Document:

ex_384344.htm

 

 

Exhibit 4.6

 

CERTAIN CONFIDENTIAL INFORMATION (MARKED BY BRACKETS AS “[***]”) HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS THE INFORMATION AS PRIVATE OR CONFIDENTIAL.

NATIONAL INSTITUTES OF HEALTH

 

START-UP PATENT LICENSE AGREEMENT — EXCLUSIVE

 

COVER PAGE

 

For the NIH’s internal use only:

 

License Number: L-236-2013/0

 

License Application Number: A-170-2013

 

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

 

	 	
			1.

				
			U.S. Patent 5,635,599 entitled -Proteins Comprising Circularly Permuted Ligands” [HHS Reference E-047-1994/0-US-01]:

			

	 	
			2.

				
			PCT Application PCT/US95/04468 entitled “Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules” [HHS Reference E-047-1994/0-PCT-02];

			

	 	
			3.

				
			Australian Patent 694211 entitled “Proteins Comprising Circularly Permuted Ligands” [HHS Reference E-047-1994/0-AU-12];

			

	 	
			4.

				
			Canadian Patent 2187283 entitled “Proteins Comprising Circularly Permuted Ligands” [HHS Reference E-047-1994/0-CA-14];

			

	 	
			5.

				
			European Patent 0754192 entitled “Proteins Comprising Circularly Permuted Ligand” [NHS Reference E-047-1994/0-EP-15], validated in

			

	 	
			a.

				
			Austria [HHS Reference E-047-1994/0-AT-11],

			

	 	
			b.

				
			Belgium [HHS Reference E-047-1994/0-13E-13],

			

	 	
			c.

				
			France [HHS Reference E-047-1994/0-FR-16],

			

	 	
			d.

				
			Italy [HHS Reference E-047-1994/0-IT-06].

			

	 	
			e.

				
			Liechtenstein [HHS Reference E-047-1994/0-LI-18],

			

	 	
			f.

				
			The Netherlands [HHS Reference E-047-1994/0-NL-09],

			

	 	
			g.

				
			Spain [HHS Reference E-047-1994/0-ES-04],

			

	 	
			h.

				
			Switzerland Reference E-047-1994/0-01-03], and

			

	 	
			i.

				
			the United Kingdom [HHS Reference E-047-1994/0-GB-05];

			

	 	
			6.

				
			U.S. Patent 6,011,002 entitled “Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules” [HHS Reference E-047-1994/1-US-01];

			

	 	
			7.

				
			U.S. Patent Application 61/105,408 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021-2010/0-US-01]; and

			

	 	
			8.

				
			U.S. Patent Application 12/579,281 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021-2010/0-US-02].

			

 

Licensee: Medicenna Therapeutics, Inc.

 

Additional Remarks: Rights to HHS technology reference E-202-2002/0 will be covered under a separate non-exclusive agreement.

 

Page 1 of 29

 

 

Public Benefit(s): There is an unmet need for the development of cancer therapeutics, particularly cancers of the central nervous system such as glioblastoma multiforme. This license will increase the chances that such a new treatment will be developed.

 

This Start-Up 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”.

			

 

 

 

 

Page 2 of 29

 

 

NIH START-UP PATENT LICENSE AGREEMENT — EXCLUSIVE

 

The NIH and the Licensee agree as follows:

 

1. BACKGROUND

 

	 	
			1.1

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

			

 

	 	
			1.2

				
			By assignment of rights from the NIH 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.

			

 

	 	
			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 is a startup company as of the date the Agreement is effective having less than fifty (50) employees, in operation less than five (5) years, receiving less than five million dollars ($5,000,000) in funding since incorporation, and is majority owned by individuals, hedge funds, or venture funds or by a company that is majority owned by individuals, hedge funds or venture funds.

			

 

	 	
			1.6

				
			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.

			

 

	 	
			1.7

				
			The Licensee warrants that it meets the program requirements:

			

 

	 	
			(a)

				
			has been in operation for less than five (5) years;

			

 

	 	
			(b)

				
			less than fifty (50) employees;

			

 

	 	
			(c)

				
			less than five million ($5M) in funding since incorporation; and

			

 

	 	
			(d)

				
			is majority owned by individuals, hedge funds, or venture funds or by a company that is majority owned by individuals, hedge funds or venture funds.

			

 

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 fitly percent (50%) of the members of the governing body of the corporation or other business entity.

			

 

Page 3 of 29

 

 

	 	
			2.2

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

			

 

	 	
			2.3

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

			

 

	 	
			2.4

				
			“Fair Market Value” means the total amount or value expressed in U.S. dollars obtained by the Licensee through the transfer or sale of its assets.

			

 

	 	
			2.5

				
			“First Commercial Sale” means the initial transfer by or on behalf of the Licensee or its sublicensees of Licensed Products or the initial practice of a Licensed Process by or on behalf of the Licensee or its sublicensees in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales.

			

 

	 	
			2.6

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

			

 

	 	
			2.7

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

			

 

	 	
			2.8

				
			“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 2.8(a):

			

 

	 	
			(i)

				
			continuations-in-part of 2.8(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 2.8(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 2.8(a): all counterpart foreign and U.S. patent applications and patents to 2.8(a) and 2.8(b), including those listed in Appendix A; and

			

 

	 	
			(d)

				
			Licensed Patent Rights shall not include 2.8(b) or 2.8(c) to the extent that they contain one or more claims directed to new matter which is not the subject matter disclosed in 2.8(a).

			

 

	 	
			2.9

				
			“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.

			

 

Page 4 of 29

 

 

	 	
			2.10  

				
			“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.

			

 

	 	
			2.11  

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

			

 

	 	
			2.12  

				
			“Liquidity Event” means (i) a firmly underwritten initial public offering and sale of the Licensee’s common stock pursuant to an effective registration statement under the Securities Act of 1933, as amended; (ii) a consolidation or merger of the Licensee with or into any other corporation or other entity or person, or any other corporate reorganization, in which the stockholders of the Licensee prior to such consolidation, merger or reorganization, receive, in consideration for such consolidation, merger or reorganization, cash (including promissory notes) or securities then listed upon a national exchange or quotation system (e.g., the New York Stock Exchange or NASDAQ) or (iii) the sale, lease or other disposition of all or substantially all of the assets of the Licensee in consideration for cash (including promissory notes) or securities then listed upon such a national exchange or quotation system.

			

 

	 	
			2.13  

				
			“Net Sales” means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of the Licensee or its sub Licensees, and from leasing, renting, or otherwise making Licensed Products available to others 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 arc with independent sales agencies or regularly employed by the Licensee, or sublicenses, and on its payroll, or for the cost of collections.

			

 

	 	
			2.14  

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

			

 

	 	
			2.15  

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

			

 

3. GRANT OF RIGHTS

 

	 	
			3.1

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

			

 

Page 5 of 29

 

 

	 	
			3.2

				
			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. SUBLICENS1NG

 

	 	
			4.1

				
			Upon written approval, which shall include prior review of any sublicense Agreement by the NIH and which shall not be unreasonably withheld, the Licensee may enter into sublicensing Agreements under the Licensed Patent Rights.

			

 

	 	
			4.2

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

			

 

	 	
			4.3

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

			

 

	 	
			4.4

				
			The Licensee agrees to forward to the NIH a 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

 

	 	
			(a)

				
			The NIH reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign Government or international organization pursuant to any existing or future treaty or Agreement to which the Government is a signatory. Prior to the First Commercial Sale, the Licensee agrees to provide the NIH with reasonable quantities of Licensed Products or materials made through the Licensed Processes for the NIH’s research use; and

			

 

	 	
			(b)

				
			In the event that the Licensed Patent Rights are Subject Inventions made under a Cooperative Research and Development Agreement (“CRADA”), the Licensee grants to the Government, pursuant to 15 U.S.C.§3710a(b)(1)(A), a nonexclusive, nontransferable. irrevocable, paid-up license to practice Licensed Patent Rights or have Licensed Patent Rights practiced throughout the world by or on behalf of the Government. In the exercise of this license, the Government shall not publicly disclose trade secrets or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or which would be considered as such if it had been obtained from a non-Federal party. Prior to the First Commercial Sale, the Licensee agrees to provide the NIH reasonable quantities of Licensed Products or materials made through the Licensed Processes for the NIH research use.

			

 

Page 6 of 29

 

 

	 	
			5.2

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

			

 

	 	
			5.3

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

			

 

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

			

 

	 	
			(i)

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

			

 

	 	
			(ii)

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

			

 

	 	
			(iii)

				
			the Licensee has failed to comply with an Agreement containing provisions described in 35 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).

			

 

Page 7 of 29

 

 

6. ROYALTIES AND REIMBURSEMENT

 

	 	
			6.1

				
			The Licensee agrees to pay the NIH a noncreditable, nonrefundable license royalty as set forth in Appendix C within one-hundred and eighty (180) days of achieving a Liquidity Event. This obligation shall survive any termination or expiration of the Agreement.

			

 

	 	
			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 sublicensing royalties as set forth in Appendix C.

			

 

	 	
			6.5

				
			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.

			

 

	 	
			6.6

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

			

 

	 	
			6.7

				
			On sales of 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.

			

 

	 	
			6.8

				
			With regard to unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights and paid by the NIH on or after the effective date of this Agreement, the Licensee agrees to pay the NIH within sixty (60) days of the NIH’s submission of a statement and request for payment, a royalty amount equivalent to fifty percent (50%) of these unreimbursed expenses.

			

 

	 	
			6.9

				
			Upon achievement of the earliest of the following triggering event: (i) Liquidity Event; (ii) grant of a sublicense: (iii) First Commercial Sale; or (iv) the third anniversary of the effective date of the Agreement, the Licensee shall pay the NIH, as additional royalties, within sixty (60) days of the NIH’s submission of a statement and request for payment to the Licensee:

			

 

	 	
			(a)

				
			All unreimbursed expenses associated with the preparation, filing, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights and paid by the NIH prior to the effective date of this Agreement;

			

 

Page 8 of 29

 

 

	 	
			(b)

				
			The remaining unreimbursed expenses associated with the preparation, tiling, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights and paid by the NIH on or after the effective date of this Agreement up until the date of the triggering event; and

			

 

	 	
			(c)

				
			One-hundred percent (100%) of the unreimbursed expenses paid by the NIH on or after the date of the triggering event associated with the preparation, tiling, prosecution, and maintenance of all patent applications and patents included within the Licensed Patent Rights.

			

 

	 	
			6.10  

				
			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 6.8 and 6.9. The Licensee agrees that all information provided by the NIH related to patent prosecution costs shall he treated as confidential commercial information and shall not be released to a third party except as required by law or a court of competent jurisdiction.

			

 

	 	
			6.11  

				
			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 Paragraphs 6.8 and 6.9 for patent-related expenses paid in that country after ninety (90) days of the effective date of the written notice.

			

 

7. PATENT FILING, PROSECUTION. AND MAINTENANCE

 

	 	
			7.1

				
			Except as otherwise provided in this Article 7, 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

				
			Licensee agrees to take responsibility for, but to consult with the NIH in the filing, prosecution, and maintenance of any and all patent applications or patents included in HITS Reference E-021¬2010/0, including any and all continuation applications, divisional applications, continuation-in-part applications, and foreign counterpart applications, and shall furnish copies of relevant patent-related documents to the NIH. For purposes of clarity, Licensee is responsible for all costs associated with the tiling, prosecution, and maintenance of any and all patent applications or patents included in HHS Reference E-021-2010/0.

			

 

	 	
			7.3

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

			

 

Page 9 of 29

 

 

8. RECORD KEEPING

 

	 	
			8.1

				
			The Licensee agrees to keep accurate and correct records of Licensed Products made, used, sold, or imported and Licensed Processes practiced under this Agreement appropriate to determine the 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. 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 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 bring the subject matter of the Licensed Patent Rights to the point of Practical Application. This Commercial Development Plan is hereby incorporated by reference into this Agreement. Based on this plan, performance Benchmarks are determined as specified in Appendix D.

			

 

	 	
			9.2

				
			The Licensee shall provide written 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.

			

 

Page 10 of 29

 

 

	 	
			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.

			

 

	 	
			9.4

				
			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 arc 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.

			

 

	 	
			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 he 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 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.

			

 

	 	
			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 one percent (1%) per month. This one percent (1%) 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).

			

 

Page 11 of 29

 

 

10. PERFORMANCE

 

	 	
			10.1  

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

			

 

	 	
			10.2  

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

			

 

	 	
			10.3  

				
			The Licensee agrees, after its First Commercial Sale, to make reasonable quantities of Licensed Products or materials produced through the use of Licensed Processes 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, the Nil with inert samples of the Licensed Products or Licensed Processes or their packaging for educational and display purposes only.

			

 

11. INFRINGEMENT AND PATENT ENFORCEMENT

 

	 	
			11.1  

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

			

 

	 	
			11.2  

				
			Pursuant to this Agreement and the provisions of 35 U.S.C. Chanter 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

			

 

Page 12 of 29

 

 

	 	
			(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 he 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.

			

 

	 	
			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. Chapter 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 shall be treated as Net Sales and subject to earned royalties.

			

 

Page 13 of 29

 

 

	 	
			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 I.

			

 

	 	
			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, the NIH may terminate this Agreement by written notice and pursue outstanding royalties owed through procedures provided by the Federal Debt Collection Act.

			

 

Page 14 of 29

 

 

	 	
			13.3  

				
			In the event that the Licensee becomes insolvent, files a petition in bankruptcy, has such a petition filed against it, determines to file a petition in bankruptcy, or receives notice of a third party’s intention to file an involuntary petition in bankruptcy, 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:

			

 

	 	
			(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 Practical Application of the Licensed Products or Licensed Processes;

			

 

	 	
			(b)

				
			has not achieved the Benchmarks as may be modified under Paragraph 9.2;

			

 

	 	
			(c)

				
			has willfully made a false statement of, or willfully omitted a material fact in the license application or in any report required by this Agreement;

			

 

	 	
			(d)

				
			has committed a material breach of a covenant or Agreement contained in this Agreement:

			

 

	 	
			(e)

				
			is not keeping Licensed Products or Licensed Processes reasonably available 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 concerns as to the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action to the NIH’s 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 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.

			

 

Page 15 of 29

 

 

	 	
			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.

			

 

	 	
			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 the NIH official. The decision of the designated the 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 expense, due to the NIH shall become immediately due and payable upon termination or expiration. If terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses with the NIH pursuant to Paragraph 4.3. Unless otherwise specifically provided for under this Agreement. upon termination 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 the N III 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 the Government 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 the Government or excuse a similar subsequent failure to perform any of these terms or conditions by the Licensee.

			

 

	 	
			14.2  

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

			

 

	 	
			14.3  

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

			

 

	 	
			14.4  

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

			

 

Page 16 of 29

 

 

	 	
			14.5  

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

			

 

	 	
			14.6  

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

			

 

	 	
			14.7  

				
			This Agreement shall not be assigned or otherwise transferred (including any transfer by legal process or by operation of law, and any transfer in bankruptcy or insolvency, or in any other compulsory procedure or order of court) 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 and such assignment occurs during an occasion other than a Liquidity Event, 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 the NIH supplied materials to comply with all applicable statutes, regulations, and guidelines, including NIH and HHS regulations and guidelines. The Licensee agrees not to use the 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 the 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 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.

			

 

Page 17 of 29

 

 

	 	
			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 Licensed Products manufactured in, shipped to, or sold in other countries shall be marked in a manner to preserve the NIH 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, Food and Drug Administration, the NIH, 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 the 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.

			

 

	 	
			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, 6.1, 9.5-9.7, 12.1-12.5, 13.9, 13.10, 14.12 and 14.15 of this Agreement shall survive termination of this Agreement.

			

 

	 	
			14.16  

				
			The terms and conditions of this Agreement shall, at the NIH’s sole option, be considered by the NIH to be withdrawn from the Licensee’s consideration and the terms and conditions of this Agreement. and the Agreement itself to be null and void, unless this Agreement is executed by the Licensee and a fully executed original is received by the NIH within sixty (60) days from the date of the NIH signature found at the Signature Page.

			

 

SIGNATURES BEGIN ON NEXT PAGE

 

Page 18 of 29

 

 

NIH Start-Up PATENT LICENSE AGREEMENT-EXCLUSIVE

 

SIGNATURE PAGE

 

For the NIH:

 

 

/s/ Richard U. Rodriguez                  9-25-13         

Richard U. Rodriguez                       Date

Director, Division of Technology Development and Transfer

Office of Technology Transfer

National Institutes of Health

 

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

 

Chief, Monitoring & Enforcement Branch

Office of Technology Transfer

National Institutes of Health

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/ Fahar Merchant                              26 Sep 2013         

Signature of Authorized Official         Date

 

Fahar Merchant         

Printed Name

 

President & CEO         

Title

 

I.         Official and Mailing Address for Agreement notices:

 

Fahar Merchant, PhD

President & CEO

Medicenna Therapeutics, Inc.

1075 West Georgia St, Suite 220

Vancouver, BC, Canada V6E 3C9

Phone: 604-608-6785

Cell: 604-671-6673

E-mail: fmerchant@medicenna.com

 

Page 19 of 29

 

 

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

 

Fahar Merchant, PhD

President & CEO

Medicenna Therapeutics, Inc.

1075 West Georgia St, Suite 220

Vancouver, BC, Canada V6E 3C9

Phone: 604-608-6785

Cell: 604-671-6673

E-mail: fmerchant@medicenna.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).

 

Page 20 of 29

 

 

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

 

Patent(s) or Patent Application(s):

 

	 	
			I.

				
			U.S. Patent 5,635,599 entitled -Proteins Comprising Circularly Permuted Ligands” [HHS Reference E¬047-1994/0-US-01];

			

 

	 	
			II.

				
			PCT Application PC7/US95/04468 entitled “Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules” [HHS Reference E-047-1994/0-PCT-02];

			

 

	 	
			III.

				
			Australian Patent 694211 entitled “Proteins Comprising Circularly Permuted Ligands” [HHS Reference E¬047-1994/0-AU-12];

			

 

	 	
			IV.

				
			Canadian Patent 2187283 entitled “Proteins Comprising Circularly Permuted Ligands” [HHS Reference E¬047-1994/0-CA-14];

			

 

	 	
			V.

