Document:

REGISTRATION RIGHTS AGREEMENT

     This  Registration  Rights Agreement (this "Agreement") is made and entered
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into  as  of  June  6, 2006, among UC Hub Group, Inc., a Nevada corporation (the
"Company"),  and the several purchasers signatory hereto (each such purchaser is
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a "Purchaser" and collectively, the "Purchasers").
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     This Agreement is made pursuant to the Securities Purchase Agreement, dated
as  of  the  date  hereof  between the Company and each Purchaser (the "Purchase
                                                                        --------
Agreement").
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     The Company and each Purchaser hereby agrees as follows:

     1.  Definitions
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     CAPITALIZED TERMS USED AND NOT OTHERWISE DEFINED HEREIN THAT ARE DEFINED IN
THE  PURCHASE AGREEMENT SHALL HAVE THE MEANINGS GIVEN SUCH TERMS IN THE PURCHASE
AGREEMENT.  As  used  in  this  Agreement,  the  following  terms shall have the
following  meanings:

          "Advice"  shall  have  the  meaning  set  forth  in  Section  6(d).
           ------

          "Effectiveness  Date"  means, with respect to the initial Registration
           -------------------
     Statement  required  to be filed hereunder, the 90th calendar day following
     the  date  hereof (the 180th calendar day in the case of a "full review" by
     the  Commission of the initial Registration Statement) and, with respect to
     any  additional  Registration  Statements which may be required pursuant to
     Section 3(c), the 60th calendar day following the date on which the Company
     first  knows,  or  reasonably  should  have  known,  that  such  additional
     Registration  Statement  is  required  hereunder; provided, however, in the
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     event  the  Company  is  notified  by  the Commission that one of the above
     Registration  Statements  will  not  be reviewed or is no longer subject to
     further review and comments, the Effectiveness Date as to such Registration
     Statement  shall  be  the fifth Trading Day following the date on which the
     Company  is  so  notified  if  such date precedes the dates required above.

          "Effectiveness  Period"  shall  have  the meaning set forth in Section
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     2(a).

          "Event" shall have the meaning set forth in Section 2(b).
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          "Event Date" shall have the meaning set forth in Section 2(b).
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          "Filing  Date"  means,  with  respect  to  the  initial  Registration
           ------------
     Statement  required  hereunder,  the  30th  calendar day following the date
     hereof  and,  with  respect to any additional Registration Statements which
     may  be  required pursuant to Section 3(c), the 30th day following the date
     on which the Company first knows, or reasonably should have known that such
     additional  Registration  Statement  is  required  hereunder.

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          "Holder" or "Holders" means the holder or holders, as the case may be,
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     from  time  to  time  of  Registrable  Securities.

          "Indemnified  Party" shall have the meaning set forth in Section 5(c).
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          "Indemnifying Party" shall have the meaning set forth in Section 5(c).
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          "Losses"  shall  have  the  meaning  set  forth  in  Section  5(a).
           ------

          "Plan  of  Distribution"  shall  have the meaning set forth in Section
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     2(a).

          "Prospectus" means the prospectus included in a Registration Statement
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     (including,  without limitation, a prospectus that includes any information
     previously  omitted  from  a  prospectus  filed  as  part  of  an effective
     registration  statement  in  reliance  upon Rule 430A promulgated under the
     Securities  Act),  as amended or supplemented by any prospectus supplement,
     with respect to the terms of the offering of any portion of the Registrable
     Securities  covered  by  a Registration Statement, and all other amendments
     and supplements to the Prospectus, including post-effective amendments, and
     all  material  incorporated  by  reference  or deemed to be incorporated by
     reference  in  such  Prospectus.

          "Registrable  Securities"  means (i) all of the shares of Common Stock
           -----------------------
     issuable  upon  conversion  in  full  of  the  Debentures,  (ii) all shares
     issuable  as principal on the Debentures assuming all permissible principal
     payments  are  made  in  shares of Common Stock and the Debentures are held
     until  maturity,  (iii)  all  Warrant  Shares,  (iv)  any additional shares
     issuable  in connection with any anti-dilution provisions in the Debentures
     or  the Warrants (in each case, without giving effect to any limitations on
     conversion  set forth in the Debenture or limitations on exercise set forth
     in  the  Warrant)  and (v) any securities issued or issuable upon any stock
     split,  dividend  or  other distribution, recapitalization or similar event
     with  respect  to  the  foregoing.

          "Registration Statement" means the registration statements required to
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     be  filed hereunder and any additional registration statements contemplated
     by  Section  3(c),  including (in each case) the Prospectus, amendments and
     supplements  to  such  registration statement or Prospectus, including pre-
     and  post-effective  amendments,  all  exhibits  thereto,  and all material
     incorporated by reference or deemed to be incorporated by reference in such
     registration  statement.

           "Rule  415"  means Rule 415 promulgated by the Commission pursuant to
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     the  Securities  Act, as such Rule may be amended from time to time, or any
     similar  rule  or  regulation  hereafter  adopted  by the Commission having
     substantially  the  same  purpose  and  effect  as  such  Rule.

          "Rule  424"  means  Rule 424 promulgated by the Commission pursuant to
           ---------
     the  Securities  Act, as such Rule may be amended from time to time, or any
     similar  rule  or

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     regulation  hereafter  adopted  by  the Commission having substantially the
     same  purpose  and  effect  as  such  Rule.

          "Selling  Shareholder  Questionnaire" shall have the meaning set forth
           -----------------------------------
     in  Section  3(a).

     2.     Shelf  Registration
            -------------------

          (a)     On or prior to each Filing Date, the Company shall prepare and
     file  with  the  Commission  a  "Shelf" Registration Statement covering the
     resale  of  150%  of  the Registrable Securities on such Filing Date for an
     offering  to  be  made  on  a  continuous  basis  pursuant to Rule 415. The
     Registration  Statement shall be on Form SB-2 (except if the Company is not
     then  eligible  to  register  for resale the Registrable Securities on Form
     SB-2,  in which case such registration shall be on another appropriate form
     in  accordance herewith) and shall contain (unless otherwise directed by at
     least  an  85% majority in interest of the Holders) substantially the "Plan
                                                                            ----
     of  Distribution"  attached hereto as Annex A. Subject to the terms of this
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     Agreement,  the  Company shall use its best efforts to cause a Registration
     Statement  to be declared effective under the Securities Act as promptly as
     possible after the filing thereof, but in any event prior to the applicable
     Effectiveness  Date,  and  shall  use  its  best  efforts  to  keep  such
     Registration  Statement  continuously  effective  under  the Securities Act
     until  all  Registrable  Securities  covered by such Registration Statement
     have been sold, or may be sold without volume restrictions pursuant to Rule
     144(k),  as  determined by the counsel to the Company pursuant to a written
     opinion  letter  to  such  effect, addressed and acceptable to the Transfer
     Agent  and  the  affected Holders (the "Effectiveness Period"). The Company
                                             --------------------
     shall  telephonically  request effectiveness of a Registration Statement as
     of  5:00  p.m.  New  York  City  time  on  a Trading Day. The Company shall
     immediately  notify  the  Holders  via  facsimile of the effectiveness of a
     Registration  Statement  on  the  same  Trading  Day  that  the  Company
     telephonically  confirms  effectiveness with the Commission, which shall be
     the  date  requested  for  effectiveness  of  a Registration Statement. The
     Company shall, by 9:30 a.m. New York City time on the Trading Day after the
     Effective  Date  (as  defined  in  the  Purchase  Agreement),  file a final
     Prospectus  with  the  Commission  as  required  by Rule 424. Failure to so
     notify  the  Holder  within  1  Trading  Day  of  such  notification  of
     effectiveness  or failure to file a final Prospectus as a foresaid shall be
     deemed  an  Event  under  Section  2(b).

