Modification of Statement of Work. Should CLIENT want to change a Statement of Work or to include additional services to be provided by LONZA, CLIENT may propose to LONZA an amendment to the Statement of Work with the desired changes or additional services (“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 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 (including, without limitation, any changes to the scope of work, estimated timelines, milestones, deliverables or compensation, as applicable) and will submit such modified version of the Statement of Work to the JSC for review and approval (provided, however, that if time constraints require faster implementation than would be permitted if JSC approval were obtained, the applicable Project Team may, as set forth in Section 2.1, implement a modified or amended version of the Statement of Work for which such Project Team is responsible). 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 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. For the avoidance of doubt, unless and until a modified version of the applicable Statement of Work has been signed by an authorized representative of each Party, the existing Statement of Work shall remain in full force and effect.
Appears in 3 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Mesoblast LTD), Manufacturing Services Agreement (Mesoblast LTD)
Modification of Statement of Work. Should CLIENT MODERNA want to change a Statement of Work or to include additional services Services to be provided by LONZA, CLIENT 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 the such Statement of Work with the desired changes or additional services Services (each a “Change Order”). LONZA will use its Best Efforts provide MODERNA with a Change Order containing a description of the required modifications to comply with such proposed change or proposal to include additional servicesthe relevant Statement of Work, and shall promptly (and in any event within fifteen (15) days) notify CLIENT if LONZA is not able to provide 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 (including, without limitation, any proposed changes to the scope pricing or other fees as well as impact on timelines as a result of worksuch modifications, estimated timelines, milestones, deliverables or compensation, as applicable) and will submit use diligent efforts to do so within [***] of receiving such modified version 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 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 JSC Commencement Date for review and approval (provideda Product, however, that if time constraints require faster implementation than would such change shall be permitted if JSC approval were obtained, the applicable Project Team may, as set forth included in Section 2.1, implement a modified or amended version of the Statement of Work for which such Project Team is responsible)Change Order. 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 an authorized representative of each Party, and both Parties. Thereafter such modified version of the Statement of Work will thereafter be deemed to have replaced the prior version of the Statement of Work. For Notwithstanding the avoidance of doubtforegoing, unless and until if a modified version of the applicable Statement of Work has been signed is not agreed to by an authorized representative of each Partyboth Parties, 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: Global Long Term Agreement, Global Long Term Agreement, Global Long Term Agreement (Moderna, Inc.)
Modification of Statement of Work. Should CLIENT TiGenix want to change a Statement of Work or to include additional services to be provided by LONZALWI, CLIENT TiGenix may propose to LONZA LWI an amendment to the Statement of Work with the desired changes or additional services (“Change Order”). LONZA will use its Best Efforts to comply with such proposed change or proposal to include additional servicesIf, and shall promptly (and in any event within fifteen (15) days) notify CLIENT if LONZA is not able to provide the resources and capabilities to accommodate such Change Order. Unless LONZA informs CLIENT using commercially reasonable efforts, LWI determines that LONZA does not have it has the resources and capabilities to accommodate such Change Order, the Project Team LWI will prepare a modified version of the applicable Statement of Work reflecting such Change Order (including, without limitation, any changes to the estimated timing, estimated charges or scope of work, estimated timelines, milestones, deliverables or compensation, as applicablea project) and will submit such modified version of the Statement of Work to the JSC TiGenix for review and approval (provided, however, that if time constraints require faster implementation than would be permitted if JSC approval were obtained, the applicable Project Team may, as set forth in Section 2.1, implement a modified or amended version of the Statement of Work for which such Project Team is responsible)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 an authorized representative of each Party, and both Parties. Whereafter such modified version of the Statement of Work will thereafter be deemed to have replaced the prior version of the Statement of Work. For Notwithstanding the avoidance of doubtforegoing, unless and until if a modified version of the applicable Statement of Work has been signed is not agreed to by an authorized representative of each Partyboth Parties, the existing Statement of Work shall remain in full force effect. If the modification of the Statement of Work proposed by TiGenix, concerns an update or modification of the Specifications described in such Statement of Work, LWI will notify TiGenix in writing of any objections it has to the draft Specifications, and effectupon 