Common use of Change Control Clause in Contracts

Change Control. 14.1 Either of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 2 contracts

Sources: Framework Agreement for the Provision of Services (ExlService Holdings, Inc.), Framework Agreement (ExlService Holdings, Inc.)

Change Control. 14.1 Either of Client Except as required by Applicable Law, or the Contractor may serve a Change Notice relating requested in writing by Topotarget, Spectrum shall not, and shall use Commercially Reasonable Efforts to an Inscope Change requiring it cause its Third Party manufacturers to not, without Topotarget’s prior approval (orsuch approval not to be unreasonably withheld, delayed or conditioned), make any changes to materials, processes, sources, manufacturing sites or equipment if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services such change affects or the Transition Plan would be used in accordance connection with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating API and/or Bulk Products to an Outscope Change upon the other of them requesting changes be supplied to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor Topotarget and would require notification to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a any Regulatory Authority with regard respect to UK Regulations after the Effective Date. 14.4 Where Client serves API or Bulk Products to be supplied to Topotarget (each, a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice“Material Change”). If reasonably practicable Spectrum or a Third Party manufacturer determines that it must make a Material Change which is required by Applicable Law, Spectrum shall notify Topotarget of such Material Change not less than [***] ([***]) days from the parties shall determine date it makes such determination or learns that a Third Party manufacturer has made such determination. Any Material Change that is not required by Applicable Law, as well as the use of different or additional manufacturing facilities or sites, must be agreed upon by both Spectrum and Topotarget, such agreement not to be unreasonably withheld, delayed or conditioned. The costs associated with any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(sMaterial Change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs Applicable Law shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed borne by the Contractor) such assets to allow Party from whose territory the Contractor to utilise requirement was imposed, and the same to provide the Services. The parties will subsequently use the costs associated with any Material Change Control Procedure with retrospective effect after implementation of the change(s) not required by Applicable Law shall be allocated at the Regulatory time the Parties agree upon the Material Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 immediately preceding sentence. Topotarget agrees that its withholding of the Securities Exchange Act agreement to a Material Change that is reasonably necessary to ensure continuity of 1934. cost supply of the Contractor funding this prior API and Bulk Product to the Charges being adjusted Topotarget shall relieve Spectrum of liability for any failure to reflect this change will be included as a specific addition as part supply API and Bulk Product to Topotarget arising from Topotarget’s withholding of the Change Control Procedure, along with any changes to ongoing costssuch agreement. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 2 contracts

Sources: License and Collaboration Agreement (Spectrum Pharmaceuticals Inc), License and Collaboration Agreement (Spectrum Pharmaceuticals Inc)

Change Control. 14.1 Either of Client or At any time during the Contractor Term either Party may serve a Change Notice relating request changes to an Inscope Change requiring it (orthis Framework Agreement, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Customer Contracts, the Gas Products, the Services, the Additional Services or and/or the Transition Disaster Recovery Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory CostsRequest”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor . The Authority shall not be required to incur consider any Change Control Request raised by the expenditure required Supplier if such request: is solely to comply increase the Charges; or is one which the Authority considers is inconsistent with the Regulatory Control Notice unless contract notice referred to in recital (C) above, including the specification in that notice of the Services and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Additional Services. The parties will subsequently use If, after discussions between them, the Parties consider that the Change Control Procedure with retrospective effect after implementation Request is technically feasible, then the Supplier shall, as soon as practicable, and in any event within twenty-eight (28) Working Days of the change(s) required receipt of a Change Control Request by the Regulatory Supplier or provision of a Change Notice to determine any necessary change Control Request to the Charges. To Authority (as the extent that capital expenditure is required but does not exceed [REDACTED]* thencase may be), unless Client elects to purchase these assets in provide the manner set out above, Authority with: a reasonable and fully itemised proposal for the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part implementation of the Change Control ProcedureRequest, along with including work to be performed, any changes amendments required to ongoing costs. 14.5 Any changes this Framework Agreement or Customer Contracts and a programme for implementation, including details of the category and time commitment of the personnel required to Regulations other than changes implement it (“Itemised Proposal”); any decrease in the costs to the Supplier of providing the Services or incurrence Additional Services following, and as a result of, implementation of UK Regulations the Change Control Request; the reasonable additional costs of implementing the Change Control Request, not including those costs which the Supplier: has already incurred at the date of the Change Control Request; or shall incur as part of a separate upgrade or modification of its systems, where such upgrade or modification has already commenced as at the date of the Change Control Request, independently of the Change Control Request; or shall have to spend in any event on the upgrade, modification or development of its own supply business systems, save to the extent of the proportion of such costs which would not have been incurred but for the need to provide the Services or Additional Services to the Customers, such additional costs not including those costs described in Clauses 9.2.3(a) and 9.2.3(b), being the “Additional Costs”; and where the Change Control Request relates to the provision of amended or new Additional Services (“Updated Additional Services”), the charges the Supplier proposes to apply for the provision of the Updated Additional Services. Upon receipt of the information to be provided to the Authority pursuant to Clause 9.2, the Authority shall have the right to: accept the Itemised Proposal, the Additional Costs and the proposed charges for the Updated Additional Services, in which case the Supplier shall implement the Change Control Request as soon as reasonably practicable; provided that if the Party making the Change Control Request has requested two (2) or more Change Control Requests within the previous two (2) Months, the Parties shall agree the time frame in which each Change Control Request shall be at implemented. The Additional Costs shall be borne by the risk Authority; reject the Itemised Proposal in which case the Change Control Request shall not be implemented; or accept the Itemised Proposal and cost reject the Additional Costs or reject the proposed charges for the Updated Additional Services in which case the Supplier shall implement the Change Control Request as soon as reasonably practicable; provided that if the Party making the Change Control Request has requested two (2) or more Change Control Requests within the previous two (2) Months the Parties shall agree the time frame in which each Change Control Request shall be implemented. Any costs shall be borne by the Authority on a pass-through, open book basis. Where the Authority has rejected the proposed charges for the Updated Additional Services, the Parties shall use their reasonable endeavours to agree the charges to apply for the provision by the Supplier to the Customer of the ContractorUpdated Additional Services. If the Parties fail to agree, the Dispute shall be resolved in accordance with Clause 18 (Disputes) on the basis that the applicable charges shall be the market price for the same or similar services available in the market in Great Britain. The charges as accepted, as agreed or as determined shall be the “Updated Additional Services Charges”. If the implementation of a Change Control Request results in a reduction in the cost to the Supplier of providing the Services or Additional Services the Parties shall agree within ten (10) Working Days how the reduction of costs should be shared and, failing such agreement, the provisions of Clause 18 (Disputes) shall apply. DISASTER RECOVERY AND BACK-UP In the event of a Disaster, the Supplier and the Authority shall each use its respective reasonable endeavours: to continue to perform, with the minimum disruption possible having regard to the nature and extent of the Disaster, its obligations under this Framework Agreement and, in the case of the Supplier, its obligations under the Customer Contracts; and to re-establish its full capacity to perform its obligations under this Framework Agreement and, in the case of the Supplier, the Customer Contracts in as timely a manner as possible having regard to the nature and extent of the Disaster. Without limitation prejudice to the generality of Clause 10.1, the Supplier agrees that, in the event of a Disaster, it shall use reasonable endeavours to ensure that all infrastructure components are restored within the Recovery Time as agreed between the Parties from time to time for such infrastructure components. For the purposes of determining whether a Recovery Time has been met, time shall start to run from the moment when the Disaster starts to materially impact on the Supplier’s ability or capacity to perform its obligations under this Framework Agreement or the Contractor may serve Customer Contracts. The Supplier shall, if required, provide the Authority with a Change Notice where these changes require copy of its Disaster Recovery Plan and back-up strategies and the Supplier shall keep its Disaster Recovery Plan and back-up strategies under review to ensure that so far as reasonably practicable the Recovery Times remain sufficient to enable it to provide Services in a different manner operationally to address the operational impact of the changesfulfil its obligations under Clauses 10.1 and 10.2 and shall adjust them if they are not sufficient.

Appears in 2 contracts

Sources: Framework Agreement for Natural Gas Supply and Additional Services, Framework Agreement

Change Control. 14.1 Either of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]***, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]*** then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 2 contracts

Sources: Framework Agreement, Framework Agreement (ExlService Holdings, Inc.)

Change Control. 14.1 Either 11.1 Any request to change the scope of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor Agreement shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement be processed in accordance with the Change Control Procedure prior to implementation of set out below:- 11.2 EDM HEALTHCARE CONSULTING LTD and the change(s) required Client shall discuss any changes proposed by the Regulatory other (‘Change’) and such discussion shall result in either: 11. 2.1 a written request for a Change Noticeby the Client; or 11. 2.2 a written recommendation for a Change by EDM HEALTHCARE CONSULTING LTD 11.2.3 or, but if this neither the Client nor EDM HEALTHCARE CONSULTING LTD should wish to submit a request or recommendation, the proposal for the Change will not proceed. 11.3 Where a written request for a Change is not reasonably practicable then Client will pay received from the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on Client, EDM HEALTHCARE CONSULTING LTD shall, unless otherwise agreed, submit a Change Request Form (‘CRF’) (in the Contractor’s standard man day rates as format set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost Proposal) to the Contractor Client within the period agreed between the Parties or, if no such period is agreed, within 15 (fifteen) Working Days from the date of complying with receipt of such request for a Change. 11.4 A written recommendation for a change by EDM HEALTHCARE CONSULTING LTD shall be submitted as a CRF direct to the Regulatory Change Notice in terms Client at the time of capital expenditure will exceed [REDACTED]*such recommendation. 11.5 For each CRF submitted, then the Contractor shall not be required Client shall, within a reasonable time: 11. 5.1 allocate a sequential number to incur the expenditure required to comply with CRF; 11.5.2 evaluate the Regulatory Control Notice unless CRF, and until Client agrees in writing to purchase (such purchase as appropriate either: 11.5.2.1 request further information; or 11.5.2.2 approve the CRF; or 11.5.2.3 notify EDM HEALTHCARE CONSULTING LTD of the rejection of the CRF; and if approved, arrange for two copies of the approved CRF to be arranged signed for and managed on behalf of the Client and EDM HEALTHCARE CONSULTING LTD. The signing of the CRF will signify acceptance of a Change by both the Client and EDM HEALTHCARE CONSULTING LTD. 11.6 Once signed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use Client and EDM HEALTHCARE CONSULTING LTD in accordance with Clause 11.5, the Change Control Procedure with retrospective effect after implementation shall be immediately effective and the Client and EDM HEALTHCARE CONSULTING LTD shall perform their respective obligations on the basis of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsagreed amendment. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 2 contracts

Sources: Consultancy Agreement, Consultancy Agreement

Change Control. 14.1 Either of Client At any time during the Term, the Catapult may request, or the Contractor Supplier may serve a Change Notice relating to an Inscope Change requiring it (orrecommend, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the scope or execution of the Services by submitting a written change order to the other party setting out the change (which may be in the form set out at Schedule 3 or any other form). If the Catapult requests, or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make Supplier recommends, a change to the scope or execution of the Services, the Supplier shall provide a written estimate to the Catapult of: the likely time required to implement the change; any necessary variations to the Fees arising from the change; the likely effect of the change on the Timetable; and any other impact of the change on this Agreement. The Supplier shall provide the written estimate, referred to in Clause 7.2 above, to the Catapult: (i) if a change is requested by the Catapult, not more than ten (10) Working Days after receipt by the Supplier of the Catapult’s request; and (ii) if a change is recommended by the Supplier, at the same time as the Supplier submits a change order to the Catapult. The Catapult and the Supplier shall respectively procure that Catapult’s Manager and the Supplier’s Manager meet as soon as possible after the written estimate is provided to the Catapult, to discuss the requested change. The Supplier shall not unreasonably withhold its consent to any change requested by the Catapult under Clause 7.1. If the Supplier requests a change to the scope or execution of the Services in order to comply with any applicable safety or statutory requirements, and such changes do not materially affect the nature or scope of the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change NoticeFees, the Contractor Catapult shall make not unreasonably withhold or delay consent to such change. No change to the scope or execution of the Services shall be valid unless and implement until such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as has been set out in Schedule 7 (the “Regulatory Costs”)writing, provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed signed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Servicesduly authorised representatives of both parties. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary Where a change to the Charges. To scope or execution of the extent Services has been proposed, the parties will continue to perform their respective obligations under this Agreement, without taking account of that capital expenditure is required but does not exceed [REDACTED]* thenrequested or recommended change, unless Client elects to purchase these assets in the manner until such change has been set out above, in writing and signed by the * Confidential treatment has been requested with respect to these portions duly authorised representatives of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsboth parties. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 2 contracts

Sources: Agreement for the Purchase of Services, Agreement for the Purchase of Services

