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

Additional Representations and Warranties of AbbVie. AbbVie further represents, warrants and covenants to Galapagos as follows: 10.3.1 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) shall be in conformity with the applicable specifications for such Molecules, Product and placebos; (ii) shall be Manufactured in conformance with GMP, all other Applicable Law, this Agreement, and any applicable quality agreement; (iii) shall have been Manufactured in facilities that are in compliance with Applicable 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 laws of other countries as to which Regulatory Approvals have been granted; and (v) may be introduced into interstate commerce pursuant to the FFDCA, and similar provisions of the laws of other countries as to which Regulatory Approvals have been granted.

Additional Representations and Warranties of AbbVie. AbbVie further represents, represents and warrants and covenants to Galapagos Receptos as follows: 10.3.1 As 8.3.1. (i) where a Third Party owns an Existing Patent, to the best of AbbVie’s knowledge, AbbVie Controls the Effective Date, neither rights and interest therein to the extent granted in the Existing In-License Agreements; (ii) where 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 Affiliates owns an Existing Patent as of the subject of a proceeding that could lead to a Person becomingDevelopment Agreement Effective Date (including, as applicableso 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 Debarred Entity or Debarred Individual, an Excluded Entity or Excluded Individual or a Convicted Entity or Convicted Individual, or added complete list of all agreements entered into prior to the FDA’s Disqualified/Restricted List, Development Agreement Effective Date by and between 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 any of its Affiliates, sublicensees on the one hand, and agentsone or more Third Parties, who are on the other hand, pursuant to which AbbVie or are otherwise participating 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 Exploitation manufacture of drug substance and drug product hereunder that conform to the Molecules 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 Products 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 who drug product that has been adulterated, misused, contaminated, tampered with or otherwise have access altered or mishandled prior to any Galapagos Information 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 other Confidential Information of Galapagos 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 obtain from such Persons during perform the Termservices set forth on Schedule 2.5 diligently, the licenses in a commercially reasonable manner, and other rights necessary for in compliance with Applicable Law. 8.3.4. AbbVie to grant to Galapagos has acquired all of the rights and licenses provided herein and for Galapagos other assets of Xxxxxx Laboratories (“Abbott”) to perform its AbbVie’s 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, including all such Moleculesright, Product title and placebosinterest to the following: (i) shall be 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 conformity with the applicable specifications for such Molecules, Product and placebosLead Indication; (ii) shall 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 Manufactured in conformance with GMPreasonably 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., all other Applicable Law, this Agreement, and pursuant to clauses (ii) through (v) of the definition of “Patents”) to any applicable quality agreementExisting Patent); (iii) shall have been Manufactured in facilities that are in compliance with Applicable Law at the time all Regulatory Documentation Controlled (prior to transfer to AbbVie) by Abbott or any of such Manufacture (including applicable inspection requirements of FDA its Affiliates; and other Regulatory Authorities); (iv) shall not be adulterated the inventory of Abbott or misbranded under the FFDCA, and similar provisions any of the laws its Affiliates (prior to transfer to AbbVie of other countries Drug Substance) (as to which Regulatory Approvals have been granted; and (v) may be introduced into interstate commerce pursuant to the FFDCA, and similar provisions of the laws of other countries as to which Regulatory Approvals have been granteddefined in Schedule 2,5).

