Responsibility for Development and Commercialization. Subject to its obligations pursuant to Section 5.2 to Section 5.5 below, Felicitex shall have the sole responsibility and discretion for the Development and Commercialization of the Optioned Compounds and the Products.
Responsibility for Development and Commercialization. OSI shall have full responsibility, at its sole expense, for the worldwide development, manufacturing and commercialization of Royalty-Bearing Products in the Field.
Responsibility for Development and Commercialization. Except for the activities conducted by ImmunoGen in accordance with Section 2.5.4, sanofi-aventis shall have the sole right, at its sole expense, for all aspects of the Development and Commercialization of Licensed Products in the Field in the Territory, including, without limitation, the conduct of: (a) all IND-enabling non-clinical studies; (b) all activities related to human clinical trials; (c) all activities relating to the manufacture and supply of Licensed Products (including all required process development and scale up work with respect thereto); and (d) all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance). Without limiting the generality of the foregoing, sanofi-aventis shall have the sole right, at its sole expense, for (i) making all Regulatory Filings for Licensed Products and filing all Drug Approval Applications and otherwise seeking all Regulatory Approvals for Licensed Products, as well as all correspondence and communications with Regulatory Authorities regarding such matters, and (ii) reporting of all adverse events to Regulatory Authorities if and to the extent required by Applicable Laws.
Responsibility for Development and Commercialization. During the License Period, Curis shall have the sole right to conduct all Development and Commercialization activities with respect to the Compounds and Products in the Field, at Curis’ sole cost and expense. Curis shall be responsible for conducting all such Development and Commercialization activities with respect to Compounds and Products in compliance with all applicable Laws.
Responsibility for Development and Commercialization. As of the Effective Date, subject to the indemnification obligations in this Agreement, Cardiome shall be responsible (financially and otherwise) for all further development (pre-clinical and clinical) for Compound in the Field in the Territory, in accordance with the requirements set forth in the [Redacted — License agreement between Lilly and Licensor] and this Agreement. Cardiome shall have responsibility for making Applications for Marketing Authorization. Cardiome or its Sublicensees, shall hold legal title to all Applications for Marketing Authorizations within the Territory, and shall assume full responsibility for the clinical protocols developed in support of such Applications for Marketing Authorization. Except as specifically set forth in this Agreement, Lilly shall have no financial obligation relating to Compound or Product. Cardiome shall be solely responsible for all regulatory obligations commensurate with ownership of such Applications for Marketing Approval and all resulting Regulatory Approvals in the Territory.
Responsibility for Development and Commercialization. Editas’ exercise of a Profit-Sharing Option shall not alter Allergan’s right to control all Development and Commercialization activities under the applicable Allergan Development Program or Allergan’s obligations hereunder with respect to such Development and Commercialization.
Responsibility for Development and Commercialization. (a) Within […***…], Dong-A shall […***…] to conduct and have completed, at Dong-A’s sole expense, the following studies (each, a “Dong-A Study”):
(i) […***…];
(ii) […***…];
(iii) […***…]; and
(iv) […***…]. Prior to initiation of each Dong-A Study, Dong-A shall provide a draft protocol for such Dong-A Study to Rx3 for review, comment and approval to ensure compliance with FDA requirements. Rx3 shall not unreasonably withhold its approval of any such draft protocol. Dong-A shall perform each Dong-A Study in accordance with the Rx3-approved protocol. Promptly following completion of each Dong-A Study, Dong-A shall disclose to Rx3 in writing in English all results of such Dong-A Study, and Rx3 shall have the right to use such results for the purpose of developing and commercializing Products in the Territory.
Responsibility for Development and Commercialization. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.
Responsibility for Development and Commercialization. Tevard’s exercise of the Tevard Option shall not alter Zogenix’s right to control all Development, Manufacturing and Commercialization activities under the Dravet Syndrome Program or Zogenix’s obligations hereunder with respect to such Development, Manufacturing and Commercialization.
Responsibility for Development and Commercialization. On and after the Effective Date, sanofi-aventis shall have the sole right, at its sole expense, for all aspects of the Development and Commercialization of Licensed Products in the Field in the Territory, including, without limitation, the conduct of: (a) all IND-enabling non-clinical studies; (b) all activities related to human clinical trials; (c) all activities relating to the manufacture and supply of Licensed Products (including all required process development and scale up work with respect thereto); and (d) all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance). Without limiting the generality of the foregoing, sanofi-aventis shall have the sole right, at its sole expense, for (i) making all Regulatory Filings for Licensed Products and filing all Drug Approval Applications and otherwise seeking all Regulatory Approvals for Licensed Products, as well as all correspondence and communications with Regulatory Authorities regarding such matters, and (ii) reporting of all adverse events to Regulatory Authorities if and to the extent required by Applicable Laws. The Parties hereby agree that subject to Section 2.3, [***] shall [***]all data, results and all other information arising from any such activities under this Agreement specifically relating to Licensed Products, including, without limitation, all [***] [***] and [***] [***] relating to Licensed Products, and all of the foregoing information, documentation and materials shall be considered Confidential Information of [***].
