Release and Shipment of Product Sample Clauses

Release and Shipment of Product. (a) Supplier shall notify Customer by electronic transmission of each Batch of Product Manufactured by it under this Agreement in accordance with this Article 7 as soon as reasonably possible, and no later than [***], after Supplier’s quality assurance department approves the Batch for release following successful completion CONFIDENTIAL of the release testing procedures and Customer approves such Batch for release, pursuant to Section 5.1(b)(ii). (b) Supplier shall pack and label shipping boxes and ship all orders of Product in a prompt and timely manner and in accordance with international transport guidelines and regulations, the Product Specifications, and Customer’s reasonable written instructions including, as applicable, for such shipment and the terms of this Agreement. (c) Supplier shall not sell or otherwise dispose of any Product except in accordance with the terms and conditions of this Agreement. (d) The Product shall be shipped [***]. All freight, applicable taxes (excluding any and all income taxes, employment taxes and the like incurred by Supplier), duties, express and delivery charges shall be for Customer’s account and shall not be subject to discount. Upon [***], delivery shall be deemed completed at which time risk of loss or damage and title to the Product shall pass to Customer.
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Release and Shipment of Product. BioVectra has the responsibility to release the Product for shipment to Omthera or its designee, provided, however, that if Product does not meet the Product Specifications, in all respects, the Product can be released only with the prior written consent of Omthera. BioVectra will not ship any Product until the Product is released by its Quality Assurance department.
Release and Shipment of Product. Supplier shall notify Customer by electronic transmission of each batch of Product manufactured by it under this Agreement in accordance with this Clause 7 as soon as reasonably possible after Supplier’s quality assurance department approves the batch for release following successful completion of the release testing procedures. Supplier shall pack and label shipping boxes and ship all orders of Product in a prompt and timely manner and in accordance with international transport guidelines and regulations, the Product Specifications, and Customer’s reasonable written instructions for such shipment and the terms of this Agreement. The Product will be sold FCA Supplier premises (as defined in Incoterms 2010). Title to Product shall remain vested in the Supplier and shall not pass to the Customer until the Fees for the Product has been paid in full and monies received by the Supplier. Risk of loss or damage of the Goods shall pass to Customer upon delivery to the common carrier.
Release and Shipment of Product. BioVectra has the responsibility to release the Product for shipment to Questcor or its designee, provided, however, that if Product does not meet the Specifications in all respects, without any deviations not approved by Questcor, the Product can be released only with the prior written consent of Questcor. BioVectra will not ship any Product to any Delivery Point, as identified by Questcor, until the Product is released.
Release and Shipment of Product. BioVectra has the responsibility for Release of the Product for shipment to PhaseBio or its designee, provided, however, that if Product does not conform to the Specifications in all respects, the Product can be released only with the prior written consent of PhaseBio. BioVectra will not ship any Product until Release of the Product by BioVectra’s Quality Assurance department.
Release and Shipment of Product. Provide a copy of executed Batch Records, deviations and investigation reports, and any applicable documentation within 1 week of BVL Batch release X Generate BVL Certificate of Analysis X Generate BVL Certificate of Compliance X Perform Product disposition X Establish and maintain shipping procedures and documentation. X X Insure Shipping of Product from BVL to Customer destination is in compliance with the Specifications for the Product, specifically including without limitation temperature shipping requirements X Approve shipping configuration and procedures. X X Package Product for shipment to specified distributors. Store and transport Product to conform to label copy storage conditions. X Request shipment of Product, specifying date of shipment, shipping address, lot number, quantity, etc. X Ship Product as specified in Batch PO per SOP. X
Release and Shipment of Product. Provide a copy of executed Batch Records, deviations and investigation reports, and any applicable documentation within 1 week of BVL Batch release X Generate BVL Certificate of Analysis X Generate BVL Certificate of Compliance X Perform Product disposition X Quality Agreement (BVL and Theravance) Page 15 Establish and maintain shipping procedures and documentation. X X Insure Shipping of Product from BVL to Customer destination is in compliance with the Specifications for the Product, specifically including without limitation temperature shipping requirements X Approve shipping configuration and procedures. X X Package Product for shipment to specified distributors. Store and transport Product to conform to label copy storage conditions. X Request shipment of Product, specifying date of shipment, shipping address, lot number, quantity, etc. X Ship Product as specified in Batch PO per SOP. X
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Release and Shipment of Product. LTS has the responsibility to release finished drug product to NGX. LTS will not ship any of NGX’s product to any destination other than NGX until NGX has released the product and authorized shipment or unless prior approval has been received from NGX to perform such shipments. A Certificate of Analysis (CofA) or applicable documentation, as well as a Certificate of Production Compliance, shall be provided to NGX by LTS for each batch of drug product produced. The CofA, or equivalent, will be generated upon completion of all testing requirements and will contain the items tested, corresponding acceptance criteria, and test results. NGX is responsible for the approval and final release of all finished drug product after review of LTS’ CofA and other required documentation. Upon approval, NGX will notify LTS of such approval by forwarding to LTS the NGX completed and approved batch release checklist.

