacts for the Parties are identified on the Contacts Information Page (page 22). Publicly available information regarding this CRADA appears on the Summary
Page (page 23). The research and development activities that will be undertaken by ICD and Collaborator in the course of this CRADA are detailed in the Research Plan, attached as Appendix A. The staffing, funding, and materials contributions of the
Parties are set forth in Appendix B. Any changes to the model CRADA are set forth in Appendix C. 
  

	Article 2.	Definitions 

 The terms listed in this Article will carry the meanings indicated throughout the CRADA.
To the extent a definition of a term as provided in this Article is inconsistent with a corresponding definition in the applicable sections of either the United States Code (U.S.C.) or the Code of Federal Regulations (C.F.R.), the definition in the
U.S.C. or C.F.R. will control. 
 “Adverse Drug Experience” or “ADE” means an Adverse Event associated
with the use of the Test Article, that is, an event where there is a reasonable possibility that the Test Article may have caused the event (a relationship between the Test Article and the event cannot be ruled out), in accordance with the
definitions of 21 C.F.R. Part 305, 310, or 312, or other applicable regulations. 
 “Adverse Event” or
“AE” means any untoward medical occurrence in a Human Subject administered Test Article. An AE does not necessarily have a causal relationship with the Test Article, that is, it can be any unfavorable and unintended sign (including
an abnormal laboratory finding), symptom, or disease temporally associated with the use of the Test Article, whether or not it is related to it. See FDA Good Clinical Practice Guideline (from International Conference on Harmonisation (ICH) E6:
“Good Clinical Practice: Consolidated Guidance, 62 Federal Register 25, 691 (1997)). 
 “Affiliate” means any
corporation or other business entity controlled by, controlling, or under common control with Collaborator at any time during the term of the CRADA. For this purpose, “control” means direct or indirect beneficial ownership of at least
fifty percent (50%) of the voting stock or at least fifty percent (50%) interest in the income of the corporation or other business entity. 

“Annual Report” means the report of progress of an IND-associated investigation that ICD, as the IND Sponsor, must submit to
the FDA within sixty (60) days of the anniversary of the effective date of the IND (pursuant to 21 C.F.R.§ 312.33). 

  

					
	PHS ICT-CRADA	 	Case Ref. No.               	 	MODEL ADOPTED June 18, 2009
	Page 2 of 52	 		 	

 “Background Invention” means an Invention conceived and first actually reduced
to practice before the Effective Date. 
 “Clinical Investigator” means, in accordance with 21 C.F.R. § 312.3, an
individual who actually conducts a clinical investigation, that is, who directs the administration or dispensation of Test Article to a subject, and who assumes responsibility for studying Human Subjects, for recording and ensuring the integrity of
research data, and for protecting the welfare and safety of Human Subjects. 
 “Collaborator Materials” means all tangible
materials not first produced in the performance of this CRADA that are owned or controlled by Collaborator and used in the performance of the Research Plan. The term “Collaborator Materials” does not include “Test Article”
(defined below). 
 “Confidential Information” means confidential scientific, business, financial information, or
Identifiable Private Information provided that the information does not include: 
  

	 	(a)	information that is publicly known or that is available from public sources; 

	 	(b)	information that has been made available by its owner to others without a confidentiality obligation; 

	 	(c)	information that is already known by the receiving Party, or information that is independently created or compiled by the receiving Party without reference to or use of the provided information; or 

	 	(d)	information that relates to potential hazards or cautionary warnings associated with the production, handling, or use of the subject matter of the Research Plan. 

“Cooperative Research and Development Agreement” or “CRADA” means this Agreement, entered into pursuant to
the Federal Technology Transfer Act of 1986, as amended (15 U.S.C. §§ 3710a et seq.), and Executive Order 12591 of April 10, 1987. 

“CRADA Data” means all recorded information first produced in the performance of the Research Plan. 

“CRADA Materials” means all tangible materials first produced in the performance of the Research Plan other than CRADA Data.

 “CRADA Principal Investigator(s)” or “CRADA PI(s)” means the person(s) designated by the Parties who
will be responsible for the scientific and technical conduct of the Research Plan. The CRADA PI may also be a Clinical Investigator. 

“CRADA Subject Invention” means any Invention of either or both Parties, conceived or first actually reduced to practice in
the performance of the Research Plan. 

  

					
	PHS ICT-CRADA	 	Case Ref. No.               	 	MODEL ADOPTED June 18, 2009
	Page 3 of 52	 		 	

 “Drug Master File” or “DMF” is described in 21 C.F.R. Part
314.420. A DMF is a submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. 

“Effective Date” means the date of the last signature of the Parties executing this Agreement. 

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

“Human Subject” means, in accordance with the definition in 45 C.F.R. § 46.102(f), a living individual about whom an
investigator conducting research obtains: 
  

	 	(a)	data through intervention or interaction with the individual; or 

	 	(b)	Identifiable Private Information. 

 “ICD Materials” means all tangible
materials not first produced in the performance of this CRADA that are owned or controlled by ICD and used in the performance of the Research Plan. 

“IND” means an “Investigational New Drug Application”, filed in accordance with 21 C.F.R. Part 312 under
which clinical investigation of an experimental drug or biologic (Test Article) is performed in Human Subjects in the United States or intended to support a United States licensing action. 

“Identifiable Private Information” or “IPI” about a Human Subject means private information from which the
identity of the subject is or may readily be ascertained. Regulations defining and governing this information include 45 C.F.R. Part 46 and 21 C.F.R. Part 50. 

“Institutional Review Board” or “IRB” means, in accordance with 45 C.F.R. Part 46, 21 C.F.R. part 56, and
other applicable regulations, an independent body comprising medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of the Human Subjects involved in a study. 

“Invention” means any invention or discovery that is or may be patentable or otherwise protected under Title 35 of the United
States Code, or any novel variety of plant which is or may be protectable under the Plant Variety Protection Act, 7 U.S.C. §§ 2321 et seq. 

“Investigator’s Brochure” means, in accordance with the definition in 21 C.F.R. § 312.23(a)(5), a document
containing information about the Test Article, including animal screening, preclinical toxicology, and detailed pharmaceutical data, including a description of possible risks and side effects to be anticipated on the basis of prior experience with
the drug or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the drug. 

  

					
	PHS ICT-CRADA	 	Case Ref. No.               	 	MODEL ADOPTED June 18, 2009
	Page 4 of 52	 		 	

 “Patent Application” means an application for patent protection for a CRADA
Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation. 

“Patent” means any issued United States patent, any international counterpart(s), and any corresponding grant(s) by a
non-U.S. government in place of a patent. 
 “Placebo” means an inactive substance identical in appearance to the material
being tested that is used to distinguish between drug action and suggestive effect of the material under study. 

“Protocol” means the formal, detailed description of a study to be performed as provided for in the Research Plan. It
describes the objective(s), design, methodology, statistical considerations, and organization of a trial. For the purposes of this CRADA, the term, Protocol, for clinical research involving Human Subjects, includes any and all associated documents,
including informed consent forms, to be provided to Human Subjects and potential participants in the study. 
 “Raw Data”
means the primary quantitative and empirical data first collected from experiments and clinical trials conducted within the scope of this CRADA. 

“Research Plan” means the statement in Appendix A of the respective research and development commitments of the Parties. The
Research Plan should describe the provisions for sponsoring the IND, clinical and safety monitoring, and data management. 

“Sponsor” means, in accordance with the definition in 21 C.F.R. § 312.3, an organization or individual who assumes legal
responsibility for supervising or overseeing clinical trials with Test Articles, and is sometimes referred to as the IND holder. 

“Steering Committee” means the research and development team whose composition and responsibilities with regard to the
research performed under this CRADA are described in Appendix A. 
 “Summary Data” means any extract or summary of the Raw
Data, generated either by, or on behalf of, ICD or by, or on behalf of, Collaborator. Summary Data may include extracts or summaries that incorporate IPI. 

“Test Article” means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food
additive, color additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the
Research Plan and Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. 

  

					
	PHS ICT-CRADA	 	Case Ref. No.               	 	MODEL ADOPTED June 18, 2009
	Page 5 of 52	 		 	

	Article 3.	Cooperative Research and Development 

  

	3.1	Performance of Research and Development. The research and development activities to be carried out under this CRADA will be performed solely by the Parties identified on the Cover Page, unless specifically stated
elsewhere in the Agreement. The CRADA PIs will be responsible for coordinating the scientific and technical conduct of this project on behalf of their employers. Any Collaborator employees who will work at ICD facilities will be required to sign a
Guest Researcher or Special Volunteer Agreement appropriately modified in view of the terms of this CRADA. 

  

	3.2	Research Plan. The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are
good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6. 

 

	3.3	Use and Disposition of Collaborator Materials and ICD Materials. The Parties agree to use Collaborator Materials and ICD Materials only in accordance with the Research Plan and Protocol(s), not to transfer these
materials to third parties except in accordance with the Research Plan and Protocol(s) or as approved by the owning or providing Party, and, upon expiration or termination of the CRADA, to dispose of these materials as directed by the owning or
providing Party. 

  

	3.4	Third-Party Rights in Collaborator’s CRADA Subject Inventions. If Collaborator has received (or will receive) support of any kind from a third party in exchange for rights in any of Collaborator’s CRADA
Subject Inventions, Collaborator agrees to ensure that its obligations to the third party are both consistent with Articles 6 through 8 and subordinate to Article 7 of this CRADA. 

 

	3.5	Disclosures to ICD. Prior to execution of this CRADA, Collaborator agrees to disclose to ICD all instances in which outstanding royalties are due under a PHS license agreement and in which Collaborator had a PHS
license terminated in accordance with 37 C.F.R. § 404.10. These disclosures will be treated as Confidential Information upon request by Collaborator in accordance with the definition in Article 2 and Paragraphs 8.3 and 8.4. 

