Adverse Drug Experience Reporting. Each Party shall fully, accurately and promptly provide the other Party with all data known to it at any time during the Term of this Agreement or thereafter, which data indicate that any Product is or may be unsafe, lacks utility, or otherwise does not meet the Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit C attached hereto (as the same may be amended from time to time by notice in writing from ALTRAZEAL to ULURU; provided that such amendment shall not conflict with any of the provisions of this Agreement). ULURU shall determine whether such information is required to be reported to the FDA and any other Regulatory Authority.
Adverse Drug Experience Reporting. Each Party shall fully, accurately and promptly provide to the other Party with all data known to it at any time during the term of this Agreement or thereafter, which data indicate that any Product marketed by WCH is or may be unsafe, lacks utility, or otherwise does not meet Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit D attached hereto (as the same may be amended from time to time by notice in writing from WCH to IMPAX). WCH shall determine whether such information is required to be reported and report the same as required, to FDA and any other Regulatory Authority.
Adverse Drug Experience Reporting. The Parties agree to use commercially reasonable efforts to reach agreement on Adverse Event Reporting Procedures which will be set forth in Exhibit D attached hereto (as the same may be amended from time to time by notice in writing from Purchaser to Supplier, the “Adverse Event Reporting Procedures”) at least three (3) months prior to Launch but shall reach such agreement no later than one (1) month prior to Launch. Supplier shall fully, accurately and promptly provide Purchaser with all data known to it at any time during the term of this Agreement or thereafter, which data indicate that any Licensed Product is or may be unsafe, lacks utility, or otherwise does not meet specifications in accordance with the Adverse Event Reporting Procedures, including, without limitation, any data or information received from Third Party partners or purchasers of Supplier that the Licensed Adjuvant is or may be unsafe, lacks utility, or otherwise does not meet specifications in accordance with the Adverse Event Reporting Procedures. Purchaser shall solely determine whether such information is required to be reported to FDA and any other Regulatory Authority.
Adverse Drug Experience Reporting. DCTD shall report all serious or unexpected adverse events to FDA in accordance with the reporting obligations of 21 CFR 312.32 and will, concurrently, forward all such reports to RPRP and Introgen. All other adverse event reports received by DCTD shall be reported to the FDA consistent with 21 CFR 312.32 and 312.
Adverse Drug Experience Reporting. If WYETH elects to proceed with Option A, the Parties shall comply with the adverse drug experience reporting requirements set forth in Exhibit H attached hereto. If WYETH elects to proceed with Option B, then the Parties shall comply with the adverse drug experience reporting requirements set forth in Exhibit I attached hereto.
Adverse Drug Experience Reporting. Until NCI Protocol #00-C-0050 (P-92) is transferred to Collaborator. DCTD NCI shall report all serious or unexpected adverse events to FDA in accordance with the reporting obligations of 21 CFR 312.32 and will, concurrently, forward all such reports to Collaborator . All other adverse event reports received by DCTD. NCI shall be reported to the FDA consistent with 21 CFR 312.32 and 312.33. In addition, copies of the Annual Reports and other pertinent IND data (including, but not limited to, Clinical Brochure data, formulation and preclinical data, including toxicology findings) will be provided to Collaborator as they become available. In the event that Collaborator informs the FDA of any serious or unexpected adverse events, Collaborator must notify the NCI at the same time. NCI will then notify the investigator(s) conducting studies under NCI-sponsored protocol. Upon transfer to Collaborator of NCI Protocol #00-C-0050 (P-92). Collaborator shall report all serious or unexpected adverse events to FDA in accordance with the reporting obligations of 21 CFR 312.32. All other adverse event reports received by Collaborator shall be reported to the FDA consistent with 21 CFR 312.32 and 312.33. Add a new Article 4.4 as follows:
Adverse Drug Experience Reporting. All Adverse Drug Experiences suspected to be associated with the use of REVLIMID®, POMALYST®, or THALOMID® and all cases of special situations received by the Pharmacy from Prescribers or patients associated with the dispensing of REVLIMID®, POMALYST®, or THALOMID® must be reported within twenty four (24) hours to Celgene so that Celgene can meet all current health authority regulations and guidelines for reporting of Adverse Drug Experiences relating to REVLIMID®, POMALYST®, and THALOMID®. · All reports of suspected pregnancy exposure must be reported immediately.
Adverse Drug Experience Reporting. In order for the Parties to comply with their respective responsibilities under this Article 6 and otherwise relating to the reporting of adverse drug experiences, to the extent either Party receives any information regarding adverse drug experiences related to the use of the Product, whether such use is within or outside of the Territory, such Party shall promptly provide the other Party with such information in accordance with the Adverse Event Reporting Procedures (as may be amended from time to time upon mutual agreement) set forth in Exhibit E.
Adverse Drug Experience Reporting. Conor shall be responsible for receiving, investigating, and documenting all adverse drug experiences relating to Conor Devices incorporating Product. Conor will be solely responsible for filing all post-marketing reports of such adverse drug experiences required by Regulatory Authorities, or as required by applicable laws or regulations. In the event that either party receives a report of an adverse drug experience relating to the use of Conor Devices incorporating the Product anywhere in the world, it shall notify the other party in writing within five (5) calendar days of initial receipt of such information, or if such event is serious and unexpected, within forty-eight (48) hours and each party shall immediately provide the other party with all information, correspondence and relevant data regarding the same. The Regulatory Committee will investigate the cause of the event and determine whether it should be reported to the Regulatory Authorities.
Adverse Drug Experience Reporting. (a) Each Party responsible for clinical trials shall, with respect to such trials, record, evaluate, summarize and review all adverse drug experiences associated with the Compound and the Products. In addition, supplemental information must be provided regarding the Compound and the Products at periodic intervals and adverse drug experiences must be reported at more frequent intervals depending upon the severity of the experience. Consequently, each Party agrees to:
(i) in a timely manner, provided to the other Party for initial and/or periodic submission to government agencies significant information on the Compound and the Products from preclinical laboratory, animal toxicology and pharmacology studies, as well as adverse drug experience reports from clinical trials and commercial experiences with the Compound and each Product;
(ii) in connection with the Compound and the Products, promptly report to the other Party the receipt of a report of any unexpected Serious Adverse Drug Experience with the Compound and the Products, if required for either Party to comply with regulatory requirements; and
(iii) in connection with marketed Products, promptly report to the other Party any serious adverse drug experience with such Products that are unexpected.
(b) For purposes of this Agreement, "Serious Adverse Drug Experience" means any adverse drug experiencing occuring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congential anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. An unexpected adverse drug experience is one that is not listed in the current labeling for a drug product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differ from the event because of greater severity or specificity.
