Patent & Technology License Agreement, dated December 31, 2021, between Plus Therapeutics, Inc. and the University of Texas Health Science Center at San Antonio

EX-10.2 2 pstv-ex102_69.htm EX-10.2 pstv-ex102_69.htm

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Exhibit 10.2

 

***Certain identified information has been omitted from this exhibit in accordance with the rules of the Securities and Exchange Commission because it is both (i) not material to investors and (ii) information that the Registrant treats as private or confidential. Such omitted information is indicated by brackets (“[***]”) in this exhibit***

 

PATENT & Technology LICENSE AGREEMENT

AGT. No. HSC-1555-LA1

This Patent and Technology License Agreement (the “Agreement”) is between the Licensor and the Licensee identified below (collectively, “Parties”, or singly, “Party”).

 

No binding agreement between the Parties will exist until this Patent & Technology License Agreement has been signed by both Parties. Unsigned drafts of this Patent & Technology License Agreement shall not be considered offers.

Background

Licensor owns or controls Licensed Subject Matter (defined in Exhibit A). Licensee desires to secure the right and license to use, develop, manufacture, market, and commercialize the Licensed Subject Matter. Licensor has determined that such use, development, and commercialization of the Licensed Subject Matter is in the public’s best interest and is consistent with Licensor’s educational and research missions and goals. Licensor desires to have the Licensed Subject Matter developed and used for the benefit of Licensee, the inventors, Licensor, and the public.

 

NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties hereby agree as follows:

 

The Terms and Conditions of the Agreement attached hereto as Exhibit A are incorporated herein by reference in their entirety (the “Terms and Conditions”). In the event of a conflict between provisions of this Agreement and the Terms and Conditions, the provisions in this Agreement shall govern. Unless defined in this Agreement, capitalized terms used in this Agreement shall have the meanings given to them in the Terms and Conditions.

 

The section numbers used in the left-hand column in the table below correspond to the section numbers in the Terms and Conditions.

 

Licensee: Plus Therapeutics, Inc.CONFIDENTIAL OTC Exclusive License (Life Sciences)

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20. Special Provision. The Parties hereby agree to the following special provisions set forth in this Section 20 with respect to this Agreement.

 

20.1 If the Regulatory Authority authorizes Licensee to combine or skip any of Milestone Events 3.1(b)1 – 3.1(b)3, the amount due under Section 3.1(b) for the event not completed shall be payable on the next Milestone Event deadline. In no event shall Licensee’s obligation to pay the milestone fees under 3.1(b) be reduced due to a Regulatory Authority’s authorization to combine or skip any milestone.

 

21. No Other Promises and Agreements; Representation by Counsel. Licensee expressly warrants and represents and does hereby state and represent that no promise or agreement which is not herein expressed has been made to Licensee in executing this Agreement except those explicitly set forth herein and in the Terms and Conditions, and that Licensee is not relying upon any statement or representation of Licensor or its representatives. Licensee is relying on Licensee’s own judgment and has had the opportunity to be represented by legal counsel. Licensee hereby warrants and represents that Licensee understands and agrees to all terms and conditions set forth in this Agreement and said Terms and Conditions.

 

22. Deadline for Execution by Licensee. If this Agreement is executed first by the Licensor and is not executed by the Licensee and received by the Licensor at the address and in the manner set forth in Section 18 of the Terms and Conditions within 30 days of the date of signature set forth under the Licensor’s signature below, then this Agreement shall be null and void and of no further effect.

 

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IN WITNESS WHEREOF, the Parties hereto have caused their duly authorized representatives to execute this Agreement.

 

 

 

 

Approved as to form:

 

 

By

John Gebhard, Ph.D.

Assistant Vice President

Office of Technology Commercialization

Date ___________________________________

Licensee: Plus Therapeutics, Inc.CONFIDENTIAL OTC Exclusive License (Life Sciences)

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EXHIBIT A

Terms and Conditions of Patent & Technology License AGREEMENT

These Terms and Conditions of the Agreement (“Terms and Conditions”) are incorporated by reference into the Agreement to which they are attached. All Section references in these Terms and Conditions shall be references to provisions in these Terms and Conditions unless explicitly stated otherwise.

 

1. Definitions

 

“Affiliate” means any business entity more than 50% owned directly or indirectly by Licensee, any business entity which owns directly or indirectly more than 50% of Licensee, or any business entity that is more than 50% owned directly or indirectly by a business entity that owns more than 50% of Licensee.  For purposes of this Agreement, Licensor shall not be considered an “Affiliate” of Licensee.

 

“Agreement” means collectively (i) these Terms and Conditions, and (ii) the Patent & Technology License Agreement.

 

“Clinical Study Report” means a comprehensive clinical and statistical description of the methods, data, and outcomes of a clinical trial, presented in text, tables, and figures to Licensee by the entity conducting the clinical study.

 

“Commercially Reasonable Efforts” shall mean that level of effort considered reasonable on a market-by-market and indication-by-indication basis, which may be different for different markets and may change over time, reflecting changes in the status of the product and the market(s) involved.

“Contract Quarter” means the three (3) month periods indicated as the Contract Quarter in Section 1 of the Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.

“Contract Year” means the twelve (12) month periods indicated as the Contract Year in Section 1 of the Agreement, or any stub period thereof at the commencement of the Agreement or the expiration or termination of the Agreement.

 

“Database Lock” means after data collection has been completed in a clinical trial, including follow up of all participants as described in the clinical trial protocol, data quality and validation exercises are undertaken. After this, the database is “locked” so no further changes can be made to clinical trial data and the data are then able to be extracted from the database for analysis.

 

“Delivery of the Clinical Study Report” means the date on which the Licensee receives the substantially complete copy of the Clinical Study Report.

 

“Effective Date” means the date indicated as the Effective Date in Section 1 of the Agreement.

 

“Equity Recipients” means collectively Board and certain individuals who are inventors of the patent applications listed in Section 1 of the Patent and Technology License Agreement as stated on the Effective Date. Licensor will inform Licensee of the appropriate allotment of equity amongst the Equity Recipients, per Section 3.6(c) of this Exhibit A.

 

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“Fair Market Value” means the cash consideration an unaffiliated, unrelated buyer would pay in an arm’s length sale of a substantially identical item sold in the same quantity, under the same terms, and at the same time and place.

 

“FDA” means United States Food and Drug Administration.

 

“Field” means the field indicated as the Field identified in Section 1 of the Patent & Technology License Agreement.

“First Commercial Sale” means, with respect to any Licensed Product, the first Sale on a commercial basis to a third party of such Licensed Product in a given jurisdiction.

“Government” means any agency, department or other unit of the United States of America or the State of Texas.

