MEDICINES CO /DE filed this form 8-K on 4 Dec 2017
terminated or suspended prior to completion due to any Proceeding initiated by a Governmental Authority, and neither the FDA nor any other applicable Governmental Authority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to Seller Parent’s Knowledge, on behalf of Seller Parent or its Subsidiaries, with respect to the Business or Products has commenced, or, to Seller Parent’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Seller Parent or any of its Subsidiaries with respect to the Business or Products.
(d) No manufacturing site owned by Seller Parent or its Subsidiaries, or to Seller Parent’s Knowledge, any of their respective contract manufacturers for pharmaceutical products, in each case, with respect to the manufacture of Vabomere, Orbactiv or Minocin IV, (i) is subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, or (ii) has received any FDA Form 483 (or other governmental entity notice of inspectional observations, “warning letters,” “untitled letters” or requests or requirements to make changes with respect to the Business or Products, or any of Seller Parent’s, any of the Subsidiaries’, or any of their respective contract manufacturer’s processes or procedures related to the Business or Products), or similar correspondence or notice from the FDA or other Governmental Authority in respect of the Business or Products and alleging or asserting noncompliance in any material respect with any applicable Law, Permit or such requests or requirements of a Governmental Authority, in each case that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to Seller Parent’s Knowledge, neither the FDA nor any other Governmental Authority is considering such action.
(e) All manufacturing operations conducted by or, to Seller Parent’s Knowledge, on behalf of, or for the benefit of, Seller Parent and its Subsidiaries with respect to Vabomere, Orbactiv or Minocin IV have been and are being conducted in compliance with applicable Laws in all material respects, including the provisions of the FDA’s current good manufacturing practice regulations at 21 C.F.R. Parts 210-211 for pharmaceutical products sold in the United States and comparable foreign Laws relating to the subject matters thereof.
(f) Seller Parent, its Subsidiaries and, to Seller Parent’s Knowledge, any contract manufacturer who manufactures Vabomere, Orbactiv or Minocin IV on behalf of Seller Parent or its Subsidiaries have not conducted or issued any recalls, field notifications, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts, “serious adverse event” reports or other notice of action relating to an alleged lack of safety or regulatory compliance with respect to the Products.
(g) Seller Parent, its Subsidiaries, and, to Seller Parent’s Knowledge, any contract manufacturer and, to Seller Parent’s Knowledge, any of their respective officers, key employees or agents, are not debarred or have been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under applicable Law, including, without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion