Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that: 9.1.1 Such Party is duly organized, validly existing and in good standing under the 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. 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. 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, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity. 9.1.4 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 such Party or its Affiliates is a party or by which such Party or its Affiliates is bound (including, with respect to MedImmune, any In-License Agreement), nor violate any Applicable Law. 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 Law currently in effect, is or will be necessary for, or in connection with, the transactions contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except as necessary to conduct clinical trials or to seek or obtain Regulatory Approvals.
Appears in 3 contracts
Sources: License and Option Agreement (Celldex Therapeutics, Inc.), License and Option Agreement (Kolltan Pharmaceuticals Inc), License and Option Agreement (Kolltan Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
9.1.1 Such 8.1.1. such Party is duly organized, validly existing and in good standing under the 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.;
9.1.2 Such 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.;
9.1.3 This 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, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and rights, judicial principles affecting the availability of specific performance and general principles of equity, equity (whether enforceability is considered a proceeding at law or equity.);
9.1.4 The 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 or any provision thereofagreement, or any instrument instrument, obligation or understanding, oral or written, to which such Party or its Affiliates either entity is a party or by which either entity is bound, or violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it; and
8.1.5. such Party has obtained all necessary consents, approvals and authorizations of all Governmental Authorities and other Persons or its Affiliates is bound (including, with respect entities required to MedImmune, any In-License Agreement), nor violate any Applicable Law.
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 Law currently in effect, is or will be necessary for, or obtained by it in connection with, with the transactions contemplated by execution and delivery of this Agreement, or for the performance by it of its obligations under this Agreement, except as necessary to conduct clinical trials or to seek or obtain Regulatory Approvals.
Appears in 3 contracts
Sources: License Agreement (Coya Therapeutics, Inc.), License Agreement (Coya Therapeutics, Inc.), Licensing Agreement
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other PartyParty that, as of the Effective Date, that:
9.1.1 (a) Such Party is duly organized, organized and validly existing and in good standing under the Applicable 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.;
9.1.2 (b) 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 hereunder.under this Agreement;
9.1.3 (c) This Agreement has been duly executed is a legal and delivered on behalf valid obligation of such Party, binding upon such Party and constitutes a legal, valid, binding obligation, enforceable against it such Party in accordance with the terms hereof, subject of this Agreement except as such enforceability may be affected by laws affecting creditors’ rights generally and [***] 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 effects of bankruptcy, insolvency or other laws of omitted portions. general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
9.1.4 equitable principles. The execution, delivery and performance of this Agreement by such Party does do not and shall not conflict with any agreement or any provision thereofagreement, or any instrument or understanding, oral or written, to which such Party or its Affiliates is a party or by which such Party may be bound, or its Affiliates is bound (including, with respect to MedImmune, any In-License Agreement), nor violate any Applicable Law.law or regulation of any court, governmental body or administrative or other agency having authority over such Party. All consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with the execution, delivery and performance of this Agreement have been obtained;
9.1.5 (d) Such Party has sufficient facilities, experienced personnel and other capabilities to enable it to perform its obligations under this Agreement; 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 Law currently in effect, is Person has or will be necessary forhave, or in connection with, as a result of the transactions contemplated by this Agreement, any right, interest or valid claim against or upon such Party for the performance any commission, fee or other compensation as a finder or broker because of any act by it such Party or of its obligations under this Agreement, except as necessary to conduct clinical trials or to seek or obtain Regulatory Approvalsany agent of such Party.
Appears in 2 contracts
Sources: License and Research Collaboration Agreement (Selecta Biosciences Inc), License and Research Collaboration Agreement (Selecta Biosciences Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
9.1.1 11.1.1 Such Party is duly organized, validly existing and in good standing under the 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.
9.1.2 11.1.2 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.
9.1.3 11.1.3 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 and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
9.1.4 11.1.4 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 such Party or its Affiliates it is a party or by which such Party or its Affiliates it is bound (including, with respect to MedImmune, any In-License Agreement)bound, nor violate any Applicable applicable Law.
9.1.5 11.1.5 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 Law applicable Laws currently in effect, is or will be necessary for, or in connection with, the transactions contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except as necessary to conduct clinical trials or to seek or obtain Regulatory ApprovalsApprovals or as may be required under the HSR Act.
