Inspections by Governmental or Regulatory Authority Sample Clauses

Inspections by Governmental or Regulatory Authority. AAIPharma shall be responsible for handling and responding to any FDA or other governmental body inspections or inquiries received by Company or AAIPharma regarding the Manufacturing of any Product during the Term. In cases where AAIPharma is required to provide significant Company or Product specific support to such inspections or inquiries, Company agrees to pay AAIPharma for the time required at the then current AAIPharma regulatory support rate. Each Party shall [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. promptly notify the other regarding any such inquiries and provide the other Party copies of any pertinent correspondence from such authorities related to the Product or services covered in this Agreement. AAIPharma shall provide to Company and any governmental body any information reasonably requested by Company and/or such governmental body concerning any governmental inspection related to any Product (with all information provided to Company being subject to the confidentiality provisions in Section 10.1 herein and with AAIPharma being able to redact any information provided to Company to remove third party confidential information that does not relate to the Products). Company agrees to fully cooperate with and assist AAIPharma in fulfilling its obligations pursuant to this Section 6.3.
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Inspections by Governmental or Regulatory Authority. Company shall be responsible for handling and responding to any FDA or other governmental body inspections or inquiries received by Client or Company regarding the Services during the Term of this Agreement. Company shall prepare for preapproval inspection at its own cost (not including out-of-pocket expenses incurred) and allow audits and inspections by the Pharmaceuticals and Medical Devices Agency (PMDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and the FDA. All out-of-pocket costs incurred by Company for regulatory agency inspections directly related to the API and/or Drug Product being Manufactured at the Facility shall be charged to Client. In cases where Company is required to provide significant Client or Drug Product specific support to such inspections or inquiries, or allow audits or inspections by regulatory agencies other than those listed above, Client agrees to pay Company for the time required, at Company’s then current regulatory support rate. Each Party shall notify the other regarding any such inquiries and provide the other Party copies of any pertinent correspondence from such authorities related to the API, Drug Product or Services covered in this Agreement. Company shall provide to Client and any governmental body any information reasonably requested by Client and/or such governmental body concerning any governmental inspection related to any API or Drug Product (with all information provided to Client being subject to the confidentiality provisions in Article 14 herein and with Company being able to redact any information provided to Client to remove third party confidential information that does not relate to the Client’s API or Drug Product). Client agrees to fully cooperate with and assist Company in fulfilling its obligations pursuant to this Section 8.2. Client shall have the right to review and comment on any communication to any regulatory authority which is related to or involves API or Drug Product
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Inspections by Governmental or Regulatory Authority. AAI DS shall be responsible for handling and responding to any FDA or other Governmental Body inspections or inquiries received by Purchaser or AAI DS regarding the Manufacturing of the Product(s) during the Term. Each Party shall promptly notify the other regarding any such inquiries. AAI DS shall provide to Purchaser and any Governmental Body any information reasonably requested by Purchaser and/or such Governmental Body concerning any governmental inspection related to the Product(s) (with all information provided to Purchaser being subject to the confidentiality provisions in Section 8.9(d) of the APA (as incorporated herein pursuant to Section 10.1) and with AAI DS being able to redact any information provided to Purchaser to remove third party confidential information that does not relate to the Product(s)). Purchaser agrees to fully cooperate with and assist AAI DS in fulfilling its obligations pursuant to this Section 6.3.
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Inspections by Governmental or Regulatory Authority. PCAS shall be responsible for handling and responding to any FDA or other governmental body inspections or inquiries received by PCAS regarding the manufacturing of any Product during the term of this Agreement, provided that for any such inquiries that relate to or that may reasonably impact the Product, PCAS shall notify Corcept within two (2) business days after receiving notice of such inspection or inquiry and provide a copy of the relevant communication from such governmental body. Corcept shall have the right to have its representatives or agents present during such inspection or response to such inquiry, which representatives may include one person from each of its manufacturing, quality and regulatory functions (for a total of three (3) representatives at each such inspection or response, provided that PCAS shall not unreasonably withhold its consent for Corcept to have additional representatives present at such event). Corcept shall have the right to approve PCAS’s responses and correspondence with such governmental body to the extent relating to or reasonably deemed to impact the Product. PCAS will cooperate with Corcept in preparing for any such inspection or inquiry response that may relate to or reasonably be deemed to impact Corcept or use of Product in the Finished Product, and will notify Corcept of any routine (e.g., biennial) regulatory inspections with in one (1) business day after the arrival of relevant inspectors, or upon notification of the relevant meeting or discussion. Corcept shall be responsible for handling and responding to any FDA or other governmental body inspections or inquiries received by Corcept regarding other aspects of the Product during the Term, provided that PCAS shall have the right to review and comment on the portions of Corcept’s responses and correspondence with such governmental bodies that relate to PCAS’s facilities or operations. Each Party shall promptly notify the other regarding any such inquiries or inspections, in advance of the occurrence thereof to the extent reasonably practicable. PCAS shall provide to Corcept and any governmental body any information reasonably requested by Corcept and/or such governmental body concerning any governmental inspection relating to any Product (with all information provided to Corcept being subject to the confidentiality provisions in Section 14 herein, and with PCAS being able to redact any information provided to Corcept to remove third-party confidential informa...
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Related to Inspections by Governmental or Regulatory Authority

  • GOVERNMENT APPROVAL OR REGISTRATION If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, the Licensee will assume all legal obligations to do so. The Licensee will notify The Regents if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. The Licensee will make all necessary filings and pay all costs including fees, penalties and all other out-of-pocket costs associated with such reporting or approval process.

