One Time Technology Transfer Costs Sample Clauses

One Time Technology Transfer Costs. 1.1 Various costs related to validation and documentation. These costs are detailed in Section #5. [CONFIDENTIAL TREATMENT REQUESTED] /*/ 1.2 Project Management Project Leader: 6 months [CONFIDENTIAL TREATMENT REQUESTED] /*/ - Primary project interface at H-S, track the project schedule, organize and chair the team meetings, budget tracking, meeting minutes, project book management, control of project scope. Facility Engineer: 6 months [CONFIDENTIAL TREATMENT REQUESTED] /*/ - Primary responsibility for facility design, utility design, demolition, renovation, equipment purchase, contractor supervision, documentation, commissioning, qualification, etc. Equipment Engineer: 6 months [CONFIDENTIAL TREATMENT REQUESTED] /*/ - Specification and purchase of the aseptic compounding booth, the chemical fume hood, the -20(Degree)C freezer, components for SIP of the control piping and drying coil of the spray dryer and five (5) tanks, permit management, electrical installation and supervision, set up of process development area, Building Automation System, drawing support, etc. Analytical Scientist: 6 months total [CONFIDENTIAL TREATMENT REQUESTED] /*/ - Familiarization/Preparation for Tech Transfer: 3 months - Review analytical package. - Ensure H-S equipment/reagents/supplies are available and in-place. - Set-up, training with [CONFIDENTIAL TREATMENT REQUESTED] /*/ representative. - Training time with Acusphere analyst. - Establish assay parameters with "training" supplies. - Tech Transfer: 3 months - Provide written draft of protocol with Acusphere procedures and input for acceptance criteria, to encompass all analytical methodologies to be transferred, edited, with final approval by both sites. - Complete the studies upon approval of the protocol. - Investigation of unexpected results and resolution of any problems. - Provide final acceptance report for approval at both sites. - Convert procedures to H-S format and receive approval from H-S and Acusphere. - Unplanned analytical support for process work. Validation Support - Sterilization Process: 3 months[CONFIDENTIAL TREATMENT REQUESTED] /*/ - Develop and validate the autoclave sterilization loads for all aseptic assembly parts and all SIP validation support. This includes full validation on [CONFIDENTIAL TREATMENT REQUESTED] /*/ processing tanks and the spray dryer skid. Production: 6 months [CONFIDENTIAL TREATMENT REQUESTED] /*/ - Development of 4 batch records to include PLGA Microspheres, AI-700, Process Simul...
AutoNDA by SimpleDocs

Related to One Time Technology Transfer Costs

  • 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.

  • Technology Transfer (a) Sublicensee acknowledges and agrees that ECC has delivered and made to Sublicensee a disclosure of a general introduction to the Technology and to its commercial feasibility prior to the execution of this Agreement. Except to the extent such information falls within one or more of the exceptions to the definition of "Confidential Information", all information disclosed by ECC to Sublicensee prior to the execution of this Agreement shall be deemed to constitute part of the Technology and shall be deemed to be confidential. The timing and extent of additional disclosure by ECC to Sublicensee shall be as set forth in subparagraph 22(b) hereof. (b) Upon execution of this Agreement, ECC shall provide Sublicensee with copies of the patents listed in Section B of Exhibit "B" hereto. Beyond that, ECC shall not be required to provide additional information concerning, or disclosure of, the Technology to Sublicensee until Sublicensee provides to ECC (i) written notice of Sublicensee's intent to commercialize a Product, which written notice shall include detailed specifications for the designated Product, and (ii) evidence, reasonably satisfactory to ECC, of Sublicensee's intent to commercialize the designated Product in the form of written documentation of orders placed by Sublicensee of the equipment needed by Sublicensee to produce and commercialize the designated Product or in the form of written documentation from Sublicensee confirming the dedication and/or modification of existing equipment necessary to produce the designated Product. Within ninety (90) days after ECC's receipt of the items described in the preceding sentence, ECC shall provide to Sublicensee the following additional disclosure: (w) a Product specific recipe for the production of the designated Product; (x) Product specific process specifications for the production of the designated Product; (y) copies of all patent applications listed in the Exhibits hereto that ECC deems relevant to the production of the designated Product; and (z) a list of known raw materials suppliers and preferred equipment vendors.

