Training; Materials; Compliance Sample Clauses

Training; Materials; Compliance. GSK will supply all training materials and instructors for the training of the OncoMed MSLs. OncoMed will be required to pay travel and accommodation expenses for its MSLs to attend any specific training events. OncoMed shall be responsible for ensuring that its MSLs have comparable levels of knowledge, experience and skills as other oncology MSL representatives employed by GSK. OncoMed will ensure that its MSLs achieve similar pass rates in training exams. As necessary and to the extent permitted by GSK commercial policies and practices, and at GSK’s request and direction, OncoMed MSLs may participate as educators in training events for GSK sales representatives for the Co-Commercialized Product. In the conduct of OncoMed’s Co-Commercialization responsibilities, OncoMed’s MSLs will use only GSK-approved documents, information and materials and will comply with all relevant GSK standard operating procedures and commercial practices and policies in effect during the Co-Commercialization period as such are communicated to OncoMed. OncoMed’s Co-Commercialization activities will be conducted in accordance with all Laws (including without limitation those promulgated by the FDA and the Division of Drug Marketing and Communications), and OncoMed’s MSLs will be required to act in accordance with GSK’s Corporate Integrity Agreement and the PhRMA Code of Conduct. At all times, OncoMed will be solely responsible for ensuring its MSLs abide by GSK’s “Regional Medical Scientist Practice Policy,” and/or Laws. As part of the training materials to be supplied to OncoMed by GSK under this Section 6.6, GSK shall provided a copy of the then-current GSK Corporate Integrity Agreement, and the GSK Regional Medical Scientist Practice Policy, and the PhRMA Code of Conduct, and Laws promulgated by the FDA and the Division of Drug Marketing and Communications, each as applicable to the conduct of OncoMed’s Co-Commercialization activities under the terms of this Agreement, and, during the term of such Co-Commercialization activities, updates to such materials, as appropriate. If an OncoMed MSL [***], each as applicable to the conduct of OncoMed’s Co-Commercialization activities under the terms of this Agreement, where such violation is [***], GSK shall notify OncoMed immediately of such violation. If such violation is determined to have been the result of [***], each as applicable to the conduct of OncoMed’s Co-Commercialization activities under the terms [***] Certain information ...
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Training; Materials; Compliance. GSK, [********], will supply all promotional and marketing materials used to promote the relevant Licensed Product in the United States as well as all product-specific training materials and trainers for the training of the EPIX sales representatives [********]. EPIX will use only GSK-approved promotional messages and materials and will comply with the GSK commercial practices and policies in effect during the co-promotion period as such are communicated to EPIX. EPIX's co-promotion activities will be conducted in accordance with all applicable laws and regulations (including, without limitation, those promulgated by the FDA and the Division of Drug Marketing and Communications). EPIX shall be responsible for ensuring that its sales force representatives have comparable levels of knowledge, experience and skills as other sales representatives employed by GSK. EPIX will ensure that its sales force representatives shall be trained to the same level and with consistent materials as GSK's own sales force representatives, and achieve similar pass rates in sales training exams, at the time of such training. EPIX's sales force representatives shall attend, as appropriate in view of GSK's policies and practices, such training seminars as are held for GSK's own sales force representatives. Any additional training events required by EPIX [********]. Subject to EPIX's right to provide the level of co-promotion services specified under Section 6.2, GSK shall not be restricted in its promotional and selling efforts to any specialist or general practice physician. At all times, EPIX will be solely responsible for ensuring its sales force abides by all applicable commercial practice standards, legal regulations and regulatory rules.
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Related to Training; Materials; Compliance

  • 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).

  • ADA Compliance A. The Americans with Disabilities Act (42 U.S.C. § 12101, et seq.) and the regulations thereunder (28 C.F.R. § 35.130) (“ADA”) prohibit discrimination against persons with disabilities by the State, whether directly or through contractual arrangements, in the provision of any aid, benefit, or service. As a condition of receiving this Agreement, the Company certifies that services, programs, and activities provided under this Agreement are and will continue to be in compliance with the ADA.

  • 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.

  • 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.

  • Y2K Compliance PFPC further represents and warrants that any and all electronic data processing systems and programs that it uses or retains in connection with the provision of services hereunder on or before January 1, 1999 will be year 2000 compliant.

  • 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.

  • Subscriber’s Compliance Nothing in this Section 4 shall affect in any way Subscriber’s obligations and agreements to comply with all applicable securities laws upon resale of the Securities.

  • Millennium Compliance Borrower shall take all action necessary to assure that there will be no material adverse change to Borrower's business by reason of the advent of the year 2000, including without limitation that all computer-based systems, embedded microchips and other processing capabilities effectively recognize and process dates after April 1, 1999, except for personal office computers and network stations which will be compliant by October 1, 1999. At FINOVA's request, Borrower shall provide to FINOVA assurance reasonably acceptable to FINOVA that Borrower's computer-based systems, embedded microchips and other processing capabilities are year 2000 compatible.

  • SAFE Compliance The Company shall comply with the SAFE Rules and Regulations, and shall use commercially reasonable efforts to cause its shareholders and option holders that are, or that are directly or indirectly owned or controlled by, PRC residents or PRC citizens, to comply with the SAFE Rules and Regulations applicable to them in connection with the Company, including without limitation, requesting each shareholder and option holder, that is, or is directly or indirectly owned or controlled by, a PRC resident or PRC citizen to complete any registration and other procedures required under applicable SAFE Rules and Regulations.

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