Master Alliance Provisions Guide (MAPGuide)

Ocugen-BBIL, COVID-19 Vaccine (Covaxin), Co-development, Supply & Commercialization Agreement

  • Information & materials sharing | Information sharing

Definitions

CMC Technology” means any Technology that relates to chemistry, manufacture and control for the Product.

First Commercial Sale” means with respect to the Product in any country in the Territory, the date of the first sale, transfer or disposition to an end user by a Party, its Affiliate or Sublicensee for value in that country after Marketing Authorization for the Product has been received in such country; provided, that the following shall not constitute a First Commercial Sale: (a) any sale of the Product by a Party, its Affiliate or Sublicensee to another Affiliate or Sublicensee of such Party; (b) any sale, transfer or disposition of the Product for research, preclinical, clinical, Development or regulatory purposes (including for use in Clinical Trials or pre-clinical studies); or (c) the sale, transfer or other disposition of the Product for a bona fide charitable purpose, including so-called “treatment IND sales,” “named patient sales,” “expanded access program” or “compassionate use sales” or to physicians or hospitals for promotional purposes (including free samples to a level and in an amount which is customary in the industry or which is reasonably proportional to the market for the Product).

Significant Development Event” means any of the following material Development events: (a) any material interaction and/or written correspondence between a Party or any of its Affiliates and any Regulatory Authority with respect to the Product; or (b) any material event or result with respect to any Clinical Trial involving the Product.

4. Co-Development of the Product

4.8. Records and Reports. Each Party shall maintain complete and accurate records of its Development Activities in accordance with good business practices and in sufficient detail, including in sufficient detail for the purpose of making patent filings and Regulatory Filings, in good scientific manner, or otherwise in a manner that reflects all work done and results achieved. Each Party may review and copy such records at reasonable times, and upon reasonable notice to the other Party. Each Party shall provide to the other Party, at least once each [***] until the First Commercial Sale of the Product in the Ocugen Territory, a reasonably detailed report that summarizes: (a) all Development Activities conducted and the results obtained by such Party with respect to the Product during the most recently completed Calendar Quarter; and (b) any Significant Development Events applicable to the Product.

4.9. Further Cooperation. Further to the Parties’ respective obligations under Section 4.3, each Party shall share with the other Party all information it obtains in its conduct of the Development Activities, including but not limited to documents and Data in regard to pre-clinical activities, clinical activities, CMC Technology, Manufacture, and Regulatory Approval in or for its Territory.

6. Commercialization

6.2. Commercialization Plan. No later than [***] prior to the anticipated First Commercial Sale of the Product in the Ocugen Territory or the BBIL Territory, as applicable, the responsible Party shall provide to the other Party its initial Commercialization Plan for its Territory. Thereafter, each Party shall provide the other Party with an updated Commercialization Plan no later than [***].

6.5. Commercialization Reports. Each Party shall maintain a record of all of its Commercialization activities in accordance with good business practices. No later than [***], such Party shall provide to the other Party a reasonably detailed report that summarizes the Commercialization activities conducted by such Party during [***].