Common use of Lonza Clause in Contracts

Lonza. Lonza hereby represents and warrants, and, as appropriate, covenants, to Trubion that: (a) to the best of Lonza's knowledge and belief, Lonza is free to supply to Trubion the Lonza Confidential Information and all other information to be supplied by Lonza to Trubion under this Agreement, and, to the best of Lonza's knowledge and belief, Lonza has the legal right to grant Trubion the rights set forth in Section 13.1(b) of this Agreement and the licenses set forth in Section 13.3 of this Agreement; Lonza has not, as of the Effective Date, entered into, and Lonza shall not in the future enter into, any obligation that would not permit or would prohibit or prevent Lonza from granting the rights and licenses set forth in Section 13 of this Agreement; (b) Lonza owns or lawfully controls the Lonza Facility, and has sufficient facilities and equipment, as well as a sufficient number of employees with such expertise and experience, as is necessary or appropriate to perform the Services in accordance with the terms hereof; (c) the Lonza Facility, and all the processes used in producing Bulk Drug and performing the Services, shall be in accordance with cGMP and shall enable Lonza to maintain in good standing all related Permits; (d) any documentation and records provided to Trubion by Lonza relating to the Services shall be accurate in all material respects; (e) Lonza has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; Lonza has not, as of the Effective Date, entered into, and Lonza shall not in the future enter into, any obligation that would not permit Lonza to perform or would prohibit or prevent Lonza from performing its obligations under this Agreement, including, for the avoidance of doubt, the granting of the rights and licenses set forth in Section 13; (f) Lonza 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. This Agreement has been duly executed and delivered on behalf of Lonza, and constitutes a legal, valid, binding obligation, enforceable against Lonza in accordance with its terms; and (g) Lonza is in compliance with all applicable Legal Requirements.

Lonza. Lonza hereby covenants, represents and warrants, and, as appropriate, covenants, warrants to Trubion Vaxcyte that: (a) to the best of Lonza's knowledge and belief, Lonza is free to supply to Trubion the Lonza Confidential Information and all other information to be supplied by Lonza to Trubion under this Agreement, and, to the best of Lonza's knowledge and belief, Lonza has the legal right to grant Trubion the rights set forth in Section 13.1(b) of this Agreement and the licenses set forth in Section 13.3 of this Agreement; Lonza has not, as of the Effective Date, entered intoServices, and Lonza Build-out shall not be performed in the future enter intoaccordance with all Applicable Laws and in a xxxxxxx-like and professional manner and otherwise in accordance with this CMSA and relevant industry standards, with all permits and approvals of any obligation that would not permit or would prohibit or prevent Lonza from granting the rights and licenses set forth Regulatory Authority in Section 13 of this Agreementplace therefor; (b) Lonza owns or lawfully controls the Lonza Facilityhas, and has sufficient facilities will at all times throughout the Term have, the requisite expertise, experience and equipment, as well as a sufficient number of employees with such expertise and experience, as is necessary or appropriate skill to perform the Services in accordance with the terms hereofits obligations hereunder; (c) Lonza shall supply the Lonza FacilityProduct and manufacture, package, ship and all store the processes used in producing Bulk Drug and performing the Services, shall be Product in accordance with cGMP Applicable Laws, the Specifications, the Quality Agreement, Vaxcyte instructions and shall enable Lonza to maintain in good standing all related Permitsthis CMSA; (d) any documentation and records provided to Trubion by Lonza relating to the Services shall be accurate in all material respects[***]; (e) Lonza has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; Lonza has not, as of the Effective Date, entered into, and Lonza shall not in the future enter into, any obligation that would not permit Lonza to perform or would prohibit or prevent Lonza from performing its obligations under this Agreement, including, for the avoidance of doubt, the granting of the rights and licenses set forth in Section 13[***]; (f) the Product will be delivered to Vaxcyte free and clear of all security interest, liens or other encumbrances of any kind or character imposed by or on account of Lonza 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. This Agreement has been duly executed and delivered on behalf of Lonza, and constitutes a legal, valid, binding obligation, enforceable against Lonza in accordance with its terms; andor any Third Party; (g) Lonza holds (and shall until the expiry of each product containing Product obtain and maintain) all necessary permits, approvals, consents, and licenses (or other regulatory approvals) to enable it to perform the Services at the Premises, Facility and Suite (and perform any other work performed or required to be performed hereunder) and to operate the Facility; (h) Lonza Background Intellectual Property, Lonza Information, New General Application Intellectual Property and Third Party Intellectual Property (and the use and receipt thereof in accordance with this CMSA), independent of any combination with Product, Vaxcyte Supplied Raw Materials, Vaxcyte Information and/or Vaxcyte Background Intellectual Property (and to Lonza’s knowledge, in combination with any of the foregoing), shall not infringe any Intellectual Property rights of a Third Party, and Lonza otherwise has the requisite Intellectual Property rights (i) in its equipment, Facilities, or other materials or Intellectual Party provided or introduced into the Services or Manufacturing Process or Product by Lonza or its Affiliates, and (ii) to perform its obligations under this CMSA (for clarity, without making any warranty regarding rights in or to Vaxcyte Information, Vaxcyte Background Intellectual Property or New Vaxcyte Intellectual Property or the use thereof), in each case, without infringing the Intellectual Property rights of any Third Party; (i) Lonza will promptly notify Vaxcyte in writing if it receives or is notified of a formal written claim from a Third Party that Lonza Background Intellectual Property, Lonza Information, or New General Application Intellectual Property (or the use and receipt thereof in compliance accordance with all applicable Legal Requirementsthis CMSA) that is being used or provided in connection with the Services or Manufacturing Process or Product infringes any Intellectual Property or other rights of that Third Party; (j) Lonza is not aware of any circumstances that would be reasonably likely to result in the results engineering concept study or other estimates of cost hereunder being materially inaccurate; (k) Lonza shall provide the construction warranty and latent defect protection as provided in Appendix C; (l) neither Lonza nor its representatives performing Services under this CMSA shall use any person or entity who (i) is excluded from or debarred under any healthcare program, including, but not limited to, the U.S. Office of Inspector General from a federally funded healthcare program under 42 U.S.C § 1320a-7 or debarred by the FDA under FDCA 21 U.S.C. § 306(a)(2) or 21 CFR part 312; (ii) is under investigation by the FDA for debarment or is otherwise disqualified or suspended from or subject to restrictions in providing services in any capacity to any entity that has an approved or pending drug product application; and (iii) appears in the list of excluded individuals/entities as published by the Department of Health and Human Services (DHHS) Office of the Inspector General (OIG List), nor in the list of debarred contractors as published in the System for Award Management by the General Services Administration (GSA List); and (m) Lonza shall notify Vaxcyte immediately if Section 14.1(l) becomes untrue, or if Lonza is notified by an enforcement agencies that an investigation has begun which could lead to such sanction, debarment, suspension, or conviction.

