Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that: (a) 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; (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; (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; (d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement 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; (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 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; and (f) 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) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compounds.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Prosensa Holding B.V.), Research and Development Collaboration and License Agreement (Prosensa Holding B.V.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(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 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 agreementsAgreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement; and
(f) 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 obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of CompoundsMaster Collaboration Agreement.
Appears in 2 contracts
Samples: Master Collaboration Agreement (Prothena Corp PLC), Master Collaboration Agreement (Prothena Corp PLC)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) 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;
(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;
(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, subject to bankruptcy, insolvency, reorganization, arrangement, winding-up, moratorium, and similar laws of general application affecting the enforcement of creditors’ rights generally, and subject to general equitable principles, including the fact that the availability of equitable remedies, such as injunctive relief or specific performance, is in the discretion of the court;
(d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or binding understanding, oral or written, to which it is a Party party or by which it is bound, nor to the best of its knowledge violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;; and
(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; and
(f) it has not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor conduct Clinical Trials or consultant that has employed) any individual to seek 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compoundsobtain Marketing Authorizations.
Appears in 2 contracts
Samples: Assignment, Sublicense and Collaboration Agreement (Merrimack Pharmaceuticals Inc), Assignment, Sublicense and Collaboration Agreement (Merrimack Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(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 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(including, in the case of Prothena, the grant of the rights to Celgene hereunder, including the Options), except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2; and
(f) 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 inquiry, has not used a contractor or consultant that has employed) any individual or entity debarred by the FDA obligations under this Agreement (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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA)including, in the case of Prothena, the grant of the rights to Celgene hereunder, including the Options), except (i) as may be required to conduct of any pre-clinical activities Clinical Trials or clinical studies of Compoundsto seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2.
Appears in 2 contracts
Samples: Master Collaboration Agreement (Prothena Corp PLC), Master Collaboration Agreement (Prothena Corp PLC)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) 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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement 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;
(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 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; and
(f) 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) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA), in the conduct of any pre-clinical activities or clinical studies of CompoundsVectors.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Orchard Rx LTD), Research and Development Collaboration and License Agreement (Orchard Rx LTD)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) 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;
(b) 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;
(c) 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;
(d) the The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a Party party or by which it is bound, nor violate any law applicable Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party;
(e) no 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 agreementsagreements except as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals; and
(f) To its knowledge, 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 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, (ii) employed any individual who or entity that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA), in the conduct of any pre-clinical activities or clinical studies of Compounds.
Appears in 2 contracts
Samples: Collaboration and License Agreement (Epizyme, Inc.), 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 DateDate of this Agreement or any Development & Commercialization Agreement, as applicable, that:
(a) such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation formation and has full corporate power and authority to enter into this Agreement or the applicable Development & Commercialization Agreement and to carry out the provisions hereofhereof or thereof, as applicable;
(b) such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement or the applicable Development & Commercialization Agreement and the performance of its obligations hereunderhereunder or thereunder, as applicable;
(c) this Agreement or the applicable Development & Commercialization 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 hereofhereof or thereof, as applicable;
(d) the execution, delivery and performance of this Agreement or the applicable Development & Commercialization Agreement by such Party does not conflict with or result in a breach of or default of any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a Party 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;; and
(e) subject to Section 3.2, 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; and
(f) it has not employed (and, agreements except as may be required to the best of its knowledge without further duty of inquiry, has not used a contractor conduct Clinical Trials or consultant that has employed) any individual to seek or entity debarred by the FDA (obtain Regulatory Approvals 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compoundsapplicable Regulatory Materials.
Appears in 2 contracts
Samples: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) such Party is duly organized, validly existing and in good standing under the laws Applicable 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;
(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;
(c) 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, except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity;
(d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereofmaterial agreement, or any instrument or understanding, oral or written, to which it is a Party 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;
(e) neither Party nor any of its Affiliates is under any material obligation to any Person, contractual or otherwise, that would reasonably be expected to materially impede the fulfillment of such Party’s obligations hereunder; and
(f) except as otherwise provided herein, no government authorization, consent, approvalApproval, 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 Laws currently in effect, is or will be necessary for, or in connection with, for 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; and
(f) 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) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compounds.
Appears in 1 contract
Samples: Exclusive License Agreement (SELLAS Life Sciences Group, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) 10.1.1 such Party is duly organizedincorporated, 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;
(b) 10.1.2 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;
(c) 10.1.3 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, subject to (i) the effect of applicable bankruptcy, insolvency, reorganization, moratorium or other similar Federal or state laws affecting the rights of creditors and (ii) the effect or availability of rules of law governing specific performance, injunctive relief or other equitable remedies (regardless of whether any such remedy is considered in a proceeding at law or in equity);
(d) 10.1.4 the executionexecution and delivery of this Agreement by such Party do not, delivery and the performance of this Agreement by such Party, including without limitation the grant of rights to the other Party does not pursuant to this Agreement, will not: (A) conflict with any agreement or any provision thereofwith, or 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 party or by which it or any Affiliate is bound, nor ; (B) conflict with any rights granted by such Party to any other Third Party or breach any obligation that such Party has to any Third Party; or (C) violate any law provision of law, statute, rule or regulation regulation, or any ruling, right, injunction, order, judgment or decree of any court, administrative agency or other governmental body or administrative or other agency having jurisdiction over such Party;; and
(e) 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; and
(f) it has not employed (and, to agreements except as may be required under the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of CompoundsStock Purchase Agreement.
Appears in 1 contract
Samples: Product Development and Commercialization Agreement (Pharmacopeia Drug Discovery Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(e) no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 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 agreementsAgreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement; and
(f) 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 obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of CompoundsMaster Collaboration Agreement.
Appears in 1 contract
Samples: Master Collaboration Agreement
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(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;
(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;
(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 hereof;extent 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; [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(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 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 agreementsAgreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement; and
(f) 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 obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of CompoundsMaster Collaboration Agreement.
Appears in 1 contract
Samples: Master Collaboration Agreement
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) 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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a Party 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;
(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 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; and
(f) 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) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEAEMA), in the conduct of any pre-clinical activities or clinical studies of Compounds.
Appears in 1 contract
Samples: Collaboration and License Agreement (Forma Therapeutics Holdings, Inc.,)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, any License Agreement Effective Date, any Co-Co Effective Date and the [***]SM Effective Date, as applicable, that:
(a) such Party is duly organized, validly existing and in good standing under the laws Laws of the jurisdiction of its incorporation formation and has full corporate power and authority to enter into this Agreement or the applicable Development & Commercialization Agreement or the [***]SM Agreement, as applicable, and to carry out the provisions hereofhereof or thereof, as applicable;
(b) such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement or the applicable Development & Commercialization Agreement or the [***]SM Agreement, as applicable, and the performance of its obligations hereunderhereunder or thereunder, as applicable;
(c) this Agreement or the applicable Development & Commercialization Agreement or the [***]SM Agreement, as applicable, 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 hereofhereof or thereof, as applicable;
(d) the execution, delivery and performance of this Agreement or the applicable Development & Commercialization Agreement or the [***]SM Agreement, as applicable, by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a Party 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;; and
(e) except for any HSR Filings that may be required under the HSR Act as addressed in Section 3.2.2, 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; and
(f) it has not employed (and, agreements except as may be required to the best of its knowledge without further duty of inquiry, has not used a contractor conduct Clinical Trials or consultant that has employed) any individual to seek or entity debarred by the FDA (obtain Regulatory Approvals 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compoundsapplicable Regulatory Materials.