				
			European Patent 0754192 entitled “Proteins Comprising Circularly Permuted Ligand” [HHS Reference E¬047-1994/0-EP-15], validated in

			

 

	 	
			(a)

				
			Austria [HHS Reference E-047-1994/0-AT- I I],

			

	 	
			(b)

				
			Belgium [HHS Reference E-047-1994/0-BE-13],

			

	 	
			(c)

				
			France [HHS Reference E-047-1994/0-FR-16],

			

	 	
			(d)

				
			Italy [HHS Reference E-047-1994/0-1T-06],

			

	 	
			(e)

				
			Liechtenstein [HHS Reference E-047-1994/0-L1-18],

			

	 	
			(f)

				
			The Netherlands [HHS Reference E-047-]994/0-NL-09],

			

	 	
			(g)

				
			Spain [HITS Reference E-047- I 994/0-ES-04],

			

	 	
			(h)

				
			Switzerland [HHS Reference E-047-1994/0-CH-03], and

			

	 	
			(i)

				
			the United Kingdom [HHS Reference E-047-1994/0-GB-05];

			

 

	 	
			VI.

				
			U.S. Patent 6,011,002 entitled “Circularly Permutated Ligands and Circularly Permuted Chimeric Molecules” [HHS Reference E-047-1994/1-US-01];

			

 

	 	
			VII.

				
			U.S. Patent Application 61/105,408 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021-2010/0-US-01]; and

			

 

	 	
			VIII. 

				
			U.S. Patent Application 12/579,281 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021-2010/0-US-02].

			

 

 

Page 21 of 29

 

 

APPENDIX B — LICENSED FIELDS OF USE AND TERRITORY

 

	 	
			I.

				
			Licensed Fields of Use:

			

 

The treatment of cancers and urological disorders that express the 1L4 receptor on their cell surface by using cpIL4-PE38KDEL.

 

	 	
			II.

				
			Licensed Territory: 

			

 

Worldwide

 

 

 

Page 22 of 29

 

 

[Royalty information (percentages and dollar amounts) were redacted for confidentiality purposes.]

 

APPENDIX C — ROYALTIES

 

Royalties:

 

	 	
			I.

				
			The Licensee agrees to pay to the NIH a noncreditable, nonrefundable license royalty according to the following schedule:

			

 

	 	
			(a)

				
			[***] of the Fair Market Value of the Licensee at the time of its first Liquidity Event where the NIH has provided no more than in vitro data concerning Licensed Products; or

			

 

	 	
			(b)

				
			[***] of the Fair Market Value of the Licensee at the time of its first Liquidity Event where the NIH has provided no more than in vivo animal or toxicology data concerning Licensed Products; or

			

 

	 	
			(c)

				
			[***] of the Fair Market Value of the Licensee at the time of its first Liquidity Event where the NIH has provided human clinical data concerning Licensed Products.

			

 

	 	
			II.

				
			The Licensee agrees to pay to the NIH a nonrefundable minimum annual royalty as follows:

			

 

	 	
			(a)

				
			Following the [***] anniversary of the effective date of this Agreement, a payment [***] will be due and payable beginning on January 1 of the next calendar year until the [***] anniversary of the effective date of this Agreement;

			

 

	 	
			(b)

				
			Following the [***] anniversary of the effective date of this Agreement, a payment of [***] will be due and payable beginning on January 1 of the next calendar year until the [***] anniversary of the effective date of this Agreement;

			

 

	 	
			(c)

				
			Following the [***] anniversary of the effective date of this Agreement, a payment of [***] will be due and payable beginning on January 1 of the next calendar year and then for each subsequent calendar year that this Agreement is in effect;

			

 

	 	
			(d)

				
			Notwithstanding subsections II (a-c) above in Appendix C of this Agreement, if the Licensee has entered into a CRADA for the commercial development of Licensed Products in the Licensed Fields of Use, the Licensee may apply its cash financial contribution under the CRADA for the previous calendar year as a credit up to the full amount of the minimum annual royalties otherwise due to the NIH (for a total period not to exceed five (5) years from the effective date of this Agreement) if the CRADA is in effect as of each January 1; and

			

 

	 	
			(e)

				
			Notwithstanding subsections II (a-d) above in Appendix C of this Agreement, if the Licensee has received a Small Business Innovative Research (SBIR) or a Small Business Technology Transfer Research (STTR) award for the commercial development of Licensed Products in the Licensed Fields of Use then the minimum annual royalty will be waived by the NIH (for a total period not to exceed five (5) years from the effective date of this Agreement) if the SBIR or STTR award is in effect as of each January 1.

			

 

Page 23 of 29

 

 

The minimum annual royalties due under this Section II of Appendix C may be credited against any earned royalties due for sales made in that year

 

	 	
			III.

				
			The Licensee agrees to pay the NIH earned royalties of [***] on Net Sales by or on behalf of the Licensee and its sublicensees.

			

 

	 	
			IV.

				
			The Licensee agrees to pay the NIH 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.

			

 

 

 

Page 24 of 29

 

 

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.

 

	
			I.

				
			Central Nervous System (CNS) Tumors

				 
	 	 	 	 
	 	
			(a)

				
			Completion of Phase II Clinical Trial

				
			4Q 2016

			
	 	
			(b)

				
			Completion of First Phase III Clinical Trial

				
			4Q 2019

			
	 	
			(c)

				
			First Regulatory Approval (FDA or Foreign Equivalent)

				
			4Q 2021

			
	 	
			(d)

				
			Second Regulatory Equivalent (FDA or Foreign Equivalent)

				
			4Q 2022

			
	 	 	 	 
	
			II.

				
			Non-CNS Tumors

				 
	 	 	 
	 	
			(a)

				
			File IND or Equivalent

				
			4Q 2016

			
	 	
			(b)

				
			Completion of First Phase I Clinical Trial

				
			4Q 2018

			
	 	
			(c)

				
			Completion of First Phase H Clinical Trial

				
			4Q 2021

			
	 	
			(d)

				
			Completion of First Phase III Clinical Trial

				
			4Q 2024

			
	 	
			(e)

				
			First Regulatory Approval (FDA or Foreign Equivalent)

				
			4Q 2026

			
	 	
			(f)

				
			Second Regulatory Equivalent (FDA or Foreign Equivalent)

				
			4Q 2027

			
	 	 	 	 
	
			III.

				
			Urological Disease

				 
	 	 	 
	 	
			(a)

				
			File IND or Equivalent

				
			4Q 2018

			
	 	
			(b)

				
			Completion of First Phase I Clinical Trial

				
			4Q 2020

			
	 	
			(c)

				
			Completion of First Phase 11 Clinical Trial

				
			4Q 2023

			
	 	
			(d)

				
			Completion of First Phase III Clinical Trial

				
			4Q 2026

			
	 	
			(e)

				
			First Regulatory Approval (FDA or Foreign Equivalent)

				
			4Q 2028

			
	 	
			(f)

				
			Second Regulatory Equivalent (FDA or Foreign Equivalent)

				
			4Q 2029

			

 

Page 25 of 29

 

 

APPENDIX E — COMMERCIAL DEVELOPMENT PLAN

 

The IL4-PE fusion protein (MDNA55) is a novel protein comprised of circularly permuted interleukin-4 (IL-4) fused to an engineered version of Pseudomonas exotoxin (PE). The IL-4 portion of MDNA55 was designed so that the molecule can bind with a very high level of specificity to IL-4 receptors on the surface of cells. The Pseudomonas exotoxin portion of MDNA55 has been designed to minimize undesirable side effects by reducing its ability to bind non-specifically to cells containing the Pseudomonas exotoxin receptor while retaining its high potency.

 

Phase I and II studies were conducted using MDNA55 for recurrent glioblastoma multiforme (GBM) and peripheral solid tumors under a Sponsor-led IND. Licensee has acquired the regulatory assets, clinical data, and product related assets, and in-licensed all relevant non-HHS patents related to MDNA55. Licensee plans to conduct the following Development Plan for continued development of MDNA55 for localized treatment of CNS tumors, non-CNS tumors and urological diseases.

 

CNS Solid Tumors

 

[***]

 

Non-CNS Solid Tumors

 

[***]

 

Urological Disease

 

[***]

[Specific development plans were redacted for confidentiality purposes.]

 

Page 26 of 29

 

 

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

			

 

Page 27 of 29

 

 

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

			
	 	
			ABM

				
			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/1TS

			
	 	
			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

			

 

Page 28 of 29

 

 

Checks

 

All checks should he made payable to “N111 Patent Licensing”

 

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

National Institutes of Health (NIH )

P.O. Box 979071

Si Louis. MO 63197-9000

 

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

 

US Bank

Government Lockbox SL-MO-C2GL

1005 Convention P1a7.a

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

 

Page 29 of 29

 

 

FIRST AMENDMENT TO L-236-2013/0

 

 

This is the first amendment (“First Amendment”) of the Agreement by and between the FDA, an agency within the Department of Health and Human Services (“HHS”) and Licensee having an effective date of September 26, 2013 and having FDA Reference Number L-236-2013/0 (“Agreement”). This First Amendment, having FDA Reference Number L-236-2013/1 includes, in addition to the amendments made below, 1) a Signature Page and 2) Attachment 1 (Royalty Payment Information).

 

WHEREAS, the FDA and the Licensee desire that the Agreement be amended a first time as set forth below in order to reflect the current Licensed Patent Rights, clarify the royalty at the time of a Liquidity Event, amend the License Field of Use, and update the corresponding Benchmarks and Commercial Development Plan.

 

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein, the FDA and the Licensee, intending to be bound, hereby mutually agree to the following:

 

1)         Appendix A, shall be deleted and replaced with the following:

 

Patent(s) or Patent Application(s):

 

U.S. Patent Application 61/105,408 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021 -2010/0-US -01] (expired);

 

U.S. Patent Application 12/579,281 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021 -2010/0-US -02] (abandoned);

 

U.S. Patent Application 13/886,034 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021-2010/0-US-03] (abandoned); and

 

U.S. Patent Application 14/812,681 entitled “Targeted Cargo Protein Combination Therapy” [HHS Reference E-021 -2010/0-US -04] (pending).

 

2)         Appendix B, Paragraph I shall be deleted and replaced with the following:

 

I.         Licensed Field of Use:

 

Combination of MDNA55 (cpIL4-PE38KDEL) with a therapeutic agent for treating tumors of the central nervous systems.

 

3)         Appendix C, Paragraph I shall be deleted and replaced with the following: [Royalty percentages and payment period were redacted for confidentiality purposes.]

 

I.         The Licensee aggress to pay to the FDA a noncreditable, nonrefundable license royalty as follows:

 

[***] of the Fair Market Value of the Licensee at the time of its first Liquidity Event. Such payment shall be paid over a [***] period in equal annual payments. The first installment shall be paid within one hundred eig ty M. days of the time of the first Liquidity Event. The second and all subsequent installment payments for shall be made within sixty (60) days of the annual anniversary date of the first Liquidity Event.

 

 

Page 1 of 6

 

 

4)         Appendix D shall be deleted and replaced with the following:

 

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 FDA that the Benchmark has been achieved.

 

Combination of MDNA55 with an approved therapeutic agent for treating tumors of the central nervous system:

 

	
			File IND or Equivalent

				
			4Q 2019

			
	 	 
	
			Completion of First Phase 1 Clinical Trial

				
			4Q 2021

			
	 	 
	
			Completion of First Phase 2 Clinical Trial

				
			4Q 2024

			
	 	 
	
			Completion of First Phase 3 Clinical Trial

				
			4Q 2027

			
	 	 
	
			First Regulatory Approval (FDA or Foreign Equivalent)

				
			4Q 2029

			
	 	 
	
			Second Regulatory Approval (FDA or Foreign Equivalent)

				
			4Q 2030

			

 

5)         Appendix E shall be deleted and replaced with the following:

 

Commercial Development Plan:

 

Licensee plans to continue Phase 2b clinical development of MDNA55 as a monotherapy for the treatment of recurrent glioblastoma (rGB). It is expected that as additional clinical data are collected, the label claim may expand to include combination approaches with approved agents such as chemotherapy (Temodar) and/or bevacizumab. Thus, in addition to the ongoing study, Licensee plans to conduct pre-clinical studies evaluating the safety and efficacy of MDNA55 in combination with approved agents for rGB and potentially other agents not currently approved for rGB such as checkpoint inhibitors. Of particular significance may be the ability of MDNA55 to eliminate brain tumor stem cells and immunosuppressive cells of the glioma tumor microenvironment. Previous data has shown that MDNA55 is capable of inhibiting growth of IL-4R expressing spheroid cultures of chemo-surviving colon cancer stem cells as well as pancreatic cancer stem cells. Although similar studies have yet to be performed in brain tumor stem cells, it is possible that MDNA55 could selectively eliminate this resistant cell population resulting in the potential for enhanced sensitivity to other therapies administered in combination with MDNA55. Licensee plans to investigate potential synergistic effects of MDNA55 in combination with other therapeutic agents using in vitro and relevant animal models.

 

6)         In the event any provision(s) of the Agreement is/are inconsistent with Attachment 1 such provision(s) is/are hereby amended to the extent required to avoid such inconsistency and to give effect to the payment information in such Attachment 1.

 

7)         All terms and conditions of the Agreement not herein amended remain binding and in effect.

 

Page 2 of 6

 

 

8)         The terms and conditions of this First Amendment shall, at the FDA’s sole option, be considered by the FDA to be withdrawn from the Licensee’s consideration and the terms and conditions of this First Amendment, and the First Amendment itself, to be null and void, unless this First Amendment is executed by the Licensee and a fully executed original is received by the FDA within sixty (60) days from the date of the FDA’s signature found at the Signature Page.

 

9)         This First Amendment is effective upon execution by all parties.

 

SIGNATURES BEGIN ON NEXT PAGE

 

 

 

 

 

Page 3 of 6

 

 

FIRST AMENDMENT TO L-236-2013-0

 

SIGNATURE PAGE

 

In Witness Whereof, the parties have executed this First Amendment on the dates set forth below. Any communication or notice to be given shall be forwarded to the respective addresses listed below.

 

For the FDA:

 

________/signed/ _____________ _____________                                  31 January 2017

Alice Y. Welch, Ph.D.                                                                                  Date

Director

FDA Technology Transfer Program

Food and Drug Administration

 

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

 

E-mail: FDATechLicensingReports@fda.hhs.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.):

 

________/signed/ _____________ ____________                                   31 January 2017

Signature of Authorized Official                                                                Date

 

Name: Fahar Merchant, Ph.D

Title: President & CEO

 

I.         Official and Mailing Address for Agreement notices:

 

Shafique Fidai, PhD

Head, Discovery and Corporate Development

Medicenna Therapeutics Inc.

200 - 1920 Yonge Street

Toronto, Ontario

M4S 3E2

604-764-1323

sfidai@medicenna.com

 

With Copy to:

Pat Ward

Chief Operating Officer

Medicenna Therapeutics Inc.

200 - 1920 Yonge Street

Toronto, Ontario

M4S 3E2

832-552-2660

pward@medicenna.com

 

Page 4 of 6

 

 

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

 

Elizabeth Williams

Chief Financial Officer

Medicenna Therapeutics Inc.

200 - 1920 Yonge Street

Toronto, Ontario

M4S 3E2

416-648-5555

ewilliams@medicenna.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).

 

 

 

 

Page 5 of 6

 

 

ATTACHMENT 1 — ROYALTY PAYMENT INFORMATION

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

 

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:

 

	
			Beneficiary Account:

				
			Federal Reserve Bank of New York or TREAS NYC

			
	
			Bank:

				
			Federal Reserve Bank of New York

			
	
			ABA#

				
			021030004

			
	
			Account Number:

				
			75060099

			
	
			SWIFT Number:

				
			FRNYUS33

			
	
			Bank Address:

				
			33 Liberty Street, New York, NY 10045

			
	
			Payment Details:

				
			License Number (L-XXX-XXXX)

			
	 	
			Name of the Licensee

			

 

Checks 

 

All checks should be made payable to “FDA or US Treasury”

 

Checks sent by US Postal Service should be sent to the following address:

 

Food and Drug Administration 8455 Colesville Road Cole — 14-14202E Silver Spring, MD 20993-0002

 

Checks sent by overnight or courier should be sent to the following address:

 

Food and Drug Administration 8455 Colesville Road, 14202E Silver Spring, MD 20910

 

Page 6 of 6ex_384338.htm

 

Exhibit 4.7 

 

CERTAIN CONFIDENTIAL INFORMATION (MARKED BY BRACKETS AS “[***]”) HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS THE INFORMATION AS PRIVATE OR CONFIDENTIAL.

 

 

STATE OF TEXAS COUNTY OF TRAVIS

 

This CANCER RESEARCH GRANT CONTRACT (“Contract”) is by and between the Cancer Prevention and Research Institute of Texas (“CPRIT”), hereinafter referred to as the “INSTITUTE”, acting through its Chief Executive Officer, and Medicenna Therapeutics, Inc., hereinafter referred to as the “RECIPIENT”, acting through its authorized signing official.

 

RECITALS

 

WHEREAS, pursuant to TEX. HEALTH & SAFETY CODE, Ch. 102, the INSTITUTE may make grants to public and private persons in this state for research into the causes and cures for all types of cancer in humans; facilities for use in research into the causes and cures for cancer; research to develop therapies, protocols, medical pharmaceuticals, or procedures for the cure or substantial mitigation of all types of cancer; and cancer prevention and control programs.

 

WHEREAS, Article III, Section 67 of the Texas Constitution expressly authorizes the State of Texas to sell general obligation bonds on behalf of the INSTITUTE and for the INSTITUTE to use the proceeds from the sale of the bonds for the purposes of cancer research and prevention programs in this state.

 

WHEREAS, the INSTITUTE issued a request for applications for RFA P-15-NEWCO-1: New Company Product Development Awards on or about April 2014.

 

WHEREAS, pursuant to TEX. HEALTH & SAFETY CODE § 102.251, and after a review by the INSTITUTE’s scientific research and prevention program committees, the INSTITUTE has approved a Grant (defined below) to be awarded to the RECIPIENT.

 

WHEREAS, to ensure that the Grant provided to the RECIPIENT pursuant to this Contract is utilized in a manner consistent with Tex. Const. Article III, Section 67 and other laws, and in exchange for receiving such Grant, the RECIPIENT agrees to comply with certain conditions and deliver certain performance.

 

WHEREAS, the RECIPIENT and the INSTITUTE desire to set forth herein the provisions relating to the awarding of such monies and the disbursement thereof to the RECIPIENT.

 

IN CONSIDERATION of the Grant and the premises, covenants, agreements, and provisions contained in this Contract, the parties agree to the following terms and conditions:

 

1

 

 

Article 2

DEFINITIONS

 

The following terms shall have the following meaning throughout this Contract and any Attachments and amendments. Other terms may be defined elsewhere in this Contract.

