Development Stage contractual stage started with the approval, by ANP, of the Development Plan proposed by the Concessionaire and which continues during the production phase while investments in xxxxx, equipment and facilities are necessary for the production of Oil and Natural Gas in accordance with the Best Practices of the Oil Industry.
Development Stage. The Development Stage of this RE Contract shall be for a period of three (3) years from the date of execution of this RE Contract during which the RE DEVELOPER shall secure Financial Closing, undertake the development, construction, installation, test and commissioning of the Project, and until COD; otherwise, the term of this RE Contract shall automatically expire.
Development Stage a. Goal: to prepare an analytically validated, Investigational Use Only Assay using the […***…] antibody, the Benchmark ULTRA platform and OptiView detection and verified to the United States’ FDA specifications that may be used to select patients in registrational trial(s) of BLU-554 in hepatocellular carcinoma (“HCC”).
b. Anticipated Timeline […***…] for HCC (the “Intended Use”). Ventana will use commercially reasonable efforts to have Ventana IUO ready for BLU-554 pivotal Clinical Trials. In the event the Ventana IUO will not be ready, a Joint Project Team will identify contingencies to select patients for such trials such as incorporating the Ventana CAP CLIA Lab.
c. Estimated Fees to Blueprint for the Intended Use: […***…] (excluding passed through1 and optional costs as described further, and assuming Blueprint has elected to […***…])
Development Stage. The Company was organized as a Texas corporation on April 21, 1989 and changed its jurisdiction of incorporation on January 26, 1995 by becoming a Utah corporation. Since it has not sustained profitable operations in any of its market sectors during the periods reflected in the attached SEC reports, the Company must be considered a development stage enterprise with limited prior operating history. Each investor should be advised that, historically and statistically, development stage entities constitute a greater risk of loss of investment than investment in a seasoned company.
Development Stage. 4.1 Preparation of Third Party Manufacturer for the Joint Development Stage
3.7.1 The Parties agree that [ * ] shall be approached first as the potential major third party manufacturer for the purpose of manufacturing Products and Drug Products meeting the cGMP standards required by the U.S FDA and supplying Products in suitable quantities for use in each Party’s individual development program and (if applicable) in the Joint Development Program. As QBI will be the first Party requiring such cGMP quality of Products, QBI will negotiate and enter into a Manufacturing and Supply Agreements securing, however, that Atugen is fully embedded into the flow of information by receiving copies of reports, changes of the program and project, quantities produced and delivered and that Atugen shall have the right and option to be supplied byQBI’s selected manufacturers. on Atugen’s expense Atugen shall prepare and provide to such common third-party manufacturers and to QBI an up-to-date dossier, which atugen has developed with its partner and which has proven to be suitable for a production of specific 801-siRNA molecules at such partners’ manufacturing facilities. It is understood and agreed that the manufacturers will have to adapt such Manufacturing Process File (the “Manufacturing Process File “) to its own conditions. The Manufacturing Process File intends to describe the Product manufacturing process in sufficient detail (and in any event, at least that level of detail indicated in Schedule D) to (i) enable the preparation of a Drug Master File (DMF) for submission in the IND application and (ii) to enable the selected third party manufacturer (or manufacturers) to practice the Product manufacturing process. For the removal of doubt it is clarified that Atugen’s obligations to prepare, deliver, and update the Manufacturing Process File pursuant to this Section 4.1 shall remain in effect even if Atugen does not participate in the Joint Development Program or its participation in the Collaboration is terminated pursuant to Section 11; however, if Atugen terminates this Agreement in its entirety pursuant to Section 11.2 (ii), Atugen has no longer such obligation pursuant to this Section 4.1. For the removal of doubt Atugen has no further obligation to prepare and provide additional information other than given in the Manufacturing Process File, even if this information may not be sufficient for the preparation of a DMF.
Development Stage. Upon submission of the DOC by the RE DEVELOPER, as confirmed by the DEPARTMENT through the issuance of a COCOC, this RE Contract shall remain in force for the balance of a period of twenty-five (25) years from Effective Date: Provided, That at the option of the RE DEVELOPER, by written notice to the DEPARTMENT not earlier than six (6) months but not later than three (3) months prior to the expiration of the twenty- five (25)-year period, and so long as the RE DEVELOPER is not in default of any material obligations under this RE Contract, the DEPARTMENT may approve the extension of this RE Contract for another twenty-five (25) years, subject to the terms and conditions to be mutually agreed upon by the Parties.
Development Stage. Upon submission of the Declaration of Commerciality by the RE DEVELOPER, as confirmed by the DEPARTMENT through the issuance of a Certificate of Confirmation of Commerciality, this RE CONTRACT shall remain in force for the balance of a period of twenty-five (25) years from Effective Date: Provided, That at the option of the RE DEVELOPER, by written notice to the DEPARTMENT not later than one (1) year prior to the expiration of the initial twenty-five (25)-year period, and so long as the RE DEVELOPER is not in default of any material obligations under this RE Contract, the DEPARTMENT may approve the extension of this RE Contract for another twenty-five (25) years, subject to the terms and conditions to be mutually agreed upon by the Parties.
Development Stage. 1.1.1 [***]
Development Stage a) Each party shall bear their own costs associated with activities related to the participation of Saskatchewan officials in jointly developing a harmonized compliance program, pre-inspection/audit planning, inspections/audits and post-inspection/audit follow-up, at the development stage.
b) Pre-inspection/audit planning, inspection/audits and post-inspection/audit follow-up shall take place in Saskatchewan or through electronic communication.
Development Stage. It is proposedthat as a minimum, the necessary consent and licence applications to build Phase 1 and itssupporting infrastructure will be submitted in Q3 2013. It is anticipated that the consent andlicence applications for Phase 2 will subsequently be submitted in 2016.