Appears in 1 contract
Samples: Master Research and Collaboration Agreement (OncoMed Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) such 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;
(b) 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;
(c) 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;
(d) the The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a Party 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;; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(e) no 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 agreementsagreements except as may be required to conduct clinical trials or to seek or obtain Regulatory Approvals of the Products; and
(f) it has 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) any individual or entity debarred excluded from reimbursement by the FDA (or subject to a similar sanction of EMEAEMA or any other Regulatory Authority) or subject of an FDA debarment or exclusion investigation or proceeding (or similar proceeding of EMA or other Regulatory Authority). To its knowledge, it has not (i) employed and has not used a contractor or consultant that has employed, any individual or entity debarred or excluded from reimbursement by the FDA (or subject to a similar sanction of EMA or any other Regulatory Authority), or, to the best of its knowledge without further duty of inquiry, (ii) employed any individual who or entity that is the subject of an FDA debarment or exclusion investigation or proceeding (or similar proceeding of EMEAEMA or other Regulatory Authority), in each case in the conduct of any pre-clinical activities or clinical studies Development of Compoundsthe Products.
Appears in 1 contract
Samples: License Agreement (XOMA Corp)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(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;
(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;
(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 hereof;extent 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; [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(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 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(including, in the case of Prothena, the grant of the rights to Celgene hereunder, including the Options), except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2; and
(f) 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 inquiry, has not used a contractor or consultant that has employed) any individual or entity debarred by the FDA obligations under this Agreement (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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA)including, in the case of Prothena, the grant of the rights to Celgene hereunder, including the Options), except (i) as may be required to conduct of any pre-clinical activities Clinical Trials or clinical studies of Compoundsto seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2.
Appears in 1 contract
Samples: Master Collaboration Agreement
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) such Such Party is duly organized, organized and 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;
(b) such Such Party has taken all corporate action necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunderunder this Agreement and has full power and authority to enter into this Agreement and perform its obligations under this Agreement;
(c) this This Agreement has been duly executed by such Party and delivered on behalf assuming due authorization, execution and delivery by the other Party, constitutes a valid and legally binding obligation of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with its terms, subject to and limited by: (i) applicable bankruptcy, insolvency, reorganization, moratorium, and other laws generally applicable to creditors’ rights; and (ii) judicial discretion in the terms hereofavailability of equitable relief;
(d) Such Party is not required to obtain, the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement 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;
(e) no government authorization, consent, approval, licenseorder, exemption or authorization of any Third Party, or is not required to complete any registration, qualification, designation, declaration or filing or registration with with, any court or governmental departmentregulatory authority, 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, with the transaction contemplated by execution and delivery of this Agreement or any other agreement or instrument executed in connection herewith, or for and the performance by it such Party of its obligations under this Agreement and such Agreement, including any grant of rights to the other agreementsParties pursuant to this Agreement; and
(e) The execution and delivery of this Agreement, and the performance by such Party of its obligations under this Agreement, including the grant of rights to the other Party pursuant to this Agreement, does not and will not: (i) conflict with, nor result in any violation of or default under any such instrument, judgment, order, writ, decree, contract or provision to which such Party is otherwise bound; (ii) give rise to any lien, charge or encumbrance upon any assets of such Party or the suspension, revocation, impairment, forfeiture or non-renewal of any material permit, license, authorization, or approval that applies to such Party, its business or operations or any of its assets or properties, except any or all of which could not reasonably be expected to have a material adverse effect on its ability to perform its obligations under this Agreement or on the rights of the other Party under this Agreement; or (iii) conflict with any rights granted by such Party to any Third Party or breach any obligation that such Party has to any Third Party.
(f) it has No representation or warranty made by a Party in this Agreement or the Other Agreements, nor any statement or record contained in any schedule or exhibit hereto or thereto furnished by a Party, contains any untrue statement of a material fact or omits any material fact necessary to make the statements contained herein or therein not employed (and, to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compoundsmisleading.
Appears in 1 contract
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective DateDate (and, for clarity, as of the effective date of each Licensed Program Addendum, as applicable, as though made then), that:
(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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(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 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 agreementsAgreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.5 of the Master Collaboration Agreement; and
(f) it has not employed obtained all necessary authorizations, consents and approvals of any Third Party that is required to be obtained by it as of the Effective Date (andor, to for clarity, the best effective date of such Licensed Program Addendum, as applicable), for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its knowledge without further duty obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.5 of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of CompoundsMaster Collaboration Agreement.