 

	
			(1)

				
			Collaborator - any entity other than the RECIPIENT having one or more personnel participating in the Project and (a) designated as a collaborator in the application submitted by the RECIPIENT requesting the Grant funds awarded by the INSTITUTE, or (b) otherwise approved in writing as a collaborator by the INSTITUTE.

			
	 	 
	
			(2)

				
			Contractor - any person or entity, other than a Collaborator or the RECIPIENT (or their respective personnel), who is contracted by the RECIPIENT to perform activities for the Project.

			
	 	 
	
			(3)

				
			Equipment - an article of tangible, nonexpendable personal property having a useful life of more than one year and an acquisition cost of $5,000 or more per unit.

			
	 	 
	
			(4)

				
			Grant  - the funding assistance authorized by TEX. HEALTH & SAFETY CODE, Ch. 102 in the amount specified in Section 2.01 and awarded by the INSTITUTE to the RECIPIENT to carry out the Project pursuant to the terms and conditions of this Contract.

			
	 	 
	
			(5)

				
			Indirect Costs - the expenses of doing business that are not readily identified with a particular grant, contract, project, function or activity, but are necessary for the general operation of the organization or the performance of the organization’s activities.

			
	 	 
	
			(6)

				
			Institute-Funded Activity - all aspects of work conducted on or as part of the Project.

			
	 	 
	
			(7)

				
			Non-Profit Organization - a university or other institution of higher education or an organization of the type described in 501(c)(3) of the Internal Revenue Code of 1986, as amended (26 U.S.C. 501 (c)(3)) and exempt from taxation under 501 (a) of the Internal Revenue Code (26 U.S.C. 501 (a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute.

			
	 	 
	
			(8)

				
			Principal Investigator/Program Director - the individual designated by the RECIPIENT to direct the Project who is principally responsible and accountable to the RECIPIENT and the INSTITUTE for the proper conduct of the Project. References herein to “Principal Investigator/Program Director” include Co-Principal Investigators or Co-Program Directors as well. The Principal Investigator/Program Director and Co-Principal Investigators or Co-Program Directors are set forth on Attachment A.

			
	 	 
	
			(9)

				
			Project  - the activities specified or generally described in the Scope of Work or otherwise in this Contract (including without limitation any of the Attachments to the Contract) that are approved by the INSTITUTE for funding, regardless of whether the of the financial support necessary to carry them out. INSTITUTE funding constitutes all or only a portion

			
	 	 
	
			(10)

				
			Recipient  Personnel - The RECIPIENT’s  Principal Investigator/Program Director and RECIPIENT’s employees and consultants working on the Project.

			

 

2

 

 

Article II 

GRANT AWARD

 

Section 2.01 Award of Monies. In accordance with the provisions of this Contract and any applicable agency administrative rules, the INSTITUTE shall disburse the proceeds of the Grant to the RECIPIENT in an amount not to exceed $14,140,090 to be used solely for the Project. This award is subject to compliance with the Scope of Work and demonstration of progress towards achievement of the milestones set forth in Section 2.02. This Grant is not intended to be a loan of money.

 

Section 2.02 Scope of Work and Milestones. The RECIPIENT shall perform the Project in accordance with this Agreement and as outlined in Application DP150031 submitted by the RECIPIENT and approved by the INSTITUTE. The RECIPIENT shall conduct the Project within the State of Texas with Texas-based employees, Contractors and/or Collaborators unless otherwise specified in the Scope of Work or the Approved Budget. The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment A in their entirety, incorporate them as if fully set forth herein, and agree that the Project description, goals, timeline and milestones included as Attachment A accurately reflect the Scope of Work of the Project to be undertaken by the RECIPIENT (the “Scope of Work”) and the milestones expected to be achieved. RECIPIENT and the INSTITUTE mutually agree that the outcome of scientific research is unpredictable and cannot be guaranteed. The RECIPIENT shall use commercially reasonable efforts to complete the goals of the Project pursuant to the timeline reflected in Attachment A and shall timely notify the INSTITUTE if  circumstances  occur  that  materially  and  adversely  affect  completion  thereof. Modifications, if any, to the Scope of Work must be agreed to in writing by both parties as set forth in Section 2.06 “Amendments and Modifications” herein. Material changes to the Scope of Work include, but are not limited to, changes in key personnel involved with the Project, the site of the Project, and the milestones expected to be achieved.

 

Section 2.03 Contract Term. The Contract shall be effective as of March 01, 2015 (the “Effective Date”) and terminate on February 28, 2018 or in accordance with the Contract termination provisions set forth in Article VIII herein, whichever shall occur first (the “Termination Date”). Unless otherwise approved by the INSTITUTE as evidenced by written communication from the INSTITUTE to the RECIPIENT and appended to the Contract, Grant funds distributed pursuant to the Contract shall be expended no earlier than the Effective Date or subsequent to the Termination Date. If, as of the Termination Date, the RECIPIENT has not used Grant money awarded by the INSTITUTE for permissible services, expenses, or costs related to the Project and has not received approval from the INSTITUTE for a no cost extension to the contract term pursuant to Section 3.11 “Carry Forward of Unspent Funds and No Cost Extension” herein, then the RECIPIENT shall not be entitled to retain such unused Grant funds from the INSTITUTE. Certain obligations as set forth in Section 9.09 of this Contract shall extend beyond the Termination Date.

 

Section 2.04 Contract Documentation. The Contract between the INSTITUTE and the RECIPIENT shall consist of this final, executed Contract, including the following Attachments to the Contract, all of which are hereby incorporated by reference:

 

	 	
			(a)

				
			Attachment A – Project Description, Goals and Timeline

			
	 	 	 
	 	(b)	Attachment B – Approved Budget, including changes approved by the INSTITUTE subsequent to execution of the Contract.
	 	 	 
	 	
			(c)

				
			Attachment C – Assurances and Certifications

			
	 	 	 
	 	
			(d)

				
			Attachment D – Intellectual Property and Revenue Sharing

			

 

 

3

 

 

	 	
			(e)

				
			Attachment E – Reporting Requirements

			
	 	 	 
	 	(f)	Attachment F – Approved Amendments to Contract, excluding budget amendments reflected in Attachment B.

 

Section 2.05 Entire Agreement. All agreements, covenants, representations, certifications and understandings between the parties hereto concerning this Contract have been merged into this written Contract. No prior contemporaneous representation, agreement or understanding, express or implied, oral or otherwise, of the parties or their agents that may have related to the subject matter hereof in any way shall be valid or enforceable unless embodied in this Contract.

Section 2.06 Amendments and Modifications. Requested amendments and modifications to the Contract must be submitted in writing to the INSTITUTE for review and approval (such approval shall not be unreasonably withheld.) Amendments and modifications (including alterations, additions, deletions, assignments and extensions) to the terms of this Contract shall be made solely in writing and shall be executed by both parties. The approved amendment shall be reflected in Attachment A if it is change to the Scope of Work, or as part of Attachment B if it is a budget amendment, or as part of Attachment F for all other changes.

Section 2.07 Relationship of the Parties The RECIPIENT shall be responsible for the conduct of the Project that is the subject of this Contract and shall direct the activities and at all times be responsible for the performance of Recipient Personnel, Collaborators, Contractors and other agents. The INSTITUTE does not assume responsibility for the conduct of the Project or any Institute-Funded Activity that is the subject of this Contract. The INSTITUTE and the RECIPIENT shall perform their respective obligations under this Contract as independent contractors and not as agents, employees, partners, joint venturers, or representatives of the other party. Neither party is permitted to make representations or commitments that bind the other party.

 

Section 2.08 Subcontracting. Any and all subcontracts entered into by the RECIPIENT in relation to the performance of activities under the Project shall be in writing and shall be subject to the requirements of this Contract. Without in any way limiting the foregoing, the RECIPIENT shall enter into and maintain a written agreement with each such permitted Contractor with terms and conditions sufficient to ensure the RECIPIENT fully complies with the terms of this Contract, including without limitation the terms set forth in Attachments C, D, and E. The RECIPIENT agrees that it shall be responsible to the INSTITUTE for the performance of and payment to any Contractor. Any reimbursements made by the RECIPIENT to a Contractor shall be made in accordance with the applicable provisions of TEX. GOV'T. CODE, Ch. 2251.

Section 2.09 Transfer or Assignment by the Recipient. This Contract is not transferable or otherwise assignable by the RECIPIENT, whether by operation of law or otherwise, without the prior written consent of the INSTITUTE, except as provided in this Section 2.09. Any such attempted transfer or assignment without the prior written consent of the INSTITUTE (except as provided in this Section 2.09) shall be null, void and of no effect. For purposes of this section, an assignment or transfer of this Contract by the RECIPIENT in connection with a merger, transfer or sale of all or substantially all of the RECIPIENT’s assets or business related to this Contract or a consolidation, change of control or similar transaction involving the RECIPIENT shall not be deemed to constitute a transfer or assignment, so long as such action does not impair or otherwise negatively impact the revenue sharing terms in Attachment D. Nothing herein shall be interpreted as superseding the requirement that the Project be undertaken in Texas with Texas-based employees.

If the Principal Investigator leaves the employment of the RECIPIENT or is replaced by the RECIPIENT for any reason during the course of the Grant with someone who is not already designated a co-Principal Investigator in the Application, the RECIPIENT shall notify the INSTITUTE prior to replacing the Principal Investigator. Written approval by the INSTITUTE is required for the replacement of the Principal Investigator with someone who is not already a co-Principal Investigator in the Application, which approval shall not be unreasonably withheld, conditioned or delayed.

 

4

 

 

Section 2.10 Representations and Certifications. The RECIPIENT represents and certifies to the best of its knowledge and belief to the INSTITUTE as follows:

 

	 	
			(a)

				
			It has legal authority to enter into, execute, and deliver this Contract, and all documents referred to herein, and it has taken all actions necessary to its execution and delivery of such documents;

			
	 	 	 
	 	
			(b)

				
			It will comply with all of the terms, conditions, provisions, covenants, requirements, and certifications in this Contract, applicable statutory provisions, agency administrative rules, and all other documents incorporated herein by reference;

			
	 	 	 
	 	
			(c)

				
			It has made no material false statement or misstatement of fact in connection with this Contract and its receipt of the Grant, and all of the information it previously submitted to the INSTITUTE or that it is required under this Contract to submit to the INSTITUTE relating to the Grant or the disbursement of any of the Grant is and will be true and correct at the time such statement is made;

			

 

	 	
			(d)

				
			It is in compliance in all material respects with provisions of its charter and of the laws of the State of Texas, and of the laws of the jurisdiction in which it was formed, and (i) there are no actions, suits, or proceedings pending, or threatened, before any judicial body or governmental authority against or affecting its ability to enter into this Contract, or any document referred to herein, or to perform any of the material acts required of it in such documents and (ii) it is not in default with respect to any order, writ, injunction, decree, or demand of any court or any governmental authority which would impair its ability to enter into this Contract, or any document referred to herein, or to perform any of the material acts required of it in such documents;

			
	 	 	 
	 	
			(e)

				
			Neither the execution and delivery of this Contract or any document referred to herein, nor compliance with any of the terms, conditions, requirements, or provisions contained in this Contract or any documents referred to herein, is prevented by, is a breach of, or will result in a breach of, any term, condition, or provision of any agreement or document to which it is now a party or by which it is bound; and

			

 

	 	
			(f)

				
			It shall furnish such satisfactory evidence regarding the representations and certifications described herein as may be required and requested by the time. INSTITUTE from time to time.

			

Section 2.11 Reliance upon Representations. By awarding the Grant and executing this Contract, the INSTITUTE is relying, and will continue to rely throughout the term of this Contract, upon the truthfulness, accuracy, and completeness of the RECIPIENT’s written assurances, certifications and representations.  Moreover,  the INSTITUTE would  not  have  entered  into  this  Contract  with  the RECIPIENT but for such written assurances, certifications and representations. The  RECIPIENT acknowledges that the INSTITUTE is relying upon such assurances, certifications and representations and acknowledges their materiality and significance.

Section 2.12 Contingent upon Availability of Grant Funds. This Contract is contingent upon funding being available for the term of the Contract and the RECIPIENT shall have no right of action against the INSTITUTE in the event that the INSTITUTE is unable to perform its obligations under this Contract as a result of the suspension, termination, withdrawal, or failure of funding to the INSTITUTE or lack of sufficient funding of the INSTITUTE for this Contract. If funds become unavailable to the INSTITUTE during the term of the Contract, Section 8.01(c) shall apply. For the sake of clarity, and except as otherwise provided by this Contract, if this Contract is not funded, then both parties are relieved of all of their obligations under this Contract. The INSTITUTE acknowledges and agrees that the Project is a multiyear project subject to Tex. Health & Safety Code, Ch. 102, Section 102.257.

 

5

 

 

Section 2.13 Confidentiality of Documents and Information. In connection with work contemplated for the Project or pursuant to complying with various provisions of this Contract, the RECIPIENT may disclose its confidential business, financial, technical, scientific information and other information to the INSTITUTE ("Confidential Information"). To assist the INSTITUTE in identifying such information, the RECIPIENT shall mark or designate the information as “confidential,” provided however that the failure to so designate does not operate as a waiver to protections provided by applicable law or this Contract. The INSTITUTE shall use no less than reasonable care to protect the confidentiality of the Confidential Information to the fullest extent permissible under the Texas Public Information Act, Texas Government Code, Chapter 552 (the “TPIA”), and, except as otherwise provided in the TPIA to prevent the disclosure of the Confidential Information to third parties for a period of time equal to three (3) years from the termination of the contract, unless the INSTITUTE and the RECIPIENT agree in writing to extend such time period, provided that this obligation shall not apply to information that:

 

	 	
			(a)

				
			was in the public domain at the time of disclosure or later became part of the public domain through no act or omission of the INSTITUTE in breach of this Contract;

			

 

	 	
			(b)

				
			was lawfully disclosed to the INSTITUTE by a third party having the right to disclose it without an obligation of confidentiality;

			
	 	 	 
	 	
			(c)

				
			was already lawfully known to the INSTITUTE without an obligation of confidentiality at the time of disclosure;

			
	 	 	 
	 	
			(d)

				
			was independently developed by the INSTITUTE without using or referring to the RECIPIENT’s Confidential Information; or

			
	 	 	 
	 	
			(e)

				
			is required by law or regulation to be disclosed.

			

 

The INSTITUTE shall hold the Confidential Information in confidence, shall not use such Confidential

Information except as provided by the terms of this Contract, and shall not disclose such Confidential Information to third parties without the prior written approval of the RECIPIENT or as otherwise allowed by the terms of the Contract. Subject in all respects to the terms of this Contract and the TPIA, the INSTITUTE has the right to use and disclose the Confidential Information reasonably in connection with the exercise of its rights under the Contract. In the event that the INSTITUTE is requested or required (by oral questions, interrogatories, requests for information or documents in legal proceedings, subpoena, civil investigative demand or other similar process by a court of competent jurisdiction or by any administrative, legislative, regulatory or self-regulatory authority or entity) to disclose any Confidential Information, the INSTITUTE shall provide the RECIPIENT with prompt written notice of any such request or requirement so that the RECIPIENT may seek a protective order or other appropriate remedy. If, in the absence of a protective order or other remedy, the INSTITUTE is nonetheless legally compelled to make any such disclosure of Confidential Information to any person, the INSTITUTE may, without liability hereunder, disclose only that portion of the Confidential Information that is legally required to be disclosed, provided that the INSTITUTE will use reasonable efforts to assist the RECIPIENT, at the RECIPIENT’s expense, in obtaining an appropriate protective order or other reliable assurance that confidential treatment will be accorded the Confidential Information. To the extent that such Confidential Information does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information hereunder.

 

6

 

 

Article III

DISBURSEMENT OF GRANT AWARD PROCEEDS

 

Section 3.01 Payment of Grant Award Proceeds. The INSTITUTE will advance Grant award proceeds upon request by the RECIPIENT, consistent with the amounts and schedule as provided in Attachment B. If the RECIPIENT does not request or the Oversight Committee does not authorize advancement of funds for some or the entire Grant award proceeds, disbursement of Grant award proceeds for services performed and allowable expenses and costs incurred pursuant to the Scope of Work will be on a reimbursement basis. To the extent that completion of certain milestones is associated with a specific tranche of funding as reflected in the Scope of Work, those milestones shall be accomplished before funding may be provided for next tranche of funding. The INSTITUTE reserves the right to terminate the Contract should a key milestone not be met.

 

Section 3.02 Requests for Reimbursement and Quarterly Financial Status Reports. If the RECIPIENT does not receive an advance disbursement of Grant proceeds, the RECIPIENT’s requests for reimbursement shall be made on INSTITUTE Form 269a (Financial Status Report). If the RECIPIENT has elected to receive an advance disbursement of Grant proceeds, RECIPIENT shall submit INSTITUTE Form 269a (Financial Status Report) to document all costs and allowable expenses paid with Grant proceeds. The RECIPIENT shall submit the INSTITUTE Form 269a quarterly to the INSTITUTE within 90 days following the end of the quarter covered by the bill. A final INSTITUTE Form 269a shall be submitted by RECIPIENT not later than 90 days after the Termination Date. An extension of time for submission deadlines specified herein must be expressly authorized in writing by the INSTITUTE.

Section 3.03 Actual Costs and Allowable Expenses. Because the Approved budget for the Project(s) as set forth in Attachment B is only an estimate, the parties agree that the RECIPIENT’s billings under this Contract will reflect the actual costs and expenses incurred in performing the Project(s), regardless of the Approved Budget, up to the total contracted amount specified in Section 2.01 “Award of Monies.” The RECIPIENT shall use Grant proceeds only for allowable expenses consistent with state law and agency administrative rules. Allowable expenses for the Project(s) shall be only as outlined in the Approved Budget and any modifications to same.

Section 3.04 Travel Expenses. Reimbursement for travel expenditures shall be in accordance with the Approved Budget. Prior written approval from the INSTITUTE must be obtained before travel that exceeds the amount included in the Approved Budget commences. Failure to obtain such prior written approval shall result in such excess travel costs constituting expenses that may not be taken into account for the purposes of calculating expenditure of Grant funds under this Contract.

