Documentation and Samples Sample Clauses

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.

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.

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...