----

----

| ARTICLE 1 DEFINITIONS AND      SCHEDULES                                                                                                                                    |   | 1                         |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------------------------|
|                                                                                                                                                                        |   |                      |
|     1.1          Definitions                                                                     |   |  1              |
|     1.2          Schedules                                                                       |   |  6              |
|                                                                                                                                                                        |   |                      |
| ARTICLE      2 THE SERVICES                                                                                                                                            |   |  6              |
|                                                                                                                                                                        |   |                      |
|     2.1          The      Services                                                               |   |        6   |
|     2.2          Service      Standard                                                           |   |  7              |
|     2.3          Quality      Assurance Agreement                                                |   |  7              |
|     2.4          Additional      Services                                                        |   |  7              |
|     2.5          Helix      Personnel on Site                                                    |   |  7              |
|     2.6          Dispute      Resolution                                                         |   |   8        |
|     2.7          Approval      of Subcontracting                                                 |   |  8              |
|                                                                                                                                                                        |   |                      |
| ARTICLE 3 PRICING AND      PAYMENT                                                                                                                                     |   | 8                         |
|                                                                                                                                                                        |   |                      |
|     3.1          Estimates                                                                       |   | 8                         |
|     3.2          Invoicing      and Payment                                                      |   | 8                         |
|     3.3          Capital      Requirements                                                       |   | 8                         |
|                                                                                                                                                                        |   |                      |
| ARTICLE 4      DELIVERIES                                                                                                                                              |   |  9              |
|                                                                                                                                                                        |   |                      |
|     4.1          Delivery      Responsibilities                                                  |   |  9              |
|                                                                                                                                                                        |   |                      |
| ARTICLE 5 COMPLIANCE      AUDITS                                                                                                                                       |   |  9              |
|                                                                                                                                                                        |   |                      |
|     5.1          Manufacturing      Audits                                                  |   |  9              |
|                                                                                                                                                                        |   |                      |
| ARTICLE 6 RECORDS AND      REGULATORY MATTERS                                                                                                                          |   |  9              |
|                                                                                                                                                                        |   |                      |
|     6.1          Permits                                                                         |   | 9                         |
|     6.2          Compliance      with cGMP                                                       |   | 9                         |
|     6.3          Access      to Records                                                          |   | 9                         |
|     6.4          Record      Maintenance                                                         |   | 10                   |
|     6.5          Accurate      Documentation                                                     |   | 10                   |
|     6.6          Claims      and Complaints                                                      |   | 10                   |
|     6.7          Regulatory      Communications and Correspondence                               |   | 10                   |
|     6.8          New      Regulatory Requirements                                                |   | 10                   |
|     6.9          Manufacturing      Records and Maintenance                                      |   | 10                   |
|     6.10        Cooperation      in Obtaining Government Approvals                                         |   | 10                   |
|     6.11        Ownership      of Regulatory Filings                                                       |   | 10                   |
|     6.12        Safety      and Efficacy Claims                                                            |   | 11                   |
|     6.13        Accident      Reports                                                                      |   | 11                   |
|                                                                                                                                                                        |   |                      |
| ARTICLE 7 QUALITY ASSURANCE;      QUALITY CONTROL; VALIDATION                                                                                                          |   | 11                   |
|                                                                                                                                                                        |   |                      |
|     7.1          Responsibility      for Quality Assurance and Quality Control                   |   | 11                   |
|     7.2          Validation      of CPL Facility; Utilities and Equipment                        |   | 11                   |
|                                                                                                                                                                        |   |                      |
| ARTICLE 8      NON-CONFORMANCE                                                                                                                                         |   | 11                   |
|                                                                                                                                                                        |   |                      |
|     8.1          Non-Conformance                                                                 |   | 11                   |
|     8.2          No      CPL Liability for Non-Conforming Product                                |   | 12                   |
|     8.3          CPL      Liability for Non-Conforming Product;    Replacement                   |   | 12                   |
|     8.4          Cooperation      in Investigations; Disposition of Non-Conforming      Product  |   | 12                   |
|     8.5          Third      Party / Arbitration                                                  |   | 12                   |
|                                                                                                                                                                        |   |                      |
| ARTICLE 9 LICENSE      GRANTS                                                                                                                                          |   | 13                   |
|                                                                                                                                                                        |   |                      |
|     9.1          Helix      Licenses to CPL                                                      |   | 13                   |
|     9.2          CPL      Licenses to Helix                                                      |   | 13                   |

----

|                                                                                                                                                                               |   |     |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------|
| ARTICLE 10 OWNERSHIP OF      INTELLECTUAL PROPERTY, MATERIALS AND      EQUIPMENT                                                                                              |   | 13       |
|                                                                                                                                                                               |   |     |
|     10.1          Intellectual      Property                                                            |   | 13  |
|     10.2          Confidential      Information                                                         |   | 13  |
|     10.3          Process      Improvements                                                             |   | 13  |
|     10.4          Product-Specific      Process Improvements                                            |   | 13  |
|     10.5          General      Process Improvements                                                     |   | 14  |
|     10.6          Helix      Materials                                                                  |   | 14  |
|     10.7          Helix      Equipment                                                                  |   | 14  |
|     10.8          CPL      Assistance                                                                   |   | 14  |
|     10.9          Limitation                                                                            |   | 14  |
|     10.10        CPL      Employee Agreements                                                                     |   | 14  |
|                                                                                                                                                                               |   |     |
| ARTICLE 11 CPL PRODUCT      WARRANTIES                                                                                                                                        |   | 15  |
|                                                                                                                                                                               |   |     |
|     11.1          Product      Warranties                                                               |   | 15  |
|     11.2          CPL      Facility                                                                     |   | 15  |
|                                                                                                                                                                               |   |     |
| ARTICLE 12 REPRESENTATIONS AND      WARRANTIES; COVENANTS                                                                                                                |   | 15  |
|                                                                                                                                                                               |   |     |
|     12.1          Mutual      Representations and Warranties                                            |   | 15  |
|     12.2          Representations      and Warranties of Helix                                          |   | 16  |
|     12.3          Representations      and Warranties of CPL                                            |   | 16  |
|     12.4          Additional      Covenants                                                             |   | 18  |
|                                                                                                                                                                               |   |     |
| ARTICLE 13      INDEMNIFICATION                                                                                                                                               |   | 18  |
|                                                                                                                                                                               |   |     |
|     13.1          Indemnification      By Helix                                                         |   | 18  |
|     13.2          Exception                                                                             |   | 18  |
|     13.3          Indemnification      By CPL                                                           |   | 18  |
|     13.4          Indemnification      Procedures                                                       |   | 19  |
|                                                                                                                                                                               |   |     |
| ARTICLE 14      INSURANCE                                                                                                                                                     |   | 19  |
|                                                                                                                                                                               |   |     |
|     14.1          CPL      Insurance                                                                    |   | 19  |
|     14.2          Helix      Insurance                                                                  |   | 20       |
|     14.3          Evidence      of Insurance                                                            |   | 20  |
|                                                                                                                                                                               |   |     |
| ARTICLE 15      CONFIDENTIALITY                                                                                                                                               |   | 20  |
|                                                                                                                                                                               |   |     |
|     15.1          CPL      Confidentiality Obligations                                                  |   | 20  |
|     15.2          Helix      Confidentiality Obligations                                                |   | 20  |
|     15.3          Responsibility      for Compliance with Confidentiality and Non-Use      Obligations  |   | 21  |
|     15.4          Terms      of Agreement                                                               |   | 21  |
|     15.5          Notification      of Mandatory Disclosure                                             |   | 21  |
|     15.6          No      Licenses                                                                      |   | 22  |
|     15.7          Equitable      Relief                                                                 |   | 22  |
|     15.8          Prior      Confidentiality Agreement                                                  |   | 22  |
|                                                                                                                                                                               |   |     |
| ARTICLE 16 PRESS RELEASES; USE      OF NAMES                                                                                                                                  |   | 22  |
|                                                                                                                                                                               |   |     |
|     16.1          Press      Releases                                                                   |   | 22  |
|     16.2          Use      of Names                                                                     |   | 22  |
|                                                                                                                                                                               |   |     |
| ARTICLE 17 TERMINATION &      CANCELLATION                                                                                                                                |   | 22  |
|                                                                                                                                                                               |   |     |
|     17.1          Termination                                                                           |   | 22       |
|     17.2          Consequences      of Termination                                                      |   | 24  |
|     17.3          Surviving      Rights                                                                 |   | 25  |
|     17.4          Cancellation      of Services                                                         |   | 25  |
|                                                                                                                                                                               |   |     |
| ARTICLE 18 FORCE      MAJEURE                                                                                                                                                 |   | 26  |
|                                                                                                                                                                               |   |     |
|     18.1          Effects      of Force Majeure                                                         |   | 26  |
|                                                                                                                                                                               |   |     |

