Provision Language
ARTICLE 10. REPRESENTATIONS AND WARRANTIES; COVENANTS
10.1. Mutual Representations and Warranties. Each Party hereby represents, warrants, and covenants (as applicable) to the other Party as follows:
(a) Corporate Existence and Power. It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.
(b) Authority and Binding Agreement. As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on itspart required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.
(c) No Conflict; Covenant. It is not a party to any agreement that would materially prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under this Agreement.
(d) No Debarment. In the course of the Development of the Product, neither Party shall use, during the Term, any employee or consultant who has been debarred by any Regulatory Authority, or, to the best of such Party’s knowledge, is the subject of debarment proceedings by a Regulatory Authority.
10.2. Additional Representations and Warranties of Visterra. Visterra represents and warrants to SIIL as of the Effective Date as follows:
(a) Subject to the rights of the U.S. federal government with respect to any government-funded invention claimed in any MIT Patent as set forth in 35 U.S.C. §§ 201-211, and the regulations promulgated thereunder, Visterra has the right under the Visterra Technology to grant the licenses to SIIL as purported to be granted pursuant to this Agreement.
(b) The MIT Agreement is in full force and effect as modified or amended prior to the Effective Date, and Visterra has provided to SIIL true and complete copies of such agreement, and any redacted portions thereof are not material to SIIL’s decision to enter into or assert its rights and perform its obligation under this Agreement. Neither Visterra nor, to Visterra’s knowledge, MIT is in default with respect to a material obligation under, and neither Visterra nor MIT has claimed or, to Visterra’s knowledge, has grounds upon which to claim, that the other party is in default with respect to a material obligation under the MIT Agreement.
(c) No Third Party other than MIT has granted Visterra a license to Patents or Information that are not Controlled by Visterra or its Affiliates but that would, if Controlled by Visterra or its Affiliates, be within the definition of Visterra Patents or Visterra Know-How.
(d) Visterra owns or Controls all of the Visterra Patents and Visterra Know-How free from encumbrances and is listed in the records of the appropriate governmental authorities as the owner of record or licensee for each registration, grant and application included in the Visterra Patents.
(e) (i) Visterra has, with respect to Patents or Know-How owned by it, obtained from all individuals who participated in any respect in the invention or authorship of any such Patents or Know-How, effective assignments of all ownership rights of such individuals in such Patents or Know-How, and (ii) to the knowledge of Visterra, with respect to Patents or Know-How licensed to Visterra under the MIT Agreement, MIT has obtained from all individuals who participated in any respect in the invention or authorship of any such Patents or Know-How, effective assignments of all ownership rights of such individuals in such Patents or Know-How, in the case of each of (i) and (ii), to the extent that any such Patents or Know-How would constitute Visterra Patents or Visterra Know-How, as applicable, if Controlled by Visterra, either pursuant to written agreement or by operation of law.
(f) All of Visterra’s and its Affiliates’ employees, officers, and consultants engaged in the Development or Commercialization of the Product have executed agreements or have existing obligations under applicable Law requiring assignment to Visterra or its Affiliates, as applicable, of all inventions made during the course of and as the result of their association with Visterra and obligating the individual to maintain as confidential Visterra’s Confidential Information as well as confidential information of other parties (including SIIL and its Affiliates) which such individual may receive, to the extent required to support Visterra’s obligations under this Agreement.
(g) All application, registration, maintenance and renewal fees in respect of Visterra Patents as of the Effective Date have been, with respect to Visterra Patents owned by Visterra and, to Visterra’s knowledge, with respect to Visterra Patents licensed to Visterra, paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining Visterra Patents.
(h) Other than the MIT Agreement, there are no agreements or arrangements to which Visterra or any of its Affiliates is a party relating to the Licensed Antibody, Product, Visterra Patents, or Visterra Know-How that would limit the rights granted to SIIL under this Agreement or that restrict or will result in a restriction on the Parties’ ability to Develop, Manufacture, use or Commercialize the Licensed Antibody or Product in the Field in the Territory;
(i) Neither Visterra nor any of its Affiliates, nor any of its or their respective officers, employees, representatives or agents has made an untrue statement of material fact or fraudulent statement to the United States Food and Drug Administration(the “FDA”) or any other Regulatory Authority with respect to the Development of the Licensed Antibody, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Antibody, or committed an act, made a statement, or failed to make a statement with respect to the Development of the Licensed Antibody.
