Common use of Modification of Statement of Work Clause in Contracts

Modification of Statement of Work. Should MODERNA want to change a Statement of Work or to include additional Services to be provided by LONZA, including any changes to the Specifications, Process or Test Methods for the Products, MODERNA may propose to LONZA (including via the JSC or JMT) an amendment to such Statement of Work with the desired changes or additional Services (each a “Change Order”). LONZA will provide MODERNA with a Change Order containing a description of the required modifications to the relevant Statement of Work, and any proposed changes to the pricing or other fees as well as impact on timelines as a result of such modifications, and will use diligent efforts to do so within [***] of receiving such notice from MODERNA. LONZA may also propose a Change Order to MODERNA, and MODERNA will use diligent efforts to answer to such proposal within [***] of receiving such proposal. If the proposed Change Order is not acceptable to the receiving Party, the Parties will promptly negotiate in good faith a Change Order that is mutually acceptable. LONZA shall continue to work under this Agreement (including under the existing Statement of Work) during any such negotiations. LONZA shall use commercially reasonable efforts to accommodate any of MODERNA’s requested changes, provided if a change is required by any Regulatory Authority on or after the Commencement Date for a Product, such change shall be included in a Change Order. The modified Statement of Work shall be binding on the Parties only if it is signed by both Parties. Thereafter such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of Work. Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to by both Parties, the existing Statement of Work shall remain in effect, unless terminated by MODERNA in accordance with this Agreement or the existing Statement of Work.

Appears in 3 contracts

Samples: Global Long Term Agreement, Global Long Term Agreement, Global Long Term Agreement (Moderna, Inc.)

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Modification of Statement of Work. Should MODERNA CLIENT want to change a Statement of Work or to include additional Services services to be provided by LONZA, including any changes to the Specifications, Process or Test Methods for the Products, MODERNA CLIENT may propose to LONZA (including via the JSC or JMT) an amendment to such the Statement of Work with the desired changes or additional Services services (each a “Change Order”). LONZA will use its Best Efforts to comply with such proposed change or proposal to include additional services, and shall promptly (and in any event within fifteen (15) days) notify CLIENT if LONZA is not able to provide MODERNA with the resources and capabilities to accommodate such Change Order. Unless LONZA informs CLIENT that LONZA does not have the resources and capabilities to accommodate such Change Order, the Project Team will prepare a modified version of the applicable Statement of Work reflecting such Change Order containing a description of the required modifications to the relevant Statement of Work(including, and without limitation, any proposed changes to the pricing scope of work, estimated timelines, milestones, deliverables or other fees compensation, as well as impact on timelines as a result of such modifications, applicable) and will use diligent efforts to do so within [***] submit such modified version of receiving such notice from MODERNA. LONZA may also propose a Change Order to MODERNA, and MODERNA will use diligent efforts to answer to such proposal within [***] the Statement of receiving such proposal. If the proposed Change Order is not acceptable Work to the receiving PartyJSC for review and approval (provided, however, that if time constraints require faster implementation than would be permitted if JSC approval were obtained, the Parties will promptly negotiate applicable Project Team may, as set forth in good faith Section 2.1, implement a Change Order that is mutually acceptable. LONZA shall continue to work under this Agreement (including under modified or amended version of the existing Statement of Work) during any Work for which such negotiations. LONZA shall use commercially reasonable efforts to accommodate any of MODERNA’s requested changes, provided if a change Project Team is required by any Regulatory Authority on or after the Commencement Date for a Product, such change shall be included in a Change Orderresponsible). The modified Statement of Work shall be binding on the Parties only if it refers to this Agreement, states that it is to be made a part thereof, and is signed by both Parties. Thereafter an authorized representative of each Party, and such modified version of the Statement of Work will thereafter be deemed to have replaced the prior version of the Statement of Work. Notwithstanding For the foregoingavoidance of doubt, if unless and until a modified version of the applicable Statement of Work is not agreed to has been signed by both Partiesan authorized representative of each Party, the existing Statement of Work shall remain in full force and effect, unless terminated by MODERNA in accordance with this Agreement or the existing Statement of Work.

