SUBMISSION OF THE DOSSIER Sample Clauses

SUBMISSION OF THE DOSSIER. 4 The manufacturer requests a certificate by submitting a copy of a dossier in English (preferably) or 5 French according to the CTD format and including the relevant part of the Quality Overall 6 Summary (QOS), and an application form duly filled in (see 7), together with samples of 7 commercial batches and fees. 8 The documentation to be provided by the manufacturer is described in specific documents 9 published by EDQM for the evaluation of the chemical purity, for TSE risk assessment, for herbal 10 drugs and preparations (see 7). For products bearing a risk of transmitting animal spongiform 11 encephalopathy agents, and for which a specific monograph exists in the European Pharmacopoeia, 12 the applicant may apply for a certificate concerning the general monograph Products with risk of 13 transmitting agents of animal spongiform encephalopathies as well as for the specific monograph, 14 or may wish only to apply for a certificate concerning the general monograph. Where no specific 16 evaluation should be supplied.
Sample 1
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Related to SUBMISSION OF THE DOSSIER

  • Submission of Tender The tender shall be submitted online in two part, viz., technical bid and financial bid. All the pages of bid being submitted must be signed and sequentially numbered by the bidder irrespective of nature of content of the documents before uploading.

  • SUBMISSION OF TENDERS 3.01 The tenderer, should submit tenders after studying the entire tender document and instructions to the tenderer's carefully, visiting the sites, for satisfying himself of the local conditions, locations, accessibility of sites, nature, extent and character of operation, may obtain all clarifications before the tendering. Submission of tender implies that the tenderer has obtained all the clarifications required by him. No claim on ground of want of knowledge, thereafter, in such respect will be entertained. The tenderer should quote rates both in figures as well as in words in Rupees per MT Per Km for different movement slabs and in Rupees per MT., for wagon handling in the two separate formats of Schedule No. II. Tenderers have to tender the rates for transportation, only on slab rates irrespective of existence of truck union. Truck operators union / Transport Cooperatives which are registered with the registrar, Firms and Societies of the respective states to be supported with a notarized copy of the valid Registration certificate can also participate in the tenders directly but they shall have to tender the rates on slab rate basis. For tenderers other than registered truck operators unions / transport cooperatives, it shall be the responsibility of the tenderer to deal with the union if existing at any rake point. Tenderer shall have to arrange the movement as per the movement plan on rake to rake basis. Increase in transportation rates during the contract period or extended period of contract shall be considered only if there is increase in diesel rate by Government of India. The increase shall be allowed as per the formula given in the relevant clause of General terms and conditions of the tender document. The same formula shall be applicable for Truck operators unions / Transport Cooperatives also.

  • SUBMISSION OF BID Bids may be submitted via the electronic submission portal at: xxxxx://xxx.xxxxxxxxxx.xxx/buyer/691, or in the Procurement Division; Internal Operations Centre II, 000 X. Xxxxx Xxxxxx; 0xx Xxxxx, Xxxxxxx, XX 00000, prior to the submission deadline. Bids will be opened per the public meeting notice. If bid will be mailed or hand delivered, ensure it is secured in a sealed envelope, addressed as follows: ORANGE COUNTY PROCUREMENT DIVISION Internal Operations Centre II 000 X. Xxxxx Xxxxxx, 0xx Xxxxx Xxxxxxx, Xxxxxxx 00000 Bidders must indicate on the sealed envelope the following:

  • Submission of Bids When the Scheduling Coordinator on behalf of the Participating Generator submits a Bid for Ancillary Services, the Participating Generator will, by the operation of this Section 4.3.1, warrant to the CAISO that it has the capability to provide that service in accordance with the CAISO Tariff and that it will comply with CAISO Dispatch Instructions for the provision of the service in accordance with the CAISO Tariff.

  • Submission of Agreement Submission of this Lease to Tenant for signature does not constitute a reservation of space or an option to acquire a right of entry. This Lease is not binding or effective until execution by and delivery to both Landlord and Tenant.

