Adverse Experience Reporting. During the term of the Agreement, each party shall notify the other immediately of any information concerning any serious or unexpected side effect, injury, toxicity or sensitivity reaction, or any unexpected incidence, and the severity thereof, associated with the clinical uses, studies, investigations, tests and marketing of the Product. For purposes of this Article 13, "
Adverse Experience Reporting. (a) Until the Registrations are transferred to Buyer, Seller shall be responsible for the adverse experience and safety reporting for the CV Products in compliance with the requirements of the FD&C Act and the regulations promulgated thereunder. After the Registrations are transferred to Buyer, Buyer shall assume such responsibility. Buyer and Seller agree to meet promptly after the Closing Date to determine mutually agreeable reporting procedures to communicate the information as required under this Section 10.4.
(b) On or before the Closing Date, Seller shall provide Buyer with a summary of the information relating to the investigation and reporting of adverse experiences regarding the CV Products and all appropriate information that is relevant to the safe use of the CV Products as of the Closing Date.
(c) After the Closing Date and until the Registrations are transferred to Buyer, Buyer agrees to promptly submit to Seller all adverse drug experience information and customer complaints brought to the attention of Buyer with respect to the CV Products, as well as any material events and matters concerning or affecting the safety or efficacy of the CV Products. Such information or customer complaints shall be forwarded to Seller to the attention of: Name: [****]* Title: Medical Director, Drug Safety Address: 0000 Xxxxxxx Xxxx Xxxxxxx Xxxx, XX 00000 Facsimile: 000-000-0000 Drug safety mailbox: xxxxxxxxxx@xxx.xxx
(d) After the Registrations have been transferred to Buyer, Seller shall assist Buyer with the provision of data relating to adverse experiences for the CV Products after such transfer to Buyer. Additionally, after the transfer of the Registrations to Buyer, Seller shall provide Buyer with all adverse drug experience information and customer complaints brought to the attention of Seller with respect to the CV Products, as well as any material events and matters concerning or affecting the safety or efficacy of the CV Products, via facsimile to the attention of: Name: [****]* Title: Director of Regulatory Affairs Address: 0 Xxxx Xxxxxxxxx Xxxxx Cedar Knolls, NJ 07927 E-mail: [****]*
Adverse Experience Reporting. Patheon shall notify Santarus promptly and not later than *** hours after it becomes aware of (a) any information concerning any potentially serious or unexpected side effect, injury, toxicity or sensitivity reaction or any unexpected incidence or other adverse experience (an "ADVERSE EXPERIENCE") and the severity thereof associated with the use of the Finished Product, whether or not determined to be attributable to the Finished Product; or (b) any information regarding any pending or threatened action which may affect the safety or efficacy claims of the Finished Product or the continued marketing of the Finished Product in any nation or jurisdiction. Further and without limiting the foregoing, Patheon shall notify Santarus by telephone and facsimile within *** hours after Patheon first becomes aware of any serious Adverse Experience that gives cause for concern or is unexpected or that is fatal, life-threatening (as it occurred), permanently disabling, requires (or prolongs) inpatient hospitalization, represents a significant hazard, or is a cancer or a congenital anomaly or represents an overdose, or any other circumstance that might necessitate a recall, expedited notification of FDA or any other relevant Government Authorities or a significant change in the label of the Finished Product, including, without limitation, information concerning *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. any incident that causes Finished Product shipped to Santarus or its labeling to be mistaken for or, applied to, another product, information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the Finished Product shipped to Santarus, or any failure of one or more batches of Finished Product shipped to Santarus to meet Specifications or to conform with Applicable Laws, and any deviation from the specified environmental conditions for shipping or storage of the Finished Product. To the extent that Santarus becomes aware of any Adverse Experience that appears to be related to the manufacture of Finished Product, Santarus shall notify Patheon promptly and not later than *** hours after Santarus becomes aware of such Adverse Experience. In connection with any such Adverse Experience, each Party shall make such reports as are necessary to comply with Applicable Laws, at its sole expense. Further, in the event a Party ...
Adverse Experience Reporting. The Institution shall notify Sponsor of serious adverse experiences, adverse experiences or drug reactions of any Study Subject in accordance with the requirements of the Protocol.
Adverse Experience Reporting. Each Party will promptly report to the other Party any information of which it becomes aware concerning any adverse drug experience in connection with the use of the Product, including the incidence and the severity thereof. Each Party shall be responsible for reporting adverse experiences in accordance with applicable Legal Requirements; provided, however, that NEW ALPHA will bear all reasonable expenses incurred by GENERICO and NEW ALPHA in connection therewith. NEW ALPHA will provide to GENERICO copies of any reports submitted to the FDA and/or Regulatory Authority relating to any adverse drug experiences that are reasonably significant. GENERICO shall be responsible for receiving and documenting any complaint regarding the Product, as well as forwarding the complaint information to the applicable Facility quality unit and responding to the customer.
