Adverse Event and Product Complaint Reporting Clause Samples
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Adverse Event and Product Complaint Reporting. Wholesale Specialty Distributor shall forward to GPI any information the Wholesale Specialty Distributor obtains from a customer regarding Adverse Events or Product Complaints (as each term is defined below). The customer reporting the Adverse Event or Product Complaint shall be instructed to call a GPI representative by calling GPI’s toll free hot line at (▇▇▇) ▇▇▇-▇▇▇▇, or such other number or numbers provided to Wholesale Specialty Distributor by GPI. For the purposes of this Agreement, “Adverse Event” means any adverse reaction associated with the use of a Product in humans, whether or not considered product related and whether or not confirmed by a health professional. The term “associated with the use of product” is not limited to a causal relationship of the reported event to the Product, and may include (i) an Adverse Event occurring in the course of the use of a Product in professional practice, (ii) an adverse event occurring from abuse of a Product, (iii) an adverse event occurring from the withdrawal of a Product, (iv) any significant failure of expected pharmacological action. For the purposes of this Agreement, a “Product Complaint” means a claim or expression of displeasure, dissatisfaction or annoyance with a Product, Product related materials or Product related information. A Product Complaint may or may not involve a formal charge or accusation. A Product Complaint may be related to, among other things, identity, purity, potency, safety or quality of the product. Notwithstanding the definition of Product Compliant, if the complaint involves a medical event in a patient, it is regarded as an Adverse Event.
Adverse Event and Product Complaint Reporting. (a) If PAG or the Company becomes aware of any Adverse Event, Special Situation, or Product Complaint relating to a BeiGene Product (as each term is defined in Appendix A), PAG or the Company will report such Adverse Event, Special Situation, or Product Complaint to BeiGene in accordance with the requirements set forth in Appendix A, “Adverse Event and Product Complaint Reporting Requirements,” which is attached hereto and incorporated herein by reference and which may be revised by BeiGene from time to time upon written notice to PAG or the Company.
(b) Unless otherwise provided by applicable law, BeiGene shall, at its sole discretion, determine whether any Adverse Event, Special Situation, or Product Complaint will be reported by BeiGene to any regulatory authority and shall prepare all required submissions.
Adverse Event and Product Complaint Reporting. Accredo will not be responsible for FDA reporting of adverse events. Accredo shall notify Company or its identified Vendor responsible for the capture and reporting of such events by warm transfer according to approved Company SOP of any Product adverse event complaint from a third party being reported to Accredo. Suspected adverse events and product complaints left on a voice message outside of business hours will be captured and forwarded to the identified Vendor for processing [****] after capture from voice message. "
Adverse Event and Product Complaint Reporting. During the Development Period, ▇▇▇▇▇▇▇▇ will update Millennium through the JDC as to (a) any Adverse Events in connection with the activities conducted pursuant to the Development Plan, (b) any Adverse Events in connection with the research or development of any products based on, incorporating or utilizing the ARC Platform; and (c) any Product Complaint Information relating to other products based on, incorporating or utilizing the ARC Platform; provided that the foregoing clauses (b) and (c) will not require ▇▇▇▇▇▇▇▇ to violate any agreements with or confidentiality obligations owed to any Third Parties.
Adverse Event and Product Complaint Reporting. During the course of this Agreement, if AllCare becomes aware of an adverse event associated with use of a Vericel product (whether or not expected or labeled), Consultant shall report the adverse event to Vericel within 1 working day, by email at ▇▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇.▇▇▇ or by telephone at ▇-▇▇▇-▇▇▇-▇▇▇▇ or in any of the following forms: (i) CIOMS I; (ii) Med Watch; or (iii) adverse event reporting form (electronic or hardcopy). Information reported shall include: patient identifiers, reporter (including reporter name and contact information), the suspect product information (drug, dose, route, date of administration), and details regarding the adverse event. If Vericel concludes that the AllCare should be trained on Vericel’s Adverse Event Reporting policy, AllCare agrees to cooperate to complete such training.
Adverse Event and Product Complaint Reporting