Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.
Project Planning GOVERNMENTAL APPROVALS; ENVIRONMENTAL COMPLIANCE; PUBLIC INFORMATION 30 4.1 Planning and Engineering Activities 30 4.2 Site Conditions 30 4.3 Governmental Approvals 30 4.4 Environmental Compliance 34 4.5 Community Outreach and Public Information 35
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Construction Phase Services 3.1.1 – Basic Construction Services
DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK
Preparatory Contract Negotiations Meetings Where operational requirements permit, the Employer will grant leave without pay to an employee to attend preparatory contract negotiations meetings.
Development of the Project 4.1 TSP's obligations in development of the Project:
a. for procuring and maintaining in full force and effect all Consents, Clearances and Permits, required in accordance with Law for development of the Project;
b. for financing, constructing, owning and commissioning each of the Element of the Project for the scope of work set out in Schedule 1 of this Agreement in accordance with:
i. the Electricity Act and the Rules made thereof;
ii. the Grid Code;
iii. the CEA Regulations applicable, and as amended from time to time, for Transmission Lines and sub-stations: • the Central Electricity Authority (Technical Standards for Connectivity to the Grid) Regulations, 2007; • Central Electricity Authority (Technical Standards for construction of Electrical Plants and Electric Lines) Regulation, 2010; • Central Electricity Authority (Grid Standard) Regulations, 2010; • Central Electricity Authority (Safety requirements for construction, operation and maintenance of Electrical Plants and Electrical Lines) Regulation, 2011; • Central Electricity Authority (Measures relating to Safety and Electricity Supply) Regulation, 2010; • Central Electricity Authority (Technical Standards for Communication System in Power System Operation) Regulations, 2020.
iv. Safety/ security Guidelines laid down by the Government;
v. Prudent Utility Practices, relevant Indian Standards and the Law; not later than the Scheduled COD as per Schedule 2 of this Agreement;
c. for entering into a Connection Agreement with the concerned parties in accordance with the Grid Code.
d. for owning the Project throughout the term of this Agreement free and clear of any encumbrances except those expressly permitted under Article 15 of this Agreement;
e. to co-ordinate and liaise with concerned agencies and provide on a timely basis relevant information with regard to the specifications of the Project that may be required for interconnecting the Project with the Interconnection Facilities;
f. for providing all assistance to the Arbitrators as they may require for the performance of their duties and responsibilities;
g. to provide to the Nodal Agency and CEA, on a monthly basis, progress reports with regard to the Project and its execution (in accordance with prescribed form) to enable the CEA to monitor and co-ordinate the development of the Project matching with the Interconnection Facilities;
h. to comply with Ministry of Power order no. 25-11/6/2018 – PG dated 02.07.2020 as well as other Guidelines issued by Govt. of India pertaining to this;
i. to procure the products associated with the Transmission System as per provisions of Public Procurement (Preference to Make in India) orders issued by Ministry of Power vide orders No. 11/5/2018 - Coord. dated 28.07.2020 for transmission sector, as amended from time to time read with Department for Promotion of Industry and Internal Trade (DPIIT) orders in this regard (Procuring Entity as defined in above orders shall deemed to have included Selected Bidder and/ or TSP). Also, to comply with Department of Expenditure, Ministry of Finance vide Order (Public Procurement No 1) bearing File No. 6/18/2019- PPD dated 23.07.2020, Order (Public Procurement No 2) bearing File No. 6/18/2019-PPD dated 23.07.2020 and Order (Public Procurement No. 3) bearing File No. 6/18/2019-PPD, dated 24.07.2020, as amended from time to time, regarding public procurement from a bidder of a country, which shares land border with India;
j. to submit to Nodal Agency information in the prescribed format [To be devised by Nodal Agency] for ensuring compliance to Article 4.1 i) above.
k. to comply with all its obligations undertaken in this Agreement.
4.2 Roles of the Nodal Agency in implementation of the Project:
4.2.1 Subject to the terms and conditions of this Agreement, the Nodal Agency shall be the holder and administrator of this Agreement and shall inter alia:
a. appoint an Independent Engineer within 90 days of the Effective Date
b. provide letters of recommendation to the concerned Indian Governmental Instrumentality, as may be requested by the TSP from time to time, for obtaining the Consents, Clearances and Permits required for the Project;
c. coordinate among TSP and upstream/downstream entities in respect of Interconnection Facilities; and
d. monitor the implementation of the Agreement and take appropriate action for breach thereof including revocation of guarantees, cancellation of Agreement, blacklisting etc
e. provide all assistance to the Arbitrators as required for the performance of their duties and responsibilities; and
f. perform any other responsibility (ies) as specified in this Agreement.
Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following:
(i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and
(ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT.
(iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION;
(iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.
Information Systems Acquisition Development and Maintenance a. Client Data – Client Data will only be used by State Street for the purposes specified in this Agreement.
