Example ContractsClausesRegulatory Audits and Inspection
Regulatory Audits and Inspection
Regulatory Audits and Inspection contract clause examples

Borrowers shall permit the representatives of Lender, from time to time during normal business hours, upon reasonable notice but not more than two times in any twelve-month period, to # visit and inspect any of their offices or properties or any other place where Collateral is located to inspect the Collateral or to examine or audit all of Borrowers’ books of account, records, reports and other papers (excluding documents that may not be disclosed under applicable Law, including HIPAA), # make copies and extracts therefrom, and # discuss Borrowers’ business, operations, prospects, properties, assets, liabilities, condition or Accounts with Borrowers’ officers, managers, and independent public accountants (the performance of the foregoing activities is referred to herein as a “site audit”), representatives of Borrowers may be present and participate in any such discussion with such accountants. In addition, Lender may conduct “desk audits” of Borrowers at Lender’s offices no more frequently than monthly by # reviewing and inspecting such Borrowers’ books and records as Lender may require Borrowers to transmit to Lender, and # discussing Borrowers’ business, operations, prospects, properties,

Regulatory Audits. Arrowhead shall cooperate in good faith in the event any Regulatory Authority inspects any site where clinical studies or Manufacturing of clinical supplies of Licensed Products are conducted by or on behalf of Arrowhead pursuant to this Agreement, whether such Audited Site is Arrowhead’s or its Affiliate's or contractor’s or subcontractor's hereunder, as permitted by and subject to the terms and conditions of any applicable agreement with a Third Party or as otherwise expressly permitted by the applicable Third Party. Arrowhead shall notify Janssen within ​ after receiving notification of any Regulatory Authority inspection, which relates to or reasonably could relate to the Licensed Product or clinical studies for the Licensed Product, at any site where clinical studies or Manufacturing of clinical supplies of Licensed Products are conducted. Taking into account the timing and notice provided by the applicable Regulatory Authority, and the terms of any applicable agreements with Third Parties and Applicable Law, Janssen shall be given a reasonable opportunity to assist in the preparation of the Audited Site for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the Audited Site, and the summary, or wrap-up, meeting with a Regulatory Authority at the conclusion of such inspection. If such attendance would result in the disclosure of Arrowhead’s, its Affiliate’s or a Third Party’s confidential information unrelated to the subject matter of this Agreement, an appropriate confidentiality agreement covering such unrelated subject matter shall be entered into. In the event that any Audited Site is found to be non-compliant with one or more Applicable Laws, Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, or current standards for pharmacovigilance practice, Arrowhead shall, promptly and in any event within ​ after receiving notification of such non-compliance, submit to Janssen a CAPA plan and shall use Commercially Reasonable Efforts to cause such non-compliant Audited Site to implement such CAPA plan promptly after submission. Arrowhead agrees to use Commercially Reasonable Efforts to include in any agreement or other written arrangement entered into after the Effective ​ = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

Regulatory Audits and Inspection. Upon ​ notification, [[Cytokinetics:Organization]] or its representatives shall be entitled to conduct an audit of the regulatory and safety/pharmacovigilance systems, procedures and practices of Ji Xing, its Affiliates, sublicensees or subcontractors (including clinical trial sites) relating to the Development, Manufacture, and Commercialization of and Medical Affairs Activities for the Product in the Field in the Territory. Ji Xing shall provide [[Cytokinetics:Organization]] with prompt advance notice of any inspection of Ji Xing, its Affiliates, sublicensees or subcontractors by any Regulatory Authority within ​ of being notified of such an inspection by the Regulatory Authority and shall provide [[Cytokinetics:Organization]] with all information pertinent thereto (including all copies of all notices, filings and correspondences received from or submitted to the Regulatory Authority in connection therewith relating to the Compound or Product). ​. To the extent required by Applicable Laws, [[Cytokinetics:Organization]] shall promptly provide Ji Xing with existing documented evidence or materials owned by holder of Regulatory Approvals that are requested by inspectors or otherwise assist Ji Xing with such regulatory inspections. ​.

