Drug Substance Specifications; DMF Sample Clauses

Drug Substance Specifications; DMF. The specifications (“Specifications”), including without limitation the route of synthesis (“Route of Synthesis”) which is included within the Specifications, for the Drug Substance are specified in Attachment 6.1 hereto. The Drug Substance shall comply with the requirements of the Specifications at the time of purchase. The current Specifications have been jointly established by the Parties (attached hereto as Attachment 6.1) and may only be amended or supplemented from time to time pursuant to the provisions below. No changes, modifications, deviations or exceptions to [ *** ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Exchange Act of 1933, as amended. the Specifications, place of manufacture, materials or fabrication manufacturing or packaging processes may be made without the prior written approval of Replidyne, which approval may be provided or withheld by Replidyne in its sole discretion.
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Related to Drug Substance Specifications; DMF

  • ODUF Packing Specifications 6.3.1 The data will be packed using ATIS EMI records. A pack will contain a minimum of one (1) message record or a maximum of ninety-nine thousand nine hundred and ninety-nine (99,999) message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of ninety-nine (99) packs and a minimum of one (1) pack.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Technical Specifications 1. A procuring entity shall not prepare, adopt or apply any technical specification or prescribe any conformity assessment procedure with the purpose or effect of creating an unnecessary obstacle to trade between the Parties.

  • 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.

  • 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.

  • 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.

  • Service Specification The Parties have agreed upon the scope and specification of the Services provided under this Service Agreement in the Service Specification.

  • 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. Items Offered as New. 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.

  • Escrow Format Specification 3.1. 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.

  • MSAA Indicator Technical Specification Document This Agreement shall be interpreted with reference to the MSAA Indicator Technical Specifications document.

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