Co-Promotion Compliance Responsibilities Sample Clauses

Co-Promotion Compliance Responsibilities. Each Party Promoting a Licensed Product in the U.S. shall in all material respects conform its practices and procedures relating to such Promotion to the FD&C Act, the PHS Act, the Pharmaceutical Research and Manufacturers of America ("PhRMA") Code of Pharmaceutical Marketing Practices (the "PhRMA Code") and the American Medical Association ("AMA") Guidelines on Gifts to Physicians from Industry (the "AMA Guidelines"), as the same may be amended from time to time, and promptly notify the other Party of and provide the other Party with a copy of any material correspondence or other reports with respect to the Promotion of a Licensed Product submitted to or received from the FDA, PhRMA or the AMA relating to the FD&C Act, the PHS Act, the PhRMA Code, or the AMA Guidelines. Outside of the U.S., the Parties shall in all material respects conform their practices and procedures relating to such Promotion to the applicable laws, rules and regulations of the applicable country in the Territory, and similarly provide the other Party with a copy of comparable correspondence or other reports as applicable in such country. Each Party shall cause each of its employees, representatives and agents, including, without limitation, each of its Sales Representatives, to do nothing which such Party knows or reasonably should know would jeopardize the goodwill or reputation of either Party or Antegren, or, as applicable, other Licensed Product.
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Co-Promotion Compliance Responsibilities. Each Party Promoting a Licensed Product in the United States shall in all material respects conform its [ * ] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission. practices and procedures relating to such Promotion to the FD&C Act, the Pharmaceutical Research and Manufacturers of America ("PhRMA") Code of ----- Pharmaceutical Marketing Practices (the "PhRMA Code") and the American Medical ---------- Association ("AMA") Guidelines on Gifts to Physicians from Industry (the "AMA --- --- Guidelines"), as the same may be amended from time to time, and promptly notify ---------- the other Party of and provide the other Party with a copy of any material correspondence or other reports with respect to the Promotion of Licensed Product submitted to or received from the FDA, PhRMA or the AMA relating to the FD&C Act, the PhRMA Code or the AMA Guidelines. Outside of the United States, the Parties shall in all material respects conform their practices and procedures relating to such Promotion to the applicable laws, rules and regulations of the applicable country in the Territory, and similarly provide the other Party with a copy of comparable correspondence or other reports as applicable in such country. Each Party shall cause each of its employees, representatives and agents, including, without limitation, each of its Sales Representatives, to do nothing which such Party knows or reasonably should know would jeopardize the goodwill or reputation of either Party or Licensed Product.
Sample 1
Co-Promotion Compliance Responsibilities. To the extent the Parties are Co-Promoting a Product in the United States, each Party shall in all material respects conform its practices and procedures relating to such Co-Promotion to the Federal Food Drug and Cosmetic Act (the “FD&C Act”), the Public Health Services Act (“PHS Act”), and other applicable laws (including state laws) and, with respect to sales under Medicare, Medicaid and related government programs, the Social Security Act, as each may be amended from time to time. Further, in its interactions with customers, each Co-Promoting Party shall pay due regard to the guidelines set forth in (a) the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (the “OIG Guidelines”), (b) the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code of Pharmaceutical Marketing Practices (the “PhRMA Code”) and (c) the American Medical Association (“AMA”) Guidelines on Gifts to Physicians from Industry (the “AMA Guidelines”), as the same may be amended from time to time. Further, each Co-Promoting Party shall promptly notify and provide the other Party with a copy of any material correspondence or other reports with respect to the Co-Promotion of a Product submitted to or received from the FDA, PhRMA or the AMA relating to the FD&C Act, the PHS Act, the PhRMA Code, or the AMA Guidelines. In Canada, the Parties shall in all material respects conform their practices and procedures relating to such Co-Promotion to the applicable laws, rules and regulations of Canada and each of the provinces and territories thereof, and similarly provide the other Party with a copy of comparable correspondence or other reports as applicable in such country.
Sample 1
Co-Promotion Compliance Responsibilities. Each Party Co-Promoting a Product shall in all material respects conform its practices and procedures relating to such Co-Promotion to the Act, the Public Health Service ("PHS Act"), the Pharmaceutical Research and Manufacturers of America ("PhRMA") Code of Pharmaceutical Marketing Practices (the "PhRMA Code") and the American Medical Association ("AMA") Guidelines on Gifts to Physicians from Industry (the "AMA Guidelines"), as the same may be amended from time to time, and the rules and regulations promulgated under any of the foregoing, and promptly notify the other Party of and provide the other Party with a copy of any material correspondence or other reports with respect to the Co-Promotion of a Product submitted to or received from the FDA (or other Regulatory Authority), PhRMA or the AMA relating to the Act, the PHS Act, the PhRMA Code, or the AMA Guidelines.
Sample 1
Co-Promotion Compliance Responsibilities. To the extent the Parties are Co-Promoting a Collaboration Product in the United States, each Party shall in all material respects conform its practices and procedures relating to such Co-Promotion to the Federal Food Drug and Cosmetic Act (the “FD&C Act”), the Public Health Services Act (“PHS Act”), and other applicable laws (including state laws) and, with respect to sales under Medicare, Medicaid and related government programs, the Social Security Act, as each may be amended from time to time. Further, in its interactions with customers, the Co-Promoting Party shall pay due regard to the guidelines set forth in the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code of Pharmaceutical Marketing Practices (the “PhRMA Code”) and the American Medical Association (“AMA”) Guidelines on Gifts to Physicians from Industry (the “AMA Guidelines”), as the same may be amended from time to time. Further, each Party shall promptly notify and provide the other Party with a copy of any material correspondence or other reports with respect to the Co-Promotion of a Collaboration Product submitted to or received from the FDA, PhRMA or the AMA relating to the FD&C Act, the PHS Act, the PhRMA Code, or the AMA Guidelines. Outside of the United States, the Parties shall in all material respects conform their practices and procedures relating to such Co-Promotion to the applicable laws, rules and regulations of the applicable country in the Territory, and similarly provide the other Party with a copy of comparable correspondence or other reports as applicable in such country.
Sample 1

