Documentation and Samples Sample Clauses

Documentation and Samples. AMAG shall maintain complete, accurate and authentic accounts, notes, data and records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the Product in accordance with the applicable laws and regulations in the United States. AMAG shall retain samples of Product from each batch of Product supplied under this Agreement after 3SBio’s acceptance of such batch under Section 5.5. AMAG shall retain such records and samples for a period of three (3) years following the date of manufacture, or longer if required by United States law, and upon 3SBio’s written request shall make available to 3SBio copies of such records and portions of such samples.
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Documentation and Samples. Orexigen shall maintain, to the extent required by Laws in connection with Orexigen’s performance of its obligations hereunder, and shall require its Third Party Manufacturers to maintain, in accordance with cGMPs and other Laws, complete, accurate and authentic accounts, notes, data and records pertaining to the Manufacture and testing of the Product. Orexigen shall make such records available to Takeda for inspection promptly following Takeda’s written request, subject to the terms of the applicable Third Party Manufacturer Agreement. Orexigen shall retain (itself or through its Third Party Manufacturers) samples from each Batch supplied under this Agreement after Takeda’s acceptance of such Batch under Article 8. Orexigen shall, at Takeda’s expense, retain such records or samples (as applicable) for a period of at least [***] ([***]) years following the date of expiration of such samples, or longer if required by Laws, and upon Takeda’s written request shall make available to Takeda copies of such records and portions of such samples, subject to the terms of the applicable Third Party Manufacturer Agreements. Takeda shall reimburse Orexigen for reasonable out-of-pocket costs incurred to retain and make available such records and samples.
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Documentation and Samples. Each Party shall maintain complete, accurate and authentic accounts, notes, data and records pertaining to the methods and facilities such Party uses for the manufacture, processing, testing, packing, labeling, holding and distribution (as applicable) of the Product, in accordance with applicable Laws. Subject to AMAG’s right to limit disclosure of CMC Information in accordance with the terms of the License Agreement, each Party shall make such records available to the other Party for inspection promptly following receipt of the other Party’s written request, and shall make available to such other Party copies of such records, provided that AMAG may redact CMC Information from such records in accordance with the terms of the License Agreement. The Parties’ rights and obligations with respect to Samples shall be as set forth in the applicable Quality Agreement.
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Documentation and Samples. (a) Broadcom will use reasonable efforts to provide documentation to Microtune demonstrating that the Reference Design Product would meet the requirements for DOCSIS 2.0, whether or not submitted by Microtune for certification to CableLabs for CW31 or CW32 (as selected under Section 2.5) subject to the foregoing: (i) If Microtune decides to submit the Reference Design Product for CW31 or CW32 (at Microtune’s option in accordance with Section 2.5), Broadcom will use reasonable efforts to provide submission documentation for CW31 or CW32 (as applicable) for the Reference Design Product (the “Certification Package”). (ii) If Microtune opts to submit the Reference Design Product for CW31 and Broadcom is not able to provide the Reference Design Product and documentation prior to the Submission Date for CW31 due to the fault of Broadcom or a problem or issue with the cable modem chip, software or documentation provided by Broadcom, then Broadcom shall timely provide the Reference Design Product and documentation for submission for CW32. If Broadcom is not able to provide the Reference Design Product and documentation prior to the Submission Date for CW31 due to the fault of Microtune or a problem or issue with the tuner, software or documentation provided by Microtune, then Broadcom shall not have any further obligations under this ARTICLE II. It is understood that issues may arise in the ordinary course of development with respect to interfacing the Broadcom cable modem chip and Microtune tuner chip, and that the parties will reasonably cooperate to resolve such issues to enable Broadcom to provide the Reference Design Product and documentation prior to the respective Submission Date. (iii) If the Reference Design Product does not receive certification after submission for a Cert Wave, and such failure to receive certification is due to the fault of Broadcom or a problem or issue with the cable modem chip, software or documentation provided by Broadcom for such Reference Design Product, then Broadcom shall, at no cost to Microtune, use reasonable efforts to resolve such problem or issue and timely provide to Microtune a new or modified Reference Design Product in order for Microtune to submit such Reference Design Product to the next Cert Wave. If the Reference Design Product does not receive certification after submission for a Cert Wave due to the fault of Microtune or a problem or issue with the tuner, software or documentation provided by Microtune, then Br...
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Related to Documentation and Samples

  • Documentation and compliance (a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses. (b) The Parties shall be able to demonstrate compliance with these Clauses. In particular, the data importer shall keep appropriate documentation on the processing activities carried out on behalf of the data exporter. (c) The data importer shall make available to the data exporter all information necessary to demonstrate compliance with the obligations set out in these Clauses and at the data exporter’s request, allow for and contribute to audits of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. In deciding on a review or audit, the data exporter may take into account relevant certifications held by the data importer.

  • Documentation and Record Keeping 1. Records to be Maintained Subrecipient shall maintain all records required by the Federal regulations specified in 24 CFR 570.506 that are pertinent to the activities to be funded under this Contract. Such records shall include, but not be limited to: a. Records providing a full description of each activity undertaken; b. Records demonstrating that each activity undertaken meets the one of the National Objectives of the CDBG program; c. Records required to determine the eligibility of activities; d. Records required to document the acquisition, improvement, use, or disposition of real property acquired or improved with CDBG assistance; e. Records documenting compliance with the fair housing and equal opportunity components of the CDBG program; f. Financial records as required by federal regulations 24 CFR 570.502, and 24 CFR 84.21-28; and g. Other records necessary to document compliance with Subpart K of 23 CFR.

  • Approval of Documentation The form and substance of all certificates, instruments and other documents delivered to Buyer under this Agreement shall be satisfactory in all reasonable respects to Buyer and its counsel.

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Construction materials (1) The restrictions of section 1605 of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5) (Recovery Act) do not apply to Recovery Act designated country manufactured construction material. The restrictions of the Buy American statute do not apply to designated country unmanufactured construction material. Consistent with U.S. obligations under international agreements, this clause implements--