Exhibit 10.47


 


Text Marked
By [* * *] Has Been Omitted Pursuant To A Request For Confidential Treatment And Was Filed Separately With The Securities And
Exchange Commission.


 


THE
National Institutes of Health


 


PATENT LICENSE
AGREEMENT – EXCLUSIVE


 


COVER PAGE


 


For the NIH internal use
only:


 


License Number:
L-107-2015/0


 


License Application Number:
A-286-2014


 


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


 


Group A


 


		I.	U.S.
                                         Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled “Adoptive
                                         cell therapy with young T cells” (HHS Ref No. E-273-2009/0-US-01);



 


		II.	U.S.
                                         Patent No. 8,383,099 issued February 26, 2013 entitled “Adoptive cell therapy with
                                         young T cells” (HHS Ref No. E-273-2009/0-US-02);



 


		III.	U.S.
                                         Patent Application No. 13/742,541 filed January 16, 2013 entitled “Adoptive cell
                                         therapy with young T cells” (HHS Ref No. E-273-2009/0-US-03);



 


		IV.	U.S.
                                         Provisional Patent Application No. 61/466,200 filed March 22, 2011entitled “Methods
                                         of growing tumor infiltrating lymphocytes in gas-permeable containers” (HHS Ref
                                         No. E-114-2011/0-US-01);



 


		V.	PCT Application
                                         No. PCT/US2012/029744 filed March 20, 2012 entitled “Methods of growing tumor infiltrating
                                         lymphocytes in gas-permeable containers” (HHS Ref No. E-114-2011/0-PCT-02);



 


		VI.	U.S.
                                         Patent Application No. 13/424,646 filed May 20, 2012 entitled “Methods of growing
                                         tumor infiltrating lymphocytes in gas-permeable containers” (HHS Ref No. E-114-2011/0-US-03);



 


Group
B


 


		I.	U.S.
                                         Provisional Patent Application No. 60/408,681, filed September 6, 2002 entitled “Immunotherapy
                                         with in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting
                                         chemotherapy” (HHS Ref No. E-275-2002/0-US-01);



 


		II.	PCT
                                         Application No. PCT/US2012/029744 filed September 5, 2003 entitled “Immunotherapy
                                         with in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting
                                         chemotherapy” (HHS Ref No. E-275-2002/1-PCT-01);
                                         A-286-2014



 


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		III.	U.S.
                                         Patent No. 8,034,334 issued October 11, 2011 entitled “Immunotherapy with in vitro-selected
                                         antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
                                         (HHS Ref No. E-275-2002/1-US-02);



 


		IV.	European
                                         Patent Application No. 03794636.5 filed April 4, 2005 entitled “Immunotherapy with
                                         in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting
                                         chemotherapy” (HHS Ref No. E-275-2002/1-EP-03);



 


		V.	Canadian
                                         Patent No. 2,497,552 issued May 27, 2014 entitled “Immunotherapy with in vitro-selected
                                         antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
                                         (HHS Ref No. E-275-2002/1-CA-04);



 


		VI.	Australian
                                         Patent No. 2003265948 issued September 3, 2009 entitled “Immunotherapy with in
                                         vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
                                         (HHS Ref No. E-275-2002/1-AU-05);



 


		VII.	U.S.
                                         Patent No. 8,287,857 issued October 16, 2012 entitled “Immunotherapy with in vitro-selected
                                         antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
                                         (HHS Ref No. E-275-2002/1-US-06);



 


Licensee: Lion Biotechnologies,
Inc.


 


Cooperative Research and
Development Agreement (CRADA) Number: C-057-2011 (NCI 02734)


 


Public Benefit(s):


 


The public will benefit
from the development of Licensed Products by the Licensee that are granted FDA approval. There is a long felt need
for better treatments for metastatic melanoma. The development of novel TIL-based therapies will provide patients with new cancer
treatment options in the realm of personalized medicine to support public health.


 


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



 


		2.4	“CRADA”
                                         means a Cooperative Research and Development Agreement.



 


		2.5	“FDA”
                                         means the Food and Drug Administration.



