Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Rhythm with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), and will use reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under the existing Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 8 contracts
Samples: Development and Manufacturing Services Agreement, Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.), Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.)
Changes to Work Orders. If the scope of work of a Work Order changes, especially the estimated timelines, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm RADIUS, or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Rhythm RADIUS with a change order containing a description of the required modifications and their effect on the scope, fees and estimated timelines specified in the Work Order (“Change Order”), ) and will use reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm RADIUS does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under on the existing Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDRADIUS.
Appears in 4 contracts
Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm Anterios, or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Rhythm Anterios with a change order Change Order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), ) and will use reasonable efforts to do so within ten (10) business days [*] of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm Anterios does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under on the existing Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDAnterios.
Appears in 3 contracts
Samples: Development and Manufacturing Services Agreement (Anterios Inc), Development and Manufacturing Services Agreement (Anterios Inc), Development and Manufacturing Services Agreement (Anterios Inc)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm Customer, or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Rhythm Customer with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), ) and will use reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm Customer does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under on the existing Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDCustomer.
Appears in 3 contracts
Samples: Supply Agreement (CorMedix Inc.), Supply Agreement (CorMedix Inc.), Supply Agreement (CorMedix Inc.)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Rhythm with a change order containing a description of the required modifications and their effect on the scope, fees (including remuneration for waste and scrap if any) and timelines specified in the Work Order (“Change Order”), and will use reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under the existing Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 3 contracts
Samples: Development and Manufacturing Services Agreement, Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.), Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may shall be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm COMPANY or by ManufacturerAmbioPharm, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer AmbioPharm will provide Rhythm COMPANY with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), and will use reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm COMPANY does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicablepractical, Manufacturer AmbioPharm will continue to work under the existing Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDCOMPANY.
Appears in 1 contract
Samples: Development and Manufacturing Services Agreement (Yumanity Therapeutics, Inc.)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm Atara or by Manufacturer, the identifying party Party will notify the other party Party in writing as soon as reasonably possible[ * ]. Manufacturer will provide Rhythm Atara with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), and will use reasonable efforts [ * ] to do so within ten (10) business days [ * ] of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both partiesParties. If Rhythm Atara does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties Parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue [ * ]; provided [ * ] Change Order. Notwithstanding anything to work under the existing Work Order contrary in the preceding sentence, during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but (a) Atara is [ * ] and (b) Manufacturer is [ * ]. Manufacturer will not commence work in accordance with the any such Change Order until it is authorized in writing by RhythmAtara and fully signed by the Parties. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Atara will be responsible for all mutually agreed upon additional fees, AS AMENDEDcosts and expenses related to any Change Order or continued performance under any existing Work Order, whether the modifications are proposed by Atara or Manufacturer, as set forth in such Change Order.
Appears in 1 contract
Samples: Commercial Manufacturing Services Agreement (Atara Biotherapeutics, Inc.)
Changes to Work Orders. If the scope of work of the Work Statement or a Work Order changes, changes then the Work Statement or applicable Work Order may be amended as provided in this Section 5.3(a)2.8. If a required modification to the Work Statement or a Work Order is identified by Rhythm Customer, or by ManufacturerCMC, the identifying party Party will notify the other party Party in writing as soon as reasonably possible. Manufacturer CMC will provide Rhythm Customer with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Statement or Work Order (“Change Order”), ) and will use reasonable efforts to do so within ten (10) business days [*] Business Days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm Customer does not approve such Change Order, and has not terminated the Work Statement or Work Order, but requests the Work Statement or Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicablepracticable and permitted under applicable law, Manufacturer CMC will continue to work under on the existing Work Statement or Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDPortola.
Appears in 1 contract
Samples: Commercial Supply Agreement (Portola Pharmaceuticals Inc)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm Atara or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Rhythm Atara with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), and will use reasonable efforts to do so within ten (10) business days [ * ] of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm Atara does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under the existing Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by RhythmAtara. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Atara will be responsible for all agreed upon additional costs and expenses related to any Change Order or continued performance under any existing Work Order, AS AMENDEDwhether proposed by Atara or Manufacturer.
Appears in 1 contract
Samples: Development and Manufacturing Services Agreement (Atara Biotherapeutics, Inc.)
Changes to Work Orders. If the scope of work of the Work Statement, an Interim Work Order, or a Work Order changes, changes then the Work Statement or applicable Work Order may be amended as provided in this Section 5.3(a)2.8. If a required modification to the Work Statement or a Work Order is identified by Rhythm Customer, or by ManufacturerCMC, the identifying party Party will notify the other party Party in writing as soon as reasonably possible. Manufacturer CMC will provide Rhythm Customer with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Statement or Work Order (“Change Order”), ) and will use reasonable efforts to do so within ten (10) business days [*] Business Days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm Customer does not approve such Change Order, and has not terminated the Work Statement or Work Order, but requests the Work Statement or Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicablepracticable and permitted under applicable law, Manufacturer CMC will continue to work under on the existing Work Statement or Work Order during any such negotiations, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDPortola.
Appears in 1 contract
Samples: Commercial Supply (Manufacturing Services) Agreement (Portola Pharmaceuticals Inc)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm Tectonic or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Rhythm Tectonic with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), ) and will use reasonable [***] efforts to do so within ten (10) business days [***] of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm Tectonic does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable [***] efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under the existing Work Order during any such negotiations; provided, provided such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDTectonic.
Appears in 1 contract
Samples: Development and Manufacturing Services Agreement (AVROBIO, Inc.)
Changes to Work Orders. If the scope of work of a Work Order changes, then the applicable Work Order may be amended as provided in this Section 5.3(a). If a required modification to a Work Order is identified by Rhythm Portola, or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. In either case, Manufacturer will provide Rhythm Portola with a change order containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Work Order (“Change Order”), ) and will use reasonable efforts to do so within ten (10) business days of receiving or providing such notice, as the case may be. No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Rhythm Portola approves any such Change Order, Portola will be responsible for the payment of any fee increase referenced in such Change Order. If Portola does not approve such Change Order, and has not terminated the Work Order, but requests the Work Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under on the existing Work Order during any such negotiations, provided the parties agree that such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Rhythm. * CONFIDENTIAL TREATMENT REQUESTED. OMITTED PORTIONS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDthe authorized representatives of both parties.
Appears in 1 contract
Samples: Development and Manufacturing Services Agreement (Portola Pharmaceuticals Inc)