Change Control. 14.1 Either of Client 10.1 Changes Not Triggered by Law or by Regulatory Authorities. This Clause 10.1 shall not be applicable to Legal/Regulatory Changes. (a) The Parties shall comply with the Contractor may serve a Change Notice documented change control procedure set out in the QA Agreement for any change affecting the Marketing Authorizations relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) Product in the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice Territory (a “Regulatory Change”). NOVARTIS will not withhold any required consent to a Change Notice”(if any) upon where the Contractor requesting Change that is to be made affects how Product is Processed for Commercialization both inside and outside the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective DateTerritory. 14.4 Where Client serves (b) All implementation costs incurred by either Party in relation to any Change, including the project, qualification, development, Validation, investment, stability testing, and regulatory submission costs, shall be borne by the initiator of the Change. In case of destruction of Packaging Material or other Components as a Regulatory Change Noticeresult of a Change, such costs shall include costs of discard of such materials at purchase price value without ▇▇▇▇-up. In case NOVARTIS shall bear any cost, the Contractor cost shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine be calculated by GW and, unless otherwise agreed to by NOVARTIS, approved by NOVARTIS before any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(sChange. 10.2 Changes Triggered by Law or by Regulatory Authorities (a) If any applicable Law or Regulatory Authority requires any Change (a “Legal/Regulatory Change”), the Party becoming aware of the required Change shall promptly notify the other Party accordingly and shall provide the other Party with copies of any documents delivered to it by the relevant Regulatory Authority, as the case may be, as soon as reasonably practicable following the receipt of such documents. (b) The Parties shall then agree on a plan to implement the Legal/Regulatory Change with a target completion date. Subject to any timeframe imposed by the applicable Law or the relevant Regulatory Authority, GW shall use reasonable efforts to ensure that the implementation of the Legal/Regulatory Changes be deferred to allow NOVARTIS time to amend any relevant Marketing Authorization. In case a timeframe is imposed by the applicable Law or the relevant Regulatory Authority, GW shall implement the Legal/Regulatory Changes within the timeframe required by the Regulatory Authority or applicable Law. (c) All costs of either Party that are related to recording with Regulatory Authorities any Legal/Regulatory Change Noticeshall be borne by GW except where the Legal/Regulatory Change relates exclusively to the Processing and/or Delivery of Product for the Territory or any part thereof, but in which case the costs incurred by either Party related to recording the Legal/Regulatory Change with Regulatory Authorities shall be borne by NOVARTIS. In case any Packaging Material or other Component must be discarded due to a Legal/Regulatory Change, NOVARTIS shall bear the costs relating to a Legal/Regulatory Change in accordance with this Clause 10.2 and shall be responsible for the cost of discarding such materials at purchase price value without ▇▇▇▇-up. 10.3 Implementation of Changes. GW will promptly inform NOVARTIS of any and all Changes that are to be made to the Process before any such Change is implemented and will also promptly inform NOVARTIS of any impact the implementation of such a Change is likely to have on the Direct Manufacturing Cost. GW will not stop Processing according to an existing Process or at an existing Facility until the relevant Change has been Validated (if this is not applicable), all necessary Registrations received and the necessary changes have been made to NOVARTIS’ Regulatory Approvals in any particular country. NOVARTIS will make such changes as soon as reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase notify GW when these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions changes have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsmade. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement

Change Control. 14.1 Either 6.1. SUPPLIER shall be solely responsible for any and all costs with respect to any change or modification that SUPPLIER intends to carry out in respect of Client the Product or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (orManufacture thereof, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make including a change to the Services or the Transition Plan within the timescale specified by Client where there is a Specifications (“Change”). 6.2. SUPPLIER shall be free to unilaterally proceed to any change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation manufacturing of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”)Products, provided that if the capital cost Products supplied after such change comply with the Specifications and the quality criteria as defined under Section 5.4. 6.3. With regard to any changes in the manufacturing which will lead to the Contractor of Products supplied no longer complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*original Specifications, then but to which the Contractor shall not be SUPPLIER and/or its manufacturing subcontractors are mandatorily submitted to, as they are required to incur the expenditure required bring SUPPLIER’s Facility and or it’s subcontractor’s Facility and any general systems, operations and procedures relating to comply its performance of Manufacturing into compliance with cGMP, applicable laws or with the requirements of applicable Regulatory Control Notice unless and until Client agrees in writing Authorities generally, SUPPLIER is obliged to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Servicesinform BUYER before implementation. The parties implementation is nevertheless not subject to BUYER’s approval. In advance of implementing a Change which will subsequently use lead to the Change Control Procedure Products supplied no longer complying with retrospective effect after implementation the original Specifications, SUPPLIER shall, upon BUYER’s request, produce sufficient stock of Product (according to the original Specifications) to enable continued manufacturing of BUYER finished medicinal product while evaluation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational potential impact of the changesChanges on BUYER’s manufacturing process is being performed. BUYER will place the required Purchase Orders in accordance to Section 3. BUYER acknowledges that the implemented Change may affect the shelf life of the Product, and in such cases the guaranteed shelf life according to Section 2.5, shall be adjusted as agreed by the Parties. 6.4. With regard to [***] SUPPLIER may not be capable to produce such stock of Product, in view of the fact, that the [***] Product out the original manufacturing process is manufactured by SUPPLIER’s subcontractor, and this supply agreement with the subcontractor will terminate within the term of this Agreement. Such termination may even lead to SUPPLIER not be capable to confirm all orders for [***] out of the original manufacturing process, depending from the quantities required.

Appears in 1 contract

Sources: Reagent Supply and Technology Transfer Agreement (89bio, Inc.)

Change Control. 14.1 Either 10.1 In recognition of Client or the Contractor may serve potentially continuing and developing nature of the Project Work, this clause sets out the process by which a Change Notice relating may be implemented. 10.2 CLKS may request a Change by submitting a Change Request to an Inscope NIIT. A Change requiring it Request will be so designated and will describe the Change requested in sufficient detail to enable NIIT to prepare a Change Proposal as described in sub-clause 10.5. 10.3 NIIT may also suggest or request a Change by submitting a Change Proposal. 10.4 NIIT must within five (or5) Business Days of receiving a Change Request submit a Change Proposal. 10.5 The Change Proposal will set out the following information: (a) a description of the Change; (b) the estimated effect of implementing the Change on the portion of the Project Work being performed at that time and on the Project Work overall; (c) the further costs, if served any, or any saving to CLKS of implementing the Change and the terms for payment if applicable; (d) a timetable and plan for implementing the Change; (e) any Acceptance Tests CLKS will conduct in relation to the work performed under the Change; (f) NIIT 's recommendation for or against implementing the Change; and (g) any other matters CLKS has set out in the Change Request. 10.6 CLKS may request further details regarding a Change. These further details must be requested by CLKS from NIIT within five (5) Business Days of receiving a Change Proposal from NIIT. NIIT will provide the Contractor, requestingdetails requested within five (5) Business Days of receiving that request. 10.7 NIIT may recommend against implementing any Change requested by CLKS if it is reasonable so to do. Each party must give its reasons for that rejection or recommendation to the other party at the same time as communicating its decision. It is acknowledged and agreed that CLKS is the ultimate decision-maker in any Change Request and NIIT must comply with any decision made by CLKS in respect of them to make an Inscope a Change. 10.8 CLKS will notify NIIT within five (5) Business Days of receiving the Change to Proposal whether it accepts that Change Proposal. If CLKS accepts the Services or Change Proposal, it must countersign the Transition Plan Change Proposal and this Agreement will be varied in accordance with the Change Control Procedure. 14.2 Either of Client or proposed with effect from the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation date of the change(s) required by the Regulatory countersignature. The Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates implemented as set out in Schedule 7 (the “Regulatory Costs”), provided Change Proposal and the Project Work will then include the Change. 10.9 In the event that if CLKS issues a Change Request for the capital cost Software prior to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*Software being ready, then the Contractor shall not parties acknowledge and agree that, having regard to the complexity of and work involved in executing the requested Change, it may be required to incur necessary for the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase Completion Date to be arranged and managed by extended. 10.10 NIIT's calculation of costs for implementing a Change will be on the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation basis of the change(sfollowing: (a) the complexity of the Change; and (b) the Per Man Month Rates required by for the Regulatory Change Notice to determine any necessary change Change. 10.11 CLKS is entitled to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects benefit of any saving of cost to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreementNIIT, and must bear any increase in such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included cost, as a specific addition as part result of the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changesbeing implemented.

Appears in 1 contract

Sources: Custom Software Development Agreement (Click2learn Inc/De/)

Change Control. 14.1 Either of Client or I.13.1. The Agency shall have the Contractor may serve a Change Notice relating right to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make request a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement provided in accordance with the Change Control Procedure prior following provisions. I.13.2. Subject to implementation the Contractor having the technical ability to provide the requested change, a change requested by the Agency shall, subject to the change control process, set out below, be implemented at the Agency’s request. I.13.3. Without prejudice to the foregoing the Agency shall also have the right to decrease the size and/or number and/or location of its premises which are to receive the Services. I.13.4. Any change described in the foregoing Articles (“Amended Service”) shall take effect as amendments (where relevant) to this Contract following the application of the change(schange control processes described below. However, for the avoidance of doubt, a decision by the Agency to request Amended Services is a decision that is within the ultimate decision of the Agency alone. I.13.5. The Contractor shall provide the Agency with a written statement of the expected effects (if any) on the Services for each Specific Contract of the Amended Service, including (but not limited to) matters such as: (a) the Charges; (b) the cost of implementing the change and where the cost is chargeable to the Agency, whether the charge is a single or recurring cost; (c) the duration of the Specific Contract and this Contract; (d) impact on existing Services; (e) whether the change involves or potentially involves any transfer of personnel under the TUPE Regulations; (f) personnel to be involved/required; (g) training to be provided; (h) documentation to be provided; (i) Deliverables and quality of service delivery; (j) working arrangements. I.13.6. If an Amended Service involves closures of premises in circumstances, other than those following a transfer, then the Agency shall give as much notice of its decision as reasonably possible. The Contractor recognises that it may not be possible for the Agency to discuss the possibility of closure until either a late stage in the process or in some cases not until the decision has been taken. I.13.7. The Agency and the Contractor shall work together in co-operation to facilitate the change in the most operationally beneficial, timely and cost-effective way possible. I.13.8. The cost of any change shall be borne as follows: (a) if the change is a requirement of the Agency as to the nature or extent of the Services or their method of performance then the cost shall be borne by the Agency; (b) if the change is a requirement of the Contractor as a result of any requirement of the Contractor to change the nature or extent of the Services or the method of their performance then the cost shall be borne by the Contractor; (c) if a change is required by any regulatory authority or change in the Regulatory Change Noticelaw and practice which affects both the Contractor and the Agency then the cost shall be borne in such proportions as shall be fair and equitable having regard to the nature and impact of the requirement. For the avoidance of doubt, but where the result of any change required by a regulatory authority reduces the costs of the Contractor in providing the Services then the Agency shall be entitled to a reasonable reduction in the Charges the same to be negotiated in good faith if this not agreed. I.13.9. The Agency and the Contractor agree that there may be occasions when the formal change control procedure is not reasonably practicable then Client will pay applicable, such as following a catastrophe or force majeure event or where an acquisition takes place on short notice. In such circumstances, the Agency and Contractor all costs and expenses properly and necessarily incurredshall co-operate in good faith. Such costs The Contractor shall be calculated on remunerated for the provision of additional services or assistance in accordance with the rates for Charges where appropriate or, if not appropriate, then using the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”)published price list or, provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*none, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless on a fair and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsreasonable basis. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Outsourcing Agreement

Change Control. 14.1 Either of Client or 6.1 Following system implementation and sign off the Contractor may serve a Change Notice Customer's Manager and the Supplier's Manager shall meet at least once every [3 months] to discuss matters relating to an Inscope Change requiring the Services. If either party wishes to change the scope or execution of the Services, it (orshall submit details of the requested change to the other in writing. 6.2 Following system implementation, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make Customer requests a change to the Services scope or execution of the Transition Plan Services, the Supplier shall, within a reasonable time, provide a written estimate to the timescale specified by Client where there is a Customer of: (a) the likely time required to implement the change; (b) any necessary variations to the Supplier's charges arising from the change; and (c) any other impact of the change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Dateon this agreement. 14.4 Where Client serves a Regulatory Change Notice6.3 If the Customer wishes the Supplier to proceed with the change, the Contractor shall make Supplier has no obligation to do so unless and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable until the parties shall determine have agreed the necessary variations to its charges, the Services and any necessary variation to the Charges or other relevant terms of this Agreement agreement to take account of the change and this agreement has been varied in accordance with clause 16. 6.4 Notwithstanding clause 6.6, the Change Control Procedure prior Supplier may, from time to implementation of time and without notice, change the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out Services in Schedule 7 (the “Regulatory Costs”)order to comply with any applicable safety or statutory requirements, provided that if such changes do not materially affect the capital cost to nature, scope of, or the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide charges for the Services. The parties will subsequently use Supplier may, from time to time and subject to Customer's prior written consent, which shall not be unreasonably withheld or delayed change the Change Control Procedure with retrospective effect after implementation Services, provided that such changes do not materially affect the nature or quality of the change(s) required by Services and, where practicable, it will give the Regulatory Change Notice to determine Customer at least three months' notice of any necessary change. 6.5 During the process of implementation, if the Customer requests a change to the Charges. To scope of services required which is at variance to the extent that capital expenditure is Summary of Understanding document and over the period of implementation has a collective impact of increasing the Supplier implementation resources required but does not exceed to satisfactorily deliver the system by a factor exceeding [REDACTED]* then, unless Client elects to purchase these assets in 10%] of the manner set out abovetotal agreed at the outset, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior Supplier will provide a written estimate to the Charges being adjusted Customer of: (a) the likely time required to reflect this change will be included as a specific addition as part of implement the Change Control Procedure, along with change/s; (b) any changes necessary variations to ongoing costs.the Supplier's charges arising from the change/s; and 14.5 Any changes to Regulations (c) any other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changeschange on this agreement. 6.6 If the Customer wishes the Supplier to proceed with the change, the Supplier has no obligation to do so unless and until the parties have agreed the necessary variations to its charges, the relevant Project Plan and any other relevant terms of this agreement to take account of the change and this agreement has been varied in accordance with clause 16. 6.7 The Supplier may charge for the time it spends assessing a request for change from the Customer on a time and materials basis in accordance with clause 7.

