Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.
Payment for Labor and Materials (a) Subject to the terms, provisions and conditions of the Loan Agreement, Borrower will promptly pay or cause to be paid when due all bills and costs for labor, materials, and specifically fabricated materials (“Labor and Material Costs”) incurred in connection with the Property and never permit to exist beyond the due date thereof in respect of the Property or any part thereof any lien or security interest, even though inferior to the liens and the security interests hereof, and in any event never permit to be created or exist in respect of the Property or any part thereof any other or additional lien or security interest other than the liens or security interests hereof except for the Permitted Encumbrances.
Development Plan The Parties’ respective responsibilities for the Development of the Collaboration Compounds and the Products are set forth in this Article 4. As of the Execution Date, the Parties have agreed upon a Development Plan for the Development of Product(s), attached to this Agreement as Exhibit A. The Development Plan may be revised from time to time by the JDC. Either Party may propose modifications to the Development Plan for Development of a Product, including clinical trial plans and time lines, and such proposed modifications shall be subject to review and approval by the JDC, provided that with respect to a Material Development Plan Amendment, a Party may propose such modifications directly to the JSC. Upon approval by the JDC (or JSC, as applicable), such modifications shall become part of the Development Plan. All Development Plans must require periodic reassessment and re-approval (each a “Go/No-go Decision”) after each clinical trial or at such times as the JDC in its discretion deems appropriate, at which point continuation of relevant Development activities shall be subject to the approval of the JDC in view of then applicable scientific, clinical, safety, [*] = 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 Act of 1933, as amended. financial and commercial factors. The Development Plan shall allocate Development activities between the Parties, based on the following principles: (i) with respect to Product(s) comprising the Lead Compound, Portola will be the lead Party for Development activities [*]; (ii) with respect to any Product comprising a Back-Up Compound, Portola will be the lead Party for Development activities until [*] for such Product; (iii) Portola has the right (but not the obligation) to be the lead Party for Development activities [*]; (iv) Biogen Idec shall be the lead party for [*] for the Products; and (v) Portola shall be the lead Party [*]. The lead Party for Development activities pertaining to any Product shall have the primary responsibility for the performance of the Development Activities according to the Development Plan and within the Development Budget. In the course of fulfilling its role as the lead developing Party for a particular Product in a particular Indication and during a particular stage of the Product Development, a Party may request the other Party to conduct certain specific Development activities, and the other Party shall have the right to accept or reject such request, at its sole discretion. In addition, Biogen Idec will include Portola in Development activities involving scientific leaders and experts worldwide, including participation in advisory board meetings.
Development Plans A Development Plan and budget for each Candidate for the balance of the Calendar Year during which the Compound or Xxxxxx Compound is designated by the JSC as a Candidate shall be prepared by Xxxxxx and submitted to the JSC promptly after the designation of such Compound or Xxxxxx Compound as provided in Sections 2.1.4(h) and 3.6. Thereafter, for each Calendar Year during the Development Program, an updated Development Plan and budget for each Candidate shall be prepared by Xxxxxx and submitted to the JSC as provided in Section 2.1.4(a) or (b), as applicable. To the extent JSC approval is required, the Parties shall manage the preparation of each Development Plan and budget in a manner designed to obtain such JSC approval no later than [*****] days prior to the end of the then-current Calendar Year. Each Development Plan and amendment thereto shall: (a) set forth (i) the Development objectives, activities, priorities, timelines, budget and resources for the Calendar Year covered by the Development Plan with reasonable specificity, (ii) the Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. Development objectives and activities to be performed for each Calendar Year period covered by the Development Plan with reasonable specificity, broken down by Calendar Quarters, (iii) the Party that shall be responsible for performing such activities, (iv) a timeline for such activities and (v) the expected Development Costs over such Calendar Year; and (b) be consistent with the other terms of this Agreement.
Study Resolution of issues surrounding Keno facility are an important part of achieving the overall goals of this Settlement. Accordingly, the Secretary, in consultation with affected Parties, shall study issues specific to the Keno facility, with specific focus on addressing water quality, fish passage, transfer of title to the Keno facility from PacifiCorp to Interior, future operations and maintenance, and landowner agreements. The study of the Keno facility will be designed with the goals of addressing these issues and maintaining the benefits the dam currently provides.
Commercialization Reports Zai shall update the JSC at each regularly scheduled JSC meeting regarding Zai’s Commercialization activities with respect to the Products in the Territory. Each such update shall be in a form to be agreed by the JSC and shall summarize Zai’s, its Affiliates’ and Sublicensees’ significant Commercialization activities with respect to the Products in the Territory, covering subject matter at a level of detail reasonably required by TPTX and sufficient to enable TPTX to determine Zai’s compliance with its diligence obligations pursuant to Section 8.1. In addition, Zai shall make available to TPTX such additional information about its Commercialization activities as may be reasonably requested by TPTX from time to time. All updates and reports generated pursuant to this Section 8.3 shall be the Confidential Information of Zai.
Population The Population shall be defined as all Paid Claims during the 12-month period covered by the Claims Review.
Protocol At the moment of the signing of the Agreement between the Government of the Republic of Singapore and the Government of the Grand Duchy of Luxembourg for the Avoidance of Double Taxation and the Prevention of Fiscal Evasion with respect to Taxes on Income and on Capital, the undersigned have agreed upon the following provisions, which shall form an integral part of the Agreement:
Commercialization Plan The Commercialization Plan will contain in reasonable detail the major Commercialization activities and the timelines for achieving such activities. Zai will deliver an initial Commercialization Plan to the JSC for review and discussion no later than 12 months prior to the anticipated date of the first filing of the first Regulatory Approval for a Licensed Product in the Territory. Thereafter, from time to time, but at least every 12 months, Zai will propose updates or amendments to the Commercialization Plan in consultation with Paratek to reflect changes in such plans, including those in response to changes in the marketplace, relative success of the Licensed Product, and other relevant factors influencing such plan and activities, and submit such proposed updated or amended plan to the JSC for review, discussion, and approval. In accordance with Section 3.2(b), the JSC will review and discuss any updates or amendments to the Commercialization Plan.
Clinical Studies The preclinical studies and tests and clinical trials described in the Registration Statement, the Time of Sale Prospectus and the Prospectus were, and, if still pending, are being conducted in all material respects in accordance with the experimental 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; the descriptions of such studies, tests and trials, and the results thereof, contained in the Registration Statement, the Time of Sale Prospectus and the Prospectus are accurate and complete in all material respects; the Company is not aware of any tests, studies or trials not described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Registration Statement, the Time of Sale Prospectus and the Prospectus; and the Company has not received any written notice or correspondence from the FDA or any foreign, state or local Governmental Authority exercising comparable authority or any institutional review board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials.