Approved Changes definition

Approved Changes means any changes (including number of subjects, duration of dosing, additional studies, additional endpoints, additional analysis, etc.) to the Isis Development Candidate-R&D Plan that are agreed to by Roche (including any changes required by a Regulatory Authority).
Approved Changes shall have the meaning ascribed to such term in para/Clause 34.6(iv) of this Agreement.
Approved Changes means any changes (including duration of dosing, additional studies, additional endpoints, additional analysis, etc.) to the TTR Registration-Directed Program Documents (including any Material Amendments) that are requested by GSK or required by a Regulatory Authority and mutually agreed by GSK and Isis.

Examples of Approved Changes in a sentence

  • The CMA shall develop the Central Settlement System to take account of Approved Changes and/or Commission Changes.

  • The CMA shall develop the Supply Point Register to take account of Approved Changes and/or Commission Changes.

  • The CMA shall develop the Supply Point Register to take account of Approved Changes and/or Commission Changes except in respect of Temporary Transfers Arrangements and Pending Permanent Disconnections, for which, such development shall be completed by 27th September, 2018.

  • The Market Operator shall develop and enhance the Supply Point Register in accordance with all Approved Changes.

  • The CMA shall develop the Central Settlement System to take account of Approved Changes and/or Commission Changes except in respect of Temporary Transfers Arrangements and Permanent Disconnections, for which, such development shall be completed by 27th September, 2018.

  • Approved Changes in the Contract Times or accepted Claims that affect the Contract Times will be addressed through the Change Order process provided in this Agreement.

  • Approved Changes in the Work or accepted Claims that affect the Contract Price will be addressed through the Change Order process provided in this Agreement.

  • Approved Changes shall be included in each Monthly Progress Schedule.

  • If Contractor/Consultant/Vendor is a DBE, contractor’s participation, less any amount subcontracted Original Contract and Utilization Plan Approved Changes Final Total $ (%) $ $ (%) Part III: Subcontractor Participation List below all subcontractors/subconsultants/suppliers (DBEs as well as non-DBEs) used in performance of the contract.

  • CME Group, Special Executive Report, S-4876, Reminder: Upcoming Approved Changes to the Wheat Futures Contract, May 15, 2009; at http://www.cmegroup.com/company/membership/membernet/files/20090518S-4876.pdf.


More Definitions of Approved Changes

Approved Changes means any changes (including duration of dosing, additional studies, additional endpoints, additional analysis, additional drug supply, etc.) to the GSK-5 Development Plan (i) that are requested by a Party or required by a Regulatory Authority, (ii) that are required to be agreed upon by the Parties under this Amendment No. 4, and (iii) that are in fact agreed upon by GSK and Isis in accordance with this Amendment No. 4 or are decided through [***] final decision making authority under Section 5.c. of this Amendment No. 4. For the avoidance of doubt, changes made to the Natural History Study in accordance with the terms of Section 1 of this Amendment No. 4 and changes made to the GSK-5 Development Plan that do not result in a Material Amendment shall not be considered "Approved Changes" as that term is used in this Amendment No. 4.
Approved Changes means the changes to the Fundamental Investment ---------------- Objectives of the Affected Funds set forth on Annex A hereto.
Approved Changes shall have the meaning ascribed to such term in Clause 5.5 of this Agreement.

Related to Approved Changes

  • Proposed Change has the meaning assigned to such term in Section 9.02(c).

  • Proposed Change Order (PCO means a document that informs Contractor of a proposed change in the Work and appropriately describes or otherwise documents such change including Contractor’s response of pricing for the proposed change.

  • Benchmark Replacement Conforming Changes means, with respect to any Benchmark Replacement, any technical, administrative or operational changes (including changes to the definition of “Base Rate,” the definition of “Interest Period,” timing and frequency of determining rates and making payments of interest and other administrative matters) that the Administrative Agent decides may be appropriate to reflect the adoption and implementation of such Benchmark Replacement and to permit the administration thereof by the Administrative Agent in a manner substantially consistent with market practice (or, if the Administrative Agent decides that adoption of any portion of such market practice is not administratively feasible or if the Administrative Agent determines that no market practice for the administration of the Benchmark Replacement exists, in such other manner of administration as the Administrative Agent decides is reasonably necessary in connection with the administration of this Agreement).

  • Major modification means any physical change in or change in the method of operation of a major stationary source that would result in a significant emissions increase of a regulated NSR pollutant and a significant net emissions increase of that pollutant from the major stationary source.

  • Specified Change of Control a “Change of Control” (or any other defined term having a similar purpose) as defined in the Senior Subordinated Note Indenture.

  • Approved List means Securities followed by the Global Fundamental Research Group and tracked on the Approved List. Securities may be added, removed, or undergo periodic ratings changes.

