Manufacturing Transition Assistance. Upon Pfizer’s request, in order to ensure continuity of supply of the Drug Substance following expiration or termination of this Agreement or Pfizer’s election to exercise its right to Manufacture or have a Third Party Manufacture the Drug Substance, Protalix shall provide reasonable assistance to Pfizer in arranging for the Manufacture of the Drug Substance by Pfizer or by an alternative supplier chosen by Pfizer, including providing technical consulting services to Pfizer or such alternative supplier and transferring know-how and other information relating to the Manufacture of the Drug Substance to Pfizer or such alternative supplier. [***] Protalix shall provide such assistance in accordance with a written transition plan (the “Manufacturing Transition Plan”) that details the actions and timelines for transitioning the Manufacture of the Drug Substance to Pfizer or such alternative supplier in a timely and efficient manner without material risk or disruption to either Protalix or Pfizer and no later than the end of the Term (if in connection with the expiration or termination of the Agreement) or no later than the time agreed to by the parties (if in connection with Pfizer’s exercise of its right to Manufacture or have a Third Party Manufacture the Drug Substance). Protalix shall provide the proposed Manufacturing Transition Plan to Pfizer for Pfizer’s written approval, which shall not be unreasonably withheld, within [***] following Pfizer’s request. In addition, upon Pfizer’s request, Protalix shall use Commercially Reasonable Efforts to cause the counterparty to any contract relating to the Manufacture of the Drug Substance (a) to consent to the partial assignment to Pfizer or such alternative supplier of those rights necessary for such manufacture by Pfizer or such alternative supplier or (b) to otherwise reasonably cooperate with Pfizer in Pfizer’s efforts to establish a new contractual relationship with such counterparty on substantially the same terms as the terms of its contract with Protalix.
Manufacturing Transition Assistance. 5.1 For a period not to exceed [*] months from the time of the execution of this Agreement (Transition Period) IBM will provide FVC with Manufacturing Transition Assistance as set forth in Attachment F. This assistance shall be in the form of consulting assistance to be provided by up to [*] people familiar with the manufacture of IBM's current VAN product. FVC will pay IBM a fee of [*] per person per month for these services. This fee is for the provision of services, indirect overhead (i.e. office space occupied by the IBM personnel) and administrative support only and does not include any additional expenses such as travel, materials, tools, subcontract activity or other costs related to the services provided. FVC shall be responsible for these additional costs. IBM will not incur such costs without first obtaining the approval of the FVC contract representative named in Section 12.1. FVC will reimburse IBM for any FVC approved expenditures which are IBM/FVC CONFIDENTIAL OCTOBER 16,1997 [*]--CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. 5 billed to IBM. THESE SKILLS AND SERVICES ARE PROVIDED ON AN AS IS BASIS WITHOUT REPRESENTATION OR WARRANTY OF ANY KIND INCLUDING RESULTS. IBM does not make any representations or warranties, concerning the results of this consulting or FVC's ability to manufacture Products or to procure components, parts, code or other materials from IBM or IBM's current suppliers. FVC assumes full risk and responsibility for procuring needed components, parts, code or other materials and for its ability to manufacture Products. At the expiration of the Transition Period FVC may purchase any remaining, finished goods, works in process and manufacturing parts Inventory as set forth in Section 4. IBM will invoice FVC monthly for the services and reimbursable expenses and FVC shall pay such invoices within 30 days of receipt by mailing payment to the address stated in the invoice.
Manufacturing Transition Assistance. If requested by Pfizer, at no cost to Pfizer, Akcea and Ionis will provide up to [***] hours of manufacturing transition assistance to Pfizer. After the first [***] hours of Akcea’s and Ionis’ time for any assistance under this Section 3.2, until Regulatory Approval in the first Major Market, if Pfizer reasonably requests, Akcea and Ionis will provide additional manufacturing transition assistance, and, Pfizer will compensate Akcea at Akcea’s then-applicable Akcea FTE Rate in accordance with Section 8.9 for Akcea’s and Ionis’ activities conducted under this Section 3.2.
Manufacturing Transition Assistance. As part of the Transition Assistance with respect to a given Licensed Program, as soon as reasonably practicable following a reasonable request by Juno, Editas shall transfer, and thereafter continue to transfer during the Term as may be reasonably requested by Juno from time to time, from Editas (or any of its Affiliates or its Third Party contract manufacturers, as applicable), to Juno (and its Designees), copies in English (in writing and in an electronic format) of all data, information and other Know-How in the Control of Editas, its Affiliates and its Third Party contract manufacturers that is necessary or reasonably useful to Manufacture any Licensed RNP Complex or Licensed Products, in order to enable Juno (and its Designees) to Manufacture Licensed RNP Complexes and Licensed Products, including to replicate any process employed by or on behalf of Editas to Manufacture any Licensed RNP Complex and Licensed Products. Such transfer shall include all processes, analytical, formulation and process development data, technical memos, batch records, manufacturing process description, complete xxxx of materials (including known critical raw materials and their screening methods and acceptance criteria), analytical methods used both for product release as well as characterization, development history summary reports and supporting data and reports, cell banking qualification and stability strategy and reports. In addition, at the reasonable request of Juno from time to time, Editas shall make its employees and consultants (including personnel of its Affiliates and Third Party contract manufacturers) available to Juno (and its Designees) to provide reasonable consultation and technical assistance in order to ensure an orderly transition of the manufacturing technology and operations to Juno (and its Designees) and to assist Juno (and its Designees) in its Manufacture of any Licensed RNP Complex and Licensed Products.
