Non-Conforming Product/Deviations Sample Clauses

Non-Conforming Product/Deviations. SDIX shall maintain systems for segregating and dispositioning Supplied Product that does not pass the Methods of Analysis. SDIX shall notify BD of any deviations that have the potential to impact the adherence of the Supplied Products to the Methods of Analysis within thirty (30) days of implementation.
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Related to Non-Conforming Product/Deviations

  • Non-Conforming Product (a) In the event Patheon discovers a potential Non-Conforming Product prior to delivery of such Product to Flexion, Patheon shall provide written notice to Flexion as soon as practicable describing in detail the Non-Conforming Product and the potential cause of such Non-Conforming Product. Flexion (or its shipping carrier) will perform a customary inspection of the Products Manufactured by Patheon on receipt. For the avoidance of doubt, such inspection will be limited to a visual inspection of the shipment-ready packaged Products (and associated shipping documentation) and Flexion will not be obliged to perform any testing of the Product. Flexion shall within (i) […***…] days after delivery thereof by Patheon or (ii) within […***…] days after Flexion discovers or is informed of a discovery of nonconformity that could not reasonably have been detected by the customary inspection on delivery (but not after the expiration date of the Product), give Patheon notice of any Non-Conforming Product (including a sample of such Non-Conforming Product, if applicable) (a “Deficiency Notice”). Subject to Flexion’s rights under 3.10 and 3.12, should Flexion fail to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Flexion on the […***…] day after delivery or discovery, as applicable. Patheon shall have no liability under this Section 2.8 for Nonconforming Product for which it has not received a Deficiency Notice within such applicable […***…] day period. (b) Patheon shall conduct a root-cause analysis to verify whether a Product constitutes a Non-Conforming Product and, if found, to determine the cause of such Non-Conforming Product (including by undertaking an appropriate evaluation of a Non-Conforming Product sample, as applicable). Flexion shall provide reasonable cooperation to Patheon in connection with any such root-cause analysis. Patheon shall notify Flexion in writing of its determination regarding whether the Product constitutes a Non-Conforming Product within […***…] days after either discovery of the Non-Conforming Product or receipt of such Deficiency Notice from Flexion, as applicable. Such notification shall include Patheon’s good faith determination of the cause of the Non-Conforming Product.

  • 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.

  • Packing Specifications 7.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Product Specifications (a) Supplier shall manufacture all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service xxxx, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

  • Non-Conforming Measures 1. Articles 2, 3 and 6 shall not apply to: (a) any existing non-conforming measure that is Maintained by the following, as set out in the Schedule of each Contracting Party in Annex I: (i) the central government of a Contracting Party; or (ii) a prefecture of Japan or a province or a Municipality of the Republic of Mozambique; (b) any existing non-conforming measure that is maintained by a local government other than a prefecture and a province and a municipality referred to in subparagraph (a)(ii); (c) the continuation or prompt renewal of any nonconforming measure referred to in subparagraphs (a) and (b); or (d) an amendment or modification to any nonconforming measure referred to in subparagraphs (a) and (b), provided that the amendment or modification does not decrease the conformity of the measure as it existed immediately before the amendment or modification with Articles 2, 3 and 6. 2. Articles 2, 3 and 6 shall not apply to any measure that a Contracting Party adopts or maintains with respect to sectors, sub-sectors or activities set out in its Schedule in Annex II. 3. Neither Contracting Party shall, under any measure adopted after the date of entry into force of this Agreement and covered by its Schedule in Annex II, require an investor of the other Contracting Party, by reason of its nationality, to sell or otherwise dispose of an investment that exists at the time when the measure becomes effective. 4. In cases where a Contracting Party makes an amendment or a modification to any existing non-conforming measure set out in its Schedule in Annex I or where a Contracting Party adopts any new or more restrictive measure with respect to sectors, sub-sectors, or activities set out in its Schedule in Annex II after the date of entry into force of this Agreement, the Contracting Party shall, prior to the implementation of the amendment or modification or the new or more restrictive measure, or in exceptional circumstances, as soon as possible thereafter: (a) notify the other Contracting Party of detailed information on such amendment or modification, or such measure; and (b) hold, upon request by the other Contracting Party, consultations in good faith with the other Contracting Party with a view to achieving mutual satisfaction. 5. Each Contracting Party shall endeavour, where appropriate, to reduce or eliminate the non-conforming measures specified in its Schedules in Annexes I and II respectively. 6. Articles 2, 3 and 6 shall not apply to any measure covered by the exceptions to, or derogations from, obligations under Articles 3 and 4 of the TRIPS Agreement, as specifically provided in Articles 3 through 5 of the TRIPS Agreement. 7. Articles 2, 3 and 6 shall not apply to any measure that a Contracting Party adopts or maintains with respect to government procurement.

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Nonconforming Work 5.6.1 Rejection, Removal and Replacement of Nonconforming Work

  • 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.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

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