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:
(a) such Party is duly organized, validly existing and in good standing under the laws 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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a Party party or by which it 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 Party;
(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 Applicable Law currently in effect, is or will be necessary for, or in connection with, for the transaction consummation of the transactions 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(including, in the case of SR, the grant of the rights to Gilead hereunder, including the Options); and
(f) it has not employed (andobtained all necessary authorizations, to the best consents and approvals of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) 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 other Person that is required to be obtained by it as of the subject of an FDA debarment investigation or proceeding Effective Date in connection with, the transaction contemplated by this Agreement (or similar proceeding of EMEA)including, in the conduct case of any pre-clinical activities or clinical studies SR, the grant of Compoundsthe rights to Gilead hereunder, including the Options).
Appears in 1 contract
Samples: Master Collaboration Agreement (Scholar Rock Holding Corp)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) such 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;
(b) 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;
(c) 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;; [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) the The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it or its Affiliates is a Party 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;
(e) no 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 agreementsagreements except as may be required to conduct clinical trials or to seek or obtain Regulatory Approvals of the Products or patent term extensions; and
(f) it has 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) any individual or entity debarred excluded from reimbursement by the FDA (or subject to a similar sanction of EMEAEMA or any other Regulatory Authority) or subject of an FDA debarment or exclusion investigation or proceeding (or similar proceeding of EMA or other Regulatory Authority). To its knowledge, it has not (i) employed and has not used a contractor or consultant that has employed, any individual or entity debarred or excluded from reimbursement by the FDA (or subject to a similar sanction of EMA or any other Regulatory Authority), or, to the best of its knowledge without further duty of inquiry, or (ii) employed any individual who or entity that is the subject of an FDA debarment or exclusion investigation or proceeding (or similar proceeding of EMEAEMA or other Regulatory Authority), in each case in the conduct of any pre-clinical activities or clinical studies Development of CompoundsProducts.
Appears in 1 contract
Samples: License Agreement (XOMA Corp)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(e) no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. 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 agreementsAgreement, except (i) as may be required to conduct Development or Commercialization activities, including conducting Clinical Trials, seeking, obtaining, or maintaining Regulatory Approvals or applicable Regulatory Materials, or Manufacturing or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement; and
(f) 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 obligations under this Agreement, except (i) as may be required to conduct Development or Commercialization activities, including conducting Clinical Trials, seeking, obtaining, or maintaining Regulatory Approvals or applicable Regulatory Materials, or Manufacturing or (ii) as set forth in Section 3.2 of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of CompoundsMaster Collaboration Agreement.
Appears in 1 contract
Samples: Global License Agreement (Prothena Corp Public LTD Co)
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:
(a) : such Party is duly organized, validly existing and in good standing under the laws Applicable 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;
(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;
(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;
(d) , except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity. the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereofmaterial agreement, or any instrument or understanding, oral or written, to which it is a Party 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;
(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 Applicable Laws currently in effect, is or will be necessary for, or in connection with, for 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. Such Party shall perform its activities pursuant to this Agreement in material compliance with Applicable Laws, including any and such all Applicable Laws related to anti-bribery and anti-corruption. Each Party shall notify the other agreements; and
(f) Party in writing promptly in the event that it has not employed (and, to actual knowledge of the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct material breach of any pre-clinical activities covenant under Section 12.1 or clinical studies the material breach of Compoundsany representation or warranty provided by either Party under Sections 12.1, 12.2 or 12.3.
Appears in 1 contract
Samples: Exclusive Patent License Agreement (NPS Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party of Endorecherche and Schering hereby represents represents, warrants and warrants covenants to the other Party, party as of the Effective Date, thatAddendum Date as follows:
(ai) such Party it is a corporation duly organized, organized and validly existing and in good standing under the laws of the state or other jurisdiction of its incorporation and or formation;
(ii) it has full corporate the power and authority to enter into execute and deliver this Agreement Addendum and to carry out the provisions hereof;
(b) such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of perform its obligations hereunder;
(ciii) the execution, delivery and performance by such party of this Agreement has been duly executed Addendum and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance its compliance with the terms hereofand provisions hereof does not conflict with or result in a breach of any of the terms and provisions of, or constitute a default under: (1) a loan agreement, guaranty, financing agreement, agreement affecting a product, or other agreement or instrument binding or affecting it or its property; (2) the provisions of its charter documents or bylaws (as applicable); or (3) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;
(div) it does not have in effect, and during the term of this Addendum shall not enter into, any oral or written agreement or arrangement that would be inconsistent with its obligations under this Addendum;
(v) the execution, delivery and performance of this Agreement Addendum by such Party party does not conflict with any agreement 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;
(e) no government authorization, require the consent, approval, licenseor authorization of, exemption of or notice, declaration, 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, any governmental or regulatory authority, and the transaction contemplated by execution, delivery or performance of this Agreement Addendum will not violate any law, rule or any other agreement or instrument executed in connection herewithregulation applicable to such party;
(vi) the execution, or for the delivery and performance of this Addendum by it has been duly authorized by all requisite corporate action and constitutes such party’s legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of its obligations general applicability relating to or affecting creditors’ rights and to the availability of particular remedies under this Agreement and such other agreementsgeneral equity principles; and
(fvii) it has not employed (andshall comply with all applicable material laws, rules and regulations relating to the best of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compoundsunder this Addendum.
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:
(a) such Party is duly organized, validly existing and in good standing under the laws Applicable 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;
(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;
(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, except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity;
(d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereofmaterial agreement, or any instrument or understanding, oral or written, to which it is a Party CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***]”, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. 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;; and
(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 Applicable Laws currently in effect, is or will be necessary for, or in connection with, for 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; and
(f) 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) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of Compounds.
Appears in 1 contract
Samples: Exclusive License Agreement (EyePoint Pharmaceuticals, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a) such Party is duly organized, validly existing and in good standing under the laws 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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which it is a Party party or by which it 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 Party;
(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 Applicable Law currently in effect, is or will be necessary for, or in connection with, for the transaction consummation of the transactions 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 (including, in the case of Relay, the grant of the rights to Licensee hereunder), except for any filing required under Antitrust Laws;
(f) that no consideration received by such other agreementsParty under this Agreement is intended by such Party to be a prohibited payment for the recommending or arranging for the referral of business or ordering of products or services, nor is any such consideration intended by such Party to induce illegal referrals of business under Applicable Law; and
(fg) it has not employed (andobtained all necessary authorizations, to the best consents and approvals of its knowledge without further duty of inquiry, has not used a contractor or consultant that has employed) 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 other Person that is required to be obtained by it as of the subject of an FDA debarment investigation or proceeding Effective Date in connection with, the transaction contemplated by this Agreement (or similar proceeding of EMEA)including, in the conduct case of any pre-clinical activities or clinical studies Relay, the grant of Compoundsthe rights to Licensee hereunder).
Appears in 1 contract
Samples: Collaboration and License Agreement (Relay Therapeutics, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(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;
(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;
(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;
(d) the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement 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 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);
(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 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 agreementsAgreement, except (i) as may be required to conduct Development or Commercialization activities, including conducting Clinical Trials, seeking, obtaining or maintaining Regulatory Approvals or applicable Regulatory Materials, or Manufacturing or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement; and
(f) 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 obligations under this Agreement, except (i) as may be required to conduct Development or Commercialization activities, including conducting Clinical Trials, seeking, obtaining or maintaining Regulatory Approvals or applicable Regulatory Materials, or Manufacturing or (ii) as set forth in Section 3.2 of inquiry, has not used a contractor or consultant that has employed) 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 that is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMEA), in the conduct of any pre-clinical activities or clinical studies of CompoundsMaster Collaboration Agreement.
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Samples: u.s. License Agreement (Prothena Corp Public LTD Co)