Roche Responsibilities Sample Clauses
Roche Responsibilities. Other than Dicerna’s supply responsibilities under Sections 8.1 and 8.2 and Dicerna’s Transfer Activities (and subject to Section 6.3), (i) Roche shall otherwise be solely responsible at its own expense for the manufacture and supply of all pre-clinical and clinical supplies of Compounds and Products, either by itself or through Third Parties, and (ii) Roche shall be solely responsible at its own expense for the commercial manufacture and commercial supply of Lead Products for sale in the Territory, either by itself or through Third Parties. After the Effective Date, Roche will commence technical development in order to have established required processes and material for Roche’s Development needs.
Roche Responsibilities. Subject to Maxygen’s rights set forth in Articles 5 and 18, Roche will have sole responsibility, for (a) all clinical development of Products for the applicable Initial Indication after Maxygen transfers to Roche the INDs for such Initial Indication pursuant to Section 12.3, and (b) all commercialization of Products in the Field in the Territory, including all Product sales and marketing.
Roche Responsibilities. Roche, at its sole cost, shall use Reasonable Diligence to (1) pursue clinical development of the Optioned Compounds in the Field from and after the date of the Option Exercise and, subject to the provisions of Section 3.1 hereof and oversight of the Joint Development Committee, be responsible for all such clinical development activities; and (2) obtain all Regulatory Approvals, including authorizations as may be required for the production, importation, pricing, reimbursement, and sale of Products in the Territory. For avoidance of doubt, Roche shall have sole discretion as to which Optioned Compound shall be pursued for further development as a Product, and Roche's decision not to pursue development of a particular Optioned Compound in favor of pursuing development of another Optioned Compound shall not constitute a breach of Roche's diligence obligations. Roche shall notify ArQule of all Serious Adverse Drug Reactions and Serious Adverse Events occurring during any clinical study of an Optioned Compound within * of Roche's notice to the applicable regulatory authority. Roche shall notify ArQule of all Adverse Drug Reactions and Adverse Events occurring during any clinical study of an Optioned Compound within * of Roche's notice to the applicable regulatory authority. Upon the Option Exercise, the Parties shall cooperate to effect on orderly transition to Roche of ArQule's database of information relating to the Optioned Compounds.
Roche Responsibilities