Initial GDP; Updates and Amendments Sample Clauses

Initial GDP; Updates and Amendments. (i) The clinical development plan and budget included in the POC Data Package delivered by Xxxxxxx to Xencor under Section 6.2.1 will be the initial GDP and Development Budget for the Licensed Products. The GDP (including the Development [***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE. ​ Budget) may be updated and amended from time to time only with the approval of the JDC (or Xxxxxxx, under Section 2.5), as described below in this Section 6.2.3.2(c). (ii) The JDC will review the GDP annually. Xxxxxxx will prepare, and submit to the JDC for review, an updated GDP (excluding the Development Budget) on or before [***] of the then-current Calendar Year. When Xxxxxxx is preparing the updated GDP, Xxxxxxx will reasonably consider Xencor’s input into the Clinical Study design and key Development activities in the GDP. Xxxxxxx will prepare, and submit to the JDC for review, an updated Development Budget covering each of [***] Calendar Years on or before [***] of the then-current Calendar Year. (iii) The JDC will use reasonable efforts to grant preliminary approval of such updates no later than [***] of each Calendar Year. (iv) Promptly after the JDC’s preliminary approval, such updates will be submitted to each Party for its internal budgeting process. (v) After each Party performs its internal budgeting process, the JDC will use reasonable efforts to grant final approval of such updates no later than [***] of each Calendar Year, at which time any approved updates will be set forth in writing in an amended version of the GDP. (vi) Either Party may submit a proposed update or amendment to the GDP to the JDC from time to time. The JDC will discuss such proposal at its next meeting and decide whether to approve such update or amendment.
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Initial GDP; Updates and Amendments. A high-level GDP for Development of the Licensed Product at least in the Initial Indication and PH-ILD is attached to this Agreement as Schedule 5.1.3 (the “High-Level GDP”). The JSC will review, discuss, and approve an initial GDP that is consistent with the High-Level GDP for the Development of the Licensed Product in the Initial Indication, [***] within [***] days following the Effective Date; provided that with respect to the Initial Indication, the initial GDP (including the initial Registration Plan set forth therein) will be the High-Level GDP (including the high-level Registration Plan set forth therein). The initial GDP (including the Development Budget) may be updated and amended from time to time only with the approval of the JDC, as described in this Agreement, including this Section 5.1.3.
Initial GDP; Updates and Amendments. (a) The clinical development plan and budget included in the POC Data Package delivered by Xxxxxxx to Fate in accordance with Section 6.2 of the Agreement shall be the initial GDP and Development Budget for the Profit Share Product. For clarity, such initial GDP and Development Budget for the Profit Share Product shall cover the [***]. If Xxxxxxx desires to make changes to such initial GDP and Development Budget, then Xxxxxxx may submit a proposed update or amendment to the GDP in accordance with Section 4.1.3(d) of this Exhibit. The GDP (including the Development Budget) may be updated and amended from time to time only with the approval of the JSC, as described below in this Section 4.1.3. (b) The JDC shall review the GDP annually and prepare any recommended updates. No later than [***] of the then-current Calendar Year, the JDC shall prepare an updated GDP (excluding the Development Budget). No later than [***] of the then-current Calendar Year, the JDC shall prepare an updated Development Budget covering each of the [***] (in accordance with Section 4.1.2(b)). (c) The JDC shall submit all such updates to the JSC for review and approval, as follows:

Related to Initial GDP; Updates and Amendments

  • CHANGE ORDERS AND AMENDMENTS A. Any alterations, additions, or deletions to the terms of this Agreement, which are required by changes in federal or state law or by regulations, are automatically incorporated without written amendment hereto, and shall become effective on the date designated by such law or by regulation. B. To ensure the legal and effective performance of this Agreement, both parties agree that any amendment that affects the performance under this Agreement must be mutually agreed upon and that all such amendments must be in writing. After a period of no less than 30 days subsequent to written notice, unless sooner implementation is required by law, such amendments shall have the effect of qualifying the terms of this Agreement and shall be binding upon the parties as if written herein. C. Customers have the right to issue a change order to any purchase orders issued to the Contractor for the purposes of clarification or inclusion of additional specifications, qualifications, conditions, etc. The change order must be in writing and agreed upon by Contractor and the Customer agency prior to issuance of any Change Order. A copy of the Change Order must be provided by the Contractor to, and acknowledged by, H-GAC.

  • Alterations and Amendments This Agreement, applicable fees and service charges may be altered or amended from time-to-time. In such event, we will provide notice to you. Any use of the Service after we provide you a notice of change will constitute your agreement to such change(s). Further, we may, from time to time, revise or update the applications, services, and/or related material, which may render all such prior versions obsolete. Consequently, we reserve the right to terminate this Agreement as to all such prior versions of the applications, services, and/or related material and limit access to only the Service's more recent revisions and updates.

