Regulatory Developments Clause Samples

Regulatory Developments. (a) All Products and all Required Permits as of the Effective Date are listed on Schedule 5.11, and Borrower has delivered to Agent a copy of all Required Permits to the extent requested by Agent; (b) Without limiting the generality of Section 5.6 above, with respect to any Product being tested or manufactured by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, (ii) Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower of (A) any material deficiency or violation of Laws and/or the Required Permits related to the manufacture of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no Governmental Authority has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; and (c) Without limiting the generality of Section 5.6 above, with respect to any Product marketed or sold by Borrower, (i) Borrower has received, and such Product is the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, (ii) Borrower has not received any notice from any applicable Governmental Authority, specifically including the FDA, notifying Borrower of (A) any material deficiency or violation of Laws and/or the Required Permits related to the marketing or sale of such Product, or (B) that any such Required Permit has been revoked or withdrawn, or (iii) no Governmental Authority has issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace.