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.
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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).
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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.
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Related to Development by Licensee

  • Research Use The Requester agrees that if access is approved, (1) the PI named in the DAR and (2) those named in the “Senior/Key Person Profile” section of the DAR, including the Information Technology Director and any trainee, employee, or contractor1 working on the proposed research project under the direct oversight of these individuals, shall become Approved Users of the requested dataset(s). Research use will occur solely in connection with the approved research project described in the DAR, which includes a 1-2 paragraph description of the proposed research (i.e., a Research Use Statement). Investigators interested in using Cloud Computing for data storage and analysis must request permission to use Cloud Computing in the DAR and identify the Cloud Service Provider (CSP) or providers and/or Private Cloud System (PCS) that they propose to use. They must also submit a Cloud Computing Use Statement as part of the DAR that describes the type of service and how it will be used to carry out the proposed research as described in the Research Use Statement. If the Approved Users plan to collaborate with investigators outside the Requester, the investigators at each external site must submit an independent DAR using the same project title and Research Use Statement, and if using the cloud, Cloud Computing Use Statement. New uses of these data outside those described in the DAR will require submission of a new DAR; modifications to the research project will require submission of an amendment to this application (e.g., adding or deleting Requester Collaborators from the Requester, adding datasets to an approved project). Access to the requested dataset(s) is granted for a period of one (1) year, with the option to renew access or close-out a project at the end of that year. Submitting Investigator(s), or their collaborators, who provided the data or samples used to generate controlled-access datasets subject to the NIH GDS Policy and who have Institutional Review Board (IRB) approval and who meet any other study specific terms of access, are exempt from the limitation on the scope of the research use as defined in the DAR.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for one Product in the Field in [***]. Pfizer will have no other diligence obligations with respect to the Development or Regulatory Approval of Products under this Agreement.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Research License Each Collaborator shall allow the other Collaborator to practice any of its Non- Subject Inventions for the purpose of performing the Cooperative Work. No license, express or implied, for commercial application(s) is granted to either Collaborator in Non-Subject Inventions by performing the Cooperative Work. For commercial application(s) of Non-Subject Inventions, a license must be obtained from the owner.