 

	3.6	Clinical Investigator Responsibilities. The Clinical Investigator will be required to submit, or to arrange for submission of, each Protocol associated with this CRADA to the IRB. In addition to the Protocol all
associated documents, including informational documents and advertisements, must be reviewed and approved by the IRB before starting the research. The research will be done in strict accordance with the Protocol(s) and no substantive changes in a
finalized Protocol will be made unless mutually agreed upon, in writing, by the Parties. Research will not commence (or will continue unchanged, if already in progress) until each substantive change to a Protocol, including those required by either
the FDA or the IRB, has been integrated in a way acceptable to the Parties, submitted to the FDA (if applicable) and approved by the IRB. 

  

					
	PHS ICT-CRADA	 	Case Ref. No.               	 	MODEL ADOPTED June 18, 2009
	Page 6 of 52	 		 	

	3.7	Investigational Applications. 

  

	 	3.7.1	If an IND is required, ICD will be the IND Sponsor and will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms). 

 

	 	3.7.2	When ICD files the IND, Collaborator agrees to provide ICD background data and information necessary to support the IND. Collaborator further agrees to provide a letter of cross-reference to all pertinent regulatory
filings sponsored by Collaborator. Collaborator’s employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s IND, DMF, other filings, or other information and
data provided to ICD by the Collaborator pursuant to this Article 3. 

  

	 	3.7.3	If Collaborator supplies Confidential Information to ICD in support of an IND filed by ICD, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8.

  

	 	3.7.4	Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. These studies, however, should not adversely affect the ability to accomplish the goal of the
Research Plan, for example, by competing for the same study population. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA. 

 

	3.8	Test Article Information and Supply. Collaborator agrees to provide ICD without charge and on a schedule that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and
acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and approved under this CRADA. Collaborator will provide a Certificate of Analysis to ICD for each lot of the
Test Article provided. 

  

	3.9	Test Article Delivery and Usage. Collaborator will ship the Test Article and, if required, Placebo to ICD in containers marked in accordance with 21 C.F.R. § 312.6. ICD agrees that the Clinical Investigators
will keep appropriate records and take reasonable steps to ensure that the Test Article is used in accordance with the Protocol(s) and applicable FDA regulations. In addition, ICD agrees that the Test Article (and all Confidential Information
supplied by Collaborator relating to the Test Article) will be used solely for the conduct of the CRADA research and development activities. Furthermore, ICD agrees that no analysis or modification of the Test Article will be performed without
Collaborator’s prior written consent. At the completion of the Research Plan, any unused quantity of Test Article will be returned to Collaborator or disposed as directed by Collaborator. Pharmacy contacts at ICD will be determined by ICD and
communicated to Collaborator. 

 Monitoring. Subject to the restrictions in Article 8 concerning IPI, and with
reasonable 

  

					
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advance notice and at reasonable times, ICD will permit Collaborator or its designee(s) to monitor the conduct of the research, as well as to audit source documents containing Raw Data, to the
extent necessary to verify compliance with FDA Good Clinical Practice (International Conference on Harmonisation (ICH) E6: “Good Clinical Practice: Consolidated Guidance; 62 Federal Register 25, 691 (1997)) and the Protocol(s). 

 

	3.10	FDA Meetings/Communications. AU meetings with the FDA concerning any clinical trial within the scope of the Research Plan will be discussed by Collaborator and ICD in advance. Each Party reserves the right to
take part in setting the agenda for, to attend, and to participate in these meetings. ICD will provide Collaborator with copies of FDA meeting minutes, all transmittal letters for IND submissions, IND safety reports, formal questions and responses
that have been submitted to the FDA, Annual Reports, and official FDA correspondence, pertaining either to the INDs under this CRADA or to the Clinical Investigators on Protocols performed in accordance with the Research Plan, except to the extent
that those documents contain the proprietary information of a third party or dissemination is prohibited by law. 

  

	Article 4.	Reports 

  

	4.1	Interim Research and Development Reports. The CRADA Pis should exchange information regularly, in writing. This exchange may be accomplished through meeting minutes, detailed correspondence, circulation of draft
manuscripts, Steering Committee reports, copies of Annual Reports and any other reports updating the progress of the CRADA research. However, the Parties must exchange updated Investigator’s Brochure, formulation and preclinical data, and
toxicology findings, as they become available. 

  

	4.2	Final Research and Development Reports. The Parties will exchange final reports of their results within [...***...] after the expiration or termination
of this CRADA. These reports will set forth the technical progress made; any publications arising from the research; and the existence of invention disclosures of potential CRADA Subject Inventions and/or any corresponding Patent Applications.

  

	4.3	Fiscal Reports. If Collaborator has agreed to provide funding to ICD under this CRADA and upon the request of Collaborator, then concurrent with the exchange of final research and development reports according to
Paragraph 4.2, ICD will submit to Collaborator a statement of all costs incurred by ICD for the CRADA. If the CRADA has been terminated, ICD will specify any costs incurred before the date of termination for which ICD has not received funds from
Collaborator, as well as for all reasonable termination costs including the cost of returning Collaborator property or removal of abandoned Collaborator property, for which Collaborator will be responsible. 

 

	4.4	 Safety Reports. In accordance with FDA requirements ICD, as the IND Sponsor, will establish and maintain records and submit safety reports to
the FDA, as required by 21 C.F.R. § 312.32 and 21 C.F.R. $12.150(b)(1), or other applicable regulations in the conduct of research under this CRADA, the Parties will comply with specific ICD guidelines and policies for reporting ADEs and AEs,
as well as procedures specified in 

  

					
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the Protocol(s). ICD must provide Collaborator with copies of all Safety Reports concurrently with their submission to the FDA, and with any other information affecting the safety of Human
Subjects in research conducted under this CRADA. 

  

	4.5	Annual Reports. ICD will provide Collaborator a copy of the Annual Report concurrently with the submission of the Annual Report to the FDA. Annual Reports will be kept confidential in accordance with Article 8.

  

	Article 5.	Staffing, Financial, and Materials Obligations 

  

	5.1	ICD and Collaborator Contributions. The contributions of any staff, funds, materials, and equipment by the Parties are set forth in Appendix B. The Federal Technology Transfer Act of 1986, 15 U.S.C.
§ 3710a(d)(1) prohibits ICD from providing funds to Collaborator for any research and development activities under this CRADA. 

  

	5.2	ICD Staffing. No ICD employees will devote 100% of their effort or time to the research and development activities under this CRADA. ICD will not use funds provided by Collaborator under this CRADA for ICD
personnel to pay the salary of any permanent ICD employee. Although personnel hired by ICD using CRADA funds will focus principally on CRADA research and development activities, Collaborator acknowledges that these personnel may nonetheless make
contributions to other research and development activities, and the activities will be outside the scope of this CRADA. 

  

	5.3	Collaborator Funding. Collaborator acknowledges that Government funds received by Collaborator from an agency of the Department of Health and Human Services may not be used to fund ICD under this CRADA. If
Collaborator has agreed to provide funds to ICD then the payment schedule appears in Appendix B and Collaborator will make payments according to that schedule. If Collaborator fails to make any scheduled payment, ICD will not be obligated to perform
any of the research and development activities specified herein or to take any other action required by this CRADA until the funds are received. ICD will use these funds exclusively for the purposes of this CRADA. Each Party will maintain separate
and distinct current accounts, records, and other evidence supporting its financial obligations under this CRADA and, upon written request, will provide the other Party a Fiscal Report according to Paragraph 4.3, which delineates all payments made
and all obligated expenses, along with the Final Research Report described in Paragraph 4.2. 

  

	5.4	Capital Equipment. Collaborator’s commitment, if any, to provide ICD with capital equipment to enable the research and development activities under the Research Plan appears in Appendix B. If Collaborator
transfers to ICD the capital equipment or provides funds for ICD to purchase it, then ICD will own the equipment. If Collaborator loans capital equipment to ICD for use during the CRADA, Collaborator will be responsible for paying all costs and fees
associated with the transport, installation, maintenance, repair, removal, or disposal of the equipment, and ICD will not be liable for any damage to the equipment. 

  

					
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	Article 6.	Intellectual Property 

  

	6.1	Ownership of CRADA Subject Inventions, CRADA Data, and CRADA Materials. Subject to the Government license described in Paragraph 7.5, the sharing requirements of Paragraph 8.1 and the regulatory filing
requirements of Paragraph 8.2, the producing Party will retain sole ownership of and title to all CRADA Subject Inventions, all copies of CRADA Data, and all CRADA Materials produced solely by its employee(s). The Parties will own jointly all CRADA
Subject Inventions invented jointly and all CRADA Materials developed jointly. 

  

	6.2	Reporting. The Parties will promptly report to each other in writing each CRADA Subject Invention reported by their respective personnel, and any Patent Applications filed thereon, resulting from the research and
development activities conducted under this CRADA. Each Party will report all CRADA Subject Inventions to the other Party in sufficient detail to determine inventor ship, which will be determined in accordance with U.S. patent law. These reports
will be treated as Confidential Information in accordance with Article 8. Formal reports will be made by and to the Patenting and Licensing Offices identified on the Contacts Information Page herein. 

 

	6.3	Filing of Patent Applications. Each Party will make timely decisions regarding the filing of Patent Applications on the CRADA Subject Inventions made solely by its employee(s), and will notify the other Party in
advance of filing. Collaborator will have the first opportunity to file a Patent Application on joint CRADA Subject Inventions and will notify PHS of its decision within [...***...] of an Invention being reported or at least
[...***...] before any patent filing deadline, whichever occurs sooner. If Collaborator fails to notify PHS of its decision within that time period or notifies PHS of its decision not to file a Patent Application, then PHS has the right to
file a Patent Application on the joint CRADA Subject Invention. Neither Party will be obligated to file a Patent Application. Collaborator will place the following statement in any Patent Application it files on a CRADA Subject Invention: “This
invention was created in the performance of a Cooperative Research and Development Agreement with the [INSERT into Agency’s model as appropriate: National Institutes of Health, Food and Drug Administration, Centers for Disease Control and
Prevention], an Agency of the Department of Health and Human Services. The Government of the United States has certain rights in this invention.” If either Party files a Patent Application on a joint CRADA Subject Invention, then the
filing Party will include a statement within the Patent Application that clearly identifies the Parties and states that the joint CRADA Subject Invention was made under this CRADA. 