 


		2.6	“First
                                         Commercial Sale” means the initial transfer by or on behalf of the Licensee
                                         or its sublicensees of the Licensed Products or the initial practice of a
                                         Licensed Process by or on behalf of the Licensee or its sublicensees in
                                         a country after obtaining regulatory approval by the U.S. Food and Drug Administration
                                         or any foreign equivalent necessary for the marketing and sale of such Licensed Product
                                         or practice of such Licensed Process 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.



 


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



 


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		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.



 


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		2.13	“Net
                                         Sales” means the total gross receipts received by Licensee for sales
                                         of Licensed Products or practice of Licensed Processes by or on behalf
                                         of the Licensee or its sublicensees, and from leasing, renting, or otherwise making
                                         the Licensed Products available to others for consideration without sale or other
                                         dispositions, whether invoiced or not, less returns and allowances, packing costs, insurance
                                         costs, freight out, taxes or excise duties imposed on the transaction (if separately
                                         invoiced), and wholesaler and cash discounts in amounts customary in the trade to the
                                         extent actually granted. No deductions shall be made for commissions paid to individuals,
                                         whether they are with independent sales agencies or regularly employed by the Licensee,
                                         or sublicensees, and on its payroll, or for the cost of collections. “Net Sales”
                                         shall not include the supply of Licensed Products or use of Licensed Processes,
                                         for use in pre-clinical or clinical studies, or for process development, quality control
                                         or assurance, storage as safety stock, transfer as a charitable donation or any other
                                         transaction for which no gross revenue is received.



 


		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 not inconsistent with the
                                         terms applicable to similar products or processes and taking into account the efficacy
                                         and safety profile of the Licensed Product or the utility of the Licensed Process
                                         and other relevant commercial, scientific, technical and other factors.



 


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



 


		2.16	“Commercially
                                         Reasonable Efforts” means, with respect to the efforts to be expended by Licensee
                                         with respect to any objective, the reasonable, diligent, good faith efforts to accomplish
                                         such objective as Licensee would normally use to accomplish a similar objective
                                         under similar circumstances. It is understood and agreed that with respect to the research,
                                         development and sale of Licensed Products or Licensed Process(es) by Licensee,
                                         such efforts shall be substantially equivalent to those efforts and resources commonly
                                         used by Licensee for products owned by it or to which it has rights, which product
                                         is at a similar stage in its development or product life cycle. Commercially Reasonable
                                         Efforts shall be determined on a market-by-market basis, and it is anticipated that
                                         the level of effort will be different for different markets, and will change over time,
                                         reflecting changes in the status of the Licensed Products or Licensed Process(es)
                                         and the market(s) involved.



 


		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 to Group A of the Licensed Patent Rights
                                         and a non-exclusive license to Group B of 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 and to practice and have practiced any Licensed Process(es)
                                         in such Licensed Fields of Use.



 


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		3.2	The
                                         NIH hereby grants and the Licensee accepts, subject to the terms and conditions
                                         of this Agreement, a non-exclusive license to Groups A and B of 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 (b-d) in Appendix B and to practice and have
                                         practiced any Licensed Process(es) in such 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 any sublicense agreement by the
                                         NIH and which shall not be unreasonably withheld or delayed, the Licensee
                                         may enter into sublicensing agreements under the Licensed Patent Rights.



 


		4.2	The
                                         Licensee agrees that any sublicenses 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 the NIH approval, which will not be unreasonably
                                         denied or delayed. 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 complete copy of each fully executed
                                         sublicense agreement postmarked within thirty (30) days of the execution of the agreement.
                                         To the extent permitted by law, the NIH agrees to maintain each sublicense agreement
                                         in confidence.



 


		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 the Licensed Productsor materials
                                         made through the Licensed Processes for 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



 


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		(b)	in the event that the Licensed Patent Rights are Subject
                                                                                                                 Inventions made under 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 the Licensed Patent
                                                                                                                 Rights or have the 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 with reasonable quantities of the Licensed Products or materials made through the Licensed
                                                                                                                 Processes for 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.



 


		5.2	The
                                         Licensee agrees that products used or sold in the United States embodying the
                                         Licensed Products or produced through use of the 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. 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, the NIH
                                         shall consult with the Licensee before granting to commercial entities a Research
                                         License or providing to them research samples of materials made through the Licensed
                                         Processes; and



 





		(b)	in exceptional circumstances, and in the event that the 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;











 


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



 


		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 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 the Licensed Products
                                         by the Licensee to 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.



