Exhibit 10.13.5
                                                                 ---------------

                                QUALITY AGREEMENT

                                     between

                               INyX PHARMA LIMITED

                                       and

                            STIEFEL LABORATORIES INC.







Date:                               March 6, 2003

For INyX Pharma Limited             /S/ Colin Hunter
                                    Position:  Director

For Stiefel Laboratories Inc.       /S/ Tessie L. Brunker
                                    Position:  Vice President, CFO and Treasurer



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                                Table of Contents

                                                                            Page
                                                                            ----


1.0   General Quality Policies.................................................4

2.0   Documentation Practices..................................................5
      2.1     Regulatory Filings...............................................5
      2.2     Technology Transfer..............................................5
      2.3     Controlled Documents.............................................5
      2.4     Change Control...................................................6
      2.5     Deviations, Non-Conformances, and Failure Investigations.........7
      2.6     Document Retention...............................................8
      2.7     Customer Complaints..............................................8
      2.8     Annual Product Review............................................9
      2.9     Annual Reports...................................................9
      2.10    Training.........................................................9

3.0   Manufacturing Standards.................................................10
      3.1     Facilities......................................................10
      3.2     Equipment.......................................................10
      3.3     Material Control................................................10
      3.4     Manufacturing / Cleaning........................................11

4.0   Inspection and Testing Requirements.....................................11
      4.1     Inspection......................................................11
      4.2     Quality Control Testing.........................................12
      4.3     Stability Program...............................................12

5.0   Audits  13
      5.1     External Audits.................................................13
      5.2     Internal Audits.................................................13
      5.3     Vendor/Supplier Qualification Program...........................13

6.0   Product Release.........................................................14
      6.1     Batch Manufacturing Record......................................14
      6.2     Analytical Results..............................................14
      6.3     Certificate of Analysis and Certificate of Conformance..........14
      6.4     Reserve Samples.................................................14
      6.5     Release Authorization and Shipping..............................15




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                                  INTRODUCTION

         As a  condition  of  business,  Stiefel  Laboratories  Inc (a New  York
corporation with its principal place of business at 255 Alhambra  Circle,  Coral
Gables,  Florida 33134) requires that all Products be manufactured in accordance
with all appropriate current Good Manufacturing  Practices (cGMP's) as described
in 21CFR part 211 and other pertinent regulatory authority requirements) and all
applicable international, federal, state and local regulations.

         This Quality and Technical  Agreement between Stiefel  Laboratories Inc
("Stiefel")  and INyX Pharma  Limited  ("INyX")  (located  at Runcorn,  England)
defines  Quality  responsibilities  as they are related to the  formulation  and
filling/packaging  of  Stiefel  Products  in  accordance  with the terms of that
certain  Supply  Agreement,  as  amended,  which  currently  exists  between the
parties.  This  Agreement  shall be effective  Tuesday,  March 6th, 2003. In the
event of any  conflict  between the  interpretation  of this  Agreement  and the
interpretation of the Supply Agreement (as it may be amended from time to time),
the terms of the Supply  Agreement shall govern all aspects of the  relationship
between the Parties  except that this  Agreement  shall  govern with  respect to
quality matters.

         A Generalized  Process and Control Flow Diagram  describing the general
flow of Product  through the INyX  facilities  is enclosed as Schedule A to this
Agreement.

         Changes to this Agreement may be made solely by an amendment in writing
signed by both parties.



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                                   DEFINITIONS

         All  capitalized  terms  herein  shall  have the same  meanings  as are
ascribed to such terms in the Supply Agreement, unless otherwise defined herein.

         For the purposes of this Agreement,  the following terms shall have the
meanings set forth below:

         "Annual  Product  Review":  The  review of  manufacturing  and  control
activities to be undertaken on an annual basis as defined by 21 CFR Part 211.

         "Active  Ingredient":  Any component of the Product that is intended to
furnish pharmacological activity or other direct effect in the diagnosis,  cure,
mitigation,  treatment,  or prevention of disease, or to affect the structure or
any function of the body of man or animals,  but does not include  intermediates
used in the synthesis of such ingredients.

         "Batch  Record":  An accurate  reproduction of the Product Master Batch
Record, checked for accuracy, dated and signed by INyX.

         "Batch or Production  Lot": A specific  quantity of Active  Ingredient,
excipients, and components processed in accordance with the Product Master Batch
Record and identified by a distinctive lot number.

         "Bulk  Product":  A drug  Product  that has been  manufactured  but not
filled or packaged into a final dosage presentation.

         "C of A" or "Certificate of Analysis": A summary of the quality control
testing,  as  described  in the  Specifications,  performed by INyX for Finished
Product supplied under this Agreement.

         "C of C" or "Certificate of Conformance":  A written certificate issued
by INyX  stating that the final  Finished  Product has been  manufactured  under
appropriate   cGMP   requirements   and  that  no   outstanding   deviations  or
non-conformances remain unresolved.

         "cGMPs": The current Good Manufacturing  Practices of FDA, as set forth
in Title 21 of the U.S. Code of Federal Regulations, Part 211.

