Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that: 10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; 10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; 10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; 10.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; 10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearance; and 10.1.6 it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under the Research Program.
Appears in 3 contracts
Samples: Product Development and Commercialization Agreement (ChemoCentryx, Inc.), Product Development and Commercialization Agreement (ChemoCentryx, Inc.), Product Development and Commercialization Agreement (ChemoCentryx, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents represents, warrants and warrants covenants to the other Party, as of the Effective Restatement Date, that:
10.1.1 such Such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the The execution, delivery and performance of this Agreement by such Party does not and will not conflict with any agreementagreement or any provision thereof, or any instrument or understanding, oral or written, to which it is or becomes a party or by which it is or becomes bound, nor violate any law Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no No government authorization, consent, approval, license, exemption of of, or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by for its execution and delivery of this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceAgreement; and
10.1.6 it has not (i) employed (and, to the best of its knowledge without further duty of inquiry, and has not used a contractor or consultant that has employed) , any Person debarred pursuant to Section 306 of the Federal Food, Drug and Cosmetic Act (the “FFDCA”), or who is the subject of a conviction described in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA such section (or subject to a similar sanction of EMEAEMA), or, to the best of its knowledge without further duty of inquiry, (ii) employed any individual who or entity which Person that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA), in the conduct of the Preclinical Activities any pre-clinical activities or Clinical Studies clinical studies of Collaboration Compounds and its activities under the Research ProgramCompounds.
Appears in 3 contracts
Samples: Collaboration and License Agreement (Epizyme, Inc.), Collaboration and License Agreement, Collaboration and License Agreement (Epizyme, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the execution, delivery and performance of this Agreement by such Party does will not constitute a default under nor conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement Convertible Promissory Note or to obtain Xxxx-Xxxxx-Xxxxxx HSR clearance; and
10.1.6 it has not employed (and, to the best of its knowledge without further duty of inquiryknowledge, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiryknowledge, use any contractor or consultant that employs; provided, that, such Party may reasonably rely on a representation made by such contractor or consultant) any individual or entity person debarred by the FDA (or subject to a similar sanction of EMEAEMEA or foreign equivalent), or, to the best of its knowledge without further duty of inquiry, or any individual who or entity person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMEA or foreign equivalent), in the conduct of the Preclinical Activities Pre-Clinical Studies or Clinical Studies of Collaboration Compounds and related Licensed Products and its activities under the Research each Program.
Appears in 3 contracts
Samples: Product Development and Commercialization Agreement (Regulus Therapeutics Inc.), Product Development and Commercialization Agreement (Regulus Therapeutics Inc.), Product Development and Commercialization Agreement (Isis Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 9.1.1 such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 9.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 9.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 9.1.4 the execution, delivery and performance of this Agreement by such Party does do not conflict with any agreementagreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation Law of any court, governmental body or administrative or other agency Governmental Authority having jurisdiction over such Party;
10.1.5 9.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewithAgreement, or for the performance by it of its obligations under this Agreement and such other agreements Agreement, except as may be required under necessary to conduct clinical studies, to transfer the Stock Purchase Agreement INDs and other Regulatory Documentation in accordance with Section 3.2 or to seek or obtain Xxxx-Xxxxx-Xxxxxx clearanceRegulatory Approvals; and
10.1.6 9.1.6 neither it has not employed (and, to the best nor any of its knowledge without further duty or its Affiliates’ employees or agents performing hereunder has ever been, or is currently: (a) debarred under 21 U.S.C. § 335a; (b) excluded, debarred, suspended, or otherwise ineligible to participate in Federal health care programs or in Federal procurement or non-procurement programs; (c) listed on the FDA’s Disqualified and Restricted Lists for clinical investigators; or (d) convicted of inquirya criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), has even if not used a contractor yet excluded, debarred, suspended, or consultant otherwise declared ineligible. If Licensee becomes aware that has employed) and in the future will not employ (or, to the best it or any of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual its Affiliates’ employees or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which agents performing hereunder is the subject of an FDA debarment any investigation or proceeding (that could lead to such Person becoming a debarred entity or similar proceeding of EMEA)individual, in an excluded entity or individual or a convicted entity or individual, Licensee shall immediately notify INFI, and INFI shall have the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under the Research Programright to immediately terminate this Agreement.
