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Manufacturing Phase Sample Clauses

Manufacturing Phase. After completion of the first registration Batch pursuant to Section 4.2(a), XOMA will cover all costs for ongoing manufacture of Drug Substance by the per-Batch charge (as calculated in Section 6.6) for Batches of Drug Substance meeting the Specifications produced at Commercial Scale.
Manufacturing Phase. Upon the payment to SAFER by SIBE of $3.3 million in cash, and the issuance of $2.2 million of Shares to SAFER, with such Shares to be held in escrow and disbursed as provided in Section 11 of this MOU (the "Manufacturing Deposit"), SAFER shall begin the manufacturing of the Plant and the equipment to be installed in the Plant (the "Equipment") (collectively, the "Manufacturing Services"). Thereafter, beginning four (4) weeks after the payment of the Manufacturing Deposit, SIBE shall make further payments to SAFER totaling $4.95 million and $3.3 million of Shares in six equal installments of $825 thousand in cash and $550 thousand of Shares each payable every four (4) weeks (collectively, with the Manufacturing Deposit, the "Manufacturing Payment"), with such Shares to be held in escrow and disbursed as provided in Section 11 of this MOU. Alternatively, If SIBE chooses the Letter of Credit method of payment to sub contractors then SIBE shall make one payment of $8.25 million in cash and issue $5.5 million of Shares to SAFER (with such Shares to be held in escrow and disbursed as provided in Section 11 of this MOU) at the time of the Manufacturing Deposit.
Manufacturing Phase. Customer is responsible for ensuring that the devices covered by this contract comply with all applicable laws and regulations, including the Food, Drug and Cosmetic Act and implementing regulations. Customer responsibilities under these provisions, include but are not limited to the following:
Manufacturing PhaseThe terms and conditions set forth in this Section A, Manufacturing Phase, Section B, Medical Device Provisions, as well as the terms and conditions set forth in Section C, Standard Terms and Conditions, shall be applicable to this portion of the Agreement. The parties may conduct a mutual review of component pricing, material xxxx-up, and labor on a semi-annual basis. Unit prices shall not be increased or decreased more often than semi-annually unless the quantity on order changes, or in the event of an engineering change that impacts either material or labor costs. Unit prices shall be determined for the quantity of Product on an individual Customer Purchase Order. (For example, if Customer orders 200 units, the 200 piece price shall apply. If the Customer's next Purchase Order is for 50 units, the 50 piece price shall apply.) Attachment C provides an example of unit cost calculations for various production rates. As part of the semi-annual reviews, Plexus shall review unit costs at various production rates and shall provide Customer with updated unit costs at these production rates. Customer's Purchase Orders for quantities outside the scope of Attachment C shall be mutually negotiated. The estimated quantity of Products is a factor used to determine unit pricing. In the event of a significant quantity change, either increasing or decreasing the estimated quantity of assemblies, the parties agree to evaluate and negotiate the impact and timing of unit price adjustments.
Manufacturing PhaseThe terms and conditions set forth in this Section B, Manufacturing Phase, as well as the terms and conditions set forth in Section C, Standard Terms and Conditions, shall be applicable to this portion of the Agreement.
Manufacturing PhaseThe vehicle is composed by several units, which can be divided in sub-units up to the single component. As shown in Figure 4, the two main macro-units, which compose the vehicle, are the powertrain (electric motor and battery system for the XXX and the internal combustion engine for the ICEV) and the glider. For both ICEV and XXX, the glider was based on Ecoinvent 2.1 [21]. Table 1 shows a list of the components included in the glider inventory. Figure 4. Macro units and components of an ICEV and XXX [23]. Table 1. Components included in the glider (for both XXX and ICEV) [21], [23]. Body&Frame Chassis and body Body&Frame Gaskets Body&Frame Front screen Body&Frame Zinc coating Body&Frame Insulation Body&Frame Paint Body&Frame Wiper