Adverse Drug Reactions. ICAgen and Lilly will immediately inform each other of any serious, unexpected adverse drug reaction reports as to any Development Compound in clinical testing or as to any Product.
Adverse Drug Reactions. Cheminor and Schein shall keep ---------------------- the other fully informed of (i) any notification or other information, whether received directly or indirectly, which might affect the marketability, safety or effectiveness of any Finished Dosage Form Product, or which might result in liability issues or otherwise necessitate action on the part of either party, or which might result in recall or seizure of any Finished Dosage Form Product and (ii) nonclinical reports with respect to any Finished Dosage Form Product. All complaints for the U.S. market relating to Finished Dosage Form Products will be handled as described in Schedule 5.5 hereto, entitled "Complaint Handling Procedures." The parties hereto shall endeavor in good faith to agree upon such other complaint handling procedures with respect to non-U.S. sales of Finished Dosage Form Product as shall be reasonably required to comply with Applicable Law and prudent business practices.
Adverse Drug Reactions. Santen and Adolor shall promptly inform each other of any adverse drug reactions regarding the Compound which is reportable to the FDA or any other Regulatory Authority in 41 sufficient time and in sufficient detail to comply with the reporting regulations of the FDA or other Regulatory Authority.
Adverse Drug Reactions. REDDY and PAR shall keep the other fully informed of (i) any notification or other information, whether received directly or indirectly, which might affect the marketability, safety or effectiveness of any Reddy Finished Product or Par Finished Product, or which might result in liability issues or otherwise necessitate action on the part of either party, or which might result in recall or seizure of any Reddy Finished Product or Par Finished Product and (ii) nonclinical reports with respect to any Reddy Finished Product or Par Finished Product.
Adverse Drug Reactions. 12.6.1 Both Parties agree to promptly exchange all information that relates to the safety of the Valentis Delivery Technologies and especially all adverse reactions relating to them.
12.6.2 Before enrollment of the first patient in a Phase I Clinical Trial relating to a Product, the Parties will adopt a standard operating procedure to govern the investigation of and action to be taken with regard to adverse drug experience reports related to the Valentis Delivery Technologies (from both clinical studies and marketing experience), such that each Party can comply with its legal obligations worldwide. The standard operating procedure will: (i) define responsibilities for adverse experience handling for initial, follow-up and/or periodic submission to government agencies of significant information on the product from pre clinical laboratory, animal toxicology and pharmacology studies and pre clinical Development and (ii) include arrangements for the exchange of serious and non-serious cases including formats and timelines, periodic safety update reports, periodic reports and answers to safety-related queries by regulatory authorities; and (iii) be promptly amended as changes in legal obligations require or as otherwise agreed to by the Parties.
Adverse Drug Reactions. All untoward reactions must be reported to the doctor and xxxx clinical pharmacist and a note made in the Nursing Record and Medical Record and on the prescription chart. The doctor or xxxx clinical pharmacist should initiate a Committee for Safety of Medicines (CSM) Yellow card report, when appropriate. Nurse Prescribing – If a patient reports a severe or unexpected reaction to a prescribed medicine it should be reported immediately to the GP by the nurse. The Yellow Card Adverse Reaction Reporting Scheme is a voluntary scheme through which doctors notify suspected adverse reactions to medicines. It is for the GP to decide, following discussion with the nurse, whether to submit a Yellow Card to the Medicines and Healthcare Products Regulatory Agency (MHRA)/Committee on Safety of Medicines.
Adverse Drug Reactions. Each party shall promptly after learning thereof notify the other in writing of any report of adverse, or possible or suspected adverse, effects of Product, and whenever either party intends to report the same to any governmental authority, such party shall, when feasible, consult with the other party with respect to such notification. Specifically, PAR shall provide NORTEC with adverse event data for filing with the FDA.
Adverse Drug Reactions. (a) Asahi shall be responsible for initial, follow-up and/or periodic submission to government agencies of significant information on each Product from preclinical laboratory, animal toxicology and pharmacology studies and Preclinical Development until such time as the FDA accepts any required adverse event or safety reporting directly from CoTherix in accordance with Section 2.4(a). On and after such date, CoTherix shall be responsible for initial, follow-up and/or periodic submission, as required by applicable law, to Regulatory Agencies in the Territory of safety information and adverse drug experience reports, and Asahi shall submit such information to CoTherix for submission by CoTherix to such Regulatory Agencies.
(b) Each Party agrees, in connection with investigational Products, to transmit to the other Party within five (5) Business Days of receipt by a Party’s central safety department or equivalent of a report of a Serious Adverse Drug Experience; provided that transmission time limit for a report of any Serious Adverse Drug Experience other than a “serious adverse drug * Confidential treatment has been requested as to certain portions of this agreement. Such omitted confidential information has been designated by asterisks and has been filed separately with the Securities and Exchange Commission. reaction” shall be addressed in the pharmacovigilance agreement to be adopted by the Parties in accordance with subsection (c) below. Each Party agrees, in connection with other investigational Fasudil Formulations, to transmit to the other Party as soon as possible (and, in any event, within fifteen (15) Business Days of receipt by Party’s central safety department or equivalent, or such earlier time period as may be required for the other Party to comply with applicable laws and regulations) any report of a Serious Adverse Drug Experience.
(c) Promptly following the execution of this Agreement, the Parties will adopt a pharmacovigilance agreement to govern the investigation of and action to be taken with regard to Fasudil Formulation-related adverse drug experience reports (from both clinical studies and marketing experience), such that each of the Parties can comply with its legal obligations worldwide. The pharmacovigilance agreement will: (i) include arrangements for the exchange of non-serious cases, Periodic Safety Update Reports, Periodic Reports and answers to safety-related queries by Regulatory Agencies; and (ii) be promptly amended as chang...
Adverse Drug Reactions. Par and Nortec shall promptly, after learning thereof, notify the other in writing of any report of adverse, or possible or suspected adverse, effects of any New Product. Whenever either party intends to report the same to any governmental authority, that party shall, when feasible, consult with the other party with respect to such notification. Specifically, and without limiting the foregoing, Par shall provide Nortec with adverse event data for filing with the FDA.
Adverse Drug Reactions. ("ADRs"). CV will be responsible for the timely completion and submission of all ADR reports to the FDA and for communications with all ADR complainants. Isis will summarize and forward to CV any adverse reaction reports ("ADR") received by Isis within five (5) business days of receipt; provided Isis will forward any such complaints which involve death or life-threatening incidents to CV within twenty-four (24) hours of receipt. CV will investigate all ADRs; provided, Isis will be responsible for all analytical testing of Product required by the investigation.
