General Assumptions. In addition to any specific assumptions set forth in a Scope of Work for the applicable Services, the following assumptions apply generally to all Development Services undertaken pursuant to or in connection with such Scope of Work: 1.1 Where applicable, GSK or its Affiliate will perform the Development Services set forth in a Scope of Work in accordance with, and subject to, the GSK Group’s policies and standard operating procedures and Applicable Law. 1.2 The Price payable by the Purchaser under a Scope of Work includes [***] Unless otherwise provided in a Scope of Work, Development Services shall be charged at the defined FTE Rate set forth in Schedule 4 (Fees) together with all of GSK’s direct costs and expenses for such Development Services and, if applicable, a management fee. Any Manufacturing required to support Development Services under a Scope of Work will be charged at an agreed per batch cost as set forth in the applicable Scope of Work. 1.3 Following the performance of the Development Services by GSK, GSK or its Affiliates shall invoice the Purchaser in accordance with Clause 12 (Invoice and Payment) and notify the Purchaser in writing of the completion of the relevant Development Service. The Purchaser must notify GSK of its approval of such Development Service and any related deliverables in writing within [***] of receipt of the notification of completion of such Development Service. GSK shall not be obliged to proceed with any activities for subsequent Development Services (if any) prior to receiving in writing the Purchaser’s approval and acceptance of each preceding Development Service and related deliverables (if any), unless otherwise agreed between the Parties. 1.4 In the event that any dispute or difference arises out of or in connection with the performance of a Development Service under a Scope of Work and the Purchaser does not give its acceptance in respect of a Development Service and any related deliverables in accordance with paragraph 1.3 above (a “Service Dispute”), each Party shall use its reasonable endeavours to resolve any such Service Dispute by prompt discussion in good faith at a managerial level appropriate to the Service Dispute in question. This procedure shall be invoked by either Party giving notice to the other setting out the issues in the Service Dispute and referring to this paragraph and, unless the Parties agree otherwise, shall be treated as having been exhausted if the Service Dispute has not been resolved within [***] after the giving of the notice. If the Service Dispute is treated as having been exhausted, GSK may terminate the relevant Scope of Work with immediate effect. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. 1.5 Neither GSK nor any of its Affiliates shall support any development work or undertake any capital expenditure in respect of the performance of the Development Services or the Manufacture of the Products under this Agreement. If any capital expenditure is identified during the Term as being required in respect of the Development Services or the Products, the Parties shall discuss and agree in writing what is required and the expenditure shall be borne by the Purchaser. In the event that the Purchaser fails to pay any sum in respect of capital expenditure for which it is to bear the cost pursuant to this paragraph 1.5, neither GSK nor its Affiliates shall bear any liability under this Agreement for any breach of its terms resulting from any failure to undertake, or delay in undertaking, such capital expenditure or any consequential failure to Manufacture (or delay in Manufacturing) the Products pursuant to this Agreement. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. The Purchaser’s request is for GSK to (i) [•] and (ii) [•]. The estimated Price (in aggregate) for GSK to complete the performance of these Development Services is [•]. In order to progress with [•], the following activities are to be performed by the Parties: Activities Goal: GSK responsibilities: Purchaser responsibilities: • Deliverables • Estimated Price • Activities Goal: GSK responsibilities: Purchaser responsibilities: • Deliverables • Estimated Price • CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
Appears in 2 contracts
Samples: Asset Purchase Agreement (Roivant Sciences Ltd.), Asset Purchase Agreement (Dermavant Sciences LTD)
General Assumptions. In addition to any specific assumptions set forth in a Scope of Work for the applicable Services, the following assumptions apply generally to all Development Services undertaken pursuant to or in connection with such Scope of Work:
1.1 Where applicable, GSK or its Affiliate will perform the Development Services set forth in a Scope of Work in accordance with, and subject to, the GSK Group’s policies and standard operating procedures and Applicable Law.
1.2 The Price payable by the Purchaser under a Scope of Work includes [***] Unless otherwise provided in a Scope of Work, Development Services shall be charged at the defined FTE Rate set forth in Schedule 4 (Fees) together with all of GSK’s direct costs and expenses for such Development Services and, if applicable, a management fee. Any Manufacturing required to support Development Services under a Scope of Work will be charged at an agreed per batch cost as set forth in the applicable Scope of Work.
1.3 Following the performance of the Development Services by GSK, GSK or its Affiliates shall invoice the Purchaser in accordance with Clause 12 (Invoice and Payment) and notify the Purchaser in writing of the completion of the relevant Development Service. The Purchaser must notify GSK of its approval of such Development Service and any related deliverables in writing within [***] of receipt of the notification of completion of such Development Service. GSK shall not be obliged to proceed with any activities for subsequent Development Services (if any) prior to receiving in writing the Purchaser’s approval and acceptance of each preceding Development Service and related deliverables (if any), unless otherwise agreed between the Parties.
