Common use of Representations and Warranties by Pfizer Clause in Contracts

Representations and Warranties by Pfizer. 10.2.1. PFIZER represents and warrants to LICENSEE as of the Effective Date that: (a) PFIZER Controls the Patent Rights and the Know-How, and is entitled to grant the licenses specified herein; PFIZER has not caused any Patent Rights to be subject to any liens or encumbrances and PFIZER has not granted to any Third Party any rights or licenses under any of the Patent Rights or Know-How that would conflict with the licenses granted to Licensee hereunder; and PFIZER does not hold Control any patents that dominate the Patent Rights; (b) PFIZER is not subject to any royalty or similar payment obligation to any Third Party with respect to the grant of rights to PFIZER to practice the Licensed Technology, except as set forth in the Collaboration and License Agreement (a true copy of which, including all amendments, has been provided to LICENSEE). The Collaboration and License Agreement remains in full force and effect and, to PFIZER’s Knowledge, Cancer Research Technology Limited is not in material breach under the Collaboration and License Agreement. PFIZER has paid all amounts due and payable under the Collaboration and License Agreement to the extent accrued on or before the Effective Date and is not in material breach of the Collaboration and License Agreement; (c) to its Knowledge, the Patent Rights have been procured from the respective Patent offices in accordance with Applicable Law; (d) to its Knowledge, PFIZER has not received any communication from a Third Party alleging that the Use of the Product in the Field within the Territory infringes, misappropriates or otherwise violates the Intellectual Property Rights of a Third Party; (e) to its Knowledge, there is no claim pending or threatened by PFIZER alleging that a Third Party is or was infringing, misappropriating or otherwise violating the Licensed Technology in the Field within the Territory; and (f) PFIZER has not, up through and including the Effective Date, Knowingly withheld any material information, including reports of Adverse Event Experiences and warning letters from Regulatory Authorities, in PFIZER’s possession from LICENSEE in connection with its due diligence relating to the Compound, Products, this Agreement and the underlying transaction. To PFIZER’s Knowledge, the clinical data related to Compound or Product that PFIZER has provided to LICENSEE prior to the Effective Date was, when access was provided to LICENSEE, up-to-date and accurate in all material respects and PFIZER has provided LICENSEE with any material updates to such clinical data that have occurred since the time such access was provided to LICENSEE. 10.2.2. As used in Section 10.2.1, “Knowledge” means first hand and actual knowledge of the officers of PFIZER and is not meant to require or imply that any particular inquiry or investigation has been undertaken including, without limitation, obtaining any type of search (independent of that performed by the actual governmental authority during the normal course of patent prosecution, as applicable, in a jurisdiction) or opinion of counsel.

Representations and Warranties by Pfizer. 10.2.1. As of the Effective Date: 10.2.1 PFIZER represents and warrants to LICENSEE as of the Effective Date that: (a) PFIZER Controls the Patent Rights and the Know-How, and is entitled to grant the licenses specified herein; PFIZER has not caused any Patent Rights to be subject to any liens or encumbrances and PFIZER has not granted to any Third Party any rights or licenses under any of the Patent Rights or Know-How that would conflict with the licenses granted to Licensee hereunder; and PFIZER does not hold Control any patents that dominate the Patent Rights; (b) PFIZER is not subject to any royalty or similar payment obligation to any Third Party with respect to the grant of rights to PFIZER to practice the Licensed Technology, except as set forth in the Collaboration and License Agreement (a true copy of which, including all amendments, has been provided to LICENSEE). The Collaboration and License Agreement remains in full force and effect and, to PFIZER’s Knowledge, Cancer Research Technology Limited is not in material breach under the Collaboration and License Agreement. PFIZER has paid all amounts due and payable under the Collaboration and License Agreement to the extent accrued on or before the Effective Date and is not in material breach of the Collaboration and License Agreement; (c) to its Knowledge, the Patent Rights have been procured from the respective Patent offices in accordance with Applicable Law; (d) to its Knowledge, PFIZER has not received any communication from a Third Party there is no claim pending or threatened alleging that the Use of the Product Licensed IP in the Licensed Field within the Territory infringes, misappropriates or otherwise violates the Intellectual Property Rights of a Third Party; (e) 10.2.2 PFIZER represents and warrants that, to its Knowledge, there is no claim pending or threatened by PFIZER alleging that a Third Party is or was infringing, misappropriating or otherwise violating the Licensed Technology IP in the Licensed Field within the Territory; 10.2.3 PFIZER represents and warrants that the Licensed IP is Controlled by PFIZER such that it can grant the licenses to the Patent Rights and Know-How to LICENSEE pursuant to