 

Section 3.05 Budget Modifications. The total Approved Budget and the assignment of costs may be adjusted based on implementation of the Scope of Work, spending patterns, and unexpended funds, but only by an amendment to the Approved Budget. In no event shall an amendment to the Approved Budget result in payments in excess of the aggregate amount specified in Section 2.01 “Award of Monies” or in approved supplemental funding for the Project, if any. The RECIPIENT may make transfers between or among lines within budget categories without prior written approval provided that:

 

	 	
			(a)

				
			The total dollar amount of all changes of any single line item within budget categories (individually and in the aggregate) is less than 10% of the total Approved Budget;

			

 

7

 

 

	 	
			(b)

				
			The transfer will not increase or decrease the total Approved Budget;

			

 

	 	
			(c)

				
			The transfer will not materially change the nature, performance level, or Scope of Work of the Project; and

			

 

	 	
			(d)

				
			The RECIPIENT submits a revised copy of the Approved Budget including a narrative justification of the changes prior to incurring costs in the new category.

			

All other budget changes or transfers require the INSTITUTE’s express prior written approval. Transfer of funds between categories in the Project’s Approved Budget may be allowed if requests are in writing, fit within the Scope of Work and the total Approved Budget, are beneficial to the achievement of the objectives of the Project, and appear to be an efficient, effective use of the INSTITUTE’s funds.

Section 3.06 Withholding Payment. The INSTITUTE may withhold Grant award proceeds from RECIPIENT if required Financial Status Reports (Form 269a) are not on file for previous quarters or for the final period, if material program requirements are not met and remain uncured after a reasonable time period to cure, if the RECIPIENT is in breach of any material term of this Contract, or in accordance with provisions of this Contract as well as applicable state or federal laws, regulations or administrative rules, and the breach remains uncured after a reasonable time period to cure. The INSTITUTE shall have the right to withhold all or part of any future payments to the RECIPIENT to offset any prior advance payments made to the RECIPIENT for ineligible expenditures that have not been refunded to the INSTITUTE by the RECIPIENT.

 

Section 3.07 Grant Funds as Supplement to Budget. The RECIPIENT shall use the Grant proceeds awarded pursuant to this Contract to supplement its overall budget. These funds will in no event supplant existing funds currently available to the RECIPIENT that have been previously budgeted and set aside for the Project. The RECIPIENT will not bill the INSTITUTE for any costs under this Contract that also have been billed or should have been billed to any other funding source.

Section 3.08 Buy Texas. The RECIPIENT shall apply good faith efforts to purchase goods and services from suppliers in Texas to the extent reasonably possible, to achieve a goal of more than 50 percent of such purchases from suppliers in Texas.

Section 3.09 Historically Underutilized Businesses. The RECIPIENT shall use reasonable efforts to purchase materials, supplies or services from a Historically Underutilized Business (HUB). The Texas Procurement and Support Services website will assist in finding HUB vendors (http://www.window.state.tx.us/procurement.) The RECIPIENT shall complete a HUB report with each annual report submitted to the INSTITUTE in accordance with Attachment E.

 

Section 3.10 Limitation on Use of Grant Award Proceeds to Pay Indirect Costs. The RECIPIENT shall not spend more than five percent of the Grant award proceeds for Indirect Costs.

 

Section 3.11 Carry Forward of Unspent Funds and No Cost Extension.  RECIPIENT may request to carry forward unspent funds into the budget for the next year. Carryover of unspent funds must be specifically approved by the INSTITUTE. The INSTITUTE may approve a no cost extension for the Contract for a period not to exceed six (6) months after the Termination Date if additional time beyond the Termination date is required to ensure adequate completion of the approved project. The Contract must be in good fiscal and programmatic standing. All terms and conditions of the Contract shall continue during any extension period and if such extension is approved, notwithstanding Section 2.03, all references to the “Termination Date” shall be deemed to mean the date of expiration of such extension period.

 

8

 

 

Article IV

AUDITS AND INSPECTIONS

 

Section 4.01 Record Keeping. The RECIPIENT, each Collaborator whose costs are funded in all or in part by the Grant shall maintain or cause to be maintained books, records, documents and other evidence (electronic or otherwise) pertaining in any way to its performance under and compliance with the terms and conditions of this Contract (“Records”). The RECIPIENT, each Collaborator and each Contractor shall use, or shall cause the entity which is maintaining such Records to use generally accepted accounting principles in the maintenance of such Records, and shall retain or require to be retained all of such Records for a period of three (3) years from the Termination Date of the Contract.

 

Section 4.02 Audits. Upon request and with reasonable notice, the RECIPIENT, each Collaborator and each Contractor whose costs are charged to the Project shall allow, or shall cause the entity which is maintaining such items to allow, the INSTITUTE, or auditors working on behalf of the INSTITUTE, including the State Auditor and/or the Comptroller of Public Accounts for the State of Texas, to review, inspect, audit, copy or abstract all of its Records during regular working hours. Acceptance of funds directly under the Contract or indirectly through a subcontract under the Contract constitutes acceptance of the authority of the INSTITUTE, or auditors working on behalf of the INSTITUTE, including the State Auditor and/or the Comptroller of Public Accounts, to conduct an audit or investigation in connection with those funds for a period of three (3) years from the Termination Date of the Contract.

 

Notwithstanding the foregoing, any RECIPIENT expending $500,000 or more in federal or state awards during its fiscal year shall obtain either an annual single audit or a program specific audit. A RECIPIENT expending funds from only one state program may elect to obtain a program specific audit in accordance with Office of Management and Budget (OMB) Circular A-133 or with the State of Texas Uniform Grant Management Standards (UGMS). A single audit is required if funds from more than one federal or state program are spent by the RECIPIENT. The audited time period is the RECIPIENT’s fiscal year, not the INSTITUTE funding period.

 

Section 4.03 Inspections. In addition to the audit rights specified in Section 4.02 “Audits”, the INSTITUTE shall have the right to conduct periodic onsite inspections within normal working hours and on a day and a time mutually agreed to by the parties, to evaluate the Institute-Funded Activity. The RECIPIENT shall fully participate and cooperate in any such evaluation efforts.

 

Section 4.04 On-going Obligation to Submit Requested Information. The RECIPIENT shall, submit other information related to the Grant to the INSTITUTE as may be reasonably requested from time-to-time by the INSTITUTE, by the Legislature or by any other funding or regulatory bodies covering the RECIPIENT's activities under this Contract.

 

Section 4.05 Duty to Resolve Deficiencies. If an audit and/or inspection under this Article IV finds there are deficiencies that should be remedied, then the RECIPIENT shall resolve and/or cure such deficiencies within a reasonable time frame specified by the INSTITUTE. Failure to do so shall constitute an Event of Default pursuant to Section 8.03 “Event of Default.” Upon the RECIPIENT’S request, the parties agree to negotiate in good faith, specific extensions so that the deficiencies. RECIPIENT can cure such deficiencies.

Section 4.06 Repayment of Grant Proceeds for Improper Use. In no event shall RECIPIENT retain Grant funds that have not been used by the RECIPIENT for purposes for which the Grant was intended or in violation of the terms of this Contract. The RECIPIENT shall repay any portion of Grant proceeds used by the RECIPIENT for purposes for which the Grant was not intended, as determined by the final results of an audit conducted pursuant to the provisions of this Contract. Unless otherwise expressly provided for in writing and appended to this Contract, the repayment shall be made to the INSTITUTE no later than forty-five (45) days upon a written request by the INSTITUTE specifying the amount to be repaid and detailing the basis upon which such request is being made and the amount shall include interest calculated at an amount not to exceed five percent (5%) annually. The RECIPIENT may request that the INSTITUTE waive the interest, subject in all cases to the INSTITUTE’S sole discretion.

9

 

 

Section 4.07 Repayment of Grant Proceeds for Relocation Outside of Texas. Unless waived by a vote of the Oversight Committee, the RECIPIENT shall repay the INSTITUTE all Grant proceeds disbursed to RECIPIENT in the event that RECIPIENT relocates its principal place of business outside of the State during the Contract term or within 3 years after the final payment of the Grant funds is made by the INSTITUTE.

 

Article V

ASSURANCES AND CERTIFICATIONS

 

Adoption of Attachment C. The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment C in their entirety, incorporate them as if fully set forth herein, and agree to perform and be bound by all such terms.

 

Article VI

INTELLECTUAL PROPERTY AND REVENUE SHARING

 

Adoption of Attachment D. The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment D in their entirety, incorporate them as if fully set forth herein, and agree to perform and be bound by all such terms.

 

Article VII 

REPORTING

 

Adoption of Attachment E. The INSTITUTE and the RECIPIENT hereby adopt the terms of Attachment E in their entirety, incorporate them as if fully set forth herein, and agree to perform and be bound by all such terms.

 

Article VIII

EARLY TERMINATION AND EVENT OF DEFAULT

 

Section 8.01 Early Termination of Contract. This Contract may be terminated prior to the Termination Date specified in Section 2.03 “Contract Term” by:

 

	 	
			(a)

				
			Mutual written consent of all parties to this Contract; or

			
	 	 	 
	 	
			(b)

				
			The INSTITUTE for an Event of Default (defined in Section 8.03) by the RECIPIENT; or

			
	 	 	 
	 	
			(c)

				
			The INSTITUTE if allocated funds should become legally unavailable during the Contract period and the INSTITUTE is unable to obtain additional funds for such purposes; or

			

 

10

 

 

	 	
			(d)

				
			The RECIPIENT for convenience.

			

 

Section 8.02 Repayment of Grant Proceeds upon Early Termination. The INSTITUTE may require the RECIPIENT to repay some or all of the disbursed Grant proceeds in the event of early termination under 8.01 (d) above or under Section 8.01(b) above, to the extent such Event of Default resulted from Grant funds being expended in violation of this Contract. To the extent that the INSTITUTE exercises this option, the INSTITUTE shall provide written notice to the RECIPIENT stating the amount to be repaid, applicable interest calculated not to exceed five percent (5%) annually, and the schedule for such repayment. The RECIPIENT may request that the INSTITUTE waive the interest, subject in all cases to the INSTITUTE’S sole discretion. In no event shall the RECIPIENT retain Grant funds that have not been used by the RECIPIENT for purposes for which the Grant was intended.

Section 8.03 Event of Default. The following events shall, unless expressly waived in writing by the INSTITUTE or fully cured by the RECIPIENT pursuant to the provisions herein, constitute an event of default (each, an “Event of Default”):

	 	
			(a)

				
			The RECIPIENT’s failure, in any material respect, to conduct the Project in accordance with the approved Scope of Work and to demonstrate progress towards achieving the milestones set forth in Section 2.02;

			
	 	 	 
	 	
			(b)

				
			The RECIPIENT’s failure to conduct the Project within the State of Texas to the extent required under this Contract unless as otherwise specified in the application, Scope of Work or Approved Budget;

			
	 	 	 
	 	
			(c)

				
			The RECIPIENT’s failure to fully comply, in any material respect, with any provision, term, condition, covenant, representation, certification, or warranty contained in this Contract or any other document incorporated herein by reference;

			
	 	 	 
	 	
			(d)

				
			The  RECIPIENT’s  failure  to  comply  with  any  applicable  federal  or  state  law, administrative rule, regulation or policy with regard to the conduct of the Project;

			
	 	 	 
	 	
			(e)

				
			The  RECIPIENT’s  material  misrepresentation  or  false  covenant,  representation, certification, or warranty made by RECIPIENT herein, in the Grant application, or in any other document furnished by RECIPIENT pursuant to this Contract that was misleading at the time that it was made; or

			
	 	 	 
	 	
			(f)

				
			The RECIPIENT ceases its business operations, has a receiver appointed for all or substantially all of its assets, makes a general assignment for the benefit of creditors, is declared insolvent by a court of competent jurisdiction or becomes the subject, as a debtor, of a proceeding under the federal bankruptcy code, which such proceedings are not dismissed within ninety (90) days after filing.

			

 

Section 8.04 Notice Required. If the RECIPIENT intends to terminate pursuant to Section 8.01(d) “Early Termination of Contract”, it shall provide written notice to the INSTITUTE pursuant to the notice provisions of Section 9.21 “Notices” no later than thirty (30) days prior to the intended date of termination.

 

If the INSTITUTE intends to terminate for an Event of Default under Section 8.01(b) by the RECIPIENT, as described in Section 8.03 “Event of Default”, the INSTITUTE shall provide written notice to the RECIPIENT pursuant to Section 9.21 “Notices” and shall include a reasonable description of the Event of Default and, if applicable, the steps necessary to cure such Event of Default. Upon receiving notice from the INSTITUTE, the RECIPIENT shall have thirty (30) days beginning on the day following the receipt of notice to cure the Event of Default. Upon request, the INSTITUTE may provide an extension of time to cure the Event of Default(s) beyond the thirty (30) day period specified herein so long as the RECIPIENT is using reasonable efforts to cure and is making reasonable progress in curing such Event(s) of Default. The extension shall be in writing and appended to the Contract. If the RECIPIENT is unable or fails to timely cure an Event of Default, unless expressly waived in writing by the INSTITUTE, this Contract shall immediately terminate as of the close of business on the final day of the allotted cure period without any further notice or action by the INSTITUTE required. In addition, and notwithstanding the foregoing, the INSTITUTE and the RECIPIENT agree that certain events that cannot be cured shall, unless expressly waived in writing by the INSTITUTE, constitute a final Event of Default under this Contract and this Contract shall terminate immediately upon the INSTITUTE giving the RECIPIENT written “Notice of Event of Default and FINAL TERMINATION.”

 

11

 

 

In the event that the INSTITUTE terminates the Contract under Section 8.01(c) above because allocated funds become legally unavailable during the Contract period, the INSTITUTE shall immediately provide written notification to the RECIPIENT of such fact pursuant to Section 9.21 “Notices.” The Contract is terminated upon the RECIPIENT’s receipt of that notification, subject to Section 9.09 “Survival of Terms.”

 

Section 8.05 Duty to Report Event of Default. The RECIPIENT shall notify the INSTITUTE in writing pursuant to Section 9.21 “Notices”, promptly and in no event more than (30) days after it obtains knowledge of the occurrence of any Event of Default. The RECIPIENT shall include a statement setting forth reasonable details of each Event of Default and the action which the RECIPIENT proposes to take with respect thereto.

 

Section 8.06 Obligations/Liabilities Affected by Early Termination. The RECIPIENT shall not incur new obligations that otherwise would have been paid for using Grant funds after the receipt of notice as provided by Section 8.04 “Notice Required”, unless expressly permitted by the INSTITUTE in writing, and shall cancel as many outstanding obligations as possible. The INSTITUTE shall not owe any fee, penalty or other amount for exercising its right to terminate the Contract in accordance with Section 8.01. In no event shall the INSTITUTE be liable for any services performed, or costs or expenses incurred, after the Termination Date of the Contract. Early termination by either party shall not nullify obligations already incurred, including the RECIPIENT’s revenue sharing obligations as set forth in Attachment D, or the performance or failure to perform obligations prior to the Termination Date.

 

Section 8.07 Interim Remedies. Upon receipt by the RECIPIENT of a notice of Event of Default, and at any time thereafter until such Event of Default is cured to the satisfaction of the INSTITUTE or this Contract is terminated, the INSTITUTE may enforce any or all of the following remedies (such rights and remedies being in addition to and not in lieu of any rights or remedies set forth herein):

 

	 	
			(a)

				
			The INSTITUTE may refrain from disbursing any amount of the Grant funds not previously disbursed; provided, however, the INSTITUTE may make such a disbursement after the occurrence of an Event of Default without thereby waiving its rights and remedies hereunder;

			
	 	 	 
	 	
			(b)

				
			The INSTITUTE may enforce any additional remedies it has in law or equity.

			

 

The rights and remedies herein specified are cumulative and not exclusive of any rights or remedies that the INSTITUTE would otherwise possess.

 

 

12

 

 

Article IX 

MISCELLANEOUS

 

Section 9.01 Uniform Grant Management Standards. Unless otherwise provided herein, the RECIPIENT  agrees that the  Uniform Grant Management Standards  (UGMS), developed by the Governor's Budget and Planning Office as directed under the Uniform Grant Management Act of 1981, TEX. GOVT. CODE, Ch. 783, apply as additional terms and conditions of this Contract and that the standards are adopted by reference in their entirety. If there is a conflict between the provisions of this Contract and UGMS, the provisions of this Contract will prevail unless expressly stated otherwise.

 

Section 9.02 Management and Disposition of Equipment. During the term of this Contract, the RECIPIENT may use Grant funds to purchase Equipment to be used for the authorized purpose of the Project, subject to the conditions set forth below. Unless otherwise provided herein, title to Equipment shall vest in the RECIPIENT upon termination of the Contract.

 

	 	
			(a)

				
			The INSTITUTE must authorize the acquisition in advance and in writing but an acquisition is deemed authorized if included in the Approved Budget for the Project;

			
	 	 	 
	 	
			(b)

				
			Equipment purchased with Grant funds must stay within the State of Texas;

			
	 	 	 
	 	
			(c)

				
			Equipment purchased with Grant funds must be materially deployed to the uses and purposes related to the Project;

			
	 	 	 
	 	
			(d)

				
			In the event the RECIPIENT is indemnified, reimbursed or otherwise compensated for any loss of, destruction of, or damage to the Equipment purchased using Grant funds, it shall use the proceeds to repair or replace said Equipment;

			
	 	 	 
	 	
			(e)

				
			Equipment may be exchanged (trade-in) or sold without the prior written approval of the INSTITUTE if the proceeds thereof shall be applied to the acquisition cost of replacement Equipment;

			
	 	 	 
	 	
			(f)

				
			The RECIPIENT may use its own property management standards and procedures provided that it observes the terms of UGMS, A-102, in all material respects;

			
	 	 	 
	 	
			(g)

				
			The title or ownership of the Equipment shall not be encumbered for purposes other than the Project nor or transferred other than to a permitted assignee of this Contract, without the prior written approval of the INSTITUTE;

			
	 	 	 
	 	
			(h)

				
			If the original or replacement Equipment is no longer needed for the originally authorized purpose or for other activities supported by the INSTITUTE, the RECIPIENT shall request disposition instructions from the INSTITUTE and, upon receipt, shall fully comply therewith; and

			
	 	 	 
	 	
			(i)

				
			If this Contract is terminated early pursuant to Section 8.01(b), (d), (e), or (f) above, the INSTITUTE shall determine the final disposition of Equipment purchased with Grant award money.

			

 

Section 9.03 Supplies and Other Expendable Property. The RECIPIENT shall classify as materials, supplies and other expendable property the allowable unit acquisition cost of such property under $5,000 necessary to carry out the Project. Title to supplies and other expendable property shall vest in the RECIPIENT upon acquisition.