Appears in 2 contracts
Sources: License Agreement (Macrogenics Inc), License Agreement (Macrogenics Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
9.1.1 Such (a) such Party is duly organized, validly existing and in good standing under the 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.;
9.1.2 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.;
9.1.3 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, subject to the effects of bankruptcy, insolvency or other insolvency, reorganization, arrangement, winding-up, moratorium, and similar laws of general application affecting the enforcement of creditor creditors’ rights generally, and judicial principles affecting subject to general equitable principles, including the fact that the availability of equitable remedies, such as injunctive relief or specific performance and general principles performance, is in the discretion of equity, whether enforceability is considered a proceeding at law or equity.the court;
9.1.4 The (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 such Party or its Affiliates it is a party or by which such Party or its Affiliates it is bound (including, with respect to MedImmune, any In-License Agreement)bound, nor to the best of its knowledge violate any Applicable Law.law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; and
9.1.5 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 Law applicable Laws currently in effect, is or will be necessary for, or in connection with, the transactions transaction contemplated by this AgreementAgreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this AgreementAgreement and such other agreements, except as necessary to conduct clinical trials Clinical Trials or to seek or obtain Regulatory ApprovalsMarketing Authorizations.
Appears in 2 contracts
Sources: 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:
9.1.1 Such 10.1.1 such Party is duly organized, validly existing and in good standing under the 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.;
9.1.2 Such 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.;
9.1.3 This 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 ;
10.1.4 the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
9.1.4 The execution, delivery and performance of this Agreement by such Party does not conflict with any agreement or any provision thereofagreement, or any instrument or understanding, oral or written, to which such Party or its Affiliates it is a party or by which such Party or its Affiliates it is bound (including, with respect to MedImmune, any In-License Agreement)bound, nor violate any Applicable Law.Laws of any Government Authority having jurisdiction over such Party; and
9.1.5 No government authorization, consent, approval, license10.1.5 no Regulatory Approvals, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreignGovernment Authority, under any Applicable Law Laws currently in effect, is or will shall be necessary for, or in connection with, the transactions transaction contemplated by this AgreementAgreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement, except as necessary to conduct clinical trials or to seek or obtain Regulatory Approvals.
Appears in 1 contract
Sources: Collaboration and License Agreement (Rexahn Pharmaceuticals, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants as of both the Execution Date and the Effective Date to the other Party, as of the Effective Date, Party that:
9.1.1 Such Party is duly organized, validly existing and in good standing under 9.1.1. it has the Applicable Laws of the jurisdiction of its incorporation and has full corporate power and authority and the legal right to enter into this Agreement and to carry out the provisions hereof.
9.1.2 Such Party perform its obligations hereunder, and that it has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.;
9.1.3 This 9.1.2. this Agreement has been duly executed and delivered on behalf of such Party, Party and constitutes a legal, valid, valid and binding obligation, obligation of such Party and is enforceable against it in accordance with the its terms hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.;
9.1.4 The execution9.1.3. all necessary consents, approvals and authorizations of all Regulatory Authorities and other parties required to be obtained by such Party in connection with the execution and delivery and performance of this Agreement by and the performance of its obligations hereunder have been obtained;
9.1.4. the execution and delivery of this Agreement and the performance of such Party does Party’s obligations hereunder (a) do not conflict with or violate any agreement requirement of Applicable Law or any provision thereofof the certificate of incorporation, bylaws or any similar instrument of such Party, as applicable, in any material way, and (b) do not conflict with, violate, or breach or constitute a default or require any instrument consent not already obtained under, any contractual obligation or understanding, oral court or written, to which such Party or its Affiliates is a party or administrative order by which such Party is bound; and
9.1.5. all employees, consultants, or its (sub)contractors (except academic collaborators or Third Parties under material transfer agreements) of such Party or Affiliates is bound (including, with respect to MedImmune, any In-License Agreement), nor violate any Applicable Law.
9.1.5 No government authorization, consent, approval, license, exemption performing development activities hereunder on behalf of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Law currently in effect, is or such Party will be necessary forobligated to assign all right, title and interest in and to any inventions developed by them, whether or in connection withnot patentable, to such Party or Affiliate, respectively, as the transactions contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except as necessary to conduct clinical trials or to seek or obtain Regulatory Approvalssole owner thereof.
Appears in 1 contract
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Collaboration Effective Date, that:
9.1.1 Such (a) such Party is duly organized, validly existing and in good standing under the Applicable 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.;
9.1.2 Such (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.;
9.1.3 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 its terms, except to the terms hereof, extent that enforcement of the rights and remedies created hereby is subject to the effects of (i) bankruptcy, insolvency or insolvency, reorganization, moratorium and other similar laws of general application affecting the enforcement of creditor rights and judicial principles affecting remedies of creditors, or (ii) laws governing specific performance, injunctive relief and other equitable remedies;
(d) the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
9.1.4 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 such Party (or any of its Affiliates Affiliates) is a party or by which such Party (or any of its Affiliates Affiliates) is bound (including, with respect to MedImmune, any In-License Agreement)bound, nor violate any Applicable Law.Law of any Governmental Authority having jurisdiction over such Party; and
9.1.5 No government authorization(e) it has obtained all necessary consents, consentapprovals and authorizations of all Governmental Authorities and any other Person required to be obtained by it as of the Collaboration Effective Date, approvalas applicable, 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 Law currently in effect, is or will be necessary for, or in connection withwith the execution, the transactions contemplated by this Agreement, or for the delivery and performance by it of its obligations under this Agreement, except (i) as necessary may be required to conduct clinical trials Clinical Trials or to seek or obtain Regulatory ApprovalsApprovals or applicable Regulatory Materials, or (ii) as set forth in Section 4.4.
Appears in 1 contract
Sources: Master Collaboration Agreement (Ikena Oncology, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
9.1.1 Such (a) such Party is duly organized, validly existing and in good standing under the 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.;
9.1.2 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.;
9.1.3 This (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, subject to the effects of except as enforcement may be affected by bankruptcy, insolvency or other similar laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and by general principles of equity, whether enforceability is considered a proceeding at law or equity.;
9.1.4 The (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 such Party or its Affiliates it is a party or by which such Party or its Affiliates it is bound (including, with respect to MedImmune, any In-License Agreement)bound, nor violate any Applicable Law.law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; and
9.1.5 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 Law Laws currently in effect, is or will be necessary for, or in connection with, for the transactions transaction contemplated by this Agreement, Agreement or for the performance by it of its obligations under this Agreement, except as necessary to conduct clinical trials any other agreement or to seek or obtain Regulatory Approvalsinstrument executed in connection herewith.
Appears in 1 contract
Sources: Exclusive License Agreement (Rexahn Pharmaceuticals, Inc.)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
9.1.1 Such (a) such Party is duly organized, validly existing and in good standing under the Applicable Laws 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.;
9.1.2 Such (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.;
9.1.3 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 its terms, except to the terms hereof, extent that enforcement of the rights and remedies created hereby is subject to the effects of (i) bankruptcy, insolvency or insolvency, reorganization, moratorium and other similar laws of general application affecting the enforcement of creditor rights and judicial principles affecting remedies of creditors, or (ii) laws governing specific performance, injunctive relief and other equitable remedies;
(d) the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.
9.1.4 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 such Party (or any of its Affiliates Affiliates) is a party or by which such Party (or any of its Affiliates Affiliates) is bound (including, with respect to MedImmune, any In-License Agreement)bound, nor violate any Applicable Law.Law of any Governmental Authority having jurisdiction over such Party (or any of its Affiliates);
9.1.5 No (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 Law currently in effect, is or will be necessary for, or in connection with, the transactions transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except as necessary may be required to conduct clinical trials Clinical Trials or to seek or obtain Regulatory ApprovalsApprovals or applicable Regulatory Materials; and
(f) except as set forth in Section 2.1.1(g), it has obtained all necessary authorizations, consents and approvals of any Third Party that is required to be obtained by it as of the Effective Date for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials.
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:
9.1.1 Such : such Party is duly organized, validly existing and in good standing under the 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.
9.1.2 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.
9.1.3 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, subject to the effects of except as enforcement may be affected by bankruptcy, insolvency or other similar laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and by general principles of equity, whether enforceability is considered a proceeding at law or equity.
9.1.4 The . 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 such Party or its Affiliates it is a party or by which such Party or its Affiliates it is bound (including, with respect to MedImmune, any In-License Agreement)bound, nor violate any Applicable Law.
9.1.5 No law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party. 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 Law Laws currently in effect, is or will be necessary for, or in connection with, for the transactions transaction contemplated by this AgreementAgreement 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, except as necessary including any and all Applicable Laws related to conduct clinical trials anti-bribery and anti-corruption. Each Party shall notify the other Party in writing promptly in the event that it has actual knowledge of the material breach of any covenant under Section 12.1 or to seek the material breach of any representation or obtain Regulatory Approvalswarranty provided by either Party under Sections 12.1, 12.2 or 12.3.
Appears in 1 contract
Sources: Exclusive Patent License Agreement (NPS Pharmaceuticals Inc)
Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
9.1.1 (a) Such Party is duly organized, validly existing and in good standing under the Applicable 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.;
9.1.2 (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.;
9.1.3 (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 the terms hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity.;
9.1.4 (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 such Party it or its Affiliates is a party or by which it or its Affiliates are bound, nor violate any Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party or its Affiliates is bound Affiliates;
(including, with respect to MedImmune, any In-License Agreement), nor violate any Applicable Law.
9.1.5 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 Law applicable Laws currently in effect, is or will be necessary for, or in connection with, the transactions transaction contemplated by this AgreementAgreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement, Agreement and such other agreements except as necessary may be required to (i) conduct clinical trials or to seek or obtain Regulatory ApprovalsApprovals of the IL-1 Products or patent extensions and (ii) under the HSR Act with respect to Novartis’ exercise of the Exclusive Option; and
(f) It is not debarred or excluded from reimbursement by the FDA (or subject to a similar sanction of EMA 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).
Appears in 1 contract