Modification of Product Specifications Sample Clauses

Modification of Product Specifications. Prior to Process Validation Completion, any changes to the Product Specifications will be reviewed and approved in writing by both Parties and, to the extent the change affects the fees set forth in a Work Plan, will be documented in a Change Order or a new or amended Work Plan by the Parties. After Process Validation Completion, Hovione will implement any modification, material or otherwise, to any Product Specifications as requested by Client or a Regulatory Authority (but under no circumstances without the consent of Client), subject to agreement by the Parties on a Change Order or a new or amended Work Plan or amendment to the Supply Price, as applicable, if such change will affect the fees set forth in a Work Plan or the costs used in the calculation of Supply Price under Section 7.2. If such modification results in the requirement to reprocess and/or retest previously Manufactured and otherwise acceptable Product, any additional costs incurred by Hovione in such reprocessing and/or retesting will be paid by * within * days after Client’s receipt of the final report of the results of the retest or reprocessing or as otherwise set forth in the relevant Work Plan. If any modification to any Product Specifications is requested by a Regulatory Authority, but not agreed to by Client and the failure of Client to provide such consent cannot otherwise be resolved as between Client and Hovione, the matter shall be resolved pursuant to Section 18; provided however; nothing contained herein shall prevent Hovione from taking any and all actions it reasonably believes are required to comply with all Applicable Laws and all obligations imposed by any Regulatory Authority.
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Modification of Product Specifications. Neither Party shall implement modifications to the Product Specifications without the other’s prior written request and approval. The Technical Agreement will contain processes for requesting and implementing changes to the Product Specifications.
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Modification of Product Specifications. (a) In the event either Party (the “Proposing Party”) desires any modification to the Product Specifications, Quality Agreement or the process descriptions for the Product filed with the FDA and other Regulatory Authorities in the Territory (a “Proposed Change”) (but excluding, for the avoidance of doubt, any Required Change), the Proposing Party shall notify the other Party by providing the other Party with a description of the Proposed Change sufficient to permit the other Party to evaluate its feasibility and cost, including the Proposing Party’s proposal regarding the allocation between the Parties of the cost associated with implementing such Proposed Change. In connection with any Proposed Change, Supplier shall prepare a report of the Manufacturing process, regulatory impact, and expense impact of implementing the Proposed Change, including identifying any additional equipment, materials, labor, or other expenses. If TESARO is the Proposing Party, Supplier shall invoice TESARO for the expense of preparing such report, and TESARO shall reimburse Supplier for such expense within 30 days after receiving Supplier’s invoice therefor. (b) If any modification to any Product Specifications or the process descriptions for the Product filed with the FDA and other Regulatory Authorities in the Territory is required by a Regulatory Authority (a “Required Change”), and the Parties fail to agree to changes to the Supply Price or responsibility for additional costs that may be incurred by Supplier due to such Required Change despite good faith attempts to reach such resolution, the matter shall be resolved pursuant to Section 15.2; provided, however nothing contained herein shall prevent either Party from taking any and all actions it reasonably believes are required to comply with all Applicable Laws and all obligations imposed by any Regulatory Authority. Supplier will implement any Required Change (but under no circumstances without the consent of TESARO), subject to agreement by the Parties on any conforming changes to the Supply Price or responsibility for additional costs that may be incurred by Supplier due to such Required Change. [***] Notwithstanding anything to the contrary set forth herein, TESARO shall remain obligated to reimburse Corden for all non-cancelable charges for all Product for which a Purchase Order has been issued as of the time of receipt of a notice from a Regulatory Authority that renders the Product unsaleable, but otherwise shall be ...
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Related to Modification of Product Specifications

  • 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.

  • 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.

  • 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.

  • DAF Specifications Developer shall submit initial specifications for the DAF, including System Protection Facilities, to Connecting Transmission Owner and NYISO at least one hundred eighty (180) Calendar Days prior to the Initial Synchronization Date; and final specifications for review and comment at least ninety (90) Calendar Days prior to the Initial Synchronization Date. Connecting Transmission Owner and NYISO shall review such specifications to ensure that the DAF are compatible with the technical specifications, operational control, and safety requirements of the Connecting Transmission Owner and NYISO and comment on such specifications within thirty (30) Calendar Days of Developer’s submission. All specifications provided hereunder shall be deemed to be Confidential Information.

  • Equipment Specifications All equipment must meet the contract specifications and all federal and State safety codes and regulations in effect at the date of manufacture. All equipment must be Original Equipment Manufacturer (OEM) equipment unless otherwise stated in the contract. All products, materials, supplies, replacement parts, and equipment offered and furnished must be new, of current manufacturer production, and must have been formally announced by the manufacturer as being commercially available, unless otherwise stated in this Contract.

  • The Specifications The Specifications are that portion of the Contract Documents consisting of the written requirements for materials, equipment, systems, standards and workmanship for the Work, and performance of related services.

  • Escrow Format Specification Deposit’s Format. Registry objects, such as domains, contacts, name servers, registrars, etc. will be compiled into a file constructed as described in draft-xxxxx-xxxxxxx-registry-data-escrow, see Part A, Section 9, reference 1 of this Specification and draft-xxxxx-xxxxxxx-dnrd-objects-mapping, see Part A, Section 9, reference 2 of this Specification (collectively, the “DNDE Specification”). The DNDE Specification describes some elements as optional; Registry Operator will include those elements in the Deposits if they are available. If not already an RFC, Registry Operator will use the most recent draft version of the DNDE Specification available at the Effective Date. Registry Operator may at its election use newer versions of the DNDE Specification after the Effective Date. Once the DNDE Specification is published as an RFC, Registry Operator will implement that version of the DNDE Specification, no later than one hundred eighty (180) calendar days after. UTF-8 character encoding will be used.

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

  • 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.

  • 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.

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