  • Supplements and Amendments This Agreement may be amended by the Depositor and the Owner Trustee, without the consent of any of the Noteholders or the Certificateholder, to cure any ambiguity, to correct or supplement any provisions in this Agreement or for the purpose of adding any provisions to or changing in any manner or eliminating any of the provisions in this Agreement or of modifying in any manner the rights of the Noteholders or the Certificateholder; provided, however, that such action shall not, as evidenced by an Opinion of Counsel, adversely affect in any material respect the interests of any Noteholder or the Certificateholder, provided further that 10 days’ (or, in the case of Fitch, 10 Business Days’) prior written notice of any such amendment be made available to each Rating Agency by the Administrator and, if Moody’s notifies the Owner Trustee that such amendment will result in a downgrading or withdrawal of the then-current rating of any class of the Notes, such amendment shall become effective with the consent of the Holders of Notes evidencing not less than a majority of the Outstanding Amount of the Notes; provided further that any solicitation of such consent shall disclose the downgrading or withdrawal that would result from such amendment. This Agreement may also be amended from time to time by the Depositor and the Owner Trustee, with prior written notice made available to the Rating Agencies by the Administrator, with the consent of the Holders of Notes evidencing not less than a majority of the Outstanding Amount of the Notes and the consent of the Certificateholder (which consents will not be unreasonably withheld) for the purpose of adding any provisions to or changing in any manner or eliminating any of the provisions of this Agreement or of modifying in any manner the rights of the Noteholders or the Certificateholder; provided, however, that no such amendment shall (a) increase or reduce in any manner the amount of, or accelerate or delay the timing of, collections of payments on Receivables or distributions that shall be required to be made for the benefit of the Noteholders or the Certificateholder or (b) reduce the aforesaid percentage of the Outstanding Amount of the Notes required to consent to any such amendment or eliminate the consent of the Certificateholder to any such amendment, without the consent of the holders of all the outstanding Notes and the Certificate. Promptly after the execution of any such amendment or consent, the Owner Trustee shall furnish written notification of the substance of such amendment or consent to the Certificateholder, the Indenture Trustee and the Administrator, which shall make such notification available to each of the Rating Agencies. It shall not be necessary for the consent of the Certificateholder, the Noteholders or the Indenture Trustee pursuant to this Section to approve the particular form of any proposed amendment or consent, but it shall be sufficient if such consent shall approve the substance thereof. Promptly after the execution of any amendment to the Certificate of Trust, the Owner Trustee shall cause the filing of such amendment with the Secretary of State. Prior to the execution of any amendment to this Agreement or the Certificate of Trust, the Owner Trustee shall be entitled to receive and rely upon an Opinion of Counsel stating that the execution of such amendment is authorized or permitted by this Agreement and that all conditions precedent to the execution of such amendment have been satisfied. The Owner Trustee may, but shall not be obligated to, enter into any such amendment which affects the Owner Trustee’s own rights, duties or immunities under this Agreement or otherwise.

  • Waiver and Amendments Any waiver, alteration, amendment, or modification of any of the terms of this Agreement shall be valid only if made in writing and signed by each of the parties hereto; provided, however, that any such waiver, alteration, amendment, or modification must be consented to on the Company’s behalf by the Board. No waiver by either of the parties hereto of their rights hereunder shall be deemed to constitute a waiver with respect to any subsequent occurrences or transactions hereunder unless such waiver specifically states that it is to be construed as a continuing waiver.

  • Modifications and Amendments The terms and provisions of this Agreement may be modified or amended only by written agreement executed by all parties hereto.

  • Updates and Upgrades Contractor grants to the Department a non-exclusive, non-transferable license to use upgrades and updates provided by Contractor during the term of the Contract. Such upgrades and updates are subject to the terms of the Contract. The Department shall download, distribute, and install all updates as released by Contractor during the length of the Contract, and Contractor strongly suggests that the Department also downloads, distributes, and installs all upgrades as released by Contractor during the length of the Contract. Contractor shall use commercially reasonable efforts to provide the Department with work-around solutions or patches to reported software problems that may affect the Department’s use of the software during the length of the Contract.