Safety and Regulatory Audits. Upon reasonable notification, NVCR or its representatives shall be entitled to conduct an audit of safety and regulatory systems, procedures or practices of Zai, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) relating to Licensed Products no more often than ​ Calendar Year. Zai shall promptly notify NVCR of any inspection of Zai, its Affiliates, sublicenses or subcontractors (including Clinical Trial sites) by any Regulatory Authority relating to Licensed Products and shall provide NVCR with all information pertinent thereto. NVCR shall have the right, but not the obligation, to be present at and participate in any such inspection.

Regulatory Audits and Inspection. Upon reasonable advance notice during regular business hours, each Party may conduct, once per Calendar Year or more frequently upon reasonable cause, an audit of safety and regulatory systems, procedures, and practices of the other Party, including on site evaluations. Such Party shall promptly notify the other Party of any inspections relating to the development or commercialization of Products by any Regulatory Authority in the Territory (with respect to Licensee) or in the Verrica Territory (with respect to Verrica). To the extent permitted by Applicable Laws or such Regulatory Authority, each Party shall permit the other Party’s representative to observe such inspection. Each Party shall also provide the other Party with copies of all correspondences submitted to or received from the Regulatory Authority relating to such inspection.

Each Loan Party shall permit Administrative Agent, or any Persons designated by it, to call at such Loan Party's places of business during regular business hours (unless an Event of Default has occurred and is continuing, then at any reasonable time), and, without hindrance or delay, to inspect the Collateral and to inspect, audit, check and make extracts from such Loan Party's books, records, journals, orders, receipts and any correspondence and other data relating to such Loan Party's business, the Collateral or any transactions between the parties hereto, and shall have the right to make such verification concerning such Loan Party's business as Administrative Agent may consider reasonable under the circumstances. Each Loan Party shall furnish to Administrative Agent such information relevant to Administrative Agent's rights under this Agreement and the other Loan Documents as Administrative Agent shall at any time and from time to time request. Administrative Agent, through its officers, employees or agents shall have the right, at any time and from time to time, to verify the validity, amount or any other matter relating to any of any Loan Party's Accounts, by mail, telephone, telecopy, electronic mail, or otherwise. Each Loan Party authorizes Administrative Agent and its agents to discuss the affairs, finances and business of such Loan Party with any officers, employees or directors of each Loan Party or with its Parent or any Affiliate or the officers, employees or directors of its Parent or any Affiliate, and to discuss the financial condition of each Loan Party with such Loan Party's independent public accountants. Any such discussions shall be without liability to Administrative Agent or to such Loan Party's independent public accountants. Administrative Agent may engage appraisers to appraise the Collateral at such intervals as Administrative Agent shall determine and each Loan Party shall cooperate with such appraisers including providing access to the Collateral and its books and records to such appraisers during regular business hours (unless an Event of Default has occurred and is continuing, then at any reasonable time). Borrowers shall pay to Administrative Agent all customary fees and all reasonable costs and out-of-pocket expenses incurred by Administrative Agent in the exercise of its rights hereunder, and all of such fees, costs and expenses shall constitute Obligations hereunder, shall be payable on demand and, until paid, shall bear interest at the highest rate then applicable to Loans hereunder. Any Lender may accompany Administrative Agent on any such audit or inspection at its own cost. Notwithstanding the foregoing, provided no Event of Default then exists, # Administrative Agent shall limit the number of field audits to no more than two (2) in any Fiscal Year, and # Borrowers shall not be required to reimburse Lender for audit fees related to such two (2) field audits in excess of $40,000 in any Fiscal Year.