 

“Gross Consideration” means all cash and non-cash consideration (e.g., securities).

 

“Inventors” (or singly, “Inventor”) means the inventors identified in the definition of Patent Rights in Section 1 of the Agreement.

 

“Licensed Patents” means the patents and patent applications listed in Section 1 of the Agreement.

“Licensed Process” means a method or process whose practice or use is covered by a Valid Claim or uses Technology Rights.

 

“Licensed Product” means any [***].

 

“Licensed Subject Matter” means Patent Rights and/or Technology Rights.

 

“Licensee” means the Party identified as the Licensee in Section 1 of the Agreement.

 

“Licensor” means the Party identified as the Licensor in Section 1 of the Agreement.

 

“Milestone Fees” means all fees identified as Milestone Fees in Section 3.1(b) of the Agreement.

 

“Net Product Sales” means, [***].

 

“Non-Royalty Sublicensing Consideration" means [***].

 

“Packaging” means fees actually paid by Licensee or its Sublicensees to unaffiliated third-party service providers for services (but not materials) required to put Licensed Product (or components thereof) into an approved, appropriately labeled container and trade dress suitable for manufacturing of the Licensed Product (or components thereof) or use with patients by medical professionals.

 

“Patent Rights” means the Licensor’s rights in:

(a) the Licensed Patents;

[***]

From time to time during the term of the Agreement, upon written agreement by both Parties, Licensee and Licensor shall update the list of all patent applications and patents within the Patent Rights.

 

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“Phase 1 Clinical Trial” means the initial introduction of Licensed Product into humans that would satisfy the requirements of 21 C.F.R. 312.21(a) or comparable laws, rules, or regulations of another Regulatory Authority.

 

“Phase 2 Clinical Trial” means a clinical trial to evaluate the safety and effectiveness of Licensed Product for a particular indication in humans that would satisfy the requirements of C.F.R. 312.21(b) or comparable laws, rules, or regulations of another Regulatory Authority.

 

“Phase 3 Clinical Trial” means a clinical trial that is designed to gather additional information about the effectiveness and safety of Licensed Product and evaluate the overall benefit-risk relationship of the Licensed Product and to define warnings, precautions, and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed that would satisfy the requirements of 21 C.F.R 312.21(c) or comparable laws, rules, or regulations of another Regulatory Authority.

 

“Product” means each therapeutic substance covered by the Licensed Subject Matter that requires new or supplemental Regulatory Approval for marketing authorization.

 

“Prosecution Counsel” means outside patent counsel that is mutually agreeable to both Parties, whereby such counsel enters into an appropriate contract and joint representation waiver with Board and the State of Texas Attorney General’s Office, and copies University on all patent documentation and correspondence. Prosecution Counsel as of the Effective Date is identified in Section 1 of the Agreement.

 

“Quarterly Payment Deadline” means the day that is [***] after the last day of any particular Contract Quarter.

 

“Regulatory Approval” means the first letter acknowledging approval and/or clearance received from the FDA or other Regulatory Authority for a Licensed Product in that jurisdiction within the Territory (whether CE mark, PMA, NDA, BLA, ANDA, 510(k), or a comparable regulatory approval or clearance letter received from a Regulatory Authority). For Japan, the definition of Regulatory Approval includes a conditional, time-limited marketing authorization.

 

“Regulatory Authority” means the regulatory agency, bureau, commission, council, department, or other governmental authority responsible for granting any necessary licenses or approvals for the marketing, Sale and use of a Licensed Product in a particular national (FDA, China National Medical Products Administration, Japanese Ministry of Health and Welfare), supra-national (European Medicines Agency), regional, state, or local jurisdiction.

 

“Sell, Sale or Sold” means any transfer or other disposition of Licensed Products for which consideration is received by Licensee, its Subsidiaries or Sublicensees. A Sale of Licensed Products will be deemed completed at the time Licensee, Affiliate, or its Subsidiary or its Sublicensee invoices, ships, performs, or receives payment for Licensed Products, whichever occurs first.

 

“Sublicense Agreement” means any agreement or arrangement pursuant to which Licensee (or an Affiliate or Subsidiary or Sublicensee) grants to any third party any of the license rights granted to the Licensee under the Agreement.

 

“Sublicense Fee” means the fee specified in Section 3.1(d) of the Agreement.

 

“Sublicensee” means any entity to whom an express sublicense has been granted under the Patent Rights and/or Technology Rights. For clarity, a third party wholesaler or distributor who has no significant responsibility for marketing and promotion of the Licensed Product within its distribution territory or field (i.e., the third party simply functions as a reseller), and who does not pay any consideration to Licensee, Affiliate, or a Subsidiary for such wholesale or distributor rights, shall not be deemed a Sublicensee; and the

 

Licensee: Plus TherapeuticsCONFIDENTIAL OTC Exclusive License (Life Sciences)

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resale by such a wholesaler or distributor shall not be treated as royalty bearing Net Sales by a Sublicensee provided that a royalty is being paid by Licensee for the initial transfer to the wholesaler or distributor pursuant to Section 3.2. This definition does not limit Licensee’s rights to grant or authorize sublicenses under the Agreement.

 

“Subsidiary” means an entity 100% owned directly or indirectly by Licensee.

 

“Technology Rights” means Licensor’s rights in technical information, know-how, processes, procedures, compositions, devices, methods, formulas, protocols, techniques, designs, drawings or data created before the Effective Date by Inventors while employed at the Licensor and within the Field which are not covered by a Valid Claim but which are necessary for practicing inventions claimed in patents and/or patent applications listed in the definition of Patent Rights whether outstanding, expired or abandoned.

 

“Territory” means the territory so indicated as the Territory in Section 1 of the Agreement.

 

“Third Party License” means any royalty-bearing license agreement with a third party which is not a Subsidiary or Affiliate of Licensee, entered into in writing by Licensee with said third party, in the absence of which the manufacture, use, import, export, or Sale of Licensed Products by Licensee infringes the relevant technology, if patented, or a misappropriation, if unpatented, that is the subject matter of such license agreement. A Third Party License does not include any license agreement for: [***].  

 

“Transport” means fees actually paid by Licensee or its Sublicensees to unaffiliated third-party service providers for services (but not materials) required to physically move Licensed Product (or the components thereof) from a Packaging location to a manufacturing, storage or distribution facility or the site of administration to a patient.

 

“Valid Claim” means a claim of an issued and unexpired patent included within the Patent Rights unless the claim has been held unenforceable or invalid by the final, un-reversed, and un-appealable decision of a court or other government body of competent jurisdiction, has been irretrievably abandoned or disclaimed, or has otherwise been finally admitted or determined to be invalid, un-patentable or unenforceable, whether through reissue, reexamination, disclaimer or otherwise.