          (b)     If:  (i)  a Registration Statement is not filed on or prior to
     its  Filing  Date  (if  the  Company files a Registration Statement without
     affording  the Holders the opportunity to review and comment on the same as
     required by Section 3(a), the Company shall not be deemed to have satisfied
     this  clause  (i)), or (ii) the Company fails to file with the Commission a
     request  for acceleration in accordance with Rule 461 promulgated under the
     Securities  Act,  within  five Trading Days of the date that the Company is
     notified  (orally  or  in  writing, whichever is earlier) by the Commission
     that  a  Registration  Statement  will not be "reviewed," or not subject to
     further review, or (iii) prior to its Effectiveness Date, the Company fails
     to  file  a  pre-effective  amendment  and  otherwise respond in writing to
     comments  made  by  the  Commission  in  respect  of  such  Registration

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     Statement  within  10  calendar  days  after  the receipt of comments by or
     notice  from  the Commission that such amendment is required in order for a
     Registration  Statement  to  be  declared effective, or (iv) a Registration
     Statement filed or required to be filed hereunder is not declared effective
     by the Commission by its Effectiveness Date, or (v) after the Effectiveness
     Date, a Registration Statement ceases for any reason to remain continuously
     effective  as  to all Registrable Securities for which it is required to be
     effective,  or  the  Holders  are  otherwise  not  permitted to utilize the
     Prospectus  therein  to resell such Registrable Securities for more than 10
     consecutive  calendar  days  or  more than an aggregate of 15 calendar days
     during  any  12-month  period (which need not be consecutive calendar days)
     (any  such  failure  or  breach  being  referred  to as an "Event", and for
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     purposes  of clause (i) or (iv) the date on which such Event occurs, or for
     purposes  of  clause (ii) the date on which such five Trading Day period is
     exceeded,  or  for purposes of clause (iii) the date which such 10 calendar
     day  period  is  exceeded,  or for purposes of clause (v) the date on which
     such  10  or  15  calendar  day  period,  as  applicable, is exceeded being
     referred  to  as  "Event  Date"),  then in addition to any other rights the
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     Holders may have hereunder or under applicable law, on each such Event Date
     and  on each monthly anniversary of each such Event Date (if the applicable
     Event shall not have been cured by such date) until the applicable Event is
     cured,  the  Company shall pay to each Holder an amount in cash, as partial
     liquidated  damages  and  not  as  a  penalty,  equal  to 2% of the initial
     Principal  Amount  of the Debenture held by such Holder, provided that such
     liquidated  damages  hereunder shall not exceed an aggregate of $60,480. If
     the  Company  fails  to pay any partial liquidated damages pursuant to this
     Section  in full within 7 days after the date payable, the Company will pay
     interest  thereon at a rate of 18% per annum (or such lesser maximum amount
     that  is  permitted  to  be paid by applicable law) to the Holder, accruing
     daily  from  the  date  such  partial liquidated damages are due until such
     amounts,  plus  all  such  interest  thereon, are paid in full. The partial
     liquidated  damages  pursuant  to  the  terms hereof shall apply on a daily
     pro-rata  basis  for  any portion of a month prior to the cure of an Event.

     3.     Registration  Procedures.
            ------------------------

     In  connection  with  the Company's registration obligations hereunder, the
Company  shall:

          (a)     Not  less  than  5  Trading  Days  prior to the filing of each
     Registration  Statement  and  not  less  than  one Trading Day prior to the
     filing  of  any  related  Prospectus or any amendment or supplement thereto
     (including  any  document  that  would  be  incorporated  or  deemed  to be
     incorporated  therein by reference), the Company shall, (i) furnish to each
     Holder  copies  of all such documents proposed to be filed, which documents
     (other  than  those incorporated or deemed to be incorporated by reference)
     will  be subject to the review of such Holders, and (ii) cause its officers
     and  directors,  counsel  and  independent  certified public accountants to
     respond  to such inquiries as shall be necessary, in the reasonable opinion
     of  respective counsel to each Holder to conduct a reasonable investigation
     within  the  meaning  of  the  Securities Act. The Company shall not file a
     Registration  Statement  or  any  such  Prospectus  or  any  amendments  or
     supplements  thereto  to which the Holders of a majority of the Registrable
     Securities  shall  reasonably

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     object  in  good  faith,  provided  that,  the  Company is notified of such
     objection  in  writing  no later than 5 Trading Days after the Holders have
     been so furnished copies of a Registration Statement or 1 Trading Day after
     the  Holders  have  been  so  furnished copies of any related Prospectus or
     amendments  or  supplements  thereto.  Each Holder agrees to furnish to the
     Company a completed Questionnaire in the form attached to this Agreement as
     Annex  B  (a "Selling Shareholder Questionnaire") not less than two Trading
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     Days  prior  to  the  Filing  Date  or by the end of the fourth Trading Day
     following  the  date  on  which  such  Holder  receives  draft materials in
     accordance  with  this  Section.

          (b)     (i)  Prepare  and  file  with  the Commission such amendments,
     including  post-effective  amendments,  to a Registration Statement and the
     Prospectus  used  in  connection  therewith  as  may be necessary to keep a
     Registration  Statement  continuously  effective  as  to  the  applicable
     Registrable  Securities  for  the Effectiveness Period and prepare and file
     with  the  Commission  such  additional Registration Statements in order to
     register  for  resale  under  the  Securities  Act  all  of the Registrable
     Securities; (ii) cause the related Prospectus to be amended or supplemented
     by  any  required  Prospectus  supplement  (subject  to  the  terms of this
     Agreement),  and as so supplemented or amended to be filed pursuant to Rule
     424;  (iii)  respond  as  promptly  as  reasonably possible to any comments
     received  from  the  Commission with respect to a Registration Statement or
     any  amendment  thereto  and as promptly as reasonably possible provide the
     Holders  true  and  complete  copies  of all correspondence from and to the
     Commission  relating to a Registration Statement (provided that the Company
     may  excise  any  information  contained  therein  which  would  constitute
     material  non-public  information as to any Holder which has not executed a
     confidentiality  agreement  with  the  Company);  and  (iv)  comply  in all
     material  respects  with  the  provisions  of  the  Securities  Act and the
     Exchange  Act with respect to the disposition of all Registrable Securities
     covered  by  a  Registration  Statement  during  the  applicable  period in
     accordance  (subject  to  the  terms  of  this Agreement) with the intended
     methods  of  disposition  by  the  Holders  thereof  set  forth  in  such
     Registration  Statement  as  so  amended  or  in  such  Prospectus  as  so
     supplemented.

          (c)     If  during the Effectiveness Period, the number of Registrable
     Securities  at any time exceeds 90% of the number of shares of Common Stock
     then registered in a Registration Statement, then the Company shall file as
     soon  as  reasonably  practicable  but  in any case prior to the applicable
     Filing  Date,  an  additional Registration Statement covering the resale by
     the  Holders  of  not  less  than  130%  of  the number of such Registrable
     Securities.

          (d)     Notify the Holders of Registrable Securities to be sold (which
     notice shall, pursuant to clauses (iii) through (vi) hereof, be accompanied
     by  an instruction to suspend the use of the Prospectus until the requisite
     changes  have  been  made)  as promptly as reasonably possible (and, in the
     case  of  (i)(A) below, not less than one Trading Day prior to such filing)
     and  (if  requested  by  any such Person) confirm such notice in writing no
     later  than  one  Trading Day following the day (i)(A) when a Prospectus or
     any  Prospectus  supplement  or  post-effective amendment to a Registration
     Statement  is  proposed  to  be filed; (B) when the Commission notifies the
     Company whether there will be a "review" of such Registration Statement and
     whenever  the  Commission  comments  in  writing  on

