By LONZA. LONZA hereby represents and warrants to CLIENT that, (i) to the best of its knowledge, it has the requisite Intellectual Property and legal rights in its equipment and Facilities, and in its Background Intellectual Property and any Third Party Intellectual Property or other Intellectual Property or materials provided or introduced by LONZA, or any aspects of the Process developed by LONZA, to be able to perform its obligations under this Agreement without giving rise to any potential cause of action by a Third Party against CLIENT for infringement of Intellectual Property; provided, however, that LONZA makes no representation or warranty with respect to any CLIENT Background IP, CLIENT New IP, Third Party Intellectual Property or other Intellectual Property or materials provided by CLIENT, or any aspects of the Process provided to LONZA by CLIENT; (ii) LONZA shall perform all the services hereunder in a xxxxxxx-like manner in accordance with this Agreement (including the applicable Statement of Work and Quality Agreement) all Applicable Laws and relevant industry standards; (iii) all Products supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (iv) each employee and permitted subcontractor of LONZA who will receive or have access to Confidential Information of CLIENT or who will perform obligations under this Agreement will agree in writing to assign any and all right, title and interest in and to all Intellectual Property of CLIENT and to protect the Confidential Information of CLIENT in accordance with this Agreement, prior to the earlier of any disclosure of Confidential Information of CLIENT to such employee or permitted subcontractor or the commencement of any such performance by such employee or permitted subcontractor; (v) LONZA shall ensure the compliance of its Affiliates with, the terms and conditions of this Agreement; and (vi) neither LONZA nor any of its employees or permitted subcontractors performing or involved with its performance under this Agreement have been “debarred” by the FDA or a Regulatory Authority in any jurisdiction outside the U.S., nor have debarment proceedings against LONZA or any of its employees or permitted subcontractors been commenced. LONZA will promptly notify CLIENT in writing if any such proceedings have commenced or if LONZA or any of its employees or permitted subcontractors is debarred by the FDA or a Regulatory Authority in any jurisdiction outside the U.S.
By LONZA i. LONZA hereby represents and warrants to MODERNA that, to the best of its knowledge, as of the Effective Date ((a)) it or its Affiliates have the requisite intellectual property rights in LONZA Equipment and Facility and the LONZA Technology to be able to perform its obligations under this Agreement, and ((b)) that LONZA’s or its Affiliates’ use of the LONZA Equipment, Facility and the LONZA Technology as contemplated in this Agreement and independent of any infringement caused solely by the use of such LONZA Equipment, Facility and the LONZA Technology in combination with the MODERNA Technology, MODERNA Manufacturing Know-How and Product, will not infringe the intellectual property rights of any Third Party.
ii. LONZA further represents and warrants that it has not and will not to its knowledge use in any capacity in connection with this Agreement the services of any individual, corporation, partnership, or association which has been debarred, excluded, or disqualified by the FDA or any other applicable Regulatory Authority. In the event that LONZA receives notice of the debarment or
i. LONZA represents, warrants and covenants that, save for security interests expressly given in favor of MODERNA or its Affiliates, it will have good and marketable title, free and clear of any pledge, lien, restriction, claim, charge, security interest and/or other encumbrance, to all Product to be delivered under this Agreement (including any Statement of Work), and all Product supplied to MODERNA shall be free and clear of all pledges, liens, restrictions, claims, charges, security interests and/or other encumbrances at the time of delivery.
