Common use of Additional Representations and Warranties of AbbVie Clause in Contracts

Additional Representations and Warranties of AbbVie. AbbVie further represents and warrants to Receptos as follows: 8.3.1. (i) where a Third Party owns an Existing Patent, to the best of AbbVie’s knowledge, AbbVie Controls the rights and interest therein to the extent granted in the Existing In-License Agreements; (ii) where AbbVie or any of its Affiliates owns an Existing Patent as of the Development Agreement Effective Date (including, as so owned, all Patents set forth on Schedule 1.38 under the headings “U.S. Patent Status” and “Foreign Patent Status”), AbbVie represents and warrants that it or its Affiliate owns, and AbbVie Controls, all right, title and interest to such Existing Patent, and (iii) AbbVie and its Affiliates have not licensed, assigned or otherwise disposed of any right, title or interest in any of the Existing Patents, such that the rights of Receptos contemplated hereunder would be adversely affected. 8.3.2. The Existing In-License Agreement Schedule reflects, to the best of AbbVie’s knowledge, a complete list of all agreements entered into prior to the Development Agreement Effective Date by and between AbbVie or any of its Affiliates, on the one hand, and one or more Third Parties, on the other hand, pursuant to which AbbVie or any of its Affiliates Control any AbbVie Patent covering, or any AbbVie Know-How specifically relating to, the composition of matter of ABT-308. 8.3.3. AbbVie shall use raw materials in the manufacture of drug substance and drug product hereunder that conform to the specifications set forth on Schedule 2.5, as verified in accordance with testing standards and procedures; AbbVie shall manufacture drug substance and drug product hereunder in accordance with, and supply drug substance and drug product hereunder that complies with, applicable cGMP requirements and the specifications set forth on Schedule 2.5; upon delivery of any quantity of drug substance or drug product hereunder (excluding Existing Inventory), such quantity shall have a shelf life of not less than *** months; AbbVie shall not supply any quantity of drug substance or drug product that has been adulterated, misused, contaminated, tampered with or otherwise altered or mishandled prior to delivery to Receptos; AbbVie shall maintain such records as are necessary and appropriate to demonstrate compliance in the manufacturing of drug substance and drug product with applicable cGMP requirements and the specifications set forth on Schedule 2.5 for a period of not less than *** months from the expiration date of each batch of drug, or such longer period as may be required by Applicable Law; the specifications set forth on Schedule 2.5 are, as of the Development Agreement Effective Date, fully in compliance with all applicable cGMP requirements, Regulatory Documentation and Applicable Law; and AbbVie shall perform the services set forth on Schedule 2.5 diligently, in a commercially reasonable manner, and in compliance with Applicable Law. 8.3.4. AbbVie has acquired all of the rights and other assets of Xxxxxx Laboratories (“Abbott”) to perform AbbVie’s obligations under this Agreement, including all right, title and interest to the following: (i) all Information Controlled (prior to transfer to AbbVie) by Abbott or any of its Affiliates that (x) is directed to a Licensed Compound, (y) is not generally known and (z) is reasonably necessary or useful for the Development of a Licensed Compound in the Lead Indication; (ii) all Patents Controlled (prior to transfer to AbbVie) by Abbott or any of its Affiliates that are reasonably necessary or useful (or, with respect to Patent applications, would be reasonably necessary or useful if such Patent applications were to issue as Patents) for the Exploitation of any Licensed Compound or Licensed Product (including the Existing Patents and all Patents related (i.e., pursuant to clauses (ii) through (v) of the definition of “Patents”) to any Existing Patent); (iii) all Regulatory Documentation Controlled (prior to transfer to AbbVie) by Abbott or any of its Affiliates; and (iv) the inventory of Abbott or any of its Affiliates (prior to transfer to AbbVie of Drug Substance) (as defined in Schedule 2,5).