  • Governmental Entity “Governmental Entity” shall mean any federal, state, local or foreign court, arbitral tribunal, administrative agency or commission or other governmental or regulatory authority or administrative agency.

  • Statutory Authority Connecticut General Statute §§ 10a-104, 10a-108, 4a-52a, and 10a-151b provide the University with authority to enter into contracts in the pursuit of its mission.

  • Governmental Body “Governmental Body” shall mean any: (a) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, local, municipal, foreign or other government; or (c) governmental or quasi-governmental authority of any nature (including any governmental division, department, agency, commission, instrumentality, official, organization, unit, body or Entity and any court or other tribunal).

  • Governing Law, Regulatory Authority, and Rules The validity, interpretation and enforcement of this Agreement and each of its provisions shall be governed by the laws of the state of New York, without regard to its conflicts of law principles. This Agreement is subject to all Applicable Laws and Regulations. Each Party expressly reserves the right to seek changes in, appeal, or otherwise contest any laws, orders, or regulations of a Governmental Authority.

  • Authorization of Governmental Authorities No action by (including any authorization, consent or approval), in respect of, or filing with, any governmental authority or regulatory body is required for, or in connection with, the valid and lawful authorization, execution, delivery and performance by it of this Agreement, subject to, in the case of the Debtors, the entry by the Bankruptcy Court of the Approval Order.

  • Approvals of Governmental Bodies As promptly as practicable after the date of this Agreement, Buyer will, and will cause each of its Related Persons to, make all filings required by Legal Requirements to be made by them to consummate the Contemplated Transactions (including all filings under the HSR Act). Between the date of this Agreement and the Closing Date, Buyer will, and will cause each Related Person to, cooperate with Sellers with respect to all filings that Sellers are required by Legal Requirements to make in connection with the Contemplated Transactions, and (ii) cooperate with Sellers in obtaining all consents identified in Part 3.2 of the Disclosure Letter; provided that this Agreement will not require Buyer to dispose of or make any change in any portion of its business or to incur any other burden to obtain a Governmental Authorization.

  • Regulatory Authority If any regulatory authority having jurisdiction (or any successor boards or agencies), a court of competent jurisdiction or other Governmental Authority with the appropriate jurisdiction (collectively, the ''Regulatory Body'') issues a rule, regulation, law or order that has the effect of cancelling, changing or superseding any term or provision of this Agreement (the ''Regulatory Requirement''), then this Agreement will be deemed modified to the extent necessary to comply with the Regulatory Requirement. Notwithstanding the foregoing, if a Regulatory Body materially modifies the terms and conditions of this Agreement and such modification(s) materially affect the benefits flowing to one or both of the Parties, as determined by either of the Parties within twenty (20) business days of the receipt of the Agreement as materially modified, the Parties agree to attempt in good faith to negotiate an amendment or amendments to this Agreement or take other appropriate action(s) so as to put each Party in effectively the same position in which the Parties would have been had such modification not been made. In the event that, within sixty (60) days or some other time period mutually agreed upon by the Parties after such modification has been made, the Parties are unable to reach agreement as to what, if any, amendments are necessary and fail to take other appropriate action to put each Party in effectively the same position in which the Parties would have been had such modification not been made, then either Party shall have the right to unilaterally terminate this Agreement forthwith.

  • Regulatory Authorities Except as described in the Registration Statement, the General Disclosure Package or the Prospectus, each of the Company and its subsidiaries: (a) is and at all times has been in material compliance with all statutes, rules or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company (“Applicable Laws”); (b) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any other federal, state or foreign governmental authority having authority over the Company (“Governmental Authority”) alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (c) possesses all Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (d) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product, operation or activity is in violation of any Applicable Laws or Authorizations and have no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (e) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such action; and (f) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission). The studies, tests and preclinical and clinical trials material to the Company and its subsidiaries taken as a whole, and conducted by or on behalf of the Company and each of its subsidiaries, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Applicable Laws and Authorizations, including, without limitation, the Federal Food, Drug and Cosmetic Act and implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package or the Prospectus are accurate and complete in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, the Company is not aware of any studies, tests or trials the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus when viewed in the context in which such results are described and the clinical state of development; and neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company or any of its subsidiaries that are material to the Company and its subsidiaries taken as a whole.

  • Consents and Approvals of Governmental Authorities No consent, approval, or authorization of, or declaration, filing, or registration with, any governmental or regulatory authority is required to be made or obtained by the Seller in connection with the execution, delivery, and performance of this Agreement or any of the other Acquisition Documents by the Seller.

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