  • Inventions Retained and Licensed I have attached hereto, as Exhibit A, a list describing all inventions, original works of authorship, developments, improvements, and trade secrets which were made by me prior to my employment with the Company (collectively referred to as “Prior Inventions”), which belong to me, which relate to the Company’s proposed business, products or research and development, and which are not assigned to the Company hereunder; or, if no such list is attached, I represent that there are no such Prior Inventions. If in the course of my employment with the Company, I incorporate into a Company product, process or machine a Prior Invention owned by me or in which I have an interest, the Company is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, worldwide license to make, have made, modify, use and sell such Prior Invention as part of or in connection with such product, process or machine.

  • Technology Research Analyst Job# 1810 General Characteristics

  • Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.

  • NOTICE AND ASSISTANCE REGARDING PATENT AND COPYRIGHT INFRINGEMENT The provisions of this clause shall be applicable only if the amount of this Agreement exceeds $100,000. (a) The Contractor shall report to the Government through BSA promptly and in reasonable written detail, each notice or claim of patent or copyright infringement based on the performance of this Agreement of which the Contractor has knowledge. (b) In the event of any claim or suit against the Government on account of any alleged patent or copyright infringement arising out of the performance of this Agreement or out of the use of any supplies furnished or work or services performed hereunder, the Contractor shall furnish to the Government when requested by the Government or BSA, all evidence and information in possession of the Contractor pertaining to such suit or claim. Such evidence and information shall be furnished at the expense of the Government except where the Contractor has agreed to indemnify the Government or BSA. (c) This clause shall be included in all subcontracts.

  • Technology License 4.1 Unless any event described in Article 2.2 or 2.3 of this Agreement occurs, all of the technology required to be licensed for any of Party B’s business shall be provided by Party A on an exclusive basis. Party A will try its best to license Party B to use the technology owned by Party A, or re-license Party B to use the technology as approved by the owner. 4.2 The Parties shall negotiate with each other to enter into specific technology license contracts to expressly specify the detail matters such as the technology to be licensed, the method to license the technology, license fees and payment.

  • Multi-year Planning Targets Schedule A may reflect an allocation for the first Funding Year of this Agreement as well as planning targets for up to two additional years, consistent with the term of this Agreement. In such an event, the HSP acknowledges that if it is provided with planning targets, these targets: a. are targets only, b. are provided solely for the purposes of planning, c. are subject to confirmation, and d. may be changed at the discretion of the Funder in consultation with the HSP. The HSP will proactively manage the risks associated with multi-year planning and the potential changes to the planning targets; and the Funder agrees that it will communicate any changes to the planning targets as soon as reasonably possible.

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Order Coordination and Order Coordination-Time Specific 2.1.9.1 “Order Coordination” (OC) allows BellSouth and Lightyear to coordinate the installation of the SL2 Loops, Unbundled Digital Loops (UDL) and other Loops where OC may be purchased as an option, to Lightyear’s facilities to limit end user service outage. OC is available when the Loop is provisioned over an existing circuit that is currently providing service to the end user. OC for physical conversions will be scheduled at BellSouth’s discretion during normal working hours on the committed due date. OC shall be provided in accordance with the chart set forth below. 2.1.9.2 “Order Coordination – Time Specific” (OC-TS) allows Lightyear to order a specific time for OC to take place. BellSouth will make every effort to accommodate Lightyear’s specific conversion time request. However, BellSouth reserves the right to negotiate with Lightyear a conversion time based on load and appointment control when necessary. This OC-TS is a chargeable option for all Loops except Unbundled Copper Loops (UCL) and Universal Digital Channel (UDC), and is billed in addition to the OC charge. Lightyear may specify a time between 9:00 a.m. and 4:00 p.m. (location time) Monday through Friday (excluding holidays). If Lightyear specifies a time outside this window, or selects a time or quantity of Loops that requires BellSouth technicians to work outside normal work hours, overtime charges will apply in addition to the OC and OC-TS charges. Overtime charges will be applied based on the amount of overtime worked and in accordance with the rates established in the Access Services Tariff, Section E13.2, for each state. The OC-TS charges for an order due on the same day at the same location will be applied on a per Local Service Request (LSR) basis.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!