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     such  Registration  Statement;  and  (C)  with  respect  to  a Registration
     Statement  or  any  post-effective  amendment,  when  the  same  has become
     effective;  (ii)  of  any request by the Commission or any other Federal or
     state  governmental  authority  for  amendments  or  supplements  to  a
     Registration  Statement  or Prospectus or for additional information; (iii)
     of  the  issuance  by  the  Commission  or  any  other  federal  or  state
     governmental  authority of any stop order suspending the effectiveness of a
     Registration Statement covering any or all of the Registrable Securities or
     the  initiation of any Proceedings for that purpose; (iv) of the receipt by
     the  Company  of  any  notification  with  respect to the suspension of the
     qualification  or  exemption  from  qualification of any of the Registrable
     Securities  for  sale in any jurisdiction, or the initiation or threatening
     of  any  Proceeding for such purpose; (v) of the occurrence of any event or
     passage  of  time  that  makes  the  financial  statements  included  in  a
     Registration  Statement  ineligible  for inclusion therein or any statement
     made in a Registration Statement or Prospectus or any document incorporated
     or  deemed  to  be incorporated therein by reference untrue in any material
     respect  or  that  requires  any  revisions  to  a  Registration Statement,
     Prospectus  or  other  documents  so  that,  in  the case of a Registration
     Statement  or  the  Prospectus, as the case may be, it will not contain any
     untrue  statement  of  a  material  fact or omit to state any material fact
     required  to be stated therein or necessary to make the statements therein,
     in  light  of the circumstances under which they were made, not misleading;
     and  (vi)  the occurrence or existence of any pending corporate development
     with  respect  to the Company that the Company believes may be material and
     that,  in  the  determination  of  the  Company,  makes  it not in the best
     interest  of  the Company to allow continued availability of a Registration
     Statement  or  Prospectus;  provided  that  any and all of such information
     shall  remain  confidential to each Holder until such information otherwise
     becomes public, unless disclosure by a Holder is required by law; provided,
                                                                       --------
     further,  notwithstanding  each Holder's agreement to keep such information
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     confidential, the Holders make no acknowledgement that any such information
     is  material,  non-public  information.

          (e)     Use  its best efforts to avoid the issuance of, or, if issued,
     obtain  the  withdrawal  of (i) any order suspending the effectiveness of a
     Registration  Statement,  or  (ii)  any suspension of the qualification (or
     exemption from qualification) of any of the Registrable Securities for sale
     in  any  jurisdiction,  at  the  earliest  practicable  moment.

          (f)     Furnish to each Holder, without charge, at least one conformed
     copy  of  each  such  Registration  Statement  and  each amendment thereto,
     including financial statements and schedules, all documents incorporated or
     deemed  to  be incorporated therein by reference to the extent requested by
     such  Person,  and  all  exhibits  to  the  extent requested by such Person
     (including  those  previously  furnished  or  incorporated  by  reference)
     promptly  after  the  filing  of  such  documents  with  the  Commission.

          (g)     Subject  to  the  terms  of this Agreement, the Company hereby
     consents  to  the  use  of such Prospectus and each amendment or supplement
     thereto  by each of the selling Holders in connection with the offering and
     sale  of  the  Registrable  Securities  covered  by such Prospectus and any
     amendment  or  supplement  thereto,  except  after the giving of any notice
     pursuant  to  Section  3(d).

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          (h)     If NASDR Rule 2710 requires any broker-dealer to make a filing
     prior to executing a sale by a Holder, the Company shall (i) make an Issuer
     Filing  with  the  NASDR,  Inc.  Corporate Financing Department pursuant to
     proposed  NASDR  Rule  2710(b)(10)(A)(i),  (ii) respond within five Trading
     Days to any comments received from NASDR in connection therewith, (iii) and
     pay  the  filing  fee  required  in  connection  therewith.

          (i)     Prior to any resale of Registrable Securities by a Holder, use
     its  commercially  reasonable  efforts  to register or qualify or cooperate
     with  the  selling  Holders  in  connection  with  the  registration  or
     qualification (or exemption from the Registration or qualification) of such
     Registrable Securities for the resale by the Holder under the securities or
     Blue  Sky laws of such jurisdictions within the United States as any Holder
     reasonably  requests in writing, to keep each registration or qualification
     (or  exemption  therefrom) effective during the Effectiveness Period and to
     do  any  and  all  other  acts or things reasonably necessary to enable the
     disposition  in such jurisdictions of the Registrable Securities covered by
     each  Registration  Statement;  provided,  that  the  Company  shall not be
     required  to  qualify generally to do business in any jurisdiction where it
     is  not  then  so qualified, subject the Company to any material tax in any
     such jurisdiction where it is not then so subject or file a general consent
     to  service  of  process  in  any  such  jurisdiction.

          (j)     If  requested  by  the  Holders, cooperate with the Holders to
     facilitate the timely preparation and delivery of certificates representing
     Registrable  Securities  to  be  delivered  to  a  transferee pursuant to a
     Registration  Statement,  which  certificates  shall be free, to the extent
     permitted  by  the  Purchase  Agreement, of all restrictive legends, and to
     enable  such  Registrable  Securities  to  be  in  such  denominations  and
     registered  in  such  names  as  any  such  Holders  may  request.

          (k)     Upon  the occurrence of any event contemplated by this Section
     3,  as  promptly as reasonably possible under the circumstances taking into
     account  the Company's good faith assessment of any adverse consequences to
     the Company and its stockholders of the premature disclosure of such event,
     prepare a supplement or amendment, including a post-effective amendment, to
     a  Registration  Statement or a supplement to the related Prospectus or any
     document  incorporated  or  deemed to be incorporated therein by reference,
     and  file  any  other  required  document so that, as thereafter delivered,
     neither a Registration Statement nor such Prospectus will contain an untrue
     statement  of  a material fact or omit to state a material fact required to
     be  stated therein or necessary to make the statements therein, in light of
     the  circumstances  under  which  they  were  made,  not misleading. If the
     Company  notifies the Holders in accordance with clauses (iii) through (vi)
     of  Section  3(d)  above  to  suspend  the  use of any Prospectus until the
     requisite changes to such Prospectus have been made, then the Holders shall
     suspend  use  of  such Prospectus. The Company will use its best efforts to
     ensure  that  the  use  of  the Prospectus may be resumed as promptly as is
     practicable. The Company shall be entitled to exercise its right under this
     Section  3(k)  to  suspend the availability of a Registration Statement and
     Prospectus,  subject  to  the  payment  of  partial

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     liquidated  damages pursuant to Section 2(b), for a period not to exceed 60
     calendar  days (which need not be consecutive days) in any 12 month period.

          (l)     Comply  with  all  applicable  rules  and  regulations  of the
     Commission.

          (m)     The  Company may require each selling Holder to furnish to the
     Company  a  certified  statement as to the number of shares of Common Stock
     beneficially  owned  by such Holder and, if required by the Commission, the
     natural  persons  thereof that have voting and dispositive control over the
     Shares.  During  any  periods  that  the  Company  is  unable  to  meet its
     obligations  hereunder  with respect to the registration of the Registrable
     Securities  solely  because  any  Holder  fails to furnish such information
     within  three Trading Days of the Company's request, any liquidated damages
     that  are  accruing at such time as to such Holder only shall be tolled and
     any  Event  that  may otherwise occur solely because of such delay shall be
     suspended  as  to  such Holder only, until such information is delivered to
     the  Company.

     4.     Registration  Expenses.  All  fees  and  expenses  incident  to  the
            ----------------------
performance  of  or compliance with this Agreement by the Company shall be borne
by  the Company whether or not any Registrable Securities are sold pursuant to a
Registration  Statement.  The  fees  and  expenses  referred to in the foregoing
sentence shall include, without limitation, (i) all registration and filing fees
(including,  without  limitation,  fees and expenses (A) with respect to filings
required  to  be  made with any Trading Market on which the Common Stock is then
listed  for  trading, (B) in compliance with applicable state securities or Blue
Sky  laws  reasonably  agreed  to  by the Company in writing (including, without
limitation, fees and disbursements of counsel for the Company in connection with
Blue  Sky qualifications or exemptions of the Registrable Securities) and (C) if
not  previously  paid  by  the Company in connection with an Issuer Filing, with
respect  to  any  filing  that  may be required to be made by any broker through
which  a  Holder  intends  to  make  sales  of  Registrable Securities with NASD
Regulation,  Inc.  pursuant  to  the  NASD  Rule  2710, so long as the broker is
receiving  no more than a customary brokerage commission in connection with such
sale,  (ii)  printing  expenses  (including,  without  limitation,  expenses  of
printing  certificates  for  Registrable Securities), (iii) messenger, telephone
and  delivery  expenses, (iv) fees and disbursements of counsel for the Company,
(v)  Securities  Act  liability  insurance,  if  the  Company  so  desires  such
insurance,  and  (vi)  fees  and  expenses  of all other Persons retained by the
Company  in connection with the consummation of the transactions contemplated by
this  Agreement.  In  addition,  the Company shall be responsible for all of its
internal  expenses  incurred  in  connection  with  the  consummation  of  the
transactions  contemplated by this Agreement (including, without limitation, all
salaries  and  expenses  of  its  officers  and  employees  performing  legal or
accounting  duties),  the  expense of any annual audit and the fees and expenses
incurred  in  connection  with  the listing of the Registrable Securities on any
securities  exchange  as  required  hereunder.  In no event shall the Company be
responsible  for  any  broker or similar commissions of any Holder or, except to
the  extent  provided  for in the Transaction Documents, any legal fees or other
costs  of  the  Holders.

