EXHIBIT 10.1

CONFIDENTIAL TREATMENT REQUEST
[ * ] INDICATES INFORMATION THAT HAS BEEN
OMITTED PURSUANT TO A CONFIDENTIAL TREATMENT
REQUEST AND THIS INFORMATION HAS BEEN FILED
UNDER SEPARATE COVER WITH THE COMMISSION.

               PRODUCT DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

                  ELITE PHARMACEUTICALS, INC. AND ORIT LABS LLC


PRODUCT DEVELOPMENT AND COMMERCIALIZATION  AGREEMENT (together with all exhibits
and schedules, the "AGREEMENT"), made as of this tenth day of January, 2006 (the
"EFFECTIVE  DATE"),  by  and  between  ELITE  LABORATORIES,   INC.,  a  Delaware
corporation  having  its  principal  place of  business  at 165  Ludlow  Avenue,
Northvale,   NJ  07657  USA,  and  ELITE   PHARMACEUTICALS,   INC.,  a  Delaware
corporation,  having its  principal  place of  business  at 165  Ludlow  Avenue,
Northvale,  NJ 07657 USA (jointly and severally  "ELITE") and Orit  Laboratories
LLC,  having its  principal  place of business  at 200  Fairfield  Avenue,  West
Caldwell,  NJ 07006 USA and its Affiliates,  ("ORIT"),  and together with ELITE,
the "PARTIES" and each individually, a "PARTY").

                                    RECITALS:

         WHEREAS,   ORIT  and   ELITE   specialize   in  the   development   and
commercialization  of time  release and other  technologies  for  pharmaceutical
providers;

         WHEREAS,  Elite is in the  business of research  and  development,  and
manufacturing   pharmaceutical   drug  products  in  a  manner  conforming  with
applicable regulations found at 21 CFR Parts 210 and 211 ("cGMPs");

         WHEREAS, ORIT is in the business of pharmaceutical  product formulation
development and  pharmaceutical  product  analytical test method development and
ANDA filing in a manner  conforming with applicable  regulations found at 21 CFR
Parts  210  and  211  ("cGMPs')  and  marketing,   sales  and   distribution  of
pharmaceutical products;

         WHEREAS,  ELITE  and  ORIT  desire  to  work  together  to  co-develop,
commercialize and/or license for manufacture and sale of, the Product;

         WHEREAS,  the  Parties  desire to set  forth  herein  their  respective
agreements and convenants with respect to the Product.

         NOW, THEREFORE,  in consideration of the recitals and the covenants and
conditions herein contained, ELITE and ORIT agree as follows:


* Portions of this exhibit have been omitted and filed separately pursuant to an
application  for  confidential  treatment filed with the Securities and Exchange
Commission  pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as
amended.

<PAGE>

          1.      DEFINITIONS

     The following  terms as used in this Agreement  shall have the meanings set
forth in this Article:

                  1.1.  "AFFILIATE"  shall mean, as to either Party,  any Person
which owns or controls or which is owned or controlled by or the common  control
with such Party to the extent of at least fifty  percent  (50%) of the equity or
voting power of the owned or controlled entity.

                  1.2.  "ANDA"  shall  have the  meaning  set  forth in  Section
3.2(b).

                  1.3  "BIOEQUIVALENCE"  shall have the  meaning  bioequivalence
according the  regulations  set forth by the  regulatory  agency in the relevant
territory for generic drug products.

                  1.3. "CFR" shall mean the Code of Federal Regulations,  as may
be amended from time to time.

                  1.4.  "CONFIDENTIAL  INFORMATION"  shall mean any  information
pertaining to the Product or the Study from time to time  communicated  by or on
behalf  of  either  Party  or the  other or  developed  pursuant  to the  Study,
including,   without  limitation,   trade  secrets,  Know-How,  pricing,  costs,
suppliers,   Licensees,   customer  information,   patent  rights,   scientific,
technical, commercial and medical product development,  product formulations and
technical  specifications  including, but not limited to the Product, methods of
analysis and testing,  manufacturing  methods,  processes and production,  batch
records,   contractual  arrangements,   results,   discoveries  and  inventions,
procedures  and forms,  and all  information  related to the  Studies  including
without limitation, the Protocol, whether of a written, oral or visual nature.

                  1.5.      "COMMERCIALIZATION",      "COMMERCIALIZING",      or
"COMMERCIALIZE"  shall mean all activities  relating to manufacture,  promotion,
distribution, marketing and sale of the Product in the Territory.

                  1.6.  "COMMITTEE"  shall have the meaning set forth in Section
2.1 hereof.

                  1.7.  "CRO" shall have the meaning set forth in Section 3.2(f)
hereof.

                  1.8.  "DEVELOPMENT  PLAN" shall mean the  Product  Development
Activity Schedule annexed hereto as Exhibit A.

                  1.9. "FDA" shall mean the U.S. Food and Drug Administration.

                  1.10.  "INTELLECTUAL  PROPERTY  RIGHTS" shall have the meaning
set forth in Section 5.2 hereof.

                  1.11. "KNOW-HOW" shall mean all technology, data, information,
formulations,  technical  specifications,  processes  and methods  necessary  or
useful  in the  manufacturing,  production,  testing  or  registration  of  drug
products, including but not limited to, the Product.


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<PAGE>

                  1.12.  "LICENSEE"  shall mean any Person  that holds a license
approved by the Parties and granted by the Parties to Commercialize  the Product
in the Territory pursuant to a License Agreement.

                  1.13. "LIEN" shall mean any lien, pledge,  mortgage,  security
interest,  claim, lease, charge,  option, right of first refusal or first offer,
easement,  transfer  restriction,  voting  requirement or any other encumbrance,
restriction or limitation.

                  1.14.  "LICENSE AGREEMENT" shall have the meaning set forth in
Section 6.1 hereof.

                  1.15. "MARKETING  AUTHORIZATION" shall mean the final approval
of all regulatory  authorities necessary to market the Product in the Territory,
including  as  applicable  pricing  and  reimbursement  approval  and all  other
approvals required in the Territory for the marketing,  distribution and sale of
the Product in the normal course of business.

                  1.16.   "PERSON"  shall  mean  any  individual,   partnership,
limited-liability company, corporation, joint venture, trust, association or any
other entity, domestic or foreign.

                  1.17.  "PRODUCT" shall mean a generic,  extended  release drug
product for treatment of anxiety based upon one or more  reference drug products
to be mutually  agreed upon by the Parties  during the Term and any renewal Term
if applicable as covered in Section 11.1.

                  1.18.  "PROPRIETARY  RIGHTS"  The  term  "Proprietary  Rights"
means,  with respect to the Product,  all know-how,  technical and clinical data
generated during the Term related to the development of the Product  (including,
without  limitation,  inventions,  whether or not  patentable and whether or not
tested  or  reduced  to  practice,  any and all data,  techniques,  discoveries,
developments,   designs,  trade  secrets,   confidential  business  information,
know-how  and  tangible  expressions,   tests,  reports,  processes,   formulae,
specifications, improvements, results, experiments, samples, statistics and test
analyses relating to the Product),  except to the extent any of the foregoing is
based on or incorporates Confidential Information of any Party to this Agreement
or of any third party.