 

2.License Grant and Commercialization

 

 

 

 

 

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2.2Subsidiaries and Affiliates

Licensee may extend the license granted herein to any Subsidiary or Affiliate (but only for so long as the relevant entity remains a Subsidiary or Affiliate) provided that the Subsidiary or Affiliate agrees in writing to be bound by the Agreement to the same extent as Licensee. For the sake of clarity, to the extent so extended to a Subsidiary or Affiliate, any specific reference to “Licensee” herein shall include such Subsidiary or Affiliate regardless of whether a specific reference to an “Subsidiary” or “Affiliate” is made in such provision. Licensee agrees to deliver such written agreement to Licensor within 30 calendar days following execution.

 

2.3Sublicensing

Licensee has the right to grant Sublicense Agreements under the Licensed Subject Matter consistent with the terms of the Agreement, subject to the following:

 

 

 

 

Licensee: Plus TherapeuticsCONFIDENTIAL OTC Exclusive License (Life Sciences)

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2.4Diligent Commercialization

Licensee by itself or through its Subsidiaries and Sublicensees will use Commercially Reasonable Efforts to make Licensed Products commercially available in the Field within the Territory. Without limiting the foregoing, Licensee will

 

 

 

2.5Litigation by Sublicensee

In each Sublicense Agreement the following clauses must be included:

 

In the event Sublicensee brings an action seeking to invalidate or render unenforceable any Licensed Patent:

 

 

 

Licensee: Plus TherapeuticsCONFIDENTIAL OTC Exclusive License (Life Sciences)

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Sublicensee shall provide written notice to Board at least three (3) months prior to bringing an action seeking to invalidate or render unenforceable a Licensed Patent. Sublicensee shall include with such written notice an identification of all prior art it believes invalidates any claim of the Licensed Patent.

 

 

3. Compensation

 

In consideration of rights granted to Licensee, Licensee will pay Licensor the following fees and royalties. Some fees and royalties are not refundable and are not creditable against other fees and royalties. Each payment will reference the Agreement number and will be sent to Licensor’s payment and accounting contact in Section 18 (Notices) of the Agreement.

 

3.1Non-Royalty Payments due from Licensee

 

 

 

 

 

Licensee: Plus TherapeuticsCONFIDENTIAL OTC Exclusive License (Life Sciences)

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Following the First Commercial Sale, Licensee will pay running royalties on Net Product Sales, as follows:

3.3[Reserved.]

 

If Licensee receives or anticipates receipt of non-cash consideration from Sales or Sublicenses, the manner in which Licensor will receive its compensation under the Agreement with respect to such non-cash consideration will be negotiated in good faith and timely agreed to in writing by the Parties.

 

3.5Litigation by Licensee

In the event Licensee brings an action seeking to invalidate or render unenforceable any Licensed Patent:

 

 

 

 

 

 

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Licensee shall provide written notice to Licensor at least three (3) months prior to bringing an action seeking to invalidate or render unenforceable a Licensed Patent. Licensee shall include with such written notice an identification of all prior art it believes invalidates any claim of the Licensed Patent.

 

3.6[Reserved.]

 

4.Reports and Plans

 

The reports specified in this Section 4 will be sent to Licensor’s payment and reporting contact identified in Section 18 (Notices) of the Agreement. If Licensor requests to have information submitted in a particular format, Licensee will use reasonable efforts to comply with such request.

 

4.1Quarterly Payment and Milestone Reports

or before each Quarterly Payment Deadline, Licensee will deliver to Licensor a true and accurate report, certified by an officer of Licensee, giving such particulars of the business conducted by Licensee, its Subsidiaries, Affiliates, and its Sublicensees (including copies of reports provided by Sublicensees and Subsidiaries to Licensee) during the preceding Contract Quarter under the Agreement as necessary for Licensor to account for Licensee’s payments, including royalties, hereunder, even if no payments are due. The reports shall continue to be delivered after the termination or expiration of the Agreement until such time as all Licensed Products permitted to be Sold after termination or expiration have been Sold or destroyed. The report shall be in the format of Exhibit B, and shall include:

 

 

Licensee: Plus TherapeuticsCONFIDENTIAL OTC Exclusive License (Life Sciences)

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The information that Licensor receives under this Section 4.1 will be deemed Confidential Information of the Licensee, subject to the exclusions listed in Section 8.7.

4.2Annual Written Progress Report and Commercialization Plan

Within [***] following the end of each Contract Year, Licensee will deliver to Licensor a true and accurate signed written progress report, that summarizes (i) Licensee’s efforts and accomplishments during the Contract Year towards upcoming Milestone Events and commercialization of Licensed Products, and (ii) Licensee’s development and commercialization plans with respect to Licensed Products for the next Contract Year. The report shall also cover such activities by Subsidiaries and Sublicensees. The report shall be in the format of Exhibit C and shall contain the following information to the extent relevant to the activities under the Agreement:

 

The information that Licensor receives under this Section 4.2 will be deemed Confidential Information of the Licensee, subject to the exclusions listed in Section 8.7.

4.3Government and Economic Development Reporting

If Licensor requests, Licensee will provide information for Licensor’s Government and economic development reporting purposes, including the following:

 

This information shall be treated as Licensee’s Confidential Information; provided that Licensor is entitled to combine such information with similar information from other Licensor licensees and publicly report such combined aggregate information, without identifying Licensee’s separate specific applicable numbers. If and when Licensee has more than 200 full-time employees, then no further economic development reports will be required from Licensee.

Licensee agrees to provide Licensor with an electronic copy of any correspondence or communication regarding Licensed Product or Licensed Process from a Regulatory Authority to Licensee within thirty (30) days of Licensee’s receipt of such correspondence or communication.

 

Licensee: Plus TherapeuticsCONFIDENTIAL OTC Exclusive License (Life Sciences)

Licensor: UT Health San AntonioEXHIBIT APage 14 of 33

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5.Payment, Records, and Audits

 

5.1Payments

All amounts referred to in the Agreement are expressed in U.S. dollars without deductions for taxes, assessments, fees, or charges of any kind. Each payment will reference the agreement number set forth at the beginning of the Agreement. All payments to Licensor will be made in U.S. dollars by check or wire transfer (Licensee to pay all wire transfer fees) payable to the payee identified in Section 18 of the Agreement and sent to the payment and reporting contact in Section 18 (Notices) of the Agreement.

 

5.2Sales Outside the U.S.