Appears in 2 contracts
Samples: License Agreement (MEI Pharma, Inc.), License Agreement (Infinity Pharmaceuticals, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreementagreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx HSR clearance; and
10.1.6 it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities any pre-clinical activities or Clinical Studies clinical studies of Collaboration Compounds and its activities under the Research ProgramCompounds.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Dynavax Technologies Corp), Research and Development Collaboration and License Agreement (Dynavax Technologies Corp)
Representations and Warranties of Both Parties. Each Party hereby represents represents, warrants, and warrants covenants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement stock purchase agreement or to obtain Xxxx-Xxxxx-Xxxxxx HSR clearance; and
10.1.6 it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities pre-clinical activities or Clinical Studies clinical studies of Collaboration Compounds and its activities under the Research ProgramCollaboration.
Appears in 2 contracts
Samples: Research and Development Collaboration, Option and License Agreement (Anacor Pharmaceuticals Inc), Research and Development Collaboration, Option and License Agreement (Anacor Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 12.1.1 such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 12.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 12.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 12.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreementagreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 12.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements agreements, except as may be required under the Stock Purchase Agreement to conduct Clinical Trials, to Manufacture Compounds or Products, or to seek or obtain Xxxx-Xxxxx-Xxxxxx clearanceRegulatory Approvals; and
10.1.6 12.1.6 Such Party is not debarred under the United States Federal Food, Drug and Cosmetic Act or comparable Applicable Laws and it has not employed (anddoes not, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not during the Term, employ (or, to or use the best services of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual person or entity debarred by that is debarred, in connection with the FDA (Development, Manufacture or subject to a similar sanction Commercialization of EMEA), or, to the best Products. If either Party becomes aware of its knowledge without further duty the debarment or threatened debarment of inquiry, any individual who person or entity which is providing services to such Party, including the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds Party itself and its Affiliates or Sublicensees, which directly or indirectly relate to activities under this Agreement, the Research Programother Party will be immediately notified in writing.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Akcea Therapeutics, Inc.), Collaboration and License Agreement (PTC Therapeutics, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the execution, delivery and performance of this Agreement by such Party, including without limitation the grant of rights to the other Party pursuant to this Agreement, does not not: (A) conflict with with, nor result in any violation of or default under, any agreement, instrument or understanding, oral or written, to which it or any Affiliate is a party or by which it or any Affiliate is bound, ; (B) conflict with any rights granted by such Party to any Third Party or breach any obligation that such Party has to any Third Party; nor (C) violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, effect is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceAgreement; and
10.1.6 it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities preclinical or Clinical Studies clinical studies of Collaboration Development Compounds and its activities under the Research Development Program.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement (Exelixis Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such (a) Such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such (b) Such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this (c) This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the (d) The execution, delivery and performance of this Agreement by such Party does not conflict with any agreementagreement or any provision thereof, or any instrument or understanding, oral or written, to which it or its Affiliates is a party or by which it is or its Affiliates are bound, nor violate any law Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such PartyParty or its Affiliates;
10.1.5 no (e) No government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required to (i) conduct clinical trials or to seek or obtain Regulatory Approvals of the IL-1 Products or patent extensions and (ii) under the Stock Purchase Agreement or HSR Act with respect to obtain Xxxx-Xxxxx-Xxxxxx clearanceNovartis’ exercise of the Exclusive Option; and
10.1.6 it has (f) It is not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor debarred or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred excluded from reimbursement by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, EMA or any individual who other Regulatory Authority) or entity which is the subject of an FDA debarment or exclusion investigation or proceeding (or similar proceeding of EMEAEMA or other Regulatory Authority), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under the Research Program.