Appears in 1 contract

Sources: Contract for the Supply and Installation of a Workforce Management System

Change Control. 14.1 Either of Client 16.1 If either Penn T or the Contractor may serve PPSL wishes to propose any amendment or modification to this Agreement (a Change Notice relating to an Inscope Change requiring "Change") then it (or, if served by the Contractor, requesting) will notify the other of them to make an Inscope that fact by sending a written notification ("Change Request"), specifying in reasonable detail the nature of the Change. 16.2 As soon as reasonably practicable (but in any event within 14 days) after sending or receipt of a Change Request), PPSL will provide Penn T with a brief written proposal in relation to the relevant Change (a "Change Proposal") including, but not limited to: (a) summary of the scope of the Change; (b) brief details of the likely impact, if any, of the Change Request on the existing Services or PPSL's obligations under this Agreement; and (c) an estimate of the Transition Plan likely cost of implementation and/or on-going operation of the relevant Change. 16.3 Where the Change is required by Relevant Law or where the Change is required or is necessary for the commercial or clinical manufacture of any formulation of Thalidomide, PPSL shall, as soon as practicable, provide to Penn T a Change Control Notice as set forth in clause 16.4 below. Where the Change relates to any other service including without limitation Excluded Services it shall be at PPSL's discretion whether to proceed under this Agreement or negotiate with Penn T the terms of a separate agreement. 16.4 If, following receipt of the Change Proposal, Penn T wishes to proceed with the proposed Change, it will notify PPSL in writing of such intention (assuming that all requisite details are not already set out in the Change Proposal). Within 30 days after receiving written notice from Penn T to proceed with the proposed Change, PPSL shall provide Penn T with a detailed written proposal (a "CHANGE CONTROL NOTICE") including, but not limited to the following matters: (a) full details of the proposed subject matter of the Change Request including any outline specifications, requirements for equipment, special conditions, deliverables or other variations of this Agreement required; (b) details of the impact, if any, of the Change Request on any existing Services or PPSL's obligations under this Agreement; (c) an itemised statement of the estimated charges made on the basis of the Fees calculation in Schedule 2 for the implementation and/or ongoing operation of the relevant Change; and (d) a timetable for the implementation, together with any proposals for acceptance, of the Change Request. 16.5 Penn T will review the proposed Change Control Notice as soon as reasonably possible after its receipt and in any event within 15 days will either accept or reject the proposed Change Control Note. If the Change Control Notice has not been formally rejected within such 15 day period, it shall be deemed accepted. If Penn T rejects the Change Control Notice, the Parties shall negotiate in good faith to agree the provisions of the Change Control Notice and where no agreement is reached within thirty (30) days of receipt by Penn T of the Change Control Notice, the issue shall be resolved in accordance with clause 32. 16.6 If Penn T accepts the proposed Change Control Notice, PPSL will make the Change in accordance with that Change Control Notice and the provisions of this Agreement. A Change Control Notice shall be treated as accepted when it is signed by Penn T and PPSL and will constitute an amendment to this Agreement. 16.7 Neither Penn T or PPSL shall have any obligation to effect any proposed Change until the relevant Change Control Notice is agreed by Penn T and pursuant to clause 16.6. 16.8 Changes agreed in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve procedure above shall constitute a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation satisfaction of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsclause 29. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Technical Services Agreement (Celgene Corp /De/)

Change Control. 14.1 Either of Client or the Contractor may serve a Change Notice The Client’s Manager and EMEs Manager shall liaise as often as is reasonably necessary to discuss matters relating to an Inscope Change requiring the Project. If either party wishes to change the scope or execution of the Services, it (or, if served by shall submit details of the Contractor, requesting) requested change to the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting writing. Where reasonably practicable, EME shall (in its absolute discretion) accommodate changes to the Services Order requested by the Client but shall be under no obligation to do so. In any event, no changes to the Order will be accepted unless requested at least 3 hours before the Start Time. Any request to change the Order shall be made by the Client to EME including alterations to call times: (if made 24 hours or less before the Start Time or on a non-business day) by telephone to the year-round telephone number notified to the Client by EME; or (if more than 24 hours before the call Time on a business day) by email to the email address notified to the Client by EME. The Client shall not be entitled to request changes to the Order by SMS, or by direct request to the Crew or the Transition Plan Crew Chief and no changes requested by the Client in accordance with this way will be accepted unless otherwise agreed between the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make Parties in writing. Where EME accepts a change to the Services or Order, it shall (as soon as reasonably practicable) raise and send to the Transition Plan within Client a further Order Confirmation detailing the timescale specified by Client where there is changes and any applicable additional Charges. If a change to the Order results in UK Regulations additional Charges, EME shall be entitled (in its absolute discretion) to issue a separate invoice for the additional Charges. Any changes accepted by EME form part of the Contract. If either party requests a change to the scope or execution of the Services, EME shall, within a direction by reasonable time, provide a Regulatory Authority written quotation to the Client of: (a) the likely time required to implement the change; T&C_Rev1.2 (b) any necessary variations to EMEs charges arising from the change; (c) the likely effect of the change on the Brief; and (d) any other impact of the change on this Agreement. If the Client wishes EME to proceed with regard the change, EME has no obligation to UK Regulations after do so unless and until the Effective Date. 14.4 Where Client serves a Regulatory Change Noticeparties have agreed the necessary variations to its charges, the Contractor shall make Brief and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other relevant terms of this Agreement to take account of the change and this Agreement has been varied in accordance with these terms and conditions Where extemporary changes are requested onsite or during production implementation that are outside the Change Control Procedure prior scope of original quotation EME recognise, informal confirmation received electronically or verbally as constituting acceptance of additional charges incurred when delivering time critical, client instructed extemporary changes. EME may, from time to implementation of time and without notice, change the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out Services in Schedule 7 (the “Regulatory Costs”)order to comply with any applicable safety or statutory requirements, provided that if such changes do not materially affect the capital cost to nature, scope of, or the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide charges for the Services. The parties will subsequently use EME may, from time to time change the Change Control Procedure with retrospective effect after implementation Services, provided that such changes do not materially affect the nature or quality of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsServices. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Terms and Conditions

Change Control. 14.1 Either of Client or the Contractor may serve 28.1 Any requirement for a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or provisions of this Agreement shall be subject to the Transition Plan in accordance with the provisions of schedule 8.2 (Change Control Procedure). 14.2 Either of Client 28.2 The Hosting Supplier shall consider throughout the Term the extent to which any actual or potential Change (whether proposed by it or someone else) might have an impact on wider FITS Services and Cross Tower Services, services and arrangements with Exiting Suppliers and its or any Other FITS Supplier’s Tower Service Agreement or any Collaborating Supplier’s Supply Agreement, shall identify this clearly as early as possible and shall co-operate with the Contractor may serve a Other FITS Suppliers, the Authority and applicable Exiting Suppliers to ensure that Change Notice relating to an Outscope Change upon is dealt with as efficiently and effectively as possible from the other of them requesting changes Authority’s perspective. In particular and without limitation to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Noticegenerality of this, the Contractor Hosting Supplier shall make provide information and implement such change within cooperation to Other FITS Suppliers, Collaborating Suppliers and to Exiting Suppliers to enable all bodies involved to assess the timescale specified in the Regulatory impact of and potential approaches to dealing with Changes. Where a particular Change Notice. If reasonably practicable the parties shall determine any necessary variation may or will require amendments to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation more than one of the change(sAgreement, Master Services Agreement, Tower Service Agreement, Supply Agreement and/or Exiting Contract, the Hosting Supplier shall work with Other FITS Suppliers, Collaborating Suppliers and the Authority (and, where applicable, the relevant Exiting Supplier) required by to ensure that the Regulatory Change Noticeapplicable change control procedures are aligned and operate to implement the Changes and associated amendments consistently. This may include, but if at the Authority’s discretion and without limitation, amending timescales which apply to change control procedures (without this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates counting as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(sFast-track Change procedure) required by and swapping between change control procedures (in which case the Regulatory Change Notice to determine any necessary detailed steps under change to control procedures may, at the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* thenAuthority’s discretion, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted be amended to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsanalysis already carried out and agreements and discussions already held). 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Hosting Services Agreement

Change Control. 14.1 Either The change control process is required to: • assess and document the impact of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (orscope changes on project schedules, if served resources, prices, payment schedule, deliverables, acceptance criteria, and other provisions of this SOW impacted by the Contractor, requesting) the other of them proposed change; • provide a formal vehicle for approval to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along proceed with any changes to ongoing coststhis SOW and; • provide a project audit record of all material changes to the original SOW. 14.5 A. Any changes, additions or deletions to the work effort hereunder including to the scope of work set out in section 3.1, will be handled as follows: I. In the case where Placer County Sheriff’s Office or ATIMS determine a change is required or desirable to the project, the requesting party will complete a change request form (Change Request or CR) and advance the CR for sign off by the other party; II. Upon execution by each party, a CR will become a Change Order and form part of this SOW; and III. If the Parties do not execute and deliver to one another a Change Order, the prior obligations of each party under this SOW will remain unchanged. B. The Project Sponsors and Project Managers (Placer County Sheriff’s Office and ATIMS) must approve all changes to Regulations other than changes this SOW, pursuant to a Change Order. C. In a situation where a proposed change will impact the project significantly, whether it be time, money or incurrence of UK Regulations shall be at the risk scope, a Change Order may need to operate as a separate and cost unique work assignment independent of the Contractorproject schedule, resources, price, payment schedule, deliverables, milestones, acceptance criteria or other provisions of this SOW. Without limitation For example, ATIMS was asked to this the Contractor may serve develop a Change Notice where these changes require Who’s-in-Custody website during a previous implementation. This change was handled as a separate work order, thereby taking it to provide Services in a different manner operationally to address the operational impact out of the changescritical path of the project. D. If and when required, the Placer County Sheriff’s Office will ensure each and every Change Order is accompanied by the appropriate pre-approved payment vehicle (purchase order, contract amendment or otherwise) to facilitate billing by ATIMS. A sample Change Request is attached in Appendix A of this document.

Appears in 1 contract

Sources: Information Systems Agreement

Change Control. 14.1 Either Notwithstanding anything herein to the contrary, NASTECH shall not amend, change or supplement any of Client the following without MERCK's prior written consent (which consent may not be unreasonably withheld or the Contractor delayed with respect to clauses (C), (E), or (G)), except as may serve a Change Notice relating be required to an Inscope Change requiring it comply with applicable laws and regulations and REGULATORY AUTHORITY requirements: (or, if served by the Contractor, requestingA) the other SPECIFICATIONS; (B) the MATERIALS; (C) the source of them to make an Inscope Change to MATERIALS; (D) the Services specifications for MATERIALS; (E) the equipment used in the MANUFACTURE; (F) the test methods used in connection with the MANUFACTURING of PRODUCT and MATERIALS; and (G) the process for MANUFACTURING PRODUCT or MATERIALS. Any change in any of the Transition Plan foregoing shall, in each case, comply with cGMPs and all applicable laws, regulations and REGULATORY AUTHORITY requirements and should be made in accordance with the Change Control Procedure. 14.2 Either CHANGE CONTROL PROCEDURE (as defined below). In the event that NASTECH needs to change any of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other foregoing, NASTECH shall (i) immediately notify MERCK of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice such change, (a “Regulatory Change Notice”ii) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Noticebe responsible, the Contractor shall make at its expense, for ensuring that all ACTIVE PHARMACEUTICAL INGREDIENT and implement PRODUCT MANUFACTURED following such change within meets the timescale specified in SPECIFICATIONS and (iii) provide MERCK with all information needed to amend the Regulatory Change Notice. If reasonably practicable the parties shall determine REGISTRATIONS and any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested regulatory filings maintained with respect to these portions of PRODUCT. NASTECH shall continue to supply MERCK with PRODUCT approved under NASTECH's DMF, MERCK's then existing REGISTRATIONS and other regulatory filings for PRODUCT until such time as the agreementACTIVE PHARMACEUTICAL INGREDIENT or PRODUCT MANUFACTURED following such change is permitted under the REGISTRATIONS and other regulatory filings for ACTIVE PHARMACEUTICAL INGREDIENT and PRODUCT. If NASTECH or its supplier is responsible for regulatory filings and obtaining REGULATORY AUTHORITY [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, and WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] approvals, NASTECH must immediately notify MERCK whether such confidential portions changes have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsapproved or rejected. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Supply Agreement (Nastech Pharmaceutical Co Inc)

Change Control. 14.1 Either (a) Subject to this Article IX, either Party may propose any change or addition to the Transition Services by written notice to the other Party specifying the proposed change in reasonable detail (such notice, a "Change Request"). (b) Seller or Buyer shall provide the other Party with a reasonably detailed written outline specification describing the nature of Client the change, an assessment of the impact of the change on the Transition Services, the Service Fees (as applicable) and an estimate of the time required to implement the change, the costs associated with the change and the terms for payment of such costs (such outline, an "Evaluation Report") within twenty (20) Business Days of receiving the Change Request. (c) The approving Party shall notify the requesting Party within ten (10) Business Days of the date on which the Evaluation Report was received whether or not the approving Party wishes to proceed with the Change Request; provided, however, that the Parties shall in good faith negotiate the terms and pricing of the Change Request before the requesting Party provides such notice to proceed. (d) Within ten (10) Business Days of receipt of the requesting Party's notice to proceed with the Change Request, the approving Party shall produce a final Evaluation Report which shall include a comprehensive list of the charges for the implementation of the Change Request ("Change Request Charges"). Any Change Request Charges shall be calculated in a manner consistent with Section 2.1. (e) Both the Seller and Buyer shall act in good faith in relation to Change Requests, and shall not unreasonably withhold any consent, or cause any delay in relation to them; provided that, notwithstanding anything to the contrary herein, the approving Party shall have sole discretion regarding whether to provide Additional Transition Services which were not performed by Seller or Buyer for the Business at any time during the one hundred eighty (180) day period prior to Closing. If the Seller and Buyer cannot agree upon a Change Request or the Contractor approving Party's final Evaluation Report (including the Change Request Charges), each of the Seller and Buyer may serve a Change Notice relating refer the matter to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan be resolved in accordance with the Change Control ProcedureSection 1.2. 14.2 Either of Client or the Contractor may serve a Change Notice relating (f) The Seller shall not have any obligation to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan commence work in accordance connection with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a any change to the approving Party Transition Services or any Additional Transaction Services until the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory relevant Change Notice, the Contractor shall make Request and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment Evaluation Report has been requested with respect agreed to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsby each Party in writing. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Transition Services Agreement (Customers Bancorp, Inc.)

