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);



 


 





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		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);



 


		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.



 


SIGNATURES BEGIN ON NEXT 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 Three Hundred and Fifty Thousand dollars ($350,00) 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.


 


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.


 


 





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		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


 


 





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Checks drawn on a U.S. bank account and sent by overnight
or courier should be sent to the following address:


 


US Bank


Government Lockbox SL-MO-C2GL


1005 Convention Plaza


St. Louis, MO 63101


Phone: 314-418-4087


 


Checks drawn on a foreign bank account
should be sent directly to the following address:


 


National Institutes of Health (NIH)


Office of Technology Transfer


Royalties Administration Unit


6011 Executive Boulevard


Suite 325, MSC 7660


Rockville, Maryland 20852


 


 





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