  • Changes The Detail Specification will be revised to include:

  • approved proposal means a proposal approved or determined under this Agreement;

  • Material Modifications means any modifications to the material related party transactions which were approved by the Audit Committee or Shareholders during the year which will change the complete nature of the transaction and in case of monetary thresholds which is in excess of 10% of the originally approved transaction, in case of exigencies only.

  • Approved Device means a device described in Subsection 20A-21-201(4) used to

  • Material Modification means any modification to an Interconnection Request that has a material adverse effect on the cost or timing of Interconnection Studies related to, or any Network Upgrades or Local Upgrades needed to accommodate, any Interconnection Request with a later Queue Position.

  • Minor modification means a modification that does not significantly alter the nongovernmental function or purpose of the software or is of the type customarily provided in the commercial marketplace.

  • Conforming Changes means, with respect to either the use or administration of Term SOFR or the use, administration, adoption or implementation of any Benchmark Replacement, any technical, administrative or operational changes (including changes to the definition of “Base Rate,” the definition of “Business Day,” the definition of “U.S. Government Securities Business Day,” the definition of “Interest Period” or any similar or analogous definition (or the addition of a concept of “interest period”), timing and frequency of determining rates and making payments of interest, timing of borrowing requests or prepayment, conversion or continuation notices, the applicability and length of lookback periods, the applicability of Section 3.05 and other technical, administrative or operational matters) that the Administrative Agent decides may be appropriate to reflect the adoption and implementation of any such rate or to permit the use and administration thereof by the Administrative Agent in a manner substantially consistent with market practice (or, if the Administrative Agent decides that adoption of any portion of such market practice is not administratively feasible or if the Administrative Agent determines that no market practice for the administration of any such rate exists, in such other manner of administration as the Administrative Agent decides is reasonably necessary in connection with the administration of this Agreement and the other Loan Documents).

  • Relevant Potential Change of Control Announcement means any public announcement or statement by the Issuer, any actual or potential bidder or any adviser acting on behalf of any actual or potential bidder relating to any potential Change of Control where within 180 days following the date of such announcement or statement, a Change of Control occurs.

  • Approved/Approval means the approval in writing.

  • Approved costs means the eligible costs or expenditures2 as approved by the Provider, and as defined in the Agreement or Decision on Grant Funding to carry out the Grant Project.

  • Successor Rate Conforming Changes means, with respect to any proposed Successor Rate for an Applicable Currency, any conforming changes to the definition of Base Rate, Interest Period, timing and frequency of determining rates and making payments of interest and other technical, administrative or operational matters (including, for the avoidance of doubt, the definition of Business Day, timing of borrowing requests or prepayment, conversion or continuation notices and length of lookback periods) as may be appropriate, in the discretion of the Administrative Agent, to reflect the adoption and implementation of such Successor Rate and to permit the administration thereof by the Administrative Agent in a manner substantially consistent with market practice for such Applicable Currency (or, if the Administrative Agent determines that adoption of any portion of such market practice for such Applicable Currency is not administratively feasible or that no market practice for the administration of such Successor Rate for such Applicable Currency exists, in such other manner of administration as the Administrative Agent determines is reasonably necessary in connection with the administration of this Agreement and any other Loan Document).

  • Approved Vendor means a person who has been approved for inclusion on an

  • Indirect cost rate proposal means the documentation prepared by a governmental unit or subdivision thereof to substantiate its request for the establishment of an indirect cost rate.

  • Substantial modification means modification of a relevant source that results in a significant increase in emissions, excluding any change in emissions resulting from by-product recovery. It shall be a matter for the Party to decide whether a modification is substantial or not;

  • Approved Project Budget means the most recent statement, approved by the FTA, of the costs of the Project, the maximum amount of Federal assistance for which the TJPA is currently eligible, the specific tasks (including specified contingencies) covered, and the estimated cost of each task.

  • Permit modification means a revision to a Title V operating permit that cannot be accomplished under the provisions for administrative permit amendments found at rule 567—22.111(455B). A permit modification for purposes of the acid rain portion of the permit shall be governed by the regulations pertaining to acid rain found at rules 567—22.120(455B) to 567—22.147(455B). This definition of “permit modification” shall be used solely for purposes of this chapter governing Title V operating permits.

  • Approved Commercial Bank means a commercial bank with a consolidated combined capital and surplus of at least $5,000,000,000.

  • Existing structure means any structure that is installed or approved for installation at the time a wireless services provider or wireless infrastructure provider provides notice to a locality or the Department of an agreement with the owner of the structure to co-locate equipment on that structure. "Existing structure" includes any structure that is currently supporting, designed to support, or capable of supporting the attachment of wireless facilities, including towers, buildings, utility poles, light poles, flag poles, signs, and water towers.

  • Permitted Modifications As defined in Section 2.02(a) of the Servicing Agreement.