 

	6.4	 Patent Expenses. Unless agreed otherwise, the Party filing a Patent Application will pay all preparation and filing expenses, prosecution fees,
issuance fees, post issuance fees, patent maintenance fees, annuities, interference expenses, and attorneys’ fees for that Patent Application and any resulting Patent(s). If a license to any CRADA Subject Invention is granted to Collaborator,
then Collaborator will be responsible for all expenses and fees, past and future, in connection with the preparation, filing, prosecution, 

  

					
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and maintenance of any Patent Applications and Patents claiming exclusively licensed CRADA Subject Inventions and will be responsible for a pro-rated share, divided equally among all licensees,
of those expenses and fees for non-exclusively licensed CRADA Subject Inventions. Collaborator may waive its exclusive option rights at any time, and incur no subsequent financial obligation for those Patent Application(s) or Patent(s).

  

	6.5	Prosecution of Patent Applications. The Party filing a Patent Application will provide the non-filing Party with a copy of any official communication relating to prosecution of the Patent Application within [...***...] of transmission of the communication. Each Party will also provide the other Party with the power to inspect and make copies of all documents retained in the applicable Patent
Application or Patent file. The Parties agree to consult with each other regarding the prosecution of Patent Applications directed to joint CRADA Subject Inventions. If Collaborator elects to file and prosecute Patent Applications on joint CRADA
Subject Inventions, then Collaborator agrees to use the U.S.P.T.O. Customer Number Practice and/or grant PHS a power(s) of attorney (or equivalent) necessary to assure PHS access to its intellectual property rights in these Patent Applications. PHS
and Collaborator will cooperate with each other to obtain necessary signatures on Patent Applications, assignments, or other documents. 

  

	Article 7.	Licensing 

  

	7.1	Background Inventions. Other than as specifically stated in this Article 7, nothing in this CRADA will be construed to grant any rights in one Party’s Background Invention(s) to the other Party, except to
the extent necessary for the Parties to conduct the research and development activities described in the Research Plan. 

  

	7.2	Collaborator’s License Option to CRADA Subject Inventions. With respect to Government rights to any CRADA Subject Invention made solely by an ICD employee(s) or made jointly by an ICD employee(s) and a
Collaborator employee(s) for which a Patent Application was filed, PHS hereby grants to Collaborator an exclusive option to elect an exclusive or nonexclusive commercialization license. The license will be substantially in the form of the
appropriate model PHS license agreement and will fairly reflect the nature of the CRADA Subject Invention, the relative contributions of the Parties to the CRADA Subject Invention and the CRADA, a plan for the development and marketing of the CRADA
Subject Invention, the risks incurred by Collaborator, and the costs of subsequent research and development needed to bring the CRADA Subject Invention to the marketplace. The field of use of the license will not exceed the scope of the Research
Plan. 

  

	7.3	 Exercise of Collaborator’s License Option. To exercise the option of Paragraph 7.2 Collaborator must submit a written notice to the PHS
Patenting and Licensing Contact identified on the Contacts Information Page (and provide a copy to the ICD Contact for CRADA Notices) within [...***...] after either (i) Collaborator receives written notice from PHS that the Patent
Application has been filed or (ii) the date on which Collaborator files the Patent Application. The written notice exercising this option will include a completed “Application for License to Public Health Service Inventions” and

  

					
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will initiate a negotiation period that expires [...***...] after the exercise of the option. If PHS has not responded in writing to the
last proposal by Collaborator within this [...***...] period, the negotiation period will be extended to expire [...***...] after PHS so responds, during which month Collaborator may accept in writing the final license proposal of PHS.
In the absence of Collaborator’s exercise of the option, or upon election of a nonexclusive license, PHS will be free to license the CRADA Subject Invention to others. These time periods may be extended at the sole discretion of PHS upon good
cause shown in writing by Collaborator. 

  

	7.4	Government License in ICD Sole CRADA Subject Inventions and Joint CRADA Subject Inventions. Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for CRADA Subject Inventions owned solely by ICD or jointly by ICD and
Collaborator, and licensed pursuant to the option of Paragraph 7.2, Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the CRADA Subject Invention or have the CRADA Subject Invention
practiced throughout the world by or on behalf of the Government. In the exercise of this license, the Government will 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 privileged or confidential if it had been obtained from a non-federal party. 

  

	7.5	Government License in Collaborator Sole CRADA Subject Inventions. Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject Inventions made solely by an employee of Collaborator, Collaborator grants to the
Government a nonexclusive, nontransferable, irrevocable, paid-up license to practice the CRADA Subject Invention or have the CRADA Subject Invention practiced throughout the world by or on behalf of the Government for research or other Government
purposes. 

  

	7.6	Third Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants Collaborator an exclusive license to a CRADA Subject Invention made solely by an ICD employee or jointly with a Collaborator
employee, the Government will retain the right to require Collaborator to grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the CRADA Subject Invention in Collaborator’s licensed field of use
on terms that are reasonable under the circumstances; or, if Collaborator fails to grant a license, to grant a license itself. The exercise of these rights by the Government will only be in exceptional circumstances and only if the Government
determines (i) the action is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator, (ii) the action is necessary to meet requirements for public use specified by federal regulations, and such
requirements are not reasonably satisfied by Collaborator; or (iii) Collaborator has failed to comply with an agreement containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this
Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. § 203(b). 

  

	7.7	 Third-Party Rights In ICD Sole CRADA Subject Inventions. For a CRADA Subject Invention conceived prior to the Effective Date solely by
an ICD employee that is first actually reduced to practice after the Effective Date in the performance of the Research 

  

					
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Plan, the option offered to Collaborator in Paragraph 7.2 may be restricted if, prior to the Effective Date, PHS had filed a Patent Application and has either offered or granted a license in the
CRADA Subject Invention to a third party. Collaborator nonetheless retains the right to apply for a license to any such CRADA Subject Invention in accordance with the terms and procedures of 35 U.S.C. § 209 and 37 C.F.R. Part 404.

  

	7.8	Joint CRADA Subject Inventions Not Exclusively Licensed by Collaborator. If Collaborator does not acquire an exclusive commercialization license in a joint CRADA Subject Invention in all fields of use then, for
those fields of use not exclusively licensed to Collaborator, each Party will have the right to use the joint CRADA Subject Invention and to license its use to others, and each Party will cooperate with the other, as necessary, to fulfill
international licensing requirements. The Parties may agree to a joint licensing approach for any remaining fields of use. 

  

	Article 8.	Rights of Access and Publication 

  

	8.1	Right of Access to CRADA Data and CRADA Materials. ICD and Collaborator agree to exchange all CRADA Data and to share all CRADA Materials. If the CRADA is terminated, both Parties agree to provide CRADA Materials
in quantities needed to complete the Research Plan. Such provision will occur before the termination date of the CRADA or sooner, if required by the Research Plan, If Collaborator possesses any human biological specimens from clinical trials under
the CRADA, the specimens must be handled as described in the Protocol or as otherwise directed by ICD before the termination date of the CRADA. 

  

	8.2	Use of CRADA Data and CRADA Materials. The Parties will be free to utilize CRADA Data and CRADA Materials internally for their own purposes, consistent with their obligations under this CRADA. The Parties may
share CRADA Data or CRADA Materials with their Affiliates, agents or contractors provided the obligations of this Article 8.2 are simultaneously conveyed. 

  

	 	8.2.1	CRADA Data. 

 Collaborator and ICD will use reasonable efforts to keep CRADA Data
confidential until published or until corresponding Patent Applications are filed. To the extent permitted by law, each Party will have the right to use any and all CRADA Data in and for any regulatory filing by or on behalf of the Party. 

 

	 	8.2.2	CRADA Materials. 

 Collaborator and ICD will use reasonable efforts to keep descriptions
of CRADA Materials confidential until published or until corresponding Patent Applications are filed. Collaborator acknowledges that the basic research mission of PHS includes sharing with third parties for further research those research resources
made in whole or in part with NIH funding. Consistent with this mission and the tenets articulated in “Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts”, December 1999,
available at http://ott.od.nih.gov/NewPages/RTguide_final.html, following 

  

					
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publication either Party may make available to third parties for further research those CRADA Materials made jointly by both PHS and Collaborator. Notwithstanding the above, if those joint CRADA
Materials are the subject of a pending Patent Application or a Patent, or were created using a patent-pending or patented material or technology, the Parties may agree to restrict distribution or freely distribute them. Either Party may distribute
those CRADA Materials made solely by the other Party only upon written consent from that other Party or that other Party’s designee. 
  

	8.3	Confidential Information. Each Party agrees to limit its disclosure of Confidential Information to the amount necessary to carry out the Research Plan, and will place a confidentiality notice on all this
information. A Party orally disclosing Confidential Information to the other Party will summarize the disclosure in writing and provide it to the other Party within [...***...] of the
disclosure. Each Party receiving Confidential Information agrees to use it only for the purposes described in the Research Plan. Either Party may object to the designation of information as Confidential Information by the other Party.

  

	8.4	Protection of Confidential Information. Confidential Information will not be disclosed, copied, reproduced or otherwise made available to any other person or entity without the consent of the owning or providing
Party except as required by a court or administrative body of competent jurisdiction, or federal law or regulation. Each Party agrees to use reasonable efforts to maintain the confidentiality of Confidential Information, which will in no instance be
less effort than the Party uses to protect its own Confidential Information. Each Party agrees that a Party receiving Confidential Information will not be liable for the disclosure of that portion of the Confidential Information which, after notice
to and consultation with the disclosing Party, the receiving Party determines may not be lawfully withheld, provided the disclosing Party has been given a reasonable opportunity to seek a court order to enjoin disclosure. 

