Development and Manufacturing Sample Clauses

Development and Manufacturing. 8.1 During the term of this Agreement, Mediwound shall use its best efforts to develop and commercially market finished pharmaceutical Products. Without limiting the generality of the foregoing, Mediwound shall fund the Development Plan in adherence with the milestones and time schedule set forth therein, without the participation of Xxxxx.
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Development and Manufacturing. EyeTech shall be the sole arbiter of decisions regarding manufacturing and development of the Antibodies and Products contemplated hereunder except that Eyetech shall act with Reasonable Diligence in making such decisions. Eyetech shall be solely responsible for the costs associated with the development, manufacture of and supply of any and all Products following the Effective Date, including without limitation for clinical trials and commercialization.
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Development and Manufacturing. Manufacturer shall manufacture and produce the System so that Paradigm can repackage the System in a cover. Manufacturer shall bear the reasonable expenses, if any, of packaging the System as subassembly. Manufacturer shall notify Paradigm of all changes from time to time made to the System and shall supply Paradigm with written notice and information concerning such changes. Each party shall keep its own master engineering and medical device files.
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Development and Manufacturing. 2.1 EZEM hereby agrees and undertakes to use its best commercial efforts:
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Development and Manufacturing. 2.2.1 Kowa, at its own cost and expense, (a) will use Commercially Reasonable Efforts to conduct the Development of the Licensed Product in the Territory set forth on Schedule 3 (the “Specified Studies”) and any related activities regarding submissions to Regulatory Authorities, and (b) use Commercially Reasonable Efforts to conduct any other studies which Kowa reasonably determines are necessary to obtain Regulatory Approval for at least one Indication; provided, however, that, (i) if any studies other than the Specified Studies are required to obtain Regulatory Approval of Licensed Product in the Territory for either Indication, Kowa may instead terminate this Agreement pursuant to Section 8.2.3, (ii) in the event that Kowa reasonably determines that any of the Specified Studies is unsuccessful, Kowa will have the right to discontinue or not to commence all remaining Specified Studies and all related activities regarding submissions to Regulatory Authorities by terminating this Agreement pursuant to Section 8.2.3 and (iii) in the event Kowa breaches its obligations in Section 2.2.1(b) CymaBay will not be entitled to any damages or equitable relief and CymaBay’s sole right with respect to such breach by Kowa of Section 2.2.1(b) will be to terminate this Agreement pursuant to Section 8.2.5. CymaBay will be responsible, [ * ], for the completion of its ongoing Development activities for the Licensed Product set forth on Schedule 4 initiated prior to the Effective Date for the Territory. CymaBay’s obligations with respect to the Development of the Licensed Product pursuant to this Section 2.2.1 excludes the initiation of any new development studies or activities. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Development and Manufacturing. 3.1 BioChemics warrants, represents and covenants that it has confirmed that each of its current Manufacturers has obtained, and BioChemics will ensure that such current Manufacturers (and any future Manufacturers) will maintain at all times during the period that they Manufacture OTC products for BioChemics, all relevant and specific OTC Product approvals required by the FDA for their respective Manufacturing facilities and that such Manufacturing facilities conform to the applicable and current cGMP. BioChemics has also confirmed that such Manufacturers have conformed to similar requirements of all other Agencies having jurisdiction over the Manufacturing and development of OTC Products at any time during the term of this Agreement.
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Development and Manufacturing. Manufacturer shall produce and manufacture the Systems for Paradigm, except for the Laser Module and Laser Handpiece, and be compensated for such services as follows:
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Development and Manufacturing. The allocation of responsibilities with respect to CMC Development activities and the Manufacture of Product and Vaccine for use in connection with the Research Program shall be as set forth in the Research Plan. The Party responsible for such CMC Development and Manufacturing (the “Manufacturing Party”) (as set forth in the Research Plan) will use a Third-Party contract development and manufacturing organization (“CDMO”) to carry out such activities unless otherwise agreed by the Committee. All ***. For instance, if *** for the *** activities contemplated under the Research Plan (for clarity, ***). Upon *** request, *** to (a) facilitate ***; (b) ensure compliance with Applicable Laws and ***, in accordance with the Research Plan; and (c) include in any agreement with the *** and a requirement that the ***, resolve any adverse audit findings to the reasonable satisfaction of ***. If *** in accordance with Section 2.8.2, then, upon *** request, *** (or ***) in a timely manner following such election. Following the Research Term (or earlier transfer of the Research Program under Section 2.8.2) Merck will be solely responsible for the Manufacture of Vaccines and Products, at *** expense.
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Development and Manufacturing 
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Related to Development and Manufacturing

  • 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).

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • 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.

  • 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.

  • 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 Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • 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.

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