                  1.19. "PROTOCOL" shall mean the protocol developed by ORIT and
ELITE in connection  with the Studies to be conducted  for, and as agreed to by,
the Parties.

                  1.20.  "REGULATORY FILING" shall have the meaning set forth in
Section 3.2(h) hereof.

                  1.21.  "REPRESENTATIVE"  shall have the  meaning  set forth in
Section 2.1 hereof.

                  1.22.  "STUDIES"  shall  mean the  clinical  trials  needed to
qualify the Product including  Bioequivalence studies for a generic drug product
submission to the appropriate regulatory agency for the relevant Territory.


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<PAGE>

                  1.23.  "TERRITORY"  shall  mean  the  United  States  and  its
territories, Canada and Mexico.

          2.      DEVELOPMENT AND COMERCIALIZATION COMMITTEE

                  2.1.  DEVELOPMENT AND  COMMERCIALIZATION  COMMITTEE Within ten
(10) days after the Effective Date, ELITE and ORIT shall establish a Development
and  Commercialization  Committee (the  "COMMITTEE")  comprised of not less than
two,  and not more than  three,  persons  ("Representatives")  selected  by each
Party. ELITE and ORIT shall each designate an equal number of Representatives to
the  Committee,  with each  Party  having  the right to  increase  the number of
Representatives  at any time to the maximum of three upon written  notice to the
other Party;  PROVIDED,  HOWEVER,  in any event,  ORIT and ELITE shall retain an
equal number of  Representatives  on the Committee and equal voting rights.  The
Committee shall carry out the duties set forth below in Section 2.4.

                  2.2. The first meeting of the  Committee  shall be held within
fifteen (15) days from the Effective  Date, at which time the  procedures of the
Committee  may be  established.  Thereafter,  the  Committee  shall meet on such
schedule as deemed appropriate by the  Representatives,  but not less frequently
than each calendar quarter,  with any one Representative being empowered to call
a meeting of the  Committee  upon at least five (5) days' notice  (which  notice
shall include a detailed description of all matters to come before the Committee
at such meeting for consideration or action).

                  2.3. At  meetings,  each Party shall have the right to provide
information for  consideration  and the Committee shall consider all such input.
All  decisions  by  the  Committee  shall  be  made  by  unanimous  vote  of the
Representatives. For greater certainty, a vote is unanimous if, and only if, all
of the  Parties'  Representatives  in  actual  attendance  at any such  meeting,
irrespective  of the Party  they  represent,  vote for the same  outcome  of any
decision to be taken.  A quorum  required for any action by the Committee  shall
consist  of at least  one  ELITE  Representative  and one  ORIT  Representative.
Participation at a meeting may be in person, by telephone  conference call or by
video  conference,  so long as all  participants  can  hear  and be heard by one
another at all times  throughout  the meeting.  If the meeting is in person,  it
shall be held alternately at ELITE's and ORIT's offices, unless otherwise agreed
by the  Representatives.  All  Representatives  serving on the  Committee not in
attendance  shall be  notified  in writing  immediately  of any action  taken or
approved by the Committee.

                  2.4. The duties of the Committee shall be to:

                           A.  Keep  the  Parties  apprised  of any  development
         issues  with  respect  to the  Product  and  effect a plan of action to
         resolve same;

                           B.  Monitor  the  performance  and  progress  of  the
         Development Plan;

                           C. Pursue and  consider  license  agreements  for the
         Commercialization



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<PAGE>

         of the  Product  in the  Territory,  or in any part  thereof,  with any
         potential Licensee suggested for consideration by either ELITE or ORIT.
         The  criteria  which  the  Committee  shall  take into  account  in the
         consideration of any such license agreements shall include, but are not
         limited to, the maximization of market penetration and revenues for the
         Product in the Territory, or in any part thereof; and

                           D. Such other matters  relating to sub paragraphs 2.4
         A,  2.4 B,  and 2.4 C  above  as may be  necessary  or  appropriate  to
         consider.

                  2.5. If the Committee  cannot  resolve any dispute  within its
purview  after  fifteen  (15) days or such other  period as may be agreed by the
Committee,  the dispute will be referred to a designated  senior officer of each
of ELITE and ORIT, and thereafter,  in the event of continued deadlock,  will be
resolved pursuant to the deadlock provisions set forth in Section 14.


         3.       RESPONSIBILITIES OF THE PARTIES

                  3.1.     THE  DEVELOPMENT PLAN

         The Development Plan, with milestones listed,  setting out the specific
responsibilities  of each of ELITE and ORIT that  will be  required  in order to
complete development of the Product, and to secure regulatory approval necessary
to the manufacture  and sale of the Product in the Territory,  is annexed hereto
as EXHIBIT A. Each of the Parties  agrees to use  commercially  reasonable  best
efforts to perform each of the milestone  activities required to be performed by
such Party on or before the dates  required  for  performance  of such  activity
under the  Development  Plan.  Subject to all the terms and  conditions  of this
Agreement,  including  but not  limited to the  provisions  of Section 5, and in
order to achieve the  milestones  set forth in the  Development  Plan,  ORIT and
ELITE hereby agree to conduct and carry out the  activities set forth in Section
3.2, in the case of ORIT and in Section 3.3, in the case of ELITE. Exhibit A can
be modified by mutual agreement of the Parties at any time.

                  Pursuant   to  the   Development   Plan  ORIT   will   provide
formulation, analytical and formulation services, and personnel, to assist ELITE
in developing the Product.  Elite will be  responsible  for all other aspects of
product  development  including  financing  the product  development  except for
ORIT's responsibilities covered in Section 3.2

                  3.2.     ORIT'S DUTIES

         ORIT  hereby  agrees  that it will  complete  in  accordance  with  the
Development  Plan,  at Elite  facilities  and  using  Elite  equipment  (Elite's
facilities remain under Elite control and Orit will work within their structure)
, certain matters as follows:

                  (A)  ORIT  will  develop  and   validate  all   pharmaceutical
analytical  methods  necessary  and  sufficient  for the  analysis  of the  drug
substance,  impurities, and degradation products, including stability indicating
methods,  and has prepared or will prepare all necessary



                                       5
<PAGE>

written  documentation  and  reports in relation  to these  methods  ready to be
inserted into the ANDA;

                  (B) ORIT  will  develop  formulations  and  processes  for the
manufacture of the Product as required for pilot  Bioequivalence  studies.  ORIT
will transfer the technology in relation to the  formulations  and the processes
to the ELITE facility  during the scale-up  process at the ELITE  facility,  and
will make such adjustments and  optimizations of such formulations and processes
during such scale-up and during the pivotal  Bioequivalence studies phase of the
development  program,  with a view to filing an Abbreviated New Drug Application
("ANDA") with the FDA with respect to the Product;

                  (C) ORIT will transfer  pharmaceutical  analytical methods and
operating procedures relating to the Product to the ELITE facility, will further
develop and validate  these  methods at ELITE  facilities,  and will provide all
reasonable technical and documentary assistance in the transfer and revalidation
process of such methods;

                  (D)  ORIT  will  provide  on-site  assistance  and  sufficient
information to designated  ELITE  personnel to allow ELITE personnel to scale up
the  process  developed  by ORIT  and to  manufacture  Product  batches  for the
additional pilot studies,  if any, and the pivotal clinical studies at the ELITE
facility.

