The Production Record Sample Clauses

The Production Record. Client and BSCP shall adhere to the Production Record in producing each Product, except to the extent that such Production Record conflicts with applicable law, in which event, Client shall comply with applicable law. Client will maintain accurate records for the production of each Product. Client shall own the Production Record and shall make copies available to BSCP. BSCP will own all BSCP Operating Documents, and shall make copies thereof available to Client upon Client's request and at Client's expense. BSCP Operating Documents shall remain BSCP Confidential Information. Client Operating Documents shall remain Client Confidential Information.
Sample 1
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The Production Record. BSCP shall adhere to the Production Record in producing each Product, except to the extent that such Production Record conflicts with applicable law, in which event, BSCP will discuss the conflict with Client and attempt to resolve the issues before complying with applicable law. BSCP will maintain accurate records for the production of each Product and will provide all batch records approved by BSCP’s QA department at Client’s request. Client shall own the Production Records and Client Operating Documents relating to each Product produced for Client. BSCP shall own all BSCP Operating Documents, and shall make copies thereof available to Client upon Client’s request and at Client’s expense. BSCP Operating Documents shall remain BSCP Confidential Information. BSCP will provide to Client documentation regarding the production of purified bulk product for the Chemistry, Manufacturing and Controls (“CMC”) section required for a Biologics License Application (“CBLA”) or an analogous Marketing Authorization Application as required by the FDA or other authorized regulatory authority.
Sample 1

Related to The Production Record

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Samples Physical examples of materials, equipment, or workmanship that are representative of some portion of the Work and that establish the standards by which such portion of the Work will be judged. The Contractor shall furnish for approval all samples required by the Contract Documents. The Work shall be in accordance with approved samples.

  • Education Records Educational Records are official records, files and data directly related to a student and maintained by the school or local education agency, including but not limited to, records encompassing all the material kept in the student’s cumulative folder, such as general identifying data, records of attendance and of academic work completed, records of achievement, and results of evaluative tests, health data, disciplinary status, test protocols and individualized education programs. For purposes of this DPA, Education Records are referred to as Student Data. Personally Identifiable Information (PII): The terms “Personally Identifiable Information” or “PII” has the same meaning as that found in U.C.A § 53E-9-301, and includes both direct identifiers (such as a student’s or other family member’s name, address, student number, or biometric number) and indirect identifiers (such as a student’s date of birth, place of birth, or mother’s maiden name). Indirect identifiers that constitute PII also include metadata or other information that, alone or in combination, is linked or linkable to a specific student that would allow a reasonable person in the school community, who does not have personal knowledge of the relevant circumstances, to identify the student with reasonable certainty. For purposes of this DPA, Personally Identifiable Information shall include the categories of information listed in the definition of Student Data.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work.

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials in formal written study reports according to Applicable Laws and national and international guidelines (e.g., ICH, cGCP, cGLP, and cGMP).

  • Metering Data At Developer’s expense, the metered data shall be telemetered to one or more locations designated by Connecting Transmission Owner, Developer and NYISO. Such telemetered data shall be used, under normal operating conditions, as the official measurement of the amount of energy delivered from the Large Generating Facility to the Point of Interconnection.

  • DOCUMENTATION; RECORDS OF PROCESSING Each party is responsible for its compliance with its documentation requirements, in particular maintaining records of processing where required under Data Protection Law. Each party shall reasonably assist the other party in its documentation requirements, including providing the information the other party needs from it in a manner reasonably requested by the other party (such as using an electronic system), in order to enable the other party to comply with any obligations relating to maintaining records of processing.

  • Calibration The comparison of a measurement system or device of unverified accuracy with a measurement system of known and greater accuracy to detect deviation of the unverified measurement system from required performance specifications (of the unverified measurement system or device) and to quantify all measured values to applicable units of the international system of units.

  • Product Data Illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by Developer to illustrate a material, product, or system for some portion of the Work.

  • Project Records ‌ As further described below, Project records include but are not limited to Grantee, financial, and voucher records. All Project records must be retained for a period of three (3) years after final payment under this Grant. All Project records are subject to audit pursuant to Section P of this Grant Agreement. Upon completion of the third year of record retention, the Grantee shall submit all Project records to CARB. Hardcopy of electronic records are suitable. Acceptable forms of electronic media include hard drives, CDs, DVDs, and flash drives. Other forms of electronic media may be allowed based on prior written concurrence from CARB.

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