(j) In the course of the Development of the Licensed Antibody, neither Visterra nor any of its Affiliates has used prior to the Effective Date any employee, agent or independent contractor who has been debarred or excluded from participation in government healthcare programs by any Regulatory Authority, or, to Visterra’s knowledge, is the subject of debarment or exclusion proceedings by a Regulatory Authority or has been convicted pursuant to § 306 of the Food, Drug, and Cosmetic Act.
(k) Visterra has not received any written notice from any Third Party asserting or alleging that any research or Development of any Product by Visterra prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party.
(l) To Visterra’s knowledge, the Development, Manufacture and Commercialization of the Product in the Licensed Territory pursuant to this Agreement will not infringe any Third Party’s valid intellectual property rights.
(m) There are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations involving the Product or the Visterra Technology relating to the Product by or against Visterra or any of its Affiliates or licensees in or before any court, Regulatory Authority or other governmental authority.
10.3. Representation and Warranty of SIIL. SIIL represents and warrants to Visterra as of the Effective Date, and covenants thereafter, that all of SIIL’s and its Affiliates’ employees, officers, and consultants engaged in the Development or Commercialization of the Product have executed agreements or have existing obligations under applicable Law requiring assignment to SIIL or its Affiliates, as applicable, of all inventions made during the course of and as the result of their association with SIIL and obligating the individual to maintain as confidential SIIL’s Confidential Information as well as confidential information of other parties (including Visterra and its Affiliates) which such individual may receive, to the extent required to support SIIL’s obligations under this Agreement.
10.4. Covenants of Visterra.
(a) During the Term, Visterra shall (i) maintain the MIT Agreement in full force and effect; (ii) promptly provide SIIL with a party’s notice of any default under the MIT Agreement; (iii) to the extent within Visterra’s reasonable control, not take any action, fail to take any action or allow any event to occur that would give MIT the right to terminate the MIT Agreement without tthe written consent of SIIL; (iv) not amend or modify the MIT Agreement in a manner that will adversely affect SIIL’s rights under this Agreement or the MIT Agreement, without SIIL’s prior written consent; (v) not exercise any right to itself terminate or waive any material right under the MIT Agreement, which waiver would adversely affect SIIL’s rights under this Agreement or the MIT Agreement without the prior written consent of SIIL; and (vi) to the extent practicable, notify SIIL prior to any termination of the MIT Agreement. In addition, Visterra shall promptly provide SIIL with a copy of any amendments to the MIT Agreement made after the Effective Date.
10.5. Disclaimer. SIIL understands that the Product is the subject of ongoing clinical research and development and that Visterra cannot assure the safety or efficacy of the Product.
10.6. No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES OTHER THAN THOSE EXPRESSLY STATED IN THIS AGREEMENT,WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
10.7. Export Control. Visterra and its Affiliates shall comply with all United States laws and regulations controlling the export of certain commodities and technical data, including all Export Administration Regulations of the United States Department of Commerce. Among other things, these laws and regulations prohibit or require a license for the export of certain types of commodities and technical data to specified countries. Visterra hereby gives written assurance that it shall comply with, and shall cause its Affiliates to comply with, all United States export control laws and regulations, that it bears sole responsibility for any violation of such laws and regulations by itself or its Affiliates, and that it shall indemnify, defend, and hold SIIL harmless (in accordance with Section 11.2) for the consequences of any such violation. SIIL hereby gives written assurance that it shall comply with, and shall cause its Affiliates to comply with, all applicable import control laws and regulations, that it bears sole responsibility for any violation of such laws and regulations by itself or its Affiliates, and that it shall indemnify, defend, and hold Visterra harmless (in accordance with Section 11.2) for the consequences of any such violation. Each Party shall reasonably cooperate with the other Party in facilitating such Party’s or its Affiliates’ compliance with any such laws and regulations.