Common use of Regulatory Issues Clause in Contracts

Regulatory Issues. (a) Except as may be disclosed on Schedule 5.6(a) hereto, during the twelve-month period ending on the Effective Date, (i) with respect to the Products only, Seller has not received: (A) any FDA Form 483s or warning letters directly relating to the Products or the facilities in which the Products are manufactured; or (B) any FDA Notices of Adverse Findings with respect to the Products; and (ii) there has not been a recall or market withdrawal of any Product by Seller, whether voluntary or involuntary.

Regulatory Issues. (a) Except as may be disclosed on Schedule 5.6(a) hereto, during the twelve-month period ending on the Effective Date, (i) with respect to the Products only, such Seller has not received: (A) any FDA Form 483s or warning letters directly relating to the Products or the facilities in which the Products are manufactured; or (B) any FDA Notices of Adverse Findings with respect to the Products; and (ii) there has not been a recall or market withdrawal of any Product by such Seller, whether voluntary or involuntary.

Regulatory Issues. (a) Except as may be disclosed set forth on Schedule 5.6(a) hereto), during the twelve-month period ending on the Effective Datedate hereof, (ia) with respect to the Products only, Seller has not received: (Ai) any FDA Form 483s or warning letters directly relating to the Products or the facilities in which the Products are manufacturedProducts; or (Bii) any FDA Notices of Adverse Findings with respect to the Products; or (iii) any warning letters or other written correspondence from the FDA concerning the Products; and (iib) there has not been a recall or market withdrawal of any Product by Seller, whether voluntary or involuntary.