Common use of Development and Commercialization of Products Clause in Contracts

Development and Commercialization of Products. Subject to the terms and conditions of this Agreement, and except as expressly set forth in the Development Plan, Roche shall control and be solely responsible for the worldwide development and commercialization of Products at its sole cost and expense. Roche shall own all data generated in the development and/or commercialization of Products, but shall promptly and fully disclose to Emisphere in writing all preclinical and clinical data generated by or on behalf of Roche, its Affiliates or their respective sublicensees with respect to a Program Carrier (other than any such data that relates to the use of a Program Carrier in combination with a ***). Emisphere shall be free to use all such data disclosed to it by Roche for any purpose (including, without limitation, in support of patent filings) other than the development, manufacture or commercialization of Products. Without limiting the generality of the foregoing, Emisphere shall be free to use such data for the purpose of researching, developing, manufacturing or commercializing Program Carriers pursuant to Article 8 hereof and/or for use in combination with any compound other than a ***. To the extent feasible, Roche shall design and conduct all toxicology studies involving Products (or cause such toxicology studies to be designed and conducted) in a manner that enables Emisphere to receive all Program Carrier-related results of such studies in one or more written reports that are separate from and independent of any such reports regarding *** or Products, and Roche shall have no obligation to disclose to Emisphere any such ***or Product-related report(s); provided, however, that Emisphere shall be permitted to review such Product-related reports to utilize data therein if required for a Regulatory Authority. In designing any toxicology studies of Program Carrier alone, Roche shall, prior to initiation, first consult Emisphere and take into due consideration any comments and advice provided by Emisphere regarding the design of such studies. (a) Roche shall have the sole right and responsibility for conducting clinical trials of Products in accordance with the Development Plan. Roche shall own all clinical data and reports related to such clinical trials. All data, including safety reports from such clinical trials, shall be maintained by Roche in a centralized database. Roche shall be the sole CTA/IND holder and will solely own all NDAs for Products. Emisphere shall have the right to cross file and reference data from Product INDs or NDAs with respect to obtaining Regulatory Approval for Program Carriers for other drugs.

Development and Commercialization of Products. 4.1 Development of Products in the Field in the Territory. Subject to the terms and conditions of this Agreement, and except as expressly set forth in during the Development PlanTerm, Roche Astellas shall control and be solely responsible for the worldwide development of and commercialization of obtaining Regulatory Approvals for Products at its sole cost and expense. Roche shall own all data generated in the development and/or commercialization Field in the Territory, including all costs associated with such activities, subject to the terms of Products, but shall promptly and fully disclose any written agreement between the parties providing for Vical to Emisphere in writing all preclinical and clinical data generated by or on behalf of Roche, its Affiliates or their respective sublicensees with respect to a Program Carrier (other than perform any such data that relates to the use of a Program Carrier in combination with a ***). Emisphere shall be free to use all such data disclosed to it by Roche for any purpose (including, without limitation, in support of patent filings) other than the development, manufacture or commercialization of Productsactivities. Without limiting the generality of the foregoing, Emisphere Astellas shall be free have sole responsibility, at Astellas’ cost and expense, for conducting clinical and non-clinical studies of Products in the Field in the Territory and for preparing, filing, obtaining and maintaining the appropriate applications with Regulatory Authorities, and for all contacts with Regulatory Authorities, regarding Products in the Field in the Territory. Astellas shall use Commercially Reasonable Efforts to use such data for the purpose of researchingdevelop, developingand to file for, manufacturing or commercializing Program Carriers pursuant to Article 8 hereof and/or for use in combination with any compound other than a obtain and maintain Regulatory Approvals for, at least one Product […***. To the extent feasible, Roche shall design …] and conduct all toxicology studies involving Products (or cause such toxicology studies to be designed and conducted) in a manner that enables Emisphere to receive all Program Carrier-related results of such studies in at least one or more written reports that are separate from and independent of any such reports regarding *** or Products, and Roche shall have no obligation to disclose to Emisphere any such Product […***or Product-related report(s); provided…] in the Field […***…]. Astellas shall perform all development and regulatory activities with respect to Products in the Field in the Territory in compliance with the Development Plan and all applicable laws, howeverrules and regulations. Furthermore, that Emisphere Astellas shall be permitted solely responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and safety data relating to review such Product-related reports Compounds and Products, in each case in the Field, to utilize data therein if required for a the appropriate Regulatory Authority. In designing any toxicology studies of Program Carrier alone, Roche shall, prior to initiation, first consult Emisphere and take into due consideration any comments and advice provided by Emisphere regarding the design of such studies. (a) Roche shall have the sole right and responsibility for conducting clinical trials of Products Authorities in accordance with the Development Planapplicable laws, rules and regulations of the relevant countries and Regulatory Authorities. Roche Prior to commencement of the first Phase 3 Clinical Trial, Vical shall own all clinical data and reports related complete transfer from Vical to such clinical trials. All data, including Astellas of the global safety reports from such clinical trials, shall be maintained by Roche in a centralized database. Roche shall be the sole CTA/IND holder and will solely own all NDAs for Products. Emisphere shall have the right to cross file and reference data from Product INDs or NDAs database with respect to obtaining Regulatory Approval for Program Carriers for other drugsCompounds and Products in the Field. In addition, each party shall cooperate, and shall cause its Affiliates, licensees and Sublicensees to cooperate, in implementing and adhering to a safety data exchange arrangement with respect to Compounds and Products in the Territory that shall be set forth in a safety data exchange agreement executed by the parties.