Appears in 3 contracts

Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Mesoblast LTD), Manufacturing Services Agreement (Mesoblast LTD)

Modification of Statement of Work. Should MODERNA TiGenix want to change a Statement of Work or to include additional Services services to be provided by LONZALWI, including any changes to the Specifications, Process or Test Methods for the Products, MODERNA TiGenix may propose to LONZA (including via the JSC or JMT) LWI an amendment to such the Statement of Work with the desired changes or additional Services services (each a “Change Order”). LONZA If, using commercially reasonable efforts, LWI determines that it has the resources and capabilities to accommodate such Change Order, LWI will provide MODERNA with prepare a modified version of the Statement of Work reflecting such Change Order containing a description of the required modifications to the relevant Statement of Work(including, and without limitation, any proposed changes to the pricing estimated timing, estimated charges or other fees as well as impact on timelines as scope of a result of such modifications, project) and will use diligent efforts to do so within [***] submit such modified version of receiving such notice from MODERNA. LONZA may also propose a Change Order to MODERNA, and MODERNA will use diligent efforts to answer to such proposal within [***] of receiving such proposal. If the proposed Change Order is not acceptable to the receiving Party, the Parties will promptly negotiate in good faith a Change Order that is mutually acceptable. LONZA shall continue to work under this Agreement (including under the existing Statement of Work) during any such negotiations. LONZA shall use commercially reasonable efforts Work to accommodate any of MODERNA’s requested changes, provided if a change is required by any Regulatory Authority on or after the Commencement Date TiGenix for a Product, such change shall be included in a Change Orderreview and comment. The modified Statement of Work shall be binding on the Parties only if it refers to this Agreement, states that it is to be made a part thereof, and is signed by both Parties. Thereafter Whereafter such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of Work. Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to by both Parties, the existing Statement of Work shall remain in effect. If the modification of the Statement of Work proposed by TiGenix, unless terminated by MODERNA concerns an update or modification of the Specifications described in accordance with this Agreement or the existing such Statement of Work, LWI will notify TiGenix in writing of any objections it has to the draft Specifications, and upon such notification, representatives of LWI and TiGenix will meet promptly to resolve such objections in good faith. Upon the Parties’ mutual agreement on the modified Specifications, the Master Production Record will be updated to incorporate the modified version of the Specifications.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (TiGenix NV), Manufacturing Services Agreement (TiGenix NV)

