Common use of Adverse Event and Product Complaint Reporting Clause in Contracts

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. 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 (▇▇▇) ▇▇▇-▇▇▇▇▇▇ will, within one (l) business day of a customer complaint or such other number or numbers provided receipt of information regarding an Adverse Event (as defined below) notify Vericel of the same by email: [***] with a copy to Wholesale Specialty Distributor [***], as may be amended by GPIVericel from time to time upon notice to ▇▇▇▇▇▇. For Information reported shall include, to the purposes extent available and legally permissible: patient identifiers, reporter (including reporter name and contact information), Product information (dose, route, date of this Agreementadministration), and details regarding the adverse event. “Adverse Event” means any adverse reaction associated with the use of a Product in humanshumans (as defined below), whether or not considered product related and whether or not confirmed by a health professional. The term “associated Associated with the use of producta product in humans” 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 Adverse Event occurring from abuse of a Product, (iii) an adverse event occurring Adverse Event occur ring from the withdrawal of a Product, or (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 Product-related materials or Product Product-related informationinfo1mation. 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 productProduct. Notwithstanding the definition of Product CompliantComplaint, if the complaint involves a medical event in a patient, it is regarded as an Adverse Event.

Adverse Event and Product Complaint Reporting. Wholesale Specialty Distributor shall forward to GPI GPT 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 '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.