Manufacturing Changes definition

Manufacturing Changes means any material design changes, or outsourcing of the manufacturing of sub-processes.
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Manufacturing Changes has the meaning set forth in Section 8.4(b).
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Manufacturing Changes means Discretionary Manufacturing Changes and Required Manufacturing Changes.
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Examples of Manufacturing Changes in a sentence

  • Prior to a Supply Chain Transfer, VIVUS will be solely responsible for all internal and external costs, including, without limitation, obsolete raw materials, regulatory filings, work-in-process, and Product, (i) associated with Required Manufacturing Changes, and (ii) all costs associated with any other manufacturing changes not requested by Purchaser.

  • Required Manufacturing Changes: (i) do not include changes to the labeling only (which are dealt with in Section 5.3 hereof), and (ii) do include changes resulting from or arising out of changes to or withdrawal of third party Materials.

  • Quoin shall promptly provide to Licensee Quoin’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Quoin resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting from the changes.

  • Licensee may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed), the Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable.

  • Facility and NPI Equipment-related Required Manufacturing Changes shall be borne by NPI.

  • Orion shall give due consideration to making Other Manufacturing Changes proposed by GTX.

  • All costs associated with Required Manufacturing Changes directly related to the [ * ] shall be borne by [ * ].

  • PharmaZell shall use commercially reasonable efforts to promptly implement such Required Manufacturing Changes.

  • For changes to the Specifications or manufacturing processes that are required by applicable Laws ("Required Manufacturing Changes"), Patheon and the Client shall cooperate in making such changes and use commercially reasonable efforts to implement such changes promptly in a manner that minimizes any effect on the supply hereunder to the Client of Product meeting Specifications.

  • Allendale may make changes to the Specifications from time-to-time, provided that all such changes, including Required Manufacturing Changes, are to be communicated to NPI in writing and acknowledged by NPI in writing.


More Definitions of Manufacturing Changes

Manufacturing Changes. Accelr8 shall notify SCHOTT in writing of any changes it plans to make in raw materials or their supplier or in its manufacturing procedures or processes at least sixty (60) days before making the changes, unless otherwise agreed to by the Parties. SCHOTT will have the right, but not the obligation, to review and approve the proposed changes, provided that such approval shall not be unreasonably withheld, and provided further that, if SCHOTT does not notify Accelr8 within thirty (30) days of receipt of such notice from Accelr8, SCHOTT shall be deemed to have approved such changes. In the event of production changes, Accelr8 and SCHOTT will cooperatively exert best efforts to resolve issues attributable to said changes that arise from complaints by SCHOTT customers who have compared Products manufactured before and after said changes.
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Related to Manufacturing Changes

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

  • Manufacturing Process means any process for—

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Manufacturing Costs means [***].

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Manufacturing Cost means [***].

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Product Schedule means PTC’s standard order form entitled “PTC Product Schedule” (including all schedules, attachments and other document(s) specifically referenced therein) or such alternative order form as may be submitted by Customer and accepted by PTC, in each case that specifies (i) the Licensed Products and/or Services ordered; and (ii) for Licensed Products, the installation address (including the Designated Country) and the Licence Term.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Service Specifications means the following documents, as applicable to the Services under Your order:

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

  • Product Specific Terms means the terms applicable to a specific item of Licensed Software as set out in Schedule 2;

  • Development Plan has the meaning set forth in Section 3.2.