Discussion of Unapproved Uses Sample Clauses
The "Discussion of Unapproved Uses" clause defines the parties' obligations and limitations regarding the mention or promotion of products or services for purposes not officially approved by regulatory authorities. Typically, this clause restricts one or both parties from discussing, marketing, or recommending a product for uses outside its approved labeling, such as off-label uses of pharmaceuticals. It may also require clear disclaimers if such discussions occur, ensuring that audiences are not misled about the product's approved applications. The core function of this clause is to ensure compliance with regulatory requirements and to mitigate legal and reputational risks associated with the unauthorized promotion of unapproved uses.
Discussion of Unapproved Uses. Sponsor will require that presenters disclose when a product is not approved in the United States for the use under discussion.
Discussion of Unapproved Uses. Joint Provider will require that presenter(s) disclose when a product is not approved in the United States for the use under discussion
Discussion of Unapproved Uses. The Accredited Provider will require that activity faculty acknowledge their obligation to disclose to the audience when a product is not approved (“off-label”) or for investigational purposes in the United States for the use under discussion.
Discussion of Unapproved Uses. Meaningful disclosure is required when a product is not approved in the United States for the use under discussion.
Discussion of Unapproved Uses. The Peripheral Nerve Society will require that faculty / presenter(s) disclose when a product is not approved in the location the course is being held for the use under discussion.
Discussion of Unapproved Uses. Instructors are required to disclose when use of a product is considered off-label or investigational. Opportunities for Debate Instructors will ensure meaningful opportunities for questioning or scientific debate.
Discussion of Unapproved Uses. Provider represents and warrants that if an unlabeled (unapproved) use of a commercial product, or an investigational use not yet approved for any purpose by the FDA, is discussed during the educational activity, Provider will require disclosure that the product is not labeled for the use under discussion or that the product is still investigational.
Discussion of Unapproved Uses. ASAM will require that presenters disclose when a product is not approved in the United States for the use under discussion.
Discussion of Unapproved Uses. CME Provider will require that presenters disclose when a product is not approved in the United States for the use under discussion. Opportunities for Debate: CME Provider will ensure opportunities for questioning or scientific debate. Funds should be in the form of an educational grant made payable to: American Osteopathic Association (Provider) or the Provider’s designated agent. Funds should be in the form of an unrestricted educational grant. All other support associated with this CME activity (e.g., distributing brochures, preparing slides) must be given with the full knowledge and approval of CME Provider. No other funds from the Company will be paid to the program director, faculty, or other involved with the CME activity (e.g., additional honoraria, extra social events, etc.). Funds may be used to cover the cost of one or more modest social activities held in conjunction with the educational program, which furthers the CME educational experience and/or allows an educational discussion and exchange of ideas. If Company sponsors a social event, the requirements set forth in Sections 1, and 3-5 will still apply. Attending CME Activity: Employees of Company may attend the CME activity, but may not engage in sales or promotional activities which include displaying any items with logos or Company name while in the space or place of the CME activity. Provider of CME: The Company may not be the agent providing the CME activity to the learners. The Company (Commercial Supporter) agrees to abide by all requirements of the AOA ACCME Policies and Procedures “and” ACCME Standards for Commercial Support℠ to ensure independence in the activity. The Provider agrees to: Abide by all requirements of the AOA ACCME Policies and Procedures “and” ACCME Standards for Commercial Support℠ to ensure independence in the activity; Acknowledge educational support from the Company in program brochures, syllabi, and other program materials. If a conflict of interest is identified, CME Provider will resolve the conflict consistent with applicable standards and guidelines as set forth by ACCME Standards for Commercial Support℠. Upon request, furnish the Company a report concerning the expenditure of the funds provided. In addition, the Provider agrees to provide the Company reportable information that is reasonably needed by the Company in order to fulfill its reporting obligations under any federal, state or local law. Accredited CME Provider: An institution, organization or affi...
Discussion of Unapproved Uses. THMEP will require that presenters disclose when a product is not approved in the United States for the use under discussion.