Lonza. Lonza hereby represents and warrants, and, as appropriate, covenants, to Trubion that: (a) to the best of Lonza's knowledge and belief, Lonza is free to supply to Trubion the Lonza Confidential Information and all other information to be supplied by Lonza to Trubion under this Agreement, and, to the best of Lonza's knowledge and belief, Lonza has the legal right to grant Trubion the rights set forth in Section 13.1(b) of this Agreement and the licenses set forth in Section 13.3 of this Agreement; Lonza has not, as of the Effective Date, entered into, and Lonza shall not in the future enter into, any obligation that would not permit or would prohibit or prevent Lonza from granting the rights and licenses set forth in Section 13 of this Agreement; (b) Lonza owns or lawfully controls the Lonza Facility, and has sufficient facilities and equipment, as well as a sufficient number of employees with such expertise and experience, as is necessary or appropriate to perform the Services in accordance with the terms hereof; (c) the Lonza Facility, and all the processes used in producing Bulk Drug and performing the Services, shall be in accordance with cGMP and shall enable Lonza to maintain in good standing all related Permits; (d) any documentation and records provided to Trubion by Lonza relating to the Services shall be accurate in all material respects; (e) Lonza has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder; Lonza has not, as of the Effective Date, CONFIDENTIAL AND PROPRIETARY entered into, and Lonza shall not in the future enter into, any obligation that would not permit Lonza to perform or would prohibit or prevent Lonza from performing its obligations under this Agreement, including, for the avoidance of doubt, the granting of the rights and licenses set forth in Section 13; (f) Lonza 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. This Agreement has been duly executed and delivered on behalf of Lonza, and constitutes a legal, valid, binding obligation, enforceable against Lonza in accordance with its terms; and (g) Lonza is in compliance with all applicable Legal Requirements.