If any currency conversion shall be required in connection with the calculation of payments hereunder, such conversion shall be made using the rate used by Licensee for its financial reporting purposes in accordance with Generally Accepted Accounting Principles (or foreign equivalent) or, in the absence of such rate, using the average of the buying and selling exchange rate for conversion between the foreign currency and U.S. Dollars, for current transactions as reported in The Wall Street Journal on the last business days of the Contract Quarter to which such payment pertains. Licensee may not make any tax withholdings from payments to Licensor, but Licensor agrees to supply to Licensee, upon written request, appropriate evidence from appropriate U.S. governmental agencies showing that Licensor is a resident of the United States of America for purposes of the U.S. income tax laws and is tax-exempt under such income tax laws.

 

5.3Late Payments

Amounts that are not paid when due will accrue a late charge from the due date until paid, at a rate equal to [***].

 

5.4Records

For a period of six years after the Contract Quarter to which the records pertain, Licensee agrees that it and its Subsidiaries and Sublicensees will each keep complete and accurate records of their Sales, Net Product Sales, Net Service Sales, Milestone Fees, and Non-Royalty Sublicensing Consideration in sufficient detail to enable such payments to be determined and audited.

 

5.5Auditing

 

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Licensee and its Affiliates will permit an independent certified public accounting firm selected by Licensor, at Licensor’s expense, to periodically examine books, ledgers, and records during regular business hours, at Licensee’s or its Affiliate’s place of business, on at least 30 days advance notice, to the extent necessary to verify any payment or report required under the Agreement. For each Sublicensee, Licensee shall obtain such audit rights for Licensor or itself. If Licensee obtains such audit rights for itself, it will promptly conduct an audit of the Sublicensee’s records upon Licensor’s request (at Licensor’s expense), and Licensee will furnish to Licensor a copy of the findings from such audit. No more than one audit of Licensee, each Affiliate, and each Sublicensee shall be conducted under this Section 5.5 in any calendar year. If any amounts that became due to Licensor within three years of when such audit is performed, have been underpaid, then Licensee shall immediately pay Licensor the amount of such underpayment plus accrued interest due in accordance with Section 5.3 within 30 days of when Licensor delivers written notice of such underpayment to Licensee. [***]. Such audits may, at Licensor’s sole discretion, consist of a self-audit conducted by Licensee at Licensee’s expense and certified in writing by an authorized officer of Licensee. All information examined pursuant to this Section 5.5 shall be deemed to be the Confidential Information of the Licensee.

 

6.Patent Expenses and Prosecution

 

6.1Patent Expenses

Licensee shall pay for (i) the amount identified in Section 3.1(a) of the Agreement, (ii) all documented, out-of-pocket expenses incurred by Licensor for filing, prosecuting, defending and maintaining Patent Rights and related patent searches from the date indicated in Section 3.1(a) of the Agreement through the Effective Date of the Agreement, and (iii) all such future expenses incurred and documented by Licensor, for so long as, and in such countries as the Agreement remains in effect. Licensee will pay all patent expenses (except for the payment called for under Section 3.1(a) of the Agreement), including past expenses that have not been invoiced as of the date indicated in Section 3.1(a) of the Agreement and future expenses, within 30 days after Licensee’s receipt of an invoice. At the election of Licensor, Licensee will either pay Prosecution Counsel directly for patent expenses or will reimburse Licensor for such patent expenses. Patent expense payment delinquencies (whether owed directly to Prosecution Counsel or to Licensor) will be considered a payment default under Section 7.3(a).

 

6.2Direction of Prosecution

 

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6.3Ownership

All patent applications and patents will be in the name of Licensor (and any co-owner identified in Section 1 of the Agreement) and owned by Licensor (and such co-owner, if any). No payments due under the Agreement will be reduced as the result of co-ownership interests in the Patent Rights by Licensee or any other party.

 

6.4Foreign Filings

In addition to the U.S., the Patent Rights shall, subject to applicable bar dates, be pursued in such foreign countries as Licensee so designates in writing to Licensor in sufficient time to reasonably enable the preparation of such additional filings, and in those foreign countries in which Licensor has filed applications prior to the Effective Date. If Licensee does not choose to pursue patent rights in a particular foreign country and Licensor chooses to do so, Licensee shall so notify Licensor and thereafter said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto. Licensor shall have the right to make alternative arrangements with Licensee for upfront payment of foreign patent expenses.

 

6.5Withdrawal from Paying Patent Costs

If at any time Licensee wishes to cease paying for any costs for a particular Patent Right or for patent prosecution in a particular jurisdiction, Licensee must give Licensor at least 90 days prior written notice and Licensee will continue to be obligated to pay for the patent costs which reasonably accrue during said notice period. Thereafter, said patent application or patent shall no longer be included in the Patent Rights and Licensee shall have no further rights thereto.

 

6.6U.S. Patent and Trademark Office Entity Size Status

Licensee represents that as of the Effective Date the entity size status of Licensee in accordance with the regulations of the U.S. Patent and Trademark Office is as set forth in Section 1 of the Agreement. Licensee will inform Licensor in writing on a timely basis of any change in its U.S. Patent and Trademark Office entity size status.

6.7Patent Term Extensions

At Licensee’s request, Licensor may seek patent term extensions under 35 U.S.C. § 156 and other comparable laws and regulations for the Patent Rights.  Licensee shall have the right to decide

 

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which patents for which Patent Term Extensions may be sought.  Licensee shall reimburse Licensor for its reasonable out-of-pocket costs and expenses incurred in connection with such activities to the extent related to the Patent Rights.

 

7.Term and Termination

 

7.1Term

Unless earlier terminated as provided herein, the term of the Agreement will commence on the Effective Date and continue on a jurisdiction-by-jurisdiction basis until the last enforceable day of the last valid claim in that jurisdiction in which the Licensed Patents are nationalized, or if Technology Rights are licensed and no Patent Rights are applicable, for a term of twenty (20) years. Upon expiration of the Term pursuant to this Section 7.1, the licenses and other rights granted to Licensee under this Agreement shall become perpetual, irrevocable, fully paid-up (notwithstanding payment obligations due and payable prior to the expiration of the Term), and non-exclusive.

 

7.2Termination by Licensee

Licensee, at its option, may terminate the Agreement, in its entirety or on a country-by-country, Patent Right-by-Patent Right basis at its option, by providing Licensor written notice of intent to terminate, which such termination effective will be ninety (90) days following receipt of such notice by Licensor.

 

7.3Termination by Licensor

Licensor, at its option, may immediately terminate the Agreement, or any part of Licensed Subject Matter, or any part of Field, or any part of Territory, or the exclusive nature of the license grant, upon delivery of written notice to Licensee of Licensor’s decision to terminate, if any of the following occur:

 

 

 

 

 

7.4Other Conditions of Termination

The Agreement will terminate:

 

 

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(b)At any time by mutual written agreement between Licensee and Licensor.