----

|     18.2          Notice      of Force Majeure; Obligations of Parties During Force  Majeure      Event  |   | 26  |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------|
|     18.3          Termination                                                                                      |   | 26  |
|                                                                                                                                                                                          |   |     |
| ARTICLE 19 ASSIGNMENT;      TRANSFER                                                                                                                                                     |   | 26       |
|                                                                                                                                                                                          |   |     |
|     19.1          Assignment                                                                                       |   | 26  |
|                                                                                                                                                                                          |   |     |
| ARTICLE 20      MISCELLANEOUS                                                                                                                                                            |   | 27  |
|                                                                                                                                                                                          |   |     |
|     20.1         Notices                                                                                                |   | 27  |
|     20.2         Applicable      Law                                                                                    |   | 27  |
|     20.3         20.3      Headings                                                                                     |   | 27  |
|     20.4         Exhibits                                                                                               |   | 27  |
|     20.5         Severability                                                                                           |   | 27  |
|     20.6          Independent      Contractors                                                                     |   | 28  |
|     20.7          Waiver                                                                                           |   | 28  |
|     20.8          Counterparts                                                                                     |   | 28  |
|     20.9          Entirety;      Amendments                                                                        |   | 28  |
|     20.10        Preference                                                                                                  |   | 28  |
|     20.11        Limitation      on Damages                                                                                  |   | 28  |
|     20.12        Time                                                                                                        |   | 29  |

----

| 1.1                | Definitions |
|-----------------------------------------------------------------|-------------|

----

| (a)          | listing      the manufacturing date, unique Batch number, and quantity of Product in      such Batch, |
|-----------------------------|-------------------------------------------------------------------------------------------------------|

| (b)          | certifying      that such Batch was manufactured in accordance with the Master Formula,      the Master Packaging Formula / Procedure and  cGMP; |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|

| (c)          | certifying      that all required quality assurance investigations are completed and      listing the same; and |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------|

| (d)          | certifying      that the Batch meets all CPL Specifications and cGMP quality control      requirements. |
|-----------------------------|---------------------------------------------------------------------------------------------------------|

| (i)          | is      known publicly or hereafter becomes known publicly through no fault of      Helix, its Affiliates or agents; |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------|

| (ii)          | becomes      available to Helix from a Third Party which is not legally prohibited from      disclosing such information, provided such information was not acquired      directly or indirectly from Helix; |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)          | was      developed by Helix independently of information obtained from CPL as      evidenced by written records; |
|-------------------------------|------------------------------------------------------------------------------------------------------------------|

| (iv)          | was      already known to Helix before receipt from CPL, as shown by its prior      written records, provided that such information was not acquired directly      or indirectly from CPL; or |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (v)          | is      released with the prior written consent of CPL  hereunder. |
|-----------------------------|--------------------------------------------------------------------|

----

18.1

| (a)          | nation,      province, county, city, town, village, district or other jurisdiction of      any nature, |
|-----------------------------|--------------------------------------------------------------------------------------------------------|

| (b)          | federal,      provincial, local, municipal, foreign or other  government, |
|-----------------------------|---------------------------------------------------------------------------|

| (c)          | governmental      or quasi-governmental authority of any nature (including any governmental      agency, branch, department, official or entity and any court or other      tribunal, including an arbitral tribunal, such as EMEA and Health Canada      as are described in thisAgreement), |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (d)          | multi-national      organization or body, or |
|-----------------------------|----------------------------------------------|

| (e)          | body      exercising, or entitled to exercise, any administrative, executive,      judicial, legislative, police, regulatory or taxing power of any      nature. |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|

10.1

----

| (i)          | is      known publicly or hereafter becomes known publicly through no fault of      CPL, its Affiliates or agents; |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------|

| (ii)          | becomes      available to CPL from a Third Party which is not legally prohibited from      disclosing such information, provided such information was not acquired      directly or indirectly from CPL; |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)          | was      developed by CPL independently of information obtained from Helix as      evidenced by written records; |
|-------------------------------|------------------------------------------------------------------------------------------------------------------|

| (iv)          | was      already known to CPL before receipt from Helix, as shown by its prior      written records, provided that such information was not acquired directly      or indirectly from CPL; or |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (v)          | is      released with the prior written consent of Helix  hereunder. |
|-----------------------------|----------------------------------------------------------------------|

6.3

----

11.1
11.2

6.3

| (a)            | obtaining      and maintaining any and all permits, licenses, filings and certifications      required by the RegulatoryAuthorities, |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|

| (b)            | compliance      with the cGMP applicable to any manufacturing or processing activities      hereunder or the CPL Facility or other facilities at which any of the      Manufacturing Process is performed,and |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| (c)            | any      laws, rules, guidelines, regulations, guidance, points to consider      documents and standards of any Governmental Authority, that apply to the      activities to be carried out under the CPL Estimates or to the CPL      Facility or other facilities at which any of the Manufacturing Process is      performed. |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

2.1

| 1.2                | Schedules |
|-----------------------------------------------------------------|-----------|

| 2.1                | The      Services |
|-----------------------------------------------------------------|-------------------|

----

| (a)           | Initially      commence the necessary packaging line improvements, storage facility      preparations and equipment procurement, installation and qualification per      CPL Estimates #0542-5, 0542-6 and0542-7; |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)           | Thereafter,      produce a Small Scale Development (Placebo) Batch per CPL Estimate      #0542.  If necessary, Helix may require CPL to produce      successive additional Small Scale Development (Placebo) Batches per CPL      Estimate #0542 until Helix indicates that it is satisfied with the      resultant Product quality. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (c)           | Thereafter,      produce Small Scale Clinical Batches (Placebo), Small Scale Clinical      Batches (Active) per CPL Estimate #0542-1, 0542-2 and, if necessary, Stand      Alone Independent Active Batches per CPL Estimate 0542-3.  In      parallel with these activities, CPL shall develop and implement the      necessary cleaning validation processes per CPL Estimate      #0542-4.  The parties acknowledge that these batches are      intended to be used for clinical testing in humans, for which CPL may be      required to produce successive clinical batches per CPL Estimates #0542-1,      0542-2 and, if necessary, 0542-3 to support multiple clinical trials      and/or to furnish fresh Product through the course of any given trial      depending on Product expirationdates. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 2.2                | Service      Standard |
|-----------------------------------------------------------------|-----------------------|

| 2.3                | Quality Assurance      Agreement |
|-----------------------------------------------------------------|----------------------------------|

| 2.4                | Additional      Services |
|-----------------------------------------------------------------|--------------------------|

| 2.5                | Helix Personnel on      Site |
|-----------------------------------------------------------------|------------------------------|

----

| 2.6                | Dispute      Resolution. |
|-----------------------------------------------------------------|--------------------------|

2.6

| 2.7                | Approval of      Subcontracting  |
|-----------------------------------------------------------------|---------------------------------------|

| (i)   | fully      qualify each such Subcontractor, and Helix shall have the right to      participate in such qualificationprocess; |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|

| (ii)   | ensure      that all such qualified Subcontractors comply with the provisions of this      Agreement, including, but not limited to, the confidentiality provisions;      and |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)   | be      responsible for each such Subcontractors performance hereunder (including,      without limitation, any breach of this Agreement by such Subcontractor),      as if CPL were itself performing such  activities. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 3.1                | Estimates |
|-----------------------------------------------------------------|-----------|

3.3

| 3.2                | Invoicing and      Payment |
|-----------------------------------------------------------------|----------------------------|

| 3.3                | Capital      Requirements |
|-----------------------------------------------------------------|---------------------------|

10.7

----

| 4.1                |  Delivery      Responsibilities |
|-----------------------------------------------------------------|--------------------------------------|

| 5.1                | Manufacturing      Audits |
|-----------------------------------------------------------------|---------------------------|

| 6.1                | Permits |
|-----------------------------------------------------------------|---------|

| 6.2                | Compliance with      cGMP |
|-----------------------------------------------------------------|---------------------------|

5.1

| 6.3                | Access to      Records |
|-----------------------------------------------------------------|------------------------|

15.2

----

| 6.4                | Record      Maintenance |
|-----------------------------------------------------------------|-------------------------|

| 6.5                | Accurate      Documentation |
|-----------------------------------------------------------------|-----------------------------|

| 6.6                | Claims and      Complaints |
|-----------------------------------------------------------------|----------------------------|

11.1
11.2

| 6.7                | Regulatory      Communications andCorrespondence |
|-----------------------------------------------------------------|--------------------------------------------------|

| 6.8                | New Regulatory      Requirements |
|-----------------------------------------------------------------|----------------------------------|

| 6.9                | Manufacturing Records      and Maintenance |
|------------------------------------------------------------|--------------------------------------------|

| 6.10             | Cooperation in      Obtaining GovernmentApprovals |
|------------------------------------------------|---------------------------------------------------|

| 6.11             | Ownership of      Regulatory Filings |
|------------------------------------------------|--------------------------------------|