 

	8.5	Human Subject Protection. The research to be conducted under this CRADA involves Human Subjects or human tissues within the meaning of 45 C.F.R. Part 46, and all research to be performed under this CRADA will
conform to applicable federal laws and regulations. Additional information is available from the HHS Office for Human Research Protections (http://www.hhs.gov/ohrp/). 

 

	8.6	Duration of Confidentiality Obligation. The obligation to maintain the confidentiality of Confidential Information will expire at the earlier of the date when the information is no longer Confidential Information
as defined in Article 2 or [...***...] after the expiration or termination date of this CRADA, except for IPI, for which the obligation to maintain confidentiality will extend indefinitely. Collaborator may request an extension to this term
when necessary to protect Confidential Information relating to products not yet commercialized. 

  

					
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	8.7	Publication. The Parties are encouraged to make publicly available the results of their research and development activities. Before either Party submits a paper or abstract for publication or otherwise intends to
publicly disclose information about a CRADA Subject Invention, CRADA Data, or CRADA Materials, the other Party will have [...***...] to review proposed manuscripts and
[...***...] to review proposed abstracts to assure that Confidential Information is protected. Either Party may request in writing that the proposed publication or other disclosure be delayed for up to [...***...] as necessary
to file a Patent Application. 

  

	Article 9.	Representations and Warranties 

  

	9.1	Representations of ICD. ICD hereby represents to Collaborator that: 

  

	 	9.1.1	ICD has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that ICD’s official signing this CRADA has authority to do so. 

 

	 	9.1.2	To the best of its knowledge and belief, neither ICD nor any of its personnel involved in this CRADA is presently subject to debarment or suspension by any agency of the Government which would directly affect its
performance of the CRADA. Should ICD or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, ICD will notify Collaborator within [...***...] of receipt of final notice. 

 

	9.2	Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to MD that: 

  

	 	9.2.1	Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 

 

	 	9.2.2	Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator
or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within [...***...] of receipt of final notice. 

 

	 	9.2.3	Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 

The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R.
§§ 210-211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and 

  

					
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Investigator’s Brochure provided. 
  

	Article 10.	Expiration and Termination 

  

	10.1	Expiration. This CRADA will expire on the last date of the term set forth on the Summary Page. In no case will the term of this CRADA extend beyond the term indicated on the Summary Page unless it is extended in
writing in accordance with Paragraph 13.6. 

  

	10.2	Termination by Mutual Consent. ICD and Collaborator may terminate this CRADA at any time by mutual written consent. 

  

	10.3	Unilateral Termination. Either ICD or Collaborator may unilaterally terminate this CRADA at any time by providing written notice at least sixty (60) days before the desired termination date. ICD may, at its
option, retain funds transferred to ICD before unilateral termination by Collaborator for use in completing the Research Plan. If Collaborator terminates this Agreement before the completion of all approved or active Protocol(s), then Collaborator
will supply enough Test Article (and Placebo, if applicable) to complete these Protocol(s) unless termination is for safety concerns. 

  

	10.4	Funding for ICD Personnel. If Collaborator has agreed to provide funding for ICD personnel and this CRADA is mutually or unilaterally terminated by Collaborator before its expiration, then Collaborator agrees
that funds for that purpose will be available to ICD for a period of [...***...] after the termination date or until the expiration date of the CRADA, whichever occurs sooner. If there are
insufficient funds to cover this expense, Collaborator agrees to pay the difference. 

  

	10.5	New Commitments. Neither Party will incur new expenses related to this CRADA after expiration, mutual termination, or a notice of a unilateral termination and will, to the extent feasible, cancel all outstanding
commitments and contracts by the termination date. Collaborator acknowledges that ICD will have the authority to retain and expend any funds for up to [...***...] subsequent to the expiration or termination date to cover any unpaid costs
obligated during the term of the CRADA in undertaking the research and development activities set forth in the Research Plan. 

  

	10.6	Collaborator Failure to Continue Development. If Collaborator suspends development of the Test Article without the transfer of its active development efforts, assets, and obligations to a third party within
[...***...] of discontinuation, Collaborator agrees that ICD may continue developing the Test Article. In that event, the following will apply: 

  

	 	10.6.1	Collaborator agrees to transfer to ICD all information necessary to enable ICD to contract for the manufacture of the Test Article and, unless abandoned for reasons relating to safety as determined by the data safety
monitoring board, to provide the Test Article (and Placebo, if any) in Collaborator’s inventory to ICD. 

  

					
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	 	10.6.2	Further, Collaborator hereby grants to ICD a nonexclusive, irrevocable, world-wide, paid-up license to practice, or have practiced for or on behalf of the Government, any Background Invention that Collaborator may
currently have or will obtain on the Test Article, its manufacture, or on any method of using the Test Article for the indication(s) described in the Research Plan, including the right to sublicense to third parties. 

 

	Article 11.	Disputes 

  

	11.1	Settlement. Any dispute arising under this CRADA which is not disposed of by agreement of the CRADA Principal Investigators will be submitted jointly to the signatories of this CRADA. If the signatories, or their
designees, are unable to jointly resolve the dispute within [...***...] after notification thereof, the Assistant Secretary for Health (or his/her designee or successor) will propose a resolution. Nothing in this Paragraph will prevent any
Party from pursuing any additional administrative remedies that may be available and, after exhaustion of such administrative remedies, pursuing all available judicial remedies. 

 

	11.2	Continuation of Work. Pending the resolution of any dispute or claim pursuant to this Article 11, the Parties agree that performance of all obligations will be pursued diligently. 

 

	Article 12.	Liability 

  

	12.1	NO WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE PARTIES MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER, INCLUDING THE CONDITIONS OF THE RESEARCH OR ANY INVENTION OR MATERIAL,
WHETHER TANGIBLE OR INTANGIBLE, MADE OR DEVELOPED UNDER OR OUTSIDE THE SCOPE OF THIS CRADA, OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH OR ANY INVENTION OR MATERIAL, OR THAT A TECHNOLOGY UTILIZED BY A PARTY
IN THE PERFORMANCE OF THE RESEARCH PLAN DOES NOT INFRINGE ANY THIRD-PARTY PATENT RIGHTS. 

  

	12.2	Indemnification and Liability. Collaborator agrees to hold the Government harmless and to indemnify the Government for all liabilities, demands, damages, expenses and losses arising out of the use by Collaborator
for any purpose of the CRADA Data, CRADA Materials or CRADA Subject Inventions produced in whole or part by ICD employees under this CRADA, unless due to the negligence or willful misconduct of ICD, its employees, or agents. The Government has no
statutory authority to indemnify Collaborator. Each Party otherwise will be liable for any claims or damages it incurs in connection with this CRADA, except that ICD, as an agency of the Government, assumes liability only to the extent provided
under the Federal Tort Claims Act , 28 U.S.C. Chapter 171. 

  

	12.3	 Force Majeure. Neither Party will be liable for any unforeseeable event beyond its reasonable control and not caused by its own fault or
negligence, which causes the Party 

  

					
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to be unable to perform its obligations under this CRADA, and which it has been unable to overcome by the exercise of due diligence. If a force majeure event occurs, the Party unable to
perform will promptly notify the other Party. It will use its best efforts to resume performance as quickly as possible and will suspend performance only for such period of time as is necessary as a result of the force majeure event.

  

	Article 13.	Miscellaneous 

  

	13.1	Governing Law. The construction, validity, performance and effect of this CRADA will be governed by U.S. federal law, as applied by the federal courts in the District of Columbia. If any provision in this CRADA
conflicts with or is inconsistent with any U.S. federal law or regulation, then the U.S. federal law or regulation will preempt that provision. 

  

	13.2	Compliance with Law.  ICD and Collaborator agree that they will comply with, and advise any contractors, grantees, or agents they have engaged to conduct the CRADA research and development activities to
comply with, all applicable Executive Orders, statutes, and HHS regulations relating to research on human subjects (45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56) and relating to the appropriate care and use of laboratory animals (7 U.S.C. §
2131 et seq.; 9 C.F.R. Part 1, Subchapter A). ICD and Collaborator will advise any contractors, grantees, or agents they have engaged to conduct clinical trials for this CRADA that they must comply with all applicable federal regulations for
the protection of Human Subjects, which may include the Standards for Privacy of Individually Identifiable Health Information set forth in 45 C.F.R. Part 164. Collaborator agrees to ensure that its employees, contractors, and agents who might have
access to a “select agent or toxin” (as that term is defined in 42 C.F.R. §§ 73.4-73.5) transferred from ICD is properly licensed to receive the “select agent or toxin”. 

 

	13.3	Waivers. None of the provisions of this CRADA will be considered waived by any Party unless a waiver is given in writing to the other Party. The failure of a Party to insist upon strict performance of any of the
terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law, will not be deemed a waiver of any rights of any Party. 

  

	13.4	Headings. Titles and headings of the articles and paragraphs of this CRADA are for convenient reference only, do not form a part of this CRADA, and will in no way affect its interpretation. 

 

	13.5	Severability. The illegality or invalidity of any provisions of this CRADA will not impair, affect, or invalidate the other provisions of this CRADA. 

 

	13.6	 Amendments. Minor modifications to the Research Plan may be made by the mutual written consent of the CRADA Principal Investigators.
Substantial changes to the CRADA, extensions of the term, or any changes to Appendix C will become effective only upon a written amendment signed by the signatories to this CRADA or by their representatives duly authorized to execute an amendment. A
change will be considered 

  

					
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substantial if it directly expands the range of the potential CRADA Subject Inventions, alters the scope or field of any license option governed by Article 7, or requires a significant increase
in the contribution of resources by either Party. 

  

	13.7	Assignment. Neither this CRADA nor any rights or obligations of any Party hereunder shall be assigned or otherwise transferred by either Party without the prior written consent of the other Party. The
Collaborator acknowledges the applicability of 41 U.S.C. § 15, the Anti Assignment Act, to this Agreement. The Parties agree that the identity of the Collaborator is material to the performance of this CRADA and that the duties under this CRADA
are nondelegable. 