Related to Release and Shipment of Product

  • Supply of Product 4.1 DAEWOONG shall manufacture and supply Product to AEON in a primary packaged and labeled form. Product packaging shall display the logo of DAEWOONG (to the extent required by applicable law) and AEON and the outer label shall be marked using English language in accordance with applicable laws and Product’s Regulatory Approvals. 4.2 AEON’s estimate sales forecast of the Product during the Term of Agreement in the Territory in the Field is set forth in Annex D. Within ninety (90) days after the Effective Date, AEON shall provide DAEWOONG with a non-binding twelve (12) month rolling forecast of its requirements of Product, which the Parties agree is not a commitment to buy any stated quantity. Thereafter, on at least a quarterly basis, AEON shall provide DAEWOONG with an updated twelve (12) month rolling forecast, together with a binding six (6) month forecast to the extent AEON has requested Safety Stock as described in Article 4.10 below. Each such forecast shah be referred to herein as a “Forecast.” 4.3 AEON may from time to time submit Purchase Orders to DAEWOONG for Product in accordance with the forecasting requirements in Article 4.2. Orders will be shipped on CIF Los Angeles port. 4.4 Once a Purchase Order for Product and Product Samples has been received by DAEWOONG, it shall be considered as irrevocable. 4.5 AEON agrees herein to place an Order for Product not later than [***] from receipt of Regulatory Approval. 4.6 Individual Purchase Orders of Product shall be placed at least [***] in advance of the required delivery date. 4.7 For the purpose of Commercialization, AEON will store and maintain the full quantity of Product in a clean, secured area in accordance with the reasonable directions and specifications provided by DAEWOONG in writing in connection thereof in the Territory. AEON will advise DAEWOONG on the applicable requirements specifically deriving from the laws and regulations in the Territory. 4.8 AEON agrees that DAEWOONG and its collaborators and agents, in DAEWOONG’s sole discretion, which collaborators and Agents will be subject to appropriate obligations of confidentiality, will have the right upon reasonable prior notice, to observe and to inspect and to audit AEON’s facility to ascertain compliance by AEON with the terms of this Agreement, including without limitation (a) the holding facilities for Product, and (b) AEON’s compliance with applicable law, including cGMP (if applicable). Following any such audit, DAEWOONG will discuss its observations and conclusions with AEON and corrective actions, if any, will be agreed upon by the Parties, and executed by AEON using Commercially Reasonable Efforts. 4.9 In addition to any other rights and remedies available to AEON, AEON shall have the right to recover lost profits in the event that DAEWOONG fails to deliver at least [***] in any [***] (a “Supply Default Event”). For purposes of this provision, lost profits would be equal to [***] of AEON operating profit (sales less direct expenses and the puce paid by AEON for such Products) on Products that have not been shipped against firm Purchase Orders during the period leading up to the Supply Default Event and bona fide Purchase Orders submitted by AEON that are consistent with the Forecast during the Supply Default Period (as defined below). Such payment shall be made with respect to all Product not shipped in the period giving rise to the Supply Default and for the period until DAEWOONG is again timely shipping Product to meet AEON’s needs (the “Supply Default Period”). The first such payment shall be made within [***] of the Supply Default Event, and every [***] thereafter. AEON agrees to permit full disclosure to DAEWOONG of AEON’s accounting records, solely related to the calculation of lost profits, for the [***] ending on the first day of the month in which the Supply Event Default occurred. In the event that DAEWOONG is unable to supply both AEON’s requirements of Product and its own and third parties’ requirements for Product, DAEWOONG shall allocate Product that DAEWOONG has in inventory and that DAEWOONG is able to Product, so that AEON receives its requirements of Product in priority to DAEWOONG and third parties. 4.10 At the request of AEON, DAEWOONG shall at its own cost and expense during the Term, maintain an amount of inventory of Product equal to AEON’s requirements for Product for [***] based on AEON’s most recent forecast (“Safety Stock”). The Safety Stock shall be (i) maintained for the sole benefit of AEON and its Affiliates, (ii) shall be stored at a secure facility in compliance with GMP, and (iii) shall not be used for the benefit of any other customer of DAEWOONG. DAEWOONG shall rotate the Safety Stock on a “First Expiry-First Out” basis for routine fulfillment of firm orders, subject to Article 7.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Marketing of Production Except for contracts listed and in effect on the date hereof on Schedule 7.19, and thereafter either disclosed in writing to the Administrative Agent or included in the most recently delivered Reserve Report (with respect to all of which contracts the Borrower represents that it or its Subsidiaries are receiving a price for all production sold thereunder which is computed substantially in accordance with the terms of the relevant contract and are not having deliveries curtailed substantially below the subject Property’s delivery capacity), no material agreements exist which are not cancelable on 60 days notice or less without penalty or detriment for the sale of production from the Borrower’s or its Subsidiaries’ Hydrocarbons (including, without limitation, calls on or other rights to purchase, production, whether or not the same are currently being exercised) that (a) pertain to the sale of production at a fixed price and (b) have a maturity or expiry date of longer than six (6) months from the date hereof.