----

| 6.12             | Safety and Efficacy      Claims |
|------------------------------------------------|---------------------------------|

6.12
11.1
11.2

| 6.13             | Accident      Reports |
|------------------------------------------------|-----------------------|

| (a)            | accidents      resulting in significant personal injury requiring more than first aid      treatment, |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------|

| (b)            | accidents      resulting in chronic illness or loss of  consciousness, |
|-----------------------------------------|------------------------------------------------------------------------|

| (c)            | accidents      resulting in material propertydamage, |
|-----------------------------------------|------------------------------------------------------|

| (d)            | accidents      resulting in material environmental release,and |
|-----------------------------------------|----------------------------------------------------------------|

| (e)            | accidents      that result in regulatory, safety, health or environmental      audits. |
|-----------------------------------------|----------------------------------------------------------------------------------------|

| 7.1                | Responsibility for      Quality Assurance and QualityControl |
|-----------------------------------------------------------------|--------------------------------------------------------------|

| 7.2                | Validation of CPL      Facility; Utilities andEquipment |
|-----------------------------------------------------------------|---------------------------------------------------------|

| 8.1                | Non-Conformance |
|------------------------------------------------------------|-----------------|

11.1
11.2
11.1
11.2

----

| 8.2                | No CPL Liability for      Non-Conforming Product |
|-----------------------------------------------------------------|--------------------------------------------------|

11.1
11.2

| 8.3                | CPL Liability for      Non-Conforming Product;Replacement |
|-----------------------------------------------------------------|-----------------------------------------------------------|

11.1
11.2

| 8.4                | Cooperation in      Investigations; Disposition of Non-Conforming    Product |
|-----------------------------------------------------------------|------------------------------------------------------------------------------|

8.5

| (a)            | such      Non-Conforming Product shall not be used in humans,  and |
|-----------------------------------------|--------------------------------------------------------------------|

| (b)            | the      warranties provided in Sections 11.1      and 11.2 of this Agreement shall not      apply to such Non-ConformingProduct. |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|

8.3
8.2

| 8.5                | Third Party /      Arbitration |
|-----------------------------------------------------------------|--------------------------------|

8.1

----

| 9.1                | Helix Licenses to      CPL |
|-----------------------------------------------------------------|----------------------------|

ARTICLE17

| 9.2                | CPL Licenses to      Helix  |
|-----------------------------------------------------------------|----------------------------------|

| 10.1             | Intellectual      Property |
|------------------------------------------------|----------------------------|

10.4

| 10.2             | Confidential      Information |
|------------------------------------------------|-------------------------------|

| 10.3             | Process      Improvements |
|------------------------------------------------|---------------------------|

| 10.4             | Product-Specific      Process Improvements |
|------------------------------------------------|--------------------------------------------|

----

| 10.5             | General Process      Improvements |
|------------------------------------------------|-----------------------------------|

| 10.6             | Helix      Materials |
|------------------------------------------------|----------------------|

| 10.7             | Helix      Equipment |
|------------------------------------------------|----------------------|

| 10.8             | CPL      Assistance |
|------------------------------------------------|---------------------|

| 10.9             | Limitation |
|------------------------------------------------|------------|

10.4

| 10.10           | CPL Employee      Agreements |
|-------------------------------------|------------------------------|

----

| 11.1             | Product      Warranties |
|------------------------------------------------|-------------------------|

| (a)             | have      been manufactured, tested, stored, packaged, labeled and      controlled  in conformance with the CPL Specifications, the      Master Formula and the Master Packaging Formula /    Procedure; |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)             | have      been transferred to Helix with a Certificate of cGMP Compliance, which is      accurate and complete with respect to each  Batch; |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|

| (c)             | have      been manufactured, packaged, handled, stored and labeled in accordance      with cGMP and all applicable Regulatory  Requirements; |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|

| (d)             | not      be adulterated or misbranded by CPL within the meaning of the FD&C      Act; and |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------|

| (e)             | have      been transferred free and clear of any liens or encumbrances of any      kind. |
|-----------------------------------------------|------------------------------------------------------------------------------------------|

| 11.2             | CPL      Facility |
|------------------------------------------------|-------------------|

| 12.1             | Mutual Representations      and Warranties |
|------------------------------------------------|--------------------------------------------|

| (i)             | this      Agreement, as executed and delivered, constitutes the valid and binding      agreement of such Party, its successors and assigns, and is enforceable in      accordance with its terms; |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (ii)             | the      execution, delivery and performance of this Agreement does not conflict      with any agreement, instrument or understanding, oral or written, to which      such Party may be bound, nor violate any law or regulation of any court,      governmental body or administrative or other agency having jurisdiction      over it; and |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)             | it      has obtained all necessary authorizations and consents required to enter      into this Agreement and to perform its obligations    hereunder. |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| 12.2             | Representations and      Warranties of Helix |
|------------------------------------------------|----------------------------------------------|

| (a)             | To      the best of Helix's knowledge as of the Effective Date, after reasonable      inquiry, Helix is free to supply to CPL the Helix Confidential Information      and any other information supplied by Helix to  CPL; |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)             | To      the best of Helix's knowledge as of the Effective Date, after reasonable      inquiry, there is no lawsuit pending against Helix that alleges patent      infringement based on the manufacture, use or sale of the Product, and as      of the Effective Date, Helix has not received any written notice alleging      infringement of a Third Party Patent based on the manufacture, use or sale      of the Product; |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (c)             | To      the best of Helix's knowledge as of the Effective Date, after reasonably      inquiry, Helix's supply to CPL of the Helix Confidential Information and      any other information Helix intends to supply to CPL hereunder, and CPL's      use thereof in accordance with the terms of and in performance of its      obligations under this Agreement, does not infringe any intellectual      property rights of any Third Party for which Helix lacks the right to      grant CPL a valid sublicense to manufacture the  Product; |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (d)             | To      the best of Helix’s knowledge as of the Effective Date, after reasonably      inquiry, the Manufacturing Process for the Product in effect as of the      Effective Date does not infringe any intellectual property rights of any      Third Party for which Helix lacks the right to grant CPL a valid      sublicense to manufacture theProduct; |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (e)             | there      is no fact known to Helix which it has not disclosed to CPL or included in      its public documents filed on SEDAR at www.sedar.com      which  adversely affects, or which may adversely affect, the      assets, liabilities (contingent or otherwise), capital, affairs, business,      prospects, operations or condition (financial or otherwise) of Helix or      the ability of Helix to perform its obligations under this      Agreement; |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (f)             | To      the best of Helix’s knowledge as of the Effective Date, after reasonable      inquiry, Helix has made CPL aware of any known hazards involved in      handling the Helix Intellectual Property;and |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (g)             | Helix      has the financial capacity to enter into and carry out this entire      Agreement. |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------|

| 12.3             | Representations and      Warranties of CPL |
|------------------------------------------------|--------------------------------------------|

| (a)             | To      the best of CPL's knowledge, of the Effective Date, after reasonable      inquiry, CPL is free to supply CPL Confidential Information to Helix and      any other information supplied by Helix toCPL; |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)             | CPL      has the financial capacity to enter into and carry out this entire      Agreement; |
|-----------------------------------------------|---------------------------------------------------------------------------------------------|

| (c)             | CPL’s      employees are not unionized as at the date of this    Agreement; |
|-----------------------------------------------|-----------------------------------------------------------------------------------|

| (d)             | To      the best of CPL's knowledge after reasonable  inquiry, |
|-----------------------------------------------|----------------------------------------------------------------|

