Audits by Amylin Sample Clauses

Audits by Amylin. With respect to Polymer Product Manufactured and supplied to Amylin hereunder, Amylin will have the right, upon written request at a mutually agreeable time and at its own expense, to review annually Alkermes’ quality control and assurance procedures and records, and to visit those sections of the Alkermes Facility used in such Manufacture and supply in order to assure compliance with this Agreement, the Specifications, cGMPs and other applicable laws, and the Quality Agreement. In addition to such annual audits, Amylin may conduct “for cause” audits. Amylin may be accompanied during any audit by an appropriate representative of its Collaboration Partner, and Amylin will be responsible for coordinating the details of such audit with its Collaboration Partner. All such audits will be conducted in accordance with the provisions of the Quality Agreement. In addition, Alkermes will use commercially reasonable efforts to obtain approval from any Third Person that Manufactures Polymer or Polymer Product, as applicable, in accordance with Section 3.13 for Amylin and its Collaboration Partner to participate in Alkermes’ quality assurance audits of such manufacturer’s facilities in which it Manufactures Polymer or Polymer Product, as applicable. Amylin and its Collaboration Partner will be subject to any terms and conditions imposed by the Third Person manufacturer with respect to such audit and Amylin will be responsible for coordinating the details of any such Third Person audit with its Collaboration Partner. Amylin agrees that Confidential Information of Alkermes will include any documents (including any made available in electronic form) and data provided to Amylin or its Collaboration Partner for the purpose of any such audits and any other information received by Amylin or its Collaboration Partner, whether in writing, orally or by observation, while on-site at the Alkermes Facility or a Third Person manufacturer’s facility to perform such audits or during the course of discussions related thereto. While on-site at the Alkermes Facility, Amylin and its Collaboration Partner agree to follow all of Alkermes’ rules, regulations and procedures with respect to conduct at the Alkermes Facility. Amylin and its Collaboration Partner will cooperate with Alkermes in taking reasonable precautions to avoid exposure of the Amylin and Collaboration Partner representatives to information regarding activities of Alkermes or a Third Person manufacturer unrelated to the Polym...
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Related to Audits by Amylin

  • Notification; Updates to Disclosure Schedule (a) During the Pre-Closing Period, the Company shall promptly notify Parent in writing of:

  • Notice of Material Actions / Change in Control The Sub-Adviser will keep the Trust and the Adviser informed of developments relating to its duties as subadviser of which the Sub-Adviser has, or should have, knowledge that would materially affect the Fund. The Sub-Adviser will promptly notify the Adviser in writing of the occurrence of any of the following events (i) it is served or otherwise receives notice of, or is threatened with, any material action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, governmental, administrative or self-regulatory agency, or public board or body, involving the affairs of the Fund and (ii) any change in the partners of the Sub-Adviser or in the actual control or management of the Sub-Adviser or change in the portfolio manager(s) primarily responsible for the day-to-day management of the Allocated Portion.

  • Field Audit and Examination Reports; Disclaimer by Lenders By signing this Agreement, each Lender:

  • Notification of Breach / Compliance Reports The Adviser shall notify the Trust immediately upon detection of (i) any material failure to manage any Fund in accordance with its investment objectives and policies or any applicable law; or (ii) any material breach of any of the Funds’ or the Adviser’s policies, guidelines or procedures. In addition, the Adviser shall provide a quarterly report regarding each Fund’s compliance with its investment objectives and policies, applicable law, including, but not limited to the 1940 Act and Subchapter M of the Code, as applicable, and the Fund’s policies, guidelines or procedures as applicable to the Adviser’s obligations under this Agreement. The Adviser agrees to correct any such failure promptly and to take any action that the Board may reasonably request in connection with any such breach. Upon request, the Adviser shall also provide the officers of the Trust with supporting certifications in connection with such certifications of Fund financial statements and disclosure controls pursuant to the Xxxxxxxx-Xxxxx Act. The Adviser will promptly notify the Trust in the event (i) the Adviser is served or otherwise receives notice of any action, suit, proceeding, inquiry or investigation, at law or in equity, before or by any court, public board, or body, involving the affairs of the Trust (excluding class action suits in which a Fund is a member of the plaintiff class by reason of the Fund’s ownership of shares in the defendant) or the compliance by the Adviser with the federal or state securities laws or (ii) an actual change in control of the Adviser resulting in an “assignment” (as defined in the 0000 Xxx) has occurred or is otherwise proposed to occur.

  • Effect of Benchmark Transition Event (i) If the Calculation Agent determines that a Benchmark Transition Event and its related Benchmark Replacement Date have occurred prior to the Reference Time (as defined below) in respect of any determination of the Benchmark (as defined below) on any date, the Benchmark Replacement will replace the then-current Benchmark for all purposes relating to the Subordinated Notes during the relevant Floating Interest Period in respect of such determination on such date and all determinations on all subsequent dates.

  • Conclusiveness of Statements; Survival of Provisions Determinations and statements of any Lender pursuant to Sections 8.1, 8.2, 8.3 or 8.4 shall be conclusive absent demonstrable error. Lenders may use reasonable averaging and attribution methods in determining compensation under Sections 8.1 and 8.4, and the provisions of such Sections shall survive repayment of the Obligations, cancellation of any Notes, expiration or termination of the Letters of Credit and termination of this Agreement.

  • Notice and Effect of Material Events The Company will immediately notify each Initial Purchaser, and confirm such notice in writing, of (x) any filing made by the Company of information relating to the offering of the Securities with any securities exchange or any other regulatory body in the United States or any other jurisdiction, and (y) prior to the completion of the placement of the Securities by the Initial Purchasers as evidenced by a notice in writing from the Initial Purchasers to the Company, any material changes in or affecting the earnings, business affairs or business prospects of the Company and its subsidiaries which (i) make any statement in the Offering Memorandum false or misleading or (ii) are not disclosed in the Offering Memorandum. In such event or if during such time any event shall occur as a result of which it is necessary, in the reasonable opinion of the Company, its counsel, the Initial Purchasers or counsel for the Initial Purchasers, to amend or supplement the Final Offering Memorandum in order that the Final Offering Memorandum not include any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in the light of the circumstances then existing, the Company will forthwith amend or supplement the Final Offering Memorandum by preparing and furnishing to each Initial Purchaser an amendment or amendments of, or a supplement or supplements to, the Final Offering Memorandum (in form and substance satisfactory in the reasonable opinion of counsel for the Initial Purchasers) so that, as so amended or supplemented, the Final Offering Memorandum will not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances existing at the time it is delivered to a Subsequent Purchaser, not misleading.

  • Notification of Incorrect Certificate The Company will, at any time during the term of this Agreement, as supplemented from time to time, advise the Manager immediately after it shall have received notice or obtained knowledge thereof, of any information or fact that would alter or affect any opinion, certificate, letter and other document provided to the Manager pursuant to Section 6 herein.

  • Provision and contents of Compliance Certificate (a) The Company shall supply a Compliance Certificate to the Agent with each set of its audited consolidated Annual Financial Statements and each set of its consolidated Quarterly Financial Statements.

  • Notification by Borrower Borrower will promptly give Notice to Lender of the occurrence of any Default or Event of Default hereunder or under any of the other Loan Documents. Borrower will also promptly give Notice to Lender of any claim of a default by Borrower, or any claim by Borrower of a default by any other party, under any property management contract or any Lease.

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