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Adverse Drug Reactions.ÌýICAgen 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.Ìý12.6.1 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.ÌýSanten 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.ÌýCheminor 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.ÌýREDDY 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.ÌýPar 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.Ìý("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.

Adverse Drug Reactions.ÌýThe following provisions shall apply to the reporting of Adverse Drug Reactions: 6.4.1 It will be APOTHECON's responsibility to report ADRs to the FDA; however, it will be solely GJT's responsibility to report ADRs required to be reported that arise during clinical testing and which are otherwise required of GJT in accordance with applicable law. 6.4.2 Each party agrees to furnish party, as hereinafter provided, with information pertaining to any ADR known to such party from any source whatsoever (other than from the other party). For such purposes, each party shall be charged with knowledge of an ADR if (and only if) such ADR has in fact been brought to the attention of the party. Each party will exercise due diligence and exert reasonable efforts to collect ADR information from its affiliates and other related parties worldwide. In the case of a serious ADR, the party in question shall report to the other party, in English, within 48 hours of knowledge of the ADR. All other ADRs shall be reported by the party in question from time to time, but not less frequently than monthly, in the same manner. 6.4.3 Each party shall maintain, in accordance with its own customary practice, appropriate detailed records of all ADR reports which have been submitted to the other party. Further, in the event that either party shall be requested for more detailed investigation by the U.S. Food and Drug Administration or other regulatory body on any ADR, such other party shall cooperate and assist the party in question with respect to such investigation. 6.4.4 Each party further shall immediately notify the other of any information received regarding any threatened or pending action by a regulatory agency 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 agency or take other action that it deems to be appropriate or required, by applicable law or regulation. 6.4.5 The obligations under this Section 6.4 shall survive for the period of time that such reporting obligations exist under applicable law.

Adverse Drug Reactions.ÌýAll 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 â€� 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.