Change Control. 14.1 Either of Client 2.3.1 Supplier may not, and shall procure that its CDMOs shall not, implement any Manufacturing Change that requires notification to or the Contractor may serve approval of a Regulatory Authority in the Territory, or requires approval of Purchaser under the terms of the Quality Agreement, until such Manufacturing Change Notice relating has been notified as required under Applicable Law, has the relevant approval from the applicable Regulatory Authority in the Territory or has been approved by Purchaser under the terms of the Quality Agreement (as applicable). 2.3.2 Subject to an Inscope Change requiring it Clause 2.3.1 and Clause 2.3.4, Supplier has the right to propose Manufacturing Changes with respect to any Drug Product (orincluding, if served by the Contractorfor clarity, requesting) the other of them to make an Inscope Change to the Services changes to, or the Transition Plan addition of, Facilities) as further set forth in this Clause 2.3 and in accordance with any applicable requirements set forth in the Change Control Procedure. 14.2 Either Quality Agreement. Unless otherwise agreed by the Parties, any Manufacturing Changes proposed by Supplier shall have a minimum target term for implementation of Client or [***] from the Contractor may serve a Change Notice relating to an Outscope Change upon date of the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory relevant Change Notice; unless a shorter time period (a) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction required by a Regulatory Authority or (b) is necessary, in Supplier’s reasonable opinion, due to safety or other regulatory concerns or as a result of recalls. If Supplier wishes to make a Manufacturing Change with regard respect to UK Regulations after the Effective Date. 14.4 Where Client serves any Drug Product, it shall provide Purchaser with prompt written notice of such determination and description of such proposed Manufacturing Change, including expected timelines for implementation (a Regulatory “Change Notice”). Upon receipt of a Change Notice, Purchaser shall promptly assess such proposed Manufacturing Change and, upon assessment of such change, and in no event no later than next meeting of the Contractor Parties or the JCC in accordance with Clause 3.1 (provided that such meeting takes place not earlier than [***] Business Days of receipt of such Change Notice), Purchaser shall make provide written notice to Supplier confirming the regulatory impact, including the impact on Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, if any, for the Territory with any estimated filing, notice and implement approval dates, as applicable and as available (“Change Response”). If Supplier reasonably believes that implementation of a proposed Manufacturing Change may be required by a Regulatory Authority on a shorter time period than the time periods set out in this Clause 2.3.2, then Supplier shall include such change within the timescale specified timelines in the Regulatory applicable Change Notice. If reasonably practicable Purchaser believes such proposed Manufacturing Change (x) impacts Purchaser’s ability to obtain or maintain the parties shall determine any necessary variation applicable Marketing Authorization, (y) requires notice to or approval of a Regulatory Authority in the Charges Territory or other (z) requires approval of Purchaser under the terms of this Agreement the Quality Agreement, then Purchaser shall include in the Change Response a request to meet with Supplier to determine if such proposed Manufacturing Change meets subclauses (x) through (z) above. Within [***] Business Days of Supplier’s receipt of Purchaser’s request to meet, or such shorter time period as may be required by such Regulatory Authority, the Parties shall meet and determine if such Manufacturing Change would (i) impact Purchaser’s ability to obtain or maintain the applicable Marketing Authorization, (ii) require notice to or approval of a Regulatory Authority in the Territory or (iii) require approval of Purchaser under the terms of the Quality Agreement. Any determination with respect to notice to or approval of a Regulatory Authority in the Territory shall be subject to Section 2.2.2 of the License Agreement. Purchaser shall provide a Change Response to Supplier within [***] Business Days of receipt of such Change Notice. (a) If a proposed Manufacturing Change other than a Required Manufacturing Change for which Supplier has provided a Change Notice (i) does not impact Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization and (ii) does not require notice to or approval of any Regulatory Authority in the Territory and (iii) does not require approval of Purchaser under the terms of the Quality Agreement, as determined in accordance with Clause 2.3.2 (each, a “Supplier Territory Manufacturing Change”), then Supplier may implement or procure the implementation of such Supplier Territory Manufacturing Change Control Procedure prior without further approval from Purchaser; provided that Supplier keeps Purchaser reasonably informed regarding the implementation of such Supplier Territory Manufacturing Change. Supplier shall have the final say with respect to any Supplier Manufacturing Change. The costs of any Supplier Manufacturing Change will be borne by [***]. (b) If a proposed Manufacturing Change other than a Required Manufacturing Change for which Supplier has provided a Change Notice (i) impacts Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization, (ii) requires notification to or the approval of a Regulatory Authority in the Territory, (iii) or requires approval of Purchaser under the terms of the Quality Agreement, as determined in accordance with Clause 2.3.2 (each, a “Major Manufacturing Change”), then Purchaser shall, as applicable (x) file any required notifications with the applicable Regulatory Authorities or (y) upon approval of such Major Manufacturing Change in accordance with this Clause 2.3.2(b), [***] obtain any required approvals from the applicable Regulatory Authorities, in each case ((x) and (y)), as soon as possible. Purchaser shall, in accordance with and subject to Section 2.2.3 of the License Agreement, be responsible for communications with the Regulatory Authorities in the Territory with respect to any such notifications or approvals and for filing any necessary documents or consents required to obtain any such approval or with respect to any required notification (as applicable). Supplier shall, upon the request of Purchaser, provide reasonable cooperation with any such filing to the extent reasonably required. Purchaser shall promptly, and in no event later than [***] Business Days thereafter, notify Supplier upon receipt of any required approval from the applicable Regulatory Authority or the filing of any required notification in order to enable Supplier to implement or procure the implementation of the change(s) required by Major Manufacturing Change. If Purchaser does not obtain approval of the Major Manufacturing Change from the applicable Regulatory Authority in a country in the Territory, or if Purchaser becomes aware of a potential failure to timely receive such approval, Purchaser shall promptly, and in no event later than [***] Business Days thereafter, notify Supplier thereof. In such event, the Parties shall discuss in good faith potential options with respect to such Major Manufacturing Change and agree on any such Major Manufacturing Change before it is implemented. Any Major Manufacturing Change that impacts Purchaser’s ability to obtain or maintain the Drug Product’s Marketing Authorization or requires the approval of a Regulatory Authority in the Territory or approval of Purchaser under the terms of the Quality Agreement shall require the mutual agreement of the Parties and the approval of the Regulatory Authority (as applicable) prior to implementation. In the event the Parties are unable to agree, then such decision regarding the Major Manufacturing Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall would be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), deadlocked; provided that if the capital cost Purchaser shall have final say with respect to any such Major Manufacturing Change to the Contractor extent relating solely to the Territory. The costs of complying any Major Manufacturing Change will be allocated in accordance with the Clause 2.3.4. 2.3.3 If a Regulatory Authority requests or requires any Manufacturing Change, or Supplier determines in good faith a Manufacturing Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure is required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* thenApplicable Law, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions the Manufacture of a Drug Product or its Specifications (each, a “Required Manufacturing Change”), then the Parties shall each, acting reasonably and in good faith, use reasonable endeavors to agree an action plan in relation to the implementation of such Required Manufacturing Change within [***] Business Days, or such shorter time period as may be required by such Regulatory Authority, of receipt of notice from the Regulatory Authority of the agreementRequired Manufacturing Change. If either Party receives notice, or is otherwise informed of, any Required Manufacturing Change, such Party will deliver notice thereof to the other Party as promptly as practicable, and such confidential portions in no event later than [***] Business Days thereafter. Supplier shall have been deleted and filed separately the final say with the Securities and Exchange Commission pursuant respect to Rule 24b-2 any Required Manufacturing Changes. The costs of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change any Required Manufacturing Change will be included as a specific addition as part of the Change Control Procedure, along allocated in accordance with any changes to ongoing costsClause 2.3.4. 14.5 Any changes to Regulations other than changes to 2.3.4 [***] shall bear any implementation costs associated with a Major Manufacturing Change or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changesRequired Manufacturing Change, unless [***].

Appears in 1 contract

Sources: Supply Agreement (NewAmsterdam Pharma Co N.V.)

Change Control. 14.1 Either The Customer may at any time request or iP Edge may at any time recommend a change or modification to any agreed Workshop Document including any Specification agreed for the purposes of Client these terms or the Contractor may serve any Services agreed to be provided hereunder (a Change Notice relating “Controlled Change”) and propose an amendment to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan these terms in accordance with the formal Change Control Procedure.Procedure (“CCP”) as set out in this clause 7 14.2 Either 7.1 Unless the Customer and iP Edge otherwise agree in writing there shall be no presumption that the obligations undertaken by either party in connection with these terms or under any Workshop Document if applicable which may be the subject of Client a Controlled Change are in any way changed until the amendment to these terms or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan Workshop Document has been effected in accordance with the CCP 7.2 The Customer and iP Edge shall first discuss Controlled Changes proposed by either party and such discussion will result in the parties agreeing either 7.2.1 to not proceed further with a Controlled Change Control Procedure.or 14.3 Client may serve 7.2.2 that the Customer shall submit a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make written request for a change to the Services or Supplier or 7.2.3 that the Transition Plan within the timescale specified by Client where there is Supplier shall submit a written recommendation for a change to the Customer 7.3 Where a written request for a change is received from the Customer, iP Edge shall, unless otherwise agreed, submit a Change Control Note (“CCN”) to the Customer within three weeks of receipt of the written request. A written recommendation for a change by iP Edge shall be submitted as a CCN direct to the Customer at the time of such recommendation 7.4 Each CCN shall be represented in UK Regulations approved project management software and contain 7.4.1 a sequential CCN number if appropriate 7.4.2 the originator and the date of the request or recommendation for the change 7.4.3 full details of the change including any changes required to Workshop Documents, Coding Designs or Application or Software specifications, functions or facilities or to Services 7.4.4 the estimated effort of the change if appropriate 7.4.5 a direction timetable for implementation together with any proposals for acceptance of the change if appropriate 7.4.6 a schedule of payments or revised payments if appropriate 7.5 In the absence of any express agreement to the contrary in a CCN, iP Edge shall not warrant that the content or implications legal or factual of any CCN is accurate or complete, each party being responsible for its own due diligence, enquiry, analysis and determinations in relation to all matters covered by any CCN. Notwithstanding the foregoing, iP Edge shall prepare any CCN with all due skill and care 7.6 For each CCN submitted the Customer shall evaluate the CCN and as appropriate either 7.6.1 request further information or 7.6.2 approve the CCN or 7.6.3 notify iP Edge of its rejection of the CCN 7.7 In the event of a Regulatory Authority with regard to UK Regulations after request for further information or rejection by the Effective Date. 14.4 Where Client serves Customer of a Regulatory Change NoticeCCN under clause 7.6, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation use their respective best endeavours to negotiate and agree an amended CCN within the Charges original period of validity of such CCN. In the event that the Customer does not approve a CCN within the period of its validity, iP Edge shall be entitled to charge its reasonable fees and charges for preparing such CCN 7.8 If approved (as originally submitted or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation as amended), such approved CCN shall be confirmed accepted by an authorised person on behalf of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs Customer and expenses properly and necessarily incurrediP Edge. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation confirmation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect CCN will signify acceptance of a formal amendment to these portions of terms and any applicable Workshop Document by both the agreement, Customer and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.iP Edge

Appears in 1 contract

Sources: Services Agreement

Change Control. 14.1 Either of Client At any time during the Term, the Catapult may request, or the Contractor Supplier may serve a Change Notice relating to an Inscope Change requiring it (orrecommend, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the scope or execution of the Services by submitting a written change order to the other party setting out the change (which may be in the form set out at Schedule 3 or any other form). If the Catapult requests, or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make Supplier recommends, a change to the scope or execution of the Services, the Supplier shall provide a written estimate to the Catapult of: the likely time required to implement the change; any necessary variations to the Fees arising from the change; the likely effect of the change on the Timetable; and any other impact of the change on this Agreement. The Supplier shall provide the written estimate, referred to in Clause 7.2 above, to the Catapult: (i) if a change is requested by the Catapult, not more than ten (10) Working Days after receipt by the Supplier of the Catapult’s request; and (ii) if a change is recommended by the Supplier, at the same time as the Supplier submits a change order to the Catapult. The Catapult and the Supplier shall respectively procure that ▇▇▇▇▇▇▇▇’s Manager and the Supplier’s Manager meet as soon as possible after the written estimate is provided to the Catapult, to discuss the requested change. The Supplier shall not unreasonably withhold its consent to any change requested by the Catapult under Clause 7.1. If the Supplier requests a change to the scope or execution of the Services in order to comply with any applicable safety or statutory requirements, and such changes do not materially affect the nature or scope of the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change NoticeFees, the Contractor Catapult shall make not unreasonably withhold or delay consent to such change. No change to the scope or execution of the Services shall be valid unless and implement until such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as has been set out in Schedule 7 (the “Regulatory Costs”)writing, provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed signed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Servicesduly authorised representatives of both parties. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary Where a change to the Charges. To scope or execution of the extent Services has been proposed, the parties will continue to perform their respective obligations under this Agreement, without taking account of that capital expenditure is required but does not exceed [REDACTED]* thenrequested or recommended change, unless Client elects to purchase these assets in the manner until such change has been set out above, in writing and signed by the * Confidential treatment has been requested with respect to these portions duly authorised representatives of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsboth parties. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Agreement for the Purchase of Services

Change Control. 14.1 Either of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to PARTIES shall make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to configuration controlled documents in observance of all notification requirements of any respective HEALTH AUTHORITY. X X SUPPLIER shall provide COMPANY with prior written notification of all changes to MANUFACTURING MATERIALS, COMPONENTS, PRODUCT, equipment and methods that may impact the Services PRODUCT-regulatory filings or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve require a notice (regulatory submission and shall not issue a “Regulatory Change Notice”) upon the Contractor requesting the Contractor MANUFACTURER’S RELEASE for any batches manufactured under such change until any needed regulatory approval are obtained. X SUPPLIER shall provide changes to make PRODUCT-specific master manufacturing and testing documentation to COMPANY for review and approval prior to implementing any such changes. X X Minor editorial or administrative changes do not need to be reported to COMPANY, but such changes must be appropriately documented and assessed according to SUPPLIER’s approved internal procedures. If a change question arises as to the Services what constitutes a minor editorial or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Noticean administrative change, the Contractor PARTIES shall make and implement such change within the timescale specified discuss a resolution in the Regulatory Change Noticegood faith. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to X After implementation of the change(sapproved changes at SUPPLIER, SUPPLIER shall use its best efforts to promptly forward a copy of the relevant revised PRODUCT-specific documents to COMPANY. X COMPANY is responsible for the timely reporting of changes in PRODUCT-specific documentation to the applicable licensee and/or HEALTH AUTHORITY. X COMPANY shall be responsible for the generation and submission of any regulatory documents. X SUPPLIER shall assist in providing and compiling information concerning any relevant parts of any regulatory submissions or supplements required by a HEALTH AUTHORITY. This shall apply to all information necessary to author regulatory submission or correspondence. X COMPANY shall provide SUPPLIER a reasonable period of time in order to review and provide comments prior to the submission of any regulatory correspondence (this includes the submission or updates thereof) relevant to SUPPLIER’s manufacturing or testing processes or facilities. Such review, possible commenting and release, respectively, shall be carried out within thirty (30) working days upon receipt of such documentation unless otherwise agreed. This clause shall not be interpreted as to prevent COMPANY from fulfilling their legal obligations if SUPPLIER does not respond within the mutually agreed timeframe. X COMPANY shall provide copies of all parts of correspondence with HEALTH AUTHORITIES relating to SUPPLIER’s manufacture of the PRODUCT to SUPPLIER. X SUPPLIER shall file and maintain for its facility a Site Device Master Record (DMR), or such equivalent, as required by the Regulatory Change NoticeFDA. X For regulatory purposes, but if this is not reasonably practicable then Client will pay COMPANY shall have the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost rights to refer to the Contractor of complying Site DMR or to other similar documents. X SUPPLIER shall upon reasonable request and prior notice, give COMPANY access during normal business hours to information in the Site DMR, and other similar documents which are necessary to complete regulatory documentation related to PRODUCT and its manufacture in SUPPLIER’s facility. X SUPPLIER shall co-operate with the Regulatory Change Notice FDA or other such regulatory body, as requested by COMPANY and in terms response to matters concerning or impacting the PRODUCT. X SUPPLIER shall notify COMPANY of capital expenditure will exceed [REDACTED]*any communication with the FDA (or other such agency) concerning the PRODUCT or impacting the PRODUCT and shall co-operate with COMPANY in the scheduling of any planned inspection concerning the PRODUCT. X Each Party shall promptly notify the other PARTY of new regulatory requirements, then which it may become aware with respect to the Contractor manufacture, testing, packaging, labeling, certifications, and storage of the PRODUCT and shall not be required to incur confer with each other about the expenditure required best means to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Servicesrequirements. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) X X If a manufacturing process change or release requirement is required by the Regulatory Change Notice a HEALTH AUTHORITY, each party shall provide reasonable technical and regulatory assistance to determine support any necessary change regulatory filings that the filing party will make to the Chargesobtain regulatory approval. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.X X

Appears in 1 contract

Sources: Services and Supply Agreement (diaDexus, Inc.)