 


		6.9	With regard to unreimbursed expenses
                                         associated with the preparation, filing, prosecution, and maintenance of all patent applications
                                         and patents to the extent 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, within sixty (60) days of the
                                         NIH’s submission of a statement and request for payment to the Licensee,
                                         an amount equivalent to these unreimbursed expenses previously paid by the NIH.



 


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		6.10	With regard to unreimbursed expenses associated with the
preparation, filing, prosecution, and maintenance of all patent applications and patents to the extent 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 sixty
(60) days 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 one
hundred percent (100%) 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.



 


		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 (other than
its Affiliates) 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 ninety (90) days written notice
to the NIH and owe no payment obligation under Paragraph 6.10 for patent-related expenses incurred in that country after
ninety (90) days of the effective date of the written notice.



 


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	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 furnish copies of relevant
patent-related documents to the Licensee.



 


		7.2	Upon
                                         the NIH’s written request, the Licensee shall 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, after Licensee has assumed responsibility for the preparation, filing,
                                         prosecution, and maintenance of Licensed Patent Rights as provided in Section
                                         7.2, the NIH may provide the Licensee with written notice that the NIH
                                         wishes to re-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 in Licensee’s possession or
                                         control 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 material matters that come to its attention
                                         that may affect the preparation, filing, prosecution, or maintenance of the Licensed
                                         Patent Rights and permit each other to provide comments and suggestions with respect
                                         to the preparation, filing, prosecution, and maintenance of the Licensed Patent Rights,
                                         which comments and suggestions shall be considered by the other party.



 


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	8.		RECORD KEEPING



 


		8.1	The
                                         Licensee agrees to keep accurate and correct records of the Licensed Products
                                         made, used, sold, or imported and the Licensed Processes practiced under this
                                         Agreement appropriate to determine the amount of royalties due the NIH.
                                         These records shall be retained for at least five (5) years following a given reporting
                                         period and shall be available during normal business hours 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. Licensee
                                         may require such auditor or accountant to enter into a confidentiality agreement with
                                         Licensee containing reasonable terms and conditions for the protection of Licensee’s
                                         non-public and proprietary information. The accountant or auditor 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 five percent (5%) for any twelve (12) month 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
                                         sixty (60) days of the date the NIH provides to the Licensee notice of
                                         the payment due.



 








	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 use Commercially Reasonable Efforts to bring Licensed Product(s) or Licensed Process(es) within 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 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 sixty (60) days 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, manufacturing, 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. The NIH 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 thirty (30) days of such occurrences.



 


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		9.4	Following the First Commercial Sale,
the Licensee shall submit to the NIH, within sixty (60) days 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 2.13 to determine Net
Sales made under Article 6 to determine royalties due. The royalty report shall also identify the site of manufacture for
the Licensed Product(s) sold in the United States.



 


		9.5	The Licensee agrees to forward semi-annually 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. For conversion of foreign currency to U.S. dollars, the conversion rate shall be
the New York foreign exchange rate quoted in The Wall Street Journal on the day preceding the day that the payment is due.
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. As reasonably requested by Licensee, NIH shall cooperate with Licensee in
applying for any valid exemption or obtaining any valid refund of such taxes paid by Licensee.



 


		9.8	Additional royalties may be assessed by the NIH
on any payment that is more than ninety (90) days overdue at the rate of [* * *] per month. This [* * *] 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 Commercially Reasonable
Efforts to bring the Licensed Products and the Licensed Processes to Practical Application. “Reasonable
commercial efforts” for the purposes of this provision shall include reasonable adherence to the Commercial Development
Plan in Appendix E and performance of the Benchmarks in Appendix D in each case as either may be amended from time
to time. The efforts of a sublicensee or an Affiliate of Licensee shall be considered the efforts of the Licensee.



 


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



 


		10.3	The Licensee agrees, after its First Commercial
Sale, to make reasonable quantities of the Licensed Products or materials produced through the use of the Licensed
Processes within the Licensed Fields of Use available to patient assistance programs.



 


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



 


		10.5	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 the 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 of which either party becomes aware.



