Inspection or Audit Sample Clauses
The Inspection or Audit clause grants one party the right to review and examine the records, operations, or facilities of the other party to ensure compliance with the terms of the agreement. Typically, this clause outlines the scope of inspections, the notice period required before an audit, and any limitations on frequency or access, such as restricting audits to business hours or requiring confidentiality. Its core function is to provide transparency and accountability, helping to detect and prevent breaches, errors, or fraud within the contractual relationship.
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Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of either Party’s facility or a facility under contract with either Party with regard to the Product, such Party shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. Each Party shall use its Commercially Reasonable Efforts to segregate, and not disclose, any Confidential Information of the other Party or other materials, correspondence and documents that are not required to be disclosed during an audit or inspection by a Regulatory Authority. To the extent that either Party receives the inspection or audit observations of such Regulatory Authority, such Party shall promptly provide the other Party with a copy of the inspection or audit observations of such Regulatory Authority. The Party holding the Product Marketing Authorization shall prepare the response to any such observations, but the submission of the response to the applicable Regulatory Authority shall be subject to the other Party’s review, and the Party holding the Product Marketing Authorization shall give due consideration to such other Party’s comments. Each Party shall implement at its own cost the actions to correct any material deficiencies with such Party’s facility or facility under contract found by the Regulatory Authority during the audit or inspection, in accordance with the requirements of the Regulatory Authority and Applicable Law. In the case of any audit or inspection of a Party’s facility or a facility under contract with such Party where such audit or inspection is not related to the Product, such Party shall promptly notify the other Party of any findings of such an audit or inspection that may have an effect on the other Party’s ability to assume its obligation and responsibilities imposed by this Agreement or the Commercialization of the Product in the Auxilium Territory.
Inspection or Audit. KeyBank shall permit HPS or HPS designee at any reasonable time, with prior notice and at HPS expense, to conduct an inspection or audit of KeyBank records relative to HPS Plan and of KeyBank accounting or auditing procedures regarding HPS Plan. HPS shall permit KeyBank designee at any reasonable time, with prior notice and at KeyBank expense, to conduct an inspection or audit of HPS records and materials relative to its Plan and of HPS accounting or auditing procedures regarding its Plan. In addition, HPS will furnish to KeyBank on an annual basis, a financial statement of HPS which has been completed based upon generally accepted accounting principles. If KeyBank, as a result of such inspection, audit, or review, reasonably concludes that it is exposed to undue financial risk or exposure based on the internal controls and security procedures of HPS, KeyBank shall notify HPS in writing of such finding and HPS shall remedy such condition within the appropriate time frame given the perceived risk or exposure. If KeyBank and HPS cannot reach agreement on an appropriate remedy, either party may terminate this Agreement in accordance with Section 2.2 hereof.
Inspection or Audit. If a Regulatory Authority desires to conduct an inspection or audit of Menarini’s facility or a facility under contract with Menarini with regard to the Product in the Menarini Territory, Menarini shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. Menarini shall notify VIVUS immediately by telephone and facsimile (with a follow-up by mail) upon, but not later than *** after learning that an audit or inspection by a Regulatory Authority is scheduled to take place, or, if there is no prior notice by any Regulatory Authority, that an audit or inspection has commenced. Menarini shall make all efforts to coordinate any scheduling of an audit or inspection by a Regulatory Authority to permit VIVUS and its representatives to attend such an audit or inspection. Menarini shall permit VIVUS and its representatives to review and comment in advance on any written communication from Menarini to any Regulatory Authority in connection with such an audit or inspection. Menarini shall promptly provide VIVUS with copies of all communications between Menarini and any Regulatory Authority related to such an audit or inspection and shall promptly propose to VIVUS actions to correct any deficiencies found by the Regulatory Authority during the audit or inspection. Menarini shall segregate, and not disclose, any Confidential Information of VIVUS or other materials, correspondence and documents that are not required to be disclosed during an audit or inspection by a Regulatory Authority. To the extent that Menarini, rather than VIVUS, receives the inspection or audit observations of such Regulatory Authority, Menarini shall provide a copy of such observations to VIVUS within *** following receipt. Menarini shall prepare the response to any such observations, but the submission of the response to the applicable Regulatory Authority shall be subject to VIVUS’s final approval of response, which approval shall not be unreasonably withheld. Upon written approval by VIVUS, Menarini shall implement at its own cost the actions to correct any material deficiencies found by the Regulatory Authority during the audit or inspection in accordance with VIVUS’ instructions, the requirements of the Regulatory Authority and the Applicable Law (“Corrective Actions”). If Menarini fails to implement the Corrective Actions in any material respect, this shall be deemed to be a material breach of this Agreement, giving rise to VIV...
