Medarex Audit Sample Clauses

Medarex Audit. Upon [***] prior notice from Medarex, independent accountants selected by Medarex may have access to the books and records of GSK or its Affiliates and sublicensees during normal business hours to conduct a review or audit for the purpose of verifying the accuracy of Genmab’s payments to Medarex with respect to the sale by GSK, its Affiliates and sublicensees of Product and compliance by Genmab with the Medarex License with respect to such payments. If any audit performed under this Clause shall indicate that any payment due from [***] to Genmab or from Genmab to Medarex was underpaid by more than [***] percent [***] due to non-compliance by GSK, its Affiliates or sublicensees with this Agreement, [***] shall pay the costs of the inspection but [***] shall be responsible to Medarex for paying such underpayment, and [***] shall promptly reimburse such underpayment to [***] and pay to [***] interest on such underpayment from the date such amount(s) were due from Genmab to Medarex, at the prime rate reported by the Chase Manhattan Bank, New York, New York plus [***] percent [***], to defray any interest on such underpayment that Genmab may be obliged to pay Medarex. Notwithstanding the foregoing, Genmab will, upon [***] request, make available to Medarex any records or report of any audit which Genmab has performed and will use its Commercially Reasonable Efforts to cause Medarex to accept the same in place of performing its own audit. For the avoidance of doubt, if Medarex discovers an underpayment of any amounts due from Genmab to Medarex through no fault of [***], then [***] will not pay the costs of the inspection.
Sample 1
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Medarex Audit. Upon [**] days prior notice from Medarex, independent accountants selected by Medarex (and who shall have agreed to be bound by written confidentiality obligations no less protective than those set forth in Section 12.09, or as otherwise agreed by the audited Party and such accountants), may have access to the books and records of TenX and its sublicensees during normal business hours to conduct a review or audit for the purpose of verifying the accuracy of Genmab’s payments to Medarex with respect to the sale by TenX and its sublicensees of Product and compliance by Genmab with the Medarex License with respect to such payments. If any audit performed under this Section 7.04 shall indicate that any payment due from Genmab to Medarex was underpaid by more than five percent (5%) due to non-compliance by TenX or its sublicensees with this Agreement, TenX shall pay the costs of the inspection and shall be responsible to Medarex for paying such underpayment and, TenX shall promptly pay to Genmab interest on such underpayment from the date such amount(s) were due from Genmab to Medarex, at the prime rate reported by the Wall Street Journal plus [**] percent ([**]%), to defray any interest on such underpayment that Genmab may be obliged to pay Medarex.
Sample 1

Related to Medarex Audit

  • Field Audits The Borrower shall permit the Bank to inspect the Inventory, other Tangible Assets and/or other business operations of the Borrower and each Subsidiary, to perform appraisals of the Equipment of the Borrower and each Subsidiary, and to inspect, audit, check and make copies of, and extracts from, the books, records, computer data, computer programs, journals, orders, receipts, correspondence and other data relating to Inventory, Accounts and any other Collateral, the results of which must be satisfactory to the Bank in the Bank’s sole and absolute discretion. All such inspections or audits by the Bank shall be at the Borrower’s sole expense, provided, however, that so long as no Event of Default or Unmatured Event of Default exists, the Borrower shall not be required to reimburse the Bank for inspections or audits more frequently than once each fiscal year.

  • Regulatory Audits BNY Mellon shall, upon reasonable prior notice when possible, make all books and records available to the applicable Voya or Voya Fund regulators and state government representatives or their designees to audit, evaluate and inspect BNY Mellon’s books and records for Voya and such Voya Fund. BNY Mellon agrees to reasonably cooperate with and assist Voya in meeting any regulatory requirements related to audits or inspections imposed upon Voya to the extent that Voya notifies BNY Mellon of such requirements.

  • 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).

  • Field The term “

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than [***].

  • Regulatory Materials (a) Alvogen shall have the sole right to control filing or submission of Regulatory Materials with the Regulatory Agencies in the Territory with respect to Product including the MAA Approval for Product and Regulatory Approvals in the Territory, subject to Section 3.2 and the oversight of and in consultation with the Executive Steering Committee, and [***]Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed. shall be responsible for managing all communications and interactions with the Regulatory Agencies in the Territory with respect to Product in the Territory. In all cases, prior to the filing of any Regulatory Materials (including the MAA for Product) for Product with the applicable Regulatory Agency, Alvogen shall provide a copy thereof to Pfenex (through the Executive Steering Committee) for its review and comment. Pfenex shall have fifteen (15) Business Days from the date it receives a copy of any Regulatory Materials with respect to the Product to provide Alvogen with comments regarding such Regulatory Materials, unless the Regulatory Agencies in the Territory or Applicable Law requires that such Regulatory Material(s) be filed on a timeline that does not reasonably permit such advanced notice, in which case Pfenex shall have as much time as is reasonably practicable to provide Alvogen with comments. Alvogen shall consider all such comments in good faith. Alvogen shall, to the extent permitted by Applicable Law, provide Pfenex with (i) reasonable advanced notice (and in no event less than fifteen (15) Business Days’ advance notice whenever feasible) of substantive meetings with any Regulatory Agency in the Territory that are either scheduled with or initiated by or on behalf of Alvogen or its Affiliates, (ii) an opportunity to have a reasonable number (but at least two (2)) representatives participate in all substantive meetings with the Regulatory Agencies in the Territory with respect to Product, and in any case keep Pfenex informed as to all material interactions with the Regulatory Agencies in the Territory with respect to Product, and (iii) a copy of any material documents, information and correspondence submitted to or received from the Regulatory Agencies in the Territory with respect to Product as soon as reasonably practicable.

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Adverse Developments Promptly after the Lessee acquires knowledge thereof, written notice of:

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