Provision Language
ARTICLE 2. Term and Termination
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C. Termination for Cause […]
1. Repurchase Against Contractors Account
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b. If this Agreement is terminated for Cause, Awardee will grant the Government a non- exclusive, paid up, license to the Awardee and subawardee patents and documentation necessary for the purpose of developing the Prototype solely for use with the INO-4800 product for COVID-19 and shall only be conducted under Inovio’s regulatory filings and solely for the pandemic period as applicable in the United States. No further use is permitted without Inovio’s explicit prior written consent, whereby any such permitted use shall be negotiated by the parties and subject to a future agreement. The Awardee shall provide the Government or its designee with a non-exclusive, paid up, license to any patent, copyright, technical data or regulatory information held by the Awardee that relates to the technology to permit the Government to pursue commercialization of the technology with a third party solely for use with the INO-4800 product for COVID-19 and shall only be conducted under Inovio’s regulatory filings and solely for the pandemic period as applicable in the United States. No further use is permitted without Inovio’s explicit prior written consent, whereby any such permitted use shall be negotiated by the parties and subject to a future agreement, on terms to be agreed between the Parties and subject to rights granted or held by third parties. The terms of this section and the obligations herein will be included in any exclusive license given by the Awardee to a third party for any intellectual property covered by this Agreement, on terms to be agreed between Awardee and such third party. This clause will survive the acquisition or merger of the Awardee by or with a third party.
ARTICLE 13. Regulatory Rights
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C. […]
2. Product Development Failure. Certain product development failures may trigger certain remedies in Section (3) below for the Government advanced developer funding the development of the work in this Agreement. This remedy is not available to the Government for any cause outside of the following:
i. if this agreement is terminated for nonperformance; or
ii. the Contractor gives notice, required to be submitted to the Government no later than 30 business days, of any formal management decision to terminate this product development effort pre-market or to file for Federal bankruptcy protection.
3. If any of the product development failures listed in section (b) occur, the Awardee, upon the request of the Government:
i. shall transfer possession, ownership and sponsorship or holdership of any Regulatory Application submitted solely for approval of the Technology (including any associated expedited review designation, priority review voucher, or marketing exclusivity eligibility or award), regulatory correspondence, and supporting regulatory information related to the Technology to the Government or its designee;
ii. shall provide DoD or its designee with a letter (“Reference Letter”) providing permission to reference any Regulatory Application submitted to the FDA for a combination drug-device product that includes the Technology;
iii. shall inform FDA of the transfer of sponsorship or holdership of the Regulatory Application transferred under section (c)(i) above or the Reference Letter issued under section (c)(ii) above; and
iv. shall negotiate in good faith a non-exclusive license, at customary industry rates and under reasonable terms and conditions, to any patent, copyright or other intellectual property owned or controlled by the Awardee, developed prior to or outside the scope of this agreement, or any technical data that is necessary for the Government to pursue commercialization of this technology with a third party for sale to the Government or otherwise.
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E. This Article 13 will survive the acquisition or merger of the Awardee by or with a third party. This Article will also be included in any subcontracts/sub agreements relating to the development of the Technology. This Article will survive the expiration of this agreement.