Independent Study A sabbatical leave may be granted for a plan of independent study, research, writing, and/or travel equivalent in time and rigor to a sabbatical for formal study. A detailed, specific plan must be submitted by the applicant and approved by the Salary and Leaves Committee as likely to improve the applicant’s teaching effectiveness, strengthen the College’s academic program, or otherwise bring a clear benefit to students. In addition, sabbaticals for independent study must generate tangible products of use to students.
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.
Feasibility Study A feasibility study will identify the potential costs, service quality and other benefits which would result from contracting out the work in question. The cost analysis for the feasibility study shall not include the Employer’s indirect overhead costs for existing salaries or wages and benefits for administrative staff or for rent, equipment, utilities, and materials, except to the extent that such costs are attributable solely to performing the services to be contracted out. Upon completion of the feasibility study, the Employer agrees to furnish the Union with a copy if the feasibility study, the bid from the Apparent Successful Bidder and all pertinent information upon which the Employer based its decision to contract out the work including, but not limited to, the total cost savings the Employer anticipates. The Employer shall not go forward with contracting out the work in question if more than sixty percent (60%) of any projected savings resulting from the contracting out are attributable to lower employee wage and benefit costs.
Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory;
(c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = 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 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.
Independent Activities 14.1 Except as expressly provided herein, each party shall have the free and unrestricted right to independently engage in and receive the full benefit of any and all business endeavours of any sort whatsoever, whether or not competitive with the endeavours contemplated herein without consulting the other or inviting or allowing the other to participate therein. No party shall be under any fiduciary or other duty to the other which will prevent it from engaging in or enjoying the benefits of competing endeavours within the general scope of the endeavours contemplated herein. The legal doctrines of "corporate opportunity" sometimes applied to persons engaged in a joint venture or having fiduciary status shall not apply in the case of any party. In particular, without limiting the foregoing, no party shall have any obligation to any other party as to:
(a) any opportunity to acquire, explore and develop any mining property, interest or right presently owned by it or offered to it outside of the Property at any time; and
(b) the erection of any mining plant, mill, smelter or refinery, whether or not such mining plant, mill, smelter or refinery treats ores or concentrates from the Property.
Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods.
(b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch.
(c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.
