API Requirements definition

API Requirements has the meaning set forth in Section 4.1 hereof.
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API Requirements. [*] The following items should be available for EMC General Availability of Product per the schedule defined in Exhibit V.
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API Requirements means conformance with (a) cGMP, (b) API Specifications, (c) the current validated process and (d) the Quality Agreement.
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Examples of API Requirements in a sentence

  • Except for SAFC’s indemnification obligations in respect of third party claims under Section 6.8 below, the remedy under this Section 4.3 shall be Company’s exclusive remedy and SAFC’s sole liability for any claim that API fails to conform to the API Requirements.

  • In addition, if the API is determined not to have met the API Requirements, SAFC shall [***].

  • Any claim by Company that API does not conform to the API Requirements shall be made in writing to SAFC within such [***] period and shall be accompanied by a detailed report of analysis prepared by or on behalf of Company.

  • The expenses related to such testing shall be borne by SAFC only if the testing confirms that API Requirements are not fulfilled, and otherwise by Company.

  • In the event of a dispute concerning the fulfilment of API Requirements, Company and SAFC shall agree on an independent testing laboratory of recognized standing in the industry selected by SAFC and approved by Company (which approval shall not be unreasonably withheld) (“Laboratory”) to determine whether any such API met the API Requirements.

  • If any API delivered to Company fails to conform to API Requirements, SAFC, [***] within a commercially reasonable period not to exceed [***] from the date that Company notifies SAFC of such nonconformity.

  • Q17: Page 15, Section 2.2.1, System API Requirements, requirement l.

  • If as a result of such inspection Company or its designee discovers that any API delivered by Manufacturer under this Agreement fails to conform with the API Requirements, Company or such designee may reject such API by providing Manufacturer written notice thereof within [*] after Company’s or its designees’s receipt of such API.

  • All API to be supplied under this Agreement shall be manufactured by Manufacturer at the facility [*] (the “Manufacturing Facility”), in conformance with the API Requirements, the Quality Agreement and the terms of this Agreement.

  • The Manufacturing Facility and all API supplied hereunder shall comply with all Applicable Laws and all API Requirements, and Manufacturer shall perform and document all manufacturing and supply activities contemplated herein in compliance with all Applicable Laws.


More Definitions of API Requirements

API Requirements means the Specifications, instructions of Company, master batch record, current, agreed standard operating procedures, Applicable Law, and any relevant warranties provided by Manufacturer hereunder, including all warranties set forth in Section 8.2. 1.4 “Applicable Laws” means: (i) all relevant U.S. and foreign federal, state and local laws, statutes, rules, regulations, and ordinances and industry standards and guidelines as in effect on the Effective Date or adopted thereafter and which are applicable to a Party's activities hereunder, including, the U.S. Federal Food, Drug and Cosmetic Act (“FDCA”); (ii) GMPs; and (iii) all applicable regulations and guidelines of any Regulatory Authority; in each case, together, with any and all amendments thereto. 1.5 “FDA” means the United States Food and Drug Administration or any successor thereto. 1.6 “GMPs” shall mean current good manufacturing practices, as provided for (and as amended from time to time) in the Current Good Manufacturing Practice regulations promulgated by the FDA under the United States Food, Drug and Cosmetic Act, 21 C.F.R. Part 210 et seq., and in the European Community directive 2003/94/EC (Principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use), as well as applicable documents developed by the International Conference on Harmonization (ICH), and similar requirements of other Regulatory Authorities, and subject to any arrangements, additions or clarifications, and the respective roles and responsibilities, agreed from time to time between the Parties. 1.7 “Regulatory Authority” means the FDA or a regulatory body with similar regulatory authority in a jurisdiction outside the United States, including without limitation the European Medicines Agency. 1.8 “Specifications” means the procedures, process parameters, analytical tests, control procedures, acceptance criteria, validation protocols, storage and release requirements and other similar requirements and specifications for the manufacture of API, as the same are set forth and attached hereto as Exhibit 1.7 (as may be updated and supplemented from time to time in accordance with Section 3.4 below). 2 [*] = 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. ...
Sample 1
API Requirements means the Specifications, instructions of Company, master batch record, current, agreed standard operating procedures, Applicable Law, and any relevant warranties provided by Manufacturer hereunder, including all warranties set forth in Section 8.2.
Sample 1

Related to API Requirements

  • OHS Requirements means all Laws applicable to the Supply and related to occupational health or safety, and all of the City Policies that relate to occupational health or safety, and includes without limitation the WCA;

  • Program Requirements means that Partner has to fulfill certain program requirements as described in detail in the applicable SAP PartnerEdge Model and the PartnerEdge Program Guide.

