Manufacturing Phase Clause Samples

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:
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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.
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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.
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Manufacturing Phase. Upon 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.
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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)
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Manufacturing Phase. The 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 ▇▇▇ and the internal combustion engine for the ICEV) and the glider. For both ICEV and ▇▇▇, 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 ▇▇▇ [23]. Table 1. Components included in the glider (for both ▇▇▇ 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
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Manufacturing Phase. The 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 ▇▇▇▇-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.
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Manufacturing Phase. The 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 ▇▇▇▇-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.
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Manufacturing Phase. The 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.
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Related to Manufacturing Phase

  • Manufacturing Technology Transfer Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.

  • 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 [***].

  • 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 ▇▇▇▇▇, 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.