Manufacturing Operations Sample Clauses

Manufacturing Operations. To the knowledge of the Company, the Company Products are being and at all times have been manufactured, imported, processed, developed, distributed, packaged, labeled, and stored in material compliance with all applicable laws, including the Federal Food, Drug, and Cosmetic Act (“FD&C Act”); the Public Health Service Act (“PHSA”); and any regulations adopted by regulatory authorities thereunder (including, as applicable, those requirements relating to good laboratory practice, good clinical practice, investigational use, and pre-market approval, as applicable). Except as otherwise disclosed in the Registration Statement and the Prospectus, as of the date hereof, neither the Company nor, to the knowledge of the Company, any of its affiliates, has received notice of any pending or threatened investigation or action from the U.S. Food and Drug Administration (the “FDA”), the U.S. Department of Justice, or any other federal, state, local, or foreign governmental authority alleging that the Company or any of its affiliates is in violation in any respect of any applicable law, including the FD&C Act, the PHSA or any similar state or local equivalents to any of the foregoing, except as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. “Company Products” means any drug product that the Company is developing under its FGFR2, PI3Kα, and SHP2 development programs on or before the date of this Agreement or at any time thereafter prior to each Settlement Date.
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Manufacturing Operations. Manufacturing Operations means the KINEX and/or its Affiliates activities in connection with the manufacture of high potency oral and sterile injectable pharmaceutical products and/or any other products and all other activities related thereto.
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Manufacturing Operations. (a) Following the Manufacturing Facility Completion, KINEX shall establish its Manufacturing Operation in or near Olean, New York at the Manufacturing Facility and shall jointly FSMC-KINEX CONFIDENTIAL SIGNATURE COPY commission, with FOUNDATION, the Manufacturing Operation as soon as possible, with a target date of December 1, 2017 (“Target Commission Date”). Following the Manufacturing Facility Completion, KINEX, at its expense, shall be responsible for operating and managing all aspects of the Manufacturing Operations at the Manufacturing Facility, including, without limitation, hiring the workforce to perform Manufacturing Operations in accordance with the terms of this Agreement, procuring the raw materials, supplies, manufacturing the pharmaceutical products, selling and distributing the pharmaceutical products, and maintaining compliance with all applicable laws. Except for the Manufacturing Facility and the Manufacturing Equipment that will be owned by FSMC and made available by FSMC to KINEX for the Manufacturing Operations, KINEX will own all the inventory, product, output, and other property it purchases or creates associated with running the Manufacturing Operation at the Manufacturing Facility. The profit or losses resulting from the Manufacturing Operation at the Manufacturing Facility shall accrue solely to KINEX. KINEX shall be responsible for all taxes, including, without limitation, federal and local taxes, associated with the Manufacturing Operation at the Manufacturing Facility.
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Manufacturing Operations. To the knowledge of the Company, the Company Products are being and at all times have been manufactured, imported, processed, developed, distributed, packaged, labeled, and stored in material compliance with all applicable laws, including the Federal Food, Drug, and Cosmetic Act (“FD&C Act”); the Public Health Service Act (“PHSA”); and any regulations adopted by regulatory authorities thereunder (including, as applicable, those requirements relating to good laboratory practice, good clinical practice, investigational use, and pre-market approval, as applicable). As of the date hereof, neither the Company nor, to the knowledge of the Company, any of its affiliates, has received notice of any pending or threatened investigation or action from the U.S. Food and Drug Administration (the “FDA”), the U.S. Department of Justice, or any other federal, state, local, or foreign governmental authority alleging that the Company or any of its affiliates is in violation in any material respect of any applicable law, including the FD&C Act, the PHSA or any similar state or local equivalents to any of the foregoing. “Company Products” means any drug product that the Company is developing under its FGFR2, PI3Kα, and SHP2 development programs on or before the date of this Agreement or at any time thereafter prior to the Closing Date.
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Manufacturing Operations. 5.1 Support activities related to Chemistry Manufacturing and Controls (CMC)
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Manufacturing Operations. All manufacturing operations conducted by the Company have been and are being conducted in compliance, in all material respects, with the FDA’s or Relevant Regulatory Authorities’ current Good Manufacturing Practices regulations, policies, and requirements for drug and biological products. In addition, each of Seller and the Company is in material compliance with all applicable registration and listing requirements set forth in 21 U.S.C. §360 and 21 CFR Part 207 and all similar applicable laws and regulations. Except as disclosed in Section 3.30(c)(1) of the Seller Disclosure Schedule, there are no FDA Form 483 notices or similar notices with respect to alleged violation of, or non-compliance with, any laws or regulations in connection with the facilities where Company manufactures any Products or Product Candidates. Except as disclosed in Section 3.30(c)(2) of the Seller Disclosure Schedule, to the knowledge of Seller and the Company, no Third Party manufacturer of Products or Product Candidates or active pharmaceutical ingredient or excipient used in any Products or Product Candidates has received an FDA Form 483 notice or similar notice with respect to alleged violation of, or non-compliance with, any laws or regulations in connection with any facility where such Third Party manufacturer manufactures any Product or Product Candidate or active pharmaceutical ingredient or excipient used in any Product or Product Candidate.
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Manufacturing Operations 
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Related to Manufacturing Operations

  • 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 Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • 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 Costs Patheon shall be allowed to adjust the Fees: (i) for costs associated with the conversion of Granulations and Components into Drug Product (the “Conversion Costs”) in respect of the Drug Product based on the most recently available final Producers’ Price Index for Pharmaceutical Product as published by the U.S. Bureau of Labor Statistics or any governmental successor thereto (“PPI”) using the procedure set forth in Section 4.3 and (ii) for Component Costs to pass on the actual amount of any increase or decrease in such costs without xxxx-up. For each Contract Year in which Patheon is entitled to adjust the Fees Patheon shall provide Client with written notice of any change in the Fees within 30 days of receipt by Patheon of the Annual Forecast. The Parties agree that the Fees shall not be adjusted more than once per Contract Year, however this limitation shall not include price adjustments under section 4.3 or 4.4. In addition, notwithstanding anything herein to the contrary, Manufacturing Fees associated with Conversion Costs shall not be increased by greater than [***]% per annum in any Contract Year during the Term. There shall be no similar limitation in terms of increases in Component Costs which shall be passed on to Client in an amount equal to the actual increase paid by Patheon without markup.

  • Joint Manufacturing Committee Promptly after the Effective Date, the Parties shall establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to oversee Manufacturing activities related to the Territory, subject to the terms of this Agreement and the oversight of the JSC. The JMC shall be responsible, without limitation, for the following:

  • 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).

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