  • SUBMISSION OF PROPOSALS (1) The Company shall on or before 30 June 1994 (or by such extended date as the Minister may allow pursuant to clause 23) and subject to the EP Act and the Environmental Approval and the provisions of this Agreement submit to the Minister to the fullest extent reasonably practicable its detailed proposals for the carrying out of the Project, which proposals shall include the location, area, layout, design, materials, time programme for the commencement and completion of construction or the provision (as the case may be) of all things necessary to complete the Project, the order in which the works necessary to complete the Project are to be carried out, and full plans and specifications for all works required to complete the Project.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Governing Law; Submission to Process EXCEPT TO THE EXTENT THAT THE LAW OF ANOTHER JURISDICTION IS EXPRESSLY ELECTED IN A TRANSACTION DOCUMENT, THIS AGREEMENT AND THE OTHER TRANSACTION DOCUMENTS, SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF LAW. EACH OF BIONOVA AND SAVIA HEREBY IRREVOCABLY SUBMITS ITSELF AND EACH OTHER RELATED PERSON TO THE NON-EXCLUSIVE JURISDICTION OF THE STATE AND FEDERAL COURTS SITTING IN THE STATE OF NEW YORK AND THE COUNTY OF NEW YORK AND AGREES AND CONSENTS THAT SERVICE OF PROCESS MAY BE MADE UPON IT OR ANY OF ITS SUBSIDIARIES IN ANY LEGAL PROCEEDING RELATING TO THE TRANSACTION DOCUMENTS BY ANY MEANS ALLOWED UNDER NEW YORK OR FEDERAL LAW. EACH OF BIONOVA AND SAVIA IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY OBJECTION THAT IT MAY NOW OR HEREAFTER HAVE TO THE LAYING OF THE VENUE OF ANY SUCH PROCEEDING BROUGHT IN SUCH A COURT AND ANY CLAIM THAT ANY SUCH PROCEEDING BROUGHT IN SUCH A COURT HAS BEEN BROUGHT IN AN INCONVENIENT FORUM.

  • Submission of Orders Each person desiring to purchase Shares in the Offering will be required to complete and execute a subscription eligibility form provided by the Company to each Dealer for use in connection with the Offering (the “Eligibility Form”) and to deliver to the Dealer such completed and executed Eligibility Form together with a check or wire transfer (“instrument of payment”) in the amount of such person’s purchase, which must be at least the minimum purchase amount set forth in the Prospectus. Those persons who purchase Shares will be instructed by the Dealer to make their instruments of payment payable to or for the benefit of “Dividend Capital Diversified Property Fund Inc.” Purchase orders received and processed by the Company prior to the close of the New York Stock Exchange (generally, 4:00 p.m. Eastern time; the “close of business”) on any business day will be executed at the price per share of the class of shares being purchased calculated at the end of such business day plus, for Class A shares only, applicable selling commissions, in accordance with the procedures described in the Prospectus. Purchase orders received and processed after the close of business on any business day, or on a day that is not a business day, will be executed at the price per share of the class of shares being purchased calculated at the end of the next business day plus, for Class A shares only, applicable selling commissions, in accordance with the procedures described in the Prospectus. Subscribers may not submit an initial purchase order until at least five (5) business days after the date on which the subscriber receives a copy of the Prospectus. If the Dealer receives an Eligibility Form or instrument of payment not conforming to the foregoing instructions, the Dealer shall return such Eligibility Form and instrument of payment directly to such subscriber not later than the end of the next business day following its receipt. Eligibility Forms and instruments of payment received by the Dealer which conform to the foregoing instructions shall be transmitted for deposit pursuant to one of the methods described in this Section II. Transmittal of received investor funds will be made in accordance with the following procedures: Where, pursuant to the Dealer’s internal supervisory procedures, internal supervisory review is conducted at the same location at which Eligibility Forms and instruments of payment are received from subscribers, Eligibility Forms and instruments of payment will be transmitted by the end of the next business day following receipt by the Dealer for deposit to Dividend Capital Diversified Property Fund Inc. as set forth in the Eligibility Form or as otherwise directed by the Company. Where, pursuant to the Dealer’s internal supervisory procedures, final and internal supervisory review is conducted at a different location, Eligibility Forms and instruments of payment will be transmitted by the end of the next business day following receipt by the Dealer to the office of the Dealer conducting such final internal supervisory review (the “Final Review Office”). The Final Review Office will in turn, by the end of the next business day following receipt by the Final Review Office, transmit such Eligibility Forms and instruments of payment for deposit to Dividend Capital Diversified Property Fund Inc. as set forth in the Eligibility Form or as otherwise directed by the Company.

  • Recognition of the U.S. Special Resolution Regimes (a) In the event that any Underwriter that is a Covered Entity becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer from such Underwriter of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were governed by the laws of the United States or a state of the United States.

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