 

7.5Effect of Termination

If the Agreement is terminated for any reason:

 

 

 

 

 

 

8.Confidentiality

 

8.1Definition

“Confidential Information” means all information that is of a confidential and proprietary nature to Licensor or Licensee and provided by one Party to the other Party under the Agreement.

 

8.2Protection and Marking

Licensor and Licensee each agree that all Confidential Information disclosed in tangible form, and marked “confidential” and forwarded to one by the other, or if disclosed orally, is designated as confidential at the time of disclosure, or that would reasonably be recognized as confidential by a professional skilled in the applicable field: (i) is to be held in strict confidence by the receiving Party, (ii) is to be used by and under authority of the receiving Party only as authorized in the Agreement, and (iii) shall not be disclosed by the receiving Party, its agents, employees, or consultants without the prior written consent of the disclosing Party or as authorized in the Agreement. Licensee has the right to use and disclose Confidential Information of Licensor reasonably in connection with the exercise of its rights under the Agreement, including without limitation disclosing to Subsidiaries, Sublicensees, potential investors, acquirers, and others on a need to know basis, if such Confidential Information is provided under conditions which reasonably protect the confidentiality thereof. Each Party’s obligation of confidence hereunder includes, without

 

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limitation, using at least the same degree of care with the disclosing Party’s Confidential Information as it uses to protect its own Confidential Information, but always at least a reasonable degree of care.

 

8.3Confidentiality of Terms of Agreement

Each Party agrees not to disclose to any third party the terms of the Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of the Agreement: (a) to advisors, actual or potential Sublicensees, acquirers or investors, and others on a need to know basis, in each case, under appropriate confidentiality obligations substantially similar to those of this Section 8; and (b) to the extent necessary to comply with applicable laws and court orders (including, without limitation, The Texas Public Information Act, as may be amended from time to time, other open records laws, decisions and rulings, and securities laws, regulations and guidance). If Licensee terminates the Agreement on a patent right-by-patent right or country-by-country basis under Section 7,2, then Licensor may disclose the terminated Patent Rights or the terminated countries to other potential third party licensees. Notwithstanding the foregoing, the existence of the Agreement shall not be considered Confidential Information.

 

8.4Disclosure Required by Court Order or Law

If the receiving Party is required to disclose Confidential Information of another Party hereto, or any terms of the Agreement, pursuant to the order or requirement of a court, administrative agency, or other governmental body or applicable law, the receiving Party may disclose such Confidential Information or terms to the extent required, provided that the receiving Party shall use reasonable efforts to provide the disclosing Party with reasonable advance notice thereof to enable the disclosing Party to seek a protective order and otherwise seek to prevent such disclosure. To the extent that Confidential Information so disclosed does not become part of the public domain by virtue of such disclosure, it shall remain Confidential Information protected pursuant to Section 8.

 

8.5Copies

Each Party agrees not to copy or record any of the Confidential Information of the other Party, except as reasonably necessary to exercise its rights or perform its obligations under the Agreement, and for archival and legal purposes.

 

8.6Continuing Obligations

Subject to the exclusions listed in Section 8.7, the Parties’ confidentiality obligations under the Agreement will survive termination of the Agreement and will continue for a period of five years thereafter.

 

8.7Exclusions

Information shall not be considered Confidential Information of a disclosing Party under the Agreement to the extent that the receiving Party can establish by competent written proof that such information:

 

(a)Was in the public domain at the time of disclosure; or

 

 

 

(d)Was already known by the recipient Party at the time of disclosure; or

 

 

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8.8Copyright Notice

The placement of a copyright notice on any Confidential Information will not be construed to mean that such information has been published and will not release the other Party from its obligation of confidentiality hereunder

8.9Publications

Licensor shall instruct the Inventors to submit to the Parties, for their review, a copy of any proposed manuscript 30 days prior to the estimated date of submission for any proposed publication (where an Inventor is an author) that specifically incorporates Licensed Subject Matter (the “Review Period”). Licensee shall treat any proposed manuscript as Licensor’s Confidential Information. If Licensee reasonably determines that the proposed publication contains new, likely patentable information directly related to the Licensed Subject Matter or Improvements herein, Licensee may request the delay of publication for the purpose of filing patent applications by Licensor for no more than sixty (60) days. If Licensee reasonably raises any other concerns with respect to such proposed publications, such as, for example, the impact of such publication on the Patent Rights, within the Review Period, the Parties agree to discuss in good faith such concerns and to reasonably seek a resolution thereof, including but not limited to filing patent applications to cover such patentable, Licensed Subject Matter or Improvements.  Regardless of such discussions, Licensee shall have the right to delete any of its solely-owned Confidential Information from the proposed publication within the Review Period. Subject to this Section 8.9, Licensor shall have the final authority to determine the scope and content of any of its publications. If no written response is received from Licensee within the Review Period, Licensee hereby consents that publication may proceed without delay.  

 

9. Infringement and Litigation

 

9.1Notification

If either Licensor’s designated office for technology commercialization or Licensee becomes aware of any infringement or potential infringement of Patent Rights, each Party shall promptly notify the other of such in writing.

 

9.2Licensee’s Enforcement Rights

Licensee shall have the first right, but not the obligation, to enforce the Patent Rights against any infringement by a third party. Licensee shall be responsible for payment of all fees and expenses associated with such enforcement incurred by both Licensee and Licensor in providing cooperation or joining as a party as provided in Section 9.5. Any monetary recovery for actual damages or punitive damages, in excess of Licensee’s documented, third-party expenses in enforcing the Patent Rights and amounts actually reimbursed by Licensee to Licensor under this Section 9.2 shall be shared by Licensee with Licensor in the same manner as Non-Royalty Sublicensing Consideration.

 

9.3Licensor’s Enforcement Rights

If Licensee does not file suit within six months after a written request by Licensor to initiate an infringement action, then Licensor shall have the right, at its sole discretion, to bring suit to enforce any Patent Right licensed hereunder against the infringing activities, with Licensor retaining all recoveries from such enforcement.  Licensor shall not settle any action covered by this Section without first obtaining the written consent of Licensee, whose consent will not be unreasonably withheld or delayed.  