  • MREL Requirements means the laws, regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities applicable to the Issuer and/or the Group, from time to time, (including any applicable transitional or grandfathering provisions), including, without limitation to the generality of the foregoing, any delegated or implementing acts (such as regulatory technical standards) adopted by the European Commission and any regulations, requirements, guidelines, rules, standards and policies relating to minimum requirements for own funds and eligible liabilities adopted by the Federal Republic of Germany or the Republic of Italy, a relevant resolution authority or the European Banking Authority from time to time (whether or not such requirements, guidelines or policies are applied generally or specifically to the Issuer and/or the Group), as any of the preceding laws, regulations, requirements, guidelines, rules, standards, policies or interpretations may be amended, supplemented, superseded or replaced from time to time.

  • Pretreatment requirements means any substantive or procedural requirement related to pretreatment, other than a pretreatment standard, imposed on an industrial user.

  • Minimum Requirements means the minimum requirements for available commercial structures. The minimum requirements may be found at this link: https://portlandgeneral.com/energy- choices/renewable-power/green-future-impact The minimum requirements may be updated from time to time to reflect PGE’s criteria from its latest Commission accepted renewable request for proposals.

  • Design requirements means the written description of the infrastructure facility to be procured pursuant to this article, including:

  • Project Requirements means the statement included in the Request for Proposal detailing the technical and other requirements of Canada which are to be met by the successful Bidder, and which are to be addressed in the Bid;

  • Safety Requirements means Prudent Electrical Practices, CPUC General Order No. 167, Contractor Safety Program Requirements, and all applicable requirements of Law, PG&E, the Utility Distribution Company, the Transmission Provider, Governmental Approvals, the CAISO, CARB, NERC and WECC.

  • Privacy Requirements shall have the meaning set forth in Section 3.19.

  • Technical Requirements means the Technical Requirements in Section VII of the tendering documents.

  • Requirements means and include schedules, details, description, statement of technical data, performance characteristics, standards (Indian as well as International) as applicable and specified in the Contract.

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • Maintenance Requirements shall have the meaning set forth in Clause 14.2;

  • Storage Injection Requirements means all volumes required by the Seller for injection into underground storage, including cushion gas, and for liquification, including fuel used for injection and in liquification plants, or for such other storage projects that may be developed expressly for the protection of supply to high priority users.

  • Operational requirements means the need to ensure that the Agency is to be operated as effectively, efficiently and economically as possible.

  • Service Requirements means the specification that the Flexibility Services must be capable of meeting, as defined in Schedule 1;

  • MREL Requirement means the minimum requirement for own funds and eligible liabilities which is or, as the case may be, will be applicable to the Issuer;

  • Listing Requirements means the Main Market Listing Requirements of Bursa Securities.

  • Relevant Requirements means all applicable Law relating to bribery, corruption and fraud, including the Bribery Act 2010 and any guidance issued by the Secretary of State for Justice pursuant to section 9 of the Bribery Act 2010;

  • Risk Retention Requirements means the credit risk retention requirements of Section 15G of the Exchange Act (15 U.S.C. §78o-11), as added by Section 941 of the Xxxx-Xxxxx Xxxx Street Reform and Consumer Protection Act.

  • Reporting Requirements As defined in Section 11.12.

  • End Client Requirements means the specific requirements of the End Client, as notified to the Supplier in writing;

  • Regulatory Requirements means all applicable federal and state statutes, regulations, regulatory guidance, judicial or administrative rulings, requirements of Governmental Contracts and standards and requirements of any accrediting or certifying organization, including, but not limited to, the requirements set forth in a Product Attachment.

  • Mandatory City Requirements means those City laws set forth in the San Francisco Municipal Code, including the duly authorized rules, regulations, and guidelines implementing such laws that impose specific duties and obligations upon Contractor.

  • Authority Requirements means the operational requirements, functions and characteristics of the Framework set out in Schedule 1 (Statement of Requirements)

  • Applicable Requirements means all applicable federal, state and local laws, regulations, rules, ordinances, codes, decrees, judgments, directives, or judicial or administrative orders, permits, licenses, authorizations, approvals and other duly authorized actions of any federal, state, local or other governmental regulatory or administrative agency, court, commission, department, board, or other governmental subdivision, legislature, rulemaking board, tribunal, or other governmental authority having jurisdiction, NYISO, NYSRC and NPCC requirements, and any applicable reliability standards.