Master Alliance Provisions Guide (MAPGuide)

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

  • Information & materials sharing | Dissemination of Results

11. Confidential Information

11.3. Publication.

(a) Clinical Trials. For the purposes of clarity, under Section 11.2(a), Ocugen shall have the right to (i) publish the results or summaries of results of all Ocugen sponsored or supported Clinical Trials, observational studies and other studies such as meta analyses, in each case conducted with respect to the Product and the protocols of such Clinical Trials on www.ClinicalTrials.gov and in each case publish the results, summaries and protocols of such Clinical Trials or studies on such other websites and repositories and at scientific congresses and in a peer-reviewed journal within such timescales as required by Applicable Law or Ocugen’s or its Affiliates’ standard operating procedures, irrespective of the outcome of such Clinical Trials or studies; and (ii) publish the status of the Product in its annual and quarterly reports and updates regarding Ocugen’s research and development pipeline. Each such publication or disclosure made in accordance with this Section 11.3(a) shall not be a breach of the confidentiality obligations provided in this Article XI and Ocugen shall be entitled to maintain or effect such publication or disclosure even following any termination of Ocugen’s rights in respect of the Product. Any disclosure made under this Section 11.3(a) that includes any Confidential Information of BBIL (excluding any information that falls under the exceptions of Sections 11.1(b) and except as otherwise set forth in Section 11.1(c)) shall be subject to the provisions set forth in Section 11.3(b). For clarity, BBIL shall not have any publication rights with respect to the research, Development, Manufacture or Commercialization of the Product in and for the Ocugen Territory or with respect to any Confidential Information of Ocugen, except as set forth in Section 11.2(b).

(b) Other Publications. With respect to any paper or presentation proposed for disclosure by Ocugen, its Affiliates or Sublicensees (or a third party to the extent such third party is required to obtain prior approval, review or comment of any paper or presentation for disclosure from Ocugen, its Affiliates or Sublicensees) that includes Confidential Information of BBIL (excluding any information that falls under the exceptions of Section 11.1(b) and except as otherwise set forth in Section11.1(c)), BBIL may review and comment on the portion of such paper or presentation that includes any Confidential Information of BBIL, including requesting removal of such Confidential Information. For any proposed publication or presentation (including posters, slides, abstracts, and manuscripts), Ocugen shall provide a copy of the relevant portion of such paper or presentation at least twenty (20) days (ten (10) days for abstracts) prior to the date of submission for publication or the date of presentation, whichever is earlier, of any of such submitted materials. BBIL shall review such submitted materials and respond to Ocugen as soon as reasonably possible, but in any case, within twenty (20) days (ten (10) days for abstracts) after receipt thereof. At BBIL’s reasonable request, Ocugen shall (a) delete from such proposed publication or presentation any Confidential Information of BBIL, or (b) delay the date of such submission for publication or the date of such presentation for sixty (60) days to permit BBIL to seek appropriate patent protection.