  • PACKING AND SHIPMENT (a) Unless otherwise specified, all Work is to be packed in accordance with good commercial practice. (b) A complete packing list shall be enclosed with all shipments. SELLER shall mark containers or packages with necessary lifting, loading, and shipping information, including the LOCKHEED XXXXXX Contract number, item number, dates of shipment, and the names and addresses of consignor and consignee. Bills of lading shall include this Contract number. (c) Unless otherwise specified, delivery shall be FOB Place of Shipment.

  • Forecasts and Purchase Orders (a) Following Regulatory Approval of one of the Initial Products during the term of this Agreement, Reliant shall provide to ASL no later than the first day of the first month of each calendar quarter a non-binding good faith estimate (“Quarterly Forecast”) by quarter of Reliant’s requirements for the Active Ingredient for the calendar quarter and the succeeding three (3) calendar quarters. Reliant will be obligated to purchase 75% of the quantities of API forecasted for the first two (2) succeeding calendar quarters of each Quarterly Forecast. Within (30) days of Regulatory Approval, Reliant shall provide an initial forecast (“Initial Forecast”) for the four calendar quarters following Regulatory Approval. (b) Reliant shall place binding purchase orders for Active Ingredient by written or electronic purchase order (or by any other means agreed to by the parties) to ASL, which shall be placed at least ninety (90) days prior to desired date of delivery. (c) ASL shall be obligated to supply Active Ingredient as ordered by Reliant. To the extent purchase orders in any calendar month exceed One Hundred Fifty percent (150%) of the Quarterly Forecast for the relevant quarter, ASL shall use its best efforts to supply 125% of the quantity ordered. (d) ASL shall maintain minimum inventory levels equal to the binding portion of the then current Quarterly Forecast. The Active Ingredient shall be shipped C.I.F. Duty Unpaid to a Designated Facility or other location agreed by the parties. Active Ingredient shall be shipped upon completion of production in temperature-controlled vehicles in accordance with the specifications including light protecting containers and the Quality Agreement in order to maintain the quality of the Active Ingredient. Carriers selected by ASL must be commercially reputable, able to track shipments and fully insured with adequate coverage to replace the value of the goods shipped. Title and risk of loss pass on delivery to the Designated Facility. (e) All shipments of Active Ingredient shall be accompanied by a packing slip and a certificate of analysis which describes the Active Ingredient, states the purchase order number, confirms that the Active Ingredient conforms in all ways with the Specifications, the Process Description and was manufactured in accordance with GMP and all other requirements of the Act. To the extent of any conflict or inconsistency between this Agreement and any purchase order, purchase order release, confirmation, acceptance or any similar document, the terms of this Agreement shall govern. (f) Reliant shall notify ASL of any short-shipment claims within thirty (30) days of receipt of a shipment of Active Ingredient. (g) ASL shall not be obligated to accept any returns of Active Ingredient other than as a result of such Active Ingredient failing to meet the Specifications in accordance with Section 2.9(a), was not manufactured in accordance with GMP, or does not otherwise comply with the manufacturing, storage and/or transportation requirements of the Act.