         "CMC":  The Chemistry, Manufacturing and Controls section of an NDA.

         "Change":  A  planned,   permanent  alteration  or  replacement  of  an
established  or  validated  specification,  process,  existing  equipment  type,
service, or facility used in the manufacture of bulk or finished Product.

         "Stiefel  Quality  Assurance":  The  Quality  Assurance  department  of
Stiefel.

         "Date of  Manufacture":  Date of introduction of the Active  Ingredient
into the manufacturing process.

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         "DMF" The Drug  Master  File for a  Product,  as filed by Miza with the
FDA.

         "Excipient":  Any substance other than the Active Ingredient present in
the Product.

         "FDA":  The  Food and  Drug  Administration  of the  United  States  of
America.

         "FDA483":  Any FDA Form 483 to  review  observational  findings  by FDA
delivered following the inspection by the FDA.

         "Finished  Product":   The  finished  dosage  form  that  contains  the
ingredients and packaging components as specified by the Master Batch Record.

         "IND": An  Investigational  New Drug Application for a Stiefel Product,
as filled by Stiefel with the FDA.

         "Manufacturing  and  Supply  Agreement":  Agreement  between  INyX  and
Stiefel Labs for the Commercial manufacture of the Products in Exhibit A.

         "Master Production  Record": A written document,  approved by both INyX
and  Stiefel QA,  which  stipulates  the unique  Product  formula  and  provides
detailed  instruction for the manufacture,  filling, and packaging of individual
Products.

         "NDA":  A New  Drug  Application  for a  Stiefel  Product,  as filed by
Stiefel with, and approved by, the FDA.

         "Non-Conformance":  A departure from an established  quality  standard.
For the purposes of this Agreement,  an "established  quality standard" includes
any GMP Standard Operating Procedure, manufacturing work order, packaging order,
raw  material or Product  specification,  analytical  control  procedure,  water
monitoring  procedure,  and/or equipment  maintenance  schedule,  or any unusual
occurrence   as  may   be   defined   in   INyX   non-conformance   procedures).
Non-conformances  may be either  anticipated or  unanticipated  departures  from
established  quality  standards;  may have the  potential  to affect the safety,
identity, strength, quality or purity of a bulk or Finished Product.

         "OOS": Out of Specification

         "Product  Master Batch  Record":  The signed master copy of the Product
Batch Record.

         "Primary Packaging  Component":  That portion of the  container/closure
system which is in direct contact with the Product at all times,  as well as all
other container materials which could reasonably affect the identity,  strength,
quality or purity of the Drug Product during its shelf life.

         "Product Batch Record File":  The compilation of  batch-specific  batch
records,  test and inspection reports,  non-conformance and deviation files, and
other  associated  records that fully describe the  manufacture and testing of a
single lot of Product.

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         "Product(s)":  means  the  Products  described  on  Exhibit  A  to  the
Manufacturing  and  Supply  Agreement  between  INyX and  Stiefel,  as it may be
amended from time to time, and which is incorporated by this reference as though
fully set forth in this paragraph.

         "Quarantine   Shipment   Authorization":    A   written   request   and
authorization from Stiefel QA for INyX to prepare and ship a lot of Product that
has been completed, tested, and internally reviewed by INyX QA.

         "Regulatory  Authority":  means  the MCA / FDA and  any  equivalent  or
additional  governmental  or regulatory  agencies  having  authority  over INyX,
INyX's  facilities,  or the Products  including,  but not limited to, the MCA in
Europe and the U.S. Drug Enforcement Agency.

         "Release Memo": Stiefel final release authorization prepared, approved,
and issued by Stiefel  QA after  review of all  relevant  batch  Production  and
testing records.

         "SOP" or "Standard Operating Procedure":  Written document, approved by
QA, which provides instruction on performing tasks essential to the operation of
a facility or process.

         "USP":  The most current  edition of the United  States  Pharmacopoeia,
including any revisions.

         "Validation":   Documented  evidence  that  the  process   consistently
produces a Product or result that meets its predetermined quality requirement.

1.0      General Quality Policies

         INyX  is  a  pharmaceutical  manufacturer  that  holds  an  appropriate
         Manufacturing License authorization and license for the Product(s) that
         are  the  subject  of this  Agreement.  Any  changes  in the  place  of
         manufacture  of  the  Products,   including  changes  made  under  that
         Manufacturing  License,  require the prior agreement of Stiefel Quality
         Assurance. In addition, while maintaining other client confidentiality,
         INyX shall inform  Stiefel  without  delay of any  restrictions  to the
         manufacturing  authorization  and license for the  Products  covered by
         this  Agreement or for any other Products which may affect the Products
         covered by this Agreement.

         In the  manufacture  of all  Products,  INyX  shall  abide by cGMPs and
         applicable  international or local regulations as they may apply to the
         Products subject to this Agreement.

         INyX   shall   take   all    appropriate    precautions    within   the
         manufacturing/filling,  warehouse,  or Product  testing  facilities  to
         prevent  actions  which may  adversely  affect the  quality of Products
         manufactured for Stiefel.

