Quality Audit of the Facility by Lilly Representatives Sample Clauses

Quality Audit of the Facility by Lilly Representatives. Lilly shall have the right, upon no less than thirty (30) days’ notice and in accordance with the Quality Agreement, to conduct an initial OUS commercial readiness audit of the Facility during regular business hours for the purpose of conducting a quality control inspection to assure cGMP compliance of the Facility used in the Manufacturing of Pen Product to be delivered to Lilly (the “Start-Up Quality Audit”). Following the Start-Up Quality Audit, upon no less than thirty (30) days’ advance written notice to Amylin and in accordance with the terms of the Quality Agreement, no more than one (1) time per Calendar Year, Amylin will permit Lilly’s representatives (such representatives to be reasonably acceptable to Amylin) to conduct an audit of the Facility during regular business hours for the purpose of conducting a quality control inspection to assure cGMP compliance of the Facility used in the Manufacturing of Pen Product to be delivered to Lilly (the “Quality Audit”); provided, however, that such restriction of one (1) such audit per Calendar Year shall not apply in cases where Lilly attends an audit or inspection conducted by a *** Confidential Treatment Requested ***Text Omitted and Filed Separately with the Securities and Exchange Commission. Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2 Regulatory Authority. In addition, Lilly representatives shall have the right to re-inspect the Facility, upon reasonable advance written notice to Amylin and during regular business hours: (i) to ensure appropriate remedial actions are being taken in response to a significant adverse finding identified during a prior Lilly Quality Audit of the Facility, (ii) if an audit of the Facility conducted by a Regulatory Authority results in a critical finding, or (iii) if any Pen Product is, or has the potential to be, recalled from the market by either Amylin and/or Lilly due to Manufacturing issues. Lilly representatives will be advised of the confidentiality obligations under this Agreement, and will follow such security, safety and facility access procedures as are reasonably designated by Amylin. Amylin may require that at all times the Lilly representatives be accompanied by an Amylin representative to assure protection of Amylin Confidential Information or confidential information of a Third Person, if applicable. Amylin will respond in writing to any written audit observation provided by Lilly within sixty (60) days in the form ...
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Related to Quality Audit of the Facility by Lilly Representatives

  • Access to Information; Independent Investigation Prior to the execution of this Agreement, the Subscriber has had the opportunity to ask questions of and receive answers from representatives of the Company concerning an investment in the Company, as well as the finances, operations, business and prospects of the Company, and the opportunity to obtain additional information to verify the accuracy of all information so obtained. In determining whether to make this investment, Subscriber has relied solely on Subscriber’s own knowledge and understanding of the Company and its business based upon Subscriber’s own due diligence investigation and the information furnished pursuant to this paragraph. Subscriber understands that no person has been authorized to give any information or to make any representations which were not furnished pursuant to this Section 2 and Subscriber has not relied on any other representations or information in making its investment decision, whether written or oral, relating to the Company, its operations and/or its prospects.

  • Independent Investigation Subscriber, in making the decision to purchase the Units, has relied upon an independent investigation of the Company and has not relied upon any information or representations made by any third parties or upon any oral or written representations or assurances from the Company, its officers, directors or employees or any other representatives or agents of the Company, other than as set forth in this Agreement. Subscriber is familiar with the business, operations and financial condition of the Company and has had an opportunity to ask questions of, and receive answers from the Company’s officers and directors concerning the Company and the terms and conditions of the offering of the Units and has had full access to such other information concerning the Company as Subscriber has requested. Subscriber confirms that all documents that it has requested have been made available and that Subscriber has been supplied with all of the additional information concerning this investment which Subscriber has requested.

  • Independence of the Asset Representations Reviewer The Asset Representations Reviewer will be an independent contractor and will not be subject to the supervision of the Issuer for the manner in which it accomplishes the performance of its obligations under this Agreement. Unless expressly authorized by the Issuer, the Asset Representations Reviewer will have no authority to act for or represent the Issuer and will not be considered an agent of the Issuer. Nothing in this Agreement will make the Asset Representations Reviewer and the Issuer members of any partnership, joint venture or other separate entity or impose any liability as such on any of them.