Additional Representations and Warranties of AbbVie. AbbVie further represents represents, warrants and warrants covenants to Receptos Galapagos as follows: 8.3.110.3.1 As of the Effective Date, neither AbbVie nor any of its employees or agents performing hereunder, have ever been, are currently, or are the subject of a proceeding that could lead to it or such employees or agents becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or listed on the FDA’s Disqualified/Restricted List. 10.3.2 If, during the Term, AbbVie, or any of its employees or agents performing hereunder, become or are the subject of a proceeding that could lead to a Person becoming, as applicable, a Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or added to the FDA’s Disqualified/Restricted List, AbbVie shall immediately notify Galapagos, and Galapagos shall have the option, at its sole discretion, to prohibit such Person from performing work under this Agreement. This provision shall survive termination or expiration of this Agreement. 10.3.3 AbbVie has obtained from its Affiliates, sublicensees, employees and agents, and from the employees and agents of its Affiliates, sublicensees and agents, who are or are otherwise participating in the Exploitation of the Molecules or Products or who otherwise have access to any Galapagos Information or other Confidential Information of Galapagos as of the Effective Date, and shall obtain from such Persons during the Term, the licenses and other rights necessary for AbbVie to grant to Galapagos the rights and licenses provided herein and for Galapagos to perform its obligations hereunder, without payments beyond those required by Article 6. 10.3.4 With respect to supplies of Molecules, Product and placebos Manufactured and supplied by or on behalf of AbbVie for use in connection with Clinical Studies or commercial distribution under this Agreement, all such Molecules, Product and placebos: (i) where a Third Party owns an Existing Patentshall be in conformity with the applicable specifications for such Molecules, to the best of AbbVie’s knowledge, AbbVie Controls the rights Product and interest therein to the extent granted in the Existing In-License Agreementsplacebos; (ii) where AbbVie or any of its Affiliates owns an Existing Patent as of the Development Agreement Effective Date (including, as so ownedshall be Manufactured in conformance with GMP, all Patents set forth on Schedule 1.38 under the headings “U.S. Patent Status” and “Foreign Patent Status”)other Applicable Law, AbbVie represents and warrants that it or its Affiliate ownsthis Agreement, and AbbVie Controls, all right, title and interest to such Existing Patent, and any applicable quality agreement; (iii) AbbVie and its Affiliates have not licensed, assigned or otherwise disposed of any right, title or interest in any of the Existing Patents, such that the rights of Receptos contemplated hereunder would be adversely affected. 8.3.2. The Existing In-License Agreement Schedule reflects, to the best of AbbVie’s knowledge, a complete list of all agreements entered into prior to the Development Agreement Effective Date by and between AbbVie or any of its Affiliates, on the one hand, and one or more Third Parties, on the other hand, pursuant to which AbbVie or any of its Affiliates Control any AbbVie Patent covering, or any AbbVie Know-How specifically relating to, the composition of matter of ABT-308. 8.3.3. AbbVie shall use raw materials in the manufacture of drug substance and drug product hereunder that conform to the specifications set forth on Schedule 2.5, as verified in accordance with testing standards and procedures; AbbVie shall manufacture drug substance and drug product hereunder in accordance with, and supply drug substance and drug product hereunder that complies with, applicable cGMP requirements and the specifications set forth on Schedule 2.5; upon delivery of any quantity of drug substance or drug product hereunder (excluding Existing Inventory), such quantity shall have a shelf life of not less than *** months; AbbVie shall not supply any quantity of drug substance or drug product been Manufactured in facilities that has been adulterated, misused, contaminated, tampered with or otherwise altered or mishandled prior to delivery to Receptos; AbbVie shall maintain such records as are necessary and appropriate to demonstrate compliance in the manufacturing of drug substance and drug product with applicable cGMP requirements and the specifications set forth on Schedule 2.5 for a period of not less than *** months from the expiration date of each batch of drug, or such longer period as may be required by Applicable Law; the specifications set forth on Schedule 2.5 are, as of the Development Agreement Effective Date, fully in compliance with all applicable cGMP requirements, Regulatory Documentation and Applicable Law; and AbbVie shall perform the services set forth on Schedule 2.5 diligently, in a commercially reasonable manner, and in compliance with Applicable Law. 8.3.4. AbbVie has acquired all Law at the time of such Manufacture (including applicable inspection requirements of FDA and other Regulatory Authorities); (iv) shall not be adulterated or misbranded under the FFDCA, and similar provisions of the rights laws of other countries as to which Regulatory Approvals have been granted; and other assets of Xxxxxx Laboratories (“Abbott”) to perform AbbVie’s obligations under this Agreement, including all right, title and interest to the following: (i) all Information Controlled (prior to transfer to AbbVie) by Abbott or any of its Affiliates that (x) is directed to a Licensed Compound, (y) is not generally known and (z) is reasonably necessary or useful for the Development of a Licensed Compound in the Lead Indication; (ii) all Patents Controlled (prior to transfer to AbbVie) by Abbott or any of its Affiliates that are reasonably necessary or useful (or, with respect to Patent applications, would be reasonably necessary or useful if such Patent applications were to issue as Patents) for the Exploitation of any Licensed Compound or Licensed Product (including the Existing Patents and all Patents related (i.e., pursuant to clauses (ii) through (v) may be introduced into interstate commerce pursuant to the FFDCA, and similar provisions of the definition laws of “Patents”) other countries as to any Existing Patent); (iii) all which Regulatory Documentation Controlled (prior to transfer to AbbVie) by Abbott or any of its Affiliates; and (iv) the inventory of Abbott or any of its Affiliates (prior to transfer to AbbVie of Drug Substance) (as defined in Schedule 2,5)Approvals have been granted.