Section 2, and further warrants and represents that the materials and documents to be provided by PFIZER to LICENSEE hereunder (including the United States IND’s for the Compound) are Controlled by PFIZER such that PFIZER has the ability to transfer such materials and documents to LICENSEE as provided herein; 10.2.4 PFIZER represents and warrants that PFIZER is not a party to any agreement or other written arrangement with any Third Party, other than OSI, pursuant to which such Third Party is granted a license to the Licensed IP with respect to the Products, and further represents and warrants that PFIZER has not received any written notice from OSI regarding any outstanding disputes in connection with which OSI is making a claim, demand or request for any reversionary rights in or to the Licensed IP; and (f) 10.2.5 PFIZER has notrepresents and warrants that no subjects are enrolled in clinical studies of the Compound that are sponsored by PFIZER, up through all invoices from sites that participated in any such studies have been paid in full, and including the Effective Date, Knowingly withheld all invoices from any material information, including reports of Adverse Event Experiences and warning letters from Regulatory Authorities, in PFIZER’s possession from LICENSEE vendors that supplied goods or services in connection with its due diligence relating to the Compound, Products, this Agreement and the underlying transaction. To PFIZER’s Knowledge, the clinical data related to Compound or Product that PFIZER has provided to LICENSEE prior to the Effective Date was, when access was provided to LICENSEE, up-to-date and accurate such studies have been paid in all material respects and PFIZER has provided LICENSEE with any material updates to such clinical data that have occurred since the time such access was provided to LICENSEEfull. 10.2.2. As used in Section 10.2.1, “Knowledge” means first hand and actual knowledge of the officers of PFIZER and is not meant to require or imply that any particular inquiry or investigation has been undertaken including, without limitation, obtaining any type of search (independent of that performed by the actual governmental authority during the normal course of patent prosecution, as applicable, in a jurisdiction) or opinion of counsel.

Representations and Warranties by Pfizer. 10.2.1. Subject to any intellectual property rights owned by Danisco and licensed to LICENSEE pursuant to the Danisco Agreement (of which PFIZER makes no representations or warranties), PFIZER represents and warrants to LICENSEE as of the Effective Date that: (a) PFIZER Controls 10.2.1. to the Patent Knowledge of PFIZER, the Use of ETC-216 in the Field does not infringe any Intellectual Property Rights and of any Third Party; 10.2.2. the Know-How, How and is entitled to grant the licenses specified herein; PFIZER has not caused any Patent Rights to be subject to any liens or encumbrances and PFIZER has not granted to any Third Party any rights or licenses under any of the Patent Rights or Know-How that would conflict with the licenses granted to Licensee hereunder; and PFIZER does not hold Control any patents that dominate the Patent Rights; (b) PFIZER is not subject to any royalty or similar payment obligation to any Third Party except as noted with respect to the grant of rights Patent Rights on Schedule B2) comprise all patents, patent applications and know-how owned or Controlled by PFIZER or its Affiliates that are necessary or optimal for LICENSEE to PFIZER to practice the Licensed Technology, except as set forth in the Collaboration and License Agreement (a true copy of which, including all amendments, has been provided to LICENSEE). The Collaboration and License Agreement remains in full force and effect and, to PFIZER’s Knowledge, Cancer Research Technology Limited is not in material breach under the Collaboration and License Agreement. PFIZER has paid all amounts due and payable under the Collaboration and License Agreement to the extent accrued on or before the Effective Date and is not in material breach of the Collaboration and License AgreementUse ETC-216; (c) 10.2.3. to its Knowledge, the Patent Rights have been procured from the respective Patent offices in accordance with Applicable Law; (d) to there is no claim pending or threatened against PFIZER or its Knowledge, PFIZER has not received any communication from a Third Party Affiliates alleging that the Use of the Product ETC-216 in the Field within the Territory infringes, misappropriates or otherwise violates the Intellectual Property Rights of a Third Party; (e) 10.2.4. to its Knowledge, PFIZER has not received written notice from a Third Party asserting or alleging that the Use of ETC-216 on or before the Effective Date infringed or misappropriated any Intellectual Property Rights of such Third Party; 10.2.5. there is no claim pending pending, or threatened to the Knowledge of PFIZER, threatened, by PFIZER alleging that a Third Party is or was infringing, misappropriating or otherwise violating the Licensed Technology (except as noted with respect to the Patent Rights on Schedule B2) in the Field in any country within the Territory; and; (f) 10.2.6. to its Knowledge, and except as noted with respect to the Patent Rights on Schedule B2, all issued patents included in the Patent Rights are valid and enforceable, and no Third Party has challenged the extent, validity or enforceability