  

	13.8	Notices. All notices pertaining to or required by this CRADA will be in writing, signed by an authorized representative of the notifying Party, and delivered by first class, registered, or certified mail, or by
an express/overnight commercial delivery service, prepaid and properly addressed to the other Party at the address designated on the Contacts Information Page, or to any other address designated in writing by the other Party. Notices will be
considered timely if 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. Notices regarding the exercise of license
options will be made pursuant to Paragraph 7.3. Either Party may change its address by notice given to the other Party in the manner set forth above. 

  

	13.9	Independent Contractors. The relationship of the Parties to this CRADA is that of independent contractors and not agents of each other or joint venturers or partners. Each Party will maintain sole and exclusive
control over its personnel and operations. 

  

	13.10	Use or Name; Press Releases. By entering into this CRADA, the Government does not directly or indirectly endorse any product or service that is or will be provided, whether directly or indirectly related to
either this CRADA or to any patent or other intellectual-property license or agreement that implements this CRADA by Collaborator, its successors, assignees, or licensees. Collaborator will not in any way state or imply that the Government or any of
its organizational units or employees endorses any product or services. Each Party agrees to provide proposed press releases that reference or rely upon the work under this CRADA to the other Party for review and comment at least five
(5) business days before publication. Either Party may disclose the Title and Abstract of the CRADA to the public without the approval of the other Party. 

  

	13.11	Reasonable Consent. Whenever a Party’s consent or permission is required under this CRADA, its consent or permission will not be unreasonably withheld. 

 

	13.12	 Export Controls. Collaborator agrees to comply with U.S. export law and regulations. If Collaborator has a need to transfer any CRADA Materials
made in whole or in part by ICD, or ICD Materials, or ICD’s Confidential Information to a person located in a country other than the United States, to an Affiliate organized under the laws of a country other than the United States, or to an
employee of Collaborator in the United States who is not a citizen or permanent resident of the United States, Collaborator will acquire any 

  

					
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and all necessary export licenses and other appropriate authorizations. 

  

	13.13	Entire Agreement. This CRADA constitutes the entire agreement between the Parties concerning the subject matter of this CRADA and supersedes any prior understanding or written or oral agreement.

  

	13.14	Survivability.  The provisions of Paragraphs 3.3, 3.4, 3.8, 4.2, 4.3, 5.3, 5.4, 6.1-9.2, 10.3-10.6, 11.1, 11.2, 12.1-12.3, 13.1-13.3, 13.7, 13.10 and 13.14 will survive the expiration or early
termination of this CRADA. 

  
 SIGNATURES BEGIN ON THE
NEXT PAGE 

  

					
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 PUBLIC HEALTH SERVICE 

COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT 

FOR INTRAMURAL-PHS CLINICAL RESEARCH 

 
 SIGNATURE PAGE 

 
 ACCEPTED AND AGREED 

BY EXECUTING THIS AGREEMENT, EACH PARTY REPRESENTS
THAT ALL STATEMENTS MADE HEREIN ARE TRUE, COMPLETE, AND ACCURATE TO
THE BEST OF ITS KNOWLEDGE. COLLABORATOR ACKNOWLEDGES THAT IT MAY BE
SUBJECT TO CRIMINAL, CIVIL, OR ADMINISTRATIVE PENALTIES FOR KNOWINGLY MAKING A
FALSE, FICTITIOUS, OR FRAUDULENT STATEMENT OR CLAIM. 
  

							
	FOR ICD:	 		 		 	
				
	 /s/ James H. Doroshow
	 		 	     8/8/12
	 	
	James H. Doroshow, M.D.	 	Date	 	
	Deputy Director for Clinical and Translational Research, NCI	 		 	
			
	FOR COLLABORATOR:	 		 	
				
	 /s/ Aya Jakobovits
	 		 	     8/13/12
	 	
	Aya Jakobovits, Ph.D.	 	Date	 	
	President & Chief Executive Officer	 		 	

  

					
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FOR INTRAMURAL-PHS CLINICAL RESEARCH 

 

 CONTACTS INFORMATION PAGE 

CRADA Notices 
  

					
	For ICD:	 		 	For Collaborator:
			
	 Technology Transfer Center
	 		 	 Aya Jakobovits, Ph.D.

	 6120 Executive Blvd., Suite 450
	 		 	 President & Chief Executive Officer

	 Rockville, MD 20852
	 		 	 Kite Pharma, Inc.

	 Tel. 301-496-0477
	 		 	 10924 Le Conte Avenue

	 Fax: 301-402-2117
	 		 	 Los Angeles, CA 90024

		 		 	 Phone: (310) 824-9999, ext. 201

		 		 	 Fax: (310) 824-9994

  
 Patenting and Licensing 

 

					
	For ICD:	 		 	For Collaborator (if separate from above):
			
	Division Director, Division of Technology	 		 	       (same as above)

	Development and Transfer	 		 	  

	NIH Office of Technology Transfer	 		 	  

	6011 Executive Boulevard, Suite 325	 		 	  

	Rockville, Maryland 20852-3804	 		 	  

	Tel: 301-496-7057	 		 	  

	Fax: 301-402-0220	 		 	  

  
  

Delivery of Materials Identified In Appendix B (if any) 
  

					
	For ICD:	 		 	For Collaborator (if separate from above):
			
	 Steven A. Rosenberg, M.D., Ph.D.
	 		 	       (same as above)

	 Surgery Branch, NCI
	 		 	  

	 10 Center Drive, MSC 1201
	 		 	  

	 Bldg. 10, CRC Room 3-3940
	 		 	  

	 Bethesda, MD 20892-1201
	 		 	  

	 Tel. 301-496-4164
	 		 	  

	 Fax: 301-402-1738
	 		 	  

  

					
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 SUMMARY PAGE 

EITHER PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION, 

RELEASE THIS SUMMARY PAGE TO THE PUBLIC. 

TITLE OF CRADA: Cooperative Research and Development Agreement for the Development of NCI Proprietary Peripheral Blood Autologous T Cell
Therapies Using Genetically Modified Peripheral. Blood Lymphocytes That Express NCI Proprietary T Cell Receptors and/or Chimeric Antigen Receptors for Use in the Immunotherapy for Patients with Metastatic Cancer, Utilizing the Expertise of Kite
Pharma in Development and Manufacturing of Cancer Immunotherapies 
  

					
	 PHS [ICD] Component:
	 		  	 National Cancer Institute (NCI)

			
	 ICD CRADA Principal Investigator:
	 		  	 Steven A Rosenberg, M.D., PhD.

			
	 Collaborator:
	 		  	 Kite Pharma, Inc.

			
	 Collaborator CRADA Principal Investigator:
	 		  	 Aya Jakobovits, Ph.D.

			
	 Term of CRADA:
	 		  	 Five (5) years from the Effective Date

 ABSTRACT OF THE RESEARCH PLAN: 

[...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 APPENDIX A 

RESEARCH PLAN 
 Title of
CRADA 
 Cooperative Research and Development Agreement for the Development of NCI Proprietary Peripheral Blood Autologous T Cell
Therapies Using Genetically Modified Peripheral Blood Lymphocytes That Express NCI Proprietary T Cell Receptors and/or Chimeric Antigen Receptors for Use in the Immunotherapy for Patients with Metastatic Cancer, Utilizing the Expertise of Kite
Pharma in Development and Manufacturing of Cancer Immunotherapies 
 NCI Principal Investigator 

Steven A. Rosenberg, M.D., Ph.D. 

Chief, Surgery Branch 
 Center for
Cancer Research (CCR) 
 National Cancer Institute (NCI) 

Collaborator Principal Investigators 

Aya Jakobovits, Ph.D. 

President & Chief Executive Officer 

Kite Pharma, Inc. 
 Term of
CRADA 
 Five (5) years from the date of the final CRADA signature. 

 
  

GOALS OF THIS CRADA 

[...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 INTRODUCTION 

[...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 EXPERTISE OF THE PARTIES

 Dr. Steven A. Rosenberg has extensive experience in the development and application of his proprietary ACT/TCR-based
therapies for patients with cancer. His laboratory has developed in vitro techniques for generating anti-tumor peripheral blood T cells by identifying genes encoding novel TCRs and generating CAR constructs (both TCRs and CARs proprietary to
NCI), and transducing them into peripheral blood lymphocytes under conditions suitable for subsequent infusion, and has developed new strategies to enhance ACT/TCR product in vivo potency and survival. Dr. Rosenberg and his colleagues at
the NCI Surgery Branch also have extensive experience in the design and conduct of clinical trials that evaluate ACT/TCR products to demonstrate their clinical benefit in cancer patients. 

Kite Pharma, Inc. (“Kite”) has assembled a highly experienced team of senior level executives, scientists and clinicians who have
extensive experience and a proven track record in the development of cancer immunotherapies. Kite’s expertise includes areas of pre-clinical and clinical research and development, regulatory, manufacturing, and product quality control and
assurance. Kite’s team has been involved with advancement to the clinic of more than 10 different novel cancer therapies, mostly immunotherapies, including two that have received FDA approval and are being commercialized. In addition, the Kite
team has broad experience in selecting and validating tumor-specific targets for immunotherapy, developing human antibody technologies, as well as selecting, characterizing and developing therapeutic tumor-specific monoclonal antibodies, and
developing product and patient selection assays. Kite’s overall expertise will facilitate and accelerate the development of NCI’s proprietary ACT/TCR products and their advancement to subsequent pivotal trials, FDA approval and
commercialization. Kite is already engaged in identifying the critical steps required for production of GMP quality ACT/TCR products in sufficient supply for multi-center studies and the process modifications that will streamline the processes. In
addition, Kite has identified a qualified Contract Manufacturing Organization (CMO) with expertise and capacity to support large phase II/III trials with ACT/TCR products. In parallel, the design of a dedicated ACT/TCR manufacturing facility to
support the conduct of Kite’s future ACT/TCR clinical studies is currently in progress. 

