Common use of By LONZA Clause in Contracts

By LONZA. LONZA hereby represents and warrants to CLIENT that, to the best of its knowledge and independent of the use of the Process, Master Production Record, Specifications, CLIENT Materials, CLIENT Confidential Information or CLIENT Background Intellectual Property: (i) it has the requisite Intellectual Property and legal rights in its equipment, Facilities, Materials, Background Intellectual Property, Third Party Intellectual Property and other Intellectual Property or materials provided or introduced by LONZA, to be able to perform its obligations under this Agreement without giving rise to a potential cause of action by a Third Party against CLIENT for infringement or another violation of Intellectual Property rights; 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 or introduced by CLIENT, or any aspects of the Process developed by CLIENT (ii) as of the Effective Date and for the duration of the Term, the Facility has the required support areas and systems to function as a commercial manufacturing facility for the Product in accordance with the terms of this Agreement; (iii) as of the Effective Date, the Facility is solely owned by LONZA or any of its Affiliates; (iv) as of the Effective Date, LONZA is unaware of any circumstances that will likely make any Materials unavailable on a timely basis and on commercially reasonable terms and conditions; (v) LONZA shall perform all the Services hereunder in a xxxxxxx-like and professional manner in accordance with this Agreement (including the applicable Statement of Work and Quality Agreement) and all Applicable Laws and relevant industry standards; (vi) all Product supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (vii) each employee and permitted subcontractor of LONZA who will receive Confidential Information of CLIENT or who will perform obligations under this Agreement will agree 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; (viii) the portions of the Facility in which manufacturing or supply of Products occurs or any Services under this Agreement are performed are in full compliance with cGMP standards, as applicable, and (ix) neither LONZA nor any of its employees or permitted subcontractors performing or involved with its performance under this Agreement have been “debarred” or “excluded” by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. nor have debarment or exclusion 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 or excluded by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. LONZA shall at all times during the term of this Agreement maintain and conduct regular maintenance, repairs and upkeep at the Facility which are consistent with the contract manufacturing industry for the manufacture of prescription pharmaceutical and biologic products and in any event as reasonably necessary or appropriate to fulfill its obligations hereunder and in each case without charge to CLIENT.

By LONZA. LONZA hereby represents and warrants to CLIENT that, to the best of its knowledge and independent of the use of the Processknowledge, Master Production Record, Specifications, CLIENT Materials, CLIENT Confidential Information or CLIENT Background Intellectual Property: (i) it has or its Affiliates have the requisite Intellectual Property and legal intellectual property rights in its equipment, Facilities, Materials, Background Intellectual Property, Third Party Intellectual Property equipment and other Intellectual Property or materials provided or introduced by LONZA, Facility to be able to perform its obligations under this Agreement, (ii) that LONZA’s or its Affiliates’ use of its equipment and Facility as contemplated in this Agreement without giving will not give rise to a potential cause of action by a Third Party against CLIENT for infringement or another violation of Intellectual Property intellectual property rights; 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 or introduced by CLIENT, or any aspects of the Process developed by CLIENT (ii) as of the Effective Date and for the duration of the Term, the Facility has the required support areas and systems to function as a commercial manufacturing facility for the Product in accordance with the terms of this Agreement; (iii) as of the Effective Date, the Facility is solely owned by LONZA or any of its Affiliates; (iv) as of the Effective Date, LONZA is unaware of any circumstances that will likely make any Materials unavailable on a timely basis and on commercially reasonable terms and conditions; (v) LONZA shall perform all the Services hereunder in a xxxxxxx-like and professional manner in accordance with this Agreement (including the applicable Statement of Work and Quality Agreement) and all Applicable Laws and relevant industry standards; (vi) all Product supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (vii) each employee and permitted subcontractor of LONZA who will receive Confidential Information of CLIENT or who will perform obligations under this Agreement will agree 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; (viii) the portions of the Facility in which manufacturing or supply of Products occurs or any Services under this Agreement are performed are in full compliance with cGMP standards, as applicable, and (ix) neither LONZA nor any of its employees Affiliates has been debarred or permitted subcontractors performing is subject to debarment pursuant to Section 306 of the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, et. seq. (the “FFDCA”) or involved analogous provisions of Applicable Law outside the United States or listed on the United States Department of Health and Human Service’s List of Excluded Individuals/Entities and the United States General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs, or any analogous lists pursuant to Applicable Law outside the United States (collectively, “Excluded Lists”), and (iv) neither LONZA nor any of its Affiliates will use in any capacity, in connection with its performance the activities to be performed under this Agreement have Agreement, any person or entity who has been “debarred” debarred pursuant to Section 306 of the FFDCA or “excluded” by the FDA or a Regulatory Authority in any jurisdiction analogous provisions of Applicable Law outside the U.S. nor have United States, or who is the subject of a conviction described in such Section or analogous provisions of Applicable Law outside the United States, or listed on any Excluded List. LONZA shall inform CLIENT in writing immediately if it or any person or entity who is performing activities hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA or analogous provisions of Applicable Law outside the United States or listed on any Excluded List, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of LONZA’s knowledge, is threatened, relating to the debarment or exclusion proceedings against conviction Section 306 of the FFDCA or analogous provisions of Applicable Law outside the United States, or listing on any Excluded List, of LONZA or any of its employees person 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 or excluded by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. LONZA shall at all times during the term of this Agreement maintain and conduct regular maintenance, repairs and upkeep at the Facility which are consistent with the contract manufacturing industry for the manufacture of prescription pharmaceutical and biologic products and in any event as reasonably necessary or appropriate to fulfill its obligations hereunder and in each case without charge to CLIENTentity performing activities hereunder.

