Patheon. Patheon covenants, represents and warrants that: (a) all Manufacturing Services hereunder shall be performed in accordance with all Applicable Laws, rules or regulations and that all Drug Product manufactured for Client will comply in all respects with the Specifications, cGMP’s, the Act and all other Applicable Laws and the Quality Agreement and all Drug Product will not at the time of delivery be adulterated or misbranded within the meaning of the Act; (b) the entering into of this Agreement by Patheon will not (i) violate any provision of law, statute, rule or regulation or any ruling, writ, injunction, order, judgment or decree of any court, administrative agency or other governmental body; or (ii) conflict with or result in any breach of any of the terms, conditions or provisions of, or constitute a default (or give rise to any right of termination, cancellation or acceleration) under, or result in the creation of any lien, security interest, charge or encumbrance upon any of the properties or assets of Patheon, under its organizational documents, as amended to date, or any material note, indenture, mortgage, lease, agreement, contract, purchase order or other instrument, document or agreement to which Patheon is a party or by which it or any of its properties or assets is bound or affected; (c) it owns or possesses adequate licenses or other intellectual property that are necessary for Patheon to perform its obligations under this Agreement and that it is unaware of any assertion or claim challenging the ownership, use or validity of any intellectual property of Patheon to be utilized hereunder. The use of any formulas, documents, materials, compounds analytical methods or other intellectual property provided by Patheon under this Agreement does not infringe the valid rights of any third party including inter alia intellectual property rights; (d) it has never been and is not currently debarred under the Act and that it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended under 21 U.S.C.§335(a) or (b). Patheon represents that it does not currently have, and covenants that it will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the United States Food, Drug and Cosmetic Act; (e) All necessary corporate and other authorizations, consents and approvals which are necessary or required for the entering into of this Agreement by Patheon have been duly obtained; (f) There are no actions or legal proceedings pending or threatened which would limit or prevent Patheon from performing the Manufacturing Services contemplated hereunder; and (g) It possesses all necessary permits, licenses and other authorizations from any regulatory Authority necessary to perform the Manufacturing Services hereunder.
Appears in 5 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)