Common use of Complaints and Recalls Clause in Contracts

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.