Additional Representations and Warranties of AbbVie. AbbVie further representsrepresents and warrants to Sionna, warrants and covenants to Galapagos as of the Effective Date, as follows: 10.3.1 8.2.1 AbbVie, by itself or though it its Affiliates, has sufficient legal or beneficial title, ownership or license rights under the Licensed IP, including by way of the licenses and rights granted to it under the Galapagos Agreement or otherwise, to grant the licenses and rights under the Licensed IP granted to Sionna under this Agreement; 8.2.2 As of the Effective Date, neither AbbVie nor is the joint owner and exclusive licensee of all right, title and interest in and to (free and clear of any Liens of any kind) the Existing Patents. To AbbVie’s knowledge, all fees required to maintain the Existing Patents have been paid to date and, to AbbVie’s knowledge, the Existing Patents are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law. 8.2.3 Other than the Galapagos Agreement, AbbVie has not entered into any agreements, either oral or written, with any Third Party under which AbbVie has in-licensed rights to the Existing Patents. 8.2.4 AbbVie has not received any written, or, to its knowledge, oral, claim or demand as of the Effective Date alleging (a) that the Existing Patents are invalid or unenforceable or (b) that the Exploitation of the Licensed Compound by AbbVie or its Affiliates in the Territory infringes or misappropriates the intellectual property rights of any Third Party; 8.2.5 There are no pending, and, to AbbVie’s knowledge, no threatened in writing, (a) actions, suits or proceedings against AbbVie involving the Licensed IP or the Licensed Compounds, (b) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Existing Patents that are in or before any patent authority (or other governmental authority performing similar functions) or (c) inventorship challenges involving the Existing Patents that are in or before any patent or other governmental authority; 8.2.6 AbbVie has not granted any license or any option for a license under, or any right, title or interest in or to, the Licensed IP to any Third Party to Exploit any Licensed Compound or a Licensed Product in any country in the Territory. AbbVie has not granted any Lien with respect to this Agreement or any of its the Licensed IP licensed by it to Sionna under this Agreement. AbbVie has not granted (and AbbVie covenants that during the Term it shall not grant) to any Third Party any license, option or other right to enforce or obtain any patent term extension for any of the Licensed Patents; and 8.2.7 To AbbVie’s knowledge, no person, other than former or current employees or agents performing hereunder, have ever been, consultants of AbbVie or Galapagos who are currently, obligated in writing to assign their inventions to AbbVie or are the subject of a proceeding that could lead to it or such employees or agents becomingGalapagos, as applicable, a Debarred Entity or Debarred Individual, is 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 inventor of 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 inventions claimed in the Exploitation of the Molecules Existing Patents filed or Products or who otherwise have access to any Galapagos Information or other Confidential Information of Galapagos issued as of the Effective Date. To AbbVie’s knowledge, there are no claims that have been asserted in writing challenging the inventorship of the Existing Patents; 8.2.8 The inventions claimed by the Existing Patents and shall obtain from such Persons during the Term, the licenses and any other rights intellectual property necessary for AbbVie the Exploitation of any Licensed Compound or Licensed Product were not conceived, reduced to grant to Galapagos the rights and licenses provided herein and for Galapagos to perform its obligations hereunderpractice, without payments beyond those required by Article 6. 10.3.4 With respect to supplies of Moleculesdiscovered, Product and placebos Manufactured and supplied by developed or on behalf of AbbVie for use otherwise made in connection with Clinical Studies any research activities funded, in whole or commercial distribution under this Agreementin part, all such Moleculesby any grants, Product and placebos: (i) shall be in conformity with the applicable specifications for such Molecules, Product and placebos; (ii) shall be Manufactured in conformance with GMP, all other Applicable Law, this Agreementfunds, and other money received from any applicable quality agreement; (iii) shall have been Manufactured in facilities that are in compliance with Applicable Law at the time governmental authority, and no governmental authority or academic institution has any right to, ownership of such Manufacture (including applicable inspection requirements any “step-in” or “march-in” rights with respect to), or right to royalties for, or to impose any restriction on the assignment, transfer, grant of FDA and licenses or other Regulatory Authorities); (iv) shall not be adulterated or misbranded under the FFDCA, and similar provisions disposal of the laws Existing Patents or the Licensed Know-How, or to impose any requirement or restriction on the Exploitation of other countries any Licensed Compound or Licensed Product as to which Regulatory Approvals have been granted; and (v) may be introduced into interstate commerce pursuant to the FFDCA, and similar provisions of the laws of other countries as to which Regulatory Approvals have been grantedcontemplated herein.

Additional Representations and Warranties of AbbVie. AbbVie further representsrepresents and warrants to Licensor, warrants and covenants as of the Target Acceptance Date with respect to Galapagos an Accepted Target, as follows: 10.3.1 As 11.3.1 To AbbVie’s Knowledge, AbbVie has the right to use all Information and Patents necessary to Develop, Manufacture and Commercialize the Discovery T-Cell Receptors that Bind to such Accepted Target and AbbVie is entitled to grant Licensor the licenses specified in Section 6.2. 11.3.2 All rights in all inventions and discoveries, made, developed, or conceived by any employee or independent contractor of the Effective Date, neither AbbVie nor or any of its employees Affiliates during the course of their employment (or agents performing hereunderother retention) by AbbVie or such Affiliate, have ever been, are currently, and included in AbbVie Background Know-How or that are the subject of a proceeding that could lead to it one (1) 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, more 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 Background Patents existing as of the Effective DateDate that claim or cover Discovery T-Cell Receptors that Bind to such Accepted Target (the “Existing AbbVie TCR Patents”) have been or will be assigned in writing to AbbVie or such Affiliate. 11.3.3 AbbVie has obtained the right (including under any Patents and other intellectual property rights) to use all Information and all other materials developed or delivered by any Third Party under any agreements between AbbVie and any such Third Party that is necessary for the Development or Commercialization of Discovery T-Cell Receptors that Bind to such Accepted Target, and shall obtain from AbbVie has the rights under each such Persons during the Term, the licenses agreement to transfer such Information or other materials to Licensor and other rights necessary for AbbVie its designees and to grant Licensor the right to Galapagos use such Information or other materials in 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 Development of Molecules, Product and placebos Manufactured and supplied by the Discovery T-Cell Receptor Constructs or on behalf of AbbVie for use the Licensed Products as set forth in connection with Clinical Studies or commercial distribution under this Agreement. [ ] = Certain confidential information contained in this document, all such Moleculesmarked by brackets, Product and placebos: (i) shall be in conformity is filed with the applicable specifications for such Molecules, Product Securities and placebos; (ii) shall be Manufactured in conformance with GMP, all other Applicable Law, this Agreement, and any applicable quality agreement; (iii) shall have been Manufactured in facilities that are in compliance with Applicable 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 Exchange Commission pursuant to Rule 406 of the laws Securities Act of other countries 1933, as to which Regulatory Approvals have been granted; and (v) may be introduced into interstate commerce pursuant to the FFDCA, and similar provisions of the laws of other countries as to which Regulatory Approvals have been grantedamended.