Unilateral Phase IIb Plans Sample Clauses

Unilateral Phase IIb Plans. Unless approved by the JDC pursuant to Section 5.5(b)(i), the Participating Phase IIb Party shall prepare for review and comment by the JDC a plan for such Phase IIb Development, exercising reasonable good faith judgment consistent with the Principles. Such Phase IIb plan shall be thereafter referred to as a “Unilateral Phase IIb Plan”. The Participating Phase IIb Party under a Unilateral Phase IIb Plan shall have the right to amend such Unilateral Phase IIb Plan, exercising reasonable good faith judgment consistent with the Principles, subject to the applicable JDC’s review and comment; provided that the Participating Phase IIb Party shall not have the right to make any such Unilateral Material Amendment without the other Party’s consent. If the JDC cannot agree on whether such an amendment is Unilateral Material Amendment within [***] days, such matter shall be referred to the JEC for resolution. If the JEC cannot resolve such matter within such [***]-day period, then such matter shall be referred to the Senior Officers of the Parties for resolution. If such Senior Officers cannot agree on such matter within [***].
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Related to Unilateral Phase IIb Plans

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • Development Plan As defined in Section 3.2(a).

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

  • Development Budget Attached hereto as Exhibit "B" and incorporated herein by this reference is the Development Budget in an amount equal to $_____________. Owner acknowledges and represents that the attached Development Budget includes the total costs and expenses to acquire, develop, renovate and construct the Real Property and the Apartment Housing.

  • Work Plans Tenant shall prepare and submit to Landlord for approval schematics covering the Tenant Improvements prepared in conformity with the applicable provisions of this Work Letter (the “Draft Schematic Plans”). The Draft Schematic Plans shall contain sufficient information and detail to accurately describe the proposed design to Landlord and such other information as Landlord may reasonably request. Landlord shall notify Tenant in writing within ten (10) business days after receipt of the Draft Schematic Plans whether Landlord approves or objects to the Draft Schematic Plans and of the manner, if any, in which the Draft Schematic Plans are unacceptable. Landlord’s failure to respond within such ten (10) business day period shall be deemed approval by Landlord. If Landlord reasonably objects to the Draft Schematic Plans, then Tenant shall revise the Draft Schematic Plans and cause Landlord’s objections to be remedied in the revised Draft Schematic Plans. Tenant shall then resubmit the revised Draft Schematic Plans to Landlord for approval, such approval not to be unreasonably withheld, conditioned or delayed. Landlord’s approval of or objection to revised Draft Schematic Plans and Tenant’s correction of the same shall be in accordance with this Section until Landlord has approved the Draft Schematic Plans in writing or been deemed to have approved them. The iteration of the Draft Schematic Plans that is approved or deemed approved by Landlord without objection shall be referred to herein as the “Approved Schematic Plans.”

  • Tenant Improvement Plans Any work proposed by Tenant at the Premises or Building (the “Tenant Improvements”) shall be subject to Landlord’s reasonable prior approval and shall be subject to the other terms and conditions of this Exhibit, which approval shall not be unreasonably withheld or delayed except for good cause shown. All architectural, engineering and other design fees shall be paid by Tenant, provided that, of the total Tenant Improvement Allowance, up to Five and No/100 Dollars (S5.00) per rentable square foot of the Premises of such fees may be subject to reimbursement under the Tenant Improvement Allowance. Tenant shall use its architect, engineers and other design professionals, all of whom shall comply with any applicable licensing or governmental requirements of the City of Santa Xxxxx and the State of California. Tenant shall cause its architect, who shall be subject to Landlord’s prior approval (“Tenant’s Architect”), which approval shall not be unreasonably withheld or delayed except for good cause shown, to prepare a draft space plan (the “Space Plan”) for the Tenant Improvements and shall submit the proposed Space Plan to Landlord for the latter’s approval (not to be unreasonably withheld or delayed) within twenty-one (21) days following mutual execution of the Lease. (If available upon mutual execution of this Lease, a mutually-approved preliminary space plan for the Tenant Improvements has been attached hereto as Exhibit C-1.) Landlord shall deliver to Tenant any written objections, questions or comments of Landlord with regard to the Space Plan, and Tenant shall cause the Space Plan to be revised to address such written comments and shall resubmit said Space Plan to Landlord for approval within five (5) business days thereafter. Such process shall continue until Landlord has approved the Space Plan. Tenant’s Architect shall then prepare working drawings and specifications for the Tenant Improvements, including architectural, structural, plumbing, mechanical, electrical, and fire protection drawings as required, suitable for permit application (the “Working Drawings”) and shall submit the proposed Working Drawings to Landlord for the latter’s approval within sixty (60) days following Landlord’s approval of the final Space Plan. The Space Plan and Working Drawings shall be subject to Landlord’s approval, which Landlord agrees shall not be unreasonably withheld or delayed. Landlord shall not be deemed to have acted unreasonably if it withholds its approval thereof because, in Landlord’s reasonable opinion as supported by statement or reports from licensed engineers, the work, as described in any such item: (i) will adversely affect Building systems, the structure of the Building or the safety of the Building and/or their occupants; (ii) will materially impair Landlord’s ability to furnish services to Tenant or other tenants at the Project; (iii) would materially increase the cost of operating the Building; (iv) would violate any governmental laws, rules or ordinances (or interpretations thereof); (v) contains or uses hazardous or toxic materials or substances not permitted under Applicable Laws; (vi) would affect the external appearance of the Building; (vii) would materially and adversely affect another tenant’s premises at the Project: or (viii) is prohibited by any mortgage, trust deed or other instrument encumbering the Building or Project. Landlord shall deliver to Tenant any written objections, questions or comments of Landlord with regard to the Working Drawings, and Tenant shall cause the Working Drawings to be revised to address such written comments and shall resubmit said Working Drawings to Landlord for approval within ten (10) business days thereafter. Such process shall continue until Landlord has approved the Working Drawings. Landlord’s approval of the Space Plan and/or the Working Drawings shall not be deemed any representation or warranty that the same comply with applicable codes.

