Development Plan Amendments. Adapt may amend any Development Plan at any time, subject to providing Lightlake an opportunity to discuss any proposed revisions prior to making such amendment and, during the first twelve (12) months following the Effective Date, by submitting such amendment to the JDC prior to such amendment becoming effective; provided, however, that no such amendment to any Development Plan may provide for an increase in Lightlake’s full-time employee obligations under the Initial Development Plan, significantly modify the types of activities that Lightlake would have to perform under the Initial Development Plan, extend Lightlake’s period of performance more than twelve (12) months after the Effective Date or increase the Lightlake Cost Cap. Confidential Treatment Requested by Lightlake Therapeutics Inc. IRS Employer Identification No. 40-0000000 Confidential treatment requested with respect to certain portions hereof denoted with “*** REDACTED ***”
Development Plan Amendments. From time to time during the Term, the JRDC shall prepare amendments, as appropriate, to the then-current Development Plan. Subject to the foregoing, the JRDC shall have the right to approve amendments to the Development Plan, with final decision-making authority as provided in Section 2.10. Once approved by the JRDC, such amended Development Plan shall replace the prior Development Plan.
Development Plan Amendments. (a) Within [**] days following the completion of activities under the Joint Research Plan, the Parties shall prepare an initial Development plan (as such plan may be updated or amended from time to time in accordance with this Agreement, the “Development Plan”) that will cover Development activities commencing with IND-Enabling Studies through Phase I Completion with respect to the proposed development candidate(s) under the Program, including a [**] budget for Development Costs. Each annual update to the Development Plan shall cover Development activities through completion of the next phase of Development and a [**] budget (or longer, if the Development activities covered by the Development Plan extend for longer than [**]).
Development Plan Amendments. From time to time as necessary after the approval of the first Development Plan, Takeda shall prepare and submit for approval to the JSC, any updates to the Development Plan. Once approved by the JSC, each amended Development Plan shall become effective and supersede the previous Development Plan as of the date of such approval.
Development Plan Amendments. During the [***], the JPT will periodically review and propose amendments to the Development Plan for approval by the JSC, to reflect the progress achieved and the further development activities to be undertaken by the Parties in the development of a Product, but not less than once every year in conjunction with the Parties’ budget and program review cycle. After completion of the [***], the Development Plan will be updated by Amgen in a manner consistent with the annual development plans for Amgen’s other clinical product programs and the terms of this Agreement, and a summary of any such updates will be provided to Micromet together with the progress reports delivered pursuant to Section 4.4.
Development Plan Amendments. If, for a Shared Product, for whatever reason Allowable Development Expenses exceed or are budgeted to exceed [***] US Dollars ($[***]) over the initial budget of Allowable Development Expenses set forth in the initial Development Plan for such Shared Product (“Initial Budget” and $[***] over such Initial Budget the “Threshold Development Costs”), Vividion shall, for such Shared Product, have the option to (a) elect to have Roche bear all Allowable Development Expenses in excess of the Threshold Development Costs (“Excess Development Opt-Out”) or (b) elect for the Development Cost Opt-Out to occur for such Shared Product as described in Section 9.5, in either case of (a) or (b) by providing written notice to Roche within [***] days of receiving written notice from Roche of such excess Allowable Development Costs exceeding or budgeted to exceed the Threshold Development Costs (“Excess Development Cost Notice”). If upon providing an Excess Development Cost Notice Vividion does not exercise the Development Cost Opt-Out for the applicable Shared Product within such [***] days notice period, Vividion may thereafter exercise the Excess Development Opt-Out or Development Cost Opt-Out effective as of the following Calendar Quarter (or sooner at Vividion’s election upon and to the extent there is an amendment to the Development Plan leading to an increase of the budget for Allowable Development Expenses and affecting the budget for the Calendar Quarter in which such exercise is made). Once exercised, the Excess Development Opt-Out may not be reversed for such Shared Product. If Vividion exercises its Excess Development Opt-Out with regards to (a) above, then Roche shall have the right recoup an amount equal to [***] percent ([***]%) of the Allowable Development Expenses incurred in excess of such Threshold Development Costs in connection with such Excess Development Opt-Out by offsetting this amount against any payments owed to Vividion for the applicable Shared Product (i.e., any milestone payments or royalties in any country, and profits from the Profit and Loss Sharing), provided that if after [***] years after the First Commercial Sale of such Shared Product in a Major Market, Roche may [***] under this Agreement. For clarity, Vividion shall continue to be responsible for sharing Allowable Development Expenses according to Section 9.3 that do not exceed the Threshold Development Costs unless it exercises a Development Cost Opt-Out. Vividion may in its discretio...
Development Plan Amendments. Developer shall submit any amendment to the Development Plan, including any amendments contained in the Developer’s Stage II Plans, to the City for review and input by the City Council.
Development Plan Amendments