 

13

 

 

Section 9.04 Acknowledgement of Grant Funding and Publicity. The parties agree to the following terms and conditions regarding acknowledging Grant funding and publicity:

 

	 	
			(a)

				
			The parties agree to fully cooperate and coordinate with each other in connection with all press releases and publications regarding the award of the Grant, the execution of the Contract and the Institute-Funded Activities.

			
	 	 	 
	 	
			(b)

				
			The RECIPIENT shall notify the INSTITUTE’s Information Specialist or similar personnel at least three business days prior to any press releases, advertising, publicity, use of CPRIT logo, or other promotional activities that pertain to the Project or any Institute-Funded Activity. In the event that the INSTITUTE wishes to participate in a joint press release, the RECIPIENT shall coordinate and cooperate with the INSTITUTE’s Information Specialist or similar personnel to develop a mutually agreeable joint press release.

			
	 	 	 
	 	
			(c)

				
			Consistent with the goal of encouraging development of scientific breakthroughs and dissemination of knowledge, publication or presentation of scholarly materials is expected and encouraged. The RECIPIENT may publish in scholarly journals or other peer-reviewed journals (including graduate theses and dissertations) and may make presentations at scientific meetings without prior notice to or consent of the INSTITUTE, except as may otherwise be set forth in this Contract. The RECIPIENT shall promptly notify the INSTITUTE when any scholarly presentations or publications have been accepted for public disclosure and shall provide the INSTITUTE with final copies of all such accepted presentations and publications. The RECIPIENT shall acknowledge receipt of the INSTITUTE funding in all publications, presentations, press releases and other materials regarding the work associated with the Institute-Funded Activities. The RECIPIENT shall promptly submit an electronic version of all published manuscripts to PubMed Central in accordance with Section 9.05 “Public Access to Research Results.”

			

 

	 	
			(d)

				
			When grant funds are used to prepare print or visual materials for educational or promotional purposes for the general public (e.g., patients), and excluding presentations and publications discussed above in subsection (c), the RECIPIENT shall provide a copy of such materials to the INSTITUTE at least ten (10) days prior to printing. The RECIPIENT shall also acknowledge receipt of the INSTITUTE funding on all such materials including, but not limited to, brochures, pamphlets, booklets, training fliers, project websites, videos and DVDs, manuals and reports, as well as on the labels and cases for audiovisual or videotape/DVD presentations.

			

Section 9.05 Public Access to Results of Institute-Funded Activities. The RECIPIENT shall submit an electronic version of its final peer-reviewed journal manuscripts that arise from Grant funds to the digital archive National Library of Medicine’s PubMed Central upon acceptance for publication. These papers must be accessible to the public on PubMed no later than 12 months after publication. This policy is subject to the terms of Attachment D and does not supplant applicable copyright law. For clarity, this policy is not intended to require the RECIPIENT to make a disclosure at a time or in any manner that would cause the RECIPIENT to abandon, waive or disclaim any intellectual property rights that it is obligated to protect pursuant to the terms of Attachment D.

Section 9.06 Work to be Conducted in State. The RECIPIENT agrees that it will use reasonable efforts to direct that any new or expanded preclinical testing, clinical trials, commercialization or manufacturing that is part of or relating to any Institute-Funded Activities take place in the State of Texas, including the establishment of facilities to meet this purpose. If the RECIPIENT decides not to conduct such work in the State of Texas, the RECIPIENT shall provide a prior written explanation to the INSTITUTE detailing the RECIPIENT’s reasons for conducting the work outside of the State of Texas and the RECIPIENT’s efforts made to conduct the work in the State of Texas.

 

14

 

 

Section 9.07 Duty to Notify. During the term of this Contract and for a period of five (5) years thereafter, the RECIPIENT is under a continuing obligation to notify the INSTITUTE’s Chief Executive Officer at the same time it is required to notify any Federal or State entity of any unexpected adverse event or condition that materially impacts the performance or general public perception of the conduct or results of the Project and Institute-Funded Activities, including any impact to the Scope of Work included in the Contract and events or results that have a serious adverse impact on human health, safety or welfare. By way of example only, if clinical testing of the results of Institute-Funded Activities reveal an unexpected risk of developing serious health conditions or death, then the RECIPIENT shall, at the same time it notifies any Federal or State entity, promptly so notify the INSTITUTE’s Chief Executive Officer even if such results are not available until after the term of this Contract. Notice required under this section shall be made as promptly as reasonably possible and shall follow the procedures set forth in Section 9.21 “Notices.”

 

Section 9.08 Severability. If any provision of this Contract is construed to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or enforceability shall not affect any other provisions hereof. The invalid, illegal or unenforceable provision shall be deemed stricken and deleted to the same extent and effect as if never incorporated herein. All other provisions shall continue as provided in this Contract.

 

Section 9.09 Survival of Terms. Termination or expiration of this Contract for any reason will not release either party from any liabilities or obligations set forth in this Contract that: (1) the Parties have expressly agreed shall survive any such termination or expiration; or (2) remain to be performed or by their nature would be intended to be applicable following any such termination or expiration. Such surviving terms include, but are not limited to, Sections 2.13, 4.01, 4.02, 4.05, 4.06, 8.02, 8.06, 9.04, 9.05, 9.06, 9.07, 9.09, 9.14, 9.15, 9.16, 9.17, 9.18, and Attachment D.

Section 9.10 Binding Effect and Assignment or Modification. This Contract and all terms, provisions and obligations set forth herein shall be binding upon and shall inure to the benefit of the parties and their successors and permitted assigns, including all other state agencies and any other agencies, departments, divisions, governmental entities, public corporations or other entities which shall be successors to either of the parties or which shall succeed to or become obligated to perform or become bound by any of the covenants, agreements or obligations hereunder of either of the parties hereto. Upon a permitted assignment of this Contract by RECIPIENT, all references to “the RECIPIENT” herein shall be deemed to refer to such permitted assignee.

Section 9.11 No Waiver of Contract Terms. Neither the failure by the RECIPIENT or the INSTITUTE, in any one or more instances, to insist upon the complete and total observance or performance of any term or provision hereof, nor the failure of the RECIPIENT or the INSTITUTE to exercise any right, privilege or remedy conferred hereunder or afforded by law, shall be construed as waiving any breach of such term or provision or the right to exercise such right, privilege or remedy thereafter. In addition, no delay on the part of either the RECIPIENT or the INSTITUTE, in exercising any right or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or remedy preclude other or further exercise thereof or the exercise of any other right or remedy.

Section 9.12 No Waiver of Sovereign Immunity. No provision of this Contract is in any way intended to constitute a waiver by the INSTITUTE, the RECIPIENT (if applicable), or the State of Texas of any immunities from suit or from liability that the have by operation of law. INSTITUTE, the RECIPIENT, or the State of Texas may

Section 9.13 Force Majeure. Neither the INSTITUTE nor the RECIPIENT will be liable for any failure or delay in performing its obligations under the Contract if such failure or delay is due to any cause beyond the reasonable control of such party, including, but not limited to, unusually severe weather, strikes, natural disasters, fire, civil disturbance, epidemic, war, court order or acts of God. The existence of such causes of delay or failure will extend the period of performance in the exercise of reasonable diligence until after the causes of delay or failure have been removed. Each party must inform the other in accordance with Section 9.21 “Notices” within five (5) business days, or as soon as it is practical, of the existence of a force majeure event or otherwise waive this right as a defense.

 

15

 

 

Section 9.14 Disclaimer of Damages. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES. THIS LIMITATION WILL APPLY REGARDLESS OF WHETHER OR NOT THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Section 9.15 Indemnification and Hold Harmless. Except as provided herein, the RECIPIENT agrees to fully indemnify and hold the INSTITUTE and the State of Texas harmless from and against any and all claims, demands, costs, expenses, liabilities, causes of action and damages of every kind and character (including reasonable attorneys fees) which may be asserted by any third party in any way related or incident to, arising out of, or in connection with (1) the RECIPIENT’s negligent, intentional or wrongful performance or failure to perform under this Contract, (2) the RECIPIENT’s receipt or use of Grant funds, or (3) any negligent, intentional or wrongful act or omission committed by the RECIPIENT as part of an Institute-Funded Activity or during the Project. In addition, the RECIPIENT agrees to fully indemnify and hold the INSTITUTE and the State of Texas harmless from and against any and all costs and expenses of every kind and character (including reasonable attorneys fees, costs of court and expert fees) that are incurred by the INSTITUTE or the State of Texas arising out of or related to a third party claim of the type specified in the preceding sentence. Notwithstanding the preceding, such indemnification shall not apply in the event of the sole or gross negligence of the INSTITUTE. If the RECIPIENT is a State of Texas agency or institution of higher education, then this Section 9.15 is subject to the extent authorized by the Texas Constitution and the laws of the State of Texas.

The RECIPIENT acknowledges and agrees that this indemnification shall apply to, but is not limited to, employment matters, taxes, personal injury, and negligence.

 

It is understood and agreed that it is not the intent of the parties to expand or increase the liability of the State of Texas under this Article. This provision is intended to prevent the RECIPIENT, the INSTITUTE and the State of Texas from attempting or appearing to assume liability it does not have the statutory or legal power to assume.

 

Section 9.16 Alternative Dispute Resolution. If applicable, the dispute resolution process provided for in TEX. GOVT. CODE, Ch. 2260 shall be used, as further described herein, to resolve any claim for breach of contract made against the INSTITUTE (excluding any uncured Event of Default). The submission, processing and resolution of a party's claim are governed by the published rules adopted by the Attorney General pursuant to TEX. GOVT. CODE, Ch. 2260, as currently effective, hereafter enacted or subsequently amended.

 

Section 9.17 Applicable Law and Venue. This Contract shall be construed and all disputes shall be considered in accordance with the laws of the State of Texas, without regard to its principles governing the conflict of laws. Provided that the RECIPIENT first complies with procedures set forth in Section 9.16 “Alternative Dispute Resolution,” exclusive venue and jurisdiction for the resolution of claims arising from or related to this Contract shall be in the federal and state courts in Travis County, Texas.

 

Section 9.18 Attorneys’ Fees. In the event of any litigation, appeal or other legal action to enforce any provision of the Contract, the RECIPIENT shall pay all expenses of such action, including attorneys' fees and costs, if the INSTITUTE is the prevailing party. If the RECIPIENT is a State of Texas agency or institution of higher education, then this Section 9.18 is subject to the extent authorized by the Texas Constitution and the laws of the State of Texas.

 

Section 9.19 Counterparts. This Contract may be executed in any number of counterparts, each of which when so executed and delivered shall be an original, but such counterparts shall together constitute one and the same instrument.

 

Section 9.20 Construction of Terms The headings used in this Contract are inserted only as a matter of convenience and for reference and shall not affect the construction or interpretation of this Contract. Where context so indicates, a word in the singular form shall include the plural, a word in the masculine form the feminine, and vice-versa. The word "including" and similar constructions (such as "includes", "included", "for example", "such as", and "e.g.") shall mean "including, without limitation" throughout this Contract. The words “and” and “or” are not intended to convey exclusivity or nonexclusivity except where expressly indicated or where the context so indicates in order to give effect to the intent of the parties.

 

Section 9.21 Notices. All notices, requests, demands and other communications will be in writing and will be deemed given on the date received as demonstrated by (i) a courier’s receipt or registered or certified mail return receipt signed by the party to whom such notice was sent, provided that such notice was sent to the Authorized Signing Official (ASO) at the address provided in the CPRIT Grants Management System, (ii) a fax confirmation page showing that such fax was successfully transmitted to the fax number provided in the CPRIT Grants Management System, or (iii) via correspondence in the CPRIT Grants Management System.

 

16

 

 

 

 

DP150031, Contract Attachment A

 

Layperson’s Summary

 

Medicenna Therapeutics Inc. is an immuno-oncology company led by experienced entrepreneurs with proven track records in cancer drug development. Medicenna is developing treatments for brain cancers that affect both adults and children, including glioblastoma multiforme (GBM). GBM tumors are the most common form of adult brain cancer, with 11,000 new cases annually in US. They are the second most common cause of brain cancer deaths. These cancers make a protein on the cancer cells’ surface called the IL-4 receptor (IL-4R). Most normal cells have no IL-4R. Medicenna has developed an anti-cancer agent, MDNA55, which is administered directly into tumors. MDNA55 targets and kills brain cancer cells, while not harming healthy cells. MDNA55 has the potential to save lives and extend survival for brain cancer patients, especially among the 60% of patients whose tumors recur. MDNA55 has shown promising clinical results among 72 adult GBM patients. The FDA has already granted MDNA55 Orphan Drug and Fast Track Designations. Medicenna’s goal is to conduct two clinical trials for GBM patients to test MNDA55’s safety, effectiveness and dosage. Texas-based drug manufacturing, clinical research organizations and clinics will support the trials, in Texas and across the U.S. Medicenna’ drug development platform will expand Texas’ cancer research capacity benefitting patients and their families, while expanding Texas’ research infrastructure and creating new high-quality jobs.

 

 

 

 

 

 

Timelines: EDITED  project_timeline.pdf

 

Goal 1: Complete Phase 2 recurrent GBM study and be ready for the pivotal Phase 3 study

ADDED

 

 

 

Objective 1: [***]

ADDED

 

 

 

 

 

 

 

Objective 2: [***]

ADDED

 

 

 

 

 

 

Objective 3: [***]

ADDED

 

 

 

 

 

 

Objective 4: [***]

ADDED

 

 

 

 

Objective 5: [***]

ADDED

 

Goal 2: Develop, qualify and test an IL-4R based in-vitro companion diagnostic (CDx) for use alongside MDNA55 in order to select GBM patients most likely to respond to treatment.

ADDED

 

Objective 1: [***]

ADDED

 

 

 

 

 

 

Objective 2: [***]

ADDED

 

 

 

 

 

 

Objective 3: [***]

ADDED

 

 

 

 

 

Objective 4: [***]

ADDED

 

Goal 3: Design a novel fusion protein with enhanced Type 2 IL-4R targeting with reduced off-target affinity, improved safety for multi-cycle repeated systemic delivery and an effective anti-tumor immune response

ADDED.

 

 

 

Objective 1: [***]

ADDED

 

 

 

 

 

 

Objective 2: [***]

ADDED

 

 

 

 

 

 

 

 

 

 

 

 

MEDICENNA THERAPEUTICS INC: TIMELINES

 

	
			Key Milestones

				
			Anticipated Date for Achieving Milestones

			
	
			GOAL 1: Complete Phase 2 recurrent GBM study and be ready for the pivotal Phase 3 study

				 
	
			Objective 1: Initiate recurrent GBM study

				
			Q2 2015

			
	
			Objective 2: Complete study enrolment

				
			Q2 2016

			
	
			Objective 3: Completion of Draft Clinical Study Report

				
			Q2 2017

			
	
			Objective 4: Complete CMC activities in preparation for readiness to start Phase 3 study

				
			Q1 2015 – Q2 2017

			
	
			Objective 5: Complete EOP-‐‐2/EMA meeting for design of Phase 3 trial

				
			Q3 2017 – Q4 2017

			
	
			GOAL 2: Develop, qualify and test an IL-‐‐4R based in-‐‐vitro companion diagnostic (CDx) for use alongside MDNA55 in order to select GBM patients most likely to respond to treatment

				 
	
			Objective 1: Develop and optimize immunohistochemistry (IHC) based assay for analyzing expression of IL-‐‐4R in GBM patient biopsies

				
			Q2 2015 – Q2 2016

			
	
			Objective 2: Qualify the IHC assay developed in Objective 1 for its readiness for use in the Phase 3 recurrent GBM study

				
			Q2 2016 – Q2 2017

			
	
			Objective 3: Develop a CDx plan to commercialization and submit to FDA at the EOP-‐‐2 meeting

				
			Q3 2017

			
	
			Objective 4: Evaluate IL-‐‐4R expression profile on Cancer Stem Cells (CSC), Tumor Associated Macrophages (TAM), and Myeloid Derived Suppressor Cells (MDSC) isolated from biopsy samples obtained from the Phase 2 recurrent GBM study

				
			Q3 2016 – Q3 2017

			
	
			GOAL 3: Design a novel fusion protein with enhanced Type 2 IL-‐‐4R targeting with reduced off-‐‐target affinity, improved safety for multi-‐‐cycle systemic delivery and an effective anti-‐‐tumor immune response

				 
	
			Objective 1: Develop process for production of a second generation IL-‐‐4R targeted fusion protein

				
			Q1 2015 – Q4 2015

			
	
			Objective 2: Complete in-‐‐vitro and in-‐‐vivo studies of second generation IL-‐‐4R targeted fusion protein to demonstrate proof-‐‐of-‐‐concept and establish therapeutic window

				
			Q1 2016 – Q4 2016

			

 

 

 

 

 

Grant ID: DP150031

 

Principal Investigator/Program Director: Fahar Merchant

 

ATTACHMENT B - Detailed Budget Form

 

[***]

 

* Note:

 

For purposes of contract initiation only:

 

	
			Federal ID#:

				 
	
			Vendor ID#:

				
			123456789

			
	
			ASO Contact:

				
			Merchant, Fahar

			
	
			Address:

				
			220-1075 West Georgia Street

			
	
			Address 2:

				 
	
			City, State, ZIP

				
			Vancouver, BC V6E3C9

			
	
			Phone:

				
			604 671 6673

			
	
			Fax:

				
			604 558 0782

			
	
			Email:

				
			fmerchant@medicenna.com

			

 

 

 

 

 

ATTACHMENT C 

 

ASSURANCES AND CERTIFICATIONS

 

This Attachment C is hereby incorporated into and made a part of that certain CANCER RESEARCH GRANT CONTRACT (“Contract”) by and between the Cancer Prevention and Research Institute of Texas (“CPRIT” or the “INSTITUTE”) and the RECIPIENT. A capitalized term used in this Attachment shall have the meaning given to term in the Contract or in the Attachments to the Contract, unless otherwise defined herein. In the event of a conflict between the provisions of this Attachment and the provisions of the Contract, this Attachment shall control.

 

By signing this Contract, RECIPIENT certifies compliance with the following assurances and certifications required by the INSTITUTE (listed below). RECIPIENT further acknowledges that its obligations pursuant to the following assurances and certifications are ongoing.