                  (E) ORIT will  provide to ELITE such  assistance  as ELITE may
require to manage and oversee the design and the conduct of pilot Bioequivalence
studies, if any, and pivotal clinical studies for the Products,  such studies to
be done at the  facilities of such third party  contract  research  organization
("CRO") as may be acceptable to both ORIT and ELITE;

                  (F) ORIT will provide to ELITE, for the purposes of regulatory
filing,  all  necessary   documentation,   including  but  not  limited  to  the
formulation and process, and reports in respect of the manufacture,  release and
packaging of the Product batches for the pivotal  clinical studies and stability
studies; and

                  (G) ORIT will provide to ELITE, for the purposes of regulatory
filing, all other reasonably necessary data, results,  documents and documentary
support.

                  3.3      ELITE'S DUTIES

         ELITE hereby agrees that it will complete certain matters in accordance
with the Development Plan as follows:

                  (A)  ELITE  will  be   responsible   for  conducting  the  CMC
(chemistry, manufacturing and controls) activities including production, quality
controls,  and  stability  studies with respect to the Product  (with input from
ORIT, if necessary);

                  (B) ELITE will allow ORIT to complete  the  necessary  lab and
development  work  necessary  under  Section  3.2  at  Elite's  facilities.  The
facilities remain under Elite's control and Orit will complete their work within
Elite's  facility  rules  and  supervision.  Elite  will  also



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<PAGE>

allow the use of necessary  laboratory and production equipment and will provide
laboratory and production materials for this work.

                  (C) ELITE  (together  with ORIT) will  manage and  oversee the
design and the conduct of pilot Bioequivalence  studies, if any, and the pivotal
Bioequivalence  studies  for  the  Product,  such  studies  to be  done  at  the
facilities of such third party CRO as may be acceptable to both Parties;

                  (D) ELITE will  oversee  the  packaging  and  labeling  of the
Product at a mutually  agreed  upon  packaging  facility  for the purpose of the
pivotal clinical studies and the stability studies;

                  (E) ELITE will  prepare  and file,  in the joint names of ORIT
and ELITE, such patent  application(s) on the Product as may be possible,  based
on the Intellectual  Property of the parties , and take all appropriate steps to
receive a grant of such patent(s) and maintain such patent(s) if granted; and

                  (F) ELITE  shall be  responsible  for the  preparation  of all
regulatory  filings  (which shall be filed in ELITE's sole name),  including all
clinical   investigational   new  drug   applications  in  connection  with  the
applications for regulatory approval for the Product in each jurisdiction of the
Territory (each a "REGULATORY FILING"), all as required under applicable laws of
the Territory.


                  3.4 REGULATORY FILINGS

                  The ELITE shall prepare any aspect of any  regulatory  filing,
and ORIT will  co-operate  with the other to provide such  assistance  as may be
requested  or  necessary  to complete  such  regulatory  filing at the  earliest
opportunity.


                  3.5 PERFORMANCE AND COSTS OF PERFORMING HEREUNDER; PAYMENT BY
ELITE

                  (A) ORIT  shall  bear [ * ]  manpower  costs  relating  to its
services for  development  of the Product  described  under  Section 3.2 hereof.
(note: Elite will provide facility, equipment and materials for this work)

                  (B)  ELITE  alone  will  bear  [ * ]  the  costs  for  Product
development which are not borne by ORIT pursuant to subsection (a) above;

                  (C) ORIT  and  ELITE  will  share [ * ] the  costs  of  patent
application preparation and filing costs.

                  (D)  ELITE  shall  pay to ORIT $[ * ] upon  execution  of this
agreement.  This money is fully  refundable to ELITE if an in vitro  dissolution
profile matching the branded product is not  satisfactorily  achieved within the
time allowed for Item 1 in Exhibit A.


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<PAGE>


                  (E) Upon satisfactory  completion of the pilot  Bioequivalence
study  for  the  U.S.  (demonstration  of  bioequivalence  according  to the FDA
requirements) Elite will pay to ORIT the sum of $[ * ].

                  (F)  It is the  intention  of the  Parties  that a  commercial
Licensee or Licensees should bear all litigation costs in relation to regulatory
filing  or  defense  of  the  Product   arising  after  filing  with  regulatory
authorities.  To the extent that such costs, as may arise after the date of this
Agreement and before or after filing,  are not borne by such Licensee(s),  ELITE
and ORIT will share in the costs of such legal  defense  of the  Product  and/or
defense against any litigation  against the Parties in respect of the Product as
follows: [ * ] by ELITE and [ * ] by ORIT.

                  3.6 STANDARD OF PERFORMANCE.  The Parties must use reasonable,
timely efforts to fulfill their respective obligations set forth in this Section
3  hereof  and  elsewhere  in this  Agreement  to  pursue  the  development  and
Commercialization of the Products in accordance with the estimated timetables as
set forth in the Development  Plan. A Party's failure to fulfill its obligations
shall  provide the other Party with the right to  terminate  this  Agreement  in
accordance with the provisions of Section 14 hereof.

                  3.7  COOPERATION.  Each Party shall use reasonable  efforts to
cooperate  with the  other  Party in  connection  with the  preparation  of each
regulatory filing relating to the Product.  ELITE shall have the right to review
and  comment  upon  any and all  prepared  applications  and  filings  prior  to
submission to the relevant  governmental  authorities.  ELITE shall  manufacture
bio-batches as required for submission purposes.

          4.      CLINICAL STUDIES

                   4.1  SELECTION OF THIRD PARTY

                   ORIT and ELITE shall  jointly  determine the identity of, and
thereafter  engage,  a reputable third party to conduct the clinical studies for
the Product in accordance  with the  Development  Plan (the  "STUDIES") and such
third party shall be  contractually  bound to fulfill its obligations to conduct
such Studies in accordance  with 21 CFR ss.312.52 and all applicable  laws. Each
of ORIT and ELITE agrees that,  during the Term (and any Renewal  Term),  except
for the Studies  contemplated  hereunder,  neither it nor any of its  Affiliates
will  conduct  clinical  studies for any other  generic  version of the targeted
branded product for the Product whether for itself or any third party.

                  4.2.  DISCONTINUANCE

                   ELITE and ORIT shall each have the right to  discontinue  the
Studies  at any time  prior to  completion  of such  Studies  upon 5 days  prior
written  notice  to the  other  Party,  if ELITE  or  ORIT,  as the case may be,
reasonably believes that any serious adverse clinical event may arise.


