Manufacturing Transition Assistance Sample Clauses

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.
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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.
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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.
Sample 1
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.
Sample 1

Related to Manufacturing Transition Assistance

  • Transition Assistance If this Contract is not renewed at the end of this term, if the Contract is otherwise terminated before project completion, or if particular work on a project is terminated for any reason, Contractor shall provide transition assistance for a reasonable, mutually agreed period of time after the expiration or termination of this Contract or particular work under this Contract. The purpose of this assistance is to allow for the expired or terminated portion of the services to continue without interruption or adverse effect, and to facilitate the orderly transfer of such services to State or its designees. The parties agree that such transition assistance is governed by the terms and conditions of this Contract, except for those terms or conditions that do not reasonably apply to such transition assistance. State shall pay Contractor for any resources utilized in performing such transition assistance at the most current Contract rates. If State terminates a project or this Contract for cause, then State may offset the cost of paying Contractor for the additional resources Contractor utilized in providing transition assistance with any damages State may have sustained as a result of Contractor’s breach.

  • Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

  • Termination Assistance Services Following the termination of this Agreement and/or any Ordering Document, the Parties may agree for Axway to provide transition services pursuant to a duly executed SOW, during which time this Agreement will continue in full force and effect solely to the extent necessary to allow such transition services to be performed. Axway agrees that the costs for any such services shall be comparable to the fees charged to other customers for similar types of services.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Routing for Operator Services and Directory Assistance Traffic For a Verizon Telecommunications Service dial tone line purchased by CBB for resale pursuant to the Resale Attachment, upon request by CBB, Verizon will establish an arrangement that will permit CBB to route the CBB Customer’s calls for operator and directory assistance services to a provider of operator and directory assistance services selected by CBB. Verizon will provide this routing arrangement in accordance with, but only to the extent required by, Applicable Law. Verizon will provide this routing arrangement pursuant to an appropriate written request submitted by CBB and a mutually agreed-upon schedule. This routing arrangement will be implemented at CBB's expense, with charges determined on an individual case basis. In addition to charges for initially establishing the routing arrangement, CBB will be responsible for ongoing monthly and/or usage charges for the routing arrangement. CBB shall arrange, at its own expense, the trunking and other facilities required to transport traffic to CBB’s selected provider of operator and directory assistance services.

  • Employee Assistance Program (EAP) Section 1. The Employer agrees to provide to the Union the statistical and program evaluation information provided to management concerning Employee Assistance Program(s). Section 2. No information gathered by an Employee Assistance Program may be used to discipline an employee. Section 3. Employees shall be entitled to use accrued sick leave for participation in an Employee Assistance Program. Section 4. Each university will offer training to local Union Stewards on the Employee Assistance Program available in their university, on university time, where an Employee Assistance Program is available.

  • Termination Assistance Upon nearing the end of the final term or termination of this Agreement, without respect to cause, the Party shall take all reasonable and prudent measures to facilitate any transition required by the State. All State property, tangible and intangible, shall be returned to the State upon demand at no additional cost to the State in a format acceptable to the State.

  • Regulatory Assistance Provider will permit regulators with jurisdiction over BFA or any BFA Recipient to examine Provider’s activities relating to its performance under this Agreement and the Services. Subject to Section 17.6, Provider will cooperate and provide all information reasonably requested by the regulator in connection with any such examination and provide reasonable assistance and access to all equipment, records, and systems requested by the regulator relating to the Services.

  • Litigation Assistance Except when it would constitute a direct conflict of interest for BA, BA will make itself available to assist CE in any administrative or judicial proceeding by testifying as witness as to an alleged violation of HIPAA, the HITECH Act, the Privacy or Security Rule, or other law relating to security or privacy.

  • Relocation Assistance The Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, (42 U.S.C. § 4601), prohibits unfair treatment of persons displaced or whose property has been acquired because of Federal or Federal-aid programs and projects.

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