----

----

----

| 1.     | Terms to be added                                |
|--------|--------------------------------------------------|
|   |                                             |
| i.     | The following section is inserted in Appendix A: |

|   | a) | Perform complete analysis on IDT batch sample received from Prana, using validated analytical methods already available with Dr Reddy’s for PBT2. (Including solid state NMR but excluding microbial testing and bacterial endotoxins)                                                                                                                                               |
|--------|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   | b) | Undertake 3 X 5gm experiments to conclude on the acetone volume equivalence to input quantity of API, which is required to reduce N-Oxide content below 3ppm. The purpose of these experiments would be to analyze performance of acetone slurry in reducing N-Oxide content in PBT2 below 3ppm. The only testing to be performed on 3 slurried samples is for N-Oxide content using LC-MS |
|   | c) | Replicate slurry procedure with the optimum volume equivalence of acetone on minimum of l0gm API. From resulted lot of PBT2 API, approximately 5gm of the slurried compound would then be used for performing complete analysis (including solid state NMR but excluding microbial testing and bacterial endotoxins) so as to generate a Certificate of Analysis (COA) for the lot.        |

|   | d) | Generate a report detailing experiments, results and conclusions drawn for Prana’s review and acceptance. |
|--------|----|-----------------------------------------------------------------------------------------------------------------|

----

| ii. | The following section is inserted in Clause 3 under “Sub-Project Pricing”: |
|-----|----------------------------------------------------------------------------------------|

| Signed for and on behalf of           |   | Signed for and on behalf of                                                     |
|---------------------------------------|--------|---------------------------------------------------------------------------------|
| Dr.Reddy’s Laboratories Limited |   | Prana Biotechnology Ltd.                                                        |
|                                  |   |                                                                            |
|                                       |   |                                                                                 |
| Signature                             |   | Signature                                                                       |
| Name: Manoj Mehrotra                  |   | Name: Caroline Head                                                             |
| V.P, CPS                              |   | CAROLINE HERD HEAD OF DEVELOPMENT                                               |
|                                  |   |                                                                            |
|                                       |   |                                                                                 |
| Witness Signature                     |   | Witness Signature                                                               |
| Witness Name: Ruturaj Kulkarni        |   | Witness Name: ELISABETH GAUTIERHead of Discovery & Nonclinical Dvt. Manager |

----

----

| 1.     | Terms to be added                                |
|--------|--------------------------------------------------|
|   |                                             |
| i.     | The following section is inserted in Appendix A: |

----

----

| ii. | The following section is inserted in Clause 3 under “Sub-Project Pricing”: |
|-----|----------------------------------------------------------------------------------------|

----

| Signed for and on behalf of Dr.Reddy’s Laboratories Limited |   | Signed for and on behalf of Prana Biotechnology Ltd. |
|-------------------------------------------------------------------|--------|------------------------------------------------------|
|                                                              |   |                                                 |
|                                                                   |   |                                                      |
| Signature                                                         |   | Signature                                            |
| Name: Manoj Mehrotra                                              |   | Name: Dianne Angus                                   |
|                                                              |   |                                                 |
|                                                                   |   |                                                      |
| Witness Signature                                                 |   | Witness Signature                                    |
| Witness Name: Ruturaj Kulkarni                                    |   | Witness Name: Elisabeth Gautier                      |

----

----

| 1.     | Terms to be varied                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |
| i.     | The following sentence in Clause 2 (as amended in the first amendment, dated 3rd February ‘09,1o the Agreement):                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |
| (b)    | Dr. Reddy’s must receive written authority from Prana’s Head of Development or its Discovery and Non-Clinical Development Manager before commencing any Sub-Project. Subject to clause 3 (b) in relation to Sub-Project 1 A, without such authority for a given Sub-Project, Dr Reddy’s must not undertake and may not charge Prana its fee for the Sub-Project or any other amount. Following such written authorization by Prana for a given Sub-project, Prana. upon Dr. Reddy’s request, will also issue a Purchase Order for the materials to be manufactured in accordance with the given Sub-Project. If in relation to a given Sub-Project, Prana provides written authority to undertake the Sub-Project after the relevant commencement date specified in the Timetable, then the Parties will agree in writing in good faith on a new Timetable to replace the existing one. |

| (b) | Dr. Reddy’s must receive written authority from Prana’s Head of Development or its Discovery and Non-Clinical Development Manager before commencing any Sub-Project. Subject to clause 3 (b) in relation to Sub-Project 1 A, without such authority for a given Sub-Project, Dr Reddy’s must not undertake and may not charge Prana its fee for the Sub-Project or any other amount. Distinct from such written authorization by Prana for a given Sub-project, Prana, upon Dr. Reddy’s request, will also issue a Purchase Order for the materials that may be manufactured in accordance with the given Sub-Project for the sole purpose of obtaining the requisite government or regulatory licenses to enable the performance of that Sub-project. For the avoidance of doubt, the issuance, by Prana, of a Purchase Order in relation to any Sub-Project shall not be construed as authorization for the commencement of that Sub-Project and as such Prana will have no liability to pay Dr. Reddy’s for the Sub-Project fees or any oilier amount. If in relation to a given Sub-Project, Prana provides written authority to undertake the Sub-Project after the relevant commencement date specified in the Timetable, then the Parties will agree in writing in good faith on a new Timetable to replace the existing one. |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| ii. | The following description of Sub-Project 2A in Clause 3, under Sub-Project Pricing; |
|-----|-------------------------------------------------------------------------------------|

| iii. | The following description of Sub-Projects 3 and 4 in Clause 3, under Sub-Project Pricing: |
|------|-------------------------------------------------------------------------------------------|

| iv. :  | The following Clause, Clause 5 of Appendix A                                                                                            |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------|
|        |                                                                                                                                    |
| 5.          | Sub-Project 2A: Manufacture of 500 gm Scale-up batch (also known as demonstration batch) using either optimized Route 2 or Route 3 |

