Provision Language
3. Fixed Price and Payment
(a) The total fixed price for the performance of activities covered in the Scope of Work by Theraclone is [***] (the Total Fixed Price).
(b) Subject to paragraph (c) below, the Total Fixed Price will be payable in the following, non-refundable installments:
(i) [***] on each of the Effective Date, [***]; and
(ii) [***] .
If the delivery of all of the Deliverables occurs prior to [***], then all remaining installments shall become due and payable to Theraclone within thirty (30) days of such delivery.
(c) The payment of each installment of the Total Fixed Price (after the initial payment on the Effective Date) is guaranteed subject to (i) thereceipt by IAVI of an invoice for such payment and (ii) the delivery of the quarterly report for such quarter (as referenced in Section 6below) reflecting acceptable performance of the Scope of Work for such quarterly period, each on the following dates:
(i) [***] and
(ii) [***].
In the event that IAVI is not satisfied with the performance of the Scope of Work for any quarterly period, then IAVI must notify Theraclone within 15 days of receipt of such quarterly report and provide reasonably detailed reasons for its lack of satisfaction. In the event that IAVI does not so notify Theraclone within such 15 day period, then IAVI will be deemed to be satisfied.
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(e) Any additional Deliverables requested from Theraclone which are mutually agreed to by the Parties will be subject to the terms and conditions of this Agreement, and paid by IAVI under a separate budget and payment plan.
Amendment 1
2. Amendment of Section 3 (Fixed Price and Payment)
Sections 3(a), (b) and (c) (Fixed Price and Payment) of the Agreement are hereby deleted and replaced as follows:
“(a) The total fixed price for the performance of activities covered in the Scope of Work by Theraclone is [***] (the Total Fixed Price).
(b) Subject to paragraph (c) below, the Total Fixed Price will be payable in the following, non-refundable installments: (i)[***] on each of the Effective Date, [***]; and (ii)[***] on or before [***]; and (iii)[***] on or before [***].
(c) The payment of each installment of the Total Fixed Price (after the initial payment on the Effective Date) is guaranteed subject to (i) the receipt by IAVI of an invoice for such payment and (ii) the delivery of the quarterly report for such quarter (as referenced in Section 6 below) reflecting acceptable performance of the Scope of Work for such quarterly period, each on the following dates: [***].
In the event that IAVI is not satisfied with the performance of the Scope of Work for any quarterly period, then IAVI must notify Theraclone within 15 days of receipt of such quarterly report and provide reasonably detailed reasons for its lack of satisfaction. In the event that IAVI does not so notify Theraclone within such 15 day period, then IAVI will be deemed to be satisfied.”
Amendment 2
2. Amendment of Section 3 (Fixed Price and Payment)
Sections 3 is amended to include the following modified or new language:
“(a) The total fixed price for the performance of activities covered in the Scope of Work by Theraclone through Amendment No.1 is [***] (the Total Fixed Price ).
(f) Theraclone acknowledges that IAVI has fully paid for the completion of the original and Amendment No. 1 Scope of Work which included a 6th Protocol G donor deliverables which have not been delivered because of the absence of the an acceptable donor sample to initiate the work.
(g) The Parties agree to further modify the Agreement under this Amendment No. 2 to address a new Scope of Work as defined in the revised Attachment 1.
(h) The Fixed Price Amount for the revised Scope of Work for this Amendment No, 2 is [***]. Payment of the non-refundable, non- creditable amount of [***] will be made upon activation of the first donor sample as contemplated in Attachment 1 to this Amendment.
ATTACHMENT IV – NIH Standard Provisions
Theraclone shall comply with the standard NIH requirements specified in this Attachment. Throughout these provisions, Theraclone shall be defined as Subawardee.
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2. Prior Approval. As outlined in the administrative requirements of the NIH Grants Policy Statement, NIH prior written approval may be required before IAVI makes certain budget modifications or undertakes particular activities. As a result, Subawardee agrees to obtain written prior approval from IAVI for the following activities and/or expenditures under this Agreement:
- Change in scope
- Change in key personnel
- Carryover of unobligated balances
- Deviation from Agreement terms and conditions
- Transfer of the Performance of Substantive Programmatic Work to a Third Party by Means of a Consortium Agreement
- Change in the specific aims approved at the time of award
- Substitution of one animal model for another
- Any change from the approved use of animals or human subjects
- Shift of the research emphasis from one disease area to another
- A clinical hold by FDA under a study involving an IND or an IDE
- Application of a new technology, e.g., changing assays from those approved to a different type of assay
- Significant rebudgeting, whether or not the particular expenditure(s) require prior approval. Significant rebudgeting occurs when expenditures in a single direct cost budget category deviate (increase or decrease) from the categorical commitment level established for the budget period by more than 25 percent of the total costs awarded. The base used for determining significant rebudgeting excludes the effects of prior-year carryover balances but includes competing and non-competing supplements.
- Incurrence of research patient care costs if costs in that category were not previously approved by NTH or if a grantee desires to rebudget additional funds beyond those approved into or rebudget funds out of the research patient care category