 


		11.2	Pursuant to this Agreement and the provisions of
35 U.S.C. Chapter 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 ninety (90) days, the Licensee shall be free to initiate suit. The NIH
shall have a continuing right to intervene in the suit. The Licensee shall take no action to compel the Government
either to initiate or to join in any suit for patent infringement. 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, 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
the first right to take these actions and shall have a continuing right to intervene in the suit; 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 of 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	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 actually collected shall
                                         first be applied by Licensee to reimburse it for all of its costs and expenses
                                         (including attorneys’ fees, expert witness fees, and any reimbursement payments
                                         made to NIH or the Government) and the balance
                                         shall be treated as Net Sales and subject to earned royalties as provided
                                         in Appendix C when and as collected.



 


		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.



 


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		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.



 


		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 in connection with or arising out
of:



 


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



 


		(b)	the design, manufacture, distribution, or use of any Licensed
Products, Licensed Processes or materials by the Licensee, or other products or processes developed 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,
or if not reasonably capable of remedy within such period, Licensee has not taken substantial steps to remedy the alleged
default within such ninety (90) day period, 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 (i) becomes insolvent,
(ii) files a petition in bankruptcy, or has such a petition filed against it and, in either case, such
petition is not dismissed within sixty (60) days, the Licensee shall immediately notify the NIH in writing.



 


		13.4	The Licensee shall have a unilateral right to terminate
this Agreement or any licenses 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, if the NIH determines 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’s satisfaction
that the Licensee has taken, or can be expected to take within a reasonable time, effective steps to achieve the Practical
Application of the Licensed Products or the Licensed Processes;



 


		(b)	has not achieved and is not reasonably likely to achieve
the Benchmarks as may be modified under Paragraph 9.2;



 





		(c)	has willfully made a material 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;



 





		(e)	is not keeping the Licensed Products or the Licensed
Processes within the scope of the Licensed Fields of Use reasonably accessible to the public after commercial use commences;



 


		(f)	cannot reasonably satisfy unmet health and safety needs;
or






 


		(g)	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, the NIH’s concerns
as to the items referenced in 13.5(a)-13.5(g). If the Licensee fails to alleviate the NIH’s reasonable concerns
as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s reasonable satisfaction,
the NIH may terminate this Agreement.



 


		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 commercially 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 for a sublicense on commercially reasonable terms and conditions.



 


		13.8	The
                                         NIH reserves the right according to 35 U.S.C. §209(d)(3) to terminate
                                         or modify this Agreement 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.



 


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		13.9	Within thirty (30)
                                         days of 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.



 


		13.10	Within ninety (90) days of 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 expenses, 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 or expiration of this Agreement, the Licensee shall return
all 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
either 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 that party.



 


		14.2	This Agreement constitutes the entire agreement between the parties relating to the subject matter of the Licensed
Patent Rights, the Licensed Products and the 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.



  


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		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) except to the Licensee’s Affiliate(s) without the prior written
consent of the NIH. The parties agree that the identity of the parties is material to the formation of this Agreement
and that the obligations under this Agreement are nondelegable. In the event that the NIH approves a
proposed assignment, the Licensee shall pay the NIH, as an additional royalty, one percent (1%) of the fair
market value of any consideration received for any assignment of this Agreement within sixty (60) days of the assignment.



 


		14.8	The Licensee agrees in its use of any NIH-supplied
biological materials that are supplied under this Agreement to comply with all applicable statutes, regulations, and guidelines,
including NIH and HHS regulations and guidelines. The Licensee agrees not to use such biological materials
for research involving human subjects or 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 such biological materials for research involving human subjects
or 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 research
involving such biological materials in human subjects or clinical trials outside of the United States shall be given no later
than sixty (60) days 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 sold in the United States with all applicable U.S. patent numbers and similarly to indicate “Patent
Pending” status. All the Licensed Products manufactured in, shipped to, or sold in other countries shall be marked
in a manner to preserve the NIH’s patent rights in those countries.



 


		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 the NIH, the FDA or the HHS or the
Government or their employees in any advertising, promotional, or sales literature 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.



 








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		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.



 


		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, 9.5-9.8, 9.9 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 sixty (60) days from the date of the NIH’s signature found at the Signature Page.