By LONZA. LONZA hereby represents and warrants to CLIENT that, (i) to the best of its knowledge and independent of the use of the Processknowledge, Master Production Record, Specifications, CLIENT Materials, CLIENT Confidential Information or CLIENT Background Intellectual Property: (i) it has the requisite Intellectual Property and legal rights in its equipment, equipment and Facilities, Materials, and in its Background Intellectual Property, Property and any Third Party Intellectual Property and 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 a any potential cause of action by a Third Party against CLIENT for infringement or another violation of Intellectual Property rightsProperty; 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 or introduced by CLIENT, or any aspects of the Process developed provided to LONZA by CLIENT CLIENT; (ii) as of the Effective Date and for the duration of the Term, the Facility has the required support areas and systems to function as a commercial manufacturing facility for the Product in accordance with the terms of this Agreement; (iii) as of the Effective Date, the Facility is solely owned by LONZA or any of its Affiliates; (iv) as of the Effective Date, LONZA is unaware of any circumstances that will likely make any Materials unavailable on a timely basis and on commercially reasonable terms and conditions; (v) LONZA shall perform all the Services services hereunder in a xxxxxxx-like and professional manner in accordance with this Agreement (including the applicable Statement of Work and Quality Agreement) and all Applicable Laws and relevant industry standards; (viiii) all Product Products supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (viiiv) 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; (viiiv) LONZA shall ensure the portions compliance of its Affiliates with, the Facility in which manufacturing or supply terms and conditions of Products occurs or any Services under this Agreement are performed are in full compliance with cGMP standards, as applicable, Agreement; and (ixvi) neither LONZA nor any of its employees or permitted subcontractors performing or involved with its performance under this Agreement have been “debarred” or “excluded” by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. U.S., nor have debarment or exclusion 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 or excluded by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. LONZA shall at all times during the term of this Agreement maintain and conduct regular maintenance, repairs and upkeep at the Facility which are consistent with the contract manufacturing industry for the manufacture of prescription pharmaceutical and biologic products and in any event as reasonably necessary or appropriate to fulfill its obligations hereunder and in each case without charge to CLIENT.U.S.