liquid (Glycol/WateEr) Axle Front axle steering Axle Axle Rear axle Breaks Brake shoes, disks, supports Breaks Brake pressure hoses Breaks Brake oil Breaks Brake shoes, supports Wheels Rims Wheels Tyres Bumper Dampers and springs Air Conditioning Compressor Air Conditioning Air distribution Air Conditioning Adapters Air Conditioning Refrigerant R134a Cockpit Cockpit Safety (Belts, AirbagBse) lts airbags Interior / Linings Linings Interior / Linings Insulation Seats Seat structure Seats Seat covers Doors Frames Doors Windows side and rear Electrics / Lights Lights Electrics / Lights Cables Electrics / Lights El. Motors St. 50% Electrics / Lights El. Motors Al 30% Electrics / Lights El. Motors Cu 20% Electronics Electronics
Manufacturing Phase. A. Customer is responsible for ensuring that the devices covered by this Agreement comply with all applicable laws and regulations, including the Food, Drug and Cosmetic Act and implementing regulations. Customer responsibilities under these provisions, include but are not limited to the following: i) Establishing the finished device specifications. ii) Ensuring that governmentally-required marketing authorizations, including any necessary Food and Drug Administration (FDA) approvals or clearances, have been obtained. iii) Determining the content of any label or labeling. iv) Making any required reports to governmental entities, including but not limited to Medical Device Reports. v) Determining whether any recall or other corrective action is required or appropriate, and developing, implementing and financing any voluntary or mandatory recall or corrective action. vi) Reviewing and approving the quality system prior to production of the devices. B. Plexus will provide Customer ongoing access to its facilities and procedures for quality assurance related to the devices covered by this Agreement. Plexus authorizes Customer to conduct periodic quality systems audits of the manufacturing processes and quality systems related to this Agreement. Plexus will manufacture the devices covered by this Agreement in accordance with its procedures for manufacturing components of medical devices or finished medical devices, as applicable. C. Customer will provide Plexus with sufficient information to verify, calibrate, operate, test and maintain any Customer supplied equipment. D. Customer shall be responsible for the software validation of any embedded product software and the validation of all Customer-supplied: (1) test equipment or test software; (2) production equipment or software; and (3)
Manufacturing PhaseThe terms and conditions set forth in this Section A, Manufacturing Phase, Section B, Medical Device Provisions, as well as the terms and conditions set forth in Section C, Standard Terms and Conditions, shall be applicable to this portion of the Agreement. The parties may conduct a mutual review of component pricing, material xxxx-up, and labor on a semi-annual basis. Unit prices shall not be increased or decreased more often than semi-annually unless the quantity on order changes, or in the event of an engineering change that impacts either material or labor costs. [***] Attachment C provides an example of unit cost calculations for various production rates. As part of the semi-annual reviews, Plexus shall review unit costs at various production rates and shall provide Customer with updated unit costs at these production rates. Customer's Purchase Orders for quantities outside the scope of Attachment C shall be mutually negotiated. The estimated quantity of Products is a factor used to determine unit pricing. In the event of a significant quantity change, either increasing or decreasing the estimated quantity of assemblies, the parties agree to evaluate and negotiate the impact and timing of unit price adjustments.
Manufacturing PhaseUpon completion of the filed testing, which is not to exceed ninety days, PACKAGED ICE shall issue its Purchase Order for a minimum of Thirty-Six Hundred LICENSED UNITS. If problems are found during the field test, the test period shall be extended for the time required to correct the problem. Upon issuance of the Purchase Order, the Manufacturing Phase shall commence in accordance with the following terms and conditions: a. The initial term of the manufacturing contract shall be the earlier of three years or until the thirty-six hundred LICENSED UNITS have been delivered.