 


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NIH PATENT
LICENSE AGREEMENT – EXCLUSIVE


 


SIGNATURE
PAGE


 


For the NIH:


 


	/S/
    RICHARD U. RODRIGUEZ	 	       02/09/15                
	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


6011 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/ ELMA HAWKINS	 	        02/09/15                
	Signature of Authorized Official	 	Date
	 	 	 
	Elma Hawkins, Ph.D.	 	 
	Printed Name	 	 
	 	 	 
	President and CEO	 	 
	Title	 	 


 


I.  Official
and Mailing Address for Agreement notices:


 


Peter Ho, Ph.D.


Director, Business Development


21900 Burbank Blvd., 3rd
Floor


Woodland Hills, CA 91367


Phone: 818-992-3127


Fax: 818-475-5194


Email: peter.ho@lionbio.com


 


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


 


Peter Ho, Ph.D.


Director, Business Development


21900 Burbank Blvd., 3rd
Floor


Woodland Hills, CA 91367


Phone: 818-992-3127


Fax: 818-475-5194


Email: peter.ho@lionbio.com


 


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):


 


Group A


 


		I.	U.S.
                                         Provisional Patent Application No. 61/237,889, filed August 26, 2009 entitled “Adoptive
                                         cell therapy with young T cells” (HHS Ref No. E-273-2009/0-US-01);



 


		II.	U.S.
                                         Patent No. 8,383,099 issued February 26, 2013 entitled “Adoptive cell therapy with
                                         young T cells” (HHS Ref No. E-273-2009/0-US-02);



 


		III.	U.S.
                                         Patent Application No. 13/742,541 filed January 16, 2013 entitled “Adoptive cell
                                         therapy with young T cells” (HHS Ref No. E-273-2009/0-US-03);



 


		IV.	U.S.
                                         Provisional Patent Application No. 61/466,200 filed March 22, 2011entitled “Methods
                                         of growing tumor infiltrating lymphocytes in gas-permeable containers” (HHS Ref
                                         No. E-114-2011/0-US-01);



 


		V.	PCT Application
                                         No. PCT/US2012/029744 filed March 20, 2012 entitled “Methods of growing tumor infiltrating
                                         lymphocytes in gas-permeable containers” (HHS Ref No. E-114-2011/0-PCT-02);



 


		VI.	U.S.
                                         Patent Application No. 13/424,646 filed May 20, 2012 entitled “Methods of growing
                                         tumor infiltrating lymphocytes in gas-permeable containers” (HHS Ref No. E-114-2011/0-US-03);



 


Group B


 


		I.	U.S.
                                         Provisional Patent Application No. 60/408,681, filed September 6, 2002 entitled “Immunotherapy
                                         with in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting
                                         chemotherapy” (HHS Ref No. E-275-2002/0-US-01);



 


		II.	PCT
                                         Application No. PCT/US2012/029744 filed September 5, 2003 entitled “Immunotherapy
                                         with in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting
                                         chemotherapy” (HHS Ref No. E-275-2002/1-PCT-01);



 


		III.	U.S.
                                         Patent No. 8,034,334 issued October 11, 2011 entitled “Immunotherapy with in vitro-selected
                                         antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
                                         (HHS Ref No. E-275-2002/1-US-02);



 


		IV.	European
                                         Patent Application No. 03794636.5 filed April 4, 2005 entitled “Immunotherapy with
                                         in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting
                                         chemotherapy” (HHS Ref No. E-275-2002/1-EP-03);



 


		V.	Canadian
                                         Patent No. 2,497,552 issued May 27, 2014 entitled “Immunotherapy with in vitro-selected
                                         antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
                                         (HHS Ref No. E-275-2002/1-CA-04);



 


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		VI.	Australian Patent No. 2003265948 issued September 3, 2009
entitled “Immunotherapy with in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
(HHS Ref No. E-275-2002/1-AU-05);



 


		VII.	U.S. Patent No. 8,287,857 issued October 16, 2012 entitled
“Immunotherapy with in vitro-selected antigen-specific lymphocytes after nonmyeloablative lymphodepleting chemotherapy”
(HHS Ref No. E-275-2002/1-US-06);



 


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APPENDIX
B – Licensed Fields of Use and Territory


 


	I.		Licensed Fields of Use:



 


		(a)	The
                                         use of the Licensed Patent Rights to develop, manufacture, and sale autologous
                                         tumor infiltrating lymphocyte adoptive cell therapy products for the treatment of metastatic
                                         melanoma.