         In the event of a  Product  recall  or field  alert (or other  activity
         relating  to  Product   quality)  INyX  shall   facilitate   access  to
         manufacturing,  analytical,  storage,  or  shipping  records  as may be
         required to develop an appropriate  regulatory strategy.  Stiefel shall
         be responsible for coordinating all Product recall  activities,  as set
         forth in greater detail in the Manufacturing and Supply Agreement.


<PAGE>

         INyX  shall  operate  a  Quality  Assurance  Unit  which  has  specific
         responsibilities  and  authorities  including  review and  approval  of
         materials   and    Products,    investigation    of   deviations    and
         Non-Conformances, and approving procedures and specifications impacting
         on the identity, strength, quality and purity of Drug Products.

         Stiefel and INyX shall each identify key quality  personnel who will be
         responsible  for  specific  areas  of  Quality  Assurance   activities,
         including quality control,  stability,  Product release, and resolution
         of quality issues.

2.0      Documentation Practices

2.1      Regulatory Filings

         2.1.1    INyX shall  maintain  appropriate  U.K., EU, or local licenses
                  required for the manufacture of pharmaceutical Products.

2.2      Technology Transfer

         2.2.1    Stiefel  shall  provide  INyX with Product  manufacturing  and
                  testing instructions and specifications,  and a representative
                  of  Stiefel  shall  (at  Stiefel's  Cost)  in  the  technology
                  transfer and implementation of the manufacturing, packaging or
                  testing process.

         2.2.2    When  appropriate,  Stiefel and INyX shall  jointly  develop a
                  written  technology  transfer  plan  that  clearly  stipulates
                  responsibilities,    accountabilities,   and   timelines   for
                  technical transfer activities.

2.3      Controlled Documents

         2.3.1    INyX  manufacturing  and  analytical  documentation  practices
                  shall be subject to frequent  review by both parties to ensure
                  compliance with the most current recognized  interpretation of
                  cGMPs for the  appropriate  phase of  Product  development  or
                  commercial manufacturing.

         2.3.2    Standard operating procedures,  specifications,  test methods,
                  and Master Batch  Production  Records shall be consistent with
                  the ANDA filing and any subsequent supplements

         2.3.3    Stiefel and INyX shall be jointly responsible for the approval
                  of  controlled   documents   (specifications,   test  methods,
                  stability protocols,  batch records, etc.) will be established
                  and approved for use.

         2.3.4    Stiefel shall provide all necessary  source data to facilitate
                  the  completion  of relevant  specifications,  etc. INyX shall
                  provide for review and  signature  approval by Stiefel for the

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                  following   documents   prior  to   implementation,   and  any
                  subsequent  changes must be made in accordance with the change
                  control procedures set forth in Section 2.4:

                  o        Master Production Records

                  o        Specifications    for   Finished   Product,    Active
                           Ingredient(s),  Excipients,  primary containers,  and
                           labeling materials.

                  o        Test methods for active drug substance,  intermediate
                           and Finished Product, cleaning evaluation

                  o        Stability protocols and monographs

                  o        Process validation and cleaning validation  protocols
                           and reports

                  o        Test methods validation protocols and reports

                  o        Technical protocols and reports specifically relating
                           to Stiefel Products

2.4      Change Control

         2.4.1    INyX   change   control   procedures   shall   address,   when
                  appropriate,   ,  computer   systems,   validated   equipment,
                  facilities  and  utilities,   personnel  training,  in-process
                  controls,  laboratory  instrumentation and methods,  materials
                  specifications,  printed components,  validated  manufacturing
                  processes,   engineering  drawings,   and  standard  operating
                  procedures.

         2.4.2    All  proposed  changes to  controlled  equipment  or documents
                  pertaining  to the Products  shall be reviewed and approved by
                  INyX QA and Stiefel QA, and shall be made in  accordance  with
                  INyX change control procedures.

         2.4.3    In  addition,  INyX  shall  notify  Stiefel  of the  following
                  changes prior to implementation:

                  o        Major equipment, utilities and facility modifications
                           that materially impact on Stiefel Products

                  o        Specifications   and   test   methods   changes   for
                           non-compendial Excipients

                  o        Test method changes for packaging components

                  o        Changes to standard  operating  procedures  that have
                           significant  impact on Stiefel  Products,  other than
                           changes which require Stiefel's  approval pursuant to
                           Section 2.4.2.

         2.4.4    INyX shall provide Stiefel with  controlled  copies of changed
                  documentation within ten (10) working days of issuance for use
                  within INyX's facilities. Specifically:

<PAGE>


                  o        Specifications for Finished Drug Product

                  o        Specifications for raw material including active drug
                           substance

                  o        Specifications for packaging components

                  o        Test methods for active drug substance,  intermediate
                           and finished drug Product, and cleaning evaluation

                  o        Master  Production  Records   (non-controlled  copies
                           acceptable)

         2.4.5    INyX  shall  provide  Stiefel  with  reference  copies  of the
                  following approved documents:

                  o        Stability protocols and monographs

                  o        Process validation protocols and reports

                  o        Cleaning validation protocols and reports

                  o        Test methods validation protocols and reports

                  o        Technical  protocols and reports  relating to Stiefel
                           Products

2.5      Deviations, Non-Conformances, and Failure Investigations

         2.5.1    INyX  shall  not  deviate  from  the  manufacturing  procedure
                  identified in the ANDA and shall not introduce any significant
                  changes  in the  manufacturing  or testing  procedure  without
                  prior approval from Stiefel.