  

					
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 Thus, the combination of the scientific and clinical expertise of the NCI Surgery Branch
together with Kite’s clinical, regulatory, manufacturing, operation, and business capabilities represents an ideal collaboration opportunity to successfully develop and commercialize multiple NCI proprietary ACT/TCR products for patients with
different cancer diseases, making these treatments widely available to patients in need. As outlined above, the NCI Surgery Branch and Kite have complementary expertise, capabilities and facilities that could be utilized to manufacture, qualify and
develop these ACT/TCR products, with the goal of realizing the application of this technology to a wide range of cancer indications. 

EXPERIMENTAL PLAN 

The experimental details that follow are approximate and may be changed upon mutual agreement of the NCI and Kite. Any change in the scope of
this CRADA will be by mutual consent and written Amendment to the CRADA. 
 [...***...]. 

[...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

DESCRIPTION OF THE CONTRIBUTIONS AND
RESPONSIBILITIES OF THE PARTIES 
 Surgery Branch, NCI 

 

	 	—	 	 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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	 	—	 	 [...***...]. 

Kite Pharma, Inc. 
  

	 	—	 	 [...***...]. 

NCI Surgery Branch and Kite Pharma, Inc. 
  

	 	—	 	 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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	 	—	 	 [...***...]. 

RELATED NCI AND COLLABORATOR AGREEMENTS: NONE 

RELATED INTELLECTUAL PROPERTY AND BUSINESS/SCIENTIFIC
EXPERTISE OF THE PARTIES 
 NCI 

1) PCT/US 11/57272 entitled “Anti-MAGE-A3 T Cell Receptors and Related Materials and Methods of Use”, filed 10/22/2011. Inventors:
Richard A. Morgan, Nachimuthu Chinnasamy, Steven A. Rosenberg and Jennifer A. Wargo. This is inclusive of all U.S. continuing applications and divisionals, and foreign applications. 

2) [...***...]. 
 3)
PCT/US 11/51537 entitled “Anti-SSX2 T Cell Receptors and Related Materials and Methods of Use”, filed 9/21/2011. Inventors; Richard A. Morgan, Nachimuthu Chinnasamy and Steven A. Rosenberg. This is inclusive of all U.S. continuing
applications and divisionals, and foreign applications. 
 4) [...***...]. 

5) PCT/US 12/29861 entitled “Anti-epidermal Growth Factor Receptor Variant III Chimeric Antigen Receptors and Use of Same for the
Treatment of Cancer”, filed 4/8/2012. Inventors: Richard A. Morgan and Steven A. Rosenberg. This is inclusive of all U.S. continuing applications and divisionals, and foreign applications. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 6) [...***...]. 

7) PCT/US10/31988 entitled “Inducible IL-12”, filed 4/22/10. 

Inventors: Richard A. Morgan, Steven A. Rosenberg and Ling Zhang. This is inclusive of all U.S. continuing applications and divisionals, and
foreign applications. 
 8) U.S. Patent No. 7,381,405 entitled “Methods of Preparing Lymphocytes That Express Interleukin-2 and
Their Use in the Treatment of Cancer,” issued 6/3/08. 
 Inventors: Ke Liu and Steven A. Rosenberg. This is inclusive of all U.S.
continuing applications and divisionals, and foreign applications. 
 9) PCT/US05/036407 entitled “Adoptive Immunotherapy With Enhanced
T Lymphocyte Survival”, filed 10/7/05. Inventors: Richard A. Morgan, Steven A. Rosenberg and Cary Hsu. This is inclusive of all U.S. continuing applications and divisionals, and foreign applications. 

10) PCT/US98/025270 entitled “Antibodies, Including Fv Molecules, and Immunoconjugates Having High Binding Affinity for Mesothelin and
Methods for Their Use,” filed 11/25/98. Inventors: Ira H. Pastan and Partha S. Chowdhury. This is inclusive of all U.S. continuing applications and divisionals, and foreign applications. 

11) PCT/US00/14829 entitled “Immunoconjugates Having High Binding Affinity”, filed 5/26/00. Inventors: Ira H. Pastan and Partha S.
Chowdhury. This is inclusive of all U.S. continuing applications and divisionals, and foreign applications. 
 12) PCT/US10/028336 entitled
“Anti-Mesothelin Antibodies”, filed 3/23/10. Inventors: Mitchell Ho and Ira H. Pastan. This is inclusive of all U.S. continuing applications and divisionals, and foreign applications. 

Kite Pharma, Inc. 
 [...***...].

  

					
		 		 	 ***Confidential Treatment Requested

 

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 [...***...]. 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 APPENDIX B 

STAFFING, FUNDING AND MATERIALS/EQUIPMENT CONTRIBUTIONS 

OF THE PARTIES 
 Staffing
Contributions: 
 ICD will provide scientific staff and other support necessary to conduct the research and other activities described in the Research
Plan. ICUs scientific staff will include ICD’s CRADA Principal Investigator and technical staff. 
 ICD estimates that
    3-5     person-years of effort per year will be required to complete the CRADA research. 
 Collaborator
will provide scientific staff and other support necessary to conduct the research and other activities described in the Research Plan. Collaborator’s scientific staff will include Collaborator’s Principal Investigator and technical staff.

 Collaborator estimates that     2-5     person-years of effort per year will be required to complete the
CRADA research. 
 Funding Contributions: 

Collaborator agrees to provide funds in the amount of $1,000,000.00 per year of the CRADA for ICD to use to acquire technical, statistical, and administrative
support for the research activities, as well as to pay for supplies and travel expenses. Collaborator will provide funds in the amount of $250,000.00 on a quarterly basis. The first quarterly installment of $250,000.00 will be due within
[...***...] of the Effective Date. Each subsequent installment will be due within [...***...] of each quarterly anniversary of the Effective Date. Collaborator agrees that ICD can allocate the funding between the various categories in
support of the CRADA research as ICDs CRADA PI sees fit. 
 CRADA PAYMENTS: 

Collaborator may make CRADA payments via www.pay.gov. If Collaborator makes CRADA payments by check, Collaborator will make the checks payable to the
National Cancer Institute and will reference the CRADA number 02716 and title “Cooperative Research and Development Agreement for the Development of NCI Proprietary Peripheral Blood Autologous T Cell Therapies Using Genetically Modified
Peripheral Blood Lymphocytes That Express NCI Proprietary T Cell Receptors and/or Chimeric Antigen Receptors for Use in the Immunotherapy for Patients with Metastatic Cancer, Utilizing the Expertise of Kite Pharma in the Development and
Manufacturing of Cancer Immunotherapies” on each check, and will send them via trackable mail or courier to: 

  

					
		 		 	 ***Confidential Treatment Requested

 

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 CRADA Funds Coordinator 

Technology Transfer Center, NCI 
 6120 Executive Blvd., Suite 450

 Rockville, MD 20852 
 CRADA Travel Payments: 

Travel arrangements for all Government staff will be made in accordance with the Federal Travel Rules and Regulations, whether arranged by ICD and funded using
either appropriated funds or CRADA funds, or arranged and funded directly by Collaborator. 
 Materials/Equipment Contributions: 

ICD will provide the following ICD Materials for use under this CRADA: 
  

			
	Test Article:	  	Peripheral blood lymphocytes transduced with T Cell Receptors (TCR) or Chimeric Antigen Receptors (CAR) grown and processed under GMP conditions, suitable for use in clinical trials under this CRADA, where ICD holds the IND for
these studies.

			
		
	ICD Materials:	  	ACT/TCR-related vectors, cells lines, cell banks, reagents and product, as well as product characterization and release assays in support of process transfer and validation at CMO.
		
	Capital Equipment:	  	None

 Collaborator will provide the following Collaborator Materials and/or capital equipment for use under this CRADA: 

 

			
	Test Article:	  	Peripheral blood lymphocytes transduced with T Cell Receptors (TCR) or Chimeric Antigen Receptors (CAR) grown and processed under GMP conditions, suitable for use in clinical trials under this CRADA, where Collaborator holds the IND
for these studies.

			
		
	Collaborator Materials:	  	None
		
	Capital Equipment:	  	None

 If either Party decides to provide additional Materials for use under this CRADA, those materials will be transferred under a
cover letter that identifies them and states that they are being provided under the terms of the CRADA. 

  

					
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 APPENDIX C 

MODIFICATIONS TO THE MODEL INTRAMURAL-PHS CLINICAL CRADA 

Amend the definition of “Background Invention” in Article 2 to read as follows: 

“Background Invention” means an Invention conceived and first actually reduced to practice before the Effective Date or an Invention
conceived and first actually reduced to practice by either Party outside the scope of the Research Plan. 
 Amend the definition of “CRADA
Data” in Article 2 to read as follows: 
 “CRADA Data” means all recorded information first produced in the performance of the
Research Plan. ICD and PHS acknowledge and agree that notwithstanding the foregoing, the expression “CRADA Data” expressly excludes any and all data, results and information generated by or for or otherwise in the possession of either
Party before the Effective Date, or generated or otherwise acquired by or on behalf of either Party after the Effective Date outside of the scope of this CRADA, which data, results and information shall be deemed to be the exclusive property of the
Party possessing such data, results and information. 
 Amend the definition of “CRADA Materials” in Article 2 to read as follows: 

“CRADA Materials” means all tangible materials first produced in the performance of the Research Plan other than CRADA Data. ICD and PHS
acknowledge and agree that notwithstanding the foregoing, the expression “CRADA Materials” expressly excludes any and all materials generated by or for or otherwise in the possession of either Party before the Effective Date, or generated
or otherwise acquired by or on behalf of either Party after the Effective Date outside of the scope of this CRADA, which materials shall be deemed to be the exclusive property of the Party possessing such materials. 