of any of the Patent Rights; 10.2.7. to its Knowledge, PFIZER has not, up through and including the Effective Date, Knowingly withheld any material informationcomplied with all Applicable Laws, including reports of Adverse Event Experiences and warning letters from Regulatory Authoritiesany disclosure requirements, in PFIZER’s possession from LICENSEE in connection with its due diligence relating the filing, prosecution and maintenance of the Patent Rights (except as noted with respect to the CompoundPatent Rights on Schedule B2); 10.2.8. PFIZER is able to grant the licenses to LICENSEE as purported to be granted pursuant to this Agreement, Products, this Agreement free and clear of any rights of any Third Party. All Patent Rights (except as noted with respect to the underlying transactionPatent Rights on Schedule B2) have been properly assigned to PFIZER and all assignment documents with respect to the Patent Rights (except as noted with respect to the Patent Rights on Schedule B2) have been properly executed and recorded in the relevant U.S. and foreign patent offices; 10.2.9. To to PFIZER’s Knowledge, the clinical data related to Compound each Regulatory Filing for ETC-216 submitted or Product that filed by PFIZER has provided to LICENSEE prior to the Effective Date wasor any of its Affiliates was true, when access was provided to LICENSEE, up-to-date complete and accurate in all material respects at the time of submission or filing and timely filed; 10.2.10. to its Knowledge, PFIZER and its Affiliates have not received any written notice that indicates that any of the Regulatory Filings submitted or filed for ETC-216 are not currently in good standing with the relevant Regulatory Authorities or that any “clinical hold” or similar regulatory action is in effect, provided, however, that PFIZER has provided LICENSEE with any material updates received a communication from the FDA dated August 15, 2007, stating that the FDA would anticipate asking PFIZER to such comprehensively summarize all pertinent in-vitro, pre-clinical, and clinical data that have occurred since both in a submission and at a face to face meeting prior to or at the time of submission of any new clinical protocols for the ETC-216 program; 10.2.11. to its Knowledge, (a) PFIZER and its Affiliates have complied in all material respects with all Applicable Laws with respect to the Use of ETC-216 prior to the Effective Date, (b) neither PFIZER nor any employee of PFIZER or its Affiliates involved in the Development of ETC-216 has been debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a), and (c) no employee of PFIZER or its Affiliates involved in the Development of ETC-216 has been placed on any of the FDA clinical investigator enforcement lists (including the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List); 10.2.12. PFIZER has disclosed to LICENSEE the data (including pre-clinical and clinical data and results), correspondence and information in the possession or control of PFIZER or its Affiliates relevant to the Development and Commercialization of ETC-216 that LICENSEE has requested; 10.2.13. there are no agreements to which PFIZER or any of its Affiliates is a party pursuant to which PFIZER or any of its Affiliates has a license or holds an immunity from suit, with respect to patents which (i) are granted or registered, or to the Knowledge of PFIZER, applied for or pending, and (ii) but for PFIZER’s or its Affiliates’ rights under such access agreement, could be asserted by a Third Party to be infringed by the Use of ETC-216 as a monotherapy. PFIZER has previously delivered or made available to LICENSEE the written agreements between PFIZER or its Affiliates, on the one hand, and any Third Parties, on the other hand, necessary for the manufacture of ETC-216 for sale in the Field in the Territory; provided, that LICENSEE acknowledges and agrees that the Danisco Agreement has only been made available in redacted form, and provided, further, that the foregoing is subject to the valid execution and delivery of the Danisco Agreement by LICENSEE, PFIZER and Danisco on or before the Effective Date hereof; 10.2.14. certain provisions (Section 3.2, Section 4 and Section 7.2 in part of the LICENSE AGREEMENT (as defined in the Danisco Agreement) and Sections 4 and 5 of the FIRST AMENDMENT (as defined in the Danisco Agreement) have been redacted because they are specific only to PFIZER and are not relevant to LICENSEE’s rights and assumed obligations under the Danisco Agreement, or they contain confidential financial or other business information of PFIZER and Danisco; and 10.2.15. all Transferred Inventory (a) was manufactured in accordance with (i) cGMP and (ii) the specifications set therefor by PFIZER and provided to LICENSEE, (b) conforms to such specifications, (c) shall, at the time of delivery to LICENSEE, not contain any material that would cause the Transferred Inventory to be adulterated or misbranded under Applicable Laws. 10.2.2. As used in Section 10.2.1, “Knowledge” means first hand and actual knowledge of the officers of PFIZER and is not meant to require or imply that any particular inquiry or investigation has been undertaken including, without limitation, obtaining any type of search (independent of that performed by the actual governmental authority during the normal course of patent prosecution, as applicable, in a jurisdiction) or opinion of counsel.