     5.     Indemnification
            ---------------

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          (a)     Indemnification  by  the  Company.  The  Company  shall,
                  ---------------------------------
     notwithstanding  any  termination  of  this  Agreement,  indemnify and hold
     harmless  each  Holder, the officers, directors, members, partners, agents,
     brokers  (including  brokers  who  offer and sell Registrable Securities as
     principal  as a result of a pledge or any failure to perform under a margin
     call  of  Common  Stock),  investment advisors and employees (and any other
     Persons  with  a  functionally  equivalent  role  of  a Person holding such
     titles, notwithstanding a lack of such title or any other title) of each of
     them,  each  Person  who  controls  any  such Holder (within the meaning of
     Section 15 of the Securities Act or Section 20 of the Exchange Act) and the
     officers,  directors, members, shareholders, partners, agents and employees
     (and  any  other  Persons  with  a functionally equivalent role of a Person
     holding  such  titles,  notwithstanding  a  lack of such title or any other
     title)  of each such controlling Person, to the fullest extent permitted by
     applicable  law,  from  and  against  any  and all losses, claims, damages,
     liabilities,  costs  (including,  without limitation, reasonable attorneys'
     fees) and expenses (collectively, "Losses"), as incurred, arising out of or
                                        ------
     relating  to  (1) any untrue or alleged untrue statement of a material fact
     contained  in  a  Registration  Statement,  any  Prospectus  or any form of
     prospectus  or in any amendment or supplement thereto or in any preliminary
     prospectus,  or  arising  out  of  or  relating  to any omission or alleged
     omission  of  a material fact required to be stated therein or necessary to
     make  the  statements  therein  (in  the  case of any Prospectus or form of
     prospectus or supplement thereto, in light of the circumstances under which
     they were made) not misleading or (2) any violation or alleged violation by
     the Company of the Securities Act, the Exchange Act or any state securities
     law,  or  any  rule  or  regulation  thereunder,  in  connection  with  the
     performance  of its obligations under this Agreement, except to the extent,
     but  only  to  the extent, that (i) such untrue statements or omissions are
     based solely upon information regarding such Holder furnished in writing to
     the Company by such Holder expressly for use therein, or to the extent that
     such information relates to such Holder or such Holder's proposed method of
     distribution  of  Registrable  Securities  and  was  reviewed and expressly
     approved  in  writing  by  such  Holder expressly for use in a Registration
     Statement,  such  Prospectus or such form of Prospectus or in any amendment
     or  supplement  thereto  (it  being understood that the Holder has approved
     Annex A hereto for this purpose) or (ii) in the case of an occurrence of an
     event  of  the  type  specified  in Section 3(d)(iii)-(vi), the use by such
     Holder  of  an  outdated  or  defective  Prospectus  after  the Company has
     notified  such  Holder  in  writing  that  the  Prospectus  is  outdated or
     defective  and  prior  to  the  receipt  by  such  Holder  of  the  Advice
     contemplated in Section 6(d). The Company shall notify the Holders promptly
     of  the  institution, threat or assertion of any Proceeding arising from or
     in connection with the transactions contemplated by this Agreement of which
     the  Company  is  aware.

          (b)     Indemnification  by  Holders. Each Holder shall, severally and
                  ----------------------------
     not  jointly,  indemnify  and  hold  harmless  the  Company, its directors,
     officers,  agents  and  employees,  each  Person  who  controls the Company
     (within  the  meaning of Section 15 of the Securities Act and Section 20 of
     the Exchange Act), and the directors, officers, agents or employees of such
     controlling  Persons,  to  the  fullest extent permitted by applicable law,
     from  and  against all Losses, as incurred, to the extent arising out of or
     based  solely upon: (x) such Holder's failure to comply with the prospectus
     delivery  requirements  of  the Securities Act or (y) any untrue or alleged
     untrue  statement  of  a  material  fact  contained  in

                                        9
<PAGE>
     any  Registration  Statement, any Prospectus, or any form of prospectus, or
     in any amendment or supplement thereto or in any preliminary prospectus, or
     arising  out  of  or  relating  to  any  omission  or alleged omission of a
     material  fact  required  to  be  stated  therein  or necessary to make the
     statements  therein  not  misleading  (i)  to  the  extent, but only to the
     extent,  that  such  untrue  statement  or  omission  is  contained  in any
     information  so  furnished  in  writing  by  such  Holder  to  the  Company
     specifically  for  inclusion  in  such  Registration  Statement  or  such
     Prospectus  or  (ii)  to  the  extent that such information relates to such
     Holder's  proposed method of distribution of Registrable Securities and was
     reviewed and expressly approved in writing by such Holder expressly for use
     in  a  Registration  Statement  (it  being  understood  that the Holder has
     approved  Annex A hereto for this purpose), such Prospectus or such form of
     Prospectus or in any amendment or supplement thereto or (ii) in the case of
     an  occurrence of an event of the type specified in Section 3(d)(iii)-(vi),
     the  use  by  such  Holder of an outdated or defective Prospectus after the
     Company has notified such Holder in writing that the Prospectus is outdated
     or  defective  and  prior  to  the  receipt  by  such  Holder of the Advice
     contemplated  in  Section  6(d).  In  no  event  shall the liability of any
     selling Holder hereunder be greater in amount than the dollar amount of the
     net  proceeds  received  by  such  Holder  upon the sale of the Registrable
     Securities  giving  rise  to  such  indemnification  obligation.

          (c)     Conduct  of  Indemnification  Proceedings.  If  any Proceeding
                  -----------------------------------------
     shall  be  brought  or  asserted  against  any Person entitled to indemnity
     hereunder  (an  "Indemnified Party"), such Indemnified Party shall promptly
                      -----------------
     notify  the Person from whom indemnity is sought (the "Indemnifying Party")
                                                            ------------------
     in  writing,  and the Indemnifying Party shall have the right to assume the
     defense  thereof,  including  the  employment  of  counsel  reasonably
     satisfactory  to  the  Indemnified  Party  and  the payment of all fees and
     expenses  incurred  in  connection with defense thereof; provided, that the
     failure  of any Indemnified Party to give such notice shall not relieve the
     Indemnifying  Party  of  its  obligations  or  liabilities pursuant to this
     Agreement,  except  (and  only)  to  the  extent  that  it shall be finally
     determined by a court of competent jurisdiction (which determination is not
     subject  to  appeal  or  further  review)  that  such  failure  shall  have
     prejudiced  the  Indemnifying  Party.