Appears in 1 contract
Representations and Warranties of Both Parties. Each Party hereby represents represents, warrants, and warrants covenants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;; [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
10.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, license or exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx HSR clearance; and
10.1.6 it has not employed and in the future will not employ (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and employed or in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employsemploy) any individual or entity Person debarred by the FDA (or subject to a similar sanction of EMEAEMA or other regulatory agency), or, to the best of its knowledge without further duty of inquiry, any individual who or entity Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA or other regulatory agency), in the conduct of the Preclinical Activities nonclinical activities or Clinical Studies clinical studies of Collaboration Compounds and its activities under the Research ProgramCollaboration.
Appears in 1 contract
Samples: Research and Development Option and License Agreement (Anacor Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 8.1.1. such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 8.1.2. such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 8.1.3. this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, valid and binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 8.1.4. the execution, delivery and performance of this Agreement by such Party does will not constitute a default under or conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor or to the best of its knowledge and belief violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 8.1.5. to the best of its knowledge and belief, no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceagreements; and
10.1.6 8.1.6. it has not employed (and, to the best of its knowledge without further duty of inquiryand belief, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiryknowledge, use any contractor or consultant that employs, provided that such Party may reasonably rely on a representation made by such contractor or consultant) any individual or entity Person debarred by the FDA (or subject to a similar sanction of EMEAEMA or foreign equivalent), or, to the best of its knowledge without further duty of inquiry, or any individual who or entity Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA or foreign equivalent), in the conduct of the Preclinical Activities Pre-Clinical Studies or Clinical Studies of Collaboration Compounds a Product and its activities under the Research ProgramR&D Plans.
Appears in 1 contract
Samples: HTT Research, Development, Option and License Agreement (Isis Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 8.1.1. such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 8.1.2. such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 8.1.3. this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, valid and binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 8.1.4. the execution, delivery and performance of this Agreement by such Party does will not constitute a default under or conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor or violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 8.1.5. no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable lawsApplicable Laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceagreements; and
10.1.6 8.1.6. it has not employed (and, to the best of its knowledge without further duty of inquiryknowledge, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiryknowledge, use any contractor or consultant that employs, provided that such Party may reasonably rely on a representation made by such contractor or consultant) any individual or entity Person debarred by the FDA (or subject to a similar sanction of EMEAEMA or foreign equivalent), or, to the best of its knowledge without further duty of inquiry, or any individual who or entity Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA or foreign equivalent), in the conduct of the Preclinical Activities Pre-Clinical Studies or Clinical Studies of Collaboration Compounds the Product and its activities under the Research each Collaboration Program.
Appears in 1 contract
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, Party and constitutes a its legal, valid, valid and binding obligation, enforceable against it in accordance with the terms hereofhereof (subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, to judicial principles affecting the availability of specific performance and to general principles of equity, whether enforceability is considered a proceeding at law or equity);
10.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor bound or violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewiththe Stock Purchase Agreement, or for the performance by it of its obligations under this Agreement and such other agreements or the Stock Purchase Agreement, except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceAgreement; and
10.1.6 it has not employed (andnot, to the best of its knowledge and without further any duty of inquiry, has not employed or used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) employed any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA), ) or, to the best of its knowledge and without further any duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under as of the Research ProgramEffective Date.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement (Targacept Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreementagreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement to obtain HSR Clearance, to conduct Clinical Trials or to seek or obtain Xxxx-Xxxxx-Xxxxxx clearanceRegulatory Approvals; and
10.1.6 it has not (i) employed (and, to the best of its knowledge without further duty of inquiry, and has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEAEMA), or, to the best of its knowledge without further duty of inquiry, or (ii) employed any individual who or entity which that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA), in the conduct of the Preclinical Activities any pre-clinical activities or Clinical Studies clinical studies of Collaboration Compounds and its activities under the Research ProgramGenome Editing Technology.
