Joint Compliance Contacts Sample Clauses

Joint Compliance Contacts. Promptly but not later than thirty (30) days following the Effective Date, the Parties shall each identify one representative to manage Material and Program Matters in connection with this Agreement (the “Joint Compliance Contacts”). The Joint Compliance Contacts shall be responsible for ensuring that the Commercialization and Medical Affairs Activities of the Parties with respect to the Product in the United States contemplated by this Agreement occur in accordance with each Party’s healthcare compliance policies and any CIA to which either of the Parties is subject. In the event either Party becomes party to a new CIA after the Effective Date, the Parties will discuss in good faith the implications of such new CIA. The Parties shall instruct the Joint Compliance Contacts to work with the appropriate personnel of each Party to accomplish the goals set forth in this Section 2.2.5 (
Sample 1
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Joint Compliance Contacts. The review of any matter referred to the Joint Compliance Contacts in accordance with this Agreement shall be conducted with the goal of resolving, or creating a solution for, any issue presented to the Joint Compliance Contacts arising from the Commercialization and Medical Affairs Activities of the Parties with respect to the Product in the United States, taking into account each Party’s healthcare compliance policies, any CIA to which either of the Parties is subject, and any guidance received by the Parties during the proposal process in respect of the matter which presented the issue referred to the Joint Compliance Contacts for review. If, after [*] Business Days following referral of the matter to the Joint Compliance Contacts, the Joint Compliance Contact of either Party believes that the Joint Compliance Contacts have reached an irreconcilable impasse despite following the escalation procedures set forth in the Materials Review Process (to the extent applicable) and cannot agree to a common approach, the Joint Compliance Contact of either Party may escalate the issue to the Compliance Executive Officers for review; provided that if, in the good faith determination of the Joint Compliance Contact of either Party, resolution of such Material and Program Matter requires [*] pursuant to applicable Law (e.g., upon an Governmental Authority request to withdraw a Promotional Material), the Joint Compliance Contact of such Party will have the right to immediately escalate the issue to the Compliance Executive Officers for review. All such Material and Program Matters so escalated to the Compliance Executive Officers shall [*]. 2.2.6
Sample 1
Joint Compliance Contacts. Promptly but not later than thirty (30) days following the Effective Date, the Parties shall each identify one representative to manage Material and Program Matters in connection with this Agreement (the “Joint Compliance Contacts”). The Joint Compliance Contacts shall be responsible for ensuring that the Commercialization and Medical Affairs Activities of the Parties with respect to the Product in the United States contemplated by this Agreement occur in accordance with each Party’s healthcare compliance policies and any CIA to which either of the Parties is subject. In the event either Party becomes party to a new CIA after the Effective Date, the Parties will discuss in good faith the implications of such new CIA. The Parties shall instruct the Joint Compliance Contacts to work with the appropriate personnel of each Party to accomplish the goals set forth in this Section 2.2.5 (Joint Compliance Contacts). The review of any matter referred to the Joint Compliance Contacts in accordance with this Agreement shall be conducted with the goal of resolving, or creating a solution for, any issue presented to the Joint Compliance Contacts arising from the Commercialization and Medical Affairs Activities of the Parties with respect to the Product in the United States, taking into account each Party’s healthcare compliance policies, any CIA to which either of the Parties is subject, and any guidance received by the Parties during the proposal process in respect of the matter which presented the issue referred to the Joint Compliance Contacts for review. If, after [*] Business Days following referral of the matter to the Joint Compliance Contacts, the Joint Compliance Contact of either Party believes that the Joint Compliance Contacts have reached an irreconcilable impasse despite following the escalation procedures set forth in the Materials Review Process (to the extent applicable) and cannot agree to a common approach, the Joint Compliance Contact of either Party may escalate the issue to the Compliance Executive Officers for review; provided that if, in the good faith determination of the Joint Compliance Contact of either Party, resolution of such Material and Program Matter requires [*] pursuant to applicable Law (e.g., upon an Governmental Authority request to withdraw a Promotional Material), the Joint Compliance Contact of such Party will have the right to immediately escalate the issue to the Compliance Executive Officers for review. All such Material and...
Sample 1

Related to Joint Compliance Contacts

  • OFAC Compliance (a) Tenant represents and warrants that (a) Tenant and each person or entity owning an interest in Tenant is (i) not currently identified on the Specially Designated Nationals and Blocked Persons List maintained by the Office of Foreign Assets Control, Department of the Treasury (“OFAC”) and/or on any other similar list maintained by OFAC pursuant to any authorizing statute, executive order or regulation (collectively, the “List”), and (ii) not a person or entity with whom a citizen of the United States is prohibited to engage in transactions by any trade embargo, economic sanction, or other prohibition of United States law, regulation, or Executive Order of the President of the United States, (b) none of the funds or other assets of Tenant constitute property of, or are beneficially owned, directly or indirectly, by any Embargoed Person (as hereinafter defined), (c) no Embargoed Person has any interest of any nature whatsoever in Tenant (whether directly or indirectly), (d) none of the funds of Tenant have been derived from any unlawful activity with the result that the investment in Tenant is prohibited by law or that the Lease is in violation of law, and (e) Tenant has implemented procedures, and will consistently apply those procedures, to ensure the foregoing representations and warranties remain true and correct at all times. The term “