          An  Indemnified  Party shall have the right to employ separate counsel
     in  any  such Proceeding and to participate in the defense thereof, but the
     fees  and  expenses  of  such  counsel  shall  be  at  the  expense of such
     Indemnified  Party or Parties unless: (1) the Indemnifying Party has agreed
     in  writing to pay such fees and expenses; (2) the Indemnifying Party shall
     have failed promptly to assume the defense of such Proceeding and to employ
     counsel  reasonably  satisfactory  to  such  Indemnified  Party in any such
     Proceeding;  or (3) the named parties to any such Proceeding (including any
     impleaded parties) include both such Indemnified Party and the Indemnifying
     Party, and counsel to the Indemnified Party shall reasonably believe that a
     material  conflict  of interest is likely to exist if the same counsel were
     to  represent  such  Indemnified Party and the Indemnifying Party (in which
     case,  if such Indemnified Party notifies the Indemnifying Party in writing
     that  it  elects  to  employ  separate  counsel  at  the  expense  of  the
     Indemnifying  Party,  the  Indemnifying  Party  shall not have the right to
     assume  the defense thereof and the reasonable fees and expenses of no more
     than  one  separate  counsel  shall  be  at the expense of the Indemnifying
     Party).  The  Indemnifying  Party  shall  not  be  liable

                                       10
<PAGE>
     for  any  settlement  of  any  such Proceeding effected without its written
     consent,  which  consent  shall not be unreasonably withheld or delayed. No
     Indemnifying  Party  shall,  without  the  prior  written  consent  of  the
     Indemnified  Party,  effect  any  settlement  of  any pending Proceeding in
     respect  of  which any Indemnified Party is a party, unless such settlement
     includes  an  unconditional  release  of  such  Indemnified  Party from all
     liability  on  claims  that  are  the  subject  matter  of such Proceeding.

          Subject  to  the  terms  of  this  Agreement,  all reasonable fees and
     expenses  of  the Indemnified Party (including reasonable fees and expenses
     to  the  extent  incurred  in connection with investigating or preparing to
     defend  such  Proceeding  in  a  manner not inconsistent with this Section)
     shall  be  paid  to  the Indemnified Party, as incurred, within ten Trading
     Days  of  written  notice thereof to the Indemnifying Party; provided, that
     the  Indemnified  Party shall promptly reimburse the Indemnifying Party for
     that portion of such fees and expenses applicable to such actions for which
     such  Indemnified  Party  is  judicially  determined  to be not entitled to
     indemnification  hereunder.

          (d)     Contribution.  If  the  indemnification  under Section 5(a) or
                  ------------
     5(b)  is  unavailable  to  an  Indemnified Party or insufficient to hold an
     Indemnified  Party  harmless  for  any Losses, then each Indemnifying Party
     shall  contribute  to the amount paid or payable by such Indemnified Party,
     in  such  proportion as is appropriate to reflect the relative fault of the
     Indemnifying  Party  and  Indemnified Party in connection with the actions,
     statements  or  omissions that resulted in such Losses as well as any other
     relevant  equitable considerations. The relative fault of such Indemnifying
     Party  and  Indemnified  Party  shall  be determined by reference to, among
     other  things,  whether  any  action  in  question, including any untrue or
     alleged untrue statement of a material fact or omission or alleged omission
     of  a  material  fact, has been taken or made by, or relates to information
     supplied by, such Indemnifying Party or Indemnified Party, and the parties'
     relative  intent,  knowledge,  access  to  information  and  opportunity to
     correct  or  prevent such action, statement or omission. The amount paid or
     payable  by  a  party as a result of any Losses shall be deemed to include,
     subject  to  the  limitations  set  forth in this Agreement, any reasonable
     attorneys'  or  other fees or expenses incurred by such party in connection
     with  any  Proceeding  to the extent such party would have been indemnified
     for  such  fees  or  expenses  if  the indemnification provided for in this
     Section  was  available  to  such  party  in  accordance  with  its  terms.

          The  parties  hereto  agree that it would not be just and equitable if
     contribution  pursuant  to  this  Section  5(d) were determined by pro rata
     allocation  or  by  any  other method of allocation that does not take into
     account  the  equitable  considerations  referred  to  in  the  immediately
     preceding  paragraph.  Notwithstanding the provisions of this Section 5(d),
     no  Holder shall be required to contribute, in the aggregate, any amount in
     excess  of  the  amount by which the net proceeds actually received by such
     Holder  from  the  sale  of  the  Registrable  Securities  subject  to  the
     Proceeding exceeds the amount of any damages that such Holder has otherwise
     been  required  to pay by reason of such untrue or alleged untrue statement
     or  omission  or  alleged  omission.

                                       11
<PAGE>
          The  indemnity  and  contribution agreements contained in this Section
     are  in addition to any liability that the Indemnifying Parties may have to
     the  Indemnified  Parties.

     6.     Miscellaneous
            -------------

     (a)     Remedies.  In  the event of a breach by the Company or by a Holder,
             --------
of  any of their respective obligations under this Agreement, each Holder or the
Company,  as  the  case  may  be,  in addition to being entitled to exercise all
rights  granted  by law and under this Agreement, including recovery of damages,
will be entitled to specific performance of its rights under this Agreement. The
Company  and  each Holder agree that monetary damages would not provide adequate
compensation  for  any losses incurred by reason of a breach by it of any of the
provisions of this Agreement and hereby further agrees that, in the event of any
action  for  specific performance in respect of such breach, it shall not assert
or  shall  waive  the  defense  that  a  remedy  at  law  would  be  adequate.

     (b)     No Piggyback on Registrations. Except as set forth on Schedule 6(b)
             -----------------------------                         -------------
attached hereto, neither the Company nor any of its security holders (other than
the  Holders  in  such  capacity  pursuant hereto) may include securities of the
Company  in  the  initial  Registration  Statement  other  than  the Registrable
Securities.  The  Company shall not file any other registration statements until
the  initial  Registration Statement required hereunder is declared effective by
the  Commission,  provided that this Section 6(b) shall not prohibit the Company
from  filing  amendments  to  registration  statements  already  filed.

     (c)     Compliance.  Each  Holder  covenants and agrees that it will comply
             ----------
with the prospectus delivery requirements of the Securities Act as applicable to
it in connection with sales of Registrable Securities pursuant to a Registration
Statement.

     (d)     Discontinued  Disposition. Each Holder agrees by its acquisition of
             -------------------------
Registrable  Securities  that,  upon receipt of a notice from the Company of the
occurrence of any event of the kind described in Section 3(d)(iii) through (vi),
such  Holder  will  forthwith  discontinue  disposition  of  such  Registrable
Securities  under  a  Registration Statement until it is advised in writing (the
"Advice")  by  the  Company that the use of the applicable Prospectus (as it may
 ------
have  been  supplemented  or  amended) may be resumed.  The Company will use its
best efforts to ensure that the use of the Prospectus may be resumed as promptly
as  it practicable.  The Company agrees and acknowledges that any periods during
which  the  Holder is required to discontinue the disposition of the Registrable
Securities  hereunder  shall  be  subject  to  the  provisions  of Section 2(b).

     (e)     Piggy-Back  Registrations.  If at any time during the Effectiveness
             -------------------------
Period  there  is  not  an  effective Registration Statement covering all of the
Registrable  Securities and the Company shall determine to prepare and file with
the  Commission  a  registration  statement  relating to an offering for its own
account  or  the account of others under the Securities Act of any of its equity
securities,  other  than  on Form S-4 or Form S-8 (each as promulgated under the
Securities  Act)  or  their then equivalents relating to equity securities to be
issued  solely  in  connection with any acquisition of any entity or business or
equity  securities  issuable  in

                                       12
<PAGE>
connection  with  the  stock  option  or  other employee benefit plans, then the
Company shall send to each Holder a written notice of such determination and, if
within  fifteen  days  after  the  date of such notice, any such Holder shall so
request in writing, the Company shall include in such registration statement all
or  any  part  of  such  Registrable  Securities  such  Holder  requests  to  be
registered;  provided,  however,  that,  the  Company  shall  not be required to
             --------   -------
register  any  Registrable  Securities  pursuant  to  this Section 6(e) that are
eligible for resale pursuant to Rule 144(k) promulgated under the Securities Act
or  that  are  the  subject  of  a  then  effective  Registration  Statement.