Related to Co-Promotion Compliance Responsibilities

  • Development Responsibilities From and after the Effective Date, BMS shall assume sole responsibility for the Development of Compounds and Products in the Field in the Territory during the Term at its own cost and expense (including responsibility for all funding, resourcing and decision-making, subject to Sections 3.3 and 3.4), except with respect to the performance by Ambrx of the Research Program activities assigned to Ambrx pursuant to the Research Plan and as otherwise may be agreed upon by the Parties in writing. BMS, by itself or through its Affiliates and Sublicensees, shall use Diligent Efforts to Develop a Compound or Product in the Field in accordance with the Development Plan for the purpose of obtaining a Regulatory Approval in each Major Market. For clarity, it is understood and acknowledged that Diligent Efforts in the Development of Compounds and Products may include sequential implementation of Clinical Trials and/or intervals between Clinical Trials for data interpretation and clinical program planning and approval.

  • Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).

  • Regulatory Responsibilities Following the approval by the FDA of an ANDA, Xxxx shall be solely responsible, with Corium’s reasonable assistance, for maintaining the ANDA for the Product including any necessary periodic reporting requirements. Furthermore, Xxxx shall be responsible for all adverse event reporting as required by the Act. Xxxx agrees to perform these activities in conformance with cGMP, the ANDA specifications and the Act. Xxxx shall provide Corium with copies of all material correspondence from or to regulatory authorities in the Territory relating to the maintenance of the ANDA.

  • Client Responsibilities During the Term and subject to the provisions of this Schedule, Client shall at its expense (unless otherwise provided for herein) fulfill, or cause to be fulfilled by the Funds or otherwise, the Client obligations, if any, set forth in each Service Exhibit to this Schedule. Client hereby represents, warrants and covenants that the execution and delivery of this Schedule by Client and the performance of Client’s obligations under this Schedule have been duly authorized by all necessary action on the part of Client. Client must comply with the provisions of this Schedule. Client agrees that DST may seek relief from Client for any infringement of this Schedule such as, but not limited to, a material violation, breach, act of negligence or gross negligence, willful misconduct, misfeasance or malfeasance committed by Client or its officers, agents and assigns, in connection with Client’s obligations and responsibilities under this Schedule.

  • ALPS’ Responsibilities In connection with its performance of TA Web, ALPS shall:

  • Joint Responsibilities In performing the Development Efforts, each party shall

  • Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • Customer Responsibilities (a) The Customer agrees to (i) promptly notify the Bank of any change that the Customer wishes to make to Exhibit B, (ii) promptly notify the Bank if any information contained in the Customer Information Sheet becomes inaccurate or untrue and (iii) indemnify the Bank for any losses resulting from the Customer's failure to adhere to the provisions of Subsection (a) of this Section 11.

  • Company Responsibilities The Company will undertake responsibilities as set forth below:

  • Contractor Responsibilities It shall be Tenant’s responsibility to cause each of Tenant’s contractors and subcontractors to:

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