----

| (i)             | CPL      has the legal right to grant Helix the licenses set forth in Section 9.2 above; |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------|

| (ii)             | as      of the Effective Date, CPL has not entered into any obligation that would      prohibit CPL from granting the licenses set forth in Section 9.2      above, and CPL shall not enter into any obligation in the future that      would prohibit CPL from granting the licenses set forth in Section 9.2      above; |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)             | CPL      has not and will not use in any capacity the services of any persons      prohibited in any way in connection with its development or manufacture of      the Product; |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iv)             | neither      CPL nor any CPL official or employee has been convicted of a felony under      U.S. federal law for conduct relating to the development or approval,      including the process for development or approval, of any drug, product,      INDA, or any other drug product application;and |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (v)             | no      CPL official or employee has been convicted under Canadian law for conduct      otherwise relating to the regulation of any drug substance or drug      product; |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (vi)             | there      is no fact known to CPL which it has not disclosed to Helix      which  adversely affects, or which may adversely affect, the      assets, liabilities (contingent or otherwise), capital, affairs, business,      prospects, operations or condition (financial or otherwise) of CPL or the      ability of CPL to perform its obligations under this      Agreement; |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (vii)             | with      the exception of a disability discrimination complaint filed with the New      York State Division of Human Rights against which CPL is currently      defending, there are no legal or governmental actions, suits, proceedings      or investigations pending or, to the knowledge of CPL, threatened, to      which CPL is or may be a party or of which property owned or leased by CPL      is or may be the subject, or related to environmental or discrimination      matters.  Except to the extent the terms of a consent decree      dated 1995 (as amended) among the State of New York, the owner of the land      on which the CPL Facility is located and others relating to environmental      conditions on a portion of the premises are applicable to CPL or its      operations, CPL is not a party to or subject to the provisions of any      injunction, judgment, decree or order of any court, regulatory body,      administrative agency or other governmental body;  and |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (viii)             | CPL      is not in violation of or in default under, any lien, mortgage, lease,      agreement or instrument, including without limitation, its financial      arrangements with any Third Party. |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (e)             | CPL      has and will maintain in place all equipment, personnel, facilities, and      supply agreements necessary to perform its obligations      hereunder. |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| 12.4             | Additional      Covenants |
|------------------------------------------------|---------------------------|

| (a)             | Helix      shall comply with all applicable laws and regulations in the performance      of Helix's obligations under thisAgreement. |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|

| (b)             | CPL      shall comply with all applicable laws and regulations in the performance      of CPL's obligations under thisAgreement. |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|

| (c)             | Each      Party shall notify the other in writing immediately in the event that any      representation and warranty contained in this Agreement becomes      untrue. |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 13.1             | Indemnification By      Helix |
|------------------------------------------------|-------------------------------|

13.2

| (a)             | Helix's      breach of any of its representations, warranties or covenants contained in      this Agreement; or |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|

| (b)             | Helix's      negligent acts or omissions or willful  misconduct. |
|------------------------------------------|------------------------------------------------------------------|

| 13.2             | Exception |
|------------------------------------------------|-----------|

13.1

| (i)             | CPL's      breach of any of its representations, warranties, or covenants contained      in  this Agreement; or |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|

| (ii)             | CPL's      negligent acts or omissions or willful  misconduct. |
|------------------------------------------------|----------------------------------------------------------------|

| 13.3             | Indemnification By      CPL |
|------------------------------------------------|-----------------------------|

| (a)             | CPL's      breach of any of its representations, warranties or covenants contained in      this Agreement; or |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------|

| (b)             | CPL's      negligent acts or omissions or willful  misconduct. |
|-----------------------------------------------|----------------------------------------------------------------|

----

| (i)             | Helix's      breach of any of its representations, warranties or covenants contained in      this Agreement; or |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------|

| (ii)             | Helix's      negligent acts or omissions or willful  misconduct. |
|------------------------------------------------|------------------------------------------------------------------|

| 13.4             | Indemnification      Procedures |
|------------------------------------------------|---------------------------------|

| 14.1             | CPL      Insurance |
|------------------------------------------------|--------------------|

| (a)           | At      all times during the period in which CPL is making any of the      Products,  general liability insurance coverage in an amount not      less than USD $10,000,000 per occurrence (annual general aggregate of not      less than USD $10,000,000) covering bodily injury, broad-form property      insurance and including blanket contractual  coverage; |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)           | At      all times during the period in which CPL is making any of the Products      and, if the insurance is on a “claims made” basis, for a period of three      (3) years thereafter, products liability / completed operations hazard      insurance coverage in an amount not less than USD $10,000,000 per claim      (annual general aggregate of not less than USD $10,000,000) covering      bodily injury, broad-form property insurance and including blanket      contractual coverage. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| 14.2             | Helix      Insurance |
|------------------------------------------------|----------------------|

| (a)           | At      all times during the period in which CPL is making any of the Products,      general liability insurance coverage in an amount not less than CDN      $5,000,000 per occurrence (annual general aggregate of not less than CDN      $5,000,000) covering bodily injury, broad-form property insurance and      including blanket contractualcoverage; |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)           | At      all times during the period in which CPL is making any of the Products      and, if the insurance is on a “claims made” basis, for a period of three      (3) years thereafter, products liability / completed operations hazard      insurance coverage in an amount not less than CDN $5,000,000 per claim      (annual general aggregate of not less than CDN $5,000,000) covering bodily      injury, broad-form property insurance and including blanket contractual      coverage. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 14.3             | Evidence of      Insurance |
|------------------------------------------------|----------------------------|

| 15.1             | CPL Confidentiality      Obligations |
|------------------------------------------------|--------------------------------------|

| (i)           | its      employees or employees of its Affiliates who are bound by similar      obligations of confidentiality and non-use and who have a need to know      such information in order to perform their duties in carrying out CPL's      obligations under this Agreement; |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (ii)           | contractors      who are bound by similar obligations of confidentiality and non-use and      who have a need to know such information in order to provide direction to      CPL or Helix regarding their respective obligations under this Agreement;      or |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)           | Regulatory      Authorities, to the extent required by law or as necessary to perform the      Services. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------|

| 15.2             | Helix Confidentiality      Obligations |
|------------------------------------------------|----------------------------------------|

| (i)           | employees,      consultants, agents or contractors of Helix or Helix's Affiliates who are      bound by similar obligations of confidentiality and nonuse and who have a      need to know such information in order to perform their duties in carrying      out Helix's obligations under this Agreement, or in order to provide      direction to |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| (ii)           | Regulatory      Authorities, to the extent required by law or as Helix considers necessary      in connection with the development, manufacturing, distribution or sale of      the Product; or |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)           | to      Third Parties in accordance with the exercise of the licenses granted to      Helix under ARTICLE      9. |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------|

| 15.3             | Responsibility for      Compliance with Confidentiality and Non-Use    Obligations |
|------------------------------------------------|------------------------------------------------------------------------------------|

| 15.4             | Terms of      Agreement |
|------------------------------------------------|-------------------------|

| 15.5             | Notification of      Mandatory Disclosure |
|------------------------------------------------|-------------------------------------------|

| (a)          | Notification and      Consultation In the event that a Party (in such case, the Notifying      Party) believes it is required by applicable statute or regulation      (including the rules and regulations of any national stock exchange on      which such Party's securities are traded), or by judicial or      administrative process to disclose any part of the other Party's (in such      case, the Notified Party) Confidential Information which is disclosed to      it under this Agreement, the Notifying Party  shall: |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (i)          | promptly      notify the Notified Party of each such requirement and identify the      documents so required thereby, so that the Notified Party may seek an      appropriate protective order or other remedy or waive compliance by the      Notifying Party with the provisions of this Agreement,  and |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (ii)          | consult      with the Notified Party on the advisability of taking legally available      steps to resist or narrow the scope of such  requirement. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)          | Limited      Disclosure If, in the absence of such a protective order or such a      waiver by the Notified Party of the provisions of this Agreement, the      Notifying Party is nonetheless required by mandatory applicable law to      disclose any part of the Notified Party's Confidential Information which      is disclosed to it under this Agreement, the Notifying Party may disclose      such Confidential Information without liability under this Agreement,      except that the Notifying Party shall furnish only that portion of the      Confidential Information which is legally  required. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

ARTICLE9

| (i)           | the      other Party and their respective Affiliates would be irreparably injured      by a material breach of the confidentiality and nonuse provisions of this      Agreement by the breaching Party or by its employees or the employees of      its Affiliates, consultants, agents or  contractors, |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (ii)           | that      monetary remedies would be inadequate to protect the other Party against      any actual or threatened material breach of the provisions of      thisARTICLE      15 by the breaching Party or by its employees or the      employees of its Affiliates, consultants, agents or contractors,      and, |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)           | without      prejudice to any other rights and remedies otherwise available to the      other Party, the breaching Party agrees, upon proof of any such actual or      threatened material breach, to the granting of equitable relief, including      injunctive relief and specific performance, in the other Party's favor      without proof of actual damages. It is further understood and agreed that      no failure or delay by either Party in exercising any right, power or      privilege hereunder shall operate as a waiver thereof, nor shall any      single or partial exercise thereof preclude any other or further exercise      thereof or the exercise of any other right, power or privilege      hereunder. |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 16.1                 | Press      Releases |
|-------------------------------------------------------------------|---------------------|

| 16.2                 | Use of      Names |
|-------------------------------------------------------------------|-------------------|

| 17.1                 | Termination  |
|-------------------------------------------------------------------|-------------------|