  • Purchase Order Pricing/Product Deviation If a deviation of pricing/product on a Purchase Order or contract modification occurs between the Vendor and the TIPS Member, TIPS must be notified within five (5) business days of receipt of change order. TIPS reserves the right to terminate this agreement for cause or no cause for convenience with a thirty (30) days prior written notice. Termination for convenience is conditionally required under Federal Regulations 2 CFR part 200 if the customer is using federal funds for the procurement. All purchase orders presented to the Vendor, but not fulfilled by the Vendor, by a TIPS Member prior to the actual termination of this agreement shall be honored at the option of the TIPS Member. The awarded Vendor may terminate the agreement with ninety (90) days prior written notice to TIPS 0000 XX Xxx Xxxxx, Xxxxxxxxx, Xxxxx 00000. The vendor will be paid for goods and services delivered prior to the termination provided that the goods and services were delivered in accordance with the terms and conditions of the terminated agreement. This termination clause does not affect the sales agreements executed by the Vendor and the TIPS Member customer pursuant to this agreement. TIPS Members may negotiate a termination for convenience clause that meets the needs of the transaction based on applicable factors, such as funding sources or other needs. Usually, purchase orders or their equal are issued by participating TIPS Member to the awarded vendor and should indicate on the order that the purchase is per the applicable TIPS Agreement Number. Orders are typically emailed to TIPS at xxxxxx@xxxx-xxx.xxx. • Awarded Vendor delivers goods/services directly to the participating member. • Awarded Vendor invoices the participating TIPS Member directly. • Awarded Vendor receives payment directly from the participating member. • Fees are due to TIPS upon payment by the Member to the Vendor. Vendor agrees to pay the participation fee to TIPS for all Agreement sales upon receipt of payment including partial payment, from the Member Entity or as otherwise agreed by TIPS in writing and signed by an authorized signatory of TIPS.

  • Shipment Dell will ship the APEX System to the Site when included as part of the APEX Service. The terms and process for shipment and delivery of the APEX System will be stated in the applicable Service Offering Description.

  • Product Specific Terms these terms apply to specific Products referenced in this section.

  • 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.

  • Conformity of production 8.1. Procedures concerning conformity of production shall comply with those set out in the 1958 Agreement, Schedule 1 (E/ECE/TRANS/505/Rev.3) and meet the following requirements: 8.2. A vehicle approved pursuant to this Regulation shall be so manufactured as to conform to the type approved by meeting the requirements of paragraph 5. above; 8.3. The Type Approval Authority which has granted approval may at any time verify the conformity of control methods applicable to each production unit. The normal frequency of such inspections shall be once every two years.

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