Common use of Isis Representations and Warranties Clause in Contracts

Isis Representations and Warranties. Isis represents and warrants to Genzyme that the statements contained in this Section 10.2 are true and correct as of the Execution Date with each such representation and warranty subject only to such exceptions, if any, as are set forth in the particular section in the Disclosure Schedule attached hereto as Exhibit F that corresponds to the particular section number in this Agreement: 10.2.1. Schedule 1.52, Schedule 1.56 and Schedule 1.99 set forth true, correct and complete lists of all Isis Core Technology Patents, Isis Manufacturing and Analytical Patents, and Product-Specific Patents, respectively, and all Licensed Patents used in the development or commercialization of Mipomersen and existing as of the Execution Date and indicates whether each such Patent is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent is licensed. 10.2.2. A true, correct and complete list of any Third Party Agreements related to Mipomersen and a true and accurate calculation of the royalty burden for Mipomersen (as it exists on the Execution Date) is set forth on Schedule 10.2.2. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 10.2.3. With respect to the Licensed Patents and all Know-How that is developed by Isis or received by Isis under an agreement with a Third Party that is used in the development or commercialization of Mipomersen [**], Isis has the sufficient legal and/or beneficial title and ownership or rights to grant the Product License to Genzyme under such Licensed Patents and Know-How and the grant of such license to Genzyme does not violate the terms of any Third Party Agreement or any other agreement Isis has with a Third Party. 10.2.4. Isis exclusively owns all rights, title, and interests in, and has good and marketable title to, (a) the Product-Specific Patents and the [**]Patent (b) any other Patent identified on Schedule 1.52 or Schedule 1.56 as being owned by Isis, free of any lien, encumbrance, restriction, or other right or interest granted to any Third Party. Isis owns or Controls all Know-How developed by Isis or received by Isis under an agreement with a Third Party that is used in the development or commercialization of Mipomersen [**]. 10.2.5. Each of the Product-Specific Patents, and each of the Licensed Patents used in the development or commercialization of Mipomersen properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Patent is issued or such application is pending. 10.2.6. With respect to all Product-Specific Patents owned by Isis, and all Licensed Patents owned by Isis and used in the development or commercialization of Mipomersen, (a) each person who has or has had any rights in or to each of such Patents has executed an agreement assigning his, her or its entire right, title and interest in and to such Patents to Isis and (b) to the best of Isis’ knowledge, each such inventor has complied in all material respects with all applicable duties of candor and good faith in dealing with any patent office, including the duty to disclose to any applicable patent office all information known to be material to patentability. 10.2.7. To the best of Isis’ knowledge, no circumstances or grounds exist that would invalidate, reduce or eliminate, in whole or in part, the enforceability, validity or scope of any Product-Specific Patent or any Licensed Patent used in the development or commercialization of Mipomersen. 10.2.8. Isis is not aware of any Patents or Know-How owned or Controlled by a Third Party that would be infringed by Genzyme during the development or commercialization of Mipomersen in its current form. To the best of Isis’ knowledge, Isis has not misappropriated from any Third Party any Know-How used in the development or commercialization of Mipomersen. 10.2.9. To the best of Isis’ knowledge, no actions, suits, claims, disputes or proceedings concerning the Licensed Patents are currently pending or are threatened, that if determined adversely to Isis would have a material adverse effect on or would impair Genzyme’s rights under the Product License. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 10.2.10. Isis is not subject to any agreement with any Third Party or to any outstanding order, judgment or decree of any court or administrative agency that restricts it in any way from granting to Genzyme the Product License. 10.2.11. Isis has not granted, or permitted to be attached, and it will not grant or permit to be attached, any lien, security interest or other encumbrance with respect to any Product-Specific Patent, or any Licensed Patent or Know-How used in the development or commercialization of Mipomersen which would adversely affect the rights granted to Genzyme hereunder. 10.2.12. Each Third Party Agreement related to Mipomersen is in full force and effect, and Isis, and to the best of Isis’ knowledge, each counterparty thereto, is in compliance in all material respects with all such Third Party Agreements and no circumstances or grounds exist that would reasonably be expected to give rise to a claim of material breach or right of rescission, termination, revision or amendment of such Third Party Agreements. 10.2.13. Isis has not assigned, licensed, sublicensed, granted any interest in or options to, or entered into an agreement with respect to the Licensed IP with a Third Party that would adversely impair Genzyme’s exclusive rights under this Agreement, except for the agreements identified on Schedule 2.1. 10.2.14. Isis has not received any claim alleging that Isis’ development of Mipomersen or use of any Product-Specific Patent or any Licensed Patent or Know-How used in the development or commercialization of Mipomersen interferes with, infringes, or misappropriates any intellectual property rights of any Third Party (including any claim that Isis must license or refrain from using any intellectual property rights of any Third Party in order to develop, make, use, sell or offer for sale Mipomersen or any product or technology using or incorporating the Licensed IP), and to the best of Isis’ knowledge, the development and commercialization of Mipomersen and the use of any Product-Specific Patent or any Licensed IP used in the development or commercialization of Mipomersen will not interfere with, infringe or misappropriate the intellectual property rights of any Third Party. To the best of Isis’ knowledge, no Third Party has interfered with, infringed upon or misappropriated the Licensed IP in the making, using or selling of a lipid lowering product. 10.2.15. Isis holds, and is operating in material compliance with, such exceptions, permits, licenses, franchises, authorizations and clearances of any governmental entity required in connection with the current development of Mipomersen. Isis has not received any warning letters or written correspondence from any governmental entity requiring the termination, suspension or modification of any clinical or pre-clinical studies or tests with respect to Mipomersen. Isis has conducted and required its contractors to conduct all clinical studies related to Mipomersen in accordance with cGCP, cGLP and Applicable Law. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. 10.2.16. As of the Execution Date, Isis has prepared, maintained and retained all Regulatory Materials required to be maintained or reported pursuant to and in accordance with Applicable Law and the Regulatory Materials do not contain any materially false or misleading statements. 10.2.17. Except for the agreements identified on Schedule 2.1, Isis has not granted to any Third Party rights under the Licensed IP to research, develop or commercialize any nucleic acid that hybridizes to a nucleic acid molecule encoding apoB.