Master Alliance Provisions Guide (MAPGuide)

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

  • Information & materials sharing | Material transfer

Definitions

Clinical Trial Materials” means clinical testing materials, including clinical supplies of the Product inappropriate containers, for use in Clinical Trials.

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

Joint Program Materials” means any tangible chemical, biological or physical materials that are collected, conceived, generated, developed or reduced to practice jointly by or on behalf of BBIL or its Affiliates’ personnel, on the one hand, and Ocugen or its Affiliates’ personnel, on the other hand, in the conduct of the Development Activities pursuant to the Development Plan.

3. Grant of Rights

3.4. Ocugen Assistance. Ocugen shall provide BBIL with all documents, information and Data in its possession as reasonably requested by BBIL or that are otherwise necessary or useful for BBIL to conduct the BBIL Development Activities under Article IV, including without limitation all Joint Program Materials under the Control of Ocugen.

3.5. BBIL Assistance. BBIL shall provide Ocugen with all documents, information and Data in its possession as reasonably requested by Ocugen or that are otherwise necessary or useful for Ocugen to conduct the Ocugen Development Activities under Article IV, including without limitation all Joint Program Materials under the Control of BBIL.

7. Manufacture and Supply of the Product

7.1. Development Supply Agreement.

(a) Subject to Section 7.4, pursuant to a development supply agreement (the “Development Supply Agreement”) to be entered into between the Parties, BBIL shall be responsible for the Manufacture and supply of all Clinical Trial Materials required for Ocugen’s non-clinical and clinical Development of the Product in the Field in and for the Ocugen Territory(including the performance of the Ocugen Development Activities). The Parties will enter into the Development Supply Agreement within [***] days after the Effective Date. The Development Supply Agreement shall contain mutually agreeable terms, including, among other things, that the maximum purchase price payable by Ocugen for Clinical Trial Materials manufactured and supplied thereunder shall not exceed [***].

(b) Except as set forth in the Development Supply Agreement, prior to the completion of the technology transfer as provided in Section 7.3(a), BBIL shall be responsible, in accordance with the Development Supply Agreement or as may otherwise be agreed between the Parties, to (i) Manufacture and supply Ocugen with such form and quantity of Clinical Trial Materials as Ocugen reasonably requires to conduct the Ocugen Development Activities and carry out Clinical Trials necessary to seek and obtain Regulatory Approval of the Product in the Field in and for the Ocugen Territory, and (ii) perform release and stability testing of the Product for use in the Field in and for the Ocugen Territory in accordance with FDA requirements and Applicable Law. In furtherance of the forgoing, within [***] days after the Effective Date, and thereafter on an as needed basis during the Term or as may otherwise be discussed and agreed by the Parties at the JSC, BBIL shall share all CMC Technology and related information for the Product with Ocugen.