Common use of NDAS; REGULATORY MATTERS Clause in Contracts

NDAS; REGULATORY MATTERS. Lilly represents and warrants that Lilly has furnished NeoSan with access to a complete copy of the NDAs, including all amendments and supplements thereto and that Lilly has no new drug applications or INDs pertaining to propoxyphene-based pharmaceutical products, whether issued, pending, abandoned, withdrawn, or in draft form, other than those pertaining to the NDAS. Although the NDAs are not "state of the art" (which NeoSan hereby acknowledges), Lilly further represents and warrants that (i) Lilly has complied in all material respects with all Applicable Laws in connection with the preparation and submission to the FDA of each of the NDAs, (ii) each of the NDAs has been approved by FDA, and, except with respect to those of the NDAs listed in SCHEDULE 4.8 attached hereto, nothing has come to the attention of Lilly which has led Lilly to believe that any of the NDAs are not in good standing with the FDA, and (iii) Lilly has filed with the FDA all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to each NDA which are material to the ability of Lilly to conduct the Activities. All of the Regulatory Approvals are owned exclusively by Lilly or its Affiliates. All Products being sold by Lilly in the United States are covered by a Regulatory Approval therein that permits such sale in the United States. There is no Action or Proceeding by any Governmental or Regulatory Authority pending or, to the knowledge of Lilly as of the Effective Date, threatened seeking the revocation or suspension of any Regulatory Approval. Except as set forth in SCHEDULE 4.8 attached hereto, during the three years prior to the date of this Agreement, Lilly and its Affiliates have not received or been subject to: (i) any FDA Form 483's directly relating to any Product or directly relating to any facility in which such Product is manufactured; (ii) any FDA Notices of Adverse Findings directly relating to any Product or directly relating to any facility in which such Product is manufactured; or (iii) any warning letters or other written correspondence from the FDA or any other Governmental or Regulatory Authority directly relating to the Product or directly relating to any facility in which such Product is manufactured, in which the FDA or such other Governmental or Regulatory Authority asserted that the operations of Seller were not in compliance with Applicable Law with respect to any Product or the facilities in which any Product is manufactured, tested or stored. Except for the representation and warranty contained in this Section 4.8, NeoSan has had full and adequate opportunity to review and evaluate the NDAs, NeoSan is relying upon its own judgment and experience in connection with the NDAs, and Lilly is assigning, selling, conveying, transferring and delivering the NDAs to NeoSan "AS IS."

NDAS; REGULATORY MATTERS. Lilly represents and warrants that Lilly has furnished NeoSan with access to a complete copy of the NDAs, including all amendments and supplements thereto and that Lilly has no new drug applications or INDs pertaining to propoxyphene-based pharmaceutical products, whether issued, pending, abandoned, withdrawn, or in draft form, other than those pertaining to the NDASNDAs. Although the NDAs are not "state of the art" (which NeoSan hereby acknowledges), Lilly further represents and warrants that (i) Lilly has complied in all material respects with all Applicable Laws in connection with the preparation and submission to the FDA of each of the NDAs, (ii) each of the NDAs has been approved by FDA, and, except with respect to those of the NDAs listed in SCHEDULE 4.8 attached hereto, nothing has come to the attention of Lilly which has led Lilly to believe that any of the NDAs are not in good standing with the FDA, and (iii) Lilly has filed with the FDA all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to each NDA which are material to the ability of Lilly to conduct the Activities. All of the Regulatory Approvals are owned exclusively by Lilly or its Affiliates. All Products being sold by Lilly in the United States are covered by a Regulatory Approval therein that permits such sale in the United States. There is no Action or Proceeding by any Governmental or Regulatory Authority pending or, to the knowledge of Lilly as of the Effective Date, threatened seeking the revocation or suspension of any Regulatory Approval. Except as set forth in SCHEDULE 4.8 attached hereto, during the three years prior to the date of this Agreement, Lilly and its Affiliates have not received or been subject to: (i) any FDA Form 483's directly relating to any Product or directly relating to any facility in which such Product is manufactured; (ii) any FDA Notices of Adverse Findings directly relating to any Product or directly relating to any facility in which such Product is manufactured; or (iii) any warning letters or other written correspondence from the FDA or any other Governmental or Regulatory Authority directly relating to the Product or directly relating to any facility in which such Product is manufactured, in which the FDA or such other Governmental or Regulatory Authority asserted that the operations of Seller were not in compliance with Applicable Law with respect to any Product or the facilities in which any Product is manufactured, tested or stored. Except for the representation and warranty contained in this Section 4.8, NeoSan has had full and adequate opportunity to review and evaluate the NDAs, NeoSan is relying upon its own judgment and experience in connection with the NDAs, and Lilly is assigning, selling, conveying, transferring and delivering the NDAs to NeoSan "AS IS."