  • Regulatory Compliance Cooperation (a) CIT/VC agrees to use commercially reasonable best efforts to avoid the occurrence of a Regulatory Problem. In the event that CIT/VC determines that it has a Regulatory Problem, the Company agrees to use commercially reasonable efforts to take all such actions as are reasonably requested by CIT/VC in order (A) to effectuate and facilitate any transfer by CIT/VC of any Securities of the Company then held by CIT/VC to any Person designated by CIT/VC (subject, however, to compliance with Section 3 of this Agreement), (B) to permit CIT/VC (or any Affiliate of CIT/VC) to exchange all or any portion of the voting Securities of the Company then held by such Person on a share-for-share basis for shares of a class of non-voting Securities of the Company, which non-voting Securities shall be identical in all respects to such voting Securities, except that such new Securities shall be non-voting and shall be convertible into voting Securities on such terms as are requested by CIT/VC in light of regulatory considerations then prevailing, and (C) to continue and preserve the respective allocation of the voting interests with respect to the Company arising out of CIT/VC's ownership of voting Securities of the Company and/or provided for in this Agreement before the transfers and amendments referred to above (including entering into such additional agreements as are requested by CIT/VC to permit any Person(s) designated by CIT/VC to exercise any voting power which is relinquished by CIT/VC upon any exchange of voting Securities for nonvoting Securities of the Company); and the Company shall enter into such additional agreements, adopt such amendments to this Agreement, the Company's Charter and the Company's By-laws and other relevant agreements and taking such additional actions, in each case as are reasonably requested by CIT/VC in order to effectuate the intent of the foregoing. If CIT/VC elects to transfer Securities of the Company to a Regulated Holder in order to avoid a Regulatory Problem, the Company shall enter into such agreements with such Regulated Holder as it may reasonably request in order to assist such Regulated Holder in complying with applicable laws, and regulations to which it is subject. Such agreements may include restrictions on the 39. redemption, repurchase or retirement of Securities of the Company that would result or be reasonably expected to result in such Regulated Holder holding more voting securities or total securities (equity and debt) than it is permitted to hold under such laws and regulations.

  • HIPAA Compliance If this Contract involves services, activities or products subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Contractor covenants that it will appropriately safeguard Protected Health Information (defined in 45 CFR 160.103), and agrees that it is subject to, and shall comply with, the provisions of 45 CFR 164 Subpart E regarding use and disclosure of Protected Health Information.

  • CRA Compliance Neither Seller nor any Seller Subsidiary has received any notice of non-compliance with the applicable provisions of the CRA and the regulations promulgated thereunder. As of the date hereof, Seller Sub’s most recent examination rating under the CRA was “satisfactory” or better. Seller knows of no fact or circumstance or set of facts or circumstances which would be reasonably likely to cause Seller or any Seller Subsidiary to receive any notice of non-compliance with such provisions of the CRA or cause the CRA rating of Seller or any Seller Subsidiary to decrease below the “satisfactory” level.

  • ISRA Compliance (a) Tenant shall, at Tenant’s own expense, comply with the Industrial Site Recovery Act, N.J.

  • AML Compliance The Dealer Manager represents to the Company that it has established and implemented anti-money laundering compliance programs in accordance with applicable law, including applicable FINRA Conduct Rules, Exchange Act Regulations and the USA PATRIOT Act, specifically including, but not limited to, Section 352 of the International Money Laundering Abatement and Anti-Terrorist Financing Act of 2001 (the “Money Laundering Abatement Act,” and together with the USA PATRIOT Act, the “AML Rules”) reasonably expected to detect and cause the reporting of suspicious transactions in connection with the offering and sale of the Offered Shares. The Dealer Manager further represents that it is currently in compliance with all AML Rules, specifically including, but not limited to, the Customer Identification Program requirements under Section 326 of the Money Laundering Abatement Act, and the Dealer Manager hereby covenants to remain in compliance with such requirements and shall, upon request by the Company, provide a certification to the Company that, as of the date of such certification (a) its AML Program is consistent with the AML Rules and (b) it is currently in compliance with all AML Rules, specifically including, but not limited to, the Customer Identification Program requirements under Section 326 of the Money Laundering Abatement Act.

  • 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).

  • FCPA Compliance The Company has not and, to the Company’s actual knowledge, none of its employees or agents at any time during the last five years have (i) made any unlawful contribution to any candidate for foreign office, or failed to disclose fully any contribution in violation of law, or (ii) made any payment to any federal or state governmental officer or official, or other person charged with similar public or quasi-public duties, other than payments required or permitted by the laws of the United States or any jurisdiction thereof.

  • Health Care Compliance Neither the Company nor any Affiliate has, prior to the Effective Time and in any material respect, violated any of the health care continuation requirements of COBRA, the requirements of FMLA, the requirements of the Health Insurance Portability and Accountability Act of 1996, the requirements of the Women's Health and Cancer Rights Act of 1998, the requirements of the Newborns' and Mothers' Health Protection Act of 1996, or any amendment to each such act, or any similar provisions of state law applicable to its Employees.

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