Master Alliance Provisions Guide (MAPGuide)

US Government – Ology Bioservices, COVID-19 Plasmid Procurement Agreement

  • Equitable Access | Ensuring continuity

2. Term and Termination

C. Termination for Cause […]

2. Termination for Cause Procedures.

If this Agreement is terminated for Cause in whole or in part, Awardee will grant the Government a non-exclusive, paid up, perpetual license to the patents and documentation necessary for the purpose of continuing development of all deliverables that were subject to the termination. Additionally, the Awardee shall provide the U.S. Government or its designee with a non-exclusive, paid up, license to any patent, copyright, technical data or regulatory information directly related to those terminated deliverables to permit the U.S. Government to pursue commercialization of the technology with a third party, 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. 

11. Regulatory Rights

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d) Product Development Failure. Certain product development failures may trigger certain remedies in Section “e.” below for the Government advanced developer funding the development of the work contemplated in the applicable SOW. 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. 

e) If any of the product development failures listed in section “d” occur, the Contractor, upon the request of the Government: 

(i) shall transfer possession, ownership and sponsorship or holdership of any Regulatory Application (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 inform FDA of the transfer of sponsorship or holdership of the Regulatory Application transferred under section (e)(i) above; and 

(iii) 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 Contractor, 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.

f) This clause will survive the acquisition or merger of the Contractor by or with a third party. This clause will also be included in any subcontracts/sub agreements relating to the development of the Technology. This clause will survive the expiration of this agreement.