----

| (a)           | At the Discretion of      Helix This Agreement may be terminated in its entirety by Helix      upon ninety (90) days written notice thereof to CPL at Helix’s sole      discretion.   |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)           |  CPL Material      Breach  This      Agreement may be terminated in its entirety by Helix upon written notice      thereof to CPL in the event of a material breach by CPL which, if capable      of being cured, is not cured within thirty (30) days after receipt of      written notice from Helix to CPL specifying in reasonable detail the      nature of such breach or, if such breach cannot be cured within such      30-day period but is capable of being cured within a reasonable time, if      CPL does not commence and diligently continue actions to cure such breach.      CPL shall not render any Services during such cure period other than those      which are necessary to cure such breach, provided that the breach is      capable of being cured within such cure period. In the event such breach      is not cured within such cure period, this Agreement shall terminate as      set forth in Helix's notice of breach and in accordance with the terms of      this ARTICLE      17; provided, however, that this Agreement shall not be      terminated prior to the end of such cure period.  Breach of any      of the provisions of ARTICLE      15 or the      Confidentiality Agreement referred to therein, or of any representation or      warranty of CPL contained herein, or any such representation or warranty      ceasing to be true, shall be deemed to constitute a material breach for      purposes of this ARTICLE      17 not capable of being cured, and accordingly, Helix may      terminate this Agreement immediately upon notice in any such      event. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (c)           | Helix Material      Breach  This Agreement may be terminated by CPL upon      written notice thereof to Helix in the event of a material breach by Helix      that is not cured within thirty (30) days after receipt of written notice      from CPL to Helix specifying in reasonable detail the nature of such      breach. In the event such breach is not cured within such cure period,      this Agreement shall terminate as set forth in CPL's notice of breach and      in accordance with the terms of this ARTICLE      17; provided, however, that this Agreement shall not be      terminated prior to the end of such cureperiod. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (d)           | Force      Majeure  A Party shall have the right to terminate this      Agreement, upon providing written notice thereof to the other Party, if,      as a result of a Force Majeure Event suffered by such other Party, (i)      such other Party is unable fully to perform its obligations under this      Agreement for any consecutive period of sixty (60) days; (ii) it is      reasonably foreseeable at the time notice of the Force Majeure Event is      given or is required to be given pursuant to Section 18.2      that such other Party will be unable fully to perform its obligations      under this Agreement for any consecutive period of sixty (60) days; or      (iii) it is reasonably uncertain, (such as in the case of a labour dispute      that could continue for an indeterminate amount of time) at the time      notice of the Force Majeure Event is given or is required to be given      pursuant to Section 18.2,      whether such other Party will be able to fully to perform its obligations      under this Agreement within the next following sixty (60)      days. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (e)           | Insolvency      Either Party may terminate this Agreement upon notice to the other      Party, |
|-----------------------------------|------------------------------------------------------------------------------------------------|

| (i)           | upon      the institution by or against that other Party of insolvency, receivership      or bankruptcy proceedings or any other proceedings for the settlement of      such Party's debts, which proceedings are not dismissed within sixty (60)      days, |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (ii)           | upon      that other Party making a general assignment for the benefit of      creditors,  taking the benefit of any statute for bankrupt or      insolvent debtors, making any proposal, assignment or arrangements with      its creditors, or taking any steps with |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| (iii)           | upon      that other Party's dissolution or cessation of  business. |
|-------------------------------------|---------------------------------------------------------------------|

| 17.2             | Consequences of      Termination |
|------------------------------------------------|----------------------------------|

| (a)           | Payment of Amounts Due        Expiration or termination of this Agreement for any      reason shall not exempt any Party from paying to any other Party any      amounts owing to such Party at the time of such expiration or      termination. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)           | Payment for Partial      Services Within 30 days of termination of this Agreement pursuant      to sections 17.1(a), (c), (d), or (e),      Helix shall pay CPL that portion of the price set forth in the relevant      Estimate(s) equal to the portion of Services provided up to the time of      such termination and not previously paid by Helix (excluding the cost of      Raw Materials which are dealt with separately in section 17.2(d)), provided that in no      event shall such proportionate price, plus the cost of any Raw Materials      purchased under section 17.2(d), exceed the full price set out in      the CPL Estimate(s) in respect of which such Services were      rendered. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (c)           | Cumulative      Remedies Except as expressly stated otherwise herein, a Party’s      right to terminate this Agreement, and any other remedies under this      Agreement, are cumulative, and nothing in this Agreement shall prevent any      Party, in the case of a breach (after expiration of any applicable cure      period and notice periods), from terminating this Agreement pursuant to      Section 17.1      and pursuing all other rights and remedies such Party may otherwise have      at law or in equity in respect of suchbreach. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (d)           | Raw Materials      Upon expiration of this Agreement or termination by Helix pursuant to      Section 17.1(b)(CPL      material breach) or 17.1(e)      (Insolvency of CPL) or Section 17.1(d)      (Force Majeure), Helix may elect (but shall have no obligation) to      purchase from CPL, at CPL's Actual & Reasonable acquisition cost plus      10%, all remaining usable Raw Materials acquired and paid for by CPL for      the manufacture of Product under this Agreement, and not previously paid      for by Helix, and which cannot be used for other CPL clients in full      within ninety (90) days.  Upon termination of this Agreement by      Helix pursuant to Section 17.1(a) (At the      Discretion of Helix) or by CPL pursuant to Section 17.1(c)      (Helix Material Breach) or 17.1(e)      (Helix Insolvency), Helix shall purchase from CPL, at CPL's Actual &      Reasonable acquisition cost plus 10%, all remaining Raw Materials acquired      and paid for by CPL, but not previously paid for by Helix or included in      the price payable by Helix under section 17.2(b), for the manufacture of Product      under this Agreement and which cannot be used for other CPL clients in      full within ninety (90) days, except as may be necessary for completion of      any portion of CPL's Services hereunder that are not immediately      terminated. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (e)           | Return of Materials      and of Helix Confidential Information; Transfer of Equipment Upon      expiration or termination of this Agreement, unless otherwise directed by      Helix, CPL shall promptly: |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (i)           | return      or, at Helix's election, destroy all quantities of the Product, with any      such destruction to be certified in writing to Helix by an authorized CPL      officer, |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

| (ii)           | return      all Helix Confidential Information to Helix, except for a single copy      and/or sample which may be retained for documentation purposes only and      which shall remain subject to the obligations of non-use and      confidentiality set forth in thisAgreement, |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iii)           | return      to Helix all retention and reserve samples being held by CPL, provided      that CPL may retain one set of such samples for documentation and      regulatory purposes only; |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (iv)           | deliver      to Helix all equipment in its possession which is the property of Helix      pursuant to this Agreement; and |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|

| (v)           | return      to Helix all interferon alpha-2b previously provided by Helix to      CPL. |
|-----------------------------------|----------------------------------------------------------------------------------------|

17.2
e)
17.1(b)

| (f)           | Return of CPL      Confidential Information Upon expiration or termination of this      Agreement, Helix shall promptly return all CPL Confidential Information to      CPL, except for a reasonable number of copies to be retained by Helix to      exercise its rights under this Agreement in relation to such CPL      Confidential Information, but which shall otherwise remain subject to the      obligations of non-use and confidentiality set forth in this      Agreement. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (g)           | Accrued Rights      Except as otherwise expressly set forth herein, any termination or      expiration of this Agreement shall be without prejudice to any right which      shall have accrued to the benefit of either Party and shall not relieve      either Party of any obligation which has accrued prior to the effective      date of such termination or expiration, which obligations shall remain in      full force and effect for the period provided therein or, if no period is      provided therein, then such obligations shall remain in full force and      effect indefinitely. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 17.3             | Surviving      Rights |
|------------------------------------------------|-----------------------|

| 17.4             | Cancellation of      Services |
|------------------------------------------------|-------------------------------|

----

| 18.1             | Effects of Force      Majeure |
|------------------------------------------------|-------------------------------|

| 18.2             | Notice of Force      Majeure;      Obligations of Parties During Force  Majeure      Event |
|------------------------------------------------|------------------------------------------------------------------------------------------------------|

| 18.3             | Termination |
|------------------------------------------------|-------------|

17.1(d)

| 19.1             | Assignment |
|------------------------------------------------|------------|

----

| 20.1             | Notices |
|------------------------------------------------|---------|

ARTICLE17

| 20.2             | Applicable      Law |
|------------------------------------------------|---------------------|

| 20.3             | 20.3           Headings |
|------------------------------------------------|--------------------------------------------------------------------------------|

| 20.4             | Exhibits |
|------------------------------------------------|----------|

| 20.5             | Severability |
|------------------------------------------------|--------------|

