Product Inquiries and Complaints Sample Clauses

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 and responding to all such inquiries, complaints, and adverse events regarding the Product, and reporting to the FDA or any other Regulatory Authority. (b) Pursuant to a reported complaint or adverse drug event pertaining to the Products Manufactured by Patheon, if the nature of the reported complaint or adverse drug event requires testing, Patheon will, upon Flexion’s request and approval, perform analytical testing of corresponding Product complaint or retention samples and provide the results thereto to Flexion as soon as reasonably practicable, but no later than […***…] days after Flexion’s request. Such testing shall be performed using approved testing procedures as set forth in the applicable Regulatory Approval or the Quality Agreement. If such analytical testing concludes that the reported complaint or adverse drug event was the result of a Patheon Nonconformance, Patheon shall reimburse Flexion for […***…] associated with such complaint or adverse drug event and incurred by Flexion with respect to such nonconforming Product, including […***…]. Costs of recalls will be dealt with in accordance with Section 3.12. If such analytical testing concludes that the reported complaint or adverse drug event was not the result of a Patheon Nonconformance, Flexion shall compensate Patheon for all costs associated with such complaint or adverse drug event and incurred by Patheon with respect to such nonconforming Product, including costs of recalls, market withdrawals, returns, and destruction. (c) If the Parties disagree as to which Party is responsible, Patheon and Flexion representatives shall attempt to resolve such dispute. If the representatives cannot resolve such dispute within […***…] days, the retention samples shall be submitted by Patheon and Flexion to an Expert and Section 2.8 shall apply.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Related to Product Inquiries and Complaints

  • Product Complaints Subdistributor shall promptly notify Distributor of (but in no event later than 24 hours after receipt), and provide, upon Distributor’s request, reasonable assistance to address and investigate, any complaint or adverse claim about any Product or its use of which Subdistributor becomes aware;

  • Delays and Complaints Delivery delays and service complaints will be monitored on a continual basis. Documented inability to perform under the conditions of the contract, via the Complaint to Vendor process (PUR 7017 form) contemplated for this Contract, may result in default proceedings and cancellation.

  • Errors, Questions, and Complaints a. In case of errors or questions about your transactions, you should as soon as possible contact us as set forth in Section 6 of the General Terms above. b. If you think your periodic statement for your account is incorrect or you need more information about a transaction listed in the periodic statement for your account, we must hear from you no later than sixty (60) days after we send you the applicable periodic statement for your account that identifies the error. You must: 1. Tell us your name; 2. Describe the error or the transaction in question, and explain as clearly as possible why you believe it is an error or why you need more information; and, 3. Tell us the dollar amount of the suspected error. c. If you tell us orally, we may require that you send your complaint in writing within ten (10) Business Days after your oral notification. Except as described below, we will determine whether an error occurred within ten (10) Business Days after you notify us of the error. We will tell you the results of our investigation within three (3) Business Days after we complete our investigation of the error, and will correct any error promptly. However, if we require more time to confirm the nature of your complaint or question, we reserve the right to take up to forty-five (45) days to complete our investigation. If we decide to do this, we will provisionally credit your Eligible Transaction Account within ten (10) Business Days for the amount you think is in error. If we ask you to submit your complaint or question in writing and we do not receive it within ten (10) Business Days, we may not provisionally credit your Eligible Transaction Account. If it is determined there was no error we will mail you a written explanation within three (3) Business Days after completion of our investigation. You may ask for copies of documents used in our investigation. We may revoke any provisional credit provided to you if we find an error did not occur.

  • Complaints If you have a complaint relating to the sale of energy by us to you, or this contract generally, you may lodge a complaint with us in accordance with our standard complaints and dispute resolution procedures. Note: Our standard complaints and dispute resolution procedures are published on our website.

  • Customer Complaints Each party hereby agrees to promptly provide to the other party copies of any written or otherwise documented complaints from customers of Dealer received by such party relating in any way to the Offering (including, but not limited to, the manner in which the Shares are offered by the Dealer Manager or Dealer), the Shares or the Company.

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Customer Inquiries 45.1 Each Party shall refer all questions regarding the other Party’s services or products directly to the other Party at a telephone number specified by that Party. 45.2 Each Party shall ensure that each of their representatives who receive inquiries regarding the other Party’s services: (i) provide the numbers described in Section 45.1 to callers who inquire about the other Party’s services or products, and (ii) do not in any way disparage or discriminate against the other Party or its products or services.

  • Complaints and Appeals As a Premera member, you have the right to offer your ideas, ask questions, voice complaints and request a formal appeal to reconsider decisions we have made. Our goal is to listen to your concerns and improve our service to you. If you need an interpreter to help with oral translation, please call us. Customer Service will be able to guide you through the service. We would like to hear from you. If you have an idea, suggestion, or opinion, please let us know. You can contact us at the addresses and telephone numbers found on the back cover. Please call us when you have questions about a benefit or coverage decision, our services, or the quality or availability of a healthcare service. We can quickly and informally correct errors, clarify benefits, or take steps to improve our service. We suggest that you call your provider of care when you have questions about the healthcare they provide.

  • Inquiries Respond to telephonic, mail, and in-person inquiries from Institutions, Account holders, or their representatives requesting information regarding matters such as shareholder account or transaction status, net asset value ("NAV") of Series shares, Series performance, Series services, plans and options, Series investment policies, Series portfolio holdings, and Series distributions and taxation thereof;

  • Investigatory Interviews ‌ A. Upon request, an employee has the right to a union representative at an investigatory interview called by the Employer, if the employee reasonably believes discipline could result. An employee may also have a union representative at a pre-disciplinary meeting. If the requested representative is not reasonably available, the employee will select another representative who is available. Employees seeking representation are responsible for contacting their representative.

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