Related to Manufacturing Phase

  • Manufacturing Technology Transfer Except as the Committee ------------ --------------------------------- may otherwise agree in writing, in order to effectuate an orderly transition of the uninterrupted availability of Product to LILLY for purposes contemplated under this Agreement, MEGABIOS, at least ninety (90) days prior to completion of the Project or completion of Phase I Clinical Trials, whichever is earlier, shall transfer to LILLY all information and instructions concerning the manufacturing process and related matters in MEGABIOS' possession which may be necessary for LILLY to manufacture Product (including information regarding obtaining necessary Lipids related thereto) for clinical trials and commercialization as contemplated hereunder including, but not limited to, analytical and manufacturing methods. MEGABIOS shall also provide assistance (in the form of consultation) to LILLY with respect to manufacturing matters for a period of [ * ] months after completion of the initial transfer of information and instructions as provided below. Such transfer and assistance by MEGABIOS will be referred to herein as the "Manufacturing Transfer." All such information, methods and instructions transferred to LILLY under this Section 4.3 shall be referred to herein as the "Manufacturing Information," and shall be maintained in confidence by LILLY pursuant to Section 7.1, except that LILLY's obligation to maintain in confidence such Manufacturing Information shall survive for ten (10) years following expiration or termination of this Agreement. LILLY agrees that it will use all such transferred Manufacturing Information only for the manufacture of the Products and shall not disclose or transfer such Manufacturing Information to any third party manufacturer except as provided in Section 2.10. MEGABIOS shall provide, and bear its costs for, up to [ * ] FTEs for a period of up to [ * ] months [ * ] in aggregate) to accomplish the Manufacturing Transfer. Such FTEs, at LILLY's request, shall include visits to LILLY's facilities by MEGABIOS personnel including up to [ * ] from MEGABIOS' head of manufacturing. MEGABIOS shall furnish any additional reasonable assistance beyond the assistance described above regarding manufacturing matters that LILLY may request and that MEGABIOS is able to provide, for up to [ * ] after the initial transfer of Manufacturing Information, providing that LILLY [ * ] incurred with respect to such additional assistance.

  • Manufacturing Services Patheon will perform the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees specified in Schedules B and C to the relevant Product Agreement. Schedule B to each Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in this list are excluded from the Price and are subject to additional fees to be paid by Client. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon will perform the Manufacturing Services solely at the Manufacturing Site, unless otherwise agreed in writing by Client. If the parties agree that Patheon will supply, and Client will purchase, at least a specified minimum percentage of Client’s requirements for a Product under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Patheon fails to remain in material compliance with its obligations under this Agreement or the applicable Product Agreement, or Patheon suspends performance under this Agreement or the applicable Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the Product. In performing the Manufacturing Services, Patheon and Client agree that:

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Manufacturing Rights (a) If QED fails to supply Product ordered by ViewRay in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then QED shall within fifteen (15) Business Days of said failure present ViewRay with a plan to remedy the problem and shall use Commercially Reasonable Efforts to execute such plan and remedy the problem or QED shall secure an alternative source of supply within a reasonable time at no additional cost to ViewRay. Any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If QED is unable to provide a plan to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then QED shall consult with ViewRay and the parties shall work together to remedy the problem. If QED is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to QED, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) If ViewRay notifies QED pursuant to Section 3.10(a), above, that ViewRay will manufacture the Products itself or through a third party, QED shall (i) deliver to ViewRay within thirty (30) days media embodying or disclosing all Program technology and Program proprietary or intellectual property rights necessary to enable ViewRay or its designee to manufacture Products conforming with the Specifications; and (ii) provide ViewRay or its designee, upon request, with reasonable assistance in establishing a back-up manufacturing line. ViewRay shall require any third party ViewRay designates to manufacture Products pursuant to this Section 3.10, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products. Notwithstanding any provision of this Section 3.10 to the contrary, in no case shall QED be required to pay ViewRay in respect of any Products purchased by ViewRay from a third party operating a back-up manufacturing line established pursuant to this Section 3.10 or manufactured by ViewRay or its Affiliates pursuant to this Section 3.10.

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • GMP The parties agree that the GMP for the Project is $ , consisting of the Preconstruction Fee, the Estimated Cost of the Work and the CM/GC Fee (stated as a fixed dollar lump sum amount), as follows: Preconstruction Fee: $ Estimated Cost of Work (Est. COW): $ CM/GC Fee ( % of Est. COW): $ GMP (Total of above categories): $ For purposes of determining the GMP, the Estimated Cost of the Work includes the CM/GC’s Contingency, costs for General Conditions Work, and the costs of all components and systems required for a complete, fully functional facility.