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. 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. 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. 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. 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.
Adverse Drug Reactions. Each Party shall promptly advise the other Party and provide the other Party with a copy by telecopier or overnight delivery service addressed to the attention of its Vice President, Clinical and Regulatory Affairs, of any reports of unexpected side effects, adverse reactions or injury ("ADR Reports") which have been brought to that Party's attention at any place within or outside the Territory and which are alleged to have been caused by the Product. ADR Reports shall include publications in journals or other media. NeoPharm shall use Due Diligence in monitoring all media for information on factors adversely or positively affecting the Product and shall promptly advise BioChem of the existence of same. Serious ADR Reports and unexpected ADR Reports (according to CIOMS criteria) shall be forwarded without delay by each Party to the other Party as soon as such reports come to either Party's attention. Any other ADR Reports shall be reported by each Party to the other on a quarterly basis. The informing Party may, and is invited to, give in writing its professional evaluation of such reports, in particular with regard to suspected causality, either together with such reports or as soon as possible at a later date. NeoPharm shall report such side effects and adverse reaction or injury to Governmental Bodies and others outside the Territory as appropriate or necessary within the time limits required by applicable Laws and BioChem shall report same to the HPB.
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. The following provisions shall apply to the reporting of Adverse Drug Reactions:
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.