         2.5.2    INyX shall have in place a written  procedure  describing  the
                  criteria and process by which deviations and  non-conformances
                  relating to the manufacture,  processing,  packaging, testing,
                  or storage of drug Product or its associated  components  that
                  may  affect  the  safety,  efficacy,  quality,  or purity  are
                  investigated, evaluated, reviewed and dispositioned.

         2.5.3    In the absence of an approved SOP specifically  describing the
                  nature of major or minor non-conformances, INyX QA and Stiefel
                  shall jointly agree if a deviation or  non-conformance is of a
                  major or minor nature. Refer to Schedule B for a list of minor
                  deviations or non-conformances. Non-conformances not listed on
                  Schedule B shall be considered as Major.

         2.5.4    For minor deviations or  non-conformances,  documentation  and
                  resolution shall be included in final batch Production package
                  sent to Stiefel for review.

         2.5.5    For major deviations or non-conformances, where possible, INyX
                  shall immediately  notify the designated person within Stiefel
                  prior to proceeding or continuing with Production.  If this is
                  not feasible, INyX shall notify Stiefel QA as soon as possible
                  and prior to INyX QA disposition of the non-conformance..

<PAGE>

         2.5.6    All deviations and non-conformances will be summarized and the
                  summary included in the batch  Production  package provided to
                  Stiefel.

         2.5.7    INyX shall  maintain  procedures  that  describe the roles and
                  responsibilities   and  activities  to  be  employed  for  the
                  investigation      of      Out-of-Specification       results,
                  out-of-tolerance  calibrations,  and any  unusual  occurrences
                  which require QA investigation  beyond normal  non-conformance
                  reporting requirements.

2.6      Document Retention

         2.6.1    All documentation  relating to the  manufacturing,  holding or
                  testing of Stiefel  Products,  whether in paper or  electronic
                  form  shall be  retained  by INyX for a  period  of three  (3)
                  years,  or one (1) year past the  expiration  date of the most
                  recent associated  Product,  whichever is longer.  During this
                  period,  this documentation  shall be available for inspection
                  by Stiefel or by an  authorized  agent  designated by Stiefel.
                  Notwithstanding  the  foregoing,   INyX  shall  not  willfully
                  discard or destroy any such documentation  during this period.
                  Thereafter,  INyX  shall  contact  Stiefel  to  determine  the
                  disposition of said documentation as follows:

                  o        Return of the documentation to Stiefel

                  o        Extended storage of documentation

                  o        Disposal of  documentation  (a formal written request
                           from Stiefel is required before disposal).

                  In either event a written request from Stiefel shall determine
                  disposition.  Documentation  shall include receiving  records,
                  materials releases and supplier C of A's, packaging  component
                  inspection  records,  equipment  cleaning  records,  and batch
                  documents including line clearances, batch production records,
                  inspection results, yield and reconciliations,  deviations and
                  Non-Conformances,  test results and final Product C of A's and
                  C of C's.

         2.6.2    INyX shall  retain  all other  documentation  relating  to the
                  manufacturing,  holding  or testing  of  Stiefel  Products  in
                  accordance with INyX's internal document retention policies.

2.7      Customer Complaints

         2.7.1    Stiefel  shall  notify  INyX of customer  complaints  received
                  after  Product   manufactured  by  INyX  is  sold,  where  the
                  complaint appears to relate to the manufacturing,  filling, or
                  packaging of the Products.  At Stiefel's  request,  INyX shall
                  conduct  internal  investigations  necessary to determine  the
                  validity of a complaint. INyX shall report the findings of the
                  investigations  to Stiefel QA within  thirty (30) days time of

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                  sample  return or  notification,  whichever  is  later.  Where
                  conclusive  investigation  is not  practical  within  a 30-day
                  period,  INyX shall provide  Stiefel with an interim report as
                  soon as practical.

2.8      Annual Product Review

         2.8.1    INyX  shall  provide  data and  on-site  assistance  to enable
                  Stiefel  to  perform  the  annual  Product   quality   reviews
                  appropriate  to the Product type and stage of  development  or
                  commercialization.  An annual  product  quality review summary
                  report with updated statistical  process analysis  information
                  shall be provided to Stiefel no less than thirty (30) calendar
                  days before the due date of the Annual Report for the Product,
                  which is due on the  anniversary  of the date the FDA approved
                  the Product  for  commercial  sale.  Refer to Schedule C for a
                  detailed  listing of the  activities  and format that shall be
                  addressed in the Annual Product Review.

