Complaints; Recalls. (a) Complaints concerning the Manufacture or supply by Seller of Products hereunder (“Product Complaints”) received by either Party will be promptly faxed and in no event later than five (5) Business Days after receipt by the recipient to the other Party to: Xxxxxx Laboratories 0000 Xxxxxxxx Xxxx X-00X, Xxxx. X0 Xxxxx Xxxxxxx, XX 00000-0000 Attention: Quality Assurance Department Fax: 000-000-0000 and Reliant Pharmaceuticals, LLC 000 Xxxxx Xxxx Liberty Corner, NJ 07938 Attention: Quality Assurance Department Fax: 000-000-0000
(b) The Parties shall cooperate with each other to investigate all complaints associated with the Manufacture or supply of Products hereunder and to complete a written report in a form reasonably satisfactory to both Parties. In the event either Party should be required to initiate a recall, field alert, Product withdrawal or field correction with respect to any Product supplied and delivered under this Agreement, that Party shall promptly notify the other Party in writing. Except where one Party is required by Law to do so, Buyer shall have the sole and exclusive right to initiate any recall, field alert, Product withdrawal or field correction and shall provide Seller with written notice thereof. Nothing contained in this Section 5.8 shall relieve the other Party of its obligations under Article 3 hereof.
Complaints; Recalls. During the Term, Alzheon shall be responsible for all matters relating to recalls and medical inquiries relating to the Licensed Products in the Field in the Territory and shall do so in conformity with all applicable Laws.
Complaints; Recalls. MERRIMACK is responsible for complaints and recalls of the Drug Product. If requested, GTC will assist MERRIMACK in the investigation of any complaint or recall that may relate to MATERIAL produced by GTC.
Complaints; Recalls. Boule will use reasonable efforts to assist Heska in investigating and correcting any problems Heska or its customers may experience with the Product. Such efforts will include visiting the Territory by Boule’s representatives only where deemed necessary by Boule. Heska will use reasonable efforts to implement any corrective action deemed necessary by Boule. Heska further agrees to reasonably cooperate with Boule in any mandatory or voluntary Product recall by assisting in the notification of all affected customers, using materials and documentation that are mutually acceptable to the Parties.
Complaints; Recalls. Buyer and Seller shall each inform the other Party in accordance with this Section 9.7 of Delatestryl® Product complaints, including product returns, that relate to Delatestryl® Product for which the other Party bears financial or regulatory responsibility. Buyer shall notify Seller within three Business Days of becoming aware of a complaint involving Delatestryl® Product sold or deemed to have been sold by Seller pursuant to Section 9.6(b) of this Agreement. Seller shall notify Buyer within three Business Days of becoming aware of a complaint involving Delatestryl® Product sold or deemed to have been sold by Buyer pursuant to Section 9.6(b) of this Agreement. All communications relating to the performance or condition of the Delatestryl® Product, and all communications relating to adverse experiences in association with, but not necessarily due to, the Delatestryl® Product that are received by any means at Seller shall be forwarded to Buyer until Seller-labeled Delatestryl® Product can reasonably be expected to no longer be available in the market place and in any event until expiry of last known lot included in the Closing Product Inventory. Each Party shall timely cooperate, as requested by the other, in investigating complaints and completing complaint investigations, including providing information applicable to each complaint. In the event of any recall of or field notification with respect to the Delatestryl® Product following the Closing, Seller shall make available such records and other information, and provide such efforts as are necessary and appropriate in connection with such recall as required by applicable Laws and in accordance with any agreements reached between Buyer and the FDA, in connection with any recall of the Delatestryl® Product.
Complaints; Recalls. Each of AD Pharma and Acura shall inform the other Party as promptly as practicable of any Product and Product Line Extension complaints. All communications relating to the performance or condition of the Product or Product Line Extension, and all communications relating to adverse experiences in association with, but not necessarily due to, the Product or Product Line Extension which are received by Acura or AD Pharma shall be forwarded to the other Party. In the event of any recall of or field notification after the Effective Date with respect to any Product or Product Line Extension, each of AD Pharma and Acura shall make available to the other Party during normal business hours and upon reasonable advance notice such records and other information as reasonably requested by such other Party in connection with any recall. AD Pharma shall be solely responsible at its cost and expense for any recalls or withdrawals of Product or Product Line Extension sold by it. AD Pharma shall be responsible for all required regulatory activities in the Territory.
Complaints; Recalls. Complaints and Adverse Reactions. DOTTIKON 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. PCYC shall notify DOTTIKON promptly, but in no event later than [ *** ] of complaints that are relevant to the Manufacturing activities conducted by DOTTIKON hereunder, except where such complaints or adverse reactions are due to inherent Product characteristics or arise from the activities of third parties unrelated to DOTTIKON. 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, DOTTIKON 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 DOTTIKON's wrongful act or omission. DOTTIKON agrees to respond to PCYC in respect to such complaint investigations involving DOTTIKON's Manufacturing of a Product or services rendered hereunder as soon as reasonably possible but in any case within [ *** ] from receipt by DOTTIKON 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.
Complaints; Recalls. Buyer and Seller shall each inform the other Party in accordance with this Section 6.4 of Plenaxisâ Product complaints, including product returns, which relate to Plenaxisâ Product for which the other Party bears financial or regulatory responsibility. Buyer shall notify Seller within three (3) Business Days of becoming aware of a complaint involving Plenaxisâ Product sold by Seller. Seller shall notify Buyer within three (3) Business Days of becoming aware of a complaint involving Plenaxisâ Product sold by Buyer. All communications relating to the performance or condition of the Plenaxisâ Product, and all communications relating to adverse experiences in association with, but not necessarily due to, the Plenaxisâ Product that are received by any means at Seller shall be forwarded to Buyer until Seller-labeled Plenaxisâ Product can reasonably be expected to no longer be available in the market place. Each Party shall timely cooperate, as requested by the other, in investigating complaints and completing complaint investigations, including providing information applicable to each complaint. In the event of any recall of or field notification with respect to the Plenaxisâ Product following the Closing, Seller shall make available such records and other information, and provide such efforts as are necessary and appropriate in connection with such recall as required by applicable Laws and in accordance with any agreements reached between Buyer and the applicable Medical Product Regulatory Authority, in connection with any recall of the Plenaxisâ Product.
Complaints; Recalls. The Company has received no customer complaints and has not issued any recalls with respect to alleged defects in its products (or the design thereof). The Company has not received any complaint, inquiry or other communication from the Federal Trade Commission or any other federal or state regulatory agency regarding the production, marketing, sale or distribution of the Company’s products.
Complaints; Recalls. 28 7.1 Complaints and Adverse Reactions.............................................28 7.2 Drug Product Defects.........................................................29 7.3 Recalls......................................................................29