Change Control. 14.1 Either (1) ▇▇▇▇▇▇ shall utilize a documented system of Client or procedures for the Contractor may serve a Change Notice relating control of quality related changes to an Inscope Change requiring it raw materials, components, packaging materials, Manufacturing Manual, and Specification, and suppliers. (or, if served 2) Any changes directly affecting the Production of the Product and its testing as set forth in Appendix 5 shall be reviewed and approved in writing by the Contractor, requesting) the other duly authorized representatives of them to make an Inscope Change NPS and ▇▇▇▇▇▇ prior to the Services respective implementation thereof. (3) In accordance with said Change Control Procedure, ▇▇▇▇▇▇ shall keep NPS informed of, and NPS shall have pre-approval of, significant contemplated changes, including improvements, in the ▇▇▇▇▇▇ Supplied Materials to be incorporated in the Product. If NPS does not reasonably agree to incorporate any such changes in the Product, ▇▇▇▇▇▇ may cease Production of the Product immediately if these changes are necessary to comply with any laws or regulations as well as practices of Regulatory Authorities. If ▇▇▇▇▇▇ agrees to continue the Transition Plan in Production of the Product without incorporation of such changes, and NPS has withheld its consent unreasonably, NPS shall bear all responsibility (including any product liability) for the consequences of any such non-incorporation. (4) In accordance with the Change Control Procedure, NPS may request that changes be incorporated in the manufacture of the Product, and ▇▇▇▇▇▇ shall implement such changes, subject to ▇▇▇▇▇▇ and NPS agreeing to any necessary amendments to the Commercial Manufacturing Agreement, including, without limitation, price adjustment, capacity and ability to incorporate such changes and approvals of any other customers of ▇▇▇▇▇▇ as may be required. 14.2 Either (5) ▇▇▇▇▇▇ agrees to keep NPS informed as set forth in this Article 23 as long this QA is in effect and force, provided however that ▇▇▇▇▇▇ actually manufactures the Product. In the event the Product is not manufactured within a time period of Client or more than three (3) years, ▇▇▇▇▇▇ shall have no obligation under this QA to inform NPS accordingly. However ▇▇▇▇▇▇ will inform NPS in writing of their intention not to continue alerting NPS to changes. If manufacture of the Contractor may serve Product resumes after a Change Notice relating to an Outscope Change upon period of greater than three (3) years then the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified that occurred in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change intervening period will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsreviewed by both parties before production starts. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Commercial Manufacturing Agreement (NPS Pharmaceuticals Inc)

Change Control. 14.1 Either Notwithstanding anything herein to the contrary, NASTECH shall not amend, change or supplement any of Client the following without MERCK's prior written consent (which consent may not be unreasonably withheld or the Contractor delayed with respect to clauses (C), (E), or (G)), except as may serve a Change Notice relating be required to an Inscope Change requiring it comply with applicable laws and regulations and REGULATORY AUTHORITY requirements: (or, if served by the Contractor, requestingA) the other SPECIFICATIONS; (B) the MATERIALS; (C) the source of them to make an Inscope Change to MATERIALS; (D) the Services specifications for MATERIALS; (E) the equipment used in the MANUFACTURE; (F) the test methods used in connection with the MANUFACTURING of PRODUCT and MATERIALS; and (G) the process for MANUFACTURING PRODUCT or MATERIALS. Any change in any of the Transition Plan foregoing shall, in each case, comply with cGMPs and all applicable laws, regulations and REGULATORY AUTHORITY requirements and should be made in accordance with the Change Control Procedure. 14.2 Either CHANGE CONTROL PROCEDURE (as defined below). In the event that NASTECH needs to change any of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other foregoing, NASTECH shall (i) immediately notify MERCK of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice such change, (a “Regulatory Change Notice”ii) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Noticebe responsible, the Contractor shall make at its expense, for ensuring that all ACTIVE PHARMACEUTICAL INGREDIENT and implement PRODUCT MANUFACTURED following such change within meets the timescale specified in SPECIFICATIONS and (iii) provide MERCK with all information needed to amend the Regulatory Change Notice. If reasonably practicable the parties shall determine REGISTRATIONS and any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested regulatory filings maintained with respect to these portions of PRODUCT. NASTECH shall continue to supply MERCK with PRODUCT approved under NASTECH's DMF, MERCK's then existing REGISTRATIONS and other regulatory filings for PRODUCT until such time as the agreementACTIVE PHARMACEUTICAL INGREDIENT or PRODUCT MANUFACTURED following such change is permitted under the REGISTRATIONS and other regulatory filings for ACTIVE PHARMACEUTICAL INGREDIENT and PRODUCT. If NASTECH or its supplier is responsible for regulatory filings and obtaining REGULATORY AUTHORITY 12 <PAGE> [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, and WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] approvals, NASTECH must immediately notify MERCK whether such confidential portions changes have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsapproved or rejected. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Supply Agreement

Change Control. 14.1 Either The Parties recognise that as a Project develops the Delivery Agent, Network Rail or a Funder may be desirous of Client a change due to (1) a variation to the Specification or (2) the occurrence of an Unforeseen Project Risk. Such a change shall be regarded as a “Prospective Change”. The Parties recognise that a Prospective Change could affect the Purchase Price and Programme. For any Prospective Change to become a Change it must be approved by the SCPF Steering Group in accordance with SCPF Requirements (and Funder where relevant) and any impact of such Prospective Change on the Purchase Price and Programme be agreed. The Delivery Agent and the SCPF Steering Group (and the Funder where relevant) will discuss in good faith the Prospective Change and its effect on the Purchase Price and the Delivery Agent agrees to provide the SCPF Steering Group (and Funder where relevant) with any additional information reasonably requested in order to fully and completely evaluate the impact of the Change. Where costs are incurred as a result of Unforeseen Project Risks, or it is believed that they will be incurred, the Delivery Agent must promptly notify the SCPF Steering Group of such a Prospective Change together with the mitigating actions proposed. A Prospective Change shall become a Change as soon as reasonably practicable, when the SCPF Steering Group confirms that an Unforeseen Project Risk has occurred and is justified in accordance with Clause 5. Those costs incurred will be verified as such by the SCPF Steering Group and to the extent such costs have been properly and efficiently incurred by the Delivery Agent, they will be funded by the SCPF Steering Group through the SCPF budget allocated to its remaining SCPF Projects. If the Delivery Agent, the SCPF Steering Group (and Funder where relevant) are unable to agree the amendment to the Purchase Price and Programme of a Prospective Change, either Party may escalate the matter in accordance with Clause 12.6. Other than for an agreed Change or Changes and subject to the Asset Protection Agreement and/or Landlord’s Consent as appropriate, the Delivery Agent shall be responsible for any increase in the cost of the Project in excess of the Purchase Price or the Contractor may serve Capped Price. Where any Change is agreed in accordance with Clause 5.2, the Parties shall set out the agreed Change in a format agreed between the Parties and signed by the Authorised Person for the Delivery Agent and the Authorised Person for the Administrator. The Delivery Agent will submit to the Administrator a written statement setting out the agreed impact of the Change Notice relating to on the Purchase Price endorsed by the SCPF Steering Group chairperson (and Funder where relevant) and the Purchase Price shall be adjusted accordingly. Completion and Purchase of the Deliverables The Delivery Agent will be liable for all costs of Works associated with a Project including Network Rail’s reasonable and proper costs incurred in connection with the Works in accordance with an Inscope Change requiring it Asset Protection Agreement and/or Landlord’s Consent as appropriate. The Delivery Agent will pay Network Rail’s costs incurred in connection with the Works (including financing costs) within 28 days of payment of the Purchase Price by the Administrator or, if served the Purchase Price is not paid in accordance with this Agreement, within 28 days of the date upon which the Purchase Price was due to be paid in accordance with this Agreement. The Delivery Agent shall nominate (and notify the Administrator of the identity of) the Authorised Person who shall be authorised to (i) seek payment by the ContractorAdministrator, requestingand (ii) confirm when, in its view, the other Deliverables) have been completed and Taken into Use. The Delivery Agent shall notify the Administrator forthwith upon changing the identity of them to make an Inscope Change to the Services or Authorised Person; The Delivery Agent shall notify the Transition Plan Administrator in writing once the Delivery Agent considers that all Deliverables in respect of a Project have been completed in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the agreed drawings, specification and design and in all other of them requesting changes to the Services or the Transition Plan respects in accordance with this Agreement in order to support the Change Control Procedure. 14.3 Client Administrator in certifying completion of the Deliverables. The Delivery Agent shall procure access for the Administrator and/or its agents to inspect the Works and the Administrator shall verify completion in relation to the Deliverables required within a Project, only (and as soon as reasonably practicable) after all of the Deliverables within a Project have been completed and provided that the Administrator is satisfied that all parts of the Deliverables within a Project comply in all respects with this Agreement. If the Administrator reasonably considers that the whole or any part of a Deliverable within a Project does not comply as aforesaid, it shall notify the Delivery Agent in writing together with full details of its opinion why completion cannot be verified The process described in Clause 6.3 and 6.4 shall be repeated until such time as Network Rail is able to verify completion in accordance with Clause 6.4. The Administrator may in its absolute discretion verify completion in respect of a discrete Deliverable (including where such Deliverable is not the last Deliverable to be completed within a Project) if the Administrator considers that such Deliverable can be Taken into Use and used safely prior to the completion of all Deliverables within a Project. As soon as practicable following: the completion of the last Deliverable (or where Clause 6.6 applies following completion of the relevant Deliverable); and the Works being Taken into Use, the Delivery Agent shall submit an invoice to the Administrator along with a letter substantially in the format shown in Schedule 3 showing the Purchase Price due in respect of the completed Deliverables. Subject to Clauses 6.8 and 6.9, payment of the amount shown in the invoice shall be due when accompanied by SCPF Steering Group’s verification of achievement of the Deliverables and any other Funder verification necessary in accordance with their relevant terms set out in Appendix 2, on the date of issue of the invoice (the "Due Date for Payment") and the final date for payment of that invoice shall be 28 days from the Due Date for Payment (the "Final Date for Payment"). Subject to Clause 6.6, no milestone or staged payments shall be applied to the Works and payments of the Purchase Price may only be paid in respect of completed Deliverables at GRIP Stage 3, GRIP Stage 5 and GRIP Stage 7 (except where a GRIP Stage 4 – 8 design and build strategy is applied and in such case, no further payment of the Purchase Price may be made to the Delivery Agent after GRIP stage 3 until the end of GRIP Stage 7). Where a Deliverable does not materially comply with this Agreement, the Administrator has no obligation to pay the Purchase Price in respect of that Deliverable. Where the Deliverables do not comply with the Specification, the SCPF Steering Group (and Funder where relevant) may at their discretion agree a reduction to the Purchase Price to reflect any decrease in the value of the Deliverables. If the Administrator disputes acting in good faith the whole or any part of any invoice submitted by the Delivery Agent then it shall serve a notice (a “Regulatory Change Notice”) upon of intention to withhold payment no later than 5 Working Days before Final Date for Payment. The notice of intention shall specify the Contractor requesting amount proposed to be withheld and the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where grounds for withholding payment or, if there is a change in UK Regulations or a direction by a Regulatory Authority with regard more than one ground, each ground and the amount attributable to UK Regulations after it. If the Effective Date. 14.4 Where Client Administrator serves a Regulatory Change Noticevalid notice under Clause 6.10, the Contractor Administrator shall make and implement such change within pay the timescale specified amount which is not in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement dispute in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change NoticeClause 6.7, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur make payment of the expenditure disputed amount, provided that, if it is subsequently ruled pursuant to any order of court or dispute resolution procedure that the whole or part of the amount specified in the notice of intention to withhold payment should be paid then such payment (and interest on such amount calculated in accordance with Clause 6.13) shall be made within 28 days after the date of such decision. Payment of the Purchase Price on completion of the Deliverables by the Administrator or the Taking into Use of the Works shall not be deemed to be confirmation that the Administrator accepts that the Delivery Agent has met the Specification, until such time as the SCPF Steering Group provides such verification in writing. Should any payment not be made 28 days after the Final Date for Payment in accordance with Clause 6.7, then interest shall be payable from the due date to the date of payment at the rate of 3 months LIBOR + 2% per annum, from time to time during any period in which the payment remains unpaid, both before and after judgment. For the avoidance of doubt it has been agreed that the Administrator will pay for the Deliverables pursuant to this Agreement on the basis of an agreed Target Price as specified in the relevant parts of Appendix 2 with a contingency available up to the Capped Price for the realisation of risks occurring as identified in the QRA and the liabilities of Network Rail under this Agreement shall be limited to the payment of the Capped Price. Subject to clause 5, the Administrator shall have no obligation to pay any amount above the Target Price in respect of a Deliverable except where the Purchase Price is, as a direct consequence of the realisation of risks occurring as identified in the QRA, supported by the relevant contingency amount set out Appendix 2. Where the Delivery Agent has been paid for completion of the Deliverables and it is subsequently found by the SCPF Steering Group that any of the Deliverables were not complete, the Delivery Agent will agree a remedial action plan with the SCPF Steering Group and carry out remedial actions to effect completion of the relevant Deliverable(s) in accordance with this plan. The Delivery Agent shall be liable for repayment of the costs it has been paid, to the extent it fails to carry out the remedial actions to effect completion of the relevant Deliverable(s). VAT and Capital Allowances Unless stated otherwise all amounts referred to in this Agreement shall be deemed to be exclusive of VAT. Where any taxable supply for VAT purposes is made under or in connection with this Agreement by one Party to the other, the payer shall in addition to any payment required for that supply pay upon presentation of a valid tax invoice such VAT as is chargeable in respect of it. During the course of construction, the Delivery Agent shall use all reasonable endeavours to provide the Administrator with such information as may be necessary and in the format reasonably required to enable it to receive the benefit of all the capital allowances in respect of the Works. Using the information provided pursuant to Clause 7.3, Network Rail shall claim all capital allowances which may be claimed in respect of the Works. The Delivery Agent will use reasonable endeavours to provide information reasonably requested by Network Rail for the purpose of claiming the full benefit of capital allowances in respect of the Works and recovering any part of the VAT element of the payments made pursuant to this Agreement. Relevant information is outlined in Appendix 3. Where the Delivery Agent unreasonably fails to provide such information reasonably requested in accordance with this clause, the Delivery Agent shall pay Network Rail such amount for capital allowances in respect of the Works or recovery of any part of the VAT element of the payments made pursuant to this Agreement which would otherwise have been recovered. Reporting, Tendering and Monitoring The Parties will comply in full with the SCPF Requirements and any other Funders’ conditions and requirements set out in Appendix 2 in relation to the delivery and management of a Project. (Except to the extent the same information is to be regularly provided pursuant to any Landlord’s Consent or Asset Protection Agreement or SCPF Requirements) the Delivery Agent shall provide the SCPF Steering Group with regular written progress reports, which may include updates from its project meetings, and in particular shall provide the SCPF Steering Group with: a forecast of future Purchase Price dates on a period by period basis; and a project plan showing the outstanding and proposed Project and its latest estimate for the completion of any Project. any information required to enable Network Rail and/or the DfT to meet its obligations under EU Procurement Requirements. The SCPF Steering Group shall provide copies of these reports to the Administrator as reasonably required. The Delivery Agent shall comply with current EU Procurement Requirements at all times in relation to the delivery of the Project and hereby warrants that: it has complied with and has secured compliance with the EU Procurement Requirements; and it shall not act or omit to act in any way that may cause the Delivery Agent, the DfT or Network Rail to breach the EU Procurement Requirements. Without prejudice to clause 8.3 above: where required the Delivery Agent must carry out appropriate tender processes, having regard to the value of the Project and EU Procurement Requirements; the Delivery Agent shall, regardless of the value of the Project being tendered, conduct a tender process in a non-discriminatory, fair and transparent manner aligned with the spirit of the EU Procurement Requirements; where the value of the Project has been identified as exceeding the relevant threshold which requires an Official Journal of the European Union (OJEU) notice to be issued the Delivery Agent shall be required to comply with the Regulatory Control Notice unless relevant EU Procurement Regulations; and until Client agrees during any tender process the Delivery Agent shall regularly update Network Rail of progress, with a minimum of monthly updates in writing respect of each stage. The Delivery Agent shall not appoint any contractor to purchase carry out the Works without notifying Network Rail of their identity. Network Rail shall (such purchase acting reasonably), within five (5) Working Days be entitled to raise objections to the proposed contractor. Where Network Rail does not respond to notification under this clause 8.4(d) the appointment shall be deemed to be arranged accepted. Where the Delivery Agent has caused the Delivery Agent, the DfT or Network Rail to breach any EU Procurement Requirements the Delivery Agent shall pay to the Administrator on demand any costs relating to such breach and managed repay on demand any element of the Purchase Price relating to the Project already paid by the ContractorAdministrator (including but not limited to discrete Deliverables, land purchase or other Project costs) such assets unless otherwise agreed by the SCPF Steering Group. Delays to allow a Project Subject to the Contractor occurrence of a Delay Event or any agreed Change to utilise the same Project Completion Date pursuant to provide Clause 5, the ServicesDelivery Agent shall procure that the Works in respect of a Project achieve completion by the Project Completion Date. The parties If, at any time, the Delivery Agent becomes aware that there will subsequently use the Change Control Procedure with retrospective effect after implementation be (or is likely to be) a delay in completion of the change(s) required Works by the Regulatory Change Notice to determine any necessary change specified Project Completion Date, the Delivery Agent shall within two (2) Working Days of becoming aware of such delay give notice to the ChargesAdministrator to that effect specifying the relevant delay. To If the Delivery Agent is (or claims to be) affected by a Delay Event: it shall take and continue to take all reasonable steps to eliminate or mitigate the consequences of such an event upon the performance of its obligations under this Agreement and, where relevant, resume performance of its obligations affected by the Delay Event as soon as practicable; and it shall neither be relieved from liability under this Agreement nor entitled to any extension of time to the extent that capital expenditure it is required but does delayed due to its failure (if any) to comply with its obligations under clause 9.3(a) above or as a result of any act, error, omission, negligence or default of the Delivery Event. If completion of a Project has not exceed [REDACTED]* thenbeen achieved by the relevant Long Stop Date, unless Client elects (subject to purchase these assets Clause 9.3) the delay is as a direct consequence of a Delay Event, then the Administrator shall have no obligation to pay the Purchase Price or any other costs associated with any Deliverable in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior relevant Project to the Charges being adjusted to reflect this change will be included as a specific addition as part of Delivery Agent and the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.De