 

9.4Validity Challenge

 

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In the event that a third party commences any re-examination, interference, opposition or nullity proceeding or challenges the validity or enforceability of, or opposes any extension of or the grant of a patent term extension request, a Supplement Protection Certificate (as per Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009) or any similar extension request with respect to any Patent Right during the Term in any country of the Territory, then Licensee shall have the initial right, but not the obligation, to take such legal action, as is reasonably required to defend the validity and enforceability of such particular Patent Right through Prosecution Counsel (“Challenged Patent”), and Licensee shall bear the costs and expenses of the defense of such Challenged Patent if it elects to undertake the defense.  Should Licensee choose to defend such Challenged Patent, control and notifications regarding responses to such Challenged Patent shall be handled in a similar manner to the provisions of Section 6.2(b).   Licensor shall give all reasonable assistance (excluding financial assistance) to Licensee in connection therewith, at Licensee’s cost and expense.  Any settlement of such legal action shall be subject to Licensor’s prior written consent, which shall not be unreasonably withheld, delayed or conditioned.  If Licensee declines or does not take legal action to defend such Challenged Patent within 30 days after the commencement of such validity or enforceability challenge, then (i) such Challenged Patent shall be removed from this Agreement, (ii) Licensee shall no longer have any rights to such Challenged Patent under this Agreement, and (iii) Licensor may choose to defend such Challenged Patent, at Licensor’s cost and expense, in which case Licensor shall have the right to control such action in Licensor’s sole discretion. For the avoidance of doubt, this Section 9.4 shall not apply to the defense of any patent challenge that is raised (x) as a counter-claim or defense by a third party that is the subject of an infringement action pursuant to Section 9.2 or 9.3, or (y) by a third party in response to an infringement action pursuant to Section 9.2 or 9.3; in either case the defense of such patent challenge will be governed by such Section 9.2 or 9.3.

9.5Cooperation between Licensor and Licensee

In any infringement suit or dispute, the Parties agree to cooperate fully with each other. At the request of the Party bringing suit, the other Party will permit reasonable access after reasonable advance notice to all relevant personnel, records, papers, information, samples, specimens, etc., during regular business hours.

 

If it is necessary to name Licensor as a party in such action, then Licensee must first obtain Licensor’s prior written permission, which permission shall not be unreasonably withheld, and to the extent authorized by the Constitution and laws of the State of Texas, shall be granted if Licensor’s joinder is necessary under applicable law for Licensee to have standing to pursue its claims.  However, notwithstanding anything to the contrary in this Agreement, Licensor shall not be obligated to join an enforcement action if Licensor determines that such joinder is likely to (i) cause reputational harm to Licensor or (ii) require use of state resources in an inappropriate or irresponsible manner. If Licensor does not grant its permission to name Licensor as a party in such suit and as a result Licensee does not have standing to pursue its claims against a product that is or would be, if approved by a Regulatory Authority, a generic or biosimilar product with respect to a Licensed Product, or otherwise is or would be a product or service that competes or would compete with a Licensed Product or Licensed Service, including without limitation an action under 42 U.S.C. § 262 or 35 U.S.C. §271(e)(2)(A) (a “Competing Product or Service”), then upon written Licensee’s request, Licensor shall assign, or if such assignment requires the approval of a Federal agency then Licensor shall request approval from the relevant Federal agency to assign, and upon Licensor’s receipt of such approval, Licensor shall assign, all rights in the particular Patent Right that Licensee intends to assert in such suit to Licensee; provided however that such assignment shall be under a separate written Assignment Agreement specifying that such assignment shall not change consideration due Licensor under this Agreement as if such Patent Right had not been assigned.   If Licensor is unable to or fails to assign such particular Patent Right to Licensee and Licensor continues to withhold its permission to be named or joined in the suit, and such claim is against a Competing Product or Service, then Licensee shall have the right, upon written notice to

 

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Licensor and without limitation of any of Licensee’s rights or remedies in connection with this Agreement, to reduce the amount of any payments under Section 3.2 to be paid to Licensor hereunder, with respect to the affected Licensed Product or Licensed Service in the applicable jurisdiction(s), by a percentage based on alleged infringer’s market share, but no more than 50% of the royalty due under Section 3.2 for the period of time during which such Competing Product or Service is sold in such jurisdiction.  Licensee shall have the right to designate counsel for any such action and shall control the litigation, provided that Licensor shall have reasonable prior input on choice of counsel on any matter where such counsel represents Licensor, and Licensee and such counsel agree to follow all required procedures of the Texas Attorney General regarding retention of outside counsel for state entities.

 

10.Export Compliance

 

Licensee understands that the Arms Export Control Act (AECA), including its implementing International Traffic In Arms Regulations (ITAR), and the Export Administration Act (EAA), including its Export Administration Regulations (EAR), are some (but not all) of the laws and regulations that comprise the U.S. export laws and regulations. Licensee further understands that the U.S. export laws and regulations include (but are not limited to): (a) ITAR and EAR product/service/data-specific requirements; (b) ITAR and EAR ultimate destination-specific requirements; (c) ITAR and EAR end user-specific requirements; (d) Foreign Corrupt Practices Act; and (e) anti-boycott laws and regulations. Licensee will comply with all then-current applicable export laws and regulations of the U.S. Government (and other applicable U.S. laws and regulations) pertaining to the Licensed Products (including any associated products, items, articles, computer software, media, services, technical data, and other information). Licensee certifies that it will not, directly or indirectly, export (including any deemed export), nor re-export (including any deemed re-export) the Licensed Products (including any associated products, items, articles, computer software, media, services, technical data, and other information) in violation of applicable U.S. laws and regulations. Licensee will include a provision in its agreements, substantially similar to this Section 10, with its Sublicensees, third party wholesalers and distributors, and physicians, hospitals or other healthcare providers who purchase a Licensed Product, requiring that these parties comply with all then-current applicable U.S. export laws and regulations and other applicable U.S. laws and regulations.

 

11.Representations and Disclaimers

 

11.1Licensor Representations

Except for the rights, if any, of the Government as set forth in Section 11.2, Licensor represents and warrants to Licensee that to the knowledge of Licensor’s designated office for technology commercialization (i) Licensor is the owner or exclusive agent of the entire right, title, and interest in and to Patent Rights (including the right, title and interest of any joint owner identified in Section 1 of the Agreement), (ii) Licensor has the right and authority to grant licenses hereunder, and (iii) Licensor has not knowingly granted and will not knowingly grant licenses or other rights under the Patent Rights that are in conflict with the terms and conditions in the Agreement.

 

11.2Government Rights

Licensee understands that Licensed Subject Matter may have been developed under a funding agreement with Government and, if so, that Government may have certain rights relative thereto. The Agreement is made subject to the Government’s rights under any such agreement and under any applicable Government law or regulation. To the extent that there is a conflict between any such agreement, such applicable law or regulation and the Agreement, the terms of such Government agreement, and applicable law or regulation, shall prevail. Licensee agrees that, to the extent required by U.S. laws and regulations, Licensed Products used or Sold in the U.S. will be manufactured substantially in the U.S., unless a written waiver is obtained in advance from the U.S. Government.

