Product Inquiries and Complaints. Rugby will promptly submit to HMRI all Product safety and efficacy inquiries, Product quality complaints and adverse drug event reports received by it, together with all available evidence and other information relating thereto. Except as otherwise required by law or governmental regulation, Rugby will be responsible for investigating and responding to all such inquiries, complaints and adverse events regarding Product. It shall be the responsibility of Rugby to comply with all federal, state and local governmental reporting requirements regarding adverse drug events and Product quality matters, except where such events or matters are caused by acts or omissions of HMRI, in which case Rugby may, consistent with applicable law and regulation, request HMRI's assistance in such compliance. Rugby will forward a copy of all FDA submissions concerning Product adverse drug events or any Product safety-related topic to HMRI within ten (10) business days of submission.
Product Inquiries and Complaints. (a) With respect to Products Manufactured by Patheon, each Party will promptly (as may be further defined in the Quality Agreement) submit to the other Party any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports received by such Party, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, Flexion, as the Party holding the applicable Regulatory Approval, will be responsible for investigating ***Confidential Treatment Requested and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority.
Product Inquiries and Complaints. Purchaser will promptly submit to Aventis copies of all Product safety and efficacy inquiries, Product quality complaints and adverse drug event reports received by it, together with all relevant evidence and other information relating thereto, in accordance with procedures to be agreed upon by the parties. Except as otherwise required by Applicable Law, Purchaser will be responsible for investigating and responding to all such inquiries, complaints and adverse events regarding Product. It shall be the responsibility of Purchaser to comply with all Applicable Law regarding adverse drug events and, except as otherwise provided herein, Product quality matters. Subject to confidentiality obligations, Aventis agrees, upon the reasonable request of Purchaser, to provide all relevant information in its possession or control relating to such complaint, inquiry or adverse event, to assist in such compliance.
Product Inquiries and Complaints. (a) With respect to Products Manufactured by Patheon, Patheon will promptly submit to Client any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports that it receives, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Patheon will promptly advise Client of any occurrence or information which arises out of the Manufacture of Products which has or could be reasonably expected to have adverse regulatory compliance and/or reporting consequences concerning the Products, and provide relevant information to Client upon request. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, Client, as the Party holding the applicable Marketing Authorization, will be responsible for investigating and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Product Inquiries and Complaints. Rugby will promptly submit to HMRI all Product safety and efficacy inquiries, Product quality complaints and adverse drug event reports received by it, together with all available evidence and other information relating thereto. Except as otherwise required by law or governmental regulation, HMRI will be responsible for investigating and responding to all such inquiries, complaints and adverse events regarding Product. It shall be the responsibility of HMRI to comply with all federal, state and local governmental reporting requirements regarding adverse drug events and Product quality matters, except where such events or matters are caused by acts or omissions of Rugby, in which case HMRI may, consistent with applicable law and regulation, request Rugby's assistance in such compliance. HMRI will forward a copy of all FDA submissions concerning Product adverse drug events or any Product safety-related topic to Rugby within five (5) business days of submission. In the event of a dispute in respect of the therapeutic action or quality of a Product: (i) if the dispute involves only Rugby and a subsequent purchaser then Rugby and HMRI shall consult prior to any compromise or settlement of such dispute; and (ii) if the dispute involves Rugby, HMRI and a subsequent purchaser then both parties must consent prior to any compromise or settlement of such dispute.
Product Inquiries and Complaints. Inyx will promptly submit to King all Product safety and efficacy inquiries, Product quality complaints and adverse drug event reports received by Inyx, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the parties. Except as otherwise required by Law or governmental regulation, King, as the party holding the applicable NDA, will be responsible for investigating and responding to all such inquiries, complaints and adverse events regarding Product. It shall be the responsibility of King, as the party holding the applicable NDA, to comply with all applicable national, federal, state and local governmental reporting requirements regarding adverse drug events and Product quality matters.
Product Inquiries and Complaints. (a) With respect to Products Manufactured by Patheon, each Party will promptly submit to the other Party any Product safety and efficacy inquiries, Product quality complaints, and adverse drug event reports received by such Party, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the Parties. Except as otherwise required by, or to comply with, Applicable Law or the terms of this Agreement, Pacira, as the Party holding the applicable Regulatory Approval, will be responsible for investigating and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority.
Product Inquiries and Complaints. Purchaser will promptly submit to Aventis all Product safety and efficacy inquiries, Product quality complaints and adverse drug event reports received by it, together with all available evidence and other information relating thereto, in accordance with procedures to be agreed upon by the parties pursuant to the Pharmacovigilance Agreement. Except as otherwise required by law or governmental regulation, Purchaser will be responsible for investigating and responding to all such inquiries, complaints and adverse events regarding Product. It shall be the responsibility of Purchaser to comply with all national, federal, state and local governmental reporting requirements regarding adverse drug events and Product quality matters, except where such events or matters are caused by or reasonably expected to be caused by acts or omissions of Aventis, in which case Purchaser may, consistent with applicable Law, request the assistance of Aventis in such compliance.
Product Inquiries and Complaints. Celgene will promptly submit to Penn all Commercial Product safety and efficacy inquiries, Commercial Product quality complaints and adverse drug event reports received by it which may concern CMC issues, together with all available evidence and other information relating thereto. Except as otherwise required by law or governmental regulation, Celgene will be responsible for investigating and responding to all such inquiries, complaints and adverse events regarding Commercial Product. It shall be the responsibility of Celgene to comply with all federal, state and local governmental reporting requirements regarding adverse drug events and Commercial Product quality matters, except where such events or matters are caused by acts or omissions of Penn, in which case Celgene may, consistent with applicable law and regulation, request Penn's assistance in such compliance. Celgene will forward a copy of FDA submissions concerning CMC issues within ten (10) business days of submission.
Product Inquiries and Complaints. Recalls. COPLEY will promptly submit to XXXX all Product safety and efficacy inquiries, Product quality complaints and adverse drug event (ADE) reports received by it, together with all available evidence and other information relating thereto. Except as otherwise required by law or governmental regulation, HMRI will be responsible for investigating and responding to all such inquiries, complaints and adverse events regarding the Product. It shall be the exclusive responsibility of HMRI to comply with all federal, state and local governmental reporting requirements regarding ADEs and Product quality matters, except where such events or matters are caused solely by acts or omissions of COPLEY, in which case HMRI may, xxxxistent with applicable law and regulation, request COPLEY's assistance in such coxxxxxxxx. HMRI will forward a copy of all FDA submissions concerning Product ADEs or any Product safety-related topic to COPLEY within ten (10) working xxxx xf submission. In the event of a dispute in respect of the therapeutic action or quality of the Product: (i) if the dispute involves only COPLEY and a subsequent purchasxx xxxn COPLEY and HMRI shall consult xxxxx to any compromise or settlement of such dispute; and (ii) if the dispute involves COPLEY, HMRI and a subsequent pxxxxxxer then both parties must consent prior to any compromise or settlement of such dispute. COPLEY shall be responsible for xxxxxrding recall materials received from HMRI designed to recover Products distributed by it and its private label customers in the event of a recall. Expenses associated with a recall are to be borne by the party at fault.
