Development, Launch and Marketing Efforts Sample Clauses

Development, Launch and Marketing Efforts. (a) Indevus shall use reasonable commercial efforts consistent with normal business practices to meet the deadlines described in this Section 8.2 or other substantially similar developmental and marketing milestones and deadlines which may be agreed between the Parties: 8.2.1 to submit an application for Product Approval for the Prescription Licensed Product within [*] after the Effective Date; provided, however, that such date (i) shall be extended for additional one (1) year periods if at such date (or any extended date), SLI reasonably determines in good faith that Indevus or any Indevus Affiliate or Sublicensee is engaged in good faith efforts to develop Licensed Product, including but not limited to clinical testing of Licensed Product; and 8.2.2 to launch a Prescription Licensed Product in the United States within six (6) monthsafter obtaining Product Approval in the United States; (b) Notwithstanding the provisions of Section 8.2 (a), SLI shall not have the right to terminate this Agreement under Section 13 in the event Indevus’ failure to fulfill its obligations under Section 8.2.1 or 8.2.2 is due to any of the following circumstances: (i) Unavailability of drug supplies needed to conduct the applicable clinical trial, including, without limitation, as a result of failure of stability or lack of a satisfactory formulation; (ii) An inability to conduct the applicable clinical trial due to action on the part of the FDA [*], including, without limitation, the placement of a clinical hold on such clinical trial; (iii) The conduct of such clinical trial would violate any applicable laws, rules or regulations; (iv) A good faith determination on the part of Indevus that the Licensed Product which is intended to be studied in the applicable clinical trial is not safe or efficacious in its then current formulation or dosage form or dose level, provided Indevus or any Indevus Affiliate is engaged in good faith efforts to pursue development of a Licensed Product; or (v) Any circumstances described in Section 16.1. (c) Notwithstanding the provisions of Section 8.2 (a), if the provisions of Section 8.2 (b) are not applicable, SLI shall nonetheless not have the right to terminate this Agreement under Section 13 in the event Indevus fails to fulfill its obligations under Section 8.2.1 (after giving effect to any then applicable extension periods provided for in Section 8.2.1) or 8.2.2 until expiration of the applicable additional extension period set forth below,...
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Related to Development, Launch and Marketing Efforts

  • 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.

  • Marketing Efforts In connection with an underwritten offering, cause its officers to use their commercially reasonable efforts to support the marketing of the Registrable Securities covered by such offering (including participation in “roadshows” or other similar marketing efforts).

  • Development Efforts 4.2.1 Hana shall use Commercially Reasonable Efforts to Develop each Product in the Territory (including carrying out its responsibilities under the Development Plan) to: (a) conduct or cause to be conducted the necessary and appropriate clinical trials as necessary to obtain and maintain Regulatory Approvals for each Product; and (b) prepare, file and prosecute or cause to be prepared, filed and prosecuted the Regulatory Submission for each Product. 4.2.2 Hana will provide INEX with written reports to keep INEX fully informed of the progress of the Development of each Product as follows: (a) at the close of each Calendar Quarter during the first twenty-four (24) months following the Effective Date of the Definitive Agreements; and (b) on or before June 31 and December 31 of each and every calendar year thereafter.

  • 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.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • 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).

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

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