----

|   | The process that is developed following the activities conducted during execution of Sub-Project 1, Sub-Project 1A (if Project 1A gets executed) and Sub-Project 2, will be used to produce at least 500 gm of PBT2 API as a demonstration batch that will conform to the agreed specification of API as jointly agreed by and between Dr. Reddy’s and Prana and establish whether the selected process is scalable to the degree required to support at least a 110kg PBT2 GMP campaign, If the process is not shown to be scalable, as jointly agreed by Prana and Dr. Reddy’s, the process will, under the scope of this Sub-Project 2A, undergo further optimization to ensure scalability. |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 5.     | Sub-Project 2A: Manufacture of PBT2 Scale-up batch (also known as demonstration batch) using either optimized Route 2 or Route 3 to a scale of approximately 1kgThe process that is developed following the activities conducted during execution of Sub-Projects 1. 1A (if Project 1A gets executed), 1B, 2 and 2B, will be used to produce approximately 1kg of PST2 API as a demonstration batch that will conform to the agreed specification of API as jointly agreed by and between Dr. Reddy’s and Prana and establish whether the selected process is scalable to the degree required to support at least a 110kg PBT2 GMP campaign. If the process is not shown to be scalable, as jointly agreed by Prana and Dr. Reddy’s, the process will, under the scope of this Sub-Project 2A, undergo further optimization to ensure scalability. A portion (approximately 500gm) of the demonstration batch may be utilised in the execution of Sub-Project 4 with the remaining material being a deliverable to Prana. Prana will authorize Dr. Reddy’s for shipping the remaining material deliverable within one month (30 Days) from the date of release of the scale-up batch. |
|--------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |
| v.     | The following Clause, Clause 7 of Appendix A:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| 7.     | Sub-Project 4: Manufacture of PBT2 Primary Reference Standard                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
|   | Dr. Reddy’s will manufacture 100 gm of PBT2 of the highest purity for use as a primary reference standard. To obtain the highest possible purity. Dr. Reddy’s will use the appropriate methods of purification such as additional recrystallisations. In addition to the purification steps in the optimized process. The material will be fully characterised for use as a primary reference standard and conform to a specification appropriate for such a primary reference standard, as jointly agreed by and between Dr. Reddy’s and Prana.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |

| 7.     | Sub-Project 4:Manufacture of PBT2 Primary Reference Standard                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   | Dr. Reddy’s will manufacture and deliver to Prana atleast 100 gm of PBT2 of the highest purity for use as a primary reference standard. To obtain the highest possible purity, Dr. Reddy’s will use the appropriate methods of purification such as additional recrystallisations. In addition to the purification steps in the optimized process. The material will be fully characterised for use as a primary reference standard and conform to a specification appropriate for such a primary reference standard, as jointly agreed by and between Dr. Reddy’s and Prana. If in case, due to repeated recrystallization activity for achieving highest purity Dr. Reddy’s discovers change in Polymorphism, then any further process development to meet desired polymorph specification will be subject to a separate Sub-Project as jointly agreed by and between Dr. Reddy’s and Prana. |

----

| Signed for and on behalf ofDr. Reddy’s Laboratories Limited |   | Signed for and on behalf ofPrana Biotechnology Ltd. |
|-------------------------------------------------------------------|--------|-----------------------------------------------------|
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Signature                                                         |   | Signature                                           |
| Name: Manoj Mehrotra                                              |   | Name: DIANNE ANGUS                                  |
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Witness Signature                                                 |   | Witness Signature                                   |
| Witness Name: RUTURAJ KULKARNI                                    |   | Witness Name: HOWARD JACOBS                         |

----

----

| i. | The following section is inserted in Appendix A: |
|----|--------------------------------------------------|

|   | 1. | Description                   |
|--------|----|-------------------------------|
|   | 2. | Identification by HPLC/FT-IR  |
|   | 3. | Assay by HPLC                 |
|   | 4. | Related substances by HPLC    |
|   | 5. | Water content by Karl Fischer |

----

|   | 6. | Polymorphic form by SS-NMR             |
|--------|----|----------------------------------------|
|   | 7. | Related substances by LC-MS and by GC. |
|   | 8. | Particle size by laser diffraction     |

| Time points       | : 0, 1, 3, 6, 9, 12, 18, 24 & 36. |
|-------------------|---------------------------------------|
| Number of samples | : 9                                   |

| Time points       | : (0), 1, 3 & 6 |
|-------------------|---------------------|
| Number of samples | : 3                 |

| 1. | Description                        |
|----|------------------------------------|
| 2. | Identification by HPLC/FT-IR       |
| 3. | Assay by HPLC                      |
| 4. | Related substances by HPLC         |
| 5. | Related substances by LC-MS and GC |
| 6. | Water content by KF                |

|   | a) | An introduction section on the batch under stability and the reason for the stability study |
|--------|----|---------------------------------------------------------------------------------------------|

----

|   | b) | A summary of the stability study protocol including a table of the testing regime   |
|--------|----|-------------------------------------------------------------------------------------|
|   | c) | The summary table as used in the interim reports                                    |
|   | d) | A summary, interpretation and discussion of the results obtained.                   |
|   | e) | A conclusion on the outcome of the stability trial.                                 |
|   | f) | Authorization as compliant to the ICH guideline by Dr. Reddy’s QA department. |

| ii. | The following section is inserted in Clause 3 under “Sub-Project Pricing”: |
|-----|----------------------------------------------------------------------------------------|

| iii. | The following section is inserted in Clause 3 under “The payment terms for each Sub-Project shall be:”: |
|------|---------------------------------------------------------------------------------------------------------------------|

| ● | 30% toward initial stability study set-up and TO testing COA release after receiving Prana’s authorization to proceed with the stability program (USD 7,500) |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ● | 30% of the value will be paid on completion of 1st year stability and sharing of the stability chart in the format proposed in Appendix B (USD 7,500)              |
| ● | 20% of the value will be paid on completion of 2nd year stability and sharing of the stability chart in the format proposed in Appendix B (USD 5,000)              |
| ● | 20% of (he value will be paid after completion of 3rd year stability and sharing of the stability chart in the format proposed in Appendix B (USD 5,000)           |

| Signed for and on behalf ofDr. Reddy’s Laboratories Limited |   | Signed for and on behalf ofPrana Biotechnology Ltd. |
|-------------------------------------------------------------------|--------|-----------------------------------------------------|
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Signature                                                         |   | Signature                                           |
| Name: Manoj Mehrotra                                              |   | Name: Dianne Angus                                  |
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Witness Signature                                                 |   | Witness Signature                                   |
| Witness Name: Ruturaj Kulkarni                                    |   | Witness Name: Graham Heery                          |

----

| Test                        |   | Method                 |   |   Specification                                                                                                                  |
|-----------------------------|--------|------------------------|--------|---------------------------------------------------------------------------------------------------------------------------------------|
| Description                 |   | Visual Inspection      |   | A while to light brown powder                                                                                                         |
| Identification              |   | FT-1R                  |   | The Infrared spectrum of the sample matches that of the reference standard                                                            |
|                        |   | HPLC                   |   | The retention time of the major peak in the sample chromatogram is within 0.2 minutes of the major peak in the standard chromatogram. |
| Polymorphic Form            |   | SS-NMR                 |   | SS-NMR consistent with the crystal structure of PBT2 form 1.                                                                          |
| Assay                       |   | HPLC                   |   | 98.0%-102.0% on dried basis                                                                                                           |
| Related Substances byHPLC   |   | HPLC                   |   | A)                                                                                                                                    | Specified IdentifiedImpurity 1:<0.15%(w/w)Quinoline diol:< 0.15% (w/w)Quinoline diacetate: < 0.15% (w/w) |
|                        |   |                   |   | B)                                                                                                                                    | Specified UnidentifiedImpurity 5: < 0.1%Impurity 6: < 0.1%Impurity 7: < 0.1% |
|                        |   |                   |   | C)                                                                                                                                    | Major unspecified impurity<0.l% |
|                        |   |                   |   | D)                                                                                                                                    | Total impuritiesrecord result |
| Related Substances by LC-MS |   | LC-MS                  |   |                                                                                                                                  | Specified IdentifiedImpurity 12: Not more than 0.004% (w/w) (40ppm)Impurity 13: Not more than 0.004% (w/w) (40ppm) |
| Related Substances by GC    |   | GC                     |   |                                                                                                                                  | Specified IdenlifiedImparity 14: Not more than 0.004% (w/w) (40 ppm) |
| Water Content               |   | Karl Fischer Titration |   |                                                                                                                                  | NMT 0.5% |
| Residual solvents           |   | GC                     |   | A)                                                                                                                                    | Methanol -≤ 0.3% |
|                        |   |                   |   | B)                                                                                                                                    | Ethanol- ≤0.5 |
|                        |   |                   |   | C)                                                                                                                                    | Heptanes-≤0.5% |
|                        |   |                   |   | D)                                                                                                                                    | Dioxane- ≤ 0.038% |
| Particle Size               |   | Laser Diffraction      |   |                                                                                                                                  | Record result |