 

Section C1.01 Demonstration of Matching Funds. Pursuant to TEX. HEALTH & SAFETY CODE § 102.255(d) and T.A.C. 25 § 703.11, RECIPIENT has an amount of funds equal to one-half of the amount of the Grant to be disbursed each fiscal year of the Contract term dedicated to the research that is the subject of the Grant as demonstrated by the form incorporated herein to Attachment C. The RECIPIENT shall update the matching funds certification and verficiation annually for each fiscal year that Grant funds are disbursed.

 

Section C1.02 Payment of Taxes. RECIPIENT‘s payment of franchise taxes is current or, if the RECIPIENT is exempt from payment of franchise taxes, that it is not subject to the State of Texas franchise tax. If franchise tax payments become delinquent during the Contract term, payments under this Contract will be withheld until the RECIPIENT's delinquent franchise tax is paid in full. The RECIPIENT also acknowledges that it is not otherwise exempt from state sales or occupancy tax as a result of this Contract.

 

Section C1.03 Compliance with Confidentiality Guidelines Relating to Personal and Medical Information.  RECIPIENT complies with all applicable laws, rules and regulations relating to personal and medical information. Without in any way limiting the foregoing, RECIPIENT maintains and enforces appropriate facility and information technology access rules and procedures to protect against inappropriate disclosure of patient records and all other documents deemed confidential by law, which are maintained in connection with the Project and Institute-Funded Activities, including provisions that comply with the requirements of the INSTITUTE’s rules, 25 T.A.C. Section 703.14. Upon request from the INSTITUTE, RECIPIENT will timely furnish a copy of the RECIPIENT’s facility and information technology access rules and procedures, as well as any other applicable confidentiality guidelines.

 

If RECIPIENT, including any Collaborators or Contractors, works directly with patients or otherwise has access to or maintains patient personal and medical information, RECIPIENT specifically addresses Health Insurance Portability and Accountability Act of 1996 regulations concerning confidentiality of personal and medical information. Any disclosure of confidential information in any way related to the Project (including information that may be required by reports and inspections) must be in accordance with all applicable laws.

 

Section C1.04 Conduct of Research or Service Provided. RECIPIENT understands that the Project must be conducted with full consideration for the ethical and medical implications of the research performed or services delivered and comply with all federal and state laws regarding the conduct of the research or service.

 

Page C1

 

 

Section C1.05 Regulatory Certificates, Licenses and Permits. All personnel, facilities and equipment involved or to be involved in the Project are certified, licensed, permitted, registered or approved by the appropriate regulating agency, where applicable. Any revocation, surrender, expiration, non-renewal, inactivation or suspension of any such certification, license, permit, registration or approval shall constitute grounds for Contract termination.

 

Section C1.06 Assurances and Certifications in Accordance with the NIH Grants Policy Statement:

 

	 	
			(a)

				
			Civil Rights. Compliance with Title VI of the Civil Rights Act of 1964.

			
	 	 	 
	 	
			(b)

				
			Handicapped Individuals. Compliance with Section 504 of the Rehabilitation Act of 1973 as amended.

			
	 	 	 
	 	
			(c)

				
			Sex Discrimination. Compliance with Section 901 of Title IX of the Education Amendments of 1972 as amended.

			
	 	 	 
	 	
			(d)

				
			Age Discrimination. Compliance with the Age Discrimination Act of 1975, as amended.

			
	 	 	 
	 	
			(e)

				
			Patents, Licenses and Inventions. Compliance with the Standard Patent Rights clauses as specified in 37 CFR, Part 401 or 35 U.S.C. 203, if appropriate and applicable, in a manner that adequately protects the INSTITUTE’S rights in the Project Results.

			
	 	 	 
	 	
			(f)

				
			Human Subjects. Compliance with the requirements of federal policy concerning the safeguarding of the rights and welfare of human subjects who are involved in activities supported by federal funds. Before any funding may be released for any Project involving human subjects, RECIPIENT must receive approval from RECIPIENT’s Institutional Review Board (IRB). Upon request, a copy of RECIPIENT’s IRB approval must be provided to the INSTITUTE.

			
	 	 	 
	 	
			(g)

				
			Human Biological/Anatomical Material. Compliance with the recommendations of the NIH Office of Human Subject Research Medical Administrative Series (MAS) #MO1-2 entitled “Procurement and Use of Human Biological Materials for Research,” and any other federal or state requirements.

			
	 	 	 
	 	
			(h)

				
			Use of Animals. Compliance with applicable portions of the Animal Welfare Act (PL 89-544 as amended) and appropriate Public Health Service Policy on Humane Care and Use of Laboratory Animals regulations. Before any funding may be released for any Project involving animal subjects, RECIPIENT must receive approval from RECIPIENT’s Institutional Animal Care and Use Committee (IACUC). Upon request, a copy of RECIPIENT’s IACUC approval must be provided to the INSTITUTE.

			
	 	 	 
	 	
			(i)

				
			Debarment and Suspension. RECIPIENT certifies that neither it nor the Principal Investigator/Project Director or any other Recipient Personnel or personnel of any Collaborator or Contractor assigned to work on the Project are debarred, suspended, proposed for debarment, declared ineligible or otherwise excluded from participation in the Project by any federal or state department or agency.

			

 

Page C2

 

 

	 	
			(j)

				
			Non-Delinquency on Federal or State Debt. RECIPIENT certifies that neither it, nor any person to be paid from funds under this Contract, is delinquent in repaying any Federal debt as defined by OMB Circular A-129 or any debt to the State of Texas.

			
	 	 	 
	 	
			(k)

				
			Eligibility to Receive Payments on State Contracts. RECIPIENT certifies that it and the Principal Investigator/Project Director are not ineligible to receive the Grant award under this Contract pursuant to Tex. Fam. Code Ann. Section 231.006 and acknowledges that this Contract may be terminated and payment may be withheld if this certification is inaccurate.

			
	 	 	 
	 	
			(l)

				
			Drug-Free Workplace. Compliance with the Drug-Free Workplace Act of 1988 (45 CFR 82).

			
	 	 	 
	 	
			(m)

				
			Misconduct in Science. Compliance with 42 CFR Part 50, Subpart A, and Final Rule as published at 54 CFR 32446, August 8, 1989.

			
	 	 	 
	 	
			(n)

				
			Objectivity of Research/Conflict of Interest. Compliance with the NIH requirement to maintain a written standard of conduct and comply with 42 CFR Part 50, Subpart F, Responsibility of Applicants for Promoting Objectivity in Research. RECIPIENT must notify the INSTITUTE of any conflicting financial interests and assure that the interest has been managed, reduced or eliminated.

			
	 	 	 
	 	
			(o)

				
			Trafficking in Persons. Compliance with the NIH regulations on trafficking in persons as published at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-055.html.

			
	 	 	 
	 	
			(p)

				
			Criminal Misconduct. RECIPIENT shall promptly report issues to the INSTITUTE involving potential civil or criminal fraud related in any way to the Project, the Institute-Funded Activity or this Contract, such as false claims or misappropriation of federal or state funds.

			

 

Section C1.07 Tobacco Free Workplace Policy. Pursuant to T.A.C. 25 § 703.20, RECIPIENT certifies that its board of directors, governing body, or similar has adopted and enforces a Tobacco-Free Workplace Policy that meets or exceeds all of the following minimum standards:

 

	 	
			(a)

				
			Prohibits the use of all forms of tobacco products, including but not limited to cigarettes, cigars, pipes, water pipes (hookah), bidis, kreteks, electronic cigarettes, smokeless tobacco, snuff and chewing tobacco;

			
	 	 	 
	 	
			(b)

				
			Designates the property to which the policy applies (“designated area”). The designated area(s) must at least comprise all buildings and structures where the CPRIT project is taking place, as well as the sidewalks, parking lots, walkways, and attached parking structures immediately adjacent but only to the extent the CPRIT Grant Recipient owns, leases as the sole tenant, or controls the building, sidewalks, parking lots and/or parking structures. In the event that the RECIPIENT does not own, lease as the sole tenant, or control the building, sidewalks, parking lots and/or parking structures, then the designated area(s) must include all areas under the RECIPIENT’s control;

			
	 	 	 
	 	
			(c)

				
			Applies to all employees and visitors in the designated area(s); and

			
	 	 	 
	 	
			(d)

				
			Provides for or refers employees to tobacco use cessation services.

			

 

 

Page C3

 

 

If RECIPIENT cannot meet the minimum standards as set forth in this section, RECIPIENT certifies that it has received an approved waiver from the INSTITUTE’s CEO for the current fiscal year.

 

Section C1.08 No Donations to the Institute or a Foundation Established to Support Institute. RECIPIENT certifies that as of June 14, 2013, it has not made and will not make a contribution, during the term of the Contract, to the INSTITUTE or to any foundation established specifically to support the INSTITUTE.

 

 

 

 

 

 

 

Page C4

 

 

 

 

 

 

DP150031 - Product Development Contract Attachment C Part 2 Matching Compliance Certification (MCC) - Initial

 

For Public or Private Institutions of Higher Education ONLY (all other entities proceed to the table below): The grant recipient may credit toward the matching funds requirement the dollar equivalent to the difference between the institution's federally approved indirect cost rate for research projects and CPRIT's five percent (5%) indirect cost allowance. If a Public or Private Institution of Higher Education intends to fulfill its match requirement using expended funds only (no federally approved indirect cost rate credit), then choose "No" on the first question and proceed to the table below.

 

If the grant recipient’s Federally Approved Indirect Cost Rate is greater than or equal to 55% (the 50% matching funds requirement and the 5% CPRIT Indirect Cost Rate), then no further action is required once the appropriate information has been entered in lines "a" through "d" below.

 

If the combined Federally Approved Indirect Cost Rate and the CPRIT Indirect Cost Rate calculated for the Project is less than 55%, then the grant recipient must use the table below to demonstrate that it has encumbered funds available and not yet expended that are dedicated to the CPRIT-funded project for the portion of the match requirement not met by the Federally Approved Indirect Cost Rate credit.

 

 

 

 

Public or Private Institution of Higher Education:

(Choose 'No' if You Are Using Encumbered Funds)                                                       No

 

 

 

 

 

	 	
			Award Year #1

				
			Award Year #2

				
			Award Year #3

				
			Current Year

			
	 	
			Total Award Amount for Award Year #1

				
			Remaining Dollar Amount to Fulfill Match Requirement

				
			Actual "Non CPRIT"

			Funds Expended

			**

				
			Total Award Amount for Award Year #2

				
			Remaining Dollar Amount to Fulfill Match Requirement

				
			Actual "Non CPRIT"

			Funds Expended

			**

				
			Total Award Amount for Award Year #3

				
			Remaining Dollar Amount to Fulfill Match Requirement

				
			Actual "Non CPRIT"

			Funds Expended

			**

				
			Match Credit/Deficiency (if any)

			
	
			Public or Private Institutions of Higher Education

				
			$0.00

				
			$0.00

				
			$0.00

				
			$0.00

				
			$0.00

				
			$0.00

				
			$0.00

				
			$0.00

				
			$0.00

				
			$0.00

			
	
			All Other Entities

				
			$2,244,130.00

				
			$1,122,065.00

				
			$0.00

				
			$7,435,500.00

				
			$0.00

				
			$0.00

				
			$4,460,460.00

				
			$0.00

				
			$0.00

				
			$1,122,065.00 DEF

			
	
			Total Non-State Funds Leveraged as a Match for Award

				 	
			$0.00

				 	
			$0.00

				 	
			$0.00

				 

 

The information above is the entity/Institution's demonstration of encumbered available funds pursuant to its certification in Attachment C. The information in the certification shall be updated annually. By approving this form the grant recipient certifies that it has the matching funds available as reflected on the form.

 

Matching Fund Deficiencies (DEF) and Credits (CR)

 

The amount that appears in the “Remaining Dollar Amount to Fulfill Match Requirement” column is calculated to meet the matching funds requirement (50%). This is the amount that is certified at the beginning of the grant. The grantee will complete the third column at the end of the project year. It is possible for the grant recipient to actually expend more or less than the amount that is certified. In that event, the surplus/deficiency may be carried forward as a credit (CR) or deficiency (DEF).

 

If the grant recipient fails to expend its matching funds requirement for the year, the deficiency may be carried forward and added to the matching fund requirement for the next project year so long as: 1.) the deficiency is equal to or less than 20% of the total matching funds required for the same period; and 2.) the grant recipient has not previously had a matching funds deficiency. For a second deficiency of any amount, or for a deficiency greater than 20% of the total matching funds required for the same period, distribution of grant funds will be suspended. Depending upon the amount of the matching fund deficiency, CPRIT may declare the grant contract in default.

 

If the grant recipient actually expends more than its matching funds requirement for the year, the surplus may be carried forward to reduce the matching fund requirement for the next project year(s).

 

* Appropriate sources for encumbered funds dedicated to the CPRIT project may include but are not necessarily limited to: (1) Federal funds (including American Recovery and Reinvestment Act of 2009 funds, and the fair market value of drug development support provided to the recipient by the National Cancer Institute (NCI) or other similar programs); (2) State of Texas funds (Non-CPRIT); (3) Other States' funds; (4) Non-governmental funds (including private funds, foundation grants, gifts and donations); and (5) Un-recovered indirect costs not to exceed 10 percent of the grant award amount, subject to the following conditions: (A) These costs are not otherwise charged against the grant as the five percent indirect funds; (B) The Institution or recipient must have a documented federal indirect cost rate or an indirect certified by an independent accounting firm; and (C) Is not allowed if the grant recipient is a public or private institution of higher education.

 

 

 

 

The following items do not qualify as encumbered funds:

	
			(1)

				
			In-kind costs; (2) Volunteer services furnished to the grant recipient; (3) Noncash contributions; (4) Income earned not available at the time of award; (5) Pre-existing real estate including building, facilities and land, (6) Deferred giving such as a charitable remainder annuity trust, a charitable remainder unitrust, or a pooled income fund; or (7) Other items as may be determined by the Oversight Committee.

			

 

** All supporting documentation for non-CPRIT funds expended are subject to compliance review.

 

 

 

 

 

 

 

 

 

ATTACHMENT D

 

INTELLECTUAL PROPERTY AND REVENUE SHARING

 

This Attachment D is hereby incorporated into and made a part of that certain CANCER RESEARCH GRANT CONTRACT (“Contract”) by and between the Cancer Prevention and Research Institute of Texas (“CPRIT” or the “INSTITUTE”) and the RECIPIENT. A capitalized term used in this Attachment shall have the meaning given the term in the Contract or in the Attachments to the Contract, unless otherwise defined herein. In the event of a conflict between the provisions of this Attachment and the provisions of the Contract, this Attachment shall control.

 

PART 1

 

OWNERSHIP AND INTELLECTUAL PROPERTY PROTECTION

 

Section D1.01 Ownership of Project Results. RECIPIENT and its Collaborators, and (to the extent applicable) any third party participating in the development of the Project Results, shall retain ownership of the Institute-Funded Technology and the Institute-Funded IPR, subject to the terms of the Contract. A Collaborator as defined in the Contract is not a third party that engages with RECIPIENT as a licensing partner.

 

Section D1.02 Transfer or Assignment of Rights to a Third Party. RECIPIENT shall notify the INSTITUTE of any proposed transfer or assignment of rights in any Project Results to a third party and provide to INSTITUTE a copy of the agreement under which the proposed transfer or assignment is to occur. RECIPIENT shall ensure that, in any assignment or transfer of Project Results, the transferee or assignee agrees in writing to: (i) recognize that the Institute-Funded IPR and Institute-Funded Technology, as applicable, is transferred or assigned subject to the licenses, interests and other rights in such Project Results provided to the INSTITUTE in the Contract and any applicable law or regulation, (ii) take all actions necessary to protect all such licenses, interests and other rights, and (iii) be responsible for and pay all amounts required under Part 4 of this Attachment D. Any attempted transfer or assignment of rights in any Project Results to a third party without written agreement to the conditions in (i) – (iii) above shall be null, void and of no effect.

 

Section D1.03 Protection of Institute-Funded IPR. Subject to Section D5.01, RECIPIENT shall use commercially reasonable efforts to appropriately protect the Institute-Funded IPR, including without limitation, diligently seeking registration and maintenance of patents and copyrights covering the Institute-Funded Technology, as appropriate. If RECIPIENT elects to abandon any patent applications filed or patents issued covering any Institute-Funded Technology in any Major Market Country, RECIPIENT shall provide the INSTITUTE with prior written notice of such election, with sufficient time (but no less than 60 days) for the INSTITUTE to exercise its rights under this Section D1.03 with respect thereto. Upon notice of the aforesaid, the INSTITUTE shall have the right, but not the obligation, to pursue protection of the applicable Institute-Funded Technology on its own behalf in such Major Market Country, including directing the filing, prosecution and maintenance of patent applications or patents covering the applicable Institute-Funded Inventions in any of such Major Market Countries for which the INSTITUTE exercises its rights under this Section D1.03. In the Major Market Countries where the INSTITUTE pursues protection of the Institute-Funded Technology under this Section D1.03, RECIPIENT agrees to grant, and does hereby grant, to the INSTITUTE a non-exclusive, irrevocable, royalty-free, perpetual license with right to sublicense in the applicable Major Market Countries to the applicable Instituted-Funded Technology and any applicable Project Results. For clarification, a determination by RECIPIENT to (i) abandon a patent application in favor of a continuation or divisional application or the like, or (ii) narrow the scope of the claimed subject matter, shall not be deemed an election to abandon such Institute-Funded IPR.

 

Page D1

 

 

Section D1.04 Cost of Protection. The INSTITUTE shall not be responsible for, and no Grant funds may be used to pay for, any costs or expenses associated with RECIPIENT’s efforts to protect the Institute- Funded IPR.

 

Section D1.05 Inventions.

 

	 	
			(a)

				
			Disclosures and Patent Applications. RECIPIENT shall notify INSTITUTE of each Institute-Funded Invention by delivering to INSTITUTE a copy of the invention disclosure within thirty (30) days after RECIPIENT receives or generates it. In the event that a patent application is filed on the invention disclosure, RECIPIENT shall provide the INSTITUTE with a complete copy of such patent application and associated filing documents within (30) days of its filing.

			
	 	 	 
	 	
			(b)

				
			Patent Prosecution and Maintenance. For all Institute-Funded Inventions for which patent protection is pursued, RECIPIENT shall provide an annual written report to the INSTITUTE regarding the status of pending applications and issued patents that are Institute-Funded IPR.

