Development by Licensee Clause Samples
Development by Licensee. It is the intention of the Parties that the Licensee Development Activities shall be exercised by Licensee in accordance with its own business judgment and in its sole and absolute discretion, at its own expense, and in accordance with this Agreement, GLP, GCP, GMP, and all Applicable Laws. Licensee shall keep Licensor reasonably informed of its progress in performing the Licensee Development Activities through the JSC (or a subcommittee established by the JSC). Licensor shall provide Licensee with all assistance that Licensee may reasonably request in connection with the Licensee Development Activities.
Development by Licensee. Licensee shall use Commercially Reasonable Efforts to perform the Licensee Development Activities at its own expense and shall do so in accordance with this Agreement, GLP, GCP, GMP, and all Applicable Laws. Licensee shall keep Licensor reasonably informed of its progress in performing the Licensee Development Activities. Without limiting the generality of the foregoing, following the end of each calendar quarter, Licensee shall prepare and provide Licensor with a reasonably detailed written report describing in detail its progress in performing the Licensee Development Activities sufficient to enable Licensor to understand and monitor Licensor’s diligence and the results thereof, through such date of such report. Licensor shall provide Licensee with all assistance that Licensee may reasonably request in connection with the Licensee Development Activities. Such reports will be discussed at the meetings of the JSC (or subcommittee established by the JSC).
Development by Licensee. Except for Development to be conducted by Licensor under Sections 4.2.1 and 4.3.1(a), after the Regulatory Documentation Assignment Date Licensee shall be solely responsible for, and shall use Commercially Reasonable Efforts to conduct, all Development activities (other than the Phase III Clinical Trial and any Regulator-Requested Trial that the Regulatory Authorities require Licensor to complete prior to the Regulatory Documentation Assignment Date) relating to the Licensed Product in the Field in the Territory pursuant to Section 4.3.1(b), as necessary for Licensee to obtain and/or maintain Regulatory Approval for the Licensed Product in the Field in the Territory, which Development shall be conducted at Licensee’s own cost and expense. Licensee shall keep Licensor reasonably informed of its plans for Development for the Licensed Product in the Territory and shall provide Licensor with copies of all documentation and correspondence relating to its efforts concerning regulatory matters relating to the Licensed Product in the Territory and developments with respect thereto, including Licensee’s expected timing with respect to submission and receipt of any and all Regulatory Approvals. Prior to filing any document or sending any correspondence to a Regulatory Authority concerning regulatory matters relating to the Licensed Product in the Territory, Licensee shall provide a draft to Licensor. Licensor shall provide its comments on such draft within ten (10) Business Days after receipt thereof and Licensee shall consult with Licensor regarding such reasonable comments, shall consider in good faith any reasonable comments provided by Licensor and shall incorporate such reasonable comments into the draft to be submitted to the Regulatory Authority. Licensee shall promptly inform Licensor of any submissions to the Regulatory Authorities regarding Regulatory Approvals and provide Licensor with copies of such submissions.