Development Plan Sample Clauses

Development Plan. The development of Licensed Product shall be governed by a written multi-year, research and development plan that sets forth the anticipated research, pre-clinical and clinical development activities to be performed with respect to such Licensed Product (and, if relevant, any Companion Diagnostic) throughout the Territory, and projected timelines for completion of such activities (the “Development Plan”). The initial Development Plan is attached as Exhibit 2, which shall be updated by the Parties *** following the formation of the JDC. On an annual basis ***, or more often as the Parties deem appropriate, the JSC shall, or shall request the JDC to, update and amend, as appropriate, the then-current Development Plan. Such updates and amendments shall reflect any changes, re-prioritization of, or additions to the development activities of the then-current Development Plan, as determined by the JSC. Updates and amendments to the Development Plan shall be approved by the JSC in accordance with the decision-making procedures in Section 3.1(c). Once approved by the JSC, each updated or amended Development Plan shall become effective and supersede the previous Development Plan as of the date of such approval or at such other time as decided by the JSC. Licensee and Company shall each use Commercially Reasonable Efforts to perform their respective tasks and obligations in conducting all activities ascribed to it in the Development Plan, substantially in accordance with the time schedules set forth therein. In the event of any inconsistency between the Development Plan and this Agreement, the terms of this Agreement shall prevail.
Development Plan. Company will deliver to Penn, a copy of an initial development plan for the Patent Rights (the “Development Plan”). The purpose of the Development Plan is (a) to demonstrate Company’s capability to bring the Patent Rights to commercialization, (b) to project the timeline for completing the necessary tasks, and (c) to measure Company’s progress against the projections. Thereafter, Company will deliver to Penn an annual updated Development Plan no later than [**] of each year during the Term. The Development Plan will include, at a minimum, the information listed in Exhibit B.
Development Plan. The Parties will undertake the Development of the Licensed Product in a collaborative and efficient manner in accordance with this ARTICLE 5. The Development of the Licensed Product in the Territory under this Agreement will be governed by a written development plan (the “Development Plan”), as such Development Plan may be revised from time to time in accordance with this Section 5.2. The Development Plan will contain in reasonable detail the major Development activities and the timelines for achieving such activities. As of the Effective Date, the Parties have agreed to the initial Development Plan, which is attached hereto as Schedule 5.2 (the “Initial Development Plan”). From time to time, but at least every 12 months, Zai will propose updates or amendments, if any, to the Development Plan in consultation with Paratek 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 approve any updates or amendments to the Development Plan.
Development Plan. Prior to exercise of the Buy-In Option by Genzyme, the Development Program shall be conducted by Dyax under a Development Plan which shall describe the proposed overall program of development for each Collaboration Product, including preclinical studies, toxicology, formulation, clinical trials and regulatory plans and other key elements necessary to obtain Regulatory Approvals for such Collaboration Product. Following the exercise of the Buy-In Option by Genzyme, the Development Program shall be conducted by Genzyme and Dyax on behalf of Kallikrein LLC under the Development Plan in effect as of such date. Pursuant to the applicable Development Plan, development work may be subcontracted by Dyax to Genzyme, or by Kallikrein LLC to Genzyme and Dyax, as applicable, at fully absorbed costs determined by GAAP. The respective charges to Dyax or Kallikrein LLC, as the case may be, shall be invoiced following completion of the work, and shall be payable by Dyax or Kallikrein LLC, as applicable, within a commercially reasonable time thereafter (but in no event later than forty-five (45) days of the date of invoice therefor). The Development Plan shall include a summary of estimated Development Costs expected during the development process through obtaining such Regulatory Approvals and a detailed description of and budget for all development activities proposed for each calendar year for each Collaboration Product.
Development Plan. The Parties have agreed upon the Initial Development Plan. Licensee shall update and modify the Development Plan from time to time to reflect all Development activities planned by Licensee to obtain Regulatory Approval for each Licensed Product in the Territory, as well as to include any changes or modifications planned by Licensee to such Development activities or to any other aspect of the Development Plan as in effect prior to such changes or modifications. Licensee shall provide to Ipsen a copy of each such update and modification of the Development Plan. The obligations of Licensee under this Section 6.3 with respect to each Licensed Product shall terminate upon the First Commercial Sale of such Licensed Product.