 


Tumor infiltrating lymphocytes (TIL)
are a subset of T lymphocytes (T cells) that migrate and are located within a tumor site. TIL isolated from these tumor sites
exhibit natural anti-tumor activity without genetic modifications. For the avoidance of doubt, cell therapy products involving
genetically modified TIL or TIL isolated by cancer-specific mutations are excluded from the Licensed Fields of
Use, unless the cell therapy products are a combination of TIL therapy with the Licensee’s proprietary
technologies or the Licensee’s in-licensed technologies.


 


	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 [* * *] within sixty (60) days from the effective date of this Agreement.



 


	II.		The Licensee agrees to pay to the NIH a nonrefundable
minimum annual royalty in the amount of [* * *]as follows:



 


		(a)	The first minimum annual royalty is due within sixty (60)
days of the effective date of this Agreement and may be prorated according to the fraction of the calendar year remaining
between the effective date of this Agreement 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.



 


		(c)	In the case of each of (a) and (b) above, such payments
shall be due so long as Licensee has not terminated this Agreement pursuant to Paragraph 13.4.



 


	III.		The Licensee agrees to pay the NIH earned
royalties of [* * *] on Net Sales by or on behalf of Licensee or its sublicensees. Licensee shall
be entitled to a credit of [* * *] against the earned royalty rate for each percent point in excess of [* * *] that
Licensee must pay to an unaffiliated licensor(s) for the manufacture and sale of Licensed Product(s) and Licensed
Process(es). Said credit however, shall not reduce the earned royalty rate due to NIH for Licensed Product(s)
and Licensed Process(es) below [* * *].



 


	IV.		The Licensee agrees to pay the NIH Benchmark
royalties within sixty (60) days of achieving each Benchmark by Licensee or its sublicensees for each Licensed
Product:



 


		(a)	[* * *] for successful completion of the first Licensee-sponsored
Phase 2 clinical study.



 


		(b)	[* * *] for successful completion of the first Licensee-sponsored
Phase 3 clinical study.



 


		(c)	[* * *] upon the first FDA approval or foreign equivalent
for a Licensed Product or Licensed Process.



 


		(d)	[* * *] for the First Commercial Sale of a Licensed
Product or Licensed Process in the United States.



 


		(e)	[* * *] for the First Commercial Sale of a Licensed
Product or Licensed Process in any foreign country for either of Licensed Field of Use.



 


For
purposes of this Agreement, “successful completion of a Licensee-sponsored Phase 2 Clinical Study”
shall mean, with respect to a specified construct, formulation and dose of a specified Licensed Product in a specified
cancer indication, the statistical demonstration in a pivotal Phase 2 Clinical Study of safety and efficacy, sufficient to
support a Phase 3 clinical trial submission by the Licensee for such specified construct, formulation and dose of such
specified Licensed Product for the treatment of such specified cancer indication.


 


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For
purposes of this Agreement, “successful completion of a Licensee-sponsored Phase 3 Clinical Study”
shall mean, with respect to a specified construct, formulation and dose of a specified Licensed Product in a specified
cancer indication, the statistical demonstration in a pivotal Phase 3 Clinical Study of safety and efficacy, sufficient to
support a BLA submission by the Licensee for such specified construct, formulation and dose of such specified Licensed
Product for the treatment of such specified cancer indication.


 


		V.	The Licensee agrees to pay the
                                         NIH:



 


(a)
additional sublicensing royalties of [* * *] on the fair market value of any consideration received for granting each sublicense
within sixty (60) days of the execution of each sublicense if any such sublicense is executed prior to FDA approval or foreign
equivalent for a Licensed Product or Licensed Process within each Licensed Field of Use from Appendix B; and


 


(b)
additional sublicensing royalties of [* * *] on the fair market value of any consideration received for granting each sublicense
within sixty (60) days of the execution of each sublicense if any such sublicense is executed following FDA approval or foreign
equivalent for a Licensed Product or Licensed Process within each Licensed Field of Use from Appendix B.