Appears in 1 contract

Sources: Asset Purchase Agreement

Change Control. 14.1 Either Before Final Acceptance of Client the System, Allied shall be entitled to request changes to the Services, the Specification or the Contractor may serve System. In the event Allied wishes such changes, Allied shall furnish AKC with a description of the changes sought ("Change Notice relating Request"), in sufficient detail to an Inscope Change requiring it permit AKC to develop a proposal (or, if served by the Contractor, requesting"Proposal") the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedurefor Allied's consideration. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with On its receipt, AKC shall review the Change Control ProcedureRequest and, if and as required from time to time, AKC may request additional information from Allied in respect of such Change Request. 14.3 Client AKC shall prepare and submit a Proposal to Allied within five (5) days (or such longer time as the Parties may serve a notice agree in the event that the Change Request is complex or the preparation of the Proposal will adversely impact AKC's obligations under this Agreement) setting out price (a “Regulatory if any), delivery and other relevant provisions which arise out of the Change Notice”) upon Request. Any pricing in respect of Change Requests will be based on the Contractor requesting the Contractor to make a change rates for Change Requests set out in Schedule G. No charge shall be made in respect of any Change Request to the Services or extent that the Transition Plan within the timescale specified Change Request arises as a result of a breach by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective DateAKC of this Agreement. 14.4 Where Client serves On receipt of AKC's Proposal, Allied shall have fourteen (14) days in which to notify AKC of its acceptance of the Proposal. Failure to accept the Proposal within this period shall be deemed to be rejection of AKC's Proposal. 14.5 If the Proposal is accepted by Allied, AKC and Allied shall execute a Regulatory schedule to be appended to this Agreement containing the Change NoticeRequest, the Contractor shall make Proposal and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation full provisions with respect to the Charges or delivery, installation, acceptance testing, cost and payment terms of such changes and any other relevant terms, and the Parties shall comply with their respective obligations in respect of such changes. The terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Noticeshall apply, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”)mutatis mutandis, provided that if the capital cost to the Contractor performance of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required Request to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does they are not exceed [REDACTED]* then, unless Client elects to purchase these assets amended by the Parties in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing coststhat schedule. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Services Agreement (Allied Healthcare International Inc)

Change Control. 14.1 Either (a) Notwithstanding anything herein to the contrary, NASTECH shall not amend, change or supplement any of Client the following without P&GP's prior written consent (which consent may not be unreasonably withheld or the Contractor delayed with respect to clauses (C), (E), or (G)), except as may serve a Change Notice relating be required to an Inscope Change requiring it comply with applicable LAWS and regulations and REGULATORY AUTHORITY requirements: (or, if served by the Contractor, requestingA) the other SPECIFICATIONS; (B) the MATERIALS; (C) the source of them to make an Inscope Change to MATERIALS; (D) the Services specifications for MATERIALS; (E) the equipment used in the MANUFACTURE; (F) the test methods used in connection with the MANUFACTURING of PRODUCT and MATERIALS; and (G) the process for MANUFACTURING PRODUCT or MATERIALS. Any change in any of the Transition Plan foregoing shall, in each case, comply with cGMPs and all applicable laws, regulations and REGULATORY AUTHORITY requirements and should be made in accordance with the Change Control Procedure. 14.2 Either CHANGE CONTROL PROCEDURE (as defined below). In the event that NASTECH needs to change any of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon foregoing, NASTECH shall (i) immediately notify P&GP of the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice requested change, (a “Regulatory Change Notice”ii) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Noticebe responsible, the Contractor shall make at its expense, for ensuring that all COMPOUND and implement PRODUCT MANUFACTURED following such change within meets the timescale specified in SPECIFICATIONS and (iii) provide P&GP with all information needed to amend the Regulatory Change Notice. If reasonably practicable the parties shall determine REGISTRATIONS and any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested regulatory filings maintained with respect to these portions of PRODUCT. NASTECH shall continue to supply P&GP with PRODUCT approved under NASTECH's DMF, P&GP's then existing REGISTRATIONS and other regulatory [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] filings for PRODUCT until such time as the agreementCOMPOUND or PRODUCT MANUFACTURED following such change is permitted under the REGISTRATIONS and other regulatory filings for COMPOUND and PRODUCT. If NASTECH or its supplier is responsible for regulatory filings and obtaining REGULATORY AUTHORITY approvals, and NASTECH must immediately notify P&GP whether such confidential portions changes have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsapproved or rejected. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Supply Agreement (Nastech Pharmaceutical Co Inc)