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 CLIENT 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, CLIENT Iovance may propose to LONZA Company an amendment to the Statement of Work with the desired changes or additional services modifications (“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 the resources and capabilities to accommodate such Change Order. Unless LONZA informs CLIENT that LONZA does not have the resources and capabilities to accommodate Upon receipt of such Change Order, Company will evaluate the Project Team Change Order and discuss with Iovance those Change Order elements that Company may reasonably accommodate. Based on such discussions, Company will prepare a modified version of the applicable Statement of Work reflecting the elements of such Change Order (including, without limitation, including any changes to the estimated timing, estimated charges or scope of work, estimated timelines, milestones, deliverables or compensation, as applicableServices) and will submit such modified version of the Statement of Work to the JSC Iovance for review and approval (providedcomment. Additionally, howeverif Company reasonably determines that a change or addition to the information provided by Iovance hereunder, that if time constraints require faster implementation than would be permitted if JSC approval were obtained, the or gained under an applicable Project Team may, as set forth in Section 2.1, implement a modified or amended version of the Statement of Work for necessitates a change to (i) the method or manner of performance of Company’s obligations hereunder including an acceleration of such obligations, (ii) production or assay batch records, or (iii) the facilities, equipment, materials, Services or site, which may cause an activity start date to be rescheduled, Company may propose a Change Order to Iovance, which Iovance will consider in good faith, but which will otherwise be subject to this Section 2.2. If the Parties agree on terms, they will execute such Project Team is responsible). The modified Statement of Work and such modified Statement of Work shall be binding on appended and become part of the Parties only if it refers to original (or prior) Statement of Work and this Agreement, states that it is to be made a part thereof, and is signed by an authorized representative of each Party, and . Thereafter such modified version of the Statement of Work will thereafter be deemed to have replaced the prior version of the Statement of WorkWork and to be binding on the Parties. For Notwithstanding the avoidance of doubtforegoing, unless and until if a modified version of the applicable Statement of Work has been signed is not agreed to and executed by an authorized representative of each Partyboth Parties, the existing then-current Statement of Work shall remain in full force and effect.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Iovance Biotherapeutics, Inc.)
Modification of Statement of Work. Should CLIENT 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, CLIENT LBIO may propose to LONZA Company an amendment to the Statement of Work with the desired changes or additional services modifications (“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 the resources and capabilities to accommodate such Change Order. Unless LONZA informs CLIENT that LONZA does not have the resources and capabilities to accommodate Upon receipt of such Change Order, Company will evaluate the Project Team Change Order and discuss with LBIO those Change Order elements that Company may reasonably accommodate. Based on such discussions, Company will prepare a modified version of the applicable Statement of Work reflecting the elements of such Change Order (including, without limitation, including any changes to the estimated timing, estimated charges or scope of work, estimated timelines, milestones, deliverables or compensation, as applicableServices) and will submit such modified version of the Statement of Work to the JSC LBIO for review and approval (providedcomment. Additionally, howeverif Company reasonably determines that a change or addition to the information provided by LBIO hereunder, that if time constraints require faster implementation than would be permitted if JSC approval were obtained, the or gained under an applicable Project Team may, as set forth in Section 2.1, implement a modified or amended version of the Statement of Work for necessitates a change to (i) the method or manner of performance of Company’s obligations hereunder including an acceleration of such obligations, (ii) production or assay batch records, or (iii) the facilities, equipment, materials, Services or site, which may cause an activity start date to be rescheduled, Company may propose a Change Order to LBIO, which LBIO will consider in good faith, but which will otherwise be subject to this Section 2.2. If the Parties agree on terms, they will execute such Project Team is responsible). The modified Statement of Work and such modified Statement of Work shall be binding on appended and become part of the Parties only if it refers to original (or prior) Statement of Work and this Agreement, states that it is to be made a part thereof, and is signed by an authorized representative of each Party, and . Thereafter such modified version of the Statement of Work will thereafter be deemed to have replaced the prior version of the Statement of WorkWork and to be binding on the Parties. For Notwithstanding the avoidance of doubtforegoing, unless and until if a modified version of the applicable Statement of Work has been signed is not agreed to and executed by an authorized representative of each Partyboth Parties, the existing then-current Statement of Work shall remain in full force and effect.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Lion Biotechnologies, Inc.)