Appears in 1 contract
Samples: Strategic Alliance and Option Agreement (Editas Medicine, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 7.1.1. such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 7.1.2. such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 7.1.3. this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, valid and binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 7.1.4. the execution, delivery and performance of this Agreement by such Party does will not constitute a default under or conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor or violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 7.1.5. no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceagreements; and
10.1.6 7.1.6. it has not employed (and, to the best of its knowledge without further duty of inquiryknowledge, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiryknowledge, use any contractor or consultant that employs, provided that such Party may reasonably rely on a representation made by such contractor or consultant) any individual or entity Person debarred by the FDA (or subject to a similar sanction of EMEAEMEA or foreign equivalent), or, to the best of its knowledge without further duty of inquiry, or any individual who or entity Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMEA or foreign equivalent), in the conduct of the Preclinical Activities Pre-Clinical Studies or Clinical Studies of Collaboration Compounds and related Licensed Products and its activities under the Research each Collaboration Program.
Appears in 1 contract
Samples: Research, Development and License Agreement (Isis Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with -76- the terms hereof;
10.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearance; and
10.1.6 it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under the Research Program.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 8.1.1. such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 8.1.2. such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 8.1.3. this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, valid and binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 8.1.4. the execution, delivery and performance of this Agreement by such Party does will not constitute a default under or conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor or violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 8.1.5. no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable lawsApplicable Laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceagreements; and
10.1.6 8.1.6. it has not employed (and, to the best of its knowledge without further duty of inquiryknowledge, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiryknowledge, use any contractor or consultant that employs, provided that such Party may reasonably rely on a representation made by such contractor or consultant) any individual or entity Person debarred by the FDA (or subject to a similar sanction of EMEAEMA or foreign equivalent), or, to the best of its knowledge without further duty of inquiry, or any individual who or entity Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA or foreign equivalent), in the conduct of the Preclinical Activities Studies or Clinical Studies of Collaboration Compounds the Products and its activities under the Research each Collaboration Program.
Appears in 1 contract
Samples: Research Collaboration, Option and License Agreement (Ionis Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 14.1.1 such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 14.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 14.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity);
10.1.4 14.1.4 the execution, delivery and performance of this Agreement by such Party does do not conflict with and do not violate: (a) such Party’s charter documents, bylaws or other organizational documents; (b) except as set forth on Schedule 14.1.4, in any agreementmaterial respect, any agreement or any provision or obligation thereof, or any instrument or understanding, oral or written, to which it is a party or by which it is bound; (c) any applicable Law; or (d) any order, nor violate any law writ, judgment, injunction decree, determination or regulation award of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 14.1.5 Except as set forth on Schedule 14.1.5, it is not under any obligation, contractual or otherwise, to any Person that, to its Knowledge, would materially impede the diligent and complete fulfillment of its obligations hereunder;
14.1.6 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations Laws currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements Agreement, except as may be required to obtain HSR Clearance, to conduct Clinical Trials, to conduct Manufacturing activities under the Stock Purchase Agreement this Agreement, or to seek or obtain Xxxx-Xxxxx-Xxxxxx clearanceRegulatory Approvals or Pricing Approvals; and
10.1.6 it has not employed (and, to the best 14.1.7 neither Party nor any of its knowledge without further duty Affiliates has been debarred or is subject to debarment and neither it nor any of inquiryits Affiliates will use in any capacity, in connection with the activities to be performed under this Agreement, any Person who has not used been debarred pursuant to Section 306 of the FFDCA or who is the subject of a contractor conviction described in such section. Each Party agrees to inform the other Party in writing promptly if it or consultant that has employed) and any such Person who is performing services hereunder is debarred or is the subject of a conviction described in the future will not employ (Section 306 or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its knowledge without further duty of inquiryor its Affiliates’ knowledge, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA)is threatened, or, relating to the best debarment or conviction of its knowledge without further duty of inquiry, it or any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under the Research Programsuch Person performing services hereunder.