Inspection or Audit. If any Governmental Authority conducts, or gives notice to Assembly of its intent to conduct, an inspection or audit at any investigational site or any Assembly office or facility or to take any other regulatory action, or otherwise makes an inquiry, in each case with respect to or involving or that would otherwise reasonably be expected to affect the Licensed Compounds or Licensed Products or the conduct of the R&D Plan, Assembly shall, unless prohibited from doing so by applicable Law, notify Allergan within three (3) Business Days after Assembly first learns of such governmental inspection or audit and, where reasonably practicable, consult with Allergan in advance of implementing, and permit Allergan to comment on, any proposed plan of action for responding to or complying with any associated demand or request of such Governmental Authority. Wherever possible, and to the extent permitted under applicable Law, Assembly shall provide Allergan with the opportunity (a) to have a representative present at any such governmental inspection or audit and (b) to review in advance and comment on any communications or submissions proposed to be made by Assembly to any Regulatory Authority in relation to any such inquiry, inspection or audit. Assembly shall not unreasonably reject any comments provided by Allergan under this ARTICLE 6.
Inspection or Audit. During the Term of this Agreement or any renewals or extensions:
(a) the Licensor or its authorized representative, shall, upon thirty (30) days prior written notice, have access to the books and records of the Licensee, during normal business hours to the extent necessary to audit the same and to verify the calculation of any royalty fee or other payment referred to in this Agreement or the attainment of the minimum performance levels set out in Article Ten of this Agreement.
(b) In the event that any such audit shall disclose an understatement of any royalty fee or other payment, the Licensee shall immediately pay such amount to the Licensor; provided further, that if any such audit shall disclose an understatement of any royalty fee or other payment of three per cent (3%) or more, the Licensee shall pay the Licensor within fifteen (15) days after receipt of notice from the Licensor, the costs of the audit incurred by the Licensor together with interest at an annual rate equal to two percent (2%) above the rate established by Citibank
A. [New York State] or its successor from time to time as its prime interest rate for commercial loans made in New York State calculated from the date when such royalty fee or other payment was due to the actual date of payment.
(c) The parties acknowledge and agree that accounting statements or reports provided by the Licensee which the Licensor does not challenge shall be deemed to be final and conclusive two (2) years after same are rendered.
Inspection or Audit. If a Regulatory Authority in the Vivus Territory desires to conduct an inspection or audit of Sanofi’s facility or a facility under contract with Sanofi with regard to the Product, Sanofi shall cooperate and cause the contract facility to cooperate with such Regulatory Authority during such inspection or audit. To the extent that Sanofi, rather than Vivus, receives the inspection or audit observations of such Regulatory Authority, Sanofi shall promptly provide a copy of such observations to Vivus. Sanofi shall prepare the response to any such observations, but the submission of the response to the applicable Regulatory Authority shall be subject to Vivus’ final approval of response, which approval shall not be unreasonably withheld. Sanofi agrees to conform its activities under this Agreement to any commitments made in such a response, except to the extent it believes in good faith that such commitments violate Applicable Laws.
Inspection or Audit. WIRES or its authorised persons may undertake an audit of any aspect of the Project, the drinker installation, maintenance and monitoring at any time. You must co‐operate fully with any inspection or audit, including giving reasonable access to your premises, records and all materials and permitting WIRES to take copies of them relevant to the Project. WIRES will give you reasonable notice of its requirements in relation to an inspection or audit and use its reasonable endeavours to minimise disruption and interference to your performance of the Project arising from an audit. Except where otherwise determined by WIRES, you are responsible for the costs of participating in an inspection/audit. You must promptly take any reasonable action required by WIRES or its authorised persons to rectify any error, non‐compliance or inaccuracy identified in an inspection/audit in relation to the Project or your performance of this Agreement.