         2.8.2    As part of the annual product review process,  Miza shall have
                  procedures  in  place  to  perform  annual  statistical  trend
                  analysis of all critical raw material, component,  in-process,
                  and  final  product  test  results   associated  with  Stiefel
                  Products.  This procedure shall be used to assess the possible
                  need for changing the raw materials',  components' and product
                  acceptance sampling, inspection and testing requirements.

2.9      Annual Reports

         2.9.1    INyX shall  provide  Stiefel with  information  necessary  for
                  Stiefel  to  prepare  annual  reports  for  submission  to any
                  Regulatory   Authorities.   In  addition  to  the  information
                  provided pursuant to Section 2.8.1, InyX shall provide Stiefel
                  with the  descriptions of any CMC change which occurred during
                  the reporting period, reports on quality investigation, and an
                  evaluation of stability data. Any information required by this
                  Section  2.9.1  other  than the  information  included  in the
                  annual product  quality  review  summary  report  discussed at
                  Section 2.8.1 must be requested by Stiefel no less than thirty
                  (30) days before Stiefel must report the information.

2.10     Training

         2.10.1   The personnel  employed in the manufacture and quality control
                  of Stiefel Products shall be suitably trained, experienced and
                  competent for their respective functions.

         2.10.2   INyX shall  maintain a documented  training  program to assure
                  all   personnel   engaged  in  the   manufacturing,   filling,
                  packaging,  shipping and distribution of Stiefel Products have
                  the education,  training,  and experience to properly  perform
                  their assigned functions in compliance with cGMP requirements.

<PAGE>

         2.10.3   INyX  shall  maintain  a system  to  assure  that  changes  to
                  controlled documents are conveyed to appropriate personnel and
                  that training on these changes is successfully completed prior
                  to the effective date of the change.

3.0      Manufacturing Standards

3.1      Facilities

         3.1.1    INyX  shall  ensure  that  the   buildings   and  grounds  are
                  maintained  in  a  manner  that  avoids  pest  attraction  and
                  ingress. Additionally,  pest control servicing of the facility
                  against  insects and rodents  shall be  scheduled on a routine
                  basis.  All pesticides or fumigants  shall be kept in a locked
                  storage  area.  Physically  separated  from any product or raw
                  material  storage  area when not in use, and shall be utilized
                  and  controlled  so as to  preclude  contamination  of Stiefel
                  Products.

3.2      Equipment

         3.2.1    INyX shall  perform  appropriate  facility and support  system
                  qualifications  to maintain the state of cGMP  compliance  for
                  all systems supporting  manufacturing  operations  appropriate
                  for the stage of development or  commercialization  of Stiefel
                  Products.

         3.2.2    INyX shall perform appropriate installation, operation and /or
                  performance qualification for all equipment and utilities used
                  for the Production and control of Stiefel Products.

         3.2.3    INyX  shall   approve   all   installation   and   operational
                  qualification  protocols  and  reports for  equipment  that is
                  dedicated  to  Stiefel  Products,   including  any  subsequent
                  revisions and/or amendments.

         3.2.4    INyX shall have in place a written  program of calibration and
                  preventative maintenance. All equipment shall be appropriately
                  tagged as to its calibration status in line with INyX internal
                  calibration policy.

3.3      Material Control

         3.3.1    INyX shall have  written  procedures  to  describe  receiving,
                  sampling, reconciliation, coding and inspection operations for
                  all  materials  received  and  intended  for  use  in  Stiefel
                  Products.

         3.3.2    Raw Materials  (Active and Excipient) and components  used for
                  the production of Stiefel Products shall be of the appropriate
                  quality as specified in approved specifications ( as specified
                  by  Stiefel  and  implemented  by InyX)  and be  sourced  from
                  approved vendors. The procedures outlined in Section 2.4 shall
                  be followed in the event that INyX is informed of any proposed
                  processing  changes  to  an  active  ingredient  or a  primary
                  packaging component, and in the event that Stiefel proposes to
                  change an Active  Ingredient or excipient  supplier or primary
                  packaging  component.  The procedures  outlined in Section 2.5

<PAGE>

                  shall be  followed  in the event that any  non-conformance  is
                  encountered  during the  storage or control of raw  materials,
                  components, or finished Product.

         3.3.3    INyX shall have clearly defined, labeled and secured areas for
                  quarantined,  rejected and approved materials, as appropriate.
                  There   shall   be   a   well-defined   written   system   for
                  identification  of materials  according to Product  type,  lot
                  number, and status.

         3.3.4    Raw Material, bulk and finished goods storage conditions shall
                  be   determined   by   specification   or  Product   labeling.
                  Environmental  controls  or  monitoring  shall  be in place to
                  ensure compliance with appropriate storage conditions.

         3.3.5    Raw  Material  retest  frequencies  and  attributes  shall  be
                  described in the appropriate raw material specification.  INyX
                  and  Stiefel  shall  agree an SOP to be followed to extend the
                  shelf-life of the raw material used for Stiefel Products.

