Adverse Experience. 8.1. DOV shall keep (and DOV shall cause its sublicensees to keep under terms and conditions equal to those set forth in this Article 8.0) Wyeth, during the term of this Agreement, promptly and fully informed of all pharmaceutical, toxicological and clinical findings relating to adverse experience of the Product or Marketed Product.
Adverse Experience. During the Term, each Party shall promptly notify the other Party of any significant event(s) that affect the marketing of the Products, including, but not limited to, adverse drug experiences and governmental inquiries. WC shall have the reporting responsibility for such events to applicable regulatory health authorities in the Territory, and BMSLC shall cooperate with WC in connection therewith as requested by WC.
Adverse Experience. During the Term, each Party shall promptly notify the other Party of any significant adverse events that relate to the Product or are required in accordance with the regulations of relevant Governmental Entities, including adverse drug experiences and governmental inquiries, and each Party shall cooperate with the other Party in connection therewith as reasonably requested by the other Party and as follows:
Adverse Experience. 9.1 As stated in Sections 9.2 and 9.3, EYEFITE shall keep (and EYEFITE shall cause its sublicensees to keep under terms and conditions equal to those set forth in this Section 9) CANFITE, during the term of this Agreement, promptly and fully informed of all pharmaceutical, toxicological and clinical findings relating to adverse experience of the Licensed Product or Licensed Compound. CANFITE shall be permitted to share with PHS all data and information provided under this Article 9 by EYEFITE.
Adverse Experience. For so long as there is unexpired Licensed Product manufactured under an Approved ANDA in Galen’s inventory, at its wholesalers or their retailers, each Party shall promptly notify the other Party of any significant event(s) that affects the marketing of the Licensed Products, including adverse drug experiences and inquiries by Governmental Authorities. The holder of the ANDA shall have the reporting responsibility for such events as provided under Applicable Law. Each of Bxxx and Gxxxx shall cooperate with the other Party in connection therewith as reasonably requested by the other Party and as follows:
Adverse Experience. 8.1 DOV shall keep (and DOV shall cause its sublicensees to keep under terms and conditions equal to those set forth in this Article 8) ACY during the term of this Agreement, promptly and fully informed of all pharmaceutical, toxicological and clinical findings relating to adverse experience of the Product and Marketed Product.
Adverse Experience. Any adverse experience information obtained by Xxxxxx shall be reported to OraSure, by telephone or by facsimile within three (3) business days after Xxxxxx’x initial receipt of any such information: provided, however, any report of a serious adverse event or any report of a death shall be reported to OraSure by telephone within twenty-four (24) hours after Xxxxxx’x receipt of the information and by facsimile within forty-eight (48) hours after Xxxxxx’x receipt of the information. Reports under this Section 6.5 shall be sent to OraSure’s Vice President, Regulatory Affairs and Quality.
Adverse Experience. An adverse experience is any unfavorable and unintended change in the structure, function or chemistry of an animal or human being and includes any injury, side-effect, toxicity or sensitivity reaciton that may be associated with the use of a Merck animal health product, whether or not the experience is considered to be causally related ot the Merck product. For a marketed product, this would also include any failure of the marketed Merck product to exhibit its expected pharmacological activity in the animal. Reports of an adverse experience may originate from a variety of sources such as: Merck or extramural research personnel, veterinarians, animal health professionals, agricultural workers, pet and livestock owners, distributors, sales personnel, marketing staffs, etc. Three important classes of adverse experiences have special reporting requirements. These are:
Adverse Experience. Until such time as the NDAs may be assigned and transferred to the Company, each Party shall promptly notify the other Party of any significant event(s) that affect the marketing of the Products, including, but not limited to, adverse drug experiences and governmental inquiries. The holder of the NDA shall have the reporting responsibility for such events as provided under applicable Law to applicable regulatory health authorities in the United States. Each of BMS and the Company shall cooperate with the other Party in connection therewith as reasonably requested by the other Party and as follows:
Adverse Experience. Duke shall promptly, in accordance with applicable laws and regulations, advise Sponsor of any adverse reactions or side effects occurring during the conduct of any Study that become known to Duke.
