Provision Language
16. Representations and Warranties
16.1 Mutual Representations and Warranties. Each Party represents and warrants to the other Party as follows:
16.1.1 Authorization. The execution, delivery and performance of this Agreement by such Party and all instruments and documents to be delivered by such Party hereunder: (i) are within the corporate power of such Party; (ii) have been duly authorized by all necessary or proper corporate action;(iii) are not in contravention of any provision of the certificate of formation or limited liability company agreement of such Party; (iv) to the knowledge of such Party, will not violate any Law or regulation or any order or decree of any court of governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which such Party is a party or by which such Party or any of its property is bound, which violation would have an adverse effect on the financial condition of such Party or on the ability of such Party to perform its obligations hereunder; and (vi) do not require any filing or registration with, or the consent or approval of, any governmental body, agency, authority or any other person, which has not been made or obtained previously (other than approvals required under the HSR Act, Regulatory Approvals required for the sale of Products and filings with Regulatory Authorities required in connection with Products).
16.1.2 Third Party Patent Rights. Such Party has no knowledge as of the Effective Date of the existence of any Valid Claim of any issued patent owned by or licensed to any Third Party that could prevent Roche from making, having made, using, offering for sale, selling or importing Product in the Territory.
16.1.3 Inventors. All of such Party’s employees, officers and contractors have executed agreements requiring assignment to such Party of all Inventions made by such individuals during the course of and as a result of their association with such Party.
16.1.4 Grants. Such Party has the lawful right to grant the other Party and its Affiliates the rights and licenses described in this Agreement.
16.1.5 No Claims. As of the Effective Date, there are no claims or investigations (other than with respect to the Parties’ HSR Act filings), pending or threatened against such Party or any of its Affiliates, at Law or in equity, or before or by any governmental authority, relating to the matters contemplated under this Agreement or that would materially adversely affect such Party’s ability to perform its obligations hereunder.
16.1.6 No Conflict. Except for obligations under the SRA, neither such Party nor any of its Affiliates is or will be under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of such Party’s Obligations hereunder.
16.1.7 No Debarment. Such Party has never been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C. §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid Program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program.
16.2 Additional PTC Representations and Warranties
16.2.1 Safety Data. PTC has disclosed to Roche (i) the results of all preclinical testing of Products in its Control and (ii) all information in itsControl concerning side effects, injury, toxicity or sensitivity reaction and incidents or severity thereof with respect to Product.
16.2.2 Ownership of Patent Rights. PTC is the exclusive owner of all right, title and interest in, or is the exclusive licensee of, the PTC Base Patent Rights. Appendix 1.62 contains a complete and accurate list of all patents and patent applications included in the PTC Base Patent Rights.
16.2.3 Validity of Patent Rights. As of the Effective Date, PTC is not in possession of information that could render invalid and/or unenforceable any claims that are in any of the PTC Base Patent Rights. PTC has no knowledge of any inventorship disputes concerning any PTC Base Patent Rights.
16.2.4 Ownership and Validity of Know-How. The PTC Know-How is legitimately in the possession of PTC and has not been misappropriated from any Third Party. PTC has taken reasonable measures to protect the confidentiality of its Know-How.
16.2.5 SRA. As of the Effective Date, the SRA is in full force and effect and neither PTC nor Foundation has been notified of any breach of the SRA or controversy concerning the performance of PTC and/or Foundation under the SRA.
16.3 Additional Roche Representation. Roche represents that it is the view of its professional advisors as of the Effective Date that no filing will be required under the HSR Act in connection with this Agreement.
18. Disclaimer
EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, PTC AND ROCHE EACH DISCLAIM ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL & COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS. IN NO EVENT SHALL THE PARTIES OR THE FOUNDATION BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY. NOTHING IN THIS ARTICLE 18 IS INTENDED TO LIMIT OR RESTRICT(I) THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY OR FOUNDATION UNDER SECTIONS 15.9, 17.1 AND 17.2, OR (II) REMEDIES AVAILABLE TO EITHER PARTY OR THE FOUNDATION WITH RESPECT TO A BREACH OF SECTION 19.1.