API Manufacturing Procedures definition

API Manufacturing Procedures means the specific methods, techniques, processes and standard operating procedures (including Quality Control Procedures) that are to be used by FFFC (or any of its Affiliates or subcontractors) in manufacturing the API under this Agreement in accordance with the API Specifications.
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Examples of API Manufacturing Procedures in a sentence

  • Promptly after the Parties have completed the Master Batch Records, and at Cempra’s request, FFFC will commence and conduct certain validation studies (the “Validation Studies”) to validate the API Manufacturing Procedures pursuant to a mutually agreeable validation plan, in preparation for commercialization, to be reasonably negotiated in good faith and agreed upon in writing by the Parties (which plan, upon such agreement in writing by the Parties, will be set forth in Exhibit H).

  • Upon Cempra’s written request, FFFC shall provide to Cempra, in English, the complete Master Batch Records, Batch Records, and any other API production records, and specific API Manufacturing Procedures and updates, and copies of the relevant documents containing any other FFFC technology used in manufacturing API, to the extent such technology and API Manufacturing Procedures are not maintained as confidential in the DMF maintained by FFFC.

  • If Cempra adopts the proposed API Specifications or API Manufacturing Procedures revision, the Transfer Prices for the API will be adjusted as per such agreement, upon the implementation of such revisions or as otherwise agreed by the Parties.

  • Before implementing any agreed revision to the API Specifications or API Manufacturing Procedures, the Project Managers shall, if needed, develop and agree on a reasonable and appropriate implementation plan, which sets forth the specific procedures to be used in preparing for and implementing such change to the API Specifications and/or API Manufacturing Procedures.

  • Notwithstanding anything to the contrary, FFFC shall not disclose any of Cempra’s Confidential Information concerning any API Manufacturing Procedures to Toyama, any Affiliate thereof, or any other Affiliate of FFFC except to the extent approved in advance and in writing by Cempra (such approval not to be unreasonably withheld).

  • FFFC shall prepare and maintain a DMF in the Territory for the API manufactured hereunder, and update such DMF as required by Applicable Law, with such DMF to contain reasonably appropriate information concerning Master Batch Records (and API Manufacturing Procedures) as necessary and appropriate for all Regulatory Submissions in the Territory and for the development, manufacture, commercialization, and use of Drug Product in the Territory.

  • FFFC shall prepare and maintain the Batch Records for each Batch of API manufactured hereunder, and shall provide Cempra, its Affiliates, and its and its Affiliates’ licensees access to such Batch Records for review and inspection, and shall provide copies thereof to Cempra upon request to the extent such technology and API Manufacturing Procedures are not maintained as confidential in the DMF maintained by FFFC.

  • If Cempra, in consultation with FFFC, determines that FFFC cannot implement the proposed revision to the API Specifications or API Manufacturing Procedures in a cost-effective manner, it may withdraw the proposed revision.

  • FFFC shall ensure that all API supplied to Cempra hereunder shall be manufactured in accordance with the API Manufacturing Procedures, cGMP, the Quality Agreement, and all other Applicable Laws, and all other applicable requirements of Regulatory Authorities, (collectively, “Regulatory Standards”) and shall comply with the API Specifications.

  • Without Cempra’s prior written consent, FFFC shall make no change to any part of the API manufacturing process, including: (i) the API Manufacturing Procedures; (ii) any validated analytical methods used to test critical Raw Materials, Intermediates, or the API; (iii) any Regulatory Submission (including but not limited to any DMF) made by FFFC for the API product; (iv) the Master Batch Records; and (v) Batch records or other process documentation.

Related to API Manufacturing Procedures

  • Manufacturing Process means any process for—

  • SOPs has the meaning set forth in Section 3.7.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Ordering Procedures means the ordering and award procedures specified in Clause 6 (Ordering Procedures) and Framework Schedule 5 (Ordering Procedure);

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Staff Vetting Procedures means the Authority’s procedures for the vetting of personnel and as advised to the Contractor by the Authority.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • 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.

  • 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.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Remarketing Procedures means the procedures for conducting Remarketings set forth in Part II of these Articles Supplementary.

  • 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.

  • Operating Procedures means the standard internal operating procedures and compliance policies established by the Company to implement the Compliance Plan.

  • API means American Petroleum Institute.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • AML/KYC Procedures means the customer due diligence procedures of a Reporting Finnish Financial Institution pursuant to the anti-money laundering or similar requirements of Finland to which such Reporting Finnish Financial Institution is subject.

  • Standard Operating Procedures or “SOP” means the procedures as specified in the Annexes or Attachments to the relevant Schedules;

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;