----

| (a)           | it      has no intention to violate any public policy, statutory or common laws,      rules, regulations, treaty or decision of any government agency or      executive body thereof of any country or community or association of      countries; |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| (b)           | that      if any word, sentence, paragraph, clause or combination thereof in this      Agreement is found by a court or executive body with judicial powers      having jurisdiction over this Agreement or any Party hereto, in a final      unappealed order, to be in violation of any such provisions in any country      or community or association of countries, such words, sentences,      paragraphs, clauses or combination shall be inoperative in such country or      community or association of countries and the remainder of this Agreement      shall remain binding upon the Parties, so long as enforcement of the      remainder does not violate the Parties overall intentions in this      transaction. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 20.6             | Independent      Contractors |
|------------------------------------------------|------------------------------|

| 20.7             | Waiver |
|------------------------------------------------|--------|

| 20.8             | Counterparts |
|------------------------------------------------|--------------|

| 20.9             | Entirety;      Amendments |
|------------------------------------------------|---------------------------|

| 20.10           | Preference |
|-------------------------------------|------------|

| 20.11           | Limitation on      Damages |
|-------------------------------------|----------------------------|

ARTICLE13
ARTICLE15

----

| 20.12           | Time |
|-------------------------------------|------|

| HELIX      BIOPHARMA CORP. |                                          | CONTRACT      PHARMACEUTICALS LIMITED NIAGARA |
|----------------------------|-----------------------------------------------|-----------------------------------------------|
|                       |                                          |                                          |   |   |
|                       |                                          |                                          |   |   |
| Per:                       | /s/      John Docherty                        |                                          | Per: | /s/      John Ross |
|                       | John      DochertyDirector      and President |                                          |   | John      RossGeneral      Manager, Niagara Operations |
| Per:                       |                                          |                                          | Per: | /s/      Paul Pickles |
|                       | [Name][Title]                                 |                                          |   | Paul      PicklesCEO |

----

----

|   | 1. | Small      Scale Developmental Batch (Placebo) |
|--------|----|------------------------------------------------|

| Estimate      # | Description                                                                                  | Price |
|-----------------|----------------------------------------------------------------------------------------------|-------|
| 0542            | Manufacture      and package one (1) 120 kgdevelopmental      placebo batch (without active) | ***   |

| 1.          | Placebo      batch size is 120 kg. |
|----------------------------|------------------------------------|

| 2.          | Cost      includes excipient raw material, applicator and foil lined      pouch. |
|----------------------------|----------------------------------------------------------------------------------|

| 3.          | Raw      materials will be tested by COA. |
|----------------------------|-------------------------------------------|

| 4.          | All      bulk and finished goods analytical testing to be conducted by PharmaDerm      Labs Ltd. |
|----------------------------|--------------------------------------------------------------------------------------------------|

| 5.          | Limited      bulk testing to include physicals for one sample per location from      top-middle-bottom of bulk batch. (See item 4  above) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

| 6.          | Includes      packaging product into approximately 5,000 vaginal applicators and pouches      for packaging equipmentqualification. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|

| 7.          | Limited      packaged testing to include physicals for one sample per location from      beginning-middle-end of packaging run. (See item 4  above) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

----

| 8.          | Includes      labor for manufacturing, packaging and related  activities. |
|----------------------------|---------------------------------------------------------------------------|

| 9.          | Includes      residual product disposal costs. |
|----------------------------|------------------------------------------------|

| 10.          | Product      not intended for commercialdistribution. |
|-----------------------------|-------------------------------------------------------|

|   | 2. | Small      Scale Clinical Batch (Placebo) |
|--------|----|-------------------------------------------|

| Estimate      #     | Description                                                                              | Price |
|---------------------|------------------------------------------------------------------------------------------|-------|
| 0542      – 1 | Manufacture      and package one (1) 120 kg clinical placebo batch (without      active) | ***   |

| 1.          | Placebo      batch size is 120 kg. |
|----------------------------|------------------------------------|

| 2.          | Cost      includes excipient raw material, applicator, foil lined pouch and      miscellaneous corrugate packagingcomponents. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------|

| 3.          | Clinical      labeling of product not included. |
|----------------------------|-------------------------------------------------|

| 4.          | Includes      full testing of excipient raw materials based on compendial      methods. |
|----------------------------|-----------------------------------------------------------------------------------------|

| 5.          | All      bulk and finished goods analytical testing to be conducted by PharmaDerm      Labs Ltd. |
|----------------------------|--------------------------------------------------------------------------------------------------|

| 6.          | Limited      bulk testing to include physicals for one sample per location from      top-middle-bottom of bulk batch. (See item 5  above) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

| 7.          | Includes      packaging product into approximately 25,000 vaginal applicators and      pouches for clinical supplystudies. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------|

| 8.          | Limited      packaged testing to include physicals for one sample per location from      beginning-middle-end of packaging run. (See item 5  above) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

| 9.          | Includes      labor for manufacturing, packaging and related  activities. |
|----------------------------|---------------------------------------------------------------------------|

| 10.          | Includes      residual product disposal costs. |
|-----------------------------|------------------------------------------------|

| 11.          | Product      not intended for commercialdistribution. |
|-----------------------------|-------------------------------------------------------|

| 12.          | Does      not include stability testing. |
|-----------------------------|------------------------------------------|

|   | 3. | Small      Scale Clinical Batch (Active) |
|--------|----|------------------------------------------|

| Estimate      # | Description                                                                               | Price |
|-----------------|-------------------------------------------------------------------------------------------|-------|
| 0542      - 2   | Manufacture      and package one (1) 120 kg batch (with active Interferon alpha      2-B) | ***   |

|  1.           | Active      batch size is 120 kg. |
|----------------------------------------|-----------------------------------|

| 2.           | Cost      includes excipient raw material, applicator, foil lined pouch and      miscellaneous corrugate packagingcomponents. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|

| 3.           | Clinical      labeling of product not included. |
|----------------------------------|-------------------------------------------------|

| 4.           | Includes      full testing of excipient raw materials based on compendial      methods. |
|----------------------------------|-----------------------------------------------------------------------------------------|

| 5.           | All      bulk and finished goods analytical testing to be conducted by PharmaDerm      Labs Ltd. |
|----------------------------------|--------------------------------------------------------------------------------------------------|

| 6.           | Approved      API will be provided at not cost to CPL by PharmaDerm Labs      Ltd. |
|----------------------------------|------------------------------------------------------------------------------------|

| 7.           | Limited      bulk testing to include physicals for one sample per location from      top-middle-bottom of bulk batch. (See item 5  above) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|

| 8.           | Includes      packaging product into approximately 25,000 vaginal applicators and      pouches for clinical supplystudies. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------|

| 9.           | Limited      packaged testing to include physicals for one sample per location from      beginning-middle-end of packaging run. (See item 5  above) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

| 10.           | Includes      labor for manufacturing, packaging and related  activities. |
|-----------------------------------|---------------------------------------------------------------------------|

----

| 11.           | Product      not intended for commercialdistribution. |
|-----------------------------------|-------------------------------------------------------|

| 12.           | Does      not include stability testing. |
|-----------------------------------|------------------------------------------|

|   | 4. | Stand      Alone Independent Active Batch |
|--------|----|-------------------------------------------|

| Estimate      #     | Description                                                                               | Price |
|---------------------|-------------------------------------------------------------------------------------------|-------|
| 0542      – 3 | Manufacture      and package one (1) 120 kg batch (with active Interferon alpha      2-B) | ***   |

| 1.          | PharmaDerm      RFQ indicates that multiple batches will be required throughout the course      of the pre-commercial phases. This particular estimate is based on      manufacturing and packaging one (1) stand alone batch with active with no      cost sharing with any previous or subsequent batches. This estimate model      has been selected since timing between batches is unknown and thus raw      material may exceed expirationdates. |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| 2.          | Active      batch size is 120 kg. |
|----------------------------|-----------------------------------|

| 3.          | Cost      includes excipient raw material, applicator, foil lined pouch and      miscellaneous corrugate packagingcomponents. |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------|

| 4.          | Clinical      labeling of product not included. |
|----------------------------|-------------------------------------------------|

| 5.          | Includes      full testing of excipient raw materials based on compendial      methods. |
|----------------------------|-----------------------------------------------------------------------------------------|

| 6.          | All      bulk and finished goods analytical testing to be conducted by PharmaDerm      Labs Ltd. |
|----------------------------|--------------------------------------------------------------------------------------------------|

| 7.          | Approved      API will be provided at no cost to CPL by PharmaDerm Labs    Ltd. |
|----------------------------|---------------------------------------------------------------------------------|

| 8.          | Includes      packaging product into approximately 25,000 vaginal applicators and      pouches for additional studies. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------|

| 9.          | Includes      labor for manufacturing and packaging  activities. |
|----------------------------|------------------------------------------------------------------|

| 10.          | Product      not intended for commercialdistribution. |
|-----------------------------|-------------------------------------------------------|

| 11.          | Does      not include stability testing. |
|-----------------------------|------------------------------------------|

|   | 5. | Cleaning      Validation |
|--------|----|--------------------------|

| Estimate            | Description                                     | Pricing |
|---------------------|-------------------------------------------------|---------|
| 0542      – 4 | Cleaning      Validation For Bulk and Packaging | ***     |
|                | Total                                           | ***     |

|   | 6. | Capital      Requirements |
|--------|----|---------------------------|

| Estimate      #     | Description                                                          | Pricing      Estimate |
|---------------------|----------------------------------------------------------------------|-----------------------|
| 0542      – 5 | Packaging      Line Equipment                                        | ***                   |
| 0542      – 6 | Raw      Material, Bulk and Packaged ProductStorage      Preparation | ***                   |
| 0542      – 7 | Bulk      Equipment and Support                                      | ***                   |
|                | Total                                                                | ***                   |

