Complaints and Adverse Events. Each of S&N and Nucryst shall notify the other party no later than the following business day, after becoming aware of any report of any serious adverse event or consumer complaint, and within ten (10) business days after becoming aware of any non-serious adverse events or consumer complaints, associated with the use of a Product, whether or not determined to be attributable to Product. Such notification shall be by facsimile or e-mail (with flagged priority). Evaluation, follow-up and reporting of all adverse events and customer complaints shall be the responsibility of S&N. Nucryst shall provide all assistance reasonably requested by S&N in the foregoing regard. Each party shall maintain a record of all reported adverse events.
Complaints and Adverse Events. The Party responsible for all permits and licenses required by any Regulatory Authority with respect to a given CoSeal Accessory(ies) (if Regulatory Authority permits or licenses are applicable) or a given CoSeal Unit(s) under this Distribution and License Agreement, including any product licenses, applications and amendments in connection therewith, shall be responsible for evaluating and investigating complaints and for reporting all Adverse Events to Regulatory Authorities in the applicable Territory. If the responsible Party becomes aware of any Adverse Events, it shall evaluate, investigate and determine the necessity of reporting all information in its possession regarding such Adverse Event as soon as practicable, in order to fulfill regulatory reporting obligations within the time frames required by Regulatory Authorities and law; provided, however, that AAC shall not be required to communicate with customers of Xxxxxx. The Parties will comply with all applicable reporting laws, rules and regulations governing Adverse Events. Xxxxxx and AAC agree to supply all complaint information including, Adverse Event information, to the responsible Party within five (5) Business Days of learning of a complaint or Adverse Event; to cooperate with investigations and corrective actions; and to comply with all applicable reporting laws, rules and regulations governing Adverse Events.
Complaints and Adverse Events. Each party agrees to inform the other party promptly (but in no event no later than forty-eight (48) hours after becoming aware of same) of any information concerning any complaint involving the Products or that might be applicable to the Products or adverse drug experience (as defined in 21 C.F.R. § 314.80), injury, toxicity, or sensitivity reaction associated with the use of the Products or that might be applicable to the Products, provided that:
(a) if the adverse drug experience is serious, as defined in 21 C.F.R. § 314.80 (including any adverse drug reaction that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer or overdose), then each party shall notify the other party within twenty-four (24) hours;
(b) all notifications to Company shall be by facsimile and on Company’s designated adverse event forms; and
(c) all notifications to Supplier shall be by facsimile and on Supplier’s designated adverse event forms.
Complaints and Adverse Events. If You or anyone in Your Practice learn of any complaint about THE COMPANY’s Products involving a real or possible product defect or adverse reaction in a product user, You agree to promptly (within one (1) business day) submit a written notification concerning the complaint to THE COMPANY, using THE COMPANY’s standard complaint or adverse event reporting form, and You agree to cooperate fully with THE COMPANY, and any government agencies concerned, in investigating and resolving the complaint. The provisions of this Section 6 concerning complaints and adverse events shall survive termination of this Agreement.
Complaints and Adverse Events. Each of S&N and Westaim shall notify the other Party no later than the following Business Day, after becoming aware of any report of any serious adverse event or consumer complaint, and within ten (10) Business Days after becoming aware of any non-serious adverse events or consumer complaints, associated with the use of a Product, whether or not determined to be attributable to Product. Such notification shall be by facsimile or e-mail (with flagged priority). Evaluation, follow-up and reporting of all adverse events and customer complaints shall be the responsibility of S&N. Westaim shall provide all assistance reasonably requested by S&N in the foregoing regard. Each Party shall maintain a record of all reported adverse events.
Complaints and Adverse Events. NASTECH hereby agrees to advise MERCK [***] of any information it receives relating to the safety, efficacy or potency of the PRODUCT. NASTECH will assist MERCK in investigating and resolving all complaints and adverse events related to the MANUFACTURING of the PRODUCT. MERCK will be responsible for communicating to any REGULATORY AGENCIES regarding PRODUCT complaints or adverse events. NASTECH will take any corrective actions agreed to by the parties to avoid future occurrences of PRODUCT complaints or adverse events. 9. INDEMNITY 9.1
Complaints and Adverse Events. The Party responsible for all permits and licenses required by any Regulatory Authority with respect to a given Accessory(ies) (if Regulatory Authority permits or licenses are applicable) or a given Ingredient(s) or Product(s) under this
Complaints and Adverse Events. Each party agrees to inform the other party promptly (but in no event more than forty-eight (48) hours after becoming aware of same) of any information concerning any complaint involving the Products or that might be applicable to the Products, or an Adverse Event, provided that:
(a) all notifications to Medtronic shall be by facsimile and on Medtronic’s designated adverse event forms (attached hereto as Schedule 2.5(a)); and
(b) all notifications to Supplier shall be by facsimile and on Supplier’s designated adverse event forms (attached hereto as Schedule 2.5(b)).
Complaints and Adverse Events. In the event that CBSMA receives any complaint or report of adverse drug events (an "ADVERSE EVENT") associated with the Manufactured Product, then CBSMA shall notify GTC on or before the next day that is not a Saturday, Sunday or federal or state holiday following the receipt thereof. GTC shall have full responsibility for fielding, investigating and responding to all Manufactured Product complaints and Adverse Events. CBSMA shall cause its manufacturing, quality assurance and quality control personnel to cooperate fully with GTC, as appropriate and needed, to investigate any Manufactured Product complaints or Adverse Events and to provide such information or assistance as is reasonably requested by GTC, in order to support GTC, in compliance with Adverse Event, field alert and other reporting requirements imposed by the FDA, or other regulatory authorities. GTC shall report to CBSMA on the resolution of complaints and Adverse Events received by CBSMA. GTC shall be responsible for any and all costs incurred by CBSMA in response to such Adverse Event.
Complaints and Adverse Events. SURMODICS hereby agrees to advise MERCK promptly (and, in any event, within [*]) of any complaint information (including adverse event information) SURMODICS receives relating to Product. SURMODICS will assist MERCK in investigating and resolving all complaints and adverse events related to the Manufacturing of the Product. MERCK will be responsible for evaluating and investigating complaints and for communicating to any Regulatory Authorities regarding Product complaints or adverse events. SURMODICS will take any corrective actions agreed to by the Parties to avoid future occurrences of Product complaints or adverse events related to the Manufacturing of the Product.