Amend the definition of “Protocol” in Article 2 to read as follows: 

“Protocol” means the formal, detailed and written description of a study to be performed as provided for in the Research Plan. It describes
the objective(s), design, methodology, statistical considerations, and organization of a trial. For the purposes of this CRADA, the term, Protocol, for clinical research involving Human Subjects, includes any and all associated documents, including
informed consent forms, to be provided to Human Subjects and potential participants in the study. Protocols written and conducted under the Research Plan during the term of the CRADA will be mutually agreed to by the Parties. Associated documents
for such Protocols will also be mutually agreed to by the Parties. 

  

					
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 Amend the definition of “Test Article” in Article 2 to read as follows: 

“Test Article” means, in accordance with 21 C.F.R. 50.3 (j), any drug (including a biological product), medical device, food additive, color
additive, electronic product, or any other article subject to regulation under the Federal Food, Drug, and Cosmetic Act that is intended for administration to humans or animals, including a drug or biologic as identified in the Research Plan and
Appendix B, that is used within the scope of the Research Plan. The Test Article may also be referred to as Investigational Agent, Study Material, or Study Product. For the purposes of this CRADA, “Test Article” shall be provided solely by
the Party which is the IND holder for a clinical study. 
 Amend Section 3.2 to read as follows: 

3.2       Research Plan.  The Parties recognize that the Research Plan describes the collaborative
research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can
modify them through an amendment, according to Paragraph 13.6. The Parties shall use reasonable efforts to achieve the goals and objectives of the Research Plan in an efficient and expeditious manner. 

Amend Section 3.3 to read as follows: 

3.3       Use and Disposition of Collaborator Materials and ICD Materials.  The Parties agree to use
Collaborator Materials and ICD Materials (together with all related written information) only in accordance with the Research Plan and Protocol(s), not to transfer these materials or written information to third parties except in accordance with the
Research Plan and Protocol(s) or as approved by the owning or providing Party, and, upon expiration or termination of the CRADA, to dispose of these materials and written information as directed by the owning or providing Party. 

Amend Section 3.6 to read as follows: 

3.6       Clinical Investigator Responsibilities. The Clinical Investigator will be required to submit, or to
arrange for submission of, each Protocol associated with this CRADA to the IRB. In addition to the Protocol all associated documents, including informational documents and advertisements, must be reviewed and approved by the IRB before starting the
research. The research will be done in strict accordance with the Protocol(s) and no substantive changes in a finalized Protocol will be made unless mutually agreed upon, in writing, by the Parties. Research will not commence (or will continue
unchanged, if already in progress) until each substantive change to a Protocol, including those required by either the FDA or the IRB, has been integrated in a way acceptable to the Parties, submitted to the FDA (if applicable) and

  

					
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approved by the IRB. The CRADA Principal Investigators shall conduct the Study and use his/her reasonable efforts to complete the research in a professional manner in accordance with the
highest professional standards. The NCI CRADA Principal Investigator shall be an employee of ICD. Neither Party shall be a party to any agreement nor have any obligation that conflicts with the provisions of this CRADA, and shall not enter into such
an conflicting agreement during the research conducted under this CRADA. If either researcher designated as the CRADA Principal Investigator is removed, unable or unwilling to continue in his or her role as CRADA Principal Investigator or terminates
his or her employment relationship with the respective Party, then that Party shall promptly provide written notice to the other Party, and shall use its reasonable efforts to find a suitable replacement to assume the role of CRADA Principal
Investigator. The other Party’s in its sole discretion, may elect not to accept such replacement, in which event either Party shall have the right to terminate the research and this CRADA subject to the terms in Article 10 of this CRADA. In the
event that the other Party accepts such replacement, a Party shall ensure that in such replacement, its CRADA Principal Investigator agrees to adhere to the terms and conditions applicable to the CRADA Principal Investigator under this CRADA. 

Amend Section 3.7 to read as follows: 

3.7        Investigational Applications. 

 

	 	3.7.1	If an IND is required, the Parties will decide which Party will be the IND Sponsor and the IND Sponsor will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms).

  

	 	3.7.2	When a Party files the IND, the other Party agrees to provide the filing party background data and information necessary to support the IND. The Parties further agree to provide a letter of cross-reference to all data
and pertinent regulatory filings sponsored by a Party under this CRADA. Both Parties’ employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Party’s IND, DMF, other
filings, or other information and data provided to one Party by the other Partypursuant to this Article 3. 

	 	3.7.3	If a Party supplies Confidential Information to the other Party in support of an IND that is filed, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8.

  

	 	3.7.4	Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. All data from those clinical trials are proprietary to Collaborator for purposes of this
CRADA. 

  

					
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 Amend Section 3.8 to read as follows: 

3.8       Test Article Information and Supply. Collaborator agrees to provide ICD without charge and on a schedule
that will ensure adequate and timely performance of the research, a sufficient quantity of formulated and acceptably labeled, clinical-grade Test Article (and, as required by the Protocol(s), Placebo) to complete the clinical trial(s) agreed to and
approved under this CRADA, where Collaborator holds the IND for these studies. Collaborator will provide a Certificate of Analysis to ICD for each lot of the Test Article provided. ICD agrees to supply a sufficient quantity of formulated and
acceptably labeled, clinical-grade Test Article to complete the clinical trial(s) under this CRADA, where ICD holds the IND for these studies, ICD will maintain a Certificate of Analysis for each lot of the Test Article provided. 

Amend Section 3.9 to read as follows: 

3.9       Test Article Delivery and Usage.  Collaborator will ship the Test Article and, if required,
Placebo to ICD in containers marked in accordance with 21 C.F.R. § 312.6 for all clinical studies in accordance with their respective obligations under Sections 3.8 and 10.3 where Collaborator holds the IND. ICD agrees that the Clinical
Investigators will keep appropriate records and take reasonable steps to ensure that the Test Article is used in accordance with the Protocol(s) and applicable FDA regulations. In addition, ICD agrees that the Test Article provided by the
Collaborator (and all Confidential Information supplied by Collaborator relating to the Test Article) will be used solely for the conduct of the CRADA research and development activities. Furthermore, ICD agrees that no analysis or modification of
the Test Article provided by the Collaborator will be performed without Collaborator’s prior written consent. At the completion of the Research Plan, any unused quantity of Test Article will be disposed unless otherwise mutually agreed by the
parties. Pharmacy contacts at ICD will be determined by ICD and communicated to Collaborator. 
 Amend Section 4.1 to read as follows: 

4.1       Interim Research and Development Reports.  The CRADA PIs shall exchange information regarding
the status of the work hereunder and the results thereof regularly (and not less than quarterly), in writing. This exchange may be accomplished through meeting minutes, detailed correspondence, circulation of draft manuscripts, Steering Committee
reports, copies of Annual Reports and any other reports updating the progress of the CRADA research. However, the Parties must exchange updated Investigator’s Brochure, formulation and preclinical data, and toxicology findings, as they become
available. Additionally, each Party shall update the other Party orally and to respond orally to inquiries not less than monthly regarding the status of the work hereunder and the results thereof. Such updates shall be either by telephone or in
person, 

  

					
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as mutually agreed by the parties; provided, that not less than once every [...***...], the Parties anticipate that such updates shall
be in person at a mutually agreed location. 
 Amend Section 5.2 to read as follows: 

5.2        ICD Staffing. No ICD employees will devote 100% of their effort or time to the research and
development activities under this CRADA. ICD will not use funds provided by Collaborator under this CRADA for ICD personnel to pay the salary of any permanent ICD employee. Although personnel hired by ICD using CRADA funds will focus principally on
CRADA research and development activities, Collaborator acknowledges that these personnel may nonetheless make contributions to other research and development activities, and such other activities will be outside the scope of this CRADA. 

Section 5.4 is deleted in its entirety and is of no force or effect in this CRADA. 

Amend Section 6.5 to read as follows: 

6.5        Prosecution of Patent Applications. The Party filing a Patent Application will provide the
non-filing Party with a copy of any official communication or filing relating to prosecution of the Patent Application within [...***...] of transmission of the communication or filing. The non-filing Party shall have reasonable opportunity to
comment thereon, and the filing Party shall reasonably consider such comments. Each Party will also provide the other Party with the power to inspect and make copies of all documents retained in the applicable Patent Application or Patent file. The
Parties agree to consult with each other regarding the prosecution of Patent Applications directed to joint CRADA Subject Inventions. If Collaborator elects to file and prosecute Patent Applications on joint CRADA Subject Inventions, then
Collaborator agrees to use the U.S.P.T.O. Customer Number Practice and/or grant PHS a power(s) of attorney (or equivalent) necessary to assure PHS access to its intellectual property rights in these Patent Applications. PHS and Collaborator will
cooperate with each other to obtain necessary signatures on Patent Applications, assignments, or other documents. 

  

					
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 Amend Section 7.1 to read as follows: 

7,1        Background Inventions.  Other than as specifically stated in this Article 7, nothing in
this CRADA will be construed to grant any rights in one Party’s Background Invention(s) to the other Party, except to the extent necessary for the Parties to conduct the research and development activities described in the Research Plan. 

Collaborator understands that any license agreement executed by PHS with Collaborator for a CRADA Subject Invention or Background Invention grants
Collaborator rights to the PHS-owned intellectual property specified in the license agreement within the agreed field of use. This license agreement(s) should not be construed by Collaborator as a license to any third party proprietary agents
utilized in the CRADA Research Plan or as freedom to operate in view of any third party proprietary agents. 
 Amend Section 7.2 to read as
follows: 
 7.2        Collaborator’s License Option to CRADA Subject Inventions.  With
respect to Government rights to any CRADA Subject Invention made solely by an ICD employee(s) or made jointly by an ICD employee(s) and a Collaborator employee(s) for which a Patent Application was filed, PHS hereby grants to Collaborator an
exclusive option to elect an exclusive or, (in the sole discretion of Collaborator) nonexclusive, commercialization license. The license will be substantially in the form of the appropriate model PHS license agreement and will fairly reflect the
nature of the CRADA Subject Invention, the relative contributions of the Parties to the CRADA Subject Invention and the CRADA, a plan for the development and marketing of the CRADA Subject Invention, the risks incurred by Collaborator, and the costs
of subsequent research and development and third party intellectual property and technology needed to bring the CRADA Subject Invention to the marketplace. The field of use of the license will be commensurate with the scope of the Research Plan,
except for diagnostic tools. The field of use for an exclusive license for diagnostic tools is limited to those products that require regulatory approval. 

