Complaints and Adverse Reactions. Each party shall promptly advise the other of any complaints, notices of Adverse Drug Experience(s) or event reports, safety issues or toxicity issues relating to the Products of which it becomes aware, and which may be the result of, or have an effect on, the Product manufacturing operations performed by Hospira. Theravance shall be responsible for all reporting of such information to Regulatory Authorities. Hospira shall promptly evaluate any complaint or notice of Adverse Drug Experience(s) and reasonably assist Theravance in responding to the same.
Complaints and Adverse Reactions. Nordion or Molecular Insight Pharmaceuticals shall provide to each other prompt notice of any information either of them receives regarding the safety of the Precursor, Reference Standards, Azedra or Isotope, including any confirmed or unconfirmed information regarding adverse, serious or unexpected events associated with Azedra that may implicate the Manufacture of Azedra or one of its components; provided, however, that Molecular Insight Pharmaceuticals shall not be required to provide clinical trial status reporting to Nordion. For serious or adverse events, notice must be given by telephone within one (1) business day after receipt of the information, followed immediately with written notice, advising the other of any adverse reaction or safety issues with respect to Azedra of which it becomes aware, regardless of the origin of such information. Any other complaints shall be reported in writing to the other party on a weekly basis. Nordion agrees to co-operate with Molecular Insight Pharmaceuticals and any governmental entity in evaluating any complaint, claim, safety or adverse use report related to Azedra. Nordion will provide timely assistance in responding to any complaints, including reviews of Batch records and retained samples as well as any necessary testing.
Complaints and Adverse Reactions. Each party shall promptly advise the other in writing of any complaints, notices of Adverse Drug Experience(s) or event reports, safety issues or toxicity issues relating to the Products of which it becomes aware, and which may be the result of, or have an effect on, the Product manufacturing operations performed by Hospira. Cempra shall be responsible for all reporting of such information to Regulatory Authorities. Hospira shall promptly evaluate any complaint or notice of Adverse Drug Experience(s) and reasonably assist Cempra in responding to the same. To such end, Hospira shall promptly comply with Cempra’s reasonable requests for information, documentation and other records in its possession that relate to Hospira’s manufacture, handling, or storage of the Product that are reasonably necessary to enable Cempra, and any Third Party designated by Cempra, to evaluate and ensure compliance with any Adverse Drug Experience(s) reporting policies and procedures and compliance with any Applicable Laws.
Complaints and Adverse Reactions. Sanwa shall advise Terrapin of any adverse reactions, safety issues or toxicity issues relating to the Licensed Products for which [ * ] of which it becomes aware, in the manner mandated by FDA regulations.
Complaints and Adverse Reactions. LONZA shall advise PCYC of any complaints, adverse reaction reports, safety issues or toxicity issues relating to any Product of which it becomes aware, regardless of the origin of such information, within the time frame required by cGMP and 21 CFR 312 and 314, and the corresponding regulations of the applicable Regulatory Authorities (collectively, the "Regulations"), but in no event later than [ *** ] from the initial complaint or report, except where such complaint or report would not be required to be reported to the applicable Regulatory Authority, in which case LONZA shall inform PCYC of such complaint or report as soon as reasonably possible. PCYC's shall notify LONZA promptly of those complaints and adverse reactions that are relevant to the Manufacturing activities conducted by LONZA hereunder, but shall not be obligated to notify LONZA of complaints or adverse reactions due to inherent Product characteristics or arising from the activities of third parties unrelated to LONZA. PCYC shall retain and manage complaints in accordance with the Regulations. The Parties hereby agree to cooperate with one another and with any Regulatory Authority in the evaluation and investigation of any complaint, claim or adverse reaction report related to the Manufacture of a Product with the intention of promptly complying with the Regulations. If any such event occurs, LONZA shall retain any unused supplies of such Product and its associated Materials (including without limitation PCYC Materials), and all associated Batch and other production records in such manner as PCYC may reasonably direct. Such retention shall be at PCYC's expense, except to the extent that such event is caused by LONZA's wrongful act or omission. LONZA agrees to respond to PCYC in respect to such complaint investigations involving LONZA's Manufacturing of a Product or services rendered hereunder as soon as reasonably possible but in any case within [ *** ] from receipt by LONZA of the report of such complaint and sample (if available), or in the case of a serious adverse event, within [ *** ] from receipt of the report of such complaint and sample (if available). PCYC and/or its designee shall serve as the sole point of contact with the FDA or other applicable governmental entity concerning any complaints, adverse reaction reports, safety issues or toxicity issues with respect to the Product. LONZA shall have the opportunity to comment upon PCYC's proposed written responses to the FDA or othe...