By LONZA. (a) Lonza shall defend TDTx and its Affiliates and each of their respective employees, officers, directors and agents, and their successors and assigns (“TDTx Indemnitees”) against any and all Claims to the extent [***] attributable to any breach by Lonza of its representations or warranties set forth in Section 14.2 or to the extent [***] attributable to any uncured material breach by Lonza of this Agreement. Lonza shall indemnify (i.e., pay) any and all Losses finally awarded to such Third Party by a court of competent jurisdiction, or agreed to in monetary settlement, with respect to any such Claims. Lonza’s obligations pursuant to this Section 12.1.2 shall not apply (i) to the extent that such Claims are subject to the indemnification obligations of TDTx under Section 12.1.1 or attributable to the gross negligence or willful misconduct of any of the TDTx Indemnitees or MEE Indemnitees, (ii) to the extent that such Claim is attributable to the allegedly infringing use of any TDTx Intellectual Property, (iii) with respect to Claims arising out of a breach by TDTx of its representations or warranties set forth in Section 13.1 or out of a breach by MEE of its representations set forth in Section 13.3 or (iv) the breach by TDTx or MEE of any of the other provisions of this Agreement. For clarity, under no condition shall Lonza be responsible for indemnifying, defending or holding harmless MEE Indemnitees for any Claims arising under this Agreement or for indemnifying, defending or holding harmless TDTx for any Claims arising under this Agreement, to the extent that any such Claim is attributable to the gross negligence or willful misconduct of any MEE Indemnitee or the breach by any MEE Indemnitee of any provision of this Agreement.
By LONZA. LONZA hereby represents and warrants to CLIENT that, [***], (i) it or its Affiliates have the requisite intellectual property rights in its equipment and Facility to be able to perform its obligations under this Agreement; (ii) that LONZA’s or its Affiliates’ use of the Lonza Background IP or its equipment and Facility as contemplated in this Agreement will not give rise to a potential cause of action by a Third Party against CLIENT for infringement or another violation of intellectual property rights and (iii) that LONZA will manufacture Product in accordance with cGMP and all applicable laws[***] (unless the Parties agree otherwise in an SOW).
By LONZA. LONZA hereby represents and warrants to CLIENT that, to the best of its knowledge, (i) it or its Affiliates have the requisite intellectual property rights in its equipment and Facility to be able to perform its obligations under this Agreement, and (ii) that LONZA’s or its Affiliates’ use of its equipment and Facility as contemplated in this Agreement will not give rise to a potential cause of action by a Third Party against CLIENT for infringement or another violation of intellectual property rights.
By LONZA. LONZA hereby represents and warrants to GAMIDA that, to the best of its knowledge, (i) it or its Affiliates have the requisite intellectual property rights in its equipment and Facility to be able to perform its obligations under this Agreement, and (ii) [*]. LONZA further represents and warrants to GAMIDA that: (a) it has the full corporate right, power, and authority to enter into this Agreement and perform its obligations hereunder; (b) it will not sub-contract any of its rights or obligations and/or the performance of the services to be rendered under this Agreement or any part thereof without prior written approval of GAMIDA and in any event it shall not nor shall it use any subcontractors for any performance of this Agreement that are on any excluded or denied party list of any agency of the United States Government, or if its export privileges are denied, suspended, or revoked by the United States Government ; (c) it has not been: (A) debarred by the United States Food and Drug Administration under any provision of the Generic Drug Enforcement Act; or (B) excluded by the Office of the Inspector General of the United States Department of Health and Human Services, or by any other authority, from participating in any health care program (such as Medicare or Medicaid) funded by any Governmental Authority and further agrees that no person who has been debarred or excluded as described above will perform any of LONZA’s obligations under the Agreement; (d) it and its subcontractors are not included on any list of restricted entities, persons, or organizations published by any member state of the European Union, the United States of America government, the United Nations, or other Governmental Authority, including the U.S. Treasury Department’s List of Specially Designated Nationals and Blocked Persons, Sectoral Sanctions Identifications List, and Foreign Sanctions Evaders List, the U.S. Commerce Department’s Entity List, Denied Persons List, and Unverified List, the U.S. State Department’s nonproliferation lists, and the EU’s Consolidated List of Designated Persons, (collectively, the “Sanctions Lists”) or are owned or controlled by a person or entity which is included on such Sanctions Lists. LONZA will use commercially reasonable efforts to notify GAMIDA in writing within five (5) business days of any actions taken or pending that threaten or confirm a debarment or exclusion of any such person.