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<PAGE>




          5.      PATENT PROSECUTION, MAINTENANCE AND DEFENSE; OWNERSHIP OF
INTELLECTUAL PROPERTY

                  5.1.  PATENTS.  During the Term (including all Renewal Terms),
ORIT and ELITE shall each have the right to file and  obligation to maintain all
patent  rights  relating  to the Product  throughout  the  Territory  and shall,
subject to the  provisions  set forth  herein,  use  reasonable  efforts to file
patent applications to protect the Product.  All patent application expenses for
the Product will be shared by the Parties on a [ * ] basis.

                  5.2.  INTELLECTUAL  PROPERTY.  Subject  to the  provisions  of
Section 5.1, all rights, title and interest in and to all intellectual  property
rights  relating  to the  Product,  including  without  limitation,  inventions,
discoveries, creations, information, data, reports, results, and/or improvements
to any confidential information, know-how, study inventions, regulatory filings,
patent  rights,  processes,  techniques,  and any  improvements,  modifications,
alterations  thereto and patents  issuing  thereon  made during the term of this
Agreement (collectively,  "Intellectual Property") are and shall, in all events,
be the sole and exclusive  property of the Party who develops such  Intellectual
Property.  Parties  hereby  agree to grant to Licensee the  exclusive  right and
license  to use  such  Intellectual  Property  in a  commercial  manner  for the
production of the Product and to the other Party for the use in the  development
of the Product.  Notwithstanding the above, in no event shall any of the Parties
hereto use the  Intellectual  Property in connection with the development of any
product  containing the active  pharmaceutical  ingredient  molecule used in the
Product.


          6.      COMMERCIALIZATION OF PRODUCT

                  6.1.  License.  As promptly as is  practicable,  the Committee
shall consider and, where appropriate,  approve one or more Licensees  suggested
by ELITE or ORIT for the Commercialization of the Product in the Territory. Such
Committee  approval shall not be unreasonably  withheld by the  Representatives.
ORIT and ELITE shall jointly  negotiate in good faith with such Licensee(s) upon
standard    industry   terms   for   an   exclusive   license   for   Licensee's
Commercialization  of the Product in all or a portion of the Territory ("LICENSE
AGREEMENT"),  the  terms of which  License  Agreement  shall  be  approved  by a
unanimous  decision  of the  Committee,  such  approval  not to be  unreasonably
withheld  by the  Representatives.  The  main  criterion  for the  grant of such
Licenses shall be the  maximization of the commercial  success of the Product in
the marketplace for any market in the Territory.

                  6.2. COMMERCIAL  MANUFACTURE.  Following ANDA approval,  Elite
shall be  responsible  for  manufacturing,  storing and overseeing the labeling,
packaging  and  shipping  of the  Product  in a manner  that  complies  with all
applicable  legal  requirements,  including  , but not  limited  to the laws and
regulations  enforced by the FDA. Elite shall be paid a transfer price as agreed
upon with the licensee and with ORIT.


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<PAGE>

                  6.3. ROYALTIES AND OTHER PROCEEDS.

                  (A) Subject to Section  6.3(b) below,  during the Term of this
Agreement  (including  all Renewal  Terms),  all license fees from each Licensee
(including,   without  limitation,   milestones,   royalties,   fees  and  other
consideration  paid by any  Licensee) and all other profits from the sale of the
Product  (including sale proceeds and other  consideration)  shall be divided by
the  Parties as follows  [but not  including  the  transfer  price as covered in
section  6.2]: [ * ] to ORIT and [ * ] to ELITE.  Each License  Agreement  shall
provide  that all fees  payable by each  Licensee  shall be paid to the  Parties
directly.  If the Product is sold to a third party in accordance with the mutual
agreement of the Parties,  the proceeds of the sale shall be divided on [ * ] to
ELITE and [ * ] to ORIT basis .

                  (B) To the extent any litigation  costs shall have been shared
[ * ] to ELITE and [ * ] to ORIT in accordance  with the  provisions of Sections
3.5(c) , 7.2 or 7.3, all amounts  payable  under  Section  6.3(a) above shall be
divided  between the Parties [ * ] to ELITE and [ * ] to ORIT. The provisions of
this  Section  6.3(b) do not apply  where  any  costs or  expenses  are the sole
obligation  of one  of  the  Parties.  For  purposes  of  this  Section  6.3(b),
"litigation  costs" shall include all litigation  costs relating to the Product,
including products liability  litigation,  patent or other intellectual property
litigation,  and  litigation  in  relation  to the  regulatory  approval  of the
Product.


         7.       INDEMNIFICATION

                  7.1. INDEMNIFICATION OBLIGATIONS OF THE PARTIES.

                   (A) Each Party shall indemnify,  defend and hold harmless the
other Party and its  Affiliates  from and  against  any and all  losses,  costs,
expenses,  liabilities,  claims, actions,  damages,  personal injury, or loss of
life,  including without limitation,  reasonable  attorney's fees (collectively,
"LOSSES"), arising directly from such Party's (i) negligent acts or omissions or
willful  misconduct,  (ii) any breach of any representation or warranty provided
by such Party to the other Party  hereunder,  and/or (iii) any  violation of the
terms of this Agreement.

                  (B) NOTWITHSTANDING ANY PROVISION TO THE CONTRARY CONTAINED IN
THIS  AGREEMENT,  IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR
ASSUME LIABILITY TO A LICENSEE FOR ANY  CONSEQUENTIAL,  INCIDENTAL,  OR PUNITIVE
DAMAGES   (INCLUDING  LOSS  OF  PROFITS,   LOSS  OF  ENTERPRISE,   AND  LOSS  OF
OPPORTUNITY),  REGARDLESS  OF WHETHER  FOR BREACH OF  WARRANTY,  CONTRACT,  TORT
(INCLUDING  NEGLIGENCE),  STRICT LIABILITY OR OTHERWISE,  EVEN IF ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.

                  7.2. INFRINGEMENT.

                   ELITE and ORIT shall jointly  investigate  and defend any and
all claims, actions



                                       10
<PAGE>

and proceedings resulting from an assertion against ELITE or ORIT (or a Licensee
if ELITE and ORIT have  agreed to  indemnify  such  Licensee)  that the  Product
infringes  upon a third  party's  intellectual  property  rights  ("Infringement
Claim"). Subject to claims ELITE may assert due to a breach of representation or
warrant by ORIT  under  Section 9 hereof,  ELITE and ORIT  shall  share [ * ] to
ELITE and [ * ] to ORIT in the cost and expenses of the defense.  ELITE and ORIT
shall be entitled to share [ * ] to ELITE and [ * ] to ORIT all amounts awarded,
if any, in connection with any such enforcement proceeding.

                   7.3.  ENFORCEMENT  PROCEEDINGS.  ELITE  and  ORIT  may  bring
enforcement  proceeding against any third party [ * ] to ELITE and [ * ] to ORIT
if ELITE and ORIT  determine  jointly that a  third-Party  is likely  materially
infringing upon the rights of ELITE, ORIT or a Licensee in the Product.  If such
enforcement proceedings are brought jointly, the Parties will share [ * ] ELITE/
[ * ] ORIT in all  costs  or  proceeds  of such  litigation,  including  without
limitation  all  awards of  damages  and  settlement  proceeds.  Subject  to any
agreement with any Licensee as may be licensed for the  commercialization of the
Product, either Party may in its sole discretion, decline to participate in such
enforcement proceeding as complainant, in which case the other Party may proceed
with the  litigation,  bearing  all costs and  receiving  all  proceeds  of such
litigation.