  • Independent Due Diligence and Decision Making Each Consenting Stakeholder hereby confirms that its decision to execute this Agreement has been based upon its independent investigation of the operations, businesses, financial and other conditions, and prospects of the Company Parties.

  • Independent Investment Decision Such Purchaser has independently evaluated the merits of its decision to purchase the Shares pursuant to the Agreement, and such Purchaser confirms that it has not relied on the advice of any other Purchaser’s business and/or legal counsel in making such decision. Such Purchaser has not relied on the business or legal advice of the Company or any of its agents, counsel or Affiliates in making its investment decision hereunder, and confirms that none of such Persons has made any representations or warranties to such Purchaser in connection with the transactions contemplated by the Transaction Documents.

  • Construction Representatives Landlord hereby appoints the following person(s) as Landlord's representative ("Landlord's Representative") to act for Landlord in all matters covered by this Work Letter Agreement: __________________________________. Tenant hereby appoints the following person(s) as Tenant's representative ("Tenant's Representative") to act for Tenant in all matters covered by this Work Letter Agreement: _____________________________. All communications with respect to the matters covered by this Work Letter Agreement shall be made to Landlord's Representative or Tenant's Representative, as the case may be, in writing in compliance with the notice provisions of the Lease. Either party may change its representative under this Work Letter Agreement at any time by written notice to the other party in compliance with the notice provisions of the Lease.

  • Buyer’s Investigation Buyer is an informed and sophisticated purchaser and is experienced in the evaluation and purchase of companies such as the Company and Spardee's Realty. Except for the environmental investigations described in Section 6.9 below, Buyer has undertaken such investigation as it has deemed necessary to enable it to make an informed and intelligent decision with respect to this Agreement, and Buyer acknowledges that the Seller Parties and the Company Group have allowed Buyer such access as has been reasonably requested by Buyer to the personnel, properties, premises and records of the Company Group for this purpose. To the extent expressly permitted hereafter under this Agreement, Buyer will undertake such further investigation as it deems necessary. Buyer acknowledges that in entering this Agreement, in acquiring the Shares and in consummating the other transactions contemplated herein, Buyer has relied solely upon its own investigation and analysis and, to the extent expressly permitted by this Agreement, the representations and warranties contained in this Agreement, and that none of the Seller Parties and the Company Group (and any of their respective agents, officers, directors, employees, Affiliates or representatives) has made any representation or warranty as to the Seller Parties, the Company Group, the Shares, this Agreement or the business of the Company Group except as expressly set forth in this Agreement, and Buyer agrees, to the fullest extent permitted by Law, that, except as expressly provided for herein or pursuant to the express provisions hereof, none of the Seller Parties (and any of their respective agents, officers, directors, employees, Affiliates or representatives) shall have any liability to Buyer (or any of its agents, officers, directors, employees, Affiliates or representatives) on any basis based upon any information made available or statements made to Buyer (or any of its agents, officers, directors, employees, Affiliates or representatives).

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

  • Other Matters Pertaining to the Asset Representations Reviewer Section 5.01 Representations, Warranties and Covenants of the Asset Representations Reviewer 9 Section 5.02 Limitation of Liability 10 Section 5.03 Indemnification of Asset Representations Reviewer 11 Section 5.04 Indemnification by Asset Representations Reviewer 11 Section 5.05 Inspections of Asset Representations Reviewer 12 Section 5.06 Delegation of Obligations 13 ARTICLE VI.

  • Information Concerning Financial Condition of the Credit Parties No Party has any responsibility for keeping any other Party informed of the financial condition of the Credit Parties or of other circumstances bearing upon the risk of nonpayment of the Original First Lien Obligations, the Original Second Lien Obligations or any Additional Obligations, as applicable. Each Party hereby agrees that no Party shall have any duty to advise any other Party of information known to it regarding such condition or any such circumstances. In the event any Party, in its sole discretion, undertakes at any time or from time to time to provide any information to any other Party to this Agreement, it shall be under no obligation (a) to provide any such information to such other Party or any other Party on any subsequent occasion, (b) to undertake any investigation not a part of its regular business routine, or (c) to disclose any other information.

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