  • Research Plans The Research Plan for the [***] Designated Target is attached as Schedule 2.2.3-1. Subsequent Research Plans agreed upon in accordance with Section 2.4.2.4 will be attached as additional sequentially numbered schedules (Schedule 2.2.3-2, Schedule 2.2.3-3, etc.).

  • Feasibility Study Buyer is granted the right to conduct engineering and/or market and economic feasibility studies of the Property and a physical inspection of the Property, including studies or inspections to determine the existence of any environmental hazards or conditions (collectively, the “Feasibility Study”) during the period (the “Feasibility Period”) commencing on the Effective Date and ending at 5:00 p.m., Central Time, on the June 3, 2010. With Seller’s permission, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours for purposes of analysis or other tests and inspections which may be deemed necessary by Buyer for the Feasibility Study. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property in connection with Buyer’s Feasibility Study; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. Seller agrees to make its representative reasonably available during normal business hours. Buyer will not alter the physical condition of the Property or conduct invasive testing without notifying Seller of its requested tests, and obtaining the written consent of Seller to any physical alteration of the Property or invasive testing. Buyer will utilize commercially reasonable diligence to conduct or cause to be conducted all inspections and tests in a manner and at times which will not unreasonably interfere with any tenant’s use and occupancy of the Property. If Buyer determines, in its sole judgment, that the Property is not suitable for any reason for Buyer’s intended use or purpose, or is not in satisfactory condition, then Buyer may terminate this Contract by written notice to Seller prior to expiration of the Feasibility Period, in which case the Xxxxxxx Money (other than the Option Money) will be returned to Buyer, and neither party shall have any further right or obligation hereunder other than as set forth herein with respect to rights or obligations which survive termination. If this Contract is not terminated pursuant to this Section 5(a), then after expiration of the Feasibility Period, after Seller has received advance notice sufficient to permit it to schedule in an orderly manner Buyer’s examination of the Property and to provide at least 24-hours’ advance written notice to any affected tenants, Buyer or its designated agents may enter upon the Property during normal business hours. Buyer or its designated representative must be accompanied by a designated representative of Seller or have received Seller’s written permission prior to entering upon the Property; provided, however, Buyer may not enter into any space leased by any tenant without being accompanied by a designated representative of Seller. If this Contract is not timely terminated pursuant to this Section 5(a), Buyer’s right to terminate this Contract pursuant to this Section 5(a) and any and all objections with respect to the Feasibility Study will be deemed to have been waived by Buyer for all purposes.

  • Development Schedule The schedule for design and development of the "BASE BUILDING WORK" (as defined below) and the "TENANT IMPROVEMENTS" (as defined below), including, without limitation, the time periods for preparation, delivery, review, and approval of construction documents and performance pursuant to such documents, shall be in accordance with the Development Schedule attached hereto as Schedule A, subject to adjustment as mutually agreed by the parties in writing or as provided in this Work Letter (the "DEVELOPMENT SCHEDULE").

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

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