----

| CUSTOM PHARMACEUTICAL SERVICESAddress of respective unit |                  | ISMS Class   | : RESTRICTED |
|----------------------------------------------------------|-----------------------|--------------|--------------|
|                                                     |                  | ISMS Version | : 1.0        |
| ANALYTICAL RESEARCH DEPARTMENT - STABILITY STUDY DATA    |
| Type of study :                                          | Storage conditions :  |         |
| Product code/ name :                                     | Primary packaging :   |         |
| Batch no. :                                              | Secondary packaging : |         |
| Duration :                                               | Study initiated on :  |         |

|             |   |   |   |          |   | Period  |
|------------------|--------|--------|--------|---------------|--------|---------|
| S.No.            |   | Test   |   | Specification |   | Initial |   | 1M |   | 2M |   | 3M |   | 6 M |   | 12 M |
|             |   |   |   |          |   |    |   |   |   |   |   |   |   |   |   |   |
| 1.               |   |   |   |          |   |    |   |   |   |   |   |   |   |   |   |   |
| 2.               |   |   |   |          |   |    |   |   |   |   |   |   |   |   |   |   |
| 3.               |   |   |   |          |   |    |   |   |   |   |   |   |   |   |   |   |
| 4.               |   |   |   |          |   |    |   |   |   |   |   |   |   |   |   |   |
| 5.               |   |   |   |          |   |    |   |   |   |   |   |   |   |   |   |   |
| Date of analysis |   |   |   |          |   |    |   |   |   |   |

| Prepared by : | Checked by : |
|---------------|-------------------|
| Date:         | Date:             |

----

----

| i.        | The following clause 8 in Appendix A in the original Agreement: |
|-----------|-----------------------------------------------------------------|
|      |                                                            |
| “8. | Sub-Project 5: GMP manufacture:                                 |

| (a) | Dr. Reddy’s will manufacture, using the process developed and optimized in Sub-Projects 1 and 1B, 40 kg of GMP PBT2 drug substance according to the applicable regulatory and statutory requirements of current Good Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 and ICH Q7) in one of the two scenarios: |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | Scenario 1 | - | 110Kg of GMP API |
|--------|------------|---|------------------|
|   | Scenario 2 | - | 40Kg of GMP APl  |

| (b) | Prana will advise Dr. Reddy’s in advance of Sub-Project 5 initiation which scenario will be required. The batch purity of the resulting PBT2 drug substance will be at least 99.8% (on as dried basis) with no individual impurity greater than 0.1% and an impurity profile equivalent to, or belter than, that of the previous PBT2 GMP batch (DA1020702.1).                                                                                                                                                                                                                                                                                                                                                                       |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (c) | The batch specifications will meet those agreed upon by both parties prior to manufacture initiation and the transferred, refined and verified analytical methods as well as the newly developed methods As described in clause 4 of this appendix, will be used for the release of drug substance.                                                                                                                                                                                                                                                                                                                                                                                                                                        |
| (d) | The batch polymorphic form will match that of PBT2 batch DA1020702.1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |
| (e) | Mother liquors, intermediates and crude samples from the GMP manufacture will be retained in the Dr. Reddy’s facilities for a period of up to 90 days after the completion of the Project. After which time Prana will have the option to either ship the materials to another site at cost to Prana, request further storage in the Dr. Reddy’s facilities at a cost to Prana agreed to by both parties or have these materials destroyed or disposed of by Dr. Reddy’s according to their regular procedures. If prior to 90 days Prana decides to engage Dr. Reddy’s for recovery development and/or impurity work using these materials, they will be retained at Dr. Reddy’s for those purposes.” |

----

| a)     | Dr. Reddy’s will manufacture, using the process developed and optimized in Sub-Projects 1 and 1B and scaled-up in Sub-Project 2A, 40 kg of GMP PBT2 drug substance according to the applicable regulatory and statutory requirements of current Good Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 and ICH Q7).                                                                                                                                                                                                                                                                                                                                                                                                  |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b)     | Prana to give authorization to Dr. Reddy’s for initiating Sub-Project 5B soon after completion of Sub-Project 2A. For avoidance of any doubts, the Subproject(s) authorization by Prana and corresponding pricing methodology adopted by Dr Reddy’s will vary considering either of the following two scenarios preferred by Prana-                                                                                                                                                                                                                                                                                                                                                                                     |
|   | Scenario 1- Authorization of Sub-Project 5B only or authorization of Sub-Project 5B independent to Sub-Project 5C.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
|   | Scenario2- Authorization of both Sub-Project 5B and Sub-Project 5C at the same time for the purpose of performing Sub-Project 5C immediately following Sub-Project 5B or earlier.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |
| c)     | Sub-Project 5B out-put will be mutually discussed and agreed on the basis of process yield achieved in Sub-Project 2A.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| d)     | The proposed manufacturing Timetable for Sub-Projects 2A, 5A, 5B and 5C, subject to clauses 2 (b) or 2 (d), is attached as Annexure 1 to this amendment.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| e)     | The batch purity of the resulting PBT2 drug substance will be at least 99.8% (on as dried basis) with no individual impurity greater than 0.1% and an impurity profile equivalent to, or better than, that of the previous PBT2 GMP batch (DA1020702.1).                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| f)     | The batch specifications will meet those agreed upon by both parties prior to manufacture initiation and the transferred, refined and verified analytical methods as well as the newly developed methods resulting from Sub-Projects 2 and 2B, will be used for the release of drug substance.                                                                                                                                                                                                                                                                                                                                                                                                                                      |
| g)     | The batch polymorphic form will match that of PBT2 batch DA1020702.1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
| h)     | Mother liquors, intermediates and crude samples from the GMP manufacture will be retained in the Dr. Reddy’s facilities for a period of up to 90 days after the completion of the Project. After which time Prana will have the option to either ship the materials to another site at cost to Prana, request further storage in the Dr. Reddy’s facilities at a cost to Prana agreed to by both parties or have these materials destroyed or disposed of by Dr. Reddy’s according to their regular procedures. If prior to 90 days Prana decides to engage Dr. Reddy’s for recovery development and/or impurity work using these materials, they will be retained at Dr. Reddy’s for those purposes. |
| i)     | Dr. Reddy’s will blend API out-put from all the batches undertaken during the campaign into a one single batch, which will be then release tested before dispatch.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| j)     | Prana to Authorize Dr. Reddy’s for shipping the campaign quantity with-in 30 days from the date of testing and release of the batch. In the event Prana delays such authorization beyond 30 days then Prana will pay Dr Reddy’s extra storage fee per month applicable and such fee will be communicated by Dr. Reddy’s to Prana before initial 30 days period expire.                                                                                                                                                                                                                                                                                                                                            |

