Development Compliance Sample Clauses

Development Compliance. IPC shall comply with, and shall require compliance by its third party contractors with, all Applicable Laws in the conduct of all activities associated with the development of the Product including in the practice of all associated analytical methods.
Development Compliance. The development and construction of the Managed Facilities shall be in accordance with this Agreement and the Collaboration Agreement.
Development Compliance. During the Term, Developers shall comply with, and shall require compliance by its Third Party contractors with all Applicable Laws in the conduct of all activities associated with the Product, including in the practice of all associated analytical methods. During the Term, Developers shall be fully responsible to Stason for all activities (actions or inactions) of any contractor that Developers may employ as if Developers had conducted such activities itself. Each of Itochu and Oishi shall not employ any contractor in connection with this Agreement without Stason’s prior written consent.
Development Compliance. Ono shall conduct its Development Activities in accordance with sound and ethical business and scientific practices, and in compliance with all Laws, GCPs and GLPs. In addition, Ono shall not use in any capacity, in connection with its Development (or Commercialization) of Product hereunder, any Person who has been debarred pursuant to Section 306 of the FD&C Act (or similar Laws outside of the U.S.), or who is the subject of a conviction described in such section, and Ono shall inform Onyx in writing immediately if it or any Person who is performing services for Ono hereunder is debarred or is the subject of a conviction described in Section 306 (or similar Laws outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Ono’s knowledge, is threatened, relating to the debarment of Ono or any Person used in any capacity by Ono in connection with its Development (or Commercialization) of Product hereunder.
Development Compliance. Each of GSK and its Affiliates, Sublicensees, and its and their Third-Party subcontractors shall conduct its respective Development activities under this Agreement in a good scientific manner and in compliance with Applicable Law, including any Applicable Laws regarding environmental, safety, industrial hygiene, Clinical Investigation Laws, Good Laboratory Practice, Good Clinical Practice or pharmacovigilance requirements, as applicable; provided, however, that, no such Person shall be obligated to undertake or continue any Development activities with respect to any Licensed Product if such Party reasonably determines that performance of such Development activity would violate any Applicable Law or pose an unacceptable safety risk to Clinical Trial subjects.
Development Compliance. Ono shall conduct its Development Activities in accordance with sound and ethical business and scientific practices, and in compliance with all Laws, GCPs and GLPs. In addition, Ono shall not use in any capacity, in connection with its Development (or Commercialization) of Product hereunder, any Person who has been debarred pursuant to Section 306 of the FD&C Act (or similar Laws outside of the U.S.), or who is the subject of a conviction described in such section, and Ono shall inform Onyx in writing immediately if it or any Person who is performing services for Ono hereunder [ ** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. is debarred or is the subject of a conviction described in Section 306 (or similar Laws outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Ono’s knowledge, is threatened, relating to the debarment of Ono or any Person used in any capacity by Ono in connection with its Development (or Commercialization) of Product hereunder.
Development Compliance. Spectrum shall comply with, and shall require compliance by its Third Party contractors with, all Applicable Laws in the conduct of all activities associated with the development and manufacture of the Products including all associated analytical methods and cGMP requirements.

Related to Development Compliance

  • Program Compliance The School Board shall be responsible for monitoring the program to provide technical assistance and to ensure program compliance.

  • FERPA Compliance In connection with all FERPA Records that Contractor may create, receive or maintain on behalf of University pursuant to the Underlying Agreement, Contractor is designated as a University Official with a legitimate educational interest in and with respect to such FERPA Records, only to the extent to which Contractor (a) is required to create, receive or maintain FERPA Records to carry out the Underlying Agreement, and (b) understands and agrees to all of the following terms and conditions without reservation:

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • CEQA Compliance The District has complied with all assessment requirements imposed upon it by the California Environmental Quality Act (Public Resource Code Section 21000 et seq. (“CEQA”) in connection with the Project, and no further environmental review of the Project is necessary pursuant to CEQA before the construction of the Project may commence.

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities 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 under development, 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 governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is 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 the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity 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).