3.4      Manufacturing / Cleaning

         3.4.1    INyX shall provide Stiefel with a copy of the completed Master
                  Production Record (in the form approved by Stiefel pursuant to
                  Section 2.4.4)  providing a sufficient level of detail for the
                  manufacture and control of Stiefel Products.

         3.4.2    INyX shall perform  appropriate process validation a frequency
                  as reasonably required by Stiefel QA. 3.4.3 INyX shall issue a
                  Batch  Record,  according  to  cGMP  requirements,  for  every
                  production batch of Product.

         3.4.4    INyX  shall  perform   appropriate   cleaning   validation  of
                  equipment as part of technology transfer or process validation
                  activities.  All  analytical  methods used to verify  cleaning
                  shall be  appropriately  validated  and  approved  by INyX and
                  Stiefel as agreed with Stiefel QA.

         3.4.5    Cleaning validation shall include detailed cleaning procedures
                  with  appropriate  sampling  techniques  to determine  Product
                  residue and cleaning agents, if used. The cleaning  validation
                  shall address the potential of cross  contamination  of any of
                  Stiefel   Product   produced   by  INyX  with  other  of  INyX
                  manufactured Products and vice versa.

4.0      Inspection and Testing Requirements

4.1      Inspection

         4.1.1    Consistent   with  Section   3.3,   INyX  shall  have  written
                  procedures for inspections that adhere to recognized standards
                  (e.g.,  military  standards,  industry  guidelines,  etc.)  in
                  conformance with cGMPs.

<PAGE>

         4.1.2    Incoming  raw  materials  (active  and  inactive),   packaging
                  components, as well as in-process and Finished Products, shall
                  be  included  in  inspection  programs.  Documentation  of all
                  inspection  results shall become a part of the permanent Batch
                  Record or otherwise traceable to a separate storage location.

4.2      Quality Control Testing

         4.2.1    INyX  shall  perform  full  specification  testing  on all raw
                  material  and  components  per approved  specifications.  With
                  prior written approval from Stiefel QA, reduced testing may be
                  allowed for excipient and packaging components,  provided that
                  vendor  has   established  a  good   performance   record  and
                  certification has been completed and approved by Stiefel.

         4.2.2    INyX shall test all raw materials and Products  using approved
                  / validated  methods  and  specifications.  For USP  Compendia
                  items,  USP  methodology  must be used for all testing  unless
                  specified otherwise in the regulatory filing or as directed in
                  writing by Stiefel.

         4.2.3    USP/BP/EP and other official pharmacopoeia reference standards
                  used in material  or Product  analysis  shall be the  approved
                  authentic   specimens  and  suitable  for  use  as  comparison
                  standards in compendia  tests and assays.  INyX shall maintain
                  procedures  for  defining the release and control of reference
                  standards utilized for the testing of Stiefel Products.

         4.2.4    There shall be written  procedures in place for  investigation
                  and disposition of out of  specification  or abnormal  testing
                  results.

         4.2.5    INyX shall not  subcontract  to third  parties any of the work
                  covered by this Agreement without the prior written consent of
                  Stiefel not to be reasonably withheld.

4.3      Stability Program

         4.3.1    When  stability  programs are carried out at INyX,  INyX shall
                  have in place  written  procedures  to ensure the  validation,
                  calibration, and maintenance of the stability chambers.

         4.3.2    Raw data shall be made available in a timely manner for review
                  by Stiefel.  INyX shall  communicate  any  aberrant or failing
                  results to Stiefel'  Quality Control  department  within three
                  (3) working days after INyX completes the out-of-specification
                  investigation.

         4.3.3    INyX and Stiefel shall jointly develop and approve a stability
                  protocol and determine individual company  responsibilities of
                  reporting and  evaluation  of data.  Refer to Schedule D for a
                  list of testing data requirements.

<PAGE>

5.0      Audits

5.1      External Audits

         5.1.1    Stiefel shall  periodically audit INyX by scheduling an agreed
                  visit with InyX at least annually, and/or requesting documents
                  for  review  to  assure  continued  adherence  to  the  agreed
                  manufacturing    process,    cGMPs   and   other    applicable
                  requirements.  Written communication shall be used to document
                  audit  observations  and to  resolve  any  identified  issues.
                  Stiefel may use the services of outside  contractors to assist
                  in the  audit  process  in  agreement  with  INyX.  Any  audit
                  requested pursuant to this Section 5.1.1 shall be requested in
                  advance,  with no less than thirty  (30) days'  notice to INyX
                  and, to the extent practical, shall be conducted during INyX's
                  normal working hours (without unduly  interfering  with INyX's
                  business).

         5.1.2    INyX shall ensure that any deficiencies highlighted during the
                  audit will be dealt with in a prompt manner following  receipt
                  of  an  official  signed  Audit  Report  from  Stiefel.  Audit
                  response with action  items,  assigned  responsibilities,  and
                  timelines will be forwarded to Stiefel within  forty-five (45)
                  working days of receipt of the formal audit report.

