Amendment 1 to Agreement dated 19th Aug’13 signed by and between Dr. Reddy’s Laboratories Limited Bollaram Road, Miyapur, Hyderabad 500 049 India (Hereinafter referred to as “Dr. Reddy’s”) and Prana Biotechnology Ltd Level 2,369 Royal Parade,...
Exhibit 4.35
Amendment 1 to Agreement dated 19th Aug’13 signed by and between
Xx. Xxxxx’x Laboratories Limited
Xxxxxxxx Xxxx, Xxxxxxx,
Xxxxxxxxx 000 000
Xxxxx
(Hereinafter referred to as “Xx. Xxxxx’x”)
and
Level 2,369 Xxxxx Xxxxxx, Xxxxxxxxx Xxxxxxxx, 0000
Xxxxxxxxx
(Hereinafter referred to as “Prana”)
Xx. Xxxxx’x and Prana are collectively referred to as the “PARTIES”
This amendment will include the following amended clauses in the above mentioned agreement and will be in effect from 26th September 2013.
1. Terms to varied.
The following project item (Sub-Project 1) in Appendix A (Project works and time table section) is set for amendment.
i. Bifurcation of Sub project 1 in Appendix A(project works and time table section)
Project item
(Sub-Project)
|
Responsible
Party
|
Milestone
Payment
|
Timeline
|
||||||
1-Completion of
Process Development
work (towards
filtration)
|
Xx.Xxxxx’x
|
USD 45,000
|
Commence April
1st 2013, “start
date”. Milestone
payment on
completion.
|
Is amended as follows
Project item
(Sub-Project)
|
Responsible
Party
|
Milestone
Payment
|
Timeline
|
||||||
1(a)- Completion of
Process Development
work (towards
filtration) till stage 4
(CDDQ-4)
|
Xx.Xxxxx’x
|
USD 36,000
|
Commence April
lst 2013, “start
date”. Milestone
payment on
completion.
|
||||||
1(b)- Completion of
Process Development
work (towards
filtration) from stage 4
(CDDQ-4) to stage 5
(CDDQ-5)
|
Xx.Xxxxx’x
|
USD 9,000
|
Commence April
lst 2013, “start
date”.Milestone
payment on
completion.
|
Page 1 of 2
The deliverables of sub project 1 (a) and 1(b) will be in line with the deliverables of Sub project 1, mentioned in the master service agreement dated 19th Aug 13.
All other terms and conditions of the original Agreement dated 19th Aug’13 remain unchanged.
In witness whereof, the parties hereto have signed this Agreement
Signed for and on behalf of
|
Signed for and on behalf of
|
|
Xx. Xxxxx’x Laboratories Limited
|
||
Signature
|
Signature
|
|
Name: Xxxxx Xxxxxxxx
|
Name: Xxxxxx Xxxxx
|
|
Witness Signature
|
Witness Signature
|
|
Witness Name: Xxxxxxx Xxxxxxxxxxx
|
Witness Name: Xxxxxxxxx Xxxxxxx
|
Page 2 of 2
Amendment 2 to Agreement Commencement Date 5th April’13 signed
by and between
Xx. Xxxxx’x Laboratories Limited
Xxxxxxxx Xxxx, Xxxxxxx,
Xxxxxxxxx 000 000
Xxxxx
(Hereinafter referred to as “Xx. Xxxxx’x”)
and
Xxxxx 0, 000 Xxxxx Xxxxxx, Xxxxxxxxx Xxxxxxxx, 0000
Xxxxxxxxx
(Hereinafter referred to as “Prana”)
Xx. Xxxxx’x and Prana are collectively referred to as the “PARTIES”
This amendment will include the following amended clauses in the above mentioned agreement and will be in effect from 31st August 2013.
|
||
1. Terms to the amendment would remain as same as that of MSA Commencement Date 5th April’13
|
||
The following project item (Sub-Project) in Appendix A (Project works and time table section) is added with the following activities as additional section -8
|
||
Sub project-section -8 in Appendix A (project works and time table section) is added with the additional line items as described below
|
Page 1 of 2
Sr.
No.
|
Project item (Sub-Project) Appendix A
|
Responsible
Party |
Milestone
Payment in USD on
completion of line item |
Expected /
Estimated
Timeline and
invoicing
|
||||||
8. EOP2, analytical & crystallization work package
|
||||||||||
a.
|
l
|
Analysis of IDT batches & sharing required set of data as per the revised Assay & RS methods
|
Xx. Xxxxx’x & Prana (sample to be provided by Prana
|
2,000
|
||||||
l
|
Comparing physical properties for all key API batches Batch Number 1457(2011 campaign), 1433(current campaign) are plant scale batches and DA1020702.1 is IDT batch. These batches will be analyzed & compared for physical properties e.g. PSD, DSC, XRPD and bulk density (if sufficient quantity is available)
|
Xx. Xxxxx’x & Prana (sample to be provided by Prana)
|
6,000
|
Sep’14
|
||||||
l
|
Expanding specifications of CDDQ-3 as a regulatory starting material & related analytical work.
|
Specification development as per requirement of Regulatory starting material
|
Xx. Xxxxx’x & Prana
|
10,000
|
||||||||
l
|
Part Compilation of data as part of CMC package for EOP2 meeting
Creating batch history for CDDQ-3,4,5i-impurity profiling, showing equivalency to the earlier material, method. Old batches may not be available, however impurity profile would be created for all the batches manufactured now onwards – Compiled data would be presented
|
Xx. Xxxxx’x & Prana
|
5,000
|
|||||||
b.
|
CMC summary for EOP2:
|
|||||||||
l
|
Expanding specifications of CDDQ-3 as a regulatory starting material & related analytical work- Method development and validation for related substances by HPLC and assay by HPLC – Compiled data would be presented
|
Xx. Xxxxx’x & Prana
|
13,000
|
Sept’ 14
|
||||||
l
|
Analytical support for crystallization development work including PSD analysis- Compiled data would be presented
|
Xx. Xxxxx’x & Prana
|
14,000
|
|||||||
c.
|
l
|
Material Generation for Crystallization work
|
Xx. Xxxxx’x
|
5,500
|
Oct’14
|
|||||
l
|
Analysis for the support on Crystallization studies for the lab samples
|
Xx. Xxxxx’x
|
13,500
|
|||||||
d.
|
l
|
Analysis of Optimized Samples and Report Finalization for Crystallization work
|
Xx. Xxxxx’x
|
8000
|
Nov’14
|
EOP2 means- End of phase 2 meeting, all other terms and conditions of the original Agreement commencement date 5th April’13 remain unchanged.
In witness whereof, the parties hereto have signed this Agreement
Signed for and on behalf of
|
Signed for and on behalf of
|
Xx. Xxxxx’x Laboratories Limited
|
|
25th Sept 2014
|
2/9/14. |
Signature
|
Signature
|
Name: Xxxxxx Xxx
|
Name: Xxxxxx Xxxxx
|
25th Sept 2014 | |
Witness Signature
|
Witness Signature
|
Witness Name: Xxxxxx Xxxxx Ramachandran
|
Witness Name: Xxxxxxxxx Xxxxxxx 2 Sept 2014
|