Modification of Statement of Work. Should MODERNA LBIO want to change modify a Statement of Work Work, including a change or revision to include additional Services the method or manner of performance of Company’s obligations under such Statement of Work, or the facilities, equipment, or materials to be provided by LONZAused in performing the Services subject to such Statement of Work, including any changes to the Specifications, Process or Test Methods for the Products, MODERNA LBIO may propose to LONZA (including via the JSC or JMT) Company an amendment to such the Statement of Work with the desired changes or additional Services modifications (each a “Change Order”). LONZA Upon receipt of such Change Order, Company will provide MODERNA with a evaluate the Change Order containing and discuss with LBIO those Change Order elements that Company may reasonably accommodate. Based on such discussions, Company will prepare a description modified version of the required modifications to the relevant Statement of Work, and Work reflecting the elements of such Change Order (including any proposed changes to the pricing estimated timing, estimated charges or other fees as well as impact on timelines as scope of Services) and will submit such modified version of the Statement of Work to LBIO for review and comment. Additionally, if Company reasonably determines that a result change or addition to the information provided by LBIO hereunder, or gained under an applicable Statement of Work necessitates a change to (i) the method or manner of performance of Company’s obligations hereunder including an acceleration of such modificationsobligations, and will use diligent efforts (ii) production or assay batch records, or (iii) the facilities, equipment, materials, Services or site, which may cause an activity start date to do so within [***] of receiving such notice from MODERNA. LONZA be rescheduled, Company may also propose a Change Order to MODERNALBIO, and MODERNA which LBIO will use diligent efforts consider in good faith, but which will otherwise be subject to answer to such proposal within [***] of receiving such proposalthis Section 2.2. If the proposed Change Order is not acceptable to the receiving PartyParties agree on terms, the Parties they will promptly negotiate in good faith a Change Order that is mutually acceptable. LONZA shall continue to work under this Agreement (including under the existing execute such modified Statement of Work) during any Work and such negotiations. LONZA shall use commercially reasonable efforts to accommodate any of MODERNA’s requested changes, provided if a change is required by any Regulatory Authority on or after the Commencement Date for a Product, such change shall be included in a Change Order. The modified Statement of Work shall be binding on appended and become part of the Parties only if it is signed by both Partiesoriginal (or prior) Statement of Work and this Agreement. Thereafter such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of WorkWork and to be binding on the Parties. Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to and executed by both Parties, the existing then-current Statement of Work shall remain in effect, unless terminated by MODERNA in accordance with this Agreement or the existing Statement of Work.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Lion Biotechnologies, Inc.)

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Modification of Statement of Work. Should MODERNA Iovance want to change modify a Statement of Work Work, including a change or revision to include additional Services the method or manner of performance of Company’s obligations under such Statement of Work, or the facilities, equipment, or materials to be provided by LONZAused in performing the Services subject to such Statement of Work, including any changes to the Specifications, Process or Test Methods for the Products, MODERNA Iovance may propose to LONZA (including via the JSC or JMT) Company an amendment to such the Statement of Work with the desired changes or additional Services modifications (each a “Change Order”). LONZA Upon receipt of such Change Order, Company will provide MODERNA with a evaluate the Change Order containing and discuss with Iovance those Change Order elements that Company may reasonably accommodate. Based on such discussions, Company will prepare a description modified version of the required modifications to the relevant Statement of Work, and Work reflecting the elements of such Change Order (including any proposed changes to the pricing estimated timing, estimated charges or other fees as well as impact on timelines as scope of Services) and will submit such modified version of the Statement of Work to Iovance for review and comment. Additionally, if Company reasonably determines that a result change or addition to the information provided by Iovance hereunder, or gained under an applicable Statement of Work necessitates a change to (i) the method or manner of performance of Company’s obligations hereunder including an acceleration of such modificationsobligations, and will use diligent efforts (ii) production or assay batch records, or (iii) the facilities, equipment, materials, Services or site, which may cause an activity start date to do so within [***] of receiving such notice from MODERNA. LONZA be rescheduled, Company may also propose a Change Order to MODERNAIovance, and MODERNA which Iovance will use diligent efforts consider in good faith, but which will otherwise be subject to answer to such proposal within [***] of receiving such proposalthis Section 2.2. If the proposed Change Order is not acceptable to the receiving PartyParties agree on terms, the Parties they will promptly negotiate in good faith a Change Order that is mutually acceptable. LONZA shall continue to work under this Agreement (including under the existing execute such modified Statement of Work) during any Work and such negotiations. LONZA shall use commercially reasonable efforts to accommodate any of MODERNA’s requested changes, provided if a change is required by any Regulatory Authority on or after the Commencement Date for a Product, such change shall be included in a Change Order. The modified Statement of Work shall be binding on appended and become part of the Parties only if it is signed by both Partiesoriginal (or prior) Statement of Work and this Agreement. Thereafter such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of WorkWork and to be binding on the Parties. Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to and executed by both Parties, the existing then-current Statement of Work shall remain in effect, unless terminated by MODERNA in accordance with this Agreement or the existing Statement of Work.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Iovance Biotherapeutics, Inc.)

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