Adverse Experience Reporting. Arvinas agrees throughout the Term of this Agreement to notify Genentech of any information of which Arvinas becomes aware concerning any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity thereof, arising in connection with a product reasonably related to any Licensed PROTAC licensed to Genentech hereunder (hereinafter “Adverse Experience”), where such Adverse Experience is “Serious” (as defined hereinafter) and associated with the clinical uses, studies, investigations, tests and marketing of such product, whether or not determined to be attributable to such product. “Serious” as used in this Section refers to an Adverse Experience which results in death, is immediately life threatening, results in persistent and significant disability/incapacity or requires in-patient hospitalization, or prolongation of existing hospitalization, or is a congenital anomaly, cancer or an overdose. Other important medical events that may jeopardize the patient or may require intervention to prevent one of the outcomes previously listed should also be considered “Serious”. If such Adverse Experience is “Highly Serious” (that is, it results in death or is immediately life threatening), Arvinas will notify Genentech within [**]. For Adverse Experiences that are Serious, but not Highly Serious, Arvinas will notify Genentech within [**].
Adverse Experience Reporting. (a) Prior to enrollment of Subjects in the Study, the Parties shall enter into a pharmacovigilance agreement setting forth the Parties’ responsibilities and obligations with respect to the procedures and timeframes for compliance with Applicable Law pertaining to safety reporting of the respective Molecules and the Combination (“PV Agreement”).
(b) The Parties shall cooperate in determining how to respond to adverse experience reports under the Study. For adverse experience reports solely related to the Corvus Molecule, Corvus shall have final decision making authority. For adverse experience reports solely related to the Genentech Molecule, Genentech shall have final decision making authority. For adverse experience reports solely related to the Combination, [***] [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. [***]. Notwithstanding the foregoing, Corvus may submit a response to Regulatory Authorities if required by a regulatory deadline.
(c) Corvus shall be responsible for reporting adverse events from the Study to Regulatory Authorities in accordance with Applicable Law, including 21 CFR § 312.32.
Adverse Experience Reporting. The Principal Investigator shall notify Sponsor of serious adverse experiences, adverse experiences or drug reactions of any Study Subject in accordance with the requirements of the Protocol.
Adverse Experience Reporting. During the term of this Agreement, each party shall notify the other immediately of any information (howsoever obtained and from whatever source) concerning any unexpected side effect, injury, toxicity or sensitivity reaction, or any unexpected incidence, and the severity thereof, associated with the clinical uses, studies, investigations, testing and marketing of the Product within or outside the Territory. For purposes of this Section 14.16, "unexpected" shall mean (x) for a non-marketed product, an experience that is not identified in nature, severity or frequency in the current clinical investigator's confidential information brochure, and (y) for a marketed product, an experience which is not listed in the current labeling for such product, and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling but differs from the event because of increased frequency or greater severity or specificity. Each party shall further notify the other immediately of any information received regarding any threatened or pending action by any regulatory authority which may affect the safety and efficacy claims of the Product. Upon receipt of any such information, the parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall be construed as restricting either party's right to make a timely report of such matter to any regulatory authority or take other action that it deems to be appropriate or required by applicable law or regulation.
Adverse Experience Reporting. 7.1 The responsibilities of the Parties for reporting of adverse drug experiences related to the Products to regulatory authorities in the Territory shall be performed in accordance with local laws and regulations. The responsibilities of the Parties for safety related or Product related inquiries shall be performed in accordance with local laws and regulations.
7.2 Without prejudice to Clause 7.1:
7.2.1 Licensee undertakes that it will maintain until the termination of this Agreement (or, as applicable, until the rights and obligations intended to survive termination of this Agreement have been fulfilled) pharmacovigilance and risk management systems, procedures and documentation needed to perform and comply with its regulatory obligations and its related obligations under this Agreement.
7.2.2 Licensee undertakes that it will ensure that it will comply with all applicable laws and regulations regarding the Products in the Territory including without limitation those laws and regulations relating to risk management, drug safety and pharmacovigilance.
7.2.3 Licensee will hold and maintain a safety database regarding the Products in the Territory.
7.2.4 Licensee will be responsible for fulfilling all Pharmacovigilance activities as per the local regulations and requirements for the Products in the Territory (this includes but is not limited to collating AE, and Pregnancy Reports, expedited and periodic reporting to regulatory agencies in the Territory, literature review, performing safety evaluation and signal detection on all available AE and Pregnancy data etc).
7.2.5 Licensee shall provide Licensor and ViiV with a report containing information regarding AEs and Pregnancy Reports which are associated with the Products and which have been received by Licensee, from both spontaneous reporting and clinical trial sources. Such report shall be provided annually and otherwise on reasonable request by the Licensor and/or ViiV.
7.2.6 Licensee shall notify the Licensor and ViiV forthwith of the receipt of an enquiry from a regulatory authority in the Territory relating to the Product that concerns any safety issue. If Licensee becomes aware of action that may or will be or has been taken by a regulatory authority for a safety reason connected with the Product, it shall immediately and in any event no later than twenty-four (24) hours after receiving such notice from a regulatory authority notify Licensor and ViiV in writing (including, but not limited to email com...