 

 

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11.3Licensor Disclaimers

EXCEPT AS SPECIFICALLY SET FORTH IN SECTION 11.1, LICENSEE UNDERSTANDS AND AGREES THAT LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, AS TO THE LICENSED PRODUCTS, OR AS TO THE OPERABILITY OR FITNESS FOR ANY USE OR PARTICULAR PURPOSE, MERCHANTABILITY, SAFETY, EFFICACY, APPROVABILITY BY REGULATORY AUTHORITIES, TIME AND COST OF DEVELOPMENT, PATENTABILITY, AND/OR BREADTH OF PATENT RIGHTS. LICENSOR MAKES NO REPRESENTATION AS TO WHETHER ANY PATENT WITHIN PATENT RIGHTS IS VALID, OR AS TO WHETHER THERE ARE ANY PATENTS NOW HELD, OR WHICH WILL BE HELD, BY OTHERS OR BY LICENSOR THAT MIGHT BE REQUIRED FOR USE OF PATENT RIGHTS IN FIELD. NOTHING IN THE AGREEMENT WILL BE CONSTRUED AS CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS TO ANY PATENTS OR TECHNOLOGY OF LICENSOR OTHER THAN THE PATENT RIGHTS, WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS, OR THE TECHNOLOGY RIGHTS SPECIFICALLY DESCRIBED HEREIN

 

11.4Licensee Representation

By execution of the Agreement, Licensee represents, acknowledges, covenants and agrees (a) that Licensee has not been induced in any way by Licensor or its employees to enter into the Agreement, and (b) that Licensee has been given an opportunity to conduct sufficient due diligence with respect to all items and issues pertaining to this Section 11 (Representations and Disclaimers) and all other matters pertaining to the Agreement; and (c) that Licensee has adequate knowledge and expertise, or has utilized knowledgeable and expert consultants, to adequately conduct the due diligence, and (d) that Licensee accepts all risks inherent herein. Licensee represents that it is a duly organized, validly existing entity of the form indicated in Section 1 of the Agreement, and is in good standing under the laws of its jurisdiction of organization as indicated in Section 1 of the Agreement, and has all necessary corporate or other appropriate power and authority to execute, deliver and perform its obligations hereunder.

 

12.Limit of Liability

 

IN NO EVENT SHALL LICENSOR, THE UNIVERSITY SYSTEM IT GOVERNS, ITS MEMBER INSTITUTIONS, INVENTORS, REGENTS, OFFICERS, EMPLOYEES, STUDENTS, AGENTS OR AFFILIATED ENTERPRISES, BE LIABLE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER ANY SUCH PARTY KNOWS OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES. OTHER THAN FOR CLAIMS AGAINST LICENSEE FOR INDEMNIFICATION (SECTION 13) OR FOR MISUSE OR MISAPPROPRIATION OR INFRINGEMENT OF LICENSOR’S INTELLECTUAL PROPERTY RIGHTS, LICENSEE WILL NOT BE LIABLE TO LICENSOR FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY OR PUNITIVE DAMAGES (INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF PROFITS OR REVENUE) ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER LICENSEE KNOWS OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.

 

13.Indemnification

 

13.1Indemnification Obligation

Subject to Section 13.2, Licensee agrees to hold harmless, defend and indemnify Licensor, the university system it governs, its member institutions, its Regents, officers, employees, students and agents (“Indemnified Parties”) from and against any liabilities, damages, causes of action, suits, judgments, liens, penalties, fines, losses, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of litigation) (collectively “Liabilities”) resulting from claims or demands brought by third parties against an Indemnified Party on account of any injury or death of persons, damage to property to the extent caused by (i) Licensee or its Affiliates

 

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or Sublicensees, (ii) the practice of Licensed Subject Matter by Licensee or its Affiliates or Sublicensees, or (iii) Licensed Products, or any other damage or loss arising out of or in connection with the Agreement or the exercise or practice by or under authority of Licensee, its Subsidiaries or their Sublicensees, or third party wholesalers or distributors, or physicians, hospitals or other healthcare providers who purchase a Licensed Product, of the rights granted hereunder. Subject to Section 13.2 and specifically only as authorized by the Constitution and laws of the State of Texas, Licensor indemnifies Licensee and solely from and against any Liabilities resulting from claims or demands brought by third parties against Licensee to the extent caused by the negligent conduct of Licensor.

 

13.2Conditions of Indemnification

Licensee shall have no responsibility or obligation under Section 13.1 for any Liabilities to the extent caused by the gross negligence or willful misconduct by an Indemnified Party or material breach of any of Licensor’s representations, warranties, covenants or obligations hereunder by any Indemnified Party. Licensor’s obligations to indemnify, and hold harmless under Section 13.1 are subject to: (a) to the extent authorized by the Texas Constitution and the laws of the State of Texas, and subject to the statutory duties of the Texas Attorney General, the Indemnified Party giving Licensee control of the defense and settlement of the claim and demand; and (b) to the extent authorized by the Texas Constitution and the laws of the State of Texas and subject to statutory duties of the Texas Attorney General, the Indemnified Party providing assistance reasonably requested by Licensee, at Licensee’s expense.

 

14.Insurance

 

14.1Insurance Requirements

Prior to any Licensed Product being used or Sold (including for the purpose of obtaining Regulatory Approval), and prior to any Licensed Service being performed by Licensee, an Affiliate, a Subsidiary, or by a Sublicensee, and for a period of five years after the Agreement expires or is terminated, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in commercially reasonable and appropriate amounts for the Licensed Product being used or Sold or the Licensed Service being performed. Licensee shall use commercially reasonable efforts to have Licensor, the university system it governs, its member institutions, Regents, officers, employees, and Inventors named as additional insureds. Such commercial general liability insurance shall provide, without limitation: (i) product liability coverage; (ii) broad form contractual liability coverage for Licensee’s indemnification under the Agreement; and (iii) coverage for litigation costs.

 

14.2Evidence of Insurance and Notice of Changes

Upon request by Licensor, Licensee shall provide Licensor with written evidence of such insurance. Additionally, Licensee shall provide Licensor with written notice of at least 60 days prior to Licensee cancelling, not renewing, or materially changing such insurance.

 

15.Assignment

 

 

(a) licensee’s entire business; or

 

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15.3 Any Other Assignment by Licensee.

This Agreement may not be assigned without Licensor’s consent except in connection with a sale or a change of control of Licensee as set forth in Section 15.2. Any other attempt to assign this Agreement by Licensee is null and void.

 

15.4 Conditions of Assignment.

In connection with any assignment, the following conditions must be met:

(c) Licensor must have received an assignment fee pursuant to Section 3.1(e).