Development Plan. Licensee will provide UM with a Development Plan reasonably acceptable to UM within six (6) months of the Effective Date of this Agreement. Such Development Plan will be added to this Agreement as Appendix B. UM shall be entitled to terminate this Agreement if Licensee fails to meet the pre-established development milestones contained in the Development Plan. The milestones may be changed as agreed upon in advance in writing by both parties. UM shall give written notice of its decision to terminate this Agreement specifying a failure of the Development Plan milestones. Unless Licensee has remedied such failure or both parties have agreed, in writing, to a revised milestone schedule (which agreement will not be unreasonably withheld) within sixty (60) days after receipt of such notice, this Agreement will be deemed to terminate as of the expiration of such sixty (60) day period.
Development Plan. All Improvements to the Property shall be constructed in accordance with the Development Plan. Borrower shall not construct any Improvements on the Property, enter into any Construction Contract, or order any supplies or materials until Borrower has received notice that Lender has consented to the Development Plan. Borrower shall not make, consent to, approve, adopt or vote in favor of any modification, amendment, supplement, or other change to the Development Plan without Lender’s prior written consent, which may be given or withheld in Lender’s sole discretion. Borrower shall construct the Improvements and develop the Property in strict accordance with the Development Plan and shall not permit any changes to the Property to occur, other than in accordance with the Development Plan.(v) Plans and Specifications. All Improvements to the Property shall be constructed in accordance with the Plans and Specifications. Borrower shall not construct any Improvements on the Property, enter into any Construction Contract, or order any supplies or materials, until Borrower as received notice that Lender has consented to the Plans and Specifications. Borrower shall not make, consent to, approve, adopt or vote in favor of any modification, amendment, supplement, or other change to the Plans and Specifications without Lender’s prior written consent, which may be given or withheld in Lender’s sole discretion. Borrower shall construct the Improvements and develop the Property in strict accordance with the Plans and Specifications.(vi) Limitation on Transfer of Amenities. Borrower will not sell, lease, transfer or otherwise dispose of the existing or future common amenities, except to the property ownersassociation created for the benefit of the owners of the Lots and upon compliance with the applicable provisions of the Deed of Trust.(vii) Lot Sales. Borrower will not sell or lease, or offer to sell or lease, any portion of the Property unless such sale or lease transaction is exempt from the requirements of the Interstate Land Sales Full Disclosure Act (15 U.S.C. 1701 et seq.) or Borrower complies with all of the provisions thereof with respect toStatements of Record” (as defined therein) and “Property Reports” (as defined therein).(viii) Utilities. Borrower shall secure utility services, including, without limitation, water and sewer taps for the Lots and shall not permit any right to obtain utility services, including, without limitation, water and sewer taps, to e...
Development Plan. The JDC shall be responsible for review of the goals and strategy for development of each Drug Product Candidate and shall prepare and oversee the implementation of an overall Development Plan for each Drug Product Candidate. The Development Plan shall, among other things, detail, schedule and fully describe the proposed toxicology studies, clinical trials, regulatory plans, clinical trial and commercial material requirements, and process development and manufacturing plans for each Drug Product Candidate, along with relevant budget information for the described items, and will outline the key elements involved in obtaining Regulatory Approval in each country where the Drug Product is to be marketed.
Development Plan. Within [*] following the exercise of a Celgene Program Option, Celgene will prepare and provide to the JRC a draft Development Plan for the applicable Celgene Development Compounds. Celgene will consider in good faith any comments provided by GlobeImmune with respect to such draft Development Plan; provided that neither GlobeImmune’s nor the JRC’s approval of the draft Development Plan is required. Celgene will provide the JRC with any updates and revisions to each Development Plan and related budgets for the JRC’s review but not approval.