----

| a)     | Dr. Reddy’s will manufacture 70Kg PBT2, using the process developed and optimized in Sub-Projects 1 and 1B and scaled-up in Sub-Project 2A and Sub-Project 5B (40Kg GMP manufacturing) and following all the applicable regulatory and statutory requirements of current Good Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 and ICH Q7), for the performance of Sub-Project 5C.                                                                                                                                                                                                                                                                                                                             |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b)     | Prana will authorize Sub-Project 5C either together with Sub-Project 5B or during later point in time as per the requirement. For avoidance of any doubts, the Subproject(s) authorization discussed in this amendment by Prana and corresponding pricing methodology adopted by Dr Reddy’s, will vary considering either of the following two scenarios preferred by Prana-                                                                                                                                                                                                                                                                                                                                                  |
|   | Scenario l- Authorization of Sub-Project 5C independently to Sub-Project 5B.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|   | Scenario 2- Authorization of both Sub-Project 5C and Sub-Project 5B at the same time for the purpose of performing Sub-Project 5C immediately following Sub-Project 5B or earlier.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| c)     | Sub-project 5C out-put will be mutually discussed and agreed on the basis of process yield achieved in Sub-Project 2A. If Sub-Project 5C authorization comes after completion of Sub-Project 5B, then the quantity for Sub-Project 5C will be decided considering yield achieved during execution of Sub-Project 5B.                                                                                                                                                                                                                                                                                                                                                                                                                |
| d)     | The proposed manufacturing Timetable for Sub-Projects 2A, 5A, 5B and 5C, subject to clauses 2 (b) or 2 (d), is attached as Annexure 1 to this amendment.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| e)     | The batch purity of the resulting PBT2 drug substance will be at least 99.8% (on as dried basis) with no individual impurity greater than 0.1% and an impurity profile equivalent to, or better than, that of the previous PBT2 GMP batch (DA1020702.1).                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| f)     | The batch specifications will meet those agreed upon by both parlies prior to manufacture initiation and the transferred, refined and verified analytical methods as well as the newly developed methods resulting from Sub-Projects 2 and 2B, will be used for the release of drug substance.                                                                                                                                                                                                                                                                                                                                                                                                                                      |
| g)     | The batch polymorphic form will match that of PBT2 batch DA1020702.1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
| h)     | Mother liquors, intermediates and crude samples from the GMP manufacture will be retained in the Dr. Reddy’s facilities for a period of up to 90 days after the completion of the Project. After which time Prana will have the option to either ship the materials to another site at cost to Prana, request further storage in the Dr. Reddy’s facilities at a cost to Prana agreed to by both parties or have these materials destroyed or disposed of by Dr. Reddy’s according to their regular procedures. If prior to 90 days Prana decides to engage Dr. Reddy’s for recovery development and/or impurity work using these materials, they will be retained at Dr. Reddy’s for those purposes. |
| i)     | Dr. Reddy’s will blend API out-put from all the batches undertaken during the campaign into a one single batch, which will be then release tested before the dispatch.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
| j)     | Prana to authorize Dr. Reddy’s for shipping the campaign quantity with-in 30 days from the date of testing and release of the batch. In the event Prana delays such authorization beyond 30 days then Prana will pay Dr Reddy’s extra storage fee per month applicable and such fee will be communicated by Dr. Reddy’s to Prana before initial 30 days period expire”                                                                                                                                                                                                                                                                                                                                      |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
| ii.    | The numbering for the following clause heading in Appendix A in the original Agreement:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |

----

|   | Scenario 1 | - | USD 1,027,000/-      |
|--------|------------|---|----------------------|
|   | Scenario 2 | - | USD 540,000/-” |

| Sub-Project 5C) | - | USD 400,000 |
|-----------------|---|-------------|

| iv. | The following description of Sub-Project payment terms in clause 3: |
|-----|---------------------------------------------------------------------|

|   | “Sub-Project 5: |
|--------|-----------------------|
|   | ●               | 40% of the value will be paid as an advance (USD 410,800/- OR USD 216,000/-) on authorisation of this Sub-project subject to clause 2(b) |
|   | ●               | 20% of the value will be paid after sharing the Certificate of Analysis (USD 205,400/- OR USD 108,000/-) |
|   | ●               | 40% of the value will be paid after material reaches the destination (USD 410,800/- OR USD 216,000/-)” |

| ● | 100% of the value will be paid on initiation of the Sub-Project (USD 150,000/-) |
|---------|---------------------------------------------------------------------------------|

----

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 200,000/-)        |
|---------|---------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 80,000/-) |
| ● | 30% of the value will be paid after material reaches the destination (USD 120,000/-)  |

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 180,000/-)            |
|---------|-------------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 72,000/-)     |
| ● | 30% of the value will be paid after material reaches the destination (USD 108,000/-) |

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 382,500/-)         |
|---------|----------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 153,000/-) |
| ● | 30% of the value will be paid after material reaches the destination (USD 229,500/-)   |

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 367,500/-)              |
|---------|---------------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 147,000/-)      |
| ● | 30% of the value will be paid after material reaches the destination (USD 220,500/-)” |

| Signed for and on behalf ofDr. Reddy’s Laboratories Limited |   | Signed for and on behalf ofPrana Biotechnology Ltd. |
|-------------------------------------------------------------------|--------|-----------------------------------------------------|
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Signature                                                         |   | Signature                                           |
| Name: Manoj Mehrotra                                              |   | Name: Dianne Angus                                  |
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Witness Signature                                                 |   | Witness Signature                                   |
| Witness Name: Ruturaj Kulkarni                                    |   | Witness Name: Graham Heery                          |