Change Control. 14.1 Either of Client or The Parties agree that where: the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor Customer wishes to make a change to the Environment; the Supplier recommends to the Customer that changes should be made to the Environment; or the volume of any Service increases beyond the volumes set out in the Purchase Order or Additional Services are required, then the Parties shall comply with the process in this clause 17.11. Where the requested change is for an Additional Service then the Customer must request Additional Services by providing the Supplier with a Change Request. Unless agreed otherwise in writing, any Additional Services shall be charged at the rates set out in the Purchase Order, or if no rates are set out in the Purchase Order, the Additional Services shall be charged at the Supplier’s then current rates for government. The Supplier is not required to provide any Additional Services until a Change Request has been signed by the Parties. If the Customer requires a Professional Service related to the performance of the Managed Services but which forms a discrete arrangement, the Customer must request that Professional Service by providing the Supplier with a Change Request and the procedures in Schedule 8 (Supply Contract Variation Procedures) will apply. The Change Request must include the details required in the Purchase Order for Professional Services and the provisions of clause 16 of these Services Terms will also apply. The details of any new, changed or Additional Services, including the scope of the Services and the Prices that are payable for them, must be set out in a Change Request and the procedures in Schedule 8 (Supply Contract Variation Procedures) will apply. For clarity, if there is any dispute arising out of or in connection with this Supply Contract, including as to whether a service or item is within the scope of the Managed Services or the Transition Plan within the timescale specified by Client where whether a service is an Additional Service or a Professional Service, or there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation other issue relating to the Charges nature, scope or other terms Price of this Agreement any service or item or the scope of a Party’s responsibilities, that dispute will be dealt with in accordance with clause 25 of this Agreement. If stated in the Change Control Procedure prior Purchase Order, the Supplier must, within 6 months, or such other date agreed by the parties, after the Services Commencement Date, develop a comprehensive Transition Out plan. The Transition Out plan must include: the Price that is payable to implementation the Supplier for performing the Transition Out Services; any costs associated with selling, transferring, assigning or relocating assets that are exclusively used in the provision of the change(s) required Managed Services; any costs associated with winding down or stranded assets; and how and when that Price and any other sums are due and payable. The Transition Out Services may include: selling, transferring, assigning or relocating assets that are exclusively used in the provision of the Managed Services and the amount payable to the Supplier for such items; providing reasonable assistance in procuring novations or assignments of the Client Contracts and Third Party Contracts to a new services provider or to the Customer; returning or, if requested by the Regulatory Change NoticeCustomer, but destroying documents or materials containing the Customer’s Confidential Information together with any reproduction of those documents or materials; transitioning the Managed Services to a new service provider or to the Customer; and if this requested by the Customer, granting or assisting the Customer (or new service provider) to procure a licence to continue using any generally commercially available software in the Australian market which is not reasonably practicable then Client the same as that being used in the System, and any software owned by the Supplier which is integral to the ongoing provision of the Managed Services, subject to payment of licence fees by the Customer (or new service provider). The Parties will review the Transition Out plan annually or at such other period agreed by the Parties in the Transition Out plan, and the Supplier must implement any agreed changes. The Customer must pay the Contractor all costs Supplier for the work necessary to provide the Transition Out plan, and expenses properly any work necessary to change or review the Transition Out plan on a time and necessarily incurred. Such costs shall be materials basis (calculated on using the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”Supply Contract, or if none are stated, at the Supplier’s then current commercial rates). Subject to clause 17.12(g) of these Services Terms, provided that if the capital cost Customer requires the Supplier to perform the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*Transition Out Services, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to it must provide the Services. The parties will subsequently use the Change Control Procedure Supplier with retrospective effect after implementation Notice In Writing of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this its requirement at least 30 days prior to the Charges date that would allow the Transition Out Services to be performed in full prior to the last day of the Contract Period (i.e. if the Transition Out Services are to last 90 days then the Customer must provide the Supplier Notice in Writing that it requires the Supplier to perform the Transition Out Services at least 120 days prior to the last day of the Contract Period). If the Supplier receives Notice in Writing under clause 17.12(e) of these Services Terms, the Supplier must provide the Transition Out Services to the Customer during the Transition Out Period, and the Customer must pay the Supplier: the Price for the Transition Out Services; any costs associated with winding down or stranded assets; and any costs associated with selling, transferring, assigning or relocating assets that are exclusively used in the provision of the Managed Services. Notwithstanding clauses 17.12(e) and 17.12(f) of these Services Terms, the Supplier has no obligation to provide Transition Out Services where the Supplier has terminated the Supply Contract under clause 26.6 of this Agreement. In the course of providing any Transition Out Services, the Supplier must, in consultation with the Customer and as stated in the Transition Out plan, (as may be applicable to the relevant type of Managed Service): return any Customer Supplied Item; freeze non-critical software changes in any of the Customer’s software that is being adjusted to reflect this change will be included as a specific addition supported as part of the Change Control Procedure, along with any changes Managed Services; provide all reasonable transition assistance for the delivery of Customer Managed Services Data to ongoing costs. 14.5 Any changes the new service provider or to Regulations other than changes to or incurrence of UK Regulations shall be at the risk Customer and cost the reloading of the Contractorproduction databases; provide a list of outstanding service desk issues (provided as a csv file or as otherwise agreed by the Parties); provide a list of the outstanding issues that are detailed on any issues register; answer questions and provide such other information as may be reasonably sought by the new service provider or by the Customer to assist it in the transition process; and surrender any remaining Customer owned reports and documents still in the Supplier’s possession. Without limitation During the Transition Out Period: the Supplier ceases to become liable to perform any part of the Managed Services as it is transitioned to a new service provider or to the Customer; the Supplier’s obligations to meet the Service Levels is reduced to a ‘best efforts’ obligation only and the Supplier is not liable for failing to meet the Service Levels; and the Customer must continue to pay in full the proportion of the Contract Price attributable to the Managed Services until the last day of the Contract Period, notwithstanding that some or all of the Managed Services may have been transitioned to a new service provider or to the Customer. For the purposes of these Services Terms, it is agreed by the Parties that clause 14 of this Agreement is subject to this clause 17.13. For the Contractor purposes of this clause 17.13, the definitions of Customer Managed Services Data and Supplier Managed Services Data are not included within the definitions of Existing Material and New Material stated in Schedule 1 (Dictionary). All Intellectual Property Rights in any: Customer Managed Services Data remain vested in the Customer; and Supplier Managed Services Data remain vested in, or are hereby transferred or assigned upon creation to, the Supplier. The Customer grants the Supplier a non-exclusive, non-transferable licence for the Contract Period for the Supplier and its Personnel to use the Customer Managed Services Data to the extent necessary for the Supplier to perform its obligations under the Supply Contract. If the Supplier provides any Supplier Managed Services Data to the Customer, the Supplier grants the Customer a non-exclusive licence to use within Australia that Supplier Managed Services Data during the Contract Period solely for the purposes of receiving the benefit of the Managed Services under the Supply Contract or assisting the Supplier to perform its obligations under the Supply Contract. If the Supplier provides the Procedures Manual to the Customer, the Supplier grants the Customer a non-exclusive licence to use within Australia any Supplier-owned Intellectual Property Rights in that Procedures Manual during the Contract Period and the Transition Out Period solely for the purposes of receiving the benefit of the Managed Services under the Supply Contract or assisting the Supplier to perform its obligations under the Supply Contract. The Supplier may serve a Change Notice where these changes require it charge for any licence to use any Supplier Managed Services Data provided that such charges are stated or referred to in the Purchase Order. Nothing in this Supply Contract grants the Customer any right to any Intellectual Property Rights in any physical infrastructure (including any telecommunications equipment, hardware, software or network) that is used to provide Services the Managed Services. Nothing in a different manner operationally clauses 17.6(g) or 17.12(b) requires the Supplier to address disclose to the operational impact Customer or any other person any of the changesSupplier’s Confidential Information or any of its proprietary information, methodologies, software tools or other items. The Customer must not, and must ensure that its users do not: process, or require the Supplier to process, any Customer Managed Services Data for any illegal, unlawful or fraudulent purposes; or use the Managed Services: for any illegal, fraudulent or defamatory purposes; to engage in the bulk transmission of unsolicited electronic mail; to send or cause to be sent any computer worms, Viruses or other similar programs; to make unauthorised access to any other computer accessible via the internet or network; to send any harassing, obscene, indecent, offensive or threatening electronic communication; or to reproduce, distribute, transmit, publish, copy or exploit any material that constitutes an infringement or breach of any Intellectual Property Right, privacy right or right of confidentiality of any person.

Appears in 1 contract

Sources: Master Supply Agreement

Change Control. 14.1 Either During the term of Client this Agreement, the State may propose changes in the Subscription Services, the Non-subscription Services or the Contractor may serve Provider’s obligations under this Agreement. The State shall deliver a Change Notice relating Order Request to an Inscope Provider’s Liaison describing the proposed changes and establishing a period for Provider to respond. Provider shall respond to the Change requiring it Order Request within the time stated by preparing at Provider’s expense and delivering to the State’s Liaison a Change Order Response, indicating: (or, if served i) the effect of the proposed changes on the amounts payable by the ContractorState under the Agreement, requesting(ii) the effect of the proposed changes (a) to the Subscription Services, (b) the Non-subscription Services and (c) on Provider’s performance of its current obligations under the Agreement, (iii) the anticipated time required for implementation of the proposed changes, and (iv) any other of them information requested in the Change Order Request or necessary for the State to make an Inscope informed decision regarding the Change Order Response. All Change Order Responses must be explicitly accepted by the State via an addendum or an amendment before any additional fees being incurred by the State. Despite Subparagraph 2.2.3, if Provider fails to respond to State’s Change Order Request within the period allotted, Provider is deemed to have accepted the Change Order Request with no effect on associated fees, performance time or required resources. Despite any other provision of this Agreement, Provider acknowledges and agrees that Provider is expected to accomplish normal and routine tasks associated with its obligations under this Agreement. No Provider requests for additional chargeable resources will be approved by the State for tasks the State deems to be normal and routine, including changes resulting from changes in federal, state or other laws, regulations ordinances or policies applicable to the site where the Subscription Services or the Transition Plan in accordance with the Change Control Procedureand Non-subscription Services are performed and delivered. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costs. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Saas Agreement

Change Control. 14.1 Either (a) Subject to this Article IX, the Buyer may propose any change or addition to the Transition Services by written notice to the Seller specifying the proposed change in reasonable detail (such notice, a “Change Request”). (b) Seller shall provide Buyer with a reasonably detailed written outline specification describing the nature of Client the change, an assessment of the impact of the change on the Transition Services, the Service Fees (as applicable) and an estimate of the time required to implement the change, the costs associated with the change and the terms for payment of such costs (such outline, an “Evaluation Report”) within twenty (20) Business Days of receiving the Change Request. (c) Buyer shall notify Seller within ten (10) Business Days of the date on which Buyer received the Evaluation Report whether or not Buyer wishes to proceed with the Contractor may serve Change Request; provided, however, that the Parties shall in good faith negotiate the terms and pricing of the Change Request before Buyer provides such notice to proceed. (d) Within ten (10) Business Days of receipt of Buyer’s notice to proceed with the Change Request, Seller shall produce a final Evaluation Report which shall include a comprehensive list of the charges for the implementation of the Change Request (“Change Request Charges”). Any Change Request Charges shall be calculated in a manner consistent with Section 2.1. (e) Both the Seller and Buyer shall act in good faith in relation to Change Requests, and shall not unreasonably withhold any consent, or cause any delay in relation to them; provided that, notwithstanding anything to the contrary herein, Seller shall have sole discretion regarding whether to provide Additional Transition Services which were not performed by Seller for the Business at any time during the one hundred eighty (180) day period prior to Closing. If the Seller and Buyer cannot agree upon a Change Notice relating Request or Seller’s final Evaluation Report (including the Change Request Charges), each of the Seller and Buyer may refer the matter to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan be resolved in accordance with the Change Control ProcedureSection 1.2. 14.2 Either of Client or the Contractor may serve a Change Notice relating (f) The Seller shall not have any obligation to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan commence work in accordance connection with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a any change to the Transition Services or any Additional Transaction Services until the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory relevant Change Notice, the Contractor shall make Request and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment Evaluation Report has been requested with respect agreed to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsby each Party in writing. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Asset Purchase Agreement (Customers Bancorp, Inc.)

Change Control. 14.1 9.1 Either of Client or the Contractor Party may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting propose changes to the scope or execution of the Services or but no proposed changes shall come into effect until a Change Order has been signed by both parties. A Change Order shall be a document setting out the Transition Plan in accordance with proposed changes and the Change Control Procedureeffect that those changes will have on: (a) the Services; (b) the Service Charges; (c) the timetable of the Services (including any Milestones); and (d) any of the terms of the Agreement. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor 9.2 If ASSA ABLOY wishes to make a change to the Services or it shall provide a draft Change Order to the Transition Plan within Customer. 9.3 The Customer may not withhold its consent to a Change Order setting out changes to the timescale specified by Client where there is Services required as a result of changes to the Applicable Laws. 9.4 If the Customer wishes to make a change in UK Regulations or to the Services: (a) it shall notify ASSA ABLOY and provide as much detail as ASSA ABLOY reasonably requires of the proposed changes, including the timing of the proposed changes; and (b) ▇▇▇▇ ▇▇▇▇▇ shall, as soon as reasonably practicable after receiving the information at sub-Clause (a) above, provide a direction by a Regulatory Authority with regard draft Change Order to UK Regulations after the Effective DateCustomer. 14.4 Where Client serves 9.5 If the Parties: (a) agree to a Regulatory Change NoticeOrder, they shall sign it and that Change Order shall amend the Contractor shall make and implement such change within Agreement; or (b) are unable to agree a Change Order, either Party may require the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation disagreement to the Charges or other terms of this Agreement be dealt with in accordance with the dispute resolution procedure in Clause 22 (Dispute Resolution). 9.6 ASSA ABLOY may charge for the time it spends on preparing and negotiating Change Control Procedure prior to implementation of the change(s) required Orders which implement changes proposed by the Regulatory Change NoticeCustomer pursuant to Clause 9.4 on a time and materials basis at ASSA ABLOY's daily rates, but if this is not reasonably practicable then Client which rates will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost made available to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsCustomer on request. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: General Terms and Conditions of Sale

Change Control. 14.1 Either Each party may request additional work over and above the work stated in this Attachment, using the change request form, provided in Appendix 1 (Change Request Form), signed by appropriately authorized representatives of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in parties. In accordance with the Change Control Procedure. 14.2 Either terms and conditions of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice [contract name] Agreement, executed between [SITA Entity] (a Regulatory Change NoticeSITA”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the and [Customer Legal Name] (“Customer”) on [Effective Date. 14.4 Where Client serves a Regulatory Change Notice], the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same Customer requests SITA to provide the Servicesadditional equipment, as described below, at the location specified in this Change Order. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation Contract Name: Parties: Reference no: Effective date (if known): Title of the change(sproposed Change: Service(s) required by to which the Regulatory proposed Change Notice to determine relates: Description of the proposed Change: [Describe the proposed Change in detail with an explanation of its importance] [Attach supporting information if appropriate] Clause(s) and/or schedule(s) of the Contract which will be modified (if any): [if necessary, provide wording of any necessary change to new / amended provisions] Cost Delivery date / timetable / other date Functionality Performance Resources Other system Documentation Training needs Third Party Other (please specify) Description of impact(s): [provide a detailed description of the Charges. To selected impact(s)] Cost implications of the extent proposed Change: [Include details of whether the current cost (if any) is reduced or increased] SECTION E Approval of proposed Change Approval SITA and Customer confirm that capital expenditure is required but does not exceed [REDACTED]* thenthey have each read the information contained in this Change Request Form, unless Client elects to purchase these assets in approve the manner proposed Change Request as set out above, and agree that the * Confidential treatment has Contract shall be treated as having been requested amended accordingly: For and on behalf of SITA Signed for and behalf of SITA by its duly authorized representative: Signed for and behalf of Customer by its duly authorized representative: This Change Order constitute part of the Service Agreement, and the definitions in the Service Agreement apply to this Change Order. All terms and conditions of the Service Agreement not modified by this Change Order remain unchanged. The Service Agreement, as modified by this Charge Order constitutes the entire agreement between the parties with respect to these portions the matters contemplated therein and supersedes all other representations of the agreementparties, whether written or oral, except if fraudulently made. The following words have these meanings in this Schedule: Restricted Data means any of the following data provided by CITY, any Airport User (including ground handlers, airlines and such confidential portions have been deleted DCS providers) and/or any other party on behalf of CITY or Airport User: a) any Confidential Information; b) any Personal Data; and filed separately c) any other data in excess of any agreed limits. Self-Service Bag Drop means a CONTRACTOR bag-drop unit and/or software application. Smart PathTM means the CONTRACTOR service module with the Securities and Exchange Commission pursuant to Rule 24b-2 capability of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsbiometric identity management. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Master Contract for Products and Services

Change Control. 14.1 Either The following Change Control process will be followed if a change to this Order Form is required: a. A Project Change Request (PCR) will be documented in an email and be the vehicle for communicating change. The PCR must describe the change, the rationale for the change and the effect the change will have on the project. b. Both the Customer and the Delivery Team Project Manager will review the proposed change and agree to implement it, recommend it for further investigation, or reject it. c. A PCR must be accepted by authorized representatives from both parties to authorize implementation of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change any agreed changes to the Services or Order Form and the Transition Plan Agreement. Until a change is agreed to, both parties will continue to act in accordance with the Change Control Procedurelatest agreed version of the Order Form. 14.2 Either d. A PCR that has been approved by authorized representatives from both parties in writing constitutes a change authorization for purposes of Client this Order Form and the Agreement. If a valid agreement exists between you (“Customer”) and Qualtrics, LLC (“Qualtrics”, an SAP America Inc. company) related to the subject matter hereof, those terms take precedence over these terms unless otherwise agreed by the Parties in relation to a specific Order Form. Refer to these GTC regularly to ensure compliance. These GTC can be found attached. Acceptance. Please read these GTC carefully before using ▇▇▇.▇▇▇▇▇▇▇▇▇.▇▇▇ (the “Website”) or the Contractor may serve a Change Notice relating to products or services offered by Qualtrics (the “Services”). These GTC take effect when you click an Outscope Change upon the other “I Accept” button or checkbox presented with these GTC or when you use any of them requesting changes to the Services or Website, whichever occurs first. If you are agreeing to these GTC on behalf of Customer, you represent to Qualtrics that you have legal authority to bind Customer. Modifications to this Agreement. Qualtrics may modify these GTC at any time by providing notice to Customer. By continuing to use the Transition Plan Services after the effective date of any modifications to these GTC, Customer agrees to be bound by the modified terms. Some Services may be subject to additional terms specific to those Services as set forth in accordance with the Change Control ProcedureService-Specific Terms ▇▇▇▇▇://▇▇▇. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change ▇▇▇▇▇▇▇▇▇.▇▇▇/service-specific-terms/, which are incorporated herein to the extent applicable. United States Federal Government Agency: If you are a United States federal government agency, use of the Services or the Transition Plan within the timescale specified by Client where there is a change subject to this amendment. Revised September 1, 2020 **************** 1. DEFINITIONS Capitalized terms used in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified this document are defined in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsGlossary. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Professional Services