                   7.4  RESPONSIBILITY  FOR  LITIGATION.  For the  avoidance  of
doubt,  it is the intention of the Parties that a  commercialization  partner or
Licensee  shall  bear the  primary  responsibility  for all  products  liability
litigation,  patent or other intellectual property litigation,  or litigation in
relation  to the  regulatory  approval of the  Product.  To the extent that such
litigation expenses are not borne by such commercialization partner or Licensee,
or to the extent that either  Party is required by operation of law to take part
in such litigation in any way, it is the intention of the Parties that all costs
and proceeds of such litigation are to be borne [ * ] by ELITE and [ * ] ORIT by
the  Parties.  Subject  to any  circumstance  under  which a Party  declines  to
participate in any enforcement proceeding as provided in Section 7.3 above, ORIT
and ELITE  shall  jointly  have  control of any such  litigation,  including  as
regards choice of counsel and settlement terms.

          8.      INSURANCE

         . Each Party  agrees to  maintain  in force,  during the Term and for a
period of 24 months thereafter,  product liability insurance coverage in minimum
limits  of  $1,000,000  per  claim  and  $5,000,000  per  occurrence.  Prior  to
commercialization,  those  limits shall be reduced to  $1,000,000  per claim and
$2,000,000 per  occurrence.  Each Party shall instruct its insurance  carrier to
notify the other Party of any change,  modification or cancellation of insurance
thirty  (30) days prior to such  change,  modification  or  cancellation  taking
effect.

          9.      REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE PARTIES

                  9.1.  ORIT  represents  and  warrants  to  ELITE,  as  of  the
Effective Date, as follows:


                                       11
<PAGE>

                        A.   ORIT has the legal right and full  corporate  power
                             and  authority to enter into this  Agreement and to
                             perform the same

                        B.   the   Agreement   constitutes   valid  and  binding
                             obligations  of ORIT,  enforceable  against ORIT in
                             accordance  with its  terms,  except as  limited by
                             applicable bankruptcy,  insolvency,  reorganization
                             and other laws of general application affecting the
                             enforcement  of creditors'  rights  generally,  and
                             except as  enforcement  of rights to indemnity  and
                             contribution hereunder may be limited by principles
                             of public policy

                        C.   ORIT has taken all corporate  action required by it
                             to  authorize  it to enter into and to perform  the
                             Agreement

                        D.   ORIT has the right to disclose  Know-How (and other
                             Intellectual  Property  Rights)  for the Product to
                             ELITE  as  well  as  all  other  information  as is
                             necessary  for  ELITE to  perform  its  obligations
                             hereunder

                        E.   There are no infringement  proceedings pending, or,
                             to ORIT's  knowledge,  threatened,  against ORIT in
                             connection  with the Product or ORITS  Intellectual
                             Property Rights

                        F.   ORIT  has  good  title  to  all  ORIT  Intellectual
                             Property Rights, free and clear of all Liens

                        G.   ORIT has not  received  any notice of  infringement
                             of,  or  conflict   with,   any  license,   patent,
                             copyright,   trademark,   service   mark  or  other
                             intellectual property right of any other Person for
                             the Product and, to the knowledge of ORIT, there is
                             no infringement  or unauthorized  use by any Person
                             of any of the ORIT Intellectual Property Rights for
                             the Product

                        H.   There are no agreements  between ORIT and any third
                             party that conflict with this Agreement

                        I.   No consent or approval of any third party, court or
                             governmental  agency is required in connection with
                             the execution and  performance of this Agreement by
                             ORIT

                 9.2.   In respect of the Clinical Studies, ELITE

                        A.   Shall,  supervise  the  conduct  of the  Studies in
                             accordance  with the terms  hereof,  to ensure that
                             such CRO as is selected to carry out the Studies is
                             contractually   bound  to  do  so,   and  does  so,
                             including by way of a transfer in writing  under 21
                             CFR  312.52,   in  accordance  with  the  Protocol,
                             generally   accepted  standards  of  good  clinical
                             practice  and  all



                                       12
<PAGE>

                             applicable  local,   state  and  Federal  laws  and
                             regulations  governing the  performance of clinical
                             investigations,   including   without   limitation,
                             regulations   governing  the  protection  of  human
                             subjects   (e.g.,   21   C.F.R.    Part   50)   and
                             Institutional  Review  Boards (e.g., 21 C.F.R. Part
                             58),  and  regulations   governing  the  conduct of
                             clinical trials (21 C.F.R. Part 312), and financial
                             disclosure  by  clinical  investigators  (21 C.F.R.
                             Part  54),   and   privacy  of   protected   health
                             information (45 C.F.R. Parts 160 and 164)

                        B.   Represents  to ORIT that its  employees  and agents
                             are not  currently  debarred by the FDA pursuant to
                             21   U.S.C.    ss.335(a)   or   involved   in   any
                             investigation  or  proceedings  which could lead to
                             debarment

                        C.   Does  not  and  will  not  knowingly  use,  in  the
                             performance  of  its  obligations  hereunder,   the
                             services of any debarred  entity or individual,  or
                             of any  individual  that  has been  convicted  of a
                             felony or who is currently under  investigation for
                             such conviction

                        D.   All laboratory,  scientific, technical and/or other
                             data  submitted to ELITE or any  regulatory  health
                             authority  relating  to the Study  shall be, to the
                             best  of  its   knowledge   at  the  time  of  such
                             submission,  complete,  true,  accurate and correct
                             and  shall  not   contain   any   knowingly   false
                             information, misrepresentation and/or omission

                        E.   Shall,  with  notification  to ORIT,  ensure that a
                             transfer in writing under 21 CFR 312.52 is provided
                             to any CRO for the Studies, which CRO shall then be
                             responsible for the identification,  documentation,
                             and  monitoring  of adverse  events in  Patients in
                             accordance  with 21 C.F.R.  ss.312.32 and 21 C.F.R.
                             ss.314.80,  the Protocol and as otherwise  required
                             under all applicable  laws,  rules and regulations,
                             and shall  promptly  report all such adverse events
                             in subjects to ORIT

                        F.   Will keep ORIT  advised of any results of the Study
                             via a written report

                        G.   Shall,  ensure that a transfer in writing  under 21
                             CFR 312.52 is provided to any CRO for the  Studies,
                             which  CRO shall  then be  responsible  to  perform
                             record   keeping  and  reporting   obligations   in
                             accordance  with 21  C.F.R.  312.62(b),  21  C.F.R.
                             312.57(c) and 21 C.F.R. 312.62(c)

                        H.   Each   Party   will   notify   the   other  of  any
                             deficiencies   and  other   issues   or   inquiries
                             presented  by the FDA or  other  regulatory  agency
                             with   respect  to  the  Study  and   provide   any
                             assistance requested by the other to satisfactorily
                             respond to the FDA or such other regulatory agency


                                       13
<PAGE>

ORIT MAKES NO OTHER  WARRANTY  OF ANY KIND,  EXPRESS OR  IMPLIED,  EXCEPT  THOSE
EXPRESSLY MADE HEREIN. ORIT SPECIFICALLY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED,  INCLUDING,  WITHOUT  LIMITATION,  ANY WARRANTY OF  MERCHANTABILITY,
NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.


