Development and Regulatory Diligence Sample Clauses

Development and Regulatory Diligence. With respect to a given Collaboration Program for which AbbVie has exercised its Option, AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for a Licensed Product for such Collaboration Program in the Major Markets. For clarity, it is acknowledged that the use by AbbVie of Commercially Reasonable Efforts to perform the Initial Post Exercise Development Plan and Budget, as the same may be amended from time-to-time through any mutually approved amendments (i.e., amendments adopted without AbbVie’s use of its deciding vote under Section 2.4.3(a)(ii) above), shall satisfy the foregoing general obligation to use Commercially Reasonable Efforts to Develop a Licensed Product for the Major Markets. *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
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Development and Regulatory Diligence. Anji Pharma will, and will cause its Affiliates and Sublicensees to, use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for at least one (1) Product in at least one (1) Indication in the Territory, at the sole cost and expense of the Anji Pharma Related Parties, and in compliance with all Applicable Laws, including all legal and regulatory requirements pertaining to the design and conduct of clinical trials. Except as otherwise set forth herein or provided by Applicable Law, Anji Pharma will have no other diligence obligations with respect to the Development or Regulatory Approval of Products under this Agreement. Anji Pharma makes no representation, warranty or covenant, either express or implied, that it will successfully Develop or obtain Regulatory Approval for any Product in any Indication in the Territory. If LipimetiX is or becomes aware of facts that might form a reasonable basis to allege that Anji Pharma has failed to meet any of its obligations under this Section 4.3, the dispute resolution procedures under Section 11.9.1 shall apply.
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Development and Regulatory Diligence. Licensee will use and will cause its Affiliates and Sublicensees to use Commercially Reasonable Efforts to (i) Develop Licensed Products (consistent with Section 3.3) for use in the Territory, (ii) to the extent additional indications or uses, or additional Licensed Products, are Developed, to seek Regulatory Approvals therefore, and (iii) to maintain in good standing and effect all Regulatory Approvals in the Territory for Licensed Products, including both those Regulatory Approvals transferred to Licensee pursuant to this Agreement and new Regulatory Approvals obtained by Licensee during the Term.
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Development and Regulatory Diligence. Licensee shall use Commercially Reasonable Efforts to develop, and to achieve Marketing Authorization for, the Licensed Product in each country and jurisdiction in the Territory. In performing such efforts, Licensee shall also observe GCP, safety standards and any other applicable Law relevant to the development of the Licensed Product in the Territory.
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Related to Development and Regulatory Diligence

  • Development Diligence Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards the next clinical Development milestone or approval milestone, as described in Sections 7.4.2 or 7.4.3, respectively. If Novartis (itself or through its Affiliates or sublicensees) fails to dedicate commercially reasonable efforts, during any [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards such next milestone, then any dispute regarding Novartis’ failure of development diligence with respect to such Profile shall be resolved in accordance with Article 13.

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

  • Commercialization Diligence Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to commercialize a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries. If Novartis commercializes a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries, Novartis will be deemed to satisfy all diligence obligations with respect to such Profile.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • 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).

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • 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.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

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