Study Data License. Subject to the terms and conditions of this Agreement, Spark hereby grants to Novartis an exclusive (even as to Spark and its Affiliates) right and license, with the right to grant sublicenses as set forth in Section 3.1.5, under Spark’s rights in study data Controlled by Spark from any clinical trials of Luxturna, solely to use such study data to Develop and Commercialize Luxturna in the Field for the Novartis Territory (including the right to cross reference or include such study data in regulatory filings made with Regulatory Authorities for the Novartis Territory). In addition, Novartis shall have the right to use any information concerning any adverse events, and any product quality and product complaints involving adverse events, related to Luxturna, to enable Novartis (or its applicable Affiliate or Sublicensee) to comply with its legal and regulatory obligations.
Study Data License. Subject to the terms and conditions of this Agreement, Novartis hereby grants to Spark, an exclusive (even as to Novartis and its Affiliates), royalty-free, fully paid-up right and license, with the right to grant sublicenses, under Novartis’ rights in study data Controlled by Novartis from any clinical trials of Luxturna conducted pursuant to this Agreement, solely to use such study data to Develop and Commercialize Luxturna in the Field for the Spark Territory (including the right to cross reference or include such study data in filings made with Regulatory Authorities for the Spark Territory). In addition, Spark shall have the right to use any information concerning any adverse events, and any product quality and product complaints involving adverse events, related to Luxturna, sufficient to enable Spark (or its applicable Affiliate or Sublicensee) to comply with its legal and regulatory obligations.
Study Data License. Subject to the terms and conditions of this Agreement, Ophthotech hereby grants to Novartis an exclusive, royalty-free, fully paid-up (except as otherwise set forth in Section 4.09(f)) right and license, with the right to grant sublicenses as set forth in Section 3.01(f), under Ophthotech’s rights in (i) study data Controlled by Ophthotech from any Ophthotech-sponsored clinical trials of Fovista conducted prior to the Effective Date or pursuant to the Existing Fovista Clinical Program, or any study data Controlled by Ophthotech arising from the Investigator Sponsored Clinical Study of Fovista as to which Ophthotech had entered into as of the Effective Date, without the need for any election under Section 4.09(f) or payment of related Development Costs, and (ii) effective upon Novartis’ election to opt in to any other Ophthotech-sponsored study under Section 4.09(f), the data from such other study, in each case ((i) and (ii)) to use such study data as necessary to Develop and Commercialize Products in the Field for the Novartis Territory (including the right to cross reference or include such study data in regulatory filings made with Regulatory Authorities for the Novartis Territory). In addition, Novartis shall have the right to use any information concerning any adverse events, and any product quality and product complaints involving adverse events, related to Products, sufficient to enable Novartis (or its applicable Affiliate or Sublicensee) to comply with its legal and regulatory obligations, without the requirement to opt in and share Development Costs, as specified in Section 4.09(f).
Study Data License. [**] and the other terms and conditions of this Agreement, Novartis hereby grants to Ophthotech, effective upon Ophthotech’s election to opt in to a Novartis-sponsored study under Section 4.09(f), an exclusive, royalty-free, fully paid-up right and license, with the right to grant sublicenses, to use the study data from such study as necessary to Develop and Commercialize products comprising Fovista in the Field for the Ophthotech Territory (including the right to cross reference or include such study data in filings made with Regulatory Authorities for the Ophthotech Territory). However, Ophthotech shall not grant any sublicenses under this Section 3.02(a) to any Third Party in the Novartis Territory during the Term without Novartis’ prior written consent, not to be unreasonably withheld, conditioned or delayed. In addition, Ophthotech shall have the right to use any information concerning any adverse events, and any product quality and product complaints involving adverse events, related to Products, sufficient to enable Ophthotech (or its applicable Affiliate or sublicensee) to comply with its legal and regulatory obligations, without the requirement to opt in and share Development Costs, as specified in Section 4.09(f).