                  9.3.  ELITE  represents  and  warrants  to  ORIT,  as  of  the
Effective Date, as follows:

                        A.   ELITE has the legal right and full corporate  power
                             and  authority to enter into this  Agreement and to
                             perform the same

                        B.   The   Agreement   constitutes   valid  and  binding
                             obligations of ELITE,  enforceable against ELITE in
                             accordance  with its  terms,  except as  limited by
                             applicable bankruptcy,  insolvency,  reorganization
                             and other laws of general application affecting the
                             enforcement  of creditors'  rights  generally,  and
                             except as  enforcement  of rights to indemnity  and
                             contribution hereunder may be limited by principles
                             of public policy

                        C.   ELITE has taken or will  have  taken all  corporate
                             action required by it to authorize it to enter into
                             and to perform the Agreement

                        D.   There are no agreements between ELITE and any third
                             party that conflict with this Agreement

                        E.   No consent or approval of any third party, court or
                             governmental  agency is required in connection with
                             the execution and  performance of this Agreement by
                             ELITE

                  9.4. In respect of the  manufacture and release of the pivotal
clinical batches and the Studies, ELITE:

                        A.   Will manufacture all clinical  materials  according
                             to generally accepted good manufacturing  practices
                             and good  laboratory  practices in accordance  with
                             all   pertinent   state   and   federal   laws  and
                             regulations,   including,  without  limitation,  in
                             accordance with 21 CFR ss.210 and ss.211

                        B.   Represents  to ORIT  that it is not  enjoined  from
                             manufacturing nor is ELITE currently  sanctioned by
                             the  FDA  pursuant  to any  issued  483  inspection
                             reports

                        C.   Represents  to ORIT that its  employees  and agents
                             are not  and  have  not  been  debarred  by the FDA
                             pursuant  to 21 USC ss.  335(a) or  involved in any
                             investigation  or  proceeding  which  could lead to
                             debarment


                                       14
<PAGE>

                        D.   Does  not  and  will  not  knowingly  use,  in  the
                             performance  of  its  obligations  hereunder,   the
                             services of any debarred  entity or individual,  or
                             of any  individual  that  has been  convicted  of a
                             felony or who is currently under  investigation for
                             such conviction

                        E.   Represents   that   all   laboratory,   scientific,
                             technical  or   commercial   information   that  is
                             submitted  by  ELITE  to ORIT or to any  regulatory
                             health authority  relating to the product should be
                             complete,  true, accurate and correct , to the best
                             of its  knowledge  at the time of such  submission,
                             and  shall  not   contain   any   knowingly   false
                             information, misrepresentation and/or omission

                        F.   Will  perform  all  necessary   record  keeping  as
                             required  under  applicable  federal and state laws
                             regarding   the   manufacture   of   the   Product,
                             environmental  impact of the  manufacturing and all
                             potential or adverse product defects

ELITE MAKES NO OTHER  WARRANTY OF ANY KIND,  EXPRESS OR  IMPLIED,  EXCEPT  THOSE
EXPRESSLY  MADE  HEREIN.  ELITE  SPECIFICALLY  DISCLAIMS  ALL OTHER  WARRANTIES,
EXPRESS  OR   IMPLIED,   INCLUDING,   WITHOUT   LIMITATION,   ANY   WARRANTY  OF
MERCHANTABILITY, NON-INFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE.

                  9.5. INSPECTION OF ELITE FACILITIES

                  If  a  Federal,   State  or  local  government  or  regulatory
authority  conducts or gives notice of an inspection of the facilities of ELITE,
ELITE will  promptly  inform  ORIT and ORIT  shall  have the right,  but not the
obligation to be present to any such inspection or regulatory action. ELITE will
provide all records and  correspondence  regarding  such action  within five (5)
business days of a request from ORIT.

         10.      OBLIGATION OF CONFIDENTIALITY

                  10.1.  The Parties are party to a  Confidentiality  Agreement,
dated as of December 1, 2005,  (the "CDA") the term of which is hereby  extended
to coincide with the term of the obligations of confidentiality  herein set out,
pursuant to which each Party agreed to maintain  confidentiality with respect to
certain  information to be disclosed by the other Party (the "Existing CDA"). In
addition to the obligations set forth in the CDA, all  Confidential  Information
disclosed by a Party  ("DISCLOSING  PARTY")  shall be treated by the other Party
("RECEIVING  PARTY") as  confidential  and shall not be disclosed or revealed to
any third party,  and shall be used solely in connection with the performance of
this Agreement,  and such Confidential Information shall not be used in whole or
in part by either Party, whether alone or in co-operation with any other person,
to formulate,  develop,  manufacture  or  commercialize  any other drug product;
PROVIDED,  HOWEVER, that Confidential  Information shall not include information
that the Receiving Party can document as having been:


                                       15
<PAGE>

                  (A)  Public  knowledge  prior  to  the  disclosure,  or  which
hereafter becomes public knowledge through no fault of the Receiving Party;

                  (B) Lawfully in the Receiving Party's  possession prior to the
time of disclosure by Disclosing Party;

                  (C) Received, after the time of disclosure, from a third party
not under a similar obligation of confidentiality to Disclosing Party; or

                  (D)  Independently  developed by Receiving  Party's  employees
without access to Disclosing  Party's  Confidential  Information or knowledge of
the Development Agreement

                  10.2. The Receiving  Party shall take all such  precautions as
it normally takes with its own  Confidential  Information,  but in no event less
than reasonable precautions, to prevent improper disclosure;  provided, however,
that Confidential Information may be disclosed within the limits required (A) to
obtain  any  authorization  from the FDA or any other  United  States or foreign
governmental  or  regulatory  agency or, with the prior  written  consent of the
Disclosing  Party;  (B) to be  disclosed  pursuant to (i) any order of any court
having  jurisdiction  and power to order such information to be released or made
public; or (ii) any lawful action of a governmental or regulatory agency.

                  10.3. In addition to and without  limiting any other  remedies
available to a Receiving  Party at law or in equity,  the Receiving  Party shall
also be entitled to seek  immediate  injunctive  relief in any court to restrain
any  breach  or  threatened  breach of a  Receiving  Party  and to  enforce  the
provisions of this Section 10. Each Party acknowledges and agrees that there may
be no  adequate  remedy at law or in equity  for any such  breach or  threatened
breach  and,  in the event that any  proceeding  is brought  seeking  injunctive
relief,  the Receiving Party shall not use as a defense thereto that there is an
adequate remedy at law.

