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).

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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.

Approved Changes means the changes to the Fundamental Investment ---------------- Objectives of the Affected Funds set forth on Annex A hereto.

Examples of Approved Changes in a sentence

• 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.

• Except to the extent that the CD’s, the Approved Changes, and/or this Exhibit provide that Tenant shall complete a portion of the Leasehold Improvements, Landlord shall cause the Leasehold Improvements to be made, constructed, or installed in a good and workmanlike manner substantially in accordance with the CD’s and Approved Changes.

• Except as expressly set forth otherwise in the CD’s and/or the Approved Changes, Landlord shall cause the Leasehold Improvements to be constructed or installed to Building Standards; provided, however, Landlord shall have the right to substitute, after providing written notice to Tenant and providing Tenant with an opportunity to approve said substitution comparable non-Building Standard materials, fixtures, finishes, and items to the extent Building Standard items are not readily available.

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

• Except as expressly set forth otherwise in the CD’ s and/or the Approved Changes, Landlord shall cause the Leasehold Improvements to be constructed or installed to Building Standards; provided, however, Landlord shall have the right to substitute comparable non-Building Standard materials, fixtures, finishes, and items to the extent Building Standard items are not readily available.

• If, however, after such accounting Isis’ actual costs incurred were less than the Additional Costs paid in advance by Roche, then Isis will provide Roche the amount of such difference in the form of a credit against the next payment (including any future payments for any then ongoing Approved Changes) to be paid by Roche to Isis under this Agreement.

• Except to the extent that the CD’ s, the Approved Changes, and/or this Exhibit provide that Tenant shall complete a portion of the Leasehold Improvements, Landlord shall cause the Leasehold Improvements to be made, constructed, or installed in a good and workmanlike manner substantially in accordance with the CD’ s and Approved Changes.

• Lessor agrees that Lessee shall not be obligated to restore the Aircraft to its configuration, coloring and appearance it had in order to merely remove the Approved Changes.

• GSK will be responsible for paying the Additional Costs resulting from Approved Changes in the manner as agreed to by the Parties pursuant to Section 7.b. On a quarterly basis, Isis will deliver to GSK an invoice for such portion of the Additional Costs that are allocated for the activities for the coming quarter [***], which GSK will pay each such invoice within [***] days after GSK’s receipt.

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 shall have the meaning ascribed to such term in para/Clause 34.6(iv) of this Agreement.

Approved Changes shall have the meaning ascribed to such term in Clause 5.5 of this Agreement.