----

----

----

| 1.     | Terms to be added                                |
|--------|--------------------------------------------------|
|   |                                             |
| i.     | The following section is inserted in Appendix A: |

|   | To check stability of desired polymorphic Form-1 of PBT2 API under stressed operational conditions employed during recrystallization & product drying. |
|--------|------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| Sr.No. |   | Experiment Description                                                                                      |   | Purpose                                                                                                         |
|--------|--------|-------------------------------------------------------------------------------------------------------------|--------|-----------------------------------------------------------------------------------------------------------------|
|   |   |                                                                                                        |   |                                                                                                            |
| 1      |   | Solubility studies in IPA, Water, IPA+Water. (On Pure API)                                                  |   |                                                                                                            |
| 1.1    |   | Solubility in IPA                                                                                           |   | To optimize the yield                                                                                           |
| 1.2    |   | Solubility in Water                                                                                         |   | and Crystallization procedure                                                                                   |
| 1.3    |   | Solubility in IPA+ Water(composition as per process 1:1)                                                    |   |                                                                                                            |
|   |   |                                                                                                        |   |                                                                                                            |
| 2      |   | Cooling profile at different intervals/rate. (On Crude API)                                                 |   |                                                                                                            |
| 2.1    |   | With 0.1 deg C/min                                                                                          |   | Need to confirm the impact of                                                                                   |
| 2.2    |   | with 0.25 deg C/min                                                                                         |   | cooling profile on the desired                                                                                  |
| 2.3    |   | With 0.5 deg C/min                                                                                          |   | polymorph and yield.                                                                                            |
| 2.4    |   | With 0.75 deg C/min                                                                                         |   |                                                                                                            |
| 2.5    |   | With 1.0 deg C/min                                                                                          |   |                                                                                                            |
|   |   |                                                                                                        |   |                                                                                                            |
| 3      |   | Impact of Hydrodynamics parameters study for polymorphic conversion with different P/V ratio (On Crude API) |   | To check the impact of hydrodynamics effect on polymorph and correlating the parameters to the plant operations |
|   |   |                                                                                                        |   |                                                                                                            |
| 4      |   | The filtration at high temperature studies. (On Crude API)                                                  |   |                                                                                                            |
| 4.1    |   | Filtration at 85 deg C                                                                                      |   | Impact of nucleation if takes place                                                                             |
| 4.2    |   | Filtration at 70 deg C                                                                                      |   | during filtration                                                                                               |
|   |   |                                                                                                        |   |                                                                                                            |
| 5      |   | Stress study related to downstream Process like drying. (On Crude API)                                      |   |                                                                                                            |
| 5.1    |   | Extended hours drying                                                                                       |   |                                                                                                            |
| 5.2    |   | At elevated temperature -10 deg C above the normal drying temp range                                        |   | To study impact of drying conditions on polymorphism                                                            |
| 5.3    |   | Drying with humidity - at 50% RH and 60% RH for 10 hours                                                    |   |                                                                                                            |
| 5.4    |   | Drying with extra solvent/moisture                                                                          |   |                                                                                                            |
|   |   |                                                                                                        |   |                                                                                                            |
| 6      |   | Identification of seeding point (on Crude API)                                                              |   | To check for onset of crystallization                                                                           |
|   |   |                                                                                                        |   |                                                                                                            |
| 7      |   | Seeding experiments                                                                                         |   | Stability of desired polymorph From-1                                                                           |
| 7.1    |   | Seeding with pure Form-1                                                                                    |   |                                                                                                            |
| 7.2    |   | Seeding with pure Form-2                                                                                    |   |                                                                                                            |

|   | a)     | HPLC purity                                                                                                                                   |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------|
|   |   |                                                                                                                                          |
|   | b)     | LCMS, as required or requested by Prana to ensure quinoline N-oxide and quinoline chloride levels meet the required specification (<3ppm). |

----

|   | c)     | SSNMR (for samples from experiment number 2, 3, 4, 5, 6 & 7)                                                                                                                                                                                                                                                            |
|--------|--------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |   |                                                                                                                                                                                                                                                                                                                        |
|   | d)     | FT-IR on selected samples to investigate its possible use to differentiate polymorphs. Towards the end of the study, Dr Reddy’s will issue the “Recrystallization Study Report” to Prana capturing the experiments, critical observations, results and recommendations for future manufacturing campaign. |

| Crude Form | Approx. 310gm |
|------------|---------------|
| Pure Form  | Approx. 80gm  |

| ii. | Approximately 2 months from the date of go-ahead from Prana and availability of API quantities. Following payment terms to be inserted in the main agreement under Clause-3 for “Payment” |
|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | ● | 50% of the value (USD 26,250) will be paid upon initiation of the Sub-Project                                                                 |
|--------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------|
|   | ● | 80% of the value (USD 42,000, includes advance already paid) will be paid once all the experiments and related results are shared with Prana. |
|   | ● | Remaining 20% of the value ($10,500) will be paid upon acceptance of sub-project report by Prana.                                             |

----

| Signed for and on behalf ofDr. Reddy’s Laboratories Limited |   | Signed for and on behalf ofPrana Biotechnology Ltd. |
|-------------------------------------------------------------------|--------|-----------------------------------------------------|
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Signature                                                         |   | Signature                                           |
| Name: Manoj Mehrotra                                              |   | Name: Dianne Angus                                  |
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Witness Signature                                                 |   | Witness Signature                                   |
| Witness Name: Ruturaj Kulkarni                                    |   | Witness Name: Ann Quick                             |

----

----

| 1. | Terms to be varied                       |
|----|------------------------------------------|
| i. | The following clause 2 of the Agreement: |

| ii. | The following clauses 8 & 9 in Appendix A of the Agreement, as amended in amendment 7: |
|-----|--------------------------------------------------------------------------------------------|

----

| a)     | Dr. Reddy’s will manufacture, using the process developed and optimized in Sub-Projects 1 and 1B and scaled-up in Sub-Project 2A, 40 kg of GMP PBT2 drug substance according to the applicable regulatory and statutory requirements of current Good Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 and ICH Q7).                                                                                                                                                                                                                                                                                                                                                                                                  |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b)     | Prana to give authorization to Dr. Reddy’s for initiating Sub-Project 5B soon after completion of Sub-Project 2A. For avoidance of any doubts, the Subproject(s) authorization by Prana and corresponding pricing methodology adopted by Dr Reddy’s will vary considering either of the following two scenarios preferred by Prana-                                                                                                                                                                                                                                                                                                                                                                                     |
|   | Scenario l- Authorization of Sub-Project 5B only or authorization of Sub-Project 5B independent to Sub-Project 5C.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
|   | Scenario 2- Authorization of both Sub-Project 5B and Sub-Project 5C at the same time for the purpose of performing Sub-Project 5C immediately following Sub-Project 5B or earlier.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| c)     | Sub-Project 5B out-put will be mutually discussed and agreed on the basis of process yield achieved in Sub-Project 2A.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| d)     | The proposed manufacturing Timetable for Sub-Projects 2A, 5A, 5B and 5C, subject to clauses 2 (b) or 2 (d), is attached as Annexure 1 to this amendment.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| e)     | The batch purity of the resulting PBT2 drug substance will be at least 99.8% (on as dried basis) with no individual impurity greater than 0.1% and an impurity profile equivalent to, or better than, that of the previous PBT2 GMP batch (DA1020702.1).                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| f)     | The batch specifications will meet those agreed upon by both parties prior to manufacture initiation and the transferred, refined and verified analytical methods as well as the newly developed methods resulting from Sub-Projects 2 and 2B, will be used for the release of drug substance.                                                                                                                                                                                                                                                                                                                                                                                                                                      |
| g)     | The batch polymorphic form will match that of PBT2 batch DA1020702.1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
| h)     | Mother liquors, intermediates and crude samples from the GMP manufacture will be retained in the Dr. Reddy’s facilities for a period of up to 90 days after the completion of the Project. After which time Prana will have the option to either ship the materials to another site at cost to Prana, request further storage in the Dr. Reddy’s facilities at a cost to Prana agreed to by both parties or have these materials destroyed or disposed of by Dr. Reddy’s according to their regular procedures. If prior to 90 days Prana decides to engage Dr. Reddy’s for recovery development and/or impurity work using these materials, they will be retained at Dr. Reddy’s for those purposes. |
| i)     | Dr. Reddy’s will blend API out-put from all the batches undertaken during the campaign into a one single batch, which will be then release tested before dispatch.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| j)     | Prana to Authorize Dr. Reddy’s for shipping the campaign quantity with-in 30 days from the date of testing and release of the batch. In the event Prana delays such authorization beyond 30 days then Prana will pay Dr Reddy’s extra storage fee per month applicable and such fee will be communicated by Dr. Reddy’s to Prana before initial 30 days period expire.”                                                                                                                                                                                                                                                                                                                                     |