  • Modifications and Updates to the Wire Center List and Subsequent Transition Periods 5.4.6.1 In the event AT&T identifies additional wire centers that meet the criteria set forth in Sections 5.4.2.1 or 5.4.2.2 above, but that were not included in the Master List of Unimpaired Wire Centers or AT&T’s List of Unimpaired Wire Centers, AT&T shall include such additional wire centers in a CNL. Each such list of additional wire centers shall be considered a Subsequent Wire Center List. AT&T will follow any limitations on the frequency with which it may issue such lists and notification procedures set forth in applicable Commission orders. 5.4.6.2 TWTC shall have thirty (30) business days to dispute the additional wire centers listed on AT&T’s CNL. Absent such dispute, effective thirty (30) business days after the date of a AT&T CNL providing a Subsequent Wire Center List, AT&T shall not be required to provide DS1 and DS3 Dedicated Transport, as applicable, in such additional wire center(s), except pursuant to the self-certification process as set forth in Section 1.9.1 of this Attachment. 5.4.6.3 For purposes of Section 5.4.6.1 above, AT&T shall make available DS1 and DS3 Dedicated Transport that were in service for TWTC in a wire center on the Subsequent Wire Center List as of the thirtieth (30th) business day after the date of AT&T’s CNL identifying the Subsequent Wire Center List (Subsequent Embedded Base) until one hundred eighty (180) days after the thirtieth (30th) business day Version: 4Q06 Standard ICA 11/30/06 from the date of AT&T’s CNL identifying the Subsequent Wire Center List (Subsequent Transition Period). 5.4.6.4 The rates set forth in Exhibit B shall apply to the Subsequent Embedded Base during the Subsequent Transition Period. 5.4.6.5 No later than one hundred eighty (180) days from AT&T’s CNL identifying the Subsequent Wire Center List, TWTC shall submit an LSR(s) or spreadsheet(s) as applicable, identifying the Subsequent Embedded Base of circuits to be disconnected or converted to other AT&T services. 5.4.6.5.1 In the case of disconnection, the applicable disconnect charges set forth in this Agreement shall apply. 5.4.6.5.2 If TWTC chooses to convert DS1 and/or DS3 Dedicated Transport to special access circuits in existence as of the Effective Date of this Agreement, AT&T will include such DS1 and/or DS3 Dedicated Transport within TWTC’s total special access circuits, and apply any discounts to which TWTC is entitled from the transition period of 3/11/2006 to the conversion date. Conversions will be subject to the switch-as-is charge set forth in Exhibit A to this Attachment 2. 5.4.6.5.3 AT&T shall not impose disconnect or nonrecurring installation charges when transitioning the Subsequent Embedded Base of DS1 and DS3 Dedicated Transport in existence as of the Effective Date of this Agreement. 5.4.6.6 If TWTC fails to submit the LSR(s) or spreadsheet(s) for all of its Subsequent Embedded Base by one hundred eighty (180) days after the date of AT&T’s CNL identifying the Subsequent Wire Center List, AT&T will identify TWTC’s remaining Subsequent Embedded Base, if any, and will transition such circuits to the equivalent tariffed AT&T service(s), or in the case of Georgia, to the equivalent 271 service(s) set forth in Exhibit 1. In the states of Florida, Kentucky, Mississippi and South Carolina, those circuits identified and transitioned by AT&T shall be subject to the applicable disconnect charges as set forth in this Agreement and the full nonrecurring charges for installation of the equivalent tariffed AT&T service as set forth in AT&T’s tariffs. In the states of Alabama, Georgia, North Carolina and Tennessee, those circuits identified and transitioned by AT&T shall be subject to the applicable switch-as-is rates set forth in Exhibit A of Attachment

  • Modification and Amendments If a Fund shall determine that the coverage required by Rule 17g-1 for the Fund has changed, or that the amount of the total coverage allocated to the Fund should otherwise by modified, it shall so notify the other Funds and shall set forth the modification which it believes to be appropriate, and the proposed treatment of any increase in or return of premium paid to the insurance company. Within 60 days after such notice, the Funds shall seek the approvals required by Rule 17g-1, and if the approvals are obtained, shall effect an amendment to this Agreement and the bond. Any Fund may terminate this Agreement (except with respect to losses occurring prior to such withdrawal) by giving at least 60 days’ written notice to the other Funds and to the Commission before the effective date of such termination. The Fund terminating the Agreement shall thereafter be removed as a named insured under the bond in accordance with Rule 17g-1 and the Fund shall be entitled to receive a pro rata portion of any return of premium paid to the insurance company.

  • Change Orders and Contract Amendments 33.1 The Procuring Entity may at any time order the Supplier through notice in accordance GCC Clause 8, to make changes within the general scope of the Contract in any one or more of the following: a) drawings, designs, or specifications, where Goods to be furnished under the Contract are to be specifically manufactured for the Procuring Entity; b) the method of shipment or packing; c) the place of delivery; and d) the Related Services to be provided by the Supplier. 33.2 If any such change causes an increase or decrease in the cost of, or the time required for, the Supplier's performance of any provisions under the Contract, an equitable adjustment shall be made in the Contract Price or in the Delivery/Completion Schedule, or both, and the Contract shall accordingly be amended. Any claims by the Supplier for adjustment under this Clause must be asserted within twenty-eight (28) days from the date of the Supplier's receipt of the Procuring Entity's change order. 33.3 Prices to be charged by the Supplier for any Related Services that might be needed but which were not included in the Contract shall be agreed upon in advance by the parties and shall not exceed the prevailing rates charged to other parties by the Supplier for similar services.

  • CHANGES AND AMENDMENTS A. Any alterations, additions, or deletions to the terms of this Agreement, which are required by changes in federal or state law or by regulations, are automatically incorporated without written amendment hereto, and shall become effective on the date designated by such law or by regulation. B. To ensure the legal and effective performance of this Agreement, both parties agree that any amendment that affects the performance under this Agreement must be mutually agreed upon and that all such amendments must be in writing. After a period of no less than 30 days subsequent to written notice, unless sooner implementation is required by law, such amendments shall have the effect of qualifying the terms of this Agreement and shall be binding upon the parties as if written herein.

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