1.4 In the event that any dispute or difference arises out of or in connection with the performance of a Development Service under a Scope of Work and the Purchaser does not give its acceptance in respect of a Development Service and any related deliverables in accordance with paragraph 1.3 above (a “Service Dispute”), each Party shall use its reasonable endeavours to resolve any such Service Dispute by prompt discussion in good faith at a managerial level appropriate to the Service Dispute in question. This procedure shall be invoked by either Party giving notice to the other setting out the issues in the Service Dispute and referring to this paragraph and, unless the Parties agree otherwise, shall be treated as having been exhausted if the Service Dispute has not been resolved within [***] after the giving of the notice. If the Service Dispute is treated as having been exhausted, GSK may terminate the relevant Scope of Work with immediate effect. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]BRACKETS, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED IS FILED WITH THE INFORMATION (I) IS NOT MATERIAL SECURITIES AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM EXCHANGE COMMISSION PURSUANT TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSEDRULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
1.5 Neither GSK nor any of its Affiliates shall support any development work or undertake any capital expenditure in respect of the performance of the Development Services or the Manufacture of the Products under this Agreement. If any capital expenditure is identified during the Term as being required in respect of the Development Services or the Products, the Parties shall discuss and agree in writing what is required and the expenditure shall be borne by the Purchaser. In the event that the Purchaser fails to pay any sum in respect of capital expenditure for which it is to bear the cost pursuant to this paragraph 1.5, neither GSK nor its Affiliates shall bear any liability under this Agreement for any breach of its terms resulting from any failure to undertake, or delay in undertaking, such capital expenditure or any consequential failure to Manufacture (or delay in Manufacturing) the Products pursuant to this Agreement. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]BRACKETS, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED IS FILED WITH THE INFORMATION (I) IS NOT MATERIAL SECURITIES AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM EXCHANGE COMMISSION PURSUANT TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSEDRULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. The Purchaser’s request is for GSK to (i) [•] and (ii) [•]. The estimated Price (in aggregate) for GSK to complete the performance of these Development Services is [•]. In order to progress with [•], the following activities are to be performed by the Parties: Activities Goal: GSK responsibilities: Purchaser responsibilities: • Deliverables • Estimated Price • Activities Goal: GSK responsibilities: Purchaser responsibilities: • Deliverables • Estimated Price • [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]BRACKETS, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED IS FILED WITH THE INFORMATION (I) IS NOT MATERIAL SECURITIES AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM EXCHANGE COMMISSION PURSUANT TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSEDRULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 1 contract
General Assumptions. In addition to any specific assumptions set forth in a Scope of Work for the applicable Services, the following assumptions apply generally to all Development Services undertaken pursuant to or in connection with such Scope of Work:
1.1 Where applicable, GSK or its Affiliate will perform the Development Services set forth in a Scope of Work in accordance with, and subject to, the GSK Group’s policies and standard operating procedures and Applicable Law.
1.2 The Price payable by the Purchaser under a Scope of Work includes [***] Unless otherwise provided in a Scope of Work, Development Services shall be charged at the defined FTE Rate set forth in Schedule 4 (Fees) together with all of GSK’s direct costs and expenses for such Development Services and, if applicable, a management fee. Any Manufacturing required to support Development Services under a Scope of Work will be charged at an agreed per batch cost as set forth in the applicable Scope of Work.
1.3 Following the performance of the Development Services by GSK, GSK or its Affiliates shall invoice the Purchaser in accordance with Clause 12 (Invoice and Payment) and notify the Purchaser in writing of the completion of the relevant Development Service. The Purchaser must notify GSK of its approval of such Development Service and any related deliverables in writing within [***] of receipt of the notification of completion of such Development Service. GSK shall not be obliged to proceed with any activities for subsequent Development Services (if any) prior to receiving in writing the Purchaser’s approval and acceptance of each preceding Development Service and related deliverables (if any), unless otherwise agreed between the Parties.
1.4 In the event that any dispute or difference arises out of or in connection with the performance of a Development Service under a Scope of Work and the Purchaser does not give its acceptance in respect of a Development Service and any related deliverables in accordance with paragraph 1.3 above (a “Service Dispute”), each Party shall use its reasonable endeavours to resolve any such Service Dispute by prompt discussion in good faith at a managerial level appropriate to the Service Dispute in question. This procedure shall be invoked by either Party giving notice to the other setting out the issues in the Service Dispute and referring to this paragraph and, unless the Parties agree otherwise, shall be treated as having been exhausted if the Service Dispute has not been resolved within [***] after the giving of the notice. If the Service Dispute is treated as having been exhausted, GSK may terminate the relevant Scope of Work with immediate effect. Schedule CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
1.5 Neither GSK nor any of its Affiliates shall support any development work or undertake any capital expenditure in respect of the performance of the Development Services or the Manufacture of the Products under this Agreement. If any capital expenditure is identified during the Term as being required in respect of the Development Services or the Products, the Parties shall discuss and agree in writing what is required and the expenditure shall be borne by the Purchaser. In the event that the Purchaser fails to pay any sum in respect of capital expenditure for which it is to bear the cost pursuant to this paragraph 1.5, neither GSK nor its Affiliates shall bear any liability under this Agreement for any breach of its terms resulting from any failure to undertake, or delay in undertaking, such capital expenditure or any consequential failure to Manufacture (or delay in Manufacturing) the Products pursuant to this Agreement. Schedule CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. Form of Scope of Work—Development Services The Purchaser’s request is for GSK to (i) [•] and (ii) [•]. The estimated Price (in aggregate) for GSK to complete the performance of these Development Services is [•]. In order to progress with [•], the following activities are to be performed by the Parties: Service 1: TBD Target Start Target Completion Assumptions Activities Goal: GSK responsibilities: Purchaser responsibilities: • Deliverables • Estimated Price • Service 2: TBD Target Start Target Completion Assumptions Activities Goal: GSK responsibilities: Purchaser responsibilities: • Deliverables • Estimated Price • Schedule CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. SCHEDULE 3 TOLL MANUFACTURE PROVISIONS
1. SUPPLEMENTARY PROVISIONS IN RELATION TO TOLL MANUFACTURE OF NEW CLINICAL PRODUCTS Save to the extent expressly amended or disapplied by virtue of this Schedule 3 (Toll Manufacture Provisions), all other terms and conditions of this Agreement apply. In this Schedule 3 (Toll Manufacture Provisions), unless otherwise specified, any reference to a paragraph is to a paragraph of this Schedule 3 (Toll Manufacture Provisions).
Appears in 1 contract
Samples: Asset Purchase Agreement