----

|   | a) | Dr. Reddy’s will manufacture, using the process developed and optimized in Sub-Projects 1, 1B and as demonstrated in Pilot Plant during execution of Sub-Project 2A, approximately 50 kg of GMP PBT2 API according to the applicable regulatory and statutory requirements of current Good Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 and ICH Q7).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |
|--------|----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   | b) | Prana to give authorization to Dr. Reddy’s for initiating Sub-Project 5B soon after completion of Sub-Project 2A.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |
|   | c) | Dr Reddy’s will take five (5) sub-batches to manufacture approximately 50 kg, with each sub-batch utilizing approximately 122 kgs of KSM. The Parties acknowledge that there is the possibility of yield variation during execution of the sub-batches which may negatively impact on the final out-put quantity. Any additional work aimed at increasing the API output quantity will be discussed in good faith between Dr Reddy’s and Prana to negotiate any additional cost implications for making-up the shortfall in the desired quantity against a separate Sub-Project. Any such Sub-Project will be subject to an amendment to this Agreement and reviewed and approved in writing by representatives from Prana and Dr. Reddy’s.                                                                                                                                                                                                               |
|   | d) | Proposed manufacturing schedule for Sub-Project 5A and 5B is attached as Annexure 1 to this amendment.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      |
|   | e) | The batch purity of the resulting PBT2 API will be at least 99.8% (on as dried basis) with no individual impurity greater than 0.1% and an impurity profile equivalent to, or better than, that of the previous PBT2 GMP batch (DA1020702.1).                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
|   | f) | The batch specifications will meet those included in Annexure 2 to this amendment. The transferred, refined and verified analytical methods as well as the newly developed methods resulting from Sub-Projects 2 and 2B, will be used for the release of API.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
|   | g) | The batch polymorphic form will match that of PBT2 batch DA1020702.1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|   | h) | Mother liquors, intermediates and crude samples from the GMP manufacture will be retained in the Dr. Reddy’s facilities for a period of up to 90 days after the completion of the Project. After which time Prana will have the option to either ship the materials to another site at cost to Prana, request further storage in the Dr. Reddy’s facilities at a cost to Prana agreed to by both parties or have these materials destroyed or disposed of by Dr. Reddy’s according to their regular procedures. If prior to 90 days Prana decides to engage Dr. Reddy’s against a separate work order and/or agreement amendment for API recovery development and/or impurity work using these materials, they will be retained at Dr. Reddy’s for those purposes until expiry of 90 day time period. In the event the storage time extends beyond 90 days, then Prana agrees to pay Dr Reddy’s mutually agreed storage cost per month. |

----

|   | i)                                                                                                        | Each sub-batch of API will be tested and released against the agreed specification. Dr. Reddy’s will blend API output either from all the batches or partially as per Prana’s preference. The blended batch(es) will be retested and released as per the agreed specification.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|--------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   | j)                                                                                                        | Prana to Authorize Dr. Reddy’s for shipping the final out-put of API from this Sub-Project within 30 days from the date of release of the batch. In the event Prana delays such authorization beyond 30 days than Prana will pay Dr Reddy’s extra storage fee applicable and such fee will be communicated by Dr. Reddy’s to Prana before 30 days period expire. Further, in the event of Dr Reddy’s storing the campaign quantity beyond 30 days, the amount due from Prana as agreed in clause 3 under “Payment Term” for Sub-Project 5B, that is payable only upon delivery of the material to the requested destination, shall not be withheld beyond 30 days from the date of release of the material and will be paid in full by Prana within 30 days. |
|   | k)                                                                                                        | Dr. Reddy’s, upon authorisation of this Sub-Project 5B by Prana, will purchase all the remaining raw materials to allow for the manufacture of a total of 50Kg PBT2 API, as described in this Sub-Project.”                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
|   |                                                                                                      |
| iii.   | The numbering for the following clause heading in Appendix A of the Agreement, as amended in amendment 7: |

| iv. | The following description of Sub-Project pricing in clause 3 of the Agreement as amended in amendment 7: |
|-----|----------------------------------------------------------------------------------------------------------|

----

| v. | The following description of Sub-Project payment terms in clause 3 of the Agreement, as amended in amendment 7: |
|----|-----------------------------------------------------------------------------------------------------------------|

| ● | 100% of the value will be paid on initiation of the Sub-Project (USD 150,000/-) |
|---------|---------------------------------------------------------------------------------|

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 200,000/-)        |
|---------|---------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 80,000/-) |
| ● | 30% of the value will be paid after material reaches the destination (USD 120,000/-)  |

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 180,000/-)        |
|---------|---------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 72,000/-) |
| ● | 30% of the value will be paid after material reaches the destination (USD 108,000/-)  |

----

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 382,500/-)         |
|---------|----------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 153,000/-) |
| ● | 30% of the value will be paid after material reaches the destination (USD 229,500/-)   |

| ● | 50% of the value will be paid on initiation of the Sub-Project (USD 367,500/-)              |
|---------|---------------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid after sharing of Certificate of Analysis (USD 147,000/-)      |
| ● | 30% of the value will be paid after material reaches the destination (USD 220,500/-)” |

| ● | 100% of the value will be paid upon execution of Sub-Project (USD 150,000) |
|---------|----------------------------------------------------------------------------|

| ● | 50% of the value will be paid upon initiation of GMP manufacture (USD 286,000/-)                                                                                                                           |
|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ● | 20% of the value will be paid upon completion of GMP manufacture (USD 114,400/-)                                                                                                                           |
| ● | Remaining 30% of the value will be paid after the API reaches the destination or within 30 days if Prana engages Dr. Reddy’s to store the API beyond 30 days from its release (USD 171,600/-)” |

| 2. | Terms to be Removed                                                                                          |
|----|--------------------------------------------------------------------------------------------------------------|
| i. | The following clause 10 in Appendix A of the Agreement as amended in Amendment 7 is removed in its entirety: |