----

|   | 0542-6: | Pre-commercial      Packaging Line Equipment includes filler product contact change parts,      associated filler process piping, applicator transfer pucks and stainless      steel Muller product transferdrums. |
|--------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | 0542-6: | Pre-commercial      Raw Material, Bulk and Package Product Storage Preparation includes      retro-fitting CPL’s existing 2C – 8C Refrigerator and -80C Freezer with      appropriate instrumentation and back-up systems to provide exposure      protection for the drug substance and drug  product. |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

|   | 0542-7: | Pre-commercial      Bulk Manufacturing Equipment includes but is not limited to: Bulk mixing      tank, chiller system, heating system and installation and      qualification. |
|--------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

----

----

----

|        AREA OF RESPONSIBILITY                                                                                                                                                                                                                                 | CPL    | PDL    |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------|
| Raw      Materials:                                                                                                                                                                                                                                                |   |   |
| · Establish      & approve specifications (grade, testing parameters, acceptance      criteria)                                                                                                                                                      |   | X      |
| · Prepare      CPL raw material specifications (grade, testing parameters, acceptance      criteria) based on PDL requirements                                                                                                                           | X      |   |
| · Vendor      Selection                                                                                                                                                                                                                                  | X      | X      |
| · Vendor      Approval                                                                                                                                                                                                                                   |   | X      |
| · Procurement      of excipient raw materials (inactive ingredients)                                                                                                                                                                                     | X      |   |
| · Procurement      of active raw materials                                                                                                                                                                                                               |   | X      |
| · Inspection,      testing documents, testing & release/rejection of excipients (inactive      ingredients). (See Appendix III)                                                                                                                      | X      |   |
| · Inspection,      testing documents, testing & release/rejection of active (See Appendix      III)                                                                                                                                                  | X      | X      |
| · Retention      of excipient raw material samples                                                                                                                                                                                                       | X      |   |
| · Retention      of active raw material samples                                                                                                                                                                                                          | X      |   |
| Lab      Testing:                                                                                                                                                                                                                                                  |   |   |
| · Selection      of lab for testing of raw materials, bulk product & finished      product                                                                                                                                                           | X      | X      |
| · Approval      of Lab                                                                                                                                                                                                                                   |   | X      |
| · Test      method transfer execution – raw materials, bulk & finished product      analytical methodology                                                                                                                                     | X      | X      |
| · Review      & approve test method transfer data for unique raw materials, bulk      & finished product                                                                                                                                         |   | X      |
| Stability:                                                                                                                                                                                                                                                         |   |   |
| · Overall      responsibility for ensuring stability programs comply with applicable      regulatory guidance & product filings. Including the          suitability of the expiry period to the formulation and packaging      system |   | X      |

----

|                                  AREA OF RESPONSIBILITY |  CPL |  PDL |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|
| · Generate      stability protocol                                                                                                                                                                                 |      | X         |
| · Approve      stability protocol                                                                                                                                                                                  | X         | X         |
| · Execute      stability protocol                                                                                                                                                                                  | X         | X         |
| · Review      stability results                                                                                                                                                                                    |      | X         |
| · Trend      stability data                                                                                                                                                                                        |      | X         |
| Packaging      Materials:                                                                                                                                                                                                    |      |      |
| · Artwork      development, review, approval & distribution                                                                                                                                                    |      | X         |
| · Establish      & approve specifications (testing parameters, acceptance      criteria)                                                                                                                       |      | X         |
| · Prepare      CPL packaging materials specifications (testing parameters, acceptance      criteria) based on PDL requirements                                                                                     | X         |      |
| · Vendor      Selection                                                                                                                                                                                            | X         | X         |
| · Vendor      Approval                                                                                                                                                                                             |      | X         |
| · Packaging      materials procurement                                                                                                                                                                             | X         |      |
| · Inspection,      inspection documents, testing & release/rejection of packaging      materials                                                                                                               | X         |      |
| Manufacturing:                                                                                                                                                                                                               |      |      |
| Master      Formula                                                                                                                                                                                                          |      | X         |
| Master      manufacturing work order preparation                                                                                                                                                                             | X         |      |
| Master      manufacturing work order approval                                                                                                                                                                                | X         | X         |
| Manufacturing      of bulk products per approved product Master Formula and      procedures                                                                                                                                  | X         |      |
| Control,      review and communicate minor deviation to PDL                                                                                                                                                                  | X         |      |
| Control,      review & approve major process deviations                                                                                                                                                                  | X         | X         |
| Establish      & approve bulk product specifications (testing parameters, acceptance      criteria)                                                                                                                      |      | X         |
| Prepare      CPL bulk product specifications (grade, testing parameters, acceptance      criteria) based on PDL requirements                                                                                                 | X         |      |
| Bulk      product test method validation                                                                                                                                                                                     |      | X         |
| Provide      bulk product sampling plan                                                                                                                                                                                      |      | X         |
| Bulk      product sampling                                                                                                                                                                                                   | X         |      |
| Bulk      product testing as per approved specification (See Appendix      III)                                                                                                                                              | X         | X         |
| Review      of manufacturing batch documents                                                                                                                                                                                 | X         | X         |
| Release/rejection      of bulk product for filling and packaging at CPL                                                                                                                                                      | X         |      |
| Packaging:                                                                                                                                                                                                                   |      |      |
| Master      Packaging Formula / Procedure                                                                                                                                                                                    |      | X         |
| Master      packaging work order preparation                                                                                                                                                                                 | X         |      |
| Master      packaging work order approval                                                                                                                                                                                    | X         | X         |
| Allocation      method of lot number of the products                                                                                                                                                                         | X         |      |

----

|                                  AREA      OF RESPONSIBILITY | CPL    |  PDL |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------|
| Allocation      method of expiry date of the products                                                                                                                                                                             |   | X         |
| Filling      and packaging of released bulk products per approved packaging work      orders                                                                                                                                      | X      |      |
| Packaging      in-process line inspection and sampling                                                                                                                                                                            | X      |      |
| Establish      & approve finished product specifications (testing parameters,      acceptance criteria)                                                                                                                       |   | X         |
| Prepare      CPL finished product specifications (grade, testing parameters, acceptance      criteria) based on PDL requirements                                                                                                  | X      |      |
| Finished      product test method validation                                                                                                                                                                                      |   | X         |
| Provide      finished product sampling plan                                                                                                                                                                                       |   | X         |
| Finished      product sampling                                                                                                                                                                                                    | X      |      |
| Finished      product testing as per approved specification (See Appendix      III)                                                                                                                                               | X      | X         |
| Review      of packaging batch documents                                                                                                                                                                                          | X      | X         |
| Preparation      of Certificate of cGMP Compliance                                                                                                                                                                                | X      |      |
| Release      of finished product for clinical packaging                                                                                                                                                                           |   | X         |
| Control,      review and communicate minor deviation to PDL                                                                                                                                                                       | X      |      |
| Control,      review & approve major process deviations                                                                                                                                                                       | X      | X         |
| Validation:                                                                                                                                                                                                                       |   |      |
| Premises      validation                                                                                                                                                                                                          | X      |      |
| Equipment      validation                                                                                                                                                                                                         | X      |      |
| Preparation      and approval of cleaning procedures                                                                                                                                                                              | X      |      |
| Cleaning      validation – residual detergent                                                                                                                                                                               | X      |      |
| Cleaning      validation – residual API (CPL swab, PDL test)                                                                                                                                                                | X      | X         |
| Test Method Validation:      overall responsibility for ensuring the test method validation complies      with applicable regulatory guidance & product filing as the product      registration holder                        |   | X         |
| Protocal      development                                                                                                                                                                                                         | X      |      |
| Protocol      approval                                                                                                                                                                                                            | X      | X         |
| Execution      of strategy & sampling plan & testing (See App.    III)                                                                                                                                                    | X      | X         |
| Summary      report development                                                                                                                                                                                                   | X      |      |
| Summary      report approval                                                                                                                                                                                                      | X      | X         |
| Manufacturing process      validation: overall responsibility for ensuring the validation      program complies with applicable regulatory guidance & product filings      as the product registration holder                 |   | X         |
| · Protocol      development                                                                                                                                                                                             | X      |      |
| · Protocol      approval                                                                                                                                                                                                | X      | X         |
| · Execution      of strategy & sampling plan                                                                                                                                                                        | X      | X         |
| · Summary      report development                                                                                                                                                                                       | X      |      |
| · Summary      report approval                                                                                                                                                                                          | X      | X         |
| Packaging process      validation: overall responsibility for ensuring the validation      program complies with applicable regulatory guidance & product filings      as the product registration holder                     |   | X         |