Regulatory Audits. The Parties shall cooperate in good faith with respect to Regulatory Authority inspections of any site or facility where Clinical Studies, manufacturing or pharmacovigilance activities with respect to the Product are conducted by or on behalf a Party pursuant to this Agreement, whether such site or facility is such Party’s or its Affiliate’s or Subcontractor’s (each an “Audited Site”), subject to terms and conditions of Third Party agreements (provided that each Party shall use reasonable efforts to ensure that Third Party agreements do not prevent the exercise of such rights). Each Party shall be given a reasonable opportunity (taking into account the timing and notice provided by the applicable Regulatory Authority) to assist in the preparation of the other Party’s Audited Sites for inspection, where appropriate, and to attend any inspection by any Regulatory Authority of the other Party’s Audited Sites, and the summary, or wrap-up, meeting with a Regulatory Authority at the conclusion of such inspection. If such attendance would result in the disclosure to the other Party of Confidential Information unrelated to the subject matter of this Agreement, the Parties shall enter into a confidentiality agreement covering such unrelated subject matter. In the event that any Audited Site is found to be non-compliant with one or more Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice or current standards for pharmacovigilance practice, the non-compliant Party shall submit to the other Party a proposed recovery plan or Corrective and Preventative Actions (“CAPA”) within a reasonable period after such non-compliant Party, its Affiliate or its Subcontractor receives notification of such non-compliance from the relevant Regulatory Authority and such non-compliant Party shall use commercially reasonable efforts to implement such recovery plan or CAPA promptly after submission. Each Party shall use commercially reasonable efforts to secure for the other Party the rights set forth in this Article 4.6(e) from its Subcontractors. In the event a Party is unable to secure such inspection rights from any of its Subcontractors, such Party agrees to secure such rights for itself and, if requested by the other Party, shall exercise such rights, ​, on behalf of the other Party and fully report the results thereof to the other Party. If Licensee desires to conduct such an audit of Licensor’s manufacturing Subcontractors, the Parties will reasonably cooperate to minimize the number of separate audits being conducted by Licensor of such Subcontractor by, for example, allowing Licensee to participate in an audit being conducted for Licensor or one of its other licensees.

Regulatory Audits and Inspection. Upon ​ notification, [[Cytokinetics:Organization]] or its representatives shall be entitled to conduct an audit of the regulatory and safety/pharmacovigilance systems, procedures and practices of Ji Xing, its Affiliates, sublicensees or subcontractors (including clinical trial sites) relating to the Development, Manufacture, and Commercialization of and Medical Affairs Activities for the Product in the Field in the Territory. Ji Xing shall provide [[Cytokinetics:Organization]] with prompt advance notice of any inspection of Ji Xing, its Affiliates, sublicensees or subcontractors by any Regulatory Authority within ​ of being notified of such an inspection by the Regulatory Authority and shall provide [[Cytokinetics:Organization]] with all information pertinent thereto (including all copies of all notices, filings and correspondences received from or submitted to the Regulatory Authority in connection therewith relating to the Compound or Product). ​. To the extent required by Applicable Laws, [[Cytokinetics:Organization]] shall promptly provide Ji Xing with existing documented evidence or materials owned by holder of Regulatory Approvals that are requested by inspectors or otherwise assist Ji Xing with such regulatory inspections. ​.

Regulatory Audits and Inspection. The Safety Agreement shall set out the rights and obligations of the Parties respecting, and the applicable procedures for, safety audits and inspection notifications.

Regulatory Audits. If MTPC receives a notice that a Regulatory Authority desires to conduct an inspection or audit of any of facilities regarding the Viela Compound or a Product, MTPC shall promptly notify Viela of such inspection or audit. The Parties shall negotiate in good faith with respect to response to such notice of an inspection or audit from Regulatory Authority. As the case may be, MTPC or Viela shall permit such inspection or audit, or obtain consent by such contracted facility for such inspection or audit, and cooperate with the Regulatory Authority for such inspection and audit. Upon written request of MTPC, Viela shall assist MTPC in connection with such inspection or audit, or obtain consent by a facility under contract with Viela and cooperate with the Regulatory Authority in the Territory for such inspection and audit. Following receipt of the inspection or audit observations of such Regulatory Authority in writing (a copy of which MTPC or Viela will promptly provide to the other Party), MTPC or Viela, as applicable, shall prepare the response to any such observations, if necessary, and shall provide a

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