| a) | Dr. Reddy’s will manufacture 70Kg PBT2, using the process developed and optimized in Sub-Projects 1 and 1B and scaled-up in Sub-Project 2A and Sub-Project 5B (40Kg GMP manufacturing) and following all the applicable regulatory and statutory requirements of current Good Manufacturing Practices (GMP) (US 21 CFR parts 210 and 211 and ICH Q7), for the performance of Sub-Project 5C.                                                                                                                                                                                                                                               |
|----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b) | Prana will authorize Sub-Project 5C either together with Sub-Project 5B or during later point in time as per the requirement. For avoidance of any doubts, the Subproject(s) authorization discussed in this amendment by Prana and corresponding pricing methodology adopted by Dr Reddy’s, will vary considering either of the following two scenarios preferred by Prana-Scenario l- Authorization of Sub-Project 5C independently to Sub-Project 5B.Scenario 2- Authorization of both Sub-Project 5C and Sub-Project 5B at the same time for the purpose of performing Sub-Project 5C immediately following Sub-Project 5B or earlier. |

----

| c) | Sub-project 5C out-put will be mutually discussed and agreed on the basis of process yield achieved in Sub-Project 2A. If Sub-Project 5C authorization comes after completion of Sub-Project 5B, then the quantity for Sub-Project 5C will be decided considering yield achieved during execution of Sub-Project 5B.                                                                                                                                                                                                                                                                                                                                                                                                                |
|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| d) | The proposed manufacturing Timetable for Sub-Projects 2A, 5A, 5B and 5C, subject to clauses 2 (b) or 2 (d), is attached as Annexure 1 to this amendment.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| e) | The batch purity of the resulting PBT2 drug substance will be at least 99.8% (on as dried basis) with no individual impurity greater than 0.1% and an impurity profile equivalent to, or better than, that of the previous PBT2 GMP batch (DA1020702.1).                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| f) | The batch specifications will meet those agreed upon by both parties prior to manufacture initiation and the transferred, refined and verified analytical methods as well as the newly developed methods resulting from Sub-Projects 2 and 2B, will be used for the release of drug substance.                                                                                                                                                                                                                                                                                                                                                                                                                                      |
| g) | The batch polymorphic form will match that of PBT2 batch DA1020702.1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
| h) | Mother liquors, intermediates and crude samples from the GMP manufacture will be retained in the Dr. Reddy’s facilities for a period of up to 90 days after the completion of the Project. After which time Prana will have the option to either ship the materials to another site at cost to Prana, request further storage in the Dr. Reddy’s facilities at a cost to Prana agreed to by both parties or have these materials destroyed or disposed of by Dr. Reddy’s according to their regular procedures. If prior to 90 days Prana decides to engage Dr. Reddy’s for recovery development and/or impurity work using these materials, they will be retained at Dr. Reddy’s for those purposes. |
| i) | Dr. Reddy’s will blend API out-put from all the batches undertaken during the campaign into a one single batch, which will be then release tested before the dispatch.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
| j) | Prana to authorize Dr. Reddy’s for shipping the campaign quantity with-in 30 days from the date of testing and release of the batch. In the event Prana delays such authorization beyond 30 days then Prana will pay Dr Reddy’s extra storage fee per month applicable and such fee will be communicated by Dr. Reddy’s to Prana before initial 30 days period expire”                                                                                                                                                                                                                                                                                                                                      |

----

| Signed for and on behalf ofDr. Reddy’s Laboratories Limited |   | Signed for and on behalf ofPrana Biotechnology Ltd. |
|-------------------------------------------------------------------|--------|-----------------------------------------------------|
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Signature                                                         |   | Signature                                           |
| Name: Manoj Mehrotra                                              |   | Name: Dianne Angus                                  |
|                                                              |   |                                                |
|                                                                   |   |                                                     |
| Witness Signature                                                 |   | Witness Signature                                   |
| Witness Name: Ruturaj Kulkarni                                    |   | Witness Name: Graham Heery                          |

----

|    |                                            | Month 1 (Nov 08) | DEc-09 | Jan-10 | Feb-10 | May-10 |
|---------|-------------------------------------------------|------------------|--------|--------|--------|--------|
|    | Weeks:                                          | 1                | 2      | 3      | 4      | 5      | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 |
|    | Activities: for 1Kg compaign non GMP            |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                            |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 1       | Availability of PO                              |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 2       | Import license for Chlorquinaidol for 1 kg |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 3       | RM Procurement                                  |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 4       | Tech Transfer                                   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 5       | GMP Document preparation and approval           |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 6       | RM analysis and release                         |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 7       | stage 1 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 8       | stage 2 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 9       | stage 3 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 10      | stage 4 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 11      | stage 5 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 12      | RC1 analysis and release                        |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 13      | RC2 analysis and release                        |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 14      | complete analysis                               |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 15      | Shipment of 0.5 Kg                              |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 16      | RC3 for reference standard in TDC               |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 17      | complete analysis                               |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| I8      | Availability of manufacturing license           |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 19      | Shipment of reference standard                  |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                            |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                            |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                            | Nov-10           | DEc-09 | Jan-10 | Feb-10 | May-10 |
|  1 |  Availability of PO for 50 KgPBT2          |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 2       | Clorquinaddol import license                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 3       | RM procurement 50kg                             |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 4       | tech transfer                                   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 5       | GMP Document preparation and approval           |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 6       | RM analysis and release                         |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 7       | Stage 1 analysis and release               |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 8       | Stage 2 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 9       | Stage 3 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 10      | stage 4 analysis  and release         |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 11      | Stage 5 analysis and release                    |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 12      | RC1 analysis and release                        |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 13      | RC2 analysis and release                        |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 14      | complete analysis                               |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 15      | Blending of 5 batches                           |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 16      | Complete analysis                               |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 17      | Dispatch                                        |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 31      | Fun GMP Documentation                           |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 32      | Manufacturing license                           |             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |

----

|   |                                       | Apr-10 | May-10 | Jun-10 | Jul-10 | Aug-10 |
|--------|--------------------------------------------|--------|--------|--------|--------|--------|
|   | Weeks:                                     | 22     | 23     | 24     | 25     | 26     | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | 40 | 41 | 42 | 43 |
|   | Activities: for 1Kg campaign non GMP       |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |                                       |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 1      | Availability of PO                         |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 2      | Import license for Chlorquinaidol for 2 kg |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 3      | RM Procurement                             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 4      | Tech Transfer                              |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 5      | GMP Document preparation and approval      |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 6      | RM analysis and release                    |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 7      | stage 1 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 8      | stage 2 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 9      | stage 3 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 10     | stage 4 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 11     | stage 5 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 12     | RC1 analysis and release                   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 13     | RC2 analysis and release                   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 14     | complete analysis                          |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 15     | Shipment of 0.5 Kg                         |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 16     | RC3 for reference standard in TDC          |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 17     | complete analysis                          |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| I8     | Availability of manufacturing license      |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 19     | Shipment of reference standard             |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |                                       |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |                                       |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |                                       | Apr-10 | May-10 | Jun-10 | Jul-10 | Aug-10 |
| 1      | Availability of PO for 50 KgPBT2           |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 2      | Clorquinaddol import license               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 3      | RM procurement 50kg                        |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 4      | tech transfer                              |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 5      | GMP Document preparation and approval      |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 6      | RM analysis and release                    |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 7      | Stage 1 analysis and release          |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 8      | Stage 2 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 9      | Stage 3 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 10     | stage 4 analysis  and release    |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 11     | Stage 5 analysis and release               |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 12     | RC1 analysis and release                   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 13     | RC2 analysis and release                   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 14     | complete analysis                          |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 15     | Blending of 5 batches                      |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 16     | Complete analysis                          |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 17     | Dispatch                                   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 31     | Fun GMP Documentation                      |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 32     | Manufacturing license                      |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |

|    |                                       | Sep-10 | Oct-10              | Nov-10 | Dec-10 |   |
|---------|--------------------------------------------|--------|---------------------|--------|--------|--------|
|    | Weeks:                                     | 44     | 45                  | 46     | 47     | 48     | 49 | 50 | 51 | 52 | 53 | 54 | 55 | 56 | 57 | 58 | 59 | 60 |
|    | Activities: for 1Kg campaign non GMP       |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|  1 | Availability of PO                         |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 2       | Import license for Chlorquinaidol for 2 kg |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 3       | RM Procurement                             |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 4       | tech Transfer                              |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 5       | GMP Document preparation and approval      |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 6       | RM analysis and release                    |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 7       | stage 1 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 8       | stage 2 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 9       | stage 3 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 10      | stage 4 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 11      | stage 5 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 12      | RC1 analysis and release                   |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 13      | RC2 analysis and release                   |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 14      | complete analysis                          |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 15      | Shipment of 0.5 Kg                         |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 16      | RC3 for reference standard in TDC          |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 17      | complete analysis                          |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| I8      | Availability of manufacturing license      |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 19      | Shipment of reference standard             |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       | Sep-10 | Oct-10              | Nov-10 | Dec-10 |   |
| 1       | Availability of PO for 50 KgPBT2           |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 2       | Clorquinaddol import license               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 3       | RM procurement 50kg                        |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 4       | tech transfer                              |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 5       | GMP Document preparation and approval      |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 6       | RM analysis and release                    |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 7       | stage 1 analysis and release          |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 8       | stage 2 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 9       | stage 3 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 10      | stage 4 analysis  and release    |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 11      | stage 5 analysis and release               |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 12      | RC1 analysis and release                   |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 13      | RC2 analysis and release                   |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 14      | complete analysis                          |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 15      | Blending of 5 batches                      |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 16      | complete analysis                          |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 17      | Dispatch                                   |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 31      | Fun GMP Documentation                      |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| 32      | Manufacturing license                      |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   |                |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   | 1kg campaign        |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   |                |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   | 50 kg campaign      |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   |                |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   | Critical activities |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   |                |   |   |   |   |   |   |   |   |   |   |   |
|    |                                       |   | RM Procurement      |   |   |   |   |   |   |   |   |   |   |   |

----

|   | Test                        |   | Method              |   | Specification |
|--------|-----------------------------|--------|---------------------|--------|---------------|
|   |                        |   |                |   |          |   |
| 1.     | Description                 |   | Visual Inspection   |   |          | A while to light brown powder |
| 2.     | Identification              |   | I. FT-IR            |   |          | The Infrared spectrum of the sample matches that of the reference standard |
|   |                        |   | II. HPLC            |   |          | The retention time of the major peak in the sample chromatogram is within 0.2 minutes of the major peak in the standard chromatogram. |
| 3.     | Polymorphic Form            |   | SS-NMR              |   |          | SS-NMR consistent with the crystal structure of PBT2 form 1. |
| 4.     | Chloride Content            |   | titration           |   |          | Not less than 10.4 and not more than 12.7 % w/w |
| 5.     | Assay                       |   | HPLC                |   |          | 98.0%-102.0% on dried basis |
| 6.     | Related Substances by HPLC  |   | HPLC                |   | A)            | Specified IdentifiedDesmethyI-PBT2: Not more than 0.1%Quinoline diol: Not more than 0.1%Quinoline diacetate: Not more than 0.1 % |
|   |                        |   |                |   | B)            | Specified UnidentifiedRRT 1.15: Not more than 0.09%RRT 1.19: Not more than 0.09%RRT 1.45: Not more than 0.08% |
|   |                        |   |                |   | C)            | Major unspecified impurityNot more than 0.09% |
|   |                        |   |                |   | D)            | Total impuritiesReport result |
| 7.     | Related Substances by LC-MS |   | LC-MS               |   |          | Specified IdentifiedQuinoline N-oxide: Not more than 3 ppmQuinoline Chloride: Not more than 3 ppm |
| 8.     | Residue on Ignition         |   | GravimetricAnalysis |   |          | Not more than 0.1% |

----

|   | Test                |   | Method                              |   | Specification                                                      |
|--------|---------------------|--------|-------------------------------------|--------|--------------------------------------------------------------------|
|   |                |   |                                |   |                                                               |   |
| 9.     | Water Content       |   | Karl Fischer Titration              |   |                                                               | TBD (but should be NMT 0.5%) |
| 10.    | Microbial Limit     |   | Microbial Test                      |   | A)                                                                 | Total aerobic microbial count: Not more than 103 cfμ/g |
|   |                |   |                                |   | B)                                                                 | Total yeast and mold count: Not more than 102 cfμ/g |
|   |                |   |                                |   | C)                                                                 | E. coli: Absent/g |
|   |                |   |                                |   | D)                                                                 | Bacterial endotoxin: Not more than 30 Eu/mg |
| 11.    | Bacterial endotoxin |   | Limulus Amebocyte Lysate (LAL) Test |   |                                                               | Not more than 30 Eu/mg |
| 12.    | Heavy Metals        |   | Titration                           |   |                                                               | 20ppm |
| 13.    | Tungsten content    |   | ICP-OES                             |   |                                                               | Not more than 250ppm |
| 14.    | Residual solvents1  |   | GC                                  |   | A)                                                                 | Isopropyl alcohol: Not more than 5000 ppm |
|   |                |   |                                |   | B)                                                                 | 1,4 Dioxane: Not more than 380 ppm |
|   |                |   |                                |   | C)                                                                 | Pyridine: Not more than 200 ppm |
|   |                |   |                                |   | D)                                                                 | Toluene: Not more than 890 ppm |
|   |                |   |                                |   | E)                                                                 | Acetone: Not more than 5000 ppm |
|   |                |   |                                |   | F)                                                                 | Heptane: Not more than 5000 ppm |
|   |                |   |                                |   | G)                                                                 | Ethanol: Not more than 5000 ppm |
| 15.    | Particle Size       |   | TBD                                 |   | D(0,l)> 3μmD(0,5)≤ 75μmD(0,9)≤ 275μm |

----

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