                  10.4.   The   Receiving   Party  may   disclose   Confidential
Information  of  the  Disclosing  Party  to  the  Receiving  Party's  employees,
consultants,  licensees,  agents,  prospective licensees and subcontractors on a
need-to-know  basis;  PROVIDED,  HOWEVER,  that (i) any such disclosure shall be
pursuant  to  a  written  confidentiality  agreement  with  terms  at  least  as
restrictive as those specified herein;  and (ii) any violation of this Agreement
by such  persons  shall be deemed a breach by the  Receiving  Party.  Any of the
persons mentioned above who are provided with access to Confidential Information
shall be informed by the Receiving  Party of the Receiving  Party's  obligations
hereunder.

                   10.5.  The  confidentiality  obligations  of each Party under
this Section 10 shall  survive the  expiration  or earlier  termination  of this
Agreement, howsoever terminated.

                  10.6.  The Parties  shall  cooperate and agree upon any public
statement concerning the existence, subject matter or any term of this Agreement
by or on behalf of any Party prior to any  issuance,  dissemination  or release.
Subject to Section 10, neither Party may issue,  disseminate or release any such
public statement without the prior written approval of the other Parties,  which
consent shall not be unreasonably withheld or delayed.


                                       16
<PAGE>

          11.     TERM AND TERMINATION

                  11.1.  Subject  to  Section  11.2  hereof,  the  term  of  the
Agreement  shall be the greater of (i) a fifteen  (15) year period from the date
the Product is first  commercially  sold in the  Territory to a third party,  or
(ii) the life of all  applicable  patent(s),  if any,  whichever  is longer (the
"TERM").  This Agreement  shall  automatically  renew for 3-year renewal periods
(each a "RENEWAL TERM") unless terminated by either Party by providing the other
Party with twelve (12) months written notice prior to any renewal period.

                  11.2. This Agreement may be terminated by a Party prior to the
end of the Term (or any applicable Renewal Term):

                        A.   By mutual agreement of the Parties; or

                        B.   Upon  breach of this  Agreement  by the other Party
                             (including,  without  limitation,  the  failure  to
                             timely   perform   in  a   reasonable   manner  any
                             obligation identified on the Development Plan), and
                             the  failure of such  breaching  Party to cure such
                             breach  with thirty (30) days of receipt of written
                             notice to the breaching Party of such breach.

                  11.3. EFFECT OF TERMINATION. Termination of this Agreement for
any reason shall be without prejudice to:

                        A.   ELITE's  and ORIT's  right to receive  all  amounts
                             accrued and unpaid  under  Section 6 up to the date
                             of such termination;

                        B.   Any provisions clearly meant to survive termination
                             or expiration of this Agreement,  including without
                             limitation       representations,       warranties,
                             indemnification and confidentiality  obligations as
                             well as  Sections 1, 7, 8, 9, 10, 11, 12, 14 and 16
                             and  solely in the case of  Section  11.5,  Section
                             6.3, shall remain in full force and effect; and

                        C.   Any other  remedies  which either Party may then or
                             thereafter have hereunder or otherwise.

                  11.4.  Subject to Section  11.5,  the Parties  agree that upon
termination of this  Agreement,  all rights in the Product,  the  formulation or
formulations  of the  Product,  the  methods  and  processes  applicable  to the
Product,  clinical data and documentation  associated with Product testing,  and
regulatory  documentation in relation to applications for approval to market the
Product,  remain with or revert to ORIT,  which may then use each or all of them
for its own purposes in its sole discretion.

                  11.5.  Upon the  termination  of this Agreement as a result of
the breach by ORIT of any  provision of this  Agreement(other  than  pursuant to
Section 7.2(a) hereof) and the failure of ORIT to cure such breach within thirty
(30) days of receipt of written  notice by ELITE to



                                       17
<PAGE>

ORIT of such  breach,  ELITE  shall  continue  to  receive an [ * ] share of all
license fees and other consideration  resulting from the licensing of rights to,
or sale of, the Product in accordance with Section 6.3 hereof.

          12.     NOTICES

                  12.1.  Any notice  provided for herein shall be in writing and
is effective  upon receipt:  (i) when  delivered by hand with proof of delivery;
(ii) when sent by facsimile with fax confirmation,  provided same is sent all by
regular  mail  within  forty-eight  (48) hours;  (iii) three (3) days  following
deposit for mailing by first class registered or certified mail,  return receipt
requested; one day following deposit for mail with an overnight carrier; or (iv)
when received by the addressee,  by delivery service (return receipt requested).
Notices shall be delivered to the addresses set forth below:

                   If to ELITE:        165 Ludlow Avenue
                                       Northvale, New Jersey 07647
                                       Attention:  Chief Executive Officer
                                       Facsimile:   (201) 750-2755

                   If to ORIT:         200 Fairfield Avenue
                                       West Caldwell, N.J.  07006
                                       Attention:
                                       Facsimile:


          13.     AGREEMENT TO PERFORM NECESSARY ACTS

                  Each Party to this  Agreement  agrees to perform  any  further
acts and execute and deliver any documents  that may be reasonably  necessary to
carry out the provisions of this Agreement.

          14.     DISPUTE RESOLUTION

                  14.1. Should any dispute or difference arise between ELITE and
ORIT or the Committee  during the Term of this Agreement,  then either Party may
forthwith  give  notice  to the  other  Party  that it wishes  such  dispute  or
difference  to be referred to a designated  senior  officer of each of ELITE and
ORIT.

                  14.2. If designated  senior officers of each of ELITE and ORIT
agree upon a resolution  or  disposition  of the matter,  they shall each sign a
statement which sets out the terms of their agreement. If, however, the Parties'
designated senior officers are still unable to resolve their differences  within
10 business days of its being  referred to them  ("DEADLOCK"),  either Party may
request  in a written  notice  to the other  Party  that such  controversy  (the
Dispute)  be  resolved  by  binding  arbitration  in the State of New  Jersey in
accordance with the rules of the American Arbitration Association (the :AAA")..


                                       18
<PAGE>

                  14.3 If the parties are unable to agree on the  identity of an
Arbitrator  within 10 days of the written  proposal of an  Arbitrator  by one of
them, either party may, with 10 days' prior notice to the other party,  apply to
the  AAA  to  appoint  an  Arbitrator  pursuant  to  the  Arbitration  Act.  The
Arbitration  shall take place and be  completed  expeditiously  with written and
verbal  submissions by the Parties to the  Arbitrator to be completed  within 45
days of the  Arbitrator's  appointment.  Pending  a final  determination  by the
Arbitrator,  the costs of the  Arbitration  shall be paid by the parties equally
and  the  parties  shall   separately  pay  their  own  respective   costs.  The
determination  of the  Arbitrator  with regard to any Dispute shall be final and
binding upon the parties and there shall be no appeal therefrom.  The Arbitrator
shall have  jurisdiction  to award the costs of the  Arbitration,  including the
fees of the  Arbitrator  as between  the  parties,  and to direct the payment of
interest in respect of any  amount,  at such rates and from and to such dates as
are determined by the Arbitrator to be appropriate.

                  14.4  Nothing  contained  herein  shall be  deemed to limit or
restrict a Party from  seeking  equitable  remedies,  such as a  preliminary  or
permanent  injunction,  if  necessary,  from a court of  competent  jurisdiction
located in the State of New Jersey, under the laws of the State of New Jersey.

