Complaints and Recalls. (a) Licensed Product Complaints. Proprius, at Proprius’ own expense, or as applicable, a Sublicensee at its own expense, shall investigate, respond to and take all appropriate corrective or other actions regarding all complaints associated with the manufacture and/or distribution of Licensed Products which are made, used, distributed or sold by or on behalf of Proprius or any of its Sublicensees in accordance with all applicable laws.
Complaints and Recalls. (a) Hospira shall notify Abbott promptly of any Product complaints involving Xxxxxx’x manufacture in sufficient time to allow Abbott to evaluate the complaints and assist Hospira in responding to such complaints.
(b) In the event that Abbott should be required to initiate a recall, field alert, Product withdrawal or field correction with respect to any Product provided under this Agreement, Abbott shall immediately notify Hospira in writing. In the event that Hospira believes that a recall, field alert, Product withdrawal, or field correction is necessary with respect to any Product provided under this Agreement, Hospira shall promptly so notify Abbott.
Complaints and Recalls. (a) Complaints. Drug Product complaints received by Client with respect to Drug Product Manufactured by Company hereunder shall be sent to Company within the time period set forth in the Quality Agreement, after receipt to: Alcami Corporation Attention: Corporate Quality 0000 Xxxxxxxxxx Xxxx Xxxxx Xxxxxxxxxx, XX 00000 Facsimile No.: (000) 000-0000 Email: xxxxxxx.xxxxxxxxxx@xxxxxxxxx.xxx As more fully described in the Quality Agreement, Company shall investigate all complaints directly associated with the Manufacture of Drug Product(s) and shall provide an update every [*] and a report to Client regarding its investigation and any conclusions. Client shall investigate all other complaints associated with the Drug Product(s).
Complaints and Recalls. 9.1 Each Party shall notify the other Party immediately by telephone and confirm in writing within twenty four (24) hours upon becoming aware of any problem relating to the Product, including where:
(a) the Product does not comply with the Product Specifications, cGMP or any matter which may affect the safety or efficacy of the Product arising during its manufacture;
(b) the Product is affected by bacteriological or other contamination;
(c) the Product is affected by significant chemical, physical or other change or deterioration or stability failures; or
(d) there are any other complaints, adverse reaction reports, safety issues or toxicity issues relating to Product of which it becomes aware.
9.2 If any of the circumstances described in Section 6.1 arise, and upon written notification from TPN, ELITE shall promptly and at its own expense conduct all such internal investigations as may be reasonably necessary to determine the validity of such complaint as they relate to manufacture of the Product. ELITE shall provide an initial report of the findings of such investigations in writing to TPN within five (5) days from the first notification acknowledging that time is of the essence in responding to the FDA and DEA within required timeframes. ELITE shall promptly complete a final report upon receipt of all pertinent data. TPN shall be responsible to respond to the complainant and provide a written copy of such response to ELITE. ELITE shall carry out any corrective actions that TPN may reasonably require in order to avoid the repetition of the complaint.
9.3 TPN shall be responsible for initiating a Product recall or withdrawal and the recall or withdrawal strategy shall be determined and developed by TPN. In the event that the need for the recall or withdrawal is caused by any failure on the part of ELITE or its Affiliates to comply with any material obligation under this Manufacturing Agreement or the Quality Agreement, or through the negligence of ELITE or Affiliates, or the failure of the Product as manufactured hereunder to meet the Product Specifications (Out Of Specification or “OOS”) due to the fault of ELITE, all documented out-of-pocket costs reasonably incurred by TPN in relation to such recall shall be borne by ELITE.
Complaints and Recalls. 16 6.6 PUBLICITY..................................................... 16 ARTICLE VII.............................................................. 17
Complaints and Recalls. Insulet shall manage all complaints, failure analysis and recalls related to the Product in the Territory in a commercially reasonably manner. In the event of a recall or potential recall of the Product in the Territory, Insulet shall notify and consult with TheraSense with regard to the measures to be taken consistent with good business practice. Such undertaking shall be at Insulet's expense; provided, however, that if the cause of such complaint, failure or recall is a flaw that is also present in the FreeStyle Meter or the Test Strips, then TheraSense shall reimburse Insulet for all reasonable costs incurred. TheraSense shall render commercially reasonable support and information to assist Insulet in managing any complaints, failures or recalls related to the Test Strips or the functioning of the Test Strips with the Remote Controller.
Complaints and Recalls. If Alliant receives a complaint or information regarding a Licensed Product which it would be required under applicable Law to disclose to a Regulatory Agency, it shall promptly, but in any event not later than twenty-four (24) hours after receipt, advise BioMarin in writing of the details of such complaint or information. Promptly thereafter, Alliant shall report such complaint or information to the appropriate Regulatory Agencies in the countries in North America, respectively, in which such Licensed Product is being commercialized, each as may be required by, and in accordance with, the appropriate Laws of the relevant countries and Regulatory Agencies. Alliant shall provide to BioMarin with all available follow-up information related to such incident (including any information in such Party’s possession as may be reasonably required by the other Party to satisfy its regulatory filing obligations).
Complaints and Recalls. In the event that a Product delivered by Syntagon is involved in any complaint from Oasmia customers or contract producer of an Oasmia registered pharmaceutical product, Oasmia shall immediately inform Syntagon and provide all necessary information to Syntagon to, in a timely manner, initiate all required investigations. Further, Syntagon shall be immediately informed of any complaints or regulatory action, investigation or recall on Oasmia products from regulatory authorities. Syntagon shall collaborate with Oasmia at its best efforts to provide all required information to Oasmia. Recalls proven to be caused by negligence from Syntagon shall be remedied by Syntagon in accordance with Section 13. Any non conformance, regulatory actions or complaints to Syntagon, by other than Oasmia, Syntagon shall without any delay inform Oasmia. Syntagon shall make all efforts possible to minimize the effect of such events.
Complaints and Recalls. 11.1 NxStage shall be responsible for initial handling of customer complaints relating to the Products and shall give prompt written notice to PISA of the same. PISA shall then take prompt action to make such internal investigations as are called for in the circumstances and report its findings to NxStage.
11.2 NxStage shall be responsible for initiating any recall action involving the Products and shall keep PISA appropriately informed of the same. PISA shall reimburse all Product recall costs attributable to PISA reasonably incurred by NxStage with prior consent of PISA, except where the Product recall is not caused by a failure of the Product to meet specifications, or misleading in-formation in bag prints, instructions for use and carton and bottle labels, and, wrong handling and storage by NxStage.
11.3 Emergency contact numbers are set out in Appendix 4.
Complaints and Recalls. 5.01 Have written procedures in place to document, investigate, and respond to all quality related complaints.
5.02 Assist in investigations as reasonably requested by Client for complaints associated with Product.
5.03 Retain complaint investigation records and evaluate trends and severity. Implement corrective and preventive actions as necessary.
5.04 Suppliers will have procedures in place to facilitate the recall of an API as necessary. Suppliers will provide assistance to the client for the recall of drug product incorporating the supplier’s API.