     (f)     Amendments and Waivers. The provisions of this Agreement, including
             ----------------------
the  provisions  of this sentence, may not be amended, modified or supplemented,
and  waivers  or  consents  to  departures from the provisions hereof may not be
given,  unless  the  same shall be in writing and signed by the Company and each
Holder  of  the  then  outstanding  Registrable Securities.  Notwithstanding the
foregoing, a waiver or consent to depart from the provisions hereof with respect
to  a matter that relates exclusively to the rights of Holders and that does not
directly  or  indirectly  affect  the  rights  of  other Holders may be given by
Holders  of  all  of  the Registrable Securities to which such waiver or consent
relates;  provided,  however,  that  the  provisions of this sentence may not be
          --------   -------
amended,  modified,  or supplemented except in accordance with the provisions of
the  immediately  preceding  sentence.

     (g)     Notices.  Any and all notices or other communications or deliveries
             -------
required  or  permitted to be provided hereunder shall be delivered as set forth
in  the  Purchase  Agreement.

     (h)     Successors  and  Assigns. This Agreement shall inure to the benefit
             ------------------------
of  and  be  binding  upon  the  successors and permitted assigns of each of the
parties  and  shall  inure  to  the  benefit of each Holder. The Company may not
assign  (except by merger) its rights or obligations hereunder without the prior
written  consent  of  all  of  the  Holders  of the then-outstanding Registrable
Securities.  Each  Holder  may  assign  their respective rights hereunder in the
manner and to the Persons as permitted under the Purchase Agreement.

     (i)     No  Inconsistent  Agreements.  Neither  the  Company nor any of its
             ----------------------------
Subsidiaries has entered, as of the date hereof, nor shall the Company or any of
its  Subsidiaries,  on  or  after  the  date  of  this Agreement, enter into any
agreement  with  respect  to  its  securities,  that  would  have  the effect of
impairing  the  rights  granted  to  the  Holders in this Agreement or otherwise
conflicts  with  the  provisions  hereof.  Except as set forth on Schedule 6(i),
                                                                  -------------
neither  the Company nor any of its subsidiaries has previously entered into any
agreement granting any registration rights with respect to any of its securities
to  any  Person  that  have  not  been  satisfied  in  full.

     (j)     Execution  and  Counterparts. This Agreement may be executed in two
             ----------------------------
or  more  counterparts, all of which when taken together shall be considered one
and  the  same  agreement and shall become effective when counterparts have been
signed  by each party and delivered to the other party, it being understood that
both parties need not sign the same counterpart. In the event that any signature
is  delivered by facsimile transmission or by e-mail delivery of a ".pdf" format
data  file,  such  signature  shall create a valid and binding obligation of the
party  executing  (or  on whose behalf such signature is executed) with the same
force  and effect as if such facsimile or ".pdf" signature page were an original
thereof.

                                       13
<PAGE>
     (k)     Governing  Law.  All  questions  concerning  the  construction,
             --------------
validity,  enforcement  and interpretation of this Agreement shall be determined
in accordance with the provisions of the Purchase Agreement.

     (l)     Cumulative  Remedies.  The  remedies provided herein are cumulative
             --------------------
and  not  exclusive  of  any  other  remedies  provided  by  law.

     (m)     Severability.  If  any  term, provision, covenant or restriction of
             ------------
this  Agreement  is  held  by  a  court of competent jurisdiction to be invalid,
illegal,  void  or  unenforceable,  the  remainder  of  the  terms,  provisions,
covenants  and  restrictions  set  forth  herein  shall remain in full force and
effect and shall in no way be affected, impaired or invalidated, and the parties
hereto  shall  use  their  commercially reasonable efforts to find and employ an
alternative  means  to achieve the same or substantially the same result as that
contemplated  by  such  term,  provision,  covenant or restriction. It is hereby
stipulated  and declared to be the intention of the parties that they would have
executed  the  remaining  terms,  provisions, covenants and restrictions without
including  any  of such that may be hereafter declared invalid, illegal, void or
unenforceable.

     (n)     Headings.  The headings in this Agreement are for convenience only,
             --------
do  not  constitute  a part of the Agreement and shall not be deemed to limit or
affect  any  of  the  provisions  hereof.

     (o)     Independent  Nature  of  Holders'  Obligations  and  Rights.  The
             -----------------------------------------------------------
obligations  of  each  Holder  hereunder  are  several  and  not  joint with the
obligations of any other Holder hereunder, and no Holder shall be responsible in
any  way  for  the performance of the obligations of any other Holder hereunder.
Nothing  contained herein or in any other agreement or document delivered at any
closing,  and no action taken by any Holder pursuant hereto or thereto, shall be
deemed  to  constitute  the  Holders  as  a partnership, an association, a joint
venture  or  any  other kind of entity, or create a presumption that the Holders
are  in  any  way  acting  in  concert  with  respect to such obligations or the
transactions  contemplated  by  this Agreement. Each Holder shall be entitled to
protect  and enforce its rights, including without limitation the rights arising
out  of this Agreement, and it shall not be necessary for any other Holder to be
joined  as  an  additional  party  in  any  proceeding  for  such  purpose.

                              ********************

                                       14
<PAGE>
     IN  WITNESS  WHEREOF,  the  parties  have executed this Registration Rights
Agreement  as  of  the  date  first  written  above.

                                     UC HUB GROUP, INC.

                                     By:
                                        -----------------------------------
                                        Name:
                                        Title:

                       [SIGNATURE PAGE OF HOLDERS FOLLOWS]

                                       15
<PAGE>
                     [SIGNATURE PAGE OF HOLDERS TO UCHB RRA]

Name of Holder:
               ------------------------

Signature of Authorized Signatory of Holder:
                                            ------------------------

Name of Authorized Signatory:
                             -----------------------

Title of Authorized Signatory:
                              ----------------------

Facsimile of Authorized Signatory:
                                  --------------------

E-mail of Authorized Signatory:
                               -----------------------

                           [SIGNATURE PAGES CONTINUE]

                                       16
<PAGE>
                                                                         ANNEX A
                              Plan of Distribution
                              --------------------

     Each  Selling  Stockholder (the "Selling Stockholders") of the common stock
                                      --------------------
and  any  of their pledgees, assignees and successors-in-interest may, from time
to  time,  sell  any  or all of their shares of common stock on the OTC Bulletin
Board  or  any  other  stock  exchange,  market or trading facility on which the
shares  are  traded  or in private transactions.  These sales may be at fixed or
negotiated  prices.  A  Selling  Stockholder  may  use  any  one  or more of the
following  methods  when  selling  shares:

          -    ordinary  brokerage  transactions  and  transactions in which the
               broker-dealer  solicits  purchasers;

          -    block  trades in which the broker-dealer will attempt to sell the
               shares  as  agent  but  may  position and resell a portion of the
               block  as  principal  to  facilitate  the  transaction;

          -    purchases  by  a  broker-dealer  as  principal  and resale by the
               broker-dealer  for  its  account;

          -    an  exchange  distribution  in  accordance  with the rules of the
               applicable  exchange;

          -    privately  negotiated  transactions;

          -    settlement  of  short sales entered into after the effective date
               of the registration statement of which this prospectus is a part;

          -    broker-dealers  may agree with the Selling Stockholders to sell a
               specified  number of such shares at a stipulated price per share;

          -    through  the  writing  or  settlement of options or other hedging
               transactions,  whether  through an options exchange or otherwise;

          -    a combination of any such methods of sale; or

          -    any other method permitted pursuant to applicable law.

     The  Selling  Stockholders  may  also  sell shares under Rule 144 under the
Securities  Act of 1933, as amended (the "Securities Act"), if available, rather
                                          --------------
than  under  this  prospectus.

     Broker-dealers  engaged  by  the Selling Stockholders may arrange for other
brokers-dealers to participate in sales.  Broker-dealers may receive commissions
or  discounts  from  the  Selling Stockholders (or, if any broker-dealer acts as
agent  for  the  purchaser  of  shares,  from  the  purchaser)  in amounts to be
negotiated,  but, except as set forth in a supplement to this Prospectus, in the
case  of an agency transaction not in excess of a customary brokerage commission
in compliance with NASDR Rule 2440; and in the case of a principal transaction a
markup  or  markdown  in  compliance  with  NASDR  IM-2440.