Amend Section 7.3 to read as follows: 

7.3        Exercise of Collaborator’s License Option.  To exercise the option of Paragraph 7.2
Collaborator must submit a written notice to the PHS Patenting and Licensing Contact identified on the Contacts Information Page (and provide a copy to the ICD Contact for CRADA Notices) within four (4) months after either (i) Collaborator
receives written notice from PHS that the Patent Application has been filed or (ii) the date on which Collaborator files the Patent Application. The written notice exercising this option will include a completed “Application for License to
Public Health Service Inventions” and will initiate a negotiation period that expires ten (10) months after the exercise of the option. If PHS has not responded in writing to the last proposal by Collaborator within this ten
(10) month period, the negotiation period will 

  

					
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be extended to expire [...***...] after PHS so responds, during which month Collaborator may accept in writing the final license
proposal of PHS. In the absence of Collaborator’s exercise of the option, or upon election of a nonexclusive license, PHS will be free to license the CRADA Subject Invention to others. These time periods may be extended at the reasonable
discretion of PHS upon good cause shown in writing by Collaborator. 
 Amend Section 8.2.2 to read as follows: 

8.2.2    CRADA Materials.  Collaborator and ICD will use reasonable efforts to keep descriptions of CRADA Materials
confidential until published or until corresponding Patent Applications are filed. Collaborator acknowledges that the basic research mission of PHS includes sharing with third parties for further research those research resources made in whole or in
part with NIH funding. Consistent with this mission and the tenets articulated in “Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts”, December 1999, available at
http://ott.od.nih.gov/NewPages/RTguide_final.html, following publication either Party may make available to third parties for further research those CRADA Materials made jointly by both PHS and Collaborator. Notwithstanding the above, if those joint
CRADA Materials are the subject of a pending Patent Application or a Patent, or were created using a patent-pending or patented material or technology, the Parties may agree to restrict distribution or freely distribute them. During the term of this
CRADA, ICD shall not distribute joint CRADA Materials to any third party for any commercial purpose. Either Party may distribute those CRADA Materials made solely by the other Party only upon written consent from that other Party or that other
Party’s designee. 
 Amend Section 8.3 to read as follows: 

8.3       Confidential Information.  Each Party agrees to limit its disclosure of Confidential Information
to the amount necessary to carry out the Research Plan, and will place a confidentiality notice on all this information. A Party orally disclosing Confidential Information to the other Party will summarize the disclosure in writing and provide it to
the other Party within [...***...] of the disclosure. Each Party receiving Confidential Information agrees to use it only for the purposes described in the Research Plan. Subject to the requirements as set out in Section 8.6 regarding
IPI. Collaborator shall have the right to share CRADA Data, CRADA Materials, reports and other Confidential Information relating, to this CRADA with third party contractors, actual or potential collaborators or licensees. and actual or potential
investors, in each case subject to written confidentiality obligations no less restrictive than those as set out in this CRADA. Either Party may object to the designation of information as Confidential Information by the other Party. Notwithstanding
any other provision in this CRADA, although certain information concerning Collaborator Materials or Test Article provided under this Agreement is confidential and will be so stamped, Collaborator recognizes that the NIH PI may need to disclose
certain information concerning CONFIDENTIAL materials 

  

					
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to patients (or to physicians or scientists where such disclosure is made in order to directly facilitate the ongoing treatment of a patient, or the development of a treatment for a patient).
Collaborator hereby authorizes such limited disclosures and the NIH PI agrees to promptly acknowledge to Collaborator the making of any such disclosure. 

Amend Section 8.4 to read as follows: 

8.4        Protection of Confidential Information.  Except as otherwise set forth in this CRADA and
subject to Paragraph 8.3, Confidential Information will not be disclosed, copied, reproduced or otherwise made available to any other person or entity without the consent of the owning or providing Party except as required by a court or
administrative body of competent jurisdiction, or federal law or regulation. Each Party agrees to use reasonable efforts to maintain the confidentiality of Confidential Information, which will in no instance be less effort than the Party uses to
protect its own Confidential Information. Each Party agrees that a Party receiving Confidential Information will not be liable for the disclosure of that portion of the Confidential Information which, after notice to and consultation with the
disclosing Party, the receiving Party determines may not be lawfully withheld, provided the disclosing Party has been given a reasonable opportunity to seek a court order to enjoin disclosure. 

Amend Section 8.6 to read as follows: 

8.6        Duration of Confidentiality Obligation.  The obligation to maintain the confidentiality of
Confidential Information as described in Paragraph 8.3, will expire at the earlier of the date when the information is no longer Confidential Information as defined in Article 2 or
[...***...] after the expiration or termination date of this CRADA, except for IPI, for which the obligation to maintain confidentiality will extend indefinitely. Collaborator may request an
extension to this term when necessary to protect Confidential Information relating to products not yet commercialized. 
 Amend Section 8.7 to
read as follows: 
 8.7        Publication.  The Parties are encouraged to make publicly available
the results of their research and development activities. Before either Party submits a paper or abstract for publication or otherwise intends to publicly disclose information about a CRADA Subject Invention, CRADA Data, or CRADA Materials, the
other Party will have [...***...] to review proposed manuscripts and [...***...] to review proposed abstracts and/or other disclosures to assure that Confidential Information is protected. Either Party may request in writing that the
proposed publication or other disclosure be delayed for up to [...***...] as necessary to file a Patent Application, or for such other period as may be required by applicable law or regulation. 

  

					
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 Amend Section 9.1 to read as follows: 

9.1        Representations of ICD.  ICD hereby represents to Collaborator that: 

9.1.1    ICD has the requisite power and authority to enter into this CRADA and to perform according to its terms, and
that ICD’s official signing this CRADA has authority to do so. 
 9.1.2    To the best of its knowledge and belief,
neither ICD nor any of its personnel involved in this CRADA is presently subject to debarment or suspension by any agency of the Government which would directly affect its performance of the CRADA. Should ICD or any of its personnel involved in this
CRADA be debarred or suspended during the term of this CRADA, ICD will notify Collaborator within [...***...] of receipt of final notice. 

9.1.3    The execution and delivery of this CRADA and the performance of ICD’s obligations hereunder (a) do not
conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation of ICD. 

Amend Section 9.2 to read as follows: 

9.2        Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD
that: 
 9.2.1    Collaborator has the requisite power and authority to enter into this CRADA and to perform according
to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 
 9.2.2    Neither
Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in
this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within [...***...] of receipt of final notice. 

9.2.3    Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B,
Collaborator is financially able to satisfy these obligations in a timely manner. 
 9.2.4    The Test Article provided
has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure
provided. 

  

					
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 9.2.5    The execution and delivery of this CRADA and the performance of
Collaborator’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation of Collaborator. 

Amend Section 10.3 to read as follows: 

10.3     Unilateral Termination.  Either ICD or Collaborator may unilaterally terminate this CRADA at any time by
providing written notice at least sixty (60) days before the desired termination date. ICD may, at its option, retain funds transferred to ICD before unilateral termination by Collaborator for use in completing the Research Plan. If
Collaborator terminates this Agreement before the completion of all approved or active Protocol(s) under this CRADA for which the Collaborator is the IND holder, then Collaborator will supply enough Test Article (and Placebo, if applicable) to
complete these Protocol(s), unless termination is for safety concerns. Upon any termination of this CRADA, ICD shall return or destroy (as directed by Collaborator) Collaborator’s Confidential Information in ICD’s possession or control
except that ICD shall be entitled to retain one archival copy thereof for the purposes of determining its obligations under this CRADA. Further, upon termination or suspension for any reason, the Parties shall cooperate and assist the other to
promptly wind down all research and development activities under this CRADA, continuing only those activities deemed necessary by reasonable medical judgment to protect the health of the Human Subjects. 

Amend Section 10.4 to read as follows: 

10.4     Funding for ICD Personnel.  If Collaborator has agreed to provide funding for ICD personnel and this CRADA
is mutually or unilaterally terminated by Collaborator before its expiration, then Collaborator agrees that funds already received by ICD for that purpose will be available to ICD for a period of
[...***...] after the termination date or until the expiration date of the CRADA, whichever occurs sooner. 

Amend Section 10.5 to read as follows: 

10.5     New Commitments.  Neither Party will incur new expenses related to this CRADA after expiration, mutual
termination, or a notice of a unilateral termination and will, to the extent feasible, cancel all outstanding commitments and contracts by the termination date. Collaborator acknowledges that ICD will have the authority to retain and expend any
funds already received by ICD for up to [...***...] subsequent to the expiration or termination date to cover any unpaid costs obligated during the term of the CRADA in undertaking the research and development activities set forth in the
Research Plan. 

  

					
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 Section 10.6 is deleted in its entirety and is of no force or effect in this CRADA. 

 
  
 Amend
Section 13.7 to read as follows: 
 13.7    Assignment.  Neither this CRADA nor any rights or obligations of
any Party hereunder shall be assigned or otherwise transferred by either Party without the prior written consent of the other Party except that Collaborator without such consent may assign this Agreement and its rights and obligations hereunder to
any one or more of its Affiliates. Collaborator will notify NIH upon such assignment to its Affiliates of such rights or obligations hereunder. Collaborator shall always have the right to perform any or all of its obligations and exercise any or all
of its rights under this Agreement through any one or more of its Affiliates. The Collaborator acknowledges the applicability of 41 U.S.C. § 15, the Anti Assignment Act, to this Agreement. The Parties agree that the identity of the Collaborator
is material to the performance of this CRADA and that the duties under this CRADA are nondelegable. 

  

					
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