----

|                                  AREA      OF RESPONSIBILITY | CPL    | PDL    |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------|
| · Protocol      development                                                                                                                                                                                             | X      |   |
| · Protocol      approval                                                                                                                                                                                                | X      | X      |
| · Execution      of strategy & sampling plan                                                                                                                                                                        | X      |   |
| · Summary      report development                                                                                                                                                                                       | X      |   |
| · Summary      report approval                                                                                                                                                                                          | X      | X      |
| Shipping:                                                                                                                                                                                                                         |   |   |
| Notification      of special storage conditions for intermediate materials and/or finished      product (Shipping specifications and instructions)                                                                                |   | X      |
| Release/rejection      of finished goods for shipping to sponsor/customer                                                                                                                                                         | X      | X      |
| Selection      of carrier for shipping and shipping conditions                                                                                                                                                                    |   | X      |
| Preparation      of shipping documents                                                                                                                                                                                            | X      |   |
| Arrangement      of shipping details (e.g. pick up)                                                                                                                                                                               | X      |   |
| Transmittal      of complete production batch documents                                                                                                                                                                           | X      |   |
| OOS      Investigations (Bulk/FP/Stability):                                                                                                                                                                                      |   |   |
| Out      of specification investigation – phase I (to be conducted exclusively by      the lab performing the applicable testing – See Appendix    III)                                                               | X      |   |
| Out      of specification investigation – phase II (re-sampling /      re-testing)                                                                                                                                          | X      | X      |
| Out      of specification approval / rejection                                                                                                                                                                                    |   | X      |
| Clinical      Product Release & Recall:                                                                                                                                                                                       |   |   |
| Release      of finished product for clinical distribution                                                                                                                                                                        |   | X      |
| Product      Recall                                                                                                                                                                                                               |   | X      |
| Participate      in product recall investigations                                                                                                                                                                                 | X      | X      |
| Retains:                                                                                                                                                                                                                          |   |   |
| Retention      of regulatory retain finished product samples                                                                                                                                                                      |   | X      |
| Retention      of finished product samples for investigational purposes                                                                                                                                                           | X      |   |
| Retention      of batch documents for at least 12 months after the expiry      date.  Notify PDL prior to destruction of batch      documents.                                                                          | X      |   |
| Investigation      of clinical complaints with respect to the following:                                                                                                                                                          |   |   |
| · Manufacturing                                                                                                                                                                                                         | X      | X      |
| · Packaging                                                                                                                                                                                                             | X      | X      |
| · Testing,      documentation and results                                                                                                                                                                               | X      | X      |
| · Effectiveness      of Product                                                                                                                                                                                         |   | X      |
| · Adverse      effects                                                                                                                                                                                                  |   | X      |
| · Reply      to complainant                                                                                                                                                                                             |   | X      |
| Change      Control:                                                                                                                                                                                                              |   |   |
| Notification      of all changes to product & process (e.g. changes in raw/packaging      materials, manufacturing processes, test methods, etc.)                                                                             | X      | X      |
| Update      of relevant documents affected by changes                                                                                                                                                                             | X      | X      |
| Audits:                                                                                                                                                                                                                           |   |   |
| Audit      of CPL facilities                                                                                                                                                                                                      | X      | X      |

----

----

| TBD | Interferon      Alpha 2-b Cream             |
|-----|---------------------------------------------|
| TBD | Placebo      for Interferon Alpha 2-b Cream |

----

| CPL      NIAGARA                                                                                                                                             | PDL                                                                                                                                                                               |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beverly      PaulyManager,      Quality AssuranceT]      (716) 887-3727F]      (716)  887-7713E] bpauly@cplltd.com                            | Praveen      KumarV.P.      & Head of Product DevelopmentT]      (306) 934 7471 ext 230F]      (306) 934 7453E]      pkumar@pharmadermlabs.com                                |
| Mike      McCormickAssociate      Manager, Product QualityT]      (716) 887-3727F]      (716)  887-7713E] mmccormick@cplltd.com                    | Kim      GasparManager,      Quality AssuranceT]      (306) 934 7471 ext 237F]      (306) 934 7453E]      kgaspar@pharmadermlabs.com                                              |
| Cathy      HowardManager,      Quality Technical ServicesT]      (716) 887-3580F]      (716)  887-3441E] choward@cplltd.com                   | Geriene      LaBineQuality      Control-in-charge & Group Leader, AnalyticalT]      (306) 934 7471 ext 227F]      (306) 934 7453E]      glabine@pharmadermlabs.com            |
| Stephen      PanaroSenior      Manager, Lab OperationsT]      (716) 887-7640F]      (716)  887-3441E] spanaro@cplltd.com                      | Ravinderjit      BattaStability      coordinator & Group Leader,Product      DevelopmentT]      (306) 934 7471 ext 239F]      (306) 934 7453E]      rbatta@pharmadermlabs.com |
| Kim      JordanDirector,      Customer Service, Purchasing & New Product TransferT]      (716) 887-7613F]      (716) 887-3733E] kjordan@cplltd.com  |                                                                                                                                                                              |

----

| Ingredient          | Grade  | Testing      Requirements                                               | Notes                                         |
|---------------------|--------|-------------------------------------------------------------------------|-----------------------------------------------|
| ***                 |   | COA      review only (CPL)                                              | Helix      will provideAPI      pre-approved  |
| ***                 | USP/NF | COA      review & ID only (CPL)or      full monograph asappropriate | New      raw material                         |
| ***                 | NF     | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 | NF     | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 | NF     | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 | USP    | COA      review & ID only (CPL)or      full monograph asappropriate | New      raw material                         |
| ***                 | USP    | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 |   | COA      review & ID only (CPL)or      full monograph asappropriate | New      raw material                         |
| ***                 | USP    | USP                                                                     | CPL      USP Water                            |
| ***                 | NF     | COA      review & ID only (CPL)or      full monograph asappropriate | New      raw material                         |
| ***                 | EP     | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 | NF     | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 | NF     | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 |   | COA      review & ID only (CPL)or      full monograph asappropriate | New      raw material                         |
| ***                 | NF     | COA      review & ID only (CPL)or      full monograph asappropriate | New      raw material                         |
| ***                 | USP    | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| ***                 | USP    | COA      review & ID only (CPL)or      full monograph asappropriate | New      raw material                         |
| ***                 | NF     | COA      review & ID only (CPL)                                     | Existing      material@      CPL              |
| Test      Parameter |   | Testing      responsibility                                             | Notes                                         |
| ***                 | n/a    | Primary      – HelixSecondary      – CPL                    | Primary      testing willbe      performed by |

----

|      |   |                                                 | Helix.      CPL may be asked to perform limited physical testing                                                          |
|-----------|--------|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| ***       | n/a    | Primary      – HelixSecondary      – CPL | Primary      testing willbe      performed byHelix.  CPL      may be asked to perform limited physical testing. |
| ***       | n/a    | To      Be Determined                                |                                                                                                                      |
| Component |   | Test      Responsibility                             | Notes                                                                                                                     |
| ***       | n/a    | CPL      – COA & Spec                      |                                                                                                                      |
| ***       | n/a    | CPL      – COA & Spec                      |                                                                                                                      |

----

| Activity      (Task)                                              | Start | Completion |
|-------------------------------------------------------------------|-------|------------|
| Initial      Kick-Off Team Meeting and Process Design Discussions | ***   | ***        |
| Tank      Drawing and Specification                               | ***   | ***        |
| Tank      Drawing Review, Comment and Revise                      | ***   | ***        |
| Tank      Drawings Approved                                       | ***   | ***        |
| Tank      Fabrication Process                                     | ***   | ***        |
| Tank      Delivery To CPL                                         | ***   | ***        |
| Uncrate      and Install                                          | ***   | ***        |
| IQOQPQ      and DOE Placebo Batch                                 | ***   | ***        |
| 1stPlacebo      Manufacturing Batch and Analytical Testing        | ***   | ***        |
| 1stPlacebo Packaging      Operation and Analytical Testing        | ***   | ***        |
| 1stActive      Manufacturing Batch and Analytical Testing         | ***   | ***        |
| 1stActive Packaging      Operation and Analytical Testing         | ***   | ***        |
| Stability      Starts – Ends                                | ***   | ***        |

| -          | Microfluidizer      and associated installation and qualification  tasks. |
|---------------------------|---------------------------------------------------------------------------|

| -          | Filler      change parts and drum emptying system and associated installation and      qualification tasks up to and including packaging line    trials. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|