         5.1.3    INyX shall inform  Stiefel of any action taken by a Regulatory
                  Authority  (including  telephone   conversation,   inspection,
                  FDA483,   recall   action,   etc.)  as  it  may   affect   the
                  manufacturing,  filling,  and  distribution  of any of Stiefel
                  Products  produced by INyX. During an inspection that involves
                  any Stiefel Product at which no  representative  of Stiefel is
                  present,  INyX shall  provide  Stiefel QA with timely  updates
                  detailing the  particulars  and issues raised which may affect
                  the quality or  marketability of Stiefel  Products.  Likewise,
                  Stiefel  shall  inform  INyX of any  action  proposed  against
                  Stiefel by a  Regulatory  Authority  which may have  impact on
                  INyX's   contract   manufacturing   operations   or   business
                  relationships.

5.2      Internal Audits

         5.2.1    INyX shall have in place written procedures intended to ensure
                  internal  monitoring  that  manufacturing,   testing,  quality
                  assurance,  packaging, holding and distribution operations are
                  in compliance with cGMP  requirements.  These records shall be
                  available for review by Stiefel.

5.3      Vendor/Supplier Qualification Program

         5.3.1    INyX and Stiefel shall jointly be  responsible  for developing
                  and  implementing  a  vendor  qualification  program  for  all
                  materials used to manufacture and/or package Stiefel Products.
                  Such programs shall be described in an SOP, or series of SOPs,
                  and  should  address  the  supplier's  ability  to  adhere  to
                  appropriate   cGMPs,   that   analytical   methods   used  are
                  appropriate,   and  that  starting  materials  are  adequately
                  examined and controlled.  In addition,  such procedures  shall
                  describe the testing  requirements for qualifying a new source
                  of raw material or component.

<PAGE>

6.0      Product Release

6.1      Batch Manufacturing Record

         6.1.1    For each batch of Product,  INyX will  provide  Stiefel with a
                  Product Batch Record File,  which provides a detailed  history
                  and record of the Production run.

         6.1.2    The Product  Batch  Record File  provided to Stiefel  shall be
                  complete  such that all  documentation  required  to perform a
                  thorough review of a Production run are present.

         6.1.3    Stiefel and INyX shall  jointly and  specifically  develop the
                  details  of the  Batch  File and how it is to be  conveyed  to
                  Stiefel  for final  review  prior to release  of the  Product.
                  Refer to Schedule D for a list of  documents to be included in
                  the Product Batch Record File.

6.2      Analytical Results

         6.2.1    Data acquired from analytical and physical  testing  performed
                  by the Quality Control  Laboratory(ies)  shall be reviewed and
                  approved by the INyX Quality Assurance Unit.

         6.2.2    Stiefel and INyX shall jointly  determine and specify the type
                  and  level of raw data that will be  included  in the  Product
                  Batch  Record  File which is  forwarded  to Stiefel  for final
                  review.  Refer to Schedule D for testing data  requirements to
                  be submitted with the Product Batch Record File.

6.3      Certificate of Analysis and Certificate of Conformance

         6.3.1    Upon review of testing results by the Quality  Assurance Unit,
                  INyX shall  prepare a  Certificate  of Analysis  detailing the
                  results of all testing performed on the Final Product.  Such C
                  of  A  will  be  approved  by  responsible  Quality  Assurance
                  personnel  and  forwarded  to Stiefel  as part of the  Product
                  Batch Record File.

         6.3.2    Upon  review of the  completed  Batch  Record  by its  Quality
                  Assurance   Unit,   INyX  shall  prepare  a   Certificate   of
                  Conformance   verifying   that  the  Final  Product  has  been
                  manufactured  under  appropriate cGMP requirements and that no
                  outstanding deviations or Non-Conformances  remain unresolved.
                  Such C of C will be approved by responsible  Quality Assurance
                  personnel  and  forwarded  to Stiefel  as part of the  Product
                  Batch Record File.

6.4      Reserve Samples

         6.4.1    INyX  shall  retain  adequate  representative  samples of each
                  batch or lot of raw materials and packaging components used in
                  the   manufacture   of  the  final  Product  to  enable  their
                  subsequent   testing,    in   duplicate,    against   approved
                  specifications. Such samples shall be retained for a period of
                  no less  than one (1) year  past  expiration  date of the last
                  batch of which that material was used.

<PAGE>

         6.4.2    INyX shall maintain Final Product reserve samples or any other
                  samples  which  may be  required  to enable  their  subsequent
                  testing,  in  duplicate,  against  approved  Finished  Product
                  Specifications. Such samples shall be retained for a period of
                  no less than one (1) year past the expiration date of the lot.

         6.4.3    Unless otherwise stated in approved Batch Records,  INyX shall
                  provide Stiefel with 36 units of Finished  Product as customer
                  samples  (12 Start,  12  Middle,  and 12 End).  These  samples
                  should be labeled as "Customer  Samples" and  forwarded to the
                  designated Stiefel  responsible person within thirty (30) days
                  of the date of release of the lot.

