Development Reports. Licensee shall provide Merck with reasonably detailed reports describing its progress with respect to its Development efforts under this Agreement (hereinafter Development Reports). Such Development Reports shall be furnished annually until the First Commercial Sale. Each Development Report shall include the following information for the Licensed Product: a description of the Development work conducted during the year in reasonable detail, including clinical studies, formulation work, manufacturing work, and other testing work and regulatory activity; timelines for such work; and key decision gates and milestones anticipated for such work. All Development Reports created by Licensee shall be deemed the Proprietary Information of Licensee and are subject to the confidentiality obligations of Article IX.
= 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.
Development Plan. An initial development plan is attached hereto as Exhibit A (such plan, as may be amended by time to time pursuant to this Agreement, the Development Plan). The Development Plan is a high-level summary of the Development activities Allergan anticipates being necessary to obtain Regulatory Approval for Licensed Products for the First Indication in the U.S. and [[Unknown Identifier]] Countries for which Allergan is using Commercially Reasonable Efforts to Develop and seek Regulatory Approval for a Licensed Product in the First Indication. For as long as Development activities under this Agreement are ongoing, on or before each anniversary of the Effective Date, Allergan shall prepare an amendment, as appropriate, to the then-current Development Plan to reflect material changes or additions to the Development of Licensed Products for the First Indication in the U.S. and [[Unknown Identifier]] Countries. Allergan shall submit all amendments to the Development Plan to UroGen and, upon such submission, the amended Development Plan will become effective and supersede the previous Development Plan.
Development Records. Allergan shall maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities hereunder, in sufficient detail to verify compliance with its obligations under this Agreement and which shall be appropriate for patent and regulatory purposes, in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Development activities hereunder, which books and records shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such books and records shall be retained by Allergan for at least years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.
Plans. If it has not done so already, within ten (10) days after the Phase 1 Expansion Space Delivery Date, [[Organization B:Organization]] shall deliver to [[Organization A:Organization]] a space plan (the “[[Organization B:Organization]] Phase 1 Space Plan”) depicting [[Organization B:Organization]]’s desired improvements in the Phase 1 Expansion Space (the “Phase 1 [[Organization B:Organization]] Improvements”). Within ten (10) days after receipt of the [[Organization B:Organization]] Phase 1 Space Plan, [[Organization A:Organization]] will review and approve or disapprove the [[Organization B:Organization]] Phase 1 Space Plan in its reasonable discretion. If [[Organization A:Organization]] disapproves the [[Organization B:Organization]] Phase 1 Space Plan, it shall state with particularity the reasons for such disapproval. If disapproved, [[Organization B:Organization]] shall revise the [[Organization B:Organization]] Phase 1 Space Plan to address [[Organization A:Organization]]’s concerns and resubmit to [[Organization A:Organization]] for review and approval or disapproval. Upon approval of the [[Organization B:Organization]] Phase 1 Space Plan, [[Organization B:Organization]] shall cause working drawings (hereafter, “[[Organization B:Organization]] Phase 1 Working Drawings”) of the Phase 1 [[Organization B:Organization]] Improvements shown on the [[Organization B:Organization]] Phase 1 Space Plan to be prepared and delivered to [[Organization A:Organization]]. The [[Organization B:Organization]] Phase 1 Working Drawings shall consist of the plans and specifications in the form of working drawings or construction drawings identifying [[Organization B:Organization]]’s interior layout of the Phase 1 Expansion Space, including complete sets of architectural, structural, mechanical, electrical, and plumbing working drawings for all Phase 1 [[Organization B:Organization]] Improvements, in each case to the extent applicable. The [[Organization B:Organization]] Phase 1 Working Drawings shall include written instructions or specifications as may be necessary or required to secure a building permit from the City of Eden Prairie for said improvements to commence in due course. The [[Organization B:Organization]] Phase 1 Working Drawings shall be prepared by architects and engineers selected by [[Organization B:Organization]] and reasonably approved by
Plans. No Borrower or Borrower Affiliate shall become a party to any Multiemployer Plan or Foreign Plan.
'Marketing and Development Operations' means marketing and development information, including but not limited to, marketing and development plans, price and cost data, price and fee amounts, pricing and billing policies, quoting procedures, marketing techniques and methods of obtaining business, forecasts and forecast assumptions and volumes, and future plans and potential strategies of the Employer which have been or are being considered.
and # FTE costs and out-of-pocket costs incurred by or on behalf of a Party or any of its Affiliates in accordance with this Agreement and directly allocable to Manufacturing activities relating to ACTR T-cells or SGI Antibodies (as applicable) for use in Development or Commercialization activities (excluding those activities covered under clause (a)), including CMC Activities specifically in support of Development or Commercialization of Development Candidates and Products. For clarity, Manufacturing Costs do not include the costs associated with general platform process improvements or scale-up activities with respect to ACTR T-cell technology, SGI Antibodies or SEA Technology that are outside of the activities approved for the Research Candidates, Development Candidates or Products in the applicable Research Plans, Early Clinical Development Plans, Late Clinical Development Plans or Joint Commercialization Plan or Supply Agreements.
Development Costs Relating to Initial Development Activities. [ ]
Development Process Generally. and intend that the ’s Work is to be treated as a “speculative” development by and that ’s approval right over the Base Building Schematics is generally limited to confirming conformance with the work described in [Schedule 1]. and intend that the process of the development of the Premises and construction of the Improvements will proceed in a collaborative, “open book” manner with the goal that the Premises will meet ’s requirements and will be undertaken in an efficient and cost-effective manner. shall use good faith efforts to carry out its obligations under this Work Letter with the standard of care to which landlords constructing projects similar to the Premises are held. shall respond to requests from timely and in good faith and not use its approval rights under this Work Letter for the purpose of delaying or frustrating the Premises being Ready for Occupancy. shall have full and current access to all material information related to the major elements of the development of the Premises and the right to participate in major decisions, all as more particularly described in, and subject to the terms and conditions of, this Work Letter. shall have the right at any time, either in the regularly scheduled Project Meetings or otherwise, to raise with in good faith any questions, concerns, suggestions or objections related to the development process, and shall consider all such questions, concerns, suggestions or objections in good faith, such that and shall work together in a reasonable,
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