         15.      NON-COMPETITION

                        For  so  long  as the  Product  to be  developed  herein
remains under active development or on sale in the marketplace in any country of
the Territory under the terms of the Agreement  herein,  the respective  Parties
covenant and agree that they will not, whether alone or in co-operation with any
other person,  develop,  formulate,  manufacture or commercialize any other drug
product which is a generic  equivalent of the targeted  branded  product for the
Product.

          16.     MISCELLANEOUS

                  16.1. Neither Party shall be liable for any failure to deliver
or receive or any delay to perform its  obligations  hereunder when such failure
or delay shall be caused  (directly or  indirectly)  by fire;  flood;  accident;
explosion;  equipment or machinery  breakdown;  sabotage;  strike,  or any labor
disturbance  (regardless of the  reasonableness of the demands of labor);  civil
commotions;  riots;  invasions;  wars  (present  or future);  acts,  restraints,
requisitions,  regulations,  or directions of any governmental entity; voluntary
or mandatory  compliance with any request of any governmental  entity;  facility
shut down;  voluntary  or  mandatory  compliance  with any request for  material
represented  to be for purposes of (directly or indirectly)  producing  articles
for national defense or national defense  facilities;  shortage of labor,  fuel,
power or raw materials;  inability to obtain raw materials or supplies; failures
of normal sources of supplies;  inability to obtain or delays of  transportation
facilities;  any act of God; any act of the other Party;  or any cause  (whether
similar or dissimilar to the foregoing)  beyond the  reasonable  control of such
Party (each cause a "FORCE MAJEURE EVENT").

                  16.2.  Either Party hereto may assign this  Agreement in whole
or in part to any Affiliate or Affiliates who shall be  substituted  directly in
whole or in part for it hereunder,  PROVIDED,  HOWEVER,  that the assignor shall
guarantee the performance of its Affiliate  assignee



                                       19
<PAGE>

hereunder.  This  Agreement  shall not  otherwise be  assignable by either Party
without the prior written consent of the other Party, which consent shall not be
unreasonably withheld.

                  16.3.  This Agreement  shall be governed by and interpreted in
accordance  with the laws of the State of New  York,  United  States of  America
without  regard to their  conflict of laws  principles,  and should legal action
become necessary to enforce its terms, the prevailing Party shall be entitled to
reasonable costs and attorneys' fees.

                  16.4.  The terms and provisions  contained in this  Agreement,
together  with  the  Existing  CDA as  amended  hereby,  constitute  the  entire
Agreement   between  the  Parties   hereof,   shall   supersede   all   previous
communications,  representations,  agreements or understandings,  either oral or
written,  between the Parties  hereto with respect to the subject  matter hereof
and no agreement or understanding varying or extending these Agreements shall be
binding upon either Party hereto, unless in writing which specifically refers to
the Agreement,  signed by fully authorized  officers or  Representatives  of the
respective  Parties and the  provisions  of these  Agreements  not  specifically
amended thereby shall remain in full force and effect.

                  16.5.  Any waiver must be explicit and in writing.  The waiver
by either of the Parties to this Agreement of any breach of any provision hereof
by the other  Party  shall  not be  construed  to be a waiver of any  succeeding
breach of such provision or a waiver of the provision itself.

                  16.6.  If and to the  extent  that any  court or  tribunal  of
competent jurisdiction holds any of the terms,  provisions or conditions or part
thereof of this Agreement, or the application hereof of any circumstances, to be
invalid or to be unenforceable in a final non-appealable order, the remainder of
this Agreement and the application of such term,  provision or condition or part
thereof to  circumstances  other  than  those as to which it is held  invalid or
unenforceable  shall  not be  affected  thereof,  and each of the  other  terms,
provisions and conditions of this  Agreement  shall be valid and  enforceable to
the fullest extent of the laws.

                  16.7. The  relationship of ELITE and ORIT under this Agreement
is that of  independent  contractors.  Neither  Party  shall be deemed to be the
agent of the other, nor authorized to take any action binding upon the other.

                  16.8. This Agreement may be executed in counterparts,  each of
which shall be deemed to be an original and all  together  shall be deemed to be
one and the same  Agreement.  All  headings in this  Agreement  are inserted for
convenience   of   reference   only  and  shall  not  affect   its   meaning  or
interpretation.




                                       20
<PAGE>



          IN WITNESS  WHEREOF,  ELITE and ORIT have executed  this  Agreement in
duplicate as of the day and year first above written.


                                          ELITE LABORATORIES, INC.

                                          By:  /s/ Bernard Berk
                                              ----------------------------------
                                              Name:  Bernard Berk
                                              Title: CEO                 1/10/06


                                          ELITE PHARMACEUTICALS, INC.

                                          By:  /s/ Bernard Berk
                                              ----------------------------------
                                              Name:  Bernard Berk
                                              Title: CEO                 1/10/06


                                          ORIT LABORATORIES LLC

                                          By:  /s/ Satish P. Patel
                                              ----------------------------------
                                              Name:  Satish P. Patel
                                              Title: President and CEO   1/10/06





                                       21
<PAGE>


                                    EXHIBIT A

                                DEVELOPMENT PLAN

                      Product Development Activity Schedule

<TABLE>
<CAPTION>
=======================================================================================================================
                                                              RESPONSIBILITY
   #                     ACTIVITIES                        -------------------                  COMMENTS
                                                          ELITE          ORIT
=======================================================================================================================
<S>                                                       <C>            <C>         <C>
         [ * ]
-----------------------------------------------------------------------------------------------------------------------
   1     [ * ]                                            [ * ]          [ * ]      [ * ] from signing of agreement
-----------------------------------------------------------------------------------------------------------------------
   2     [ * ]                                            [ * ]          [ * ]
-----------------------------------------------------------------------------------------------------------------------
         [ * ]                                            [ * ]          [ * ]
-----------------------------------------------------------------------------------------------------------------------
   3     [ * ]                                                                       [ * ] after completion of Step 1
-----------------------------------------------------------------------------------------------------------------------
         [ * ]                                            [ * ]          [ * ]       [ * ] after completion of Step 3
-----------------------------------------------------------------------------------------------------------------------
         [ * ]                                            [ * ]          [ * ]      [ * ] after completion of Step 3A
-----------------------------------------------------------------------------------------------------------------------
         [ * ]                                            [ * ]          [ * ]       [ * ] after signing of agreement
-----------------------------------------------------------------------------------------------------------------------
   4     [ * ]                                            [ * ]          [ * ]
-----------------------------------------------------------------------------------------------------------------------
   5     [ * ]                                            [ * ]          [ * ]
-----------------------------------------------------------------------------------------------------------------------
   6     [ * ]                                                                          [ * ] after completion of
                                                          [ * ]          [ * ]       successful pivotal study report
-----------------------------------------------------------------------------------------------------------------------
   7     [ * ]                                                                              Marketing Partner
-----------------------------------------------------------------------------------------------------------------------
</TABLE>




                                       22