         6.4.4    INyX  shall be  responsible  for the  examination  of  reserve
                  samples  as part of the annual  Product  review  described  at
                  Section  2.8.1 above.  The  examination  shall be conducted as
                  required by Title 21 U.S. Code of Federal  Regulations Section
                  211.170,   and  the  results  of  the  examination   shall  be
                  communicated   in  accordance   with  Section  2.8.1  of  this
                  Agreement.  Provided  InyX  allows  Stiefel  access to reserve
                  sample  storage,  Stiefel will assist with the  examination of
                  reserve samples.

6.5      Release Authorization and Shipping

         6.5.1    The Quality Assurance Unit of INyX is responsible for internal
                  release of the Final Product to Stiefel.

         6.5.2    Based on review of the Product  Batch Record and Stiefel's own
                  internal release procedures, Stiefel QA is responsible for the
                  final disposition of the Product to market.

         6.5.3    Stiefel QA shall communicate the release of batches to InyX QA
                  via authorization in the form of a release memo accompanied by
                  a Stiefel Certificate of Analysis.

         6.5.4    In some  instances  Stiefel may request INyX to ship  reviewed
                  but not yet released Finished Product to Stiefel  distribution
                  center or other firms for the  purposes of further  processing
                  or packaging and labeling. In such instances,  Stiefel QA will
                  provide  INyX  QA  with   specific   written   authority   and
                  instructions for shipping under quarantine conditions.

         6.5.5    INyX shall have in place an SOP that adequately  describes the
                  requirements  and  procedures  necessary  to ship  Product and
                  samples to Stiefel  utilizing  transportation  as  directed by
                  Stiefel.


<PAGE>

                                INDEX OF EXHIBITS
                                -----------------

Schedule A        Generalized Process and Control Flow Diagram

Schedule B        List of Minor Deviations

Schedule C        Requirements for Annual Product Review

Schedule D        Analytical Data Requirements

Schedule E        Batch Production Record File



<PAGE>

                                   Schedule A

                  Generalized Process and Control Flow Diagram



<PAGE>


                                   Schedule B

                            List of Minor Deviations

The  following  non-conformances  are  considered  as "Minor" and do not require
Stiefel's immediate notification:

         o        Typographical  errors in official  approved  documents that do
                  not affect the form, fit or function of the intended document

         o        Deviations from scheduled  maintenance or calibration  schemes
                  for equipment used to  manufacture  or test Stiefel  Products,
                  provided that INyX QA Group has evaluated the  consequence  of
                  such deviation and determined that Product quality,  safety or
                  efficacy has not been materially compromised

         o        Reconciliation  of  excipient  raw  material  beyond  approved
                  range,   provided   that  INyX  QA  Group  has  evaluated  the
                  consequence  of such  deviation  and  determined  that Product
                  quality,   safety  or   efficacy   has  not  been   materially
                  compromised

         o        OOS that have been conclusively determined to be the result of
                  laboratory error

         o        Deviations  resulting from minor machine  adjustment  that may
                  result in rejected Product

         o        Deviations from Standard Operating Procedures that do not have
                  a bearing on Product quality



<PAGE>

                                   Schedule C

                     Requirements for Annual Product Review

         o        Reference: 21CFR170(b) and 180(e)

         o        All batches manufactured and filled to Anniversary Date

                                Table of Contents

A.       Approval Page

B.       Introduction

C.       Retain Samples Examination (n= to be determined by procedure)

         o        Table A

         o        Visual examination for can corrosion or leakage

D.       Batch Document Review

         1.       Raw Material and Component Review

         o        Table B

         o        Non-conformances

         o        Evaluation against specification limits

         2.       Bulk Manufacture

         o        Table C

         o        Non-conformances

         o        Evaluation against specification limits

         3.       Filling

         o        Table D

         o        Non-conformances

         o        Evaluation against specification (table)

         4.       Finished Product Evaluation

         o        Table E

<PAGE>

         o        Non-conformances

         o        Evaluation against final Product specifications including AQL

         5.       Method Change Review

         o        Table F

         o        Evaluation and discussion

         6.       Process Change Review

         o        Table G

         o        Evaluation and discussion

         7.       Components Documents Review

         o        Table H

         o        Evaluation and summary of changes

         8.       Equipment and Facility Qualification Changes

         o        Table I

         o        Evaluation and discussion

         9.       Stability Evaluation

         o        Evaluation and discussion

         10.      Product Complaints

         o        Table K

         o        Evaluation and discussion

E.       Summary and Conclusion



<PAGE>

                      Typical APR Evaluation Table Headers



<PAGE>

                                   Schedule D

                          Analytical Data Requirements



<PAGE>

                                   Schedule E

                            Product Batch Record File

o        Certificate of Analysis

o        Certificate of GMP Compliance

o        Stiefel's comments and INyX response

o        In-Process Specification and Test Result Packet

o        Deviation Report Summary

o        Individual Deviation Reports

o        Manufacturing Batch Production Record

o        Engineering Ste-Up Sheet Document

o        Filling Batch Production Record

o        IPC Filling Record

o        Analytical Data Packet

o        Cleaning Report

o        Authorization to Ship in Quarantine (if any)

o        Shipping Documents