			

 

Section D1.06 Required Agreements with Recipient Personnel and Contractors. The RECIPIENT shall have, maintain and enforce written policies or agreements applicable to Recipient Personnel and Contractors with terms sufficient to enable RECIPIENT to fully comply with all terms and conditions of this Contract, including that Recipient Personnel and Contractors agree to and hereby assign any Institute- Funded Inventions to RECIPIENT. RECIPIENT shall promptly report to INSTITUTE any material breach of such policies or agreements relating to or affecting any of the provisions of this Contract.

 

Section D1.07 Agreements with Collaborators. All agreements between RECIPIENT and a Collaborator, or a third party participating in the development of the Project Results, relating to or affecting joint ownership of any Project Result shall recognize the licenses, interests and other rights provided to the INSTITUTE in the Contract. RECIPIENT shall provide to the INSTITUTE a copy of each such agreement affecting joint ownership of any Project Result.

 

PART 2

 

NON-COMMERCIAL LICENSES

 

Section D2.01 RECIPIENT License. In granting an Exclusive License to any Project Results, RECIPIENT shall retain the right to Exploit all Project Results (including material embodiments thereof) for education, research and other non-commercial purposes, and the right to grant the licenses pursuant to Section D2.02 below.

 

Section D2.02 INSTITUTE License. RECIPIENT agrees to grant, and does hereby grant, to the INSTITUTE a non-exclusive, irrevocable, royalty-free, perpetual, worldwide license with right to sublicense under the Project Results and, subject to any existing third party rights, any Necessary Additional IPR to Exploit all Project Results (including material embodiments of Project Results) by the INSTITUTE, other governmental entities and agencies of the State of Texas, and private or independent institutions of higher education (as defined by Texas law) located in Texas, for education, research and other non-commercial purposes only pursuant to industry-standard confidentiality and/or material transfer agreements to be entered into between the parties, as applicable. RECIPIENT shall make the Institute-Funded Technology available by reasonable means to the INSTITUTE in order for the INSTITUTE to exercise its rights under this Section D2.02, at no cost to RECIPIENT. A copy of any written license granted by INSTITUTE under this Section D2.02 will be provided to RECIPIENT by INSTITUTE within ten (10) days of the effective date of such license.

 

Section D2.03 No Implied Licenses. No implied licenses are granted under this Agreement including without limitation any license to any Intellectual Property Rights owned or controlled by RECIPIENT outside of the Institute-Funded IPR. Nothing in this Agreement shall be construed to impose an obligation on RECIPIENT to license or otherwise make available any of its Intellectual Property Rights or other resources owned or controlled by it except as expressly provided in this Agreement.

 

Page D2

 

 

PART 3 

 

COMMERCIALIZATION OF PROJECT RESULTS

 

Section D3.01 Commercialization Strategy. RECIPIENT shall be under a continuing obligation throughout the term of this Contract to enhance and improve the commercial development plan submitted with the Application and to provide an annual written report to the INSTITUTE regarding the RECIPIENT’s and its licensee’s efforts to commercialize or otherwise bring to practical application Project Results. The INSTITUTE may, at its option and at any time, provide RECIPIENT with comments regarding the RECIPIENT’s commercial development plan and strategy, in which case RECIPIENT shall consider in good faith and, if appropriate, use reasonable efforts to account for and incorporate the INSTITUTE’s input into such commercial development plan and strategy.

 

Section D3.02 Commercialization Efforts. The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

 

Section D3.03 Licensing of Project Results. Each License Agreement entered into by the RECIPIENT shall include an acknowledgement by the licensee that (i) such License Agreement is subject to the INSTITUTE’s licenses, interests and other rights under this Contract, and (ii) to the extent that there is a conflict between the terms of the License Agreement and the terms of this Contract, the terms of this Contract shall prevail. In addition, all License Agreements shall include terms obligating the licensee to report to the RECIPIENT such information as is required for the RECIPIENT to fully comply with the terms of the Contract, including without limitation the reporting obligations set forth in Attachment E, and to allow RECIPIENT to make the grants specified in Sections D2.02. The RECIPIENT shall monitor the performance of its licensees and such licensees’ compliance with the terms of the License Agreements and shall take commercially reasonable actions to enforce the terms of all License Agreements. The RECIPIENT shall promptly report to the INSTITUTE any material breach of a License Agreement relating to or affecting any of the material provisions of this Contract.

 

Section D3.04 Cost of Licensing Activities. The INSTITUTE shall not be responsible for, and no Grant funds may be used to pay for, any costs or expenses associated with the RECIPIENT’s Licensing Activities.

 

Section D3.05 Survival. The licenses, rights and obligations set forth in this Attachment D, except Section D3.01, shall survive any termination of this Contract, including any termination for convenience by RECIPIENT.

 

Section D3.06 Recipient Opt-Out. In the event RECIPIENT determines, after diligently attempting to comply with the terms of Section D3.02, to cease its efforts, either directly or through a licensee, to commercialize or otherwise bring to practical application the Project Results, it will so notify the INSTITUTE in writing promptly thereafter. Such written notice must identify the Project Results and provide a reasonable explanation of the reasons for the RECIPIENT’s election. Upon receipt of such notice, the INSTITUTE and RECIPIENT shall meet within thirty (30) days to review the Project Results and rationale for the RECIPIENT’s election. Provided that RECIPIENT’s determination to cease its efforts was not based on material safety concerns related to the Project Results, the INSTITUTE and RECIPIENT shall engage in good faith negotiations regarding an alternative commercialization strategy and/or revenue sharing approach.

 

Page D3

 

 

The INSTITUTE and RECIPIENT may consider, among other options, an award of equity in the RECIPIENT, expansion or modification of the Institute Funded Activity to cover other commercial products or commercial services being advanced by the RECIPIENT, or some combination thereof. Unless otherwise agreed, if the INSTITUTE and RECIPIENT are unable to achieve an alternative strategy or agreement within one-hundred and eighty (180) days of the RECIPIENT’s initial notice of election, and provided that RECIPIENT’s determination to cease its efforts was not based on material safety concerns related to the Project Results, the INSTITUTE shall have the right, but not the obligation, to exercise its rights in Section D5.01 in relation to the Project Results at the INSTITUTE’s expense. If the INSTITUTE elects to exercise its rights under Section D5.01 in relation to the Project Results, the INSTITUTE shall notify the RECIPIENT in writing within the later of 220 days of INSTITUTE’s receipt of the RECIPIENT’s initial notice of election or thirty (30) days following a declaration by one of the Parties that good faith negotiations have failed. In the event that the INSTITUTE exercises its option under this Section D3.06, the RECIPIENT shall cooperate with the INSTITUTE’s efforts and provide to INSTITUTE sufficient information such as relevant feasibility studies, trial results, regulatory summaries, and pertinent schedules or deadlines in relation to the Project Results, in commercializing or otherwise bringing to practical application the applicable Project Results at the INSTITUTE’s cost. For clarity, so long as the RECIPIENT is making efforts to commercialize at least one Commercial Product or Commercial Service, RECIPIENT shall have no obligation to provide the written notice as described in this Section D3.06.

 

PART 4 

 

REVENUE SHARING

 

Section D4.01 Revenue Sharing Percentages. In consideration for the Grant Award Proceeds paid to the RECIPIENT by the INSTITUTE under the Contract:

 

	 	
			a.

				
			RECIPIENT shall pay to the INSTITUTE during the Revenue Term the following payments until the INSTITUTE receives the aggregate amount of REDACTED of the Grant Award Proceeds:

			

 

	 	
			(i)

				
			a revenue sharing percentage of REDACTED of Revenue for Cumulative Revenue

			

 

greater than five million U.S. dollars (USD$ 5,000,000) and less than or equal to five hundred million U.S. dollars (USD$ 500,000,000);

 

	 	
			(ii)

				
			a revenue sharing percentage of REDACTED of Revenue for Cumulative Revenue greater than five hundred million U.S. dollars (USD$ 500,000,000) and less than or equal to one billion

			

 

U.S. dollars (USD $1,000,000,000); and

 

	 	
			(iii)

				
			a revenue sharing percentage of REDACTED of Revenue for Cumulative Revenue greater than one billion U.S. dollars (USD $1,000,000,000).

			

 

For clarity, no payments will be made by the RECIPIENT to the INSTITUTE under this Section D4.01(a) until the Cumulative Revenue of the Recipient is greater than five million U.S. dollars (USD

$5,000,000).

 

	 	
			b.

				
			In the event the RECIPIENT and/or its licensee is required to obtain a license under Intellectual Property Rights of one or more Third Parties in order to make Sales of Commercial Products and/or Commercial Services in any given country (“Participating License Sources”), then the revenue sharing percentages set forth under Section D4.01(a)(i)-(iii) may be reduced by REDACTED paid to such Third Parties on Commercial Products and/or Commercial Services in such country, as applicable, provided that in no event will the payments otherwise due to the INSTITUTE under Section D4.01(a) be less than fifty percent (50%) of the payments that would be payable to the INSTITUTE absent the effects of this Section D4.01(b).  REDACTED

			

 

Page D4

 

 

Section D4.02 Continued Revenue Sharing. In the event the INSTITUTE receives during the Revenue Term the aggregate amount of REDACTED of the Grant Award Proceeds from the RECIPIENT, the RECIPIENT will continue to pay the INSTITUTE a revenue sharing percentage of REDACTED of Revenue for all Revenue generated during the remainder of the Revenue Term. For clarity, this revenue sharing percentage cannot be reduced as set forth in Section D4.01(b).

 

Section D4.03 Equity. Nothing herein prohibits the INSTITUTE from negotiating with the RECIPIENT for an equity share in the RECIPIENT in addition to or in lieu of the revenue sharing set forth in Sections D4.01 and D4.02, when mutually agreed to by the INSTITUTE and the RECIPIENT. But under no circumstances is the INSTITUTE obligated to negotiate for an equity share in the RECIPIENT in lieu of the revenue sharing set forth herein.

 

Section D4.04 Statements and Timing of Payments. All payments owed pursuant to this Part 4 shall be made to the Cancer Prevention and Research Institute of Texas, and are payable on or before the thirtieth day following the end of the calendar quarter in which the Revenue is received or, in the case of Section D4.05, the monetary recovery is received. For each payment specified in Sections D4.01 and D4.02, the payment shall be accompanied by a statement specifying for such calendar quarter: (i) the Contract to which the payment relates, (ii) the identities of, royalty percentages, and amounts actually paid to any Participating License Sources, (iii) the License Agreements, if any, to which the payment relates, (iv) the quantity of all Sales of each Commercial Product and Commercial Service since the last payment, if Sales are applicable to the current payment, (v) the gross consideration from all such Sales, if Sales are applicable to the current payment, and (vi) a calculation of the amount of the payment to the Cancer Prevention and Research Institute of Texas.

 

Section D4.05 Recoveries in Enforcement Actions. In the event that the RECIPIENT receives any monetary recovery from its enforcement of Institute-Funded IPR against infringement by a third party, then it shall pay to the State of Texas a share of such monetary recovery, including any punitive damages, less the documented fees and expenses that are directly associated with such enforcement and are paid by RECIPIENT to third parties, at the same rate and in the same manner as it shares Revenue pursuant to Sections D4.01 and D4.02 (including any adjustments allowed by Section D4.01(b)). For clarity, if the enforcement action is resolved by way of the execution of a License Agreement with the allegedly infringing third party and such License Agreement is consistent with this Part 4, then this Section D4.05 is not intended to apply to such License Agreement or the consideration specified therein.

 

Section D4.06 Revenue-Related Records. In addition to satisfying the requirements of Article IV of the Contract and Section E1.03 of Attachment E, the RECIPIENT shall keep complete and accurate Revenue- related records until the fourth anniversary of the date of the payment of the last payment owed hereunder, in sufficient detail to permit the INSTITUTE to confirm the accuracy of the statements delivered to the INSTITUTE under Section D4.04 and the calculation of the payments owed hereunder.

 

Section D4.07 Audit of Revenue-Related Records. Upon at least fifteen (15) days’ advance written notice, the RECIPIENT shall permit the INSTITUTE or its representatives or agents, at the INSTITUTE’s expense, to examine the Revenue-related records of the RECIPIENT pursuant to Section D4.06 once per calendar year during regular business hours for the purpose of and to the extent necessary to verify the RECIPIENT’s compliance with this Part 4. The rights of the INSTITUTE under this Section D4.07 shall terminate on the fourth anniversary of the date of the payment of the last payment owed hereunder. In the event that any such examination reveals an underpayment to the INSTITUTE of greater than five percent (5%) of the amounts previously paid by the RECIPIENT to the INSTITUTE, then the RECIPIENT shall reimburse the INSTITUTE for the cost of such examination.

 

Page D5

 

 

PART 5

 

OPT-OUT AND DEFAULT

 

Section D5.01 RECIPIENT Opt-Out. If the INSTITUTE elects to exercise its rights in relation to the Project Results under Section D3.06, the INSTITUTE shall have the right, but not the obligation, to pursue protection of the Applicable Institute-Funded IPR on its own behalf, including directing the filing, prosecution and maintenance of patents covering the applicable Institute-Funded Inventions and/or to commercialize or otherwise bring to practical application Project Results covered by the Applicable Institute-Funded IPR, at its own cost, either directly or through one or more licensees. For the purposes of this Part 5, “Applicable Institute-Funded IPR” shall mean all Project Results. If the INSTITUTE elects to exercise any such rights under this Section D5.01, it shall notify RECIPIENT in writing pursuant to the notification requirements in Section D3.06 and RECIPIENT shall thereafter comply with the terms of Section D5.03 with regard to the Applicable Institute-Funded IPR.

 

Section D5.02 RECIPIENT Default. In the event that the INSTITUTE notifies RECIPIENT in writing of RECIPIENT’s failure to materially comply with its obligations under Section D3.02, and RECIPIENT fails within sixty (60) days of such notice either: (a) to cure such failure, or in the event that such failure cannot be reasonably cured within such 60-day period, to provide to INSTITUTE a plan to cure such failure that INSTITUTE deems acceptable, (b) to provide written notice to the INSTITUTE that such failure was due to material safety concerns, or (c) to provide proper notice pursuant to Section 3.06, then without further action on the part of the RECIPIENT or INSTITUTE, the RECIPIENT shall be deemed to have provided the INSTITUTE the complete, written notice of its cessation of efforts as described in Section 3.06, and the INSTITUTE shall be free to exercise its rights under Section 3.06.

 

Section D5.03 RECIPIENT Cooperation upon Opt-Out or Default. In the event that the INSTITUTE exercises any of its rights under Section D5.01, the RECIPIENT shall:

 

	 	
			(1)

				
			subject to any existing third party rights, transfer and assign, and does hereby assign, all of its right, title and interest in and to the applicable Project Results to the INSTITUTE or the INSTITUTE’s designee, to the maximum extent allowed by law, including where relevant and necessary to facilitate the foregoing transfer, requesting and diligently attempting to obtain any approvals required by law or otherwise in relation to such transfer, and subject to any existing third party rights, hereby grants to the INSTITUTE a non-exclusive, royalty-free, perpetual, fully transferable and sublicensable license under any Institute-Funded Technology and Necessary Additional IPR to Exploit the Project Results for the development, manufacture and sale of Commercial Products and Commercial Services and for all other purposes reasonably related thereto;

			

	 	
			(2)

				
			to the extent that RECIPIENT is unable to transfer all of its right, title and interest in and to the applicable Project Results to the INSTITUTE as specified in Section D5.03(1), and subject to any existing third party rights, RECIPIENT hereby grants to the INSTITUTE an exclusive, royalty-free, perpetual, fully transferable and sublicensable license under the Applicable Institute-Funded IPR to Exploit the Project Results for the development, manufacture and sale of Commercial Products and Commercial Services and for all other purposes reasonably related thereto, provided that the INSTITUTE may exercise the foregoing rights only after exercising its right under Section D5.01;

			

	 	
			(3)

				
			cooperate with the INSTITUTE’s efforts, and at the INSTITUTE’s cost, in protecting Applicable Institute-Funded IPR and Institute-Funded Technology, and in commercializing or otherwise bringing to practical application the applicable Project Results, including making relevant Recipient Personnel (to the extent still obligated to RECIPIENT), Contractors, Collaborators, records (including without limitation, laboratory notebooks, electronic records and data), papers, information, samples, specimens and other materials related to the applicable Project Results reasonably available for such purposes and executing any documents and taking any further action reasonably necessary to effectuate the intent of this Section D5.03; and

			 

			

Page D6

 

 

	 	
			(4)

				
			subject to applicable law, not take any action that would oppose or impede the INSTITUTE’s ability to protect the applicable Project Results.

			

 

If the INSTITUTE exercises its rights under Sections D5.01, the RECIPIENT shall have no further claim to or interest in the applicable Project Results, except as set forth in Section D2.01 of this Attachment and shall not be entitled to any share of Revenue or any other compensation with respect to such Project Results, except to the minimum extent required by law, if any. To the extent that the INSTITUTE has exercised its rights under Section D5.01 and RECIPIENT is unable to transfer all of its right, title and interest in and to the applicable Project Results to the INSTITUTE as specified in D5.03(1), then the INSTITUTE’s license set forth in D5.03(2) includes the right, but not the obligation, for the INSTITUTE at its cost to: (i) direct the filing, prosecution and maintenance of patents covering the applicable Project Results, and (ii) enforce all Applicable Institute-Funded IPR relevant to the Project Results against any infringement by a third party. Subject to the statutory duties of the Texas Attorney General, if any, RECIPIENT shall cooperate fully with the INSTITUTE in any action brought by the INSTITUTE to enforce the Institute-Funded IPR in the applicable Project Results, at the INSTITUTE’s cost, including without limitation, joining the enforcement action in name as a party plaintiff after all required approvals are obtained; provided that the INSTITUTE or its designee shall have full control over such enforcement action and shall receive and retain all monetary and other recoveries resulting from such enforcement actions, including any punitive damages.

 

PART 6 

 

DEFINITIONS

 

Throughout this Attachment D, the following underlined terms shall have the meanings given below.

 

	
			(1)

				
			Commercial Product means anything that is based on, utilizes or is developed from, or materially incorporates, the Project Results and that is capable of being sold, licensed, transferred or conveyed to another party or is capable of otherwise being Exploited or disposed of, whether in exchange for consideration or not.

			
	 	 
	(2)	
			Commercial Service means any service performed that is based on, utilizes or is developed from, or materially incorporates, the Project Results. For clarity, Commercial Service does not include non- commercial research and development performed by RECIPIENT or its Collaborators or licensees.

			
	 	 
	(3)	
			Cumulative Revenue means after the First Commercial Sale worldwide of a Commercial Product or Commercial Service, the sum of all Revenue in all years and calendar quarters up to the calendar quarter in which the applicable revenue sharing percentage in Section D4.01 is being paid.

			
	 	 
	(4)	
			Exclusive License means a License Agreement under which the specific rights granted to the licensee with respect to the Project Results, including without limitation scope of use and territorial rights, are granted on an exclusive basis.

			
	 	 
	(5)	
			Exclusivity means any exclusivities granted by the government in a country to provide an entity with protection from competitors in the commercial market for a defined period of time, including but not limited to patent-based exclusivities (and any patent term extensions, supplementary protection certificates or patent term adjustments thereof, and the like), and market-based “data” exclusivities (e.g., orphan drugs, new chemical entities, biologics, new formulations or combinations, and pediatric, and the like). For the avoidance of doubt, Exclusivity shall not mean any protection gained solely from either trade secrets or trademarks.

			

 

 

Page D7

 

 

	
			(6)

				
			Exploit or Exploitation means make, have made, use, sell, offer to sell, import, export, or otherwise commercialize, dispose of, practice, copy, distribute, create derivative works of, publicly perform or publicly display.

			
	 	 
	
			(7)

				
			First Commercial Sale means the first bona fide arm’s length Sale of a Commercial Product or Commercial Service to a Third Party by or on behalf of RECIPIENT or its licensees for monetary value, for use or consumption by the end user of such Commercial Product or Commercial Service. For clarity, Sales of a Commercial Product or Commercial Service for registration samples, clinical trial purposes or compassionate use sales, named patient use, test marketing, sampling and promotional uses, inter- company transfers to affiliates of RECIPIENT or its licensees, shall not constitute a First Commercial Sale.

			
	 	 
	
			(8)

				
			Grant Award Proceeds means the sum of all monies paid by INSTITUTE to RECIPIENT under the Contract. For clarity, Grant Award Proceeds will not be diminished by the amount of any funds repaid to INSTITUTE by RECIPIENT under Section 4.07 of the Contract.

			
	 	 
	
			(9)

				
			Institute-Funded IPR means any and all Intellectual Property Rights in and to Institute-Funded Technology. In no event shall Institute-Funded IPR include any intellectual property rights and/or technology in existence and owned/controlled by the RECIPIENT prior to the receipt of funds from the INSTITUTE or arising from activities conducted independently of the Project or acquired independently of the Project.

			
	 	 
	
			(10)

				
			Institute-Funded Invention means an Invention conceived or first reduced to practice by or on behalf of RECIPIENT, including by Recipient Personnel, Contractor(s) and/or Collaborator(s) in the performance of Institute-Funded Activity.

			
	 	 
	
			(11)

				
			Institute-Funded Technology means any and all of the following resulting or arising, in whole or in part, from Institute-Funded Activity during the Contract term: (a) proprietary and confidential information, including but not limited to data, trade secrets, materials and know-how; (b) databases, compilations and collections of data; (c) tools, methods and processes; and (d) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all instantiations of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug formulations, devices, diagnostics, biomarkers, reagents, methodologies and research tools. Institute-Funded Technology includes Institute-Funded Inventions. Institute-Funded Technology shall not include items that were conceived of, in existence, or owned/controlled by RECIPIENT prior to receipt of funds from the INSTITUTE or arising from activities conducted independently of the Project or acquired independently of the Project, such as: (a) proprietary and confidential information, including but not limited to data, trade secrets, materials and know-how; (b) databases, compilations and collections of data; (c) tools, methods and processes; and (d) works of authorship, excluding all scholarly works, but including, without limitation, computer programs, source code and executable code, whether embodied in software, firmware or otherwise, documentation, files, records, data and mask works; and all instantiations of the foregoing in any form and embodied in any form, including but not limited to therapeutics, drugs, drug delivery systems, drug formulations, devices, diagnostics, biomarkers, reagents, methodologies and research tools.

			
	 	 
	
			(12)

				
			Intellectual Property Rights or IPR means any and all of the following and all rights in, arising out of, or associated therewith: (a) all United States and foreign patents and utility models and applications therefor, and all reissues, re-examinations, divisionals, renewals, substitutions, extensions, provisionals, continuations and continuations-in part thereof, and equivalent or similar rights anywhere in the world in inventions and discoveries; (b) all trade secrets and rights in know-how, materials and proprietary information; (c) all copyrights, copyright registrations and applications therefor, and all other rights corresponding thereto throughout the world; (d) all mask works, mask work registrations and applications therefor, and any equivalent or similar rights in semiconductor masks, layouts, architectures or topology; and (e) any similar, corresponding or equivalent rights to any of the foregoing anywhere in the world.

			

 

Page D8

 

 

	
			(13)

				
			Invention means any idea, composition of matter, method, device, process or discovery that is conceived and/or reduced to practice, whether patentable or not.

			
	 	 
	
			(14)

				
			License Agreement means an agreement by which an owner of a Project Result grants any right to Exploit such Project Result to a Third Party in exchange for consideration.

			
	 	 
	
			(15)

				
			Licensing Activities means the efforts of RECIPIENT or its Collaborator to negotiate, execute or enforce a License Agreement.

			
	 	 
	
			(16)

				
			Major Market Country means one or more of the following: Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, and United States of America.

			
	 	 
	
			(17)

				
			Necessary Additional IPR means any Intellectual Property Rights (a) owned by RECIPIENT, and (b) identified by the Institute and agreed to in writing by RECIPIENT, that are not Project Results but are necessary to Exploit the Project Results for the specific purposes set forth in the applicable Section of this Attachment D.

			
	 	 
	
			(18)

				
			Project Results means any and all Institute-Funded Technology and Institute-Funded IPR.

			
	 	 
	
			(19)

				
			Revenue means the gross consideration, whether cash (for example, but not by way of limitation, any milestone fees, license fees, sublicense fees, or assignment fees) or non-cash (for example, but not by way of limitation, securities, direct equity interest, indirect equity interest, trade or barter considerations, and the like), received from Sales to a Third Party by or on behalf of the RECIPIENT and its licensees (including RECIPIENT’s affiliates and sublicensees of RECIPIENT’s licensee), net of: (a) trade or quantity discounts or rebates, credits, allowances or refunds given for rejected or returned Commercial Products or Commercial Services, (b) any sales, value-added or other tax or governmental charge levied on the sale, transportation or delivery of a Commercial Product or Commercial Service (but excluding any income tax owed by the RECIPIENT), and (c) any separately stated charges for freight, postage, shipping and insurance. The foregoing notwithstanding, any consideration: (i) received and used by RECIPIENT or its licensees for the purpose of research or development of Commercial Products and Commercial Services, or (ii) received from Sales made solely in the performance of clinical trials designed to obtain regulatory approval for a Commercial Product or Commercial Service, or (iii) received by RECIPIENT or its licensees from Sales made for compassionate use where no profit was obtained by RECIPIENT or its licensees shall not be included in this term.

			
	 	 
	
			(20)

				
			Revenue Term means the period commencing on the date of the First Commercial Sale of a Commercial Product or Commercial Service and ending, on a country-by-country basis, when there is not, or there no longer exists, any Exclusivity for the Commercial Product or Commercial Service in such country. If there is no Exclusivity for a Commercial Product or Commercial Service in any Major Market Country, the Revenue Term shall mean the period commencing on the date of the First Commercial Sale of such Commercial Product or Commercial Service and ending twelve (12) years later.

			
	 	 
	
			(21)

				
			Sale or Sales means any sale, license, lease, transfer, conveyance or other Exploitation or disposition of a Commercial Product or Commercial Service for which consideration from a first Third Party is received. For clarity, transfer or assignment of a Commercial Product or Commercial Service in connection with a merger, consolidation, transfer or sale of all, or substantially all, of RECIPIENT’s business or assets, or change of control or similar transaction involving the RECIPIENT will not constitute a Sale.

			
	 	 
	
			(22)

				
			Third Party means a party other than (a) the RECIPIENT, (b) any affiliate or licensee of the RECIPIENT, either directly or through any sublicenses, or (c) an entity that enjoys any special course of dealing with any of (a) or (b) above.

			

 

Other terms may be defined elsewhere in this Attachment or in the Contract.

Page D9

 

 

 

ATTACHMENT E

 

REPORTING REQUIREMENTS

 

This Attachment E is hereby incorporated into and made a part of that certain CANCER RESEARCH GRANT CONTRACT (“Contract”) by and between the Cancer Prevention and Research Institute of Texas (“CPRIT” or the “INSTITUTE”) and the RECIPIENT. A capitalized term used in this Attachment shall have the meaning given to term in the Contract or in the Attachments to the Contract, unless otherwise defined herein. In the event of a conflict between the provisions of this Attachment and the provisions of the Contract, this Attachment shall control.

 

INSTITUTE and RECIPIENT agree as follows:

 

ANNUAL REPORTING

 

Section E1.01 Annual Reports. The RECIPIENT shall submit reports annually to the INSTITUTE within 60 days of the anniversary of the Effective Date of this Contract or at such other time as may be specified herein. The reports shall be submitted by the means and in the form(s) required by the INSTITUTE and shall be signed by the Principal Investigator/Program Director and the RECIPIENT’s Authorized Signing Official. To the extent possible, the reports shall only include information that may be shared publicly. However, if it is necessary to submit information in the reports that the RECIPIENT considers confidential in order to fully comply with the terms of this Contract, then the RECIPIENT shall use reasonable efforts to mark such information as “confidential” and shall, to the extent practicable , to segregate such information within the reports to facilitate its redaction should redaction ever be necessary or appropriate.

 

Section E1.02 Contents of Reports. Each report shall contain a signed verification (electronic signature is acceptable) of RECIPIENT’s compliance with each of its obligations as set forth in the Contract and shall include the following for the period covered by such report, as may then be applicable:

 

	
			(a)

				
			Project Data. During the term of the Contract, RECIPIENT shall include in its annual report each of the following (except that the final annual report due under this part (a) shall be due within ninety (90) days after the end of the term of the Contract):

			

 

	 	
			(1)

				
			A brief statement of the progress made to under the Scope of Work, including the progress to achieve the Project Goals and Timelines set forth in Attachment A.

			
	 	 	 
	 	
			(2)

				
			A brief statement of the Project Goals for the twelve months following submission of the report.

			
	 	 	 
	 	
			(3)

				
			New jobs created in the preceding twelve month period as a result of the Grant funds awarded to RECIPIENT.

			
	 	 	 
	 	
			(4)

				
			An inventory of the Equipment purchased for the Project using Grant funds.

			
	 	 	 
	 	
			(5)

				
			A HUB report in accordance with Section 3.08 “Historically Underutilized Businesses” of the Contract.

			

 

	
			(b)

				
			Commercialization Data. During the term of the Contract and continuing thereafter for so long as RECIPIENT has ongoing obligations to the INSTITUTE with respect to protection, development, commercialization and licensing of Project Results pursuant to Attachment D, RECIPIENT shall provide information about commercialization activities in a format specified by the INSTITUTE.

			

 

	
			(c)

				
			Revenue Sharing Data. During the term of the Contract and continuing thereafter for so long as RECIPIENT has ongoing obligations to the INSTITUTE with respect to revenue sharing pursuant to Attachment D:

			

 

	 	
			(1)

				
			A statement of the identities of the funding sources, amounts and dates of funding for all funding sources for the Project.

			
	 	 	 
	 	
			(3)

				
			A brief statement of the RECIPIENT’s efforts to secure additional funds to support the Project.

			
	 	 	 
	 	
			(4)

				
			All financial information necessary to verify the calculation of the revenue sharing amounts specified in Attachment D.

			

 

(d) Additional Data. In addition to the foregoing, RECIPIENT shall use commercially reasonable efforts to also promptly report any other information required by this Contract or otherwise reasonably requested by the INSTITUTE, the Legislature, or any other funding or regulatory bodies covering the RECIPIENT’s activities under this Contract.

 

Section E1.03 Record Keeping and Audits. The provisions of Article IV of the Contract shall apply fully to all information reported to the INSTITUTE pursuant to this Attachment, except that the right of the State of Texas to audit and the RECIPIENT’s obligation to maintain Records shall continue until four years after the date of each such report made by RECIPIENT hereunder.

 

Section E1.04 Confidentiality of Documents and Information. The provisions of Section 2.13 “Confidentiality of Documents and Information” of the Contract shall apply fully to all Confidential Information reported, delivered or submitted to the INSTITUTE pursuant to this Attachment E.

 

 

 

 

 

As indicated by the signatures below, the INSTITUTE and the RECIPIENT agree to the following amendments to the CPRIT Contract:

 

Original Contract End Date: 28 Feb 2018

 

Current Contract End Date: 28 Feb 2018

 

Proposed Contract End Date: 28 Feb 2019

 

Justification: Medicenna respectfully requests an extension to our contract end date of February 28, 2018 . [***] [Business rationale for the extension request redacted for competitive reasons]

 

Contract Document F: Parties hereby agree that the RECIPIENT is granted a twelve-month extension of time from the date of the original contract termination date reflected in Section 2.03 of the Contract for purposes of concluding the approved scope of work as authorized by the Contract. Accordingly, the February 28, 2018 termination date is deleted in Section 2.03 and replaced with February 28, 2019. All terms and conditions of the Contract continue during the extension period. Parties agree that this extension is a “no-cost” extension and approval of this amendment does not approve, grant or confer additional grant funds in excess of the amount originally awarded.

 

Description: The February 28, 2018 termination date is deleted in Section 2.03 and replaced with February 28, 2019.

 

	RECIPIENT	INSTITUTE
	Medicenna Therapeutics, Inc.	Cancer Prevention & Research Institute of Texas
	ASO Name: Merchant, Fahar	CEO Name: Roberts, Wayne
	Submitted Date: 26 Sep 2017	Approved Date: 23 Oct 2017
	 	 

 

 

 

 

As indicated by the signatures below, the INSTITUTE and the RECIPIENT agree to the following amendments to the CPRIT Contract:

 

Original Contract End Date: 28 Feb 2018

 

Current Contract End Date: 28 Feb 2019

 

Proposed Contract End Date: 28 Aug 2019

 

Justification: Medicenna respectfully requests a six-month extension of our contract which is currently aimed to end on February 28, 2019.

[***]

[rationale for the extension request redacted for competitive reasons]

 

Contract Document F: Parties hereby agree that the RECIPIENT is granted a second extension of time, for an additional six months from the termination date reflected in the Attachment F-No Cost Extension (Version 1) approved on October 23, 2017, for purposes of concluding the approved scope of work as authorized by the Contract. Accordingly, the February 28, 2019 termination date is replaced with August 28, 2019. All terms and conditions of the Contract continue during the extension period. Parties agree that this extension is a “no-cost” extension and approval of this amendment does not approve, grant or confer additional grant funds in excess of the amount originally awarded.

 

 

 

 

 

 

 

 

 

 

Description: The February 28, 2019 termination date is replaced with August 28, 2019 for purposes of concluding the approved scope of work as authorized by the Contract.

 

 

	RECIPIENT	INSTITUTE
	Medicenna Therapeutics, Inc.	Cancer Prevention & Research Institute of Texas
	ASO Name: Merchant, Fahar	CEO Name: Roberts, Wayne
	Submitted Date: 03 Dec 2018	Approved Date: 04 Feb 2019

 

 

 

 

Page 2 of 2

 

 

 

 

As indicated by the signatures below, the INSTITUTE and the RECIPIENT agree to the following amendments to the CPRIT Contract:

 

Original Contract End Date: 28 Feb 2018

 

Current Contract End Date: 28 Aug 2019

 

Proposed Contract End Date: 28 Feb 2020

 

Justification: Medicenna respectfully requests a six-month extension of our contract which is currently aimed to end on August 28, 2019.

[***]

In order to successfully complete the deliverables above and to achieve the objectives laid out in our CPRIT agreement we request a six-month extension to February 28, 2020. [Business rationale for the extension request redacted for competitive reasons]

 

Contract Document F: Parties hereby agree that the RECIPIENT is granted a third six-month extension of time from the termination date reflected in the Attachment F-No Cost Extension (Version 2) approved on February 4, 2019, for purposes of concluding the approved scope of work as authorized by the Contract. Accordingly, the August 28, 2019 termination date is replaced with February 28, 2020. All terms and conditions of the Contract continue during the extension period. Parties agree that this extension is a “no-cost” extension and approval of this amendment does not approve, grant or confer additional grant funds in excess of the amount originally awarded.

 

Description: The August 28, 2019 termination date is replaced with February 28, 2020 for purposes of concluding the approved scope of work as authorized by the Contract.

 

	RECIPIENT	INSTITUTE
	Medicenna Therapeutics, Inc.	Cancer Prevention & Research Institute of Texas
	ASO Name: Merchant, Fahar	CEO Name: Roberts, Wayne
	Submitted Date: 12 Jul 2019	Approved Date: 24 Jul 2019

 

 

 

Page 1 of 1

 

 

 

 

	
			Grant ID: DP150031

			No Cost Extension with Attachment F 

				PI/PD/CR: Fahar Merchant

                                                                                                                                                            

As indicated by the signatures below, the INSTITUTE and the RECIPIENT agree to the following amendments to the CPRIT Contract:

 

Original Contract End Date: 28 Feb 2018

 

Current Contract End Date: 28 Feb 2020

 

Proposed Contract End Date: 28 Aug 2020

 

Justification: Medicenna respectfully requests a six-month extension of our contract which is currently set to end on February 28, 2020.

[***]

request an extension to August 31, 2020 in order to complete the EOP2 and any necessary follow up. [Business rationale for the extension request redacted for competitive reasons]

 

Contract Document F: Parties hereby agree that the RECIPIENT is granted a fourth six-month extension of time from the termination date reflected in the Attachment F-No Cost Extension (Version 3) approved on July 24, 2019, for purposes of concluding the approved scope of work as authorized by the Contract. Accordingly, the February 28, 2020 termination date is replaced with August 28, 2020. All terms and conditions of the Contract continue during the extension period. Parties agree that this extension is a “no-cost” extension and approval of this amendment does not approve, grant or confer additional grant funds in excess of the amount originally awarded.

 

Description: The February 28, 2020 termination date is replaced with August 28, 2020 for purposes of concluding the approved scope of work as authorized by the Contract.

 

	RECIPIENT	INSTITUTE
	Medicenna Therapeutics, Inc.	Cancer Prevention & Research Institute of Texas
	ASO Name: Merchant, Fahar	CEO Name: Roberts, Wayne
	Submitted Date: 09 Dec 2019	Approved Date: 06 Jan 2020

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