Production & Validation Sample Clauses

Production & Validation. 9.1 Maintains, qualifies and validates the Facilities, equipment and processes associated with Processing the API, including cleaning validation or verification. x 9.2 Reviews and approves validation of processes directly associated with manufacturing of the API. x 9.3 Stores Validation Protocols and Reports, and upon request provides a copy of API related validation documentation to the other party. The other party must be informed before destruction of any Validation Protocols or Reports related to the API. x 9.4 Manufactures and tests the API at the facilities in accordance with the Product Master Batch Records, the SOPs referenced therein and the Specifications. x 9.5 Makes the final determination of whether to use the API in clinical trials or commercially. x 9.6 Uses appropriately validated or qualified analytical methods for routine API testing. x 9.7 Maintains adequately trained staff and appropriate records of training and competence. x 9.8 Generates Master Batch Record. x 9.9 Approves Master Batch Record. x x 9.10 Generates Product Specifications. x
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Production & Validation. The Owner and KL shall mutually agree on a Third Party engineering firm to test and confirm the actual Nameplate Capacity of such Production Plant (a “Validation”). In the event that such Production Plant’s actual Nameplate Capacity does nor meet or exceed the desired Nameplate Capacity set forth in the Project Requirements, the Owner shall not be required to pay any Royalty Fees as set forth in Section 4.2 below until such time as the Production Plant meets or exceeds its Nameplate Capacity.

Related to Production & Validation

  • Validation To validate the notice requirements outlined in Section 5.3, the Assuming Institution shall provide the Receiver (i) an Affidavit of Publication to meet the publication requirements outlined in Section 5.3(a) and (ii) the Assuming Institution will prepare an Affidavit of Mailing in a form substantially similar to Exhibit 2.3B after mailing the seven (7) day Notice to Depositors as required under Section 5.3(b).

  • Fabrication Making up data or results and recording or reporting them.

  • Production Lessee shall, subject to applicable laws, regulations and orders, operate and produce all xxxxx upon the leased land so long as the same are capable of producing in paying quantities, and shall operate the same so as to produce at a rate commensurate with the rate of production of xxxxx on adjoining lands within the same field and within the limits of good engineering practice, except for such times as there exist neither market nor storage therefore, and except for such limitations on, or suspensions of, production as may be approved in writing by Lessor. Lessee shall be responsible for adequate site security on all producing properties.

  • 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. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Interoperability To the extent required by applicable law, Cisco shall provide You with the interface information needed to achieve interoperability between the Software and another independently created program. Cisco will provide this interface information at Your written request after you pay Cisco’s licensing fees (if any). You will keep this information in strict confidence and strictly follow any applicable terms and conditions upon which Cisco makes such information available.

  • Interconnection Facilities Engineering Procurement and Construction Interconnection Facilities, Network Upgrades, and Distribution Upgrades shall be studied, designed, and constructed pursuant to Good Utility Practice. Such studies, design and construction shall be based on the assumed accuracy and completeness of all technical information received by the Participating TO and the CAISO from the Interconnection Customer associated with interconnecting the Large Generating Facility.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Assembly (a) The Contracting Parties shall have an Assembly. (b) Each Contracting Party shall be represented by one delegate who may be assisted by alternate delegates, advisors and experts. (c) The expenses of each delegation shall be borne by the Contracting Party that has appointed the delegation. The Assembly may ask WIPO to grant financial assistance to facilitate the participation of delegations of Contracting Parties that are regarded as developing countries in conformity with the established practice of the General Assembly of the United Nations or that are countries in transition to a market economy. (a) The Assembly shall deal with matters concerning the maintenance and development of this Treaty and the application and operation of this Treaty. (b) The Assembly shall perform the function allocated to it under Article 26(2) in respect of the admission of certain intergovernmental organizations to become party to this Treaty. (c) The Assembly shall decide the convocation of any diplomatic conference for the revision of this Treaty and give the necessary instructions to the Director General of WIPO for the preparation of such diplomatic conference. (a) Each Contracting Party that is a State shall have one vote and shall vote only in its own name. (b) Any Contracting Party that is an intergovernmental organization may participate in the vote, in place of its Member States, with a number of votes equal to the number of its Member States which are party to this Treaty. No such intergovernmental organization shall participate in the vote if any one of its Member States exercises its right to vote and vice versa. (4) The Assembly shall meet in ordinary session once every two years upon convocation by the Director General of WIPO. (5) The Assembly shall establish its own rules of procedure, including the convocation of extraordinary sessions, the requirements of a quorum and, subject to the provisions of this Treaty, the required majority for various kinds of decisions.

  • Network Interconnection Architecture Each Party will plan, design, construct and maintain the facilities within their respective systems as are necessary and proper for the provision of traffic covered by this Agreement. These facilities include but are not limited to, a sufficient number of trunks to the point of interconnection with the tandem company, and sufficient interoffice and interexchange facilities and trunks between its own central offices to adequately handle traffic between all central offices within the service areas at a P.01 grade of service or better. The provisioning and engineering of such services and facilities will comply with generally accepted industry methods and practices, and will observe the rules and regulations of the lawfully established tariffs applicable to the services provided.

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