Amendment 1.3 to Agreement dated 26th Dec ’08 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 4.23
Amendment 1.3 to Agreement dated 26th Dec ’08 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 additional and amended clauses in the above mentioned Agreement (plus amendments) and will be in effect from 14 February 2012 onwards.
1. | Terms to be included |
i. | The following new clause-12 in Appendix A of the Agreement: |
“12. Sub-Project 4A: Qualification of Xx Xxxxx’x Reference Standard in comparison with IDT Reference Standard
a) | Xx. Xxxxx’x will analyse the Xx Xxxxx’x Reference Standard (CDDQ5RS1101) and the IDT Reference Standard (DA102301.1) side-by-side using Xx Xxxxx’x methods. | |||
b) | This will include: | |||
i. | Description, per Method of Analysis AR&D-GTP-001. | |||
ii. | Identification by FT-IR, Mass, NMR(13C and 1 H NMR), Elemental composition by HR-MS, per Method of Analysis AR&D-GTP-003 | |||
iii. | Chloride content, per Method of Analysis MF/CDDQ5-002/02 | |||
iv. | Identification, Assay and Related substances by HPLC, per Method of Analysis MF/CDDQ5-001/05 | |||
v. | Related substances by LC-MS, per Methods of Analysis MF/CDDQ5-004/0/3 and MF/CDDQ5-003/02 | |||
vi. | Residue on ignition, per Method of Analysis AR&D-GTP-0010 | |||
vii. | Water content by KF, per Method of Analysis AR&D-GTP-005 | |||
viii. | Heavy metals, per Method of Analysis AR&D-GTP-0011 | |||
ix. | Residual solvents by GC, per Method of Analysis MF/CDDQ5-007/02 (excluding Methanol) | |||
c) | Related Substances analysis to be performed in one sequence. Same tests to be performed on same day or in same sequence for reference standards of Xx. Xxxxx’x and IDT. |
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d) | Report containing all raw data and comments on comparability of the two Reference Standards to be provided. This should be an addendum to the existing Reference Standard report titled “Report on PBT2 reference standard preparation (I-CDDQ-10-0318)”. |
ii. | The following description of new Sub-Project 4A under Sub-Project Pricing in clause 3 of the Agreement | |
“Sub-Project 4A: Qualification of Xx Xxxxx’x Reference Standard in comparison with IDT Reference Standard – USD 4,000/-” | ||
iii. | The following description of new Sub-Project payment terms in clause 3 of the Agreement | |
“Sub-Project 4A: | ||
● | 100% upon sharing the final report to Prana (USD 4,000/-)” | |
2. | Terms to be varied | |
i. | The current numbering of the following clause heading in Appendix A of the Agreement, as amended in Amendment 10: |
“12. Sub-Project 6: Stability Study (48 months)”
is amended as follows
“13. Sub-Project 6: Stability Study (48 months)”
All other terms and conditions of the original Agreement dated 26th Dec’08 and those included in Amendments 1 to 12 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 | Prana Biotechnology Ltd. | |
Signature | Signature | |
Name: Xxxxx Xxxxxxxx | Name: Xxxxxx Xxxxx | |
Witness Signature | Witness Signature | |
Witness Name: Xxxxx Xxxxxxxx | Witness Name: Xxxxxxxxx Xxxxxxx |
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