By LONZA. LONZA hereby represents and warrants to CLIENT that, (i) to the best of its knowledge and independent of the use of the Processknowledge, Master Production Record, Specifications, CLIENT Materials, CLIENT Confidential Information or CLIENT Background Intellectual Property: (i) it has the requisite Intellectual Property and legal rights in its equipment, equipment and Facilities, Materials, and in its Background Intellectual Property, Property and any Third Party Intellectual Property and or other Intellectual Property or materials provided or introduced by LONZA, or any THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. aspects of the Process developed by LONZA, to be able to perform its obligations under this Agreement without giving rise to a any potential cause of action by a Third Party against CLIENT for infringement or another violation of Intellectual Property rightsProperty; 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 or introduced by CLIENT, or any aspects of the Process developed provided to LONZA by CLIENT CLIENT; (ii) as of the Effective Date and for the duration of the Term, the Facility has the required support areas and systems to function as a commercial manufacturing facility for the Product in accordance with the terms of this Agreement; (iii) as of the Effective Date, the Facility is solely owned by LONZA or any of its Affiliates; (iv) as of the Effective Date, LONZA is unaware of any circumstances that will likely make any Materials unavailable on a timely basis and on commercially reasonable terms and conditions; (v) LONZA shall perform all the Services services hereunder in a xxxxxxx-like and professional manner in accordance with this Agreement (including the applicable Statement of Work and Quality Agreement) and all Applicable Laws and relevant industry standards; (viiii) all Product Products supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (viiiv) 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; (viiiv) LONZA shall ensure the portions compliance of its Affiliates with, the Facility in which manufacturing or supply terms and conditions of Products occurs or any Services under this Agreement are performed are in full compliance with cGMP standards, as applicable, Agreement; and (ixvi) neither LONZA nor any of its employees or permitted subcontractors performing or involved with its performance under this Agreement have been “debarred” or “excluded” by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. U.S., nor have debarment or exclusion 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 or excluded by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. LONZA shall at all times during the term of this Agreement maintain and conduct regular maintenance, repairs and upkeep at the Facility which are consistent with the contract manufacturing industry for the manufacture of prescription pharmaceutical and biologic products and in any event as reasonably necessary or appropriate to fulfill its obligations hereunder and in each case without charge to CLIENT.U.S.

By LONZA. LONZA hereby represents and warrants to CLIENT that, (i) to the best of its knowledge and independent of the use of the Processknowledge, Master Production Record, Specifications, CLIENT Materials, CLIENT Confidential Information or CLIENT Background Intellectual Property: (i) it has the requisite Intellectual Property and legal rights in its equipment, equipment and Facilities, Materials, and in its Background Intellectual Property, Property and any Third Party Intellectual Property and 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 a any potential cause of action by a Third Party against CLIENT for infringement or another violation of Intellectual Property rightsProperty; 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 or introduced by CLIENT, or any aspects of the Process developed provided to LONZA by CLIENT CLIENT; (ii) as of the Effective Date and for the duration of the Term, the Facility has the required support areas and systems to function as a commercial manufacturing facility for the Product in accordance with the terms of this Agreement; (iii) as of the Effective Date, the Facility is solely owned by LONZA or any of its Affiliates; (iv) as of the Effective Date, LONZA is unaware of any circumstances that will likely make any Materials unavailable on a timely basis and on commercially reasonable terms and conditions; (v) LONZA shall perform all the Services services hereunder in a xxxxxxxwxxxxxx-like and professional manner in accordance with this Agreement (including the applicable Statement of Work and Quality Agreement) and all Applicable Laws and relevant industry standards; (viiii) all Product Products supplied under this Agreement will be free and clear of any security interest, lien, or other encumbrance; (viiiv) 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; (viiiv) LONZA shall ensure the portions compliance of its Affiliates with, the Facility in which manufacturing or supply terms and conditions of Products occurs or any Services under this Agreement are performed are in full compliance with cGMP standards, as applicable, Agreement; and (ixvi) neither LONZA nor any of its employees or permitted subcontractors performing or involved with its performance under this Agreement have been “debarred” or “excluded” by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. U.S., nor have debarment or exclusion 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 or excluded by the FDA or a Regulatory Authority in any jurisdiction outside the U.S. LONZA shall at all times during the term of this Agreement maintain and conduct regular maintenance, repairs and upkeep at the Facility which are consistent with the contract manufacturing industry for the manufacture of prescription pharmaceutical and biologic products and in any event as reasonably necessary or appropriate to fulfill its obligations hereunder and in each case without charge to CLIENT.U.S.