Change Control. 14.1 Either 17.1 If either party wishes to propose any amendment or modification to this agreement (including, the scope or details of Client the Services (or any part of them) (a Change) then it will notify the Contractor may serve other party of that fact by sending a Change Notice relating Request to the other party’s Nominated Representative, specifying in as much detail as is reasonably practicable the nature of the Change. 17.2 As soon as reasonably practicable (but in any event within 14 days) after the sending or receipt of a Change Request, Service Provider will provide Client with a brief written proposal in relation to the relevant Change (a Change Proposal) including, but not limited to: (a) a summary of the scope of the Change; (b) brief details of the likely impact, if any, of the Change Request on any existing Services; (c) a statement of the cost of investigating and preparing a detailed written proposal in respect of the Change; and (d) an estimate of the likely cost of implementation and/or on-going operation of the relevant Change, including any increase of or reduction in the Charges or additional Charges payable for the proposed Change, which will be commensurate with the change in Service Providers cost to deliver the revised scope . 17.3 If, following receipt of the Change Proposal under clause 17.2, Client wishes to proceed with the proposed Change it will notify Service Provider in writing, who will as soon as reasonably practicable and in any event within 30 days (or such longer period as the parties may, acting reasonably, agree) after receiving Client’s written notice to proceed with the proposed Change, provide Client with a detailed written proposal (a Change Control Note) including, but not limited, to the following matters: (a) full details of the proposed subject matter of the Change Request including any outline specifications, special conditions or other variations to the agreement required; (b) details of the impact, if any, of the Change Request on any existing Services; (c) a statement of the cost of implementation and/or on-going operation of the relevant Change, including any increase of or reduction in the Charges or additional Charges payable for the proposed Change, which will be commensurate with the change in Service Providers cost to deliver the revised scope; and (d) a timetable for the implementation, together with any proposals for acceptance, of the Change Request. 17.4 If Client wishes to proceed with the proposed Change and it has notified Service Provider in accordance with clause 17.3, Service Provider may charge Client, and Client will pay, the amount stated pursuant to clause 17.2(c) for the preparation of a Change Control Note. 17.5 Client will review the proposed Change Control Note as soon as reasonably possible (but in any event no later than 10 days) after its receipt and will either accept or reject the proposed Change Control Note or propose changes to the Change Control Note. If Client accepts the proposed Change Control Note, Service Provider will make the change in accordance with that Change Control Note. Both parties must act reasonably in relation to Change Requests, and Client will not unreasonably withhold or delay any consent in relation to them if they adversely affect the provision of the Services. If the parties cannot reach agreement on any Change Control Note, either party may escalate the matter for resolution in accordance with Schedule 7. 17.6 Notwithstanding the procedure in clauses 17.1 to 17.5, if any Changes are necessary to respond to an Inscope Change requiring it (or, if served by emergency situation that will materially affect the Contractor, requesting) the other provision of them to make an Inscope Change to the Services or and it is not reasonably practical to agree the Transition Plan contents of that Change in advance in accordance with the foregoing provisions, then (a) the affected party will notify the other party of the need for an urgent Change, (b) Service Provider will immediately or as soon as reasonably practicable make that Change, (c) Service Provider will then document the Change as soon as reasonably practicable and (d) the parties will use their respective reasonable endeavours to agree the relevant Change Control Procedure. 14.2 Either of Client or Note as soon as reasonably practicable. If the Contractor parties cannot agree that Change Control Note within 14 days after it has been submitted by Service Provider to Client, either party may serve a Change Notice relating to an Outscope Change upon escalate the other of them requesting changes to the Services or the Transition Plan matter for resolution in accordance with the Change Control ProcedureSchedule 7. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change to the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates 17.7 Except as set out in Schedule 7 (clause 17.6, neither party will have any obligation to commence work in connection with any Change until the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory relevant Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed Note is agreed by the Contractor) such assets to allow parties in writing. 17.8 If any Change results in a Project the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure prepare and agree a Project Work Package in respect of that Project in accordance with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsclause 7. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Master Services Agreement (Via Net Works Inc)

Change Control. 14.1 Either The following Change Control process will be followed if a change to this Order Form is required: a. A Project Change Request (PCR) will be documented in an email and be the vehicle for communicating change. The PCR must describe the change, the rationale for the change and the effect the change will have on the project. b. Both the Customer and the Delivery Team Project Manager will review the proposed change and agree to implement it, recommend it for further investigation, or reject it. c. A PCR must be accepted by authorized representatives from both parties to authorize implementation of Client or the Contractor may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change any agreed changes to the Services or Order Form and the Transition Plan Agreement. Until a change is agreed to, both parties will continue to act in accordance with the Change Control Procedurelatest agreed version of the Order Form. 14.2 Either d. A PCR that has been approved by authorized representatives from both parties in writing constitutes a change authorization for purposes of Client this Order Form and the Agreement. QUALTRICS CONFIDENTIAL If a valid agreement exists between you (“Customer”) and Qualtrics, LLC (“Qualtrics”, an SAP America Inc. company) related to the subject matter hereof, those terms take precedence over these terms unless otherwise agreed by the Parties in relation to a specific Order Form. Refer to these GTC regularly to ensure compliance. These GTC can be found attached. Acceptance. Please read these GTC carefully before using ▇▇▇.▇▇▇▇▇▇▇▇▇.▇▇▇ (the “Website”) or the Contractor may serve a Change Notice relating to products or services offered by Qualtrics (the “Services”). These GTC take effect when you click an Outscope Change upon the other “I Accept” button or checkbox presented with these GTC or when you use any of them requesting changes to the Services or Website, whichever occurs first. If you are agreeing to these GTC on behalf of Customer, you represent to Qualtrics that you have legal authority to bind Customer. Modifications to this Agreement. Qualtrics may modify these GTC at any time by providing notice to Customer. By continuing to use the Transition Plan Services after the effective date of any modifications to these GTC, Customer agrees to be bound by the modified terms. Some Services may be subject to additional terms specific to those Services as set forth in accordance with the Change Control ProcedureService-Specific Terms ▇▇▇▇▇://▇▇▇. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make a change ▇▇▇▇▇▇▇▇▇.▇▇▇/service-specific-terms/, which are incorporated herein to the extent applicable. United States Federal Government Agency: If you are a United States federal government agency, use of the Services or the Transition Plan within the timescale specified by Client where there is a change subject to this amendment. Revised September 1, 2020 **************** 1. DEFINITIONS Capitalized terms used in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified this document are defined in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as set out in Schedule 7 (the “Regulatory Costs”), provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsGlossary. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Order Form

Change Control. 14.1 Either of Client At any time during the Term, the Catapult may request, or the Contractor Supplier may serve a Change Notice relating to an Inscope Change requiring it (orrecommend, if served by the Contractor, requesting) the other of them to make an Inscope Change to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the scope or execution of the Services by submitting a written change order to the other party setting out the change (which may be in the form set out at Schedule 3 or any other form). If the Catapult requests, or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make Supplier recommends, a change to the scope or execution of the Services, the Supplier shall provide a written estimate to the Catapult of: the likely time required to implement the change; any necessary variations to the Fees arising from the change; the likely effect of the change on the Timetable; and any other impact of the change on this Agreement. The Supplier shall provide the written estimate, referred to in Clause 7.2 above, to the Catapult: (i) if a change is requested by the Catapult, not more than ten (10) Working Days after receipt by the Supplier of the Catapult’s request; and (ii) if a change is recommended by the Supplier, at the same time as the Supplier submits a change order to the Catapult. The Catapult and the Supplier shall respectively procure that Catapult’s Manager and the Project Manager meet as soon as possible after the written estimate is provided to the Catapult, to discuss the requested change. The Supplier shall not unreasonably withhold its consent to any change requested by the Catapult under Clause 7.1. If the Supplier requests a change to the scope or execution of the Services in order to comply with any applicable safety or statutory requirements, and such changes do not materially affect the nature or scope of the Services or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change NoticeFees, the Contractor Catapult shall make not unreasonably withhold or delay consent to such change. No change to the scope or execution of the Services shall be valid unless and implement until such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation to the Charges or other terms of this Agreement in accordance with the Change Control Procedure prior to implementation of the change(s) required by the Regulatory Change Notice, but if this is not reasonably practicable then Client will pay the Contractor all costs and expenses properly and necessarily incurred. Such costs shall be calculated on the Contractor’s standard man day rates as has been set out in Schedule 7 (the “Regulatory Costs”)writing, provided that if the capital cost to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed signed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Servicesduly authorised representatives of both parties. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary Where a change to the Charges. To scope or execution of the extent Services has been proposed, the parties will continue to perform their respective obligations under this Agreement, without taking account of that capital expenditure is required but does not exceed [REDACTED]* thenrequested or recommended change, unless Client elects to purchase these assets in the manner until such change has been set out above, in writing and signed by the * Confidential treatment has been requested with respect to these portions duly authorised representatives of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsboth parties. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

Appears in 1 contract

Sources: Agreement for the Purchase of Services

Change Control. 14.1 Either of Client or the Contractor EMBL-EBI may serve a Change Notice relating to an Inscope Change requiring it (or, if served by the Contractor, requesting) the other of them to make an Inscope Change notice in writing to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.2 Either of Client or the Contractor may serve a Change Notice relating to an Outscope Change upon the other of them requesting changes to the Services or the Transition Plan in accordance with the Change Control Procedure. 14.3 Client may serve a notice (a “Regulatory Change Notice”) upon the Contractor requesting the Contractor to make Service Provider request a change to the Services (including requests for certain Services to be omitted or the Transition Plan within the timescale specified by Client where there is a change in UK Regulations or a direction by a Regulatory Authority with regard certain services to UK Regulations after the Effective Date. 14.4 Where Client serves a Regulatory Change Notice, the Contractor shall make and implement such change within the timescale specified in the Regulatory Change Notice. If reasonably practicable the parties shall determine any necessary variation be added to the Services), giving details of the proposed change, including the proposed date of implementation (the “Change”). The Service Provider shall, within 28 days of receiving EMBL-EBI’s notice requesting a Change, provide a written estimate to EMBL-EBI of: the likely time required to implement the Change; any variations to the Service Charges or arising from the Change; and any other impact of the Change on the terms of this Agreement (the “Estimate”). As soon as practicable after the Service Provider receives the Estimate, the parties shall discuss and agree the issues set out in the Estimate, and to this end, the Service Provider shall: supply evidence that it has used reasonable endeavours (including, where practicable, sought competitive quotes) to minimise any increase in costs; and demonstrate how any costs to be incurred have been measured. If the parties cannot agree on the contents of the Estimate within 45 days of the Service Provider receiving EMBL-EBI’s notice requesting a Change, then the dispute will be determined in accordance with the Change Control Procedure prior to implementation Dispute Resolution Procedure. As soon as practicable after the contents of the change(sEstimate have been agreed or otherwise determined pursuant to clause 15.4, EMBL-EBI shall either confirm in writing the Estimate (as modified) required or withdraw its request for a Change. Unless and until EMBL-EBI has provided the Service Provider with such confirmation, the parties shall continue to perform their respective obligations under this Agreement without taking account of the proposed Change. For the avoidance of doubt, nothing in this clause 15 shall prevent EMBL-EBI from exercising its right of first refusal under clause 14. EMBL-EBI will own all right, title and interest in and to all of the data processed by the Regulatory Change Notice, but if this EMBL-EBI Equipment which is not reasonably practicable then Client will pay accessible from within the Contractor all costs and expenses properly and necessarily incurredDesignated Area. Such costs The Service Provider shall be calculated on solely responsible for establishing and maintaining procedures assuring secure access to the Contractor’s standard man day rates as set out EMBL-EBI Equipment situated within the Designated Area in accordance with Schedule 7 [see Services Schedule] (the “Regulatory CostsSecurity Procedures”), provided that if . The Service Provider shall advise EMBL-EBI as soon as it becomes aware of any breach or potential breach of the capital cost Security Procedures. Under no circumstances should the Service Provider attempt to gain access to the Contractor of complying with the Regulatory Change Notice in terms of capital expenditure will exceed [REDACTED]*, then the Contractor shall not be required to incur the expenditure required to comply with the Regulatory Control Notice unless and until Client agrees in writing to purchase (such purchase to be arranged and managed data being processed by the Contractor) such assets to allow the Contractor to utilise the same to provide the Services. The parties will subsequently use the Change Control Procedure with retrospective effect after implementation of the change(s) required by the Regulatory Change Notice to determine any necessary change to the Charges. To the extent that capital expenditure is required but does not exceed [REDACTED]* then, unless Client elects to purchase these assets in the manner set out above, the * Confidential treatment has been requested with respect to these portions of the agreement, and such confidential portions have been deleted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. cost of the Contractor funding this prior to the Charges being adjusted to reflect this change will be included as a specific addition as part of the Change Control Procedure, along with any changes to ongoing costsEMBL-EBI Equipment. 14.5 Any changes to Regulations other than changes to or incurrence of UK Regulations shall be at the risk and cost of the Contractor. Without limitation to this the Contractor may serve a Change Notice where these changes require it to provide Services in a different manner operationally to address the operational impact of the changes.

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Sources: Datacentre Services Agreement