Complaints and Adverse Reactions. CPDC or POINT shall provide to each other prompt notice of any information either Party receives regarding the safety of the Precursor, reference standards, excipients, Product or isotopes, including any confirmed or unconfirmed information regarding adverse, serious or unexpected events associated with any product that may implicate the manufacture of the Product or one of its components; provided, however, that POINT shall not be required to provide Clinical Trial reporting to CPDC. For all complaints with respect to the Product of which a Party becomes aware concerning adverse reactions or safety issues, notice must be given by telephone within [***] business day after receipt of the information, followed immediately with written notice, advising the other Party, regardless of the origin of such information. Any other complaints shall be reported in writing to the other party on a [***] basis. CPDC agrees to co-operate with POINT and any Regulatory Authority in evaluating any complaint, claim, safety or adverse use report related to the Product. CPDC will provide timely assistance in responding to any such complaints, including reviews of Batch records and retained samples as well as any necessary testing within reason.
Complaints and Adverse Reactions. Customer shall have primary responsibility for safety monitoring and consumer complaint investigation; provided that Supplier shall reasonably cooperate and provide assistance as reasonably requested by Supplier in any such complaint investigation. In connection therewith, Supplier shall provide to Customer copies of all information it uniquely has in its possession that is necessary to allow Customer to make timely reports as required by any Regulatory Authority regarding the Product. Supplier shall notify Customer in accordance with agreed upon complaint handling procedures of any information concerning any complaint involving the possible failure of the Product to meet any requirement of applicable Laws and any serious or unexpected side effect, injury, toxicity or other reaction or any unexpected incidents associated with the use of the Product.
Complaints and Adverse Reactions. 12.3.1 Either party shall provide to the other Party prompt notice of any information regarding the safety of any Drug Products, including any confirmed or unconfirmed information regarding adverse, serious or unexpected events or reactions associated with any Drug Products. For serious or adverse events, notice must be given by telephone within one (1) Business Day after receipt of the information, followed immediately with written notice, advising the other Parties of any adverse reaction or safety issues with respect to the Drug Products of which it becomes aware, regardless of the origin of such information, and in addition to any reporting requirements to any Governmental Authority as required by any Regulatory Approval. Any other complaints shall be reported in writing to the other Party on a weekly basis, in addition to any reporting requirements to any Governmental Authority as required by any Regulatory Approval. The Parties agree to co-operate with each other and any Governmental Authority in evaluating any complaint, claim, safety or adverse use report related to any Drug Products. The Parties will provide timely assistance in responding to any complaints, including reviews of records and retained samples as well as any necessary testing. Psygen may maintain any information or material communicated to Psygen as part of this Section 12.3.1 as part of the Psygen Data. For clarity, any such information or material maintained as part of the Psygen Data shall be the property of each of the Parties, provided that Psygen treat the identity of Purchaser as the source of the information as Confidential Information.
Complaints and Adverse Reactions. BI PHARMA KG shall notify COULXXX xxxediately by telephone and not later than 5 (five) working days in writing after receipt by BI PHARMA KG's quality assurance department of any and all complaints, adverse reaction reports, safety issues or toxicity issues relating to Product (each an "Adverse Event Report"), regardless of the origin of such information, BI PHARMA KG shall advise COULXXX xx such Adverse Event Report. COULXXX xxxll be responsible for adverse event notification to the respective regulatory authorities regarding all such Adverse Event Reports. COULXXX'x xxxigation to notify BI PHARMA KG immediately by telephone and no later than 5 (five) working days in writing of such Adverse Event Reports of which COULXXX xxxomes aware shall extend only to those that may have relevance to the manufacturing and supply activities conducted by BI PHARMA KG. The parties agree to cooperate with each other and any regulatory authority in evaluating any Adverse Event Reports related to the manufacture and supply of the Product.
Complaints and Adverse Reactions. HCC shall within twenty-four (24) hours advise Pharmacyclics of any complaints, adverse reaction reports, safety issues or toxicity issues relating to Product or Drug Substance of which it becomes aware, regardless of the origin of such information. Pharmacyclics' obligation to notify HCC promptly of such complaints shall extend only to those complaints which may have a relevance to the manufacturing activities conducted by HCC and shall not extend to complaints or adverse reactions due to inherent Product or Drug Substance characteristics or arising from the activities of third parties unrelated to HCC. HCC agrees to cooperate with Pharmacyclics and any Governmental Entity in evaluating any complaint, claim, or adverse reaction report related to the manufacture of the Product or Drug Substance. In addition to the foregoing, Pharmacyclics shall provide HCC a quarterly summary report of all Serious Adverse Experiences (as defined in 21 CFR 312.32) and Adverse Drug Experiences (as defined in 21 CFR 314.80) with respect to Product or Drug Substance suffered during such quarter.