 

If the foregoing conditions are not met, then the assignment shall be deemed null and void.

 

16.Governmental Markings

 

16.1Patent Markings

Licensee agrees that all Licensed Products Sold by Licensee, Subsidiaries, or Sublicensees will be legibly marked with the number of any applicable patent(s) licensed hereunder as part of the Patent Rights in accordance with each country’s patent marking laws, including Title 35, U.S. Code, or if such marking is not practicable, shall so mark the accompanying outer box or product insert for Licensed Products accordingly. Licensee will not engage in false marketing of Licensed Products and Licensee will be responsible for any damages and penalties imposed for false marketing claims.

 

16.2Governmental Approvals and Marketing of Licensed Products

Licensee will be responsible for obtaining all necessary governmental approvals for the development, production, distribution, advertising, Sale, and use of any Licensed Product or performance of any Licensed Service, at Licensee’s expense, including, without limitation, any safety studies. Licensee will have sole responsibility for any warning labels, packaging and instructions as to the use and the quality control for any Licensed Product or Licensed Service.

 

16.3Foreign Registration and Laws

Licensee agrees to register the Agreement with any foreign governmental agency that requires such registration; and Licensee will pay all costs and legal fees in connection with such registration. Licensee is responsible for compliance with all foreign laws affecting the Agreement or the Sale of Licensed Products to the extent there is no conflict with United States law, in which case United States law will control.

 

17.Use of Name

 

 

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Licensee will not use the name, trademarks or other marks of Licensor (or the name of the university system it governs, its member institutions, any of its Regents or employees) without the advance written consent of Licensor. Licensor may use Licensee’s name and logo for annual reports, brochures, website and internal reports without prior consent. Nothing in this Article is intended to restrict either Party from disclosing the existence of and nature of this Agreement (including the name of the other Party) or from including the existence of and nature of this Agreement in the routine reporting of its activities provided that such disclosure or reporting is limited to statements of fact.

 

18.Notices

 

Any notice or other communication of the Parties required or permitted to be given or made under the Agreement will be in writing and will be deemed effective when sent in a manner that provides confirmation or acknowledgement of delivery and received at the address set forth in Section 18 of the Agreement (or as changed by written notice pursuant to this Section 18). Notices required under the Agreement may be delivered via E-mail provided such notice is confirmed in writing as indicated.

 

Notices shall be provided to each Party as specified in the “Contact for Notice” address set forth in Section 18 of the Agreement. Each Party shall update the other Party in writing with any changes in such contact information.

 

19.General Provisions

 

19.1Binding Effect

The Agreement is binding upon and inures to the benefit of the Parties hereto, their respective executors, administrators, heirs, permitted assigns, and permitted successors in interest.

 

19.2Construction of Agreement

Headings are included for convenience only and will not be used to construe the Agreement. The Parties acknowledge and agree that both Parties substantially participated in negotiating the provisions of the Agreement; therefore, both Parties agree that any ambiguity in the Agreement shall not be construed more favorably toward one Party than the other Party, regardless of which Party primarily drafted the Agreement.

 

19.3Counterparts and Signatures

The Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same instrument. A Party may evidence its execution and delivery of the Agreement by transmission of a signed copy of the Agreement via facsimile or email. In such event, the Party shall promptly provide the original signature page(s) to the other Party.

 

19.4Compliance with Laws

Licensee will comply with all applicable federal, state and local laws and regulations, including, without limitation, all export laws and regulations.

 

19.5Governing Law

The Agreement will be construed and enforced in accordance with laws of the U.S. with respect to patent law and the State of Texas for all other aspects of this Agreement, without regard to choice of law and conflicts of law principles.

 

19.6Modification

 

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Any modification of the Agreement will be effective only if it is in writing and signed by duly authorized representatives of both Parties. No modification will be made by email communications.

 

19.7Severability

If any provision hereof is held to be invalid, illegal or unenforceable in any jurisdiction, the Parties hereto shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties, and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such other provisions in any other jurisdiction, so long as the essential essence of the Agreement remains enforceable.

 

19.8Third Party Beneficiaries

Nothing in the Agreement, express or implied, is intended to confer any benefits, rights or remedies on any entity, other than the Parties and their permitted successors and assigns. However, if there is a joint owner of any Patent Rights identified in Section 1 of the Agreement (other than Licensee), then Licensee hereby agrees that the following provisions of these Terms and Conditions extend to the benefit of the co-owner identified therein (excluding the Licensee to the extent it is a co-owner) as if such co-owner was identified in each reference to the Licensor: the retained rights under clause (b) of Section 2.1; Section 11.3 (Licensor Disclaimers); Section 12 (Limitation of Liability); Section 13 (Indemnification); Section 14.1 (Insurance Requirements); Section 17 (Use of Name); and Section 19.10 (Sovereign Immunity, if applicable).

 

19.9Waiver

Neither Party will be deemed to have waived any of its rights under the Agreement unless the waiver is in writing and signed by such Party. No delay or omission of a Party in exercising or enforcing a right or remedy under the Agreement shall operate as a waiver thereof.

 

19.10Sovereign Immunity

Nothing in the Agreement shall be deemed or treated as any waiver of Licensor’s sovereign immunity.

 

19.11Entire Agreement

The Agreement constitutes the entire Agreement between the Parties regarding the subject matter hereof, and supersedes all prior written or verbal agreements, representations and understandings relative to such matters.

 

19.12Claims Against Licensor for Breach of Agreement

Licensee acknowledges that any claim for breach of the Agreement asserted by Licensee against Licensor shall be subject to Chapter 2260 of the Texas Government Code and that the process provided therein shall be Licensee’s sole and exclusive process for seeking a remedy for any and all alleged breaches of the Agreement by Licensor or the State of Texas.

 

19.13Jurisdiction and Venue

The parties hereby irrevocably submit to the exclusive jurisdiction of a court of competent jurisdiction in Bexar County Texas, and, by execution and delivery of this Agreement, each party (a) accepts, generally and unconditionally, the jurisdiction of such court and any related appellate court, and (b) irrevocably waives any objection it may now or hereafter have as to the venue of any such suit, action or proceeding brought in such court or that such court is an inconvenient forum.

 

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Any dispute or controversy arising out of or relating to this Agreement, its construction or its actual or alleged breach may be resolved through mediation or non-binding arbitration in the city of San Antonio, Texas.  The use of any method of alternative dispute resolution will not be construed by either Party in a manner that would adversely affect the other Party's rights in court. Nothing in this section will prevent one Party from resorting to judicial proceedings if good faith efforts to resolve a dispute have been unsuccessful or if injunctive relief is necessary to prevent serious and irreparable harm to one Party or third parties.

 

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