 


(c)
Notwithstanding anything in this Agreement to the contrary, any such consideration will not include the following:


  


		(1)	Bona fide support research and development activities corresponding
directly to the development of Licensed Product(s) and/or Licensed Process(es), which do not exceed Licensee's fully-burdened
cost for undertaking such research and development, and limited to support which is received after the effective date of this
Agreement specifically excluding any support which is used by Licensee to offset research and development expenses which are incurred
prior to the effective date of this Agreement;



 


		(2)	Proceeds derived from debt financing received after the
effective date of this Agreement, to the extent that such financing is at market rates;



 


		(3)	Consideration received after the effective date of this
Agreement for the purchase of an equity interest in Licensee to the extent that the price per share paid for such equity does
not exceed by more than twenty-five pecent (25%) the average closing price of such equity on the stock exchange for the thirty
(30) consecutive business days immediately preceding the date on which said stock is transferred, or if such equity is not so
traded, then the fair market value of such equity as reasonably agreed to by the parties or as determined in the same financing
round involving non-sublicensee investors;



 


		(4)	As earned royalties on Net Sales or sales by sublicensee(s);
and



 


		(5)	Any non-monetary consideration which is specifically in
the form of license(s) received in exchange for the grant of a sublicense, if such license(s) are necessary or useful for the
development of Licensed Product(s) and/or Licensed Process(es).



 


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APPENDIX
D – Benchmarks and Performance


 


The Licensee agrees to the
following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark,
shall notify the NIH that the Benchmark has been achieved.


 


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



 


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APPENDIX
E – Commercial Development Plan


 


Licensee intends to use the
licensed technology to develop and commercialize a product based on T cells derived from tumors or tumor-infiltrating lymphocytes
(TILs) to treat patients with melanoma, HPV cancers, bladder cancer, breast cancer, lung cancer, and other solid tumors.


 


In August 2011, Licensee
entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop and
evaluate improved adoptive cell transfer (ACT) based immunotherapies using TILs to treat patients with metastatic melanoma utilizing
the business development expertise and resources of Licensee (C-057-2011, NCI 02734). The CRADA includes the development
of improved methods for the generation and selection of TIL, standard operating procedures (SOPs) for large-scale TIL growth,
selection and testing to support the FDA approval of an ACT/TIL therapy approach. It further includes clinical trials designed
and implemented to evaluate the clinical effectiveness of ACT/TIL therapy resulting from large-scale techniques in patients with
metastatic melanoma based on the proprietary NCI Surgery Branch technology and approaches developed as part of the CRADA. In January
2015, Licensee and the NCI amended the CRADA to add HPV cancers (such as cervical, anal, and head and neck cancers), bladder
cancer, breast cancer, and lung cancer.


 


The overall strategy for commercial
development and program prioritization for an ACT/TIL product for the treatment of metastatic melanoma is summarized below:


 


[* * *]


 


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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:	 	 	 	 
	Freight	 	 	3,000	 
	Returns	 	 	7,000	 
	Total Net Sales	 	 	143,250	 
	 	 	 	 	 
	Royalty Rate	 	 	8	%
	Royalty Due	 	 	11,460	 
	Less Creditable Payments	 	 	10,000	 
	Net Royalty Due	 	 	1,460	 



 


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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 its 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:	Federal Reserve Bank of New York
    or TREAS NYC
	Bank:	Federal Reserve Bank of New York
	ABA#	021030004
	Account Number:	75080031
	Bank Address:	33 Liberty Street, New York, NY 10045
	Payment Details:	License Number (L-XXX-XXXX)
	 	Name of the Licensee


 


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:	Federal Reserve Bank of New York/ITS or FRBNY/ITS
	Bank:	Citibank N.A. (New York)
	SWIFT Code:	CITIUS33
	Account Number:	36838868
	Bank Address:	388 Greenwich Street, New York, NY 10013
	Payment Details (Line 70):	NIH 75080031
	 	License Number (L-XXX-XXXX)
	 	Name of the Licensee
	Detail of Charges (line 71a):	Charge Our


 


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:


 


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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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