                                       17
<PAGE>
     In  connection  with the sale of the common stock or interests therein, the
Selling  Stockholders may enter into hedging transactions with broker-dealers or
other  financial  institutions,  which  may in turn engage in short sales of the
common  stock  in  the  course of hedging the positions they assume. The Selling
Stockholders  may  also  sell shares of the common stock short and deliver these
securities  to  close  out  their  short positions, or loan or pledge the common
stock  to  broker-dealers  that  in  turn may sell these securities. The Selling
Stockholders  may  also  enter  into  option  or  other  transactions  with
broker-dealers  or  other  financial institutions or the creation of one or more
derivative  securities which require the delivery to such broker-dealer or other
financial  institution  of  shares offered by this prospectus, which shares such
broker-dealer  or  other  financial  institution  may  resell  pursuant  to this
prospectus  (as  supplemented  or  amended  to  reflect  such  transaction).

     The Selling Stockholders and any broker-dealers or agents that are involved
in  selling  the shares may be deemed to be "underwriters" within the meaning of
the  Securities  Act  in  connection  with  such  sales.  In  such  event,  any
commissions  received  by  such  broker-dealers  or agents and any profit on the
resale  of  the  shares  purchased  by  them  may  be  deemed to be underwriting
commissions or discounts under the Securities Act.  Each Selling Stockholder has
informed  the  Company  that  it  does not have any written or oral agreement or
understanding,  directly or indirectly, with any person to distribute the Common
Stock. In no event shall any broker-dealer receive fees, commissions and markups
which,  in  the  aggregate,  would  exceed  eight  percent  (8%).

     The  Company  is  required to pay certain fees and expenses incurred by the
Company  incident  to the registration of the shares.  The Company has agreed to
indemnify  the  Selling Stockholders against certain losses, claims, damages and
liabilities,  including  liabilities  under  the  Securities  Act.

     Because  Selling Stockholders may be deemed to be "underwriters" within the
meaning  of  the Securities Act, they will be subject to the prospectus delivery
requirements  of the Securities Act including Rule 172 thereunder.  In addition,
any  securities  covered  by  this prospectus which qualify for sale pursuant to
Rule  144  under the Securities Act may be sold under Rule 144 rather than under
this  prospectus.  There  is  no  underwriter  or  coordinating broker acting in
connection  with  the  proposed  sale  of  the  resale  shares  by  the  Selling
Stockholders.

     We  agreed  to  keep this prospectus effective until the earlier of (i) the
date  on  which  the  shares  may  be resold by the Selling Stockholders without
registration  and  without  regard  to  any volume limitations by reason of Rule
144(k)  under the Securities Act or any other rule of similar effect or (ii) all
of  the  shares have been sold pursuant to this prospectus or Rule 144 under the
Securities  Act  or any other rule of similar effect.  The resale shares will be
sold  only  through  registered or licensed brokers or dealers if required under
applicable  state  securities  laws.  In addition, in certain states, the resale
shares may not be sold unless they have been registered or qualified for sale in
the  applicable  state  or  an  exemption from the registration or qualification
requirement  is  available  and  is  complied  with.

     Under  applicable  rules and regulations under the Exchange Act, any person
engaged  in  the distribution of the resale shares may not simultaneously engage
in  market making activities with respect to the common stock for the applicable
restricted  period,  as  defined  in  Regulation

                                       18
<PAGE>
M,  prior  to  the  commencement  of the distribution.  In addition, the Selling
Stockholders  will  be  subject to applicable provisions of the Exchange Act and
the  rules  and  regulations thereunder, including Regulation M, which may limit
the  timing  of purchases and sales of shares of the common stock by the Selling
Stockholders  or  any  other  person.  We  will  make  copies of this prospectus
available  to  the  Selling  Stockholders  and have informed them of the need to
deliver  a  copy of this prospectus to each purchaser at or prior to the time of
the  sale  (including  by  compliance  with  Rule 172 under the Securities Act).

                                       19
<PAGE>
                                                                         ANNEX B

                               UC HUB GROUP, INC.

                 SELLING SECURITYHOLDER NOTICE AND QUESTIONNAIRE

     The  undersigned  beneficial  owner  of  common stock, par value $0.001 per
share  (the  "Common  Stock"),  of UC Hub Group, Inc., a Nevada corporation (the
              -------------
"Company"),  (the  "Registrable  Securities")  understands  that the Company has
 -------            -----------------------
filed  or  intends  to  file  with  the  Securities and Exchange Commission (the
"Commission")  a  registration  statement  on  Form  SB-2  (the  "Registration
 ----------                                                       ------------
Statement") for the registration and resale under Rule 415 of the Securities Act
---------
of  1933,  as  amended (the "Securities Act"), of the Registrable Securities, in
                             --------------
accordance with the terms of the Registration Rights Agreement, dated as of June
6,  2006  (the  "Registration  Rights  Agreement"),  among  the  Company and the
                 -------------------------------
Purchasers  named  therein.  A  copy  of  the  Registration  Rights Agreement is
available  from  the  Company  upon request at the address set forth below.  All
capitalized  terms not otherwise defined herein shall have the meanings ascribed
thereto  in  the  Registration  Rights  Agreement.

     Certain  legal  consequences  arise  from  being  named  as  a  selling
securityholder  in  the  Registration  Statement  and  the  related  prospectus.
Accordingly, holders and beneficial owners of Registrable Securities are advised
to  consult their own securities law counsel regarding the consequences of being
named  or  not  being  named  as  a  selling  securityholder in the Registration
Statement  and  the  related  prospectus.

                                     NOTICE

     The  undersigned  beneficial  owner  (the  "Selling  Securityholder")  of
                                                 -----------------------
Registrable Securities hereby elects to include the Registrable Securities owned
by  it and listed below in Item 3 (unless otherwise specified under such Item 3)
in  the  Registration  Statement.

                                       20
<PAGE>
The  undersigned  hereby  provides  the following information to the Company and
represents  and  warrants  that  such  information  is  accurate:

                                  QUESTIONNAIRE

1.   NAME.

     (a)  Full Legal Name of Selling Securityholder

             -------------------------------------------------------------------

     (b)     Full Legal Name of Registered Holder (if not the same as (a) above)
             through  which  Registrable  Securities  Listed in Item 3 below are
             held:

             -------------------------------------------------------------------

     (c)     Full  Legal  Name  of Natural Control Person (which means a natural
             person  who  directly  or indirectly alone or with others has power
             to  vote  or  dispose  of  the  securities  covered  by  the
             questionnaire):

             -------------------------------------------------------------------

2.  ADDRESS FOR NOTICES TO SELLING SECURITYHOLDER:

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
  Telephone:
            --------------------------------------------------------------------
  Fax:
      --------------------------------------------------------------------------
  Contact Person:
                 ---------------------------------------------------------------

3.  BENEFICIAL OWNERSHIP OF REGISTRABLE SECURITIES:

     (a)     Type  and  Principal  Amount of Registrable Securities beneficially
             Owned  (not  including the Registrable Securities that are issuable
             pursuant  to  the  Purchase  Agreement):

             -------------------------------------------------------------------

             -------------------------------------------------------------------

             -------------------------------------------------------------------

                                       21
<PAGE>
4.  BROKER-DEALER STATUS:

     (a)     Are  you  a  broker-dealer?

                               Yes [_]     No [_]

     (b)     If  "yes"  to  Section  4(a),  did  you  receive  your  Registrable
               Securities as compensation for investment banking services to the
               Company.

                               Yes [_]     No [_]

     Note:   If  no,  the  Commission's  staff  has indicated that you should be
             identified  as  an  underwriter  in  the  Registration  Statement.

     (c)     Are  you  an  affiliate  of  a  broker-dealer?

                               Yes [_]     No [_]

     (d)     If you are an affiliate of a broker-dealer, do you certify that you
             bought  the  Registrable  Securities  in  the  ordinary  course  of
             business,  and  at  the  time  of  the  purchase of the Registrable
             Securities  to  be resold, you had no agreements or understandings,
             directly  or  indirectly,  with  any  person  to  distribute  the
             Registrable  Securities?