Appears in 1 contract
Samples: Collaboration and Option Agreement (Voyager Therapeutics, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents represents, warrants, and warrants covenants to the other Party, as of the Effective Date, that:
10.1.1 8.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 8.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 8.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 8.1.4 the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 8.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Merger Agreement or to obtain Xxxx-Xxxxx-Xxxxxx HSR clearance; and
10.1.6 8.1.6 to the best of its knowledge, it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEAEMA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment * Confidential treatment requested. investigation or proceeding (or similar proceeding of EMEAEMA), in the conduct of the Preclinical Activities pre-clinical activities or Clinical Studies clinical trials of Collaboration Compounds and its activities under the Research ProgramProduct.
Appears in 1 contract
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 (a) such Party is duly organized, validly existing and in good standing under the laws Applicable Law of the jurisdiction of its incorporation formation and has full corporate power and authority to enter into this Agreement Agreement, and to carry out the provisions hereof;
10.1.2 (b) such Party has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 (c) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with its terms, except to the terms hereofextent that enforcement of the rights and remedies created hereby is subject to (i) bankruptcy, insolvency, reorganization, moratorium and other similar laws of general application affecting the rights and remedies of creditors, or (ii) laws governing specific performance, injunctive relief and other equitable remedies;
10.1.4 (d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreementagreement or any provision thereof, or any instrument or understanding, oral or written, to which it such Party (or any of its Affiliates) is a party or by which it such Party (or any of its Affiliates) is bound, nor violate any law or regulation Applicable Law of any court, governmental body or administrative or other agency Governmental Authority having jurisdiction over such PartyParty (or any of its Affiliates);
10.1.5 (e) except as set forth in Section 2.1.1(g), no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations Applicable Law currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewithAgreement, or for the performance by it of its obligations under this Agreement and such other agreements Agreement, except as may be required under the Stock Purchase Agreement to conduct Clinical Trials or to seek or obtain Xxxx-Xxxxx-Xxxxxx clearanceRegulatory Approvals or applicable Regulatory Materials; and
10.1.6 (f) except as set forth in Section 2.1.1(g), it has not employed (andobtained all necessary authorizations, consents and approvals of any Third Party that is required to be obtained by it as of the best Effective Date for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its knowledge without further duty of inquiryobligations under this Agreement, has not used a contractor except as may be required to conduct Clinical Trials or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor seek or consultant that employs) any individual obtain Regulatory Approvals or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under the Research Programapplicable Regulatory Materials.
Appears in 1 contract
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
10.1.1 such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;
10.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
10.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof;
10.1.4 the execution, delivery and performance of this Agreement by such Party, including without limitation the grant of rights to the other Party pursuant to this Agreement, does not not: (A) conflict with with, nor result in any violation of or default under, any agreement, instrument or understanding, oral or written, to which it or any Affiliate is a party or by which it or any Affiliate is bound, ; (B) conflict with any rights granted by such Party to any Third Party or breach any obligation that such Party has to any Third Party; nor (C) violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
10.1.5 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable laws, rules or regulations currently in effect, effect is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other agreements except as may be required under the Stock Purchase Agreement or to obtain Xxxx-Xxxxx-Xxxxxx clearanceAgreement; and
10.1.6 it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) and in the future will not employ (or, to the best of its knowledge without further duty of inquiry, use any contractor or consultant that employs) any individual or entity debarred by the FDA (or subject to a similar sanction of EMEA), or, to the best of its knowledge without further duty of inquiry, any individual who or entity which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of the Preclinical Activities or Clinical Studies of Collaboration Compounds and its activities under the Research Program.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement (Exelixis, Inc.)