                               Yes [_]     No [_]

     Note:   If  no,  the  Commission's  staff  has indicated that you should be
             identified  as  an  underwriter  in  the  Registration  Statement.

5.  BENEFICIAL OWNERSHIP OF OTHER SECURITIES OF THE COMPANY OWNED BY THE SELLING
             SECURITYHOLDER.

     Except  as  set  forth  below  in  this  Item 5, the undersigned is not the
     beneficial  or registered owner of any securities of the Company other than
     the  Registrable  Securities  listed  above  in  Item  3.

     (a)     Type  and  Amount  of  Other  Securities  beneficially owned by the
             Selling  Securityholder:

             -------------------------------------------------------------------

             -------------------------------------------------------------------

                                       22
<PAGE>
6.  RELATIONSHIPS WITH THE COMPANY:

     Except  as  set  forth  below,  neither  the  undersigned  nor  any  of its
     affiliates,  officers,  directors or principal equity holders (owners of 5%
     of  more of the equity securities of the undersigned) has held any position
     or  office  or has had any other material relationship with the Company (or
     its  predecessors  or  affiliates)  during  the  past  three  years.

     State any exceptions here:

     ---------------------------------------------------------------------------

     ---------------------------------------------------------------------------

     The  undersigned  agrees to promptly notify the Company of any inaccuracies
or  changes  in the information provided herein that may occur subsequent to the
date  hereof  at  any  time  while the Registration Statement remains effective.

     By  signing  below,  the  undersigned  consents  to  the  disclosure of the
information  contained  herein  in  its  answers  to  Items  1 through 6 and the
inclusion  of  such  information  in  the Registration Statement and the related
prospectus  and  any  amendments  or  supplements  thereto.  The  undersigned
understands  that  such  information  will  be  relied  upon  by  the Company in
connection  with  the preparation or amendment of the Registration Statement and
the  related  prospectus.

     IN  WITNESS  WHEREOF  the  undersigned, by authority duly given, has caused
this  Notice  and Questionnaire to be executed and delivered either in person or
by  its  duly  authorized  agent.

Dated:                                  Beneficial Owner:
      -----------------------------                      -----------------------

                                        By:
                                           -------------------------------------
                                           Name:
                                           Title:

PLEASE  FAX  A  COPY OF THE COMPLETED AND EXECUTED NOTICE AND QUESTIONNAIRE, AND
RETURN  THE  ORIGINAL  BY  OVERNIGHT  MAIL,  TO:

                                       23Exhibit 10.17

    
      

    

    
       

      Exhibit
        10.17

      

      Subject
        to a request for confidential treatment, certain provisions of this agreement
        have been intentionally omitted. The omitted portions subject to the
        confidential treatment request are designated by three asterisks (***). A
        complete version of this agreement has been separately filed with the Securities
        and Exchange Commission.

      

      NRP104

      

      ACTIVE
        PHARMACEUTICAL INGREDIENT

      

      SUPPLY
        AGREEMENT

       

      by
        and
        between

      

      
        	
                Supplier
                  Name:

              	 	
                Organichem
                  Corporation

              
	 	 	 
	
                Address:

              	 	
                33
                  Riverside Avenue

                Rensselaer,
                  New York 12144

              

      

      

      (“ORGANICHEM”)

       

      and

      

      
        	
                Sponsor
                  Name:

              	 	
                NEW
                  RIVER Pharmaceuticals Inc.

              
	 	 	 
	
                Address:

              	 	
                1881
                  Grove Avenue

                Radford,
                  Virginia 24141

              

      

      

      (“NEW
        RIVER”)

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

       

      TABLE
        OF
        CONTENTS

      

      
        	 	 	 	
                PAGE

              
	 	 	 	
                 

              
	
                ARTICLE
                  1.

              	 	
                DEFINITIONS.
                  

              	
                2

              
	 	 	 	 
	
                ARTICLE
                  2.

              	 	
                MANUFACTURE.
                  

              	
                5

              
	 	 	 	 
	
                ARTICLE
                  3.

              	 	
                PURCHASE
                  ORDERS, TESTING AND SUPPLY. 

              	
                8

              
	 	 	 	 
	
                ARTICLE
                  4.

              	 	
                FORECASTS
                  AND FIRM ORDERS. 

              	
                12

              
	 	 	 	 
	
                ARTICLE
                  5.

              	 	
                SHIPPING
                  AND DELIVERY; ACCEPTANCE AND REJECTION. 

              	
                15

              
	 	 	 	 
	
                ARTICLE
                  6. 

              	 	
                PRICE
                  FOR BULK API. 

              	
                17

              
	 	 	 	 
	
                ARTICLE
                  7.

              	 	
                PAYMENT.
                  

              	
                19

              
	 	 	 	 
	
                ARTICLE
                  8.

              	 	
                TERM.
                  

              	
                19

              
	 	 	 	 
	
                ARTICLE
                  9.

              	 	
                TERMINATION.
                  

              	
                19

              
	 	 	 	 
	
                ARTICLE
                  10.

              	 	
                ORGANICHEM
                  REPRESENTATIONS, WARRANTIES AND COVENANTS. 

              	
                23

              
	 	 	 	 
	
                ARTICLE
                  11.

              	 	
                INSPECTIONS,
                  RECALLS AND SEIZURES. 

              	
                26

              
	 	 	 	 
	
                ARTICLE
                  12. 

              	 	
                LIABILITY
                  AND INSURANCE. 

              	
                28

              
	 	 	 	 
	
                ARTICLE
                  13. 

              	 	
                INDEMNIFICATION.
                  

              	
                29

              
	 	 	 	 
	
                ARTICLE
                  14. 

              	 	
                CONFIDENTIALITY
                  AND NON-USE. 

              	
                30

              
	 	 	 	 
	
                ARTICLE
                  15. 

              	 	
                INTELLECTUAL
                  PROPERTY. 

              	
                31

              
	 	 	 	 
	
                ARTICLE
                  16. 

              	 	
                ASSIGNMENT.
                  

              	
                32

              
	 	 	 	 
	
                ARTICLE
                  17. 

              	 	
                CHOICE
                  OF LAW; JURISDICTION. 

              	
                33

              
	 	 	 	 
	
                ARTICLE
                  18.

              	 	
                FORCE
                  MAJEURE. 

              	
                33

              
	 	 	 	 
	
                ARTICLE
                  19. 

              	 	
                SEVERABILITY.
                  

              	
                33

              
	 	 	 	 
	
                ARTICLE
                  20.

              	 	
                HEADINGS.
                  

              	
                34

              
	 	 	 	 
	
                ARTICLE
                  21.

              	 	
                 USE
                  OF NAMES. 

              	
                34

              
	 	 	 	 
	
                ARTICLE
                  22.

              	 	
                 INDEPENDENT
                  CONTRACTOR. 

              	
                34

              
	 	 	 	 
	
                ARTICLE
                  23.

              	 	
                WAIVER.
                  

              	
                34

              
	 	 	 	 
	
                ARTICLE
                  24.

              	 	
                PUBLIC
                  DISCLOSURE. 

              	
                35

              
	 	 	 	 
	
                ARTICLE
                  25. 

              	 	
                NOTICES.
                  

              	
                35

              
	 	 	 	 
	
                ARTICLE
                  26.

              	 	
                ENTIRE
                  AGREEMENT. 

              	
                36

              
	
                 

              	 	 	 
	
                [***].

              	 	 	
                 

              
	 	 	 	 
	
                APPENDIX
                  B

              	 	
                MUTUAL
                  CONFIDENTIALITY AGREEMENT.

              	
                 

              
	 	 	 	 
	
                APPENDIX
                  C 

              	 	
                QUALITY
                  AGREEMENT.

              	
                 

              
	 	 	 	 
	
                APPENDIX
                  D

              	 	
                LIST
                  OF SCHEDULES.

              	
                 

              

      

      
        
          
          

        

        
          -i-

          
            

          

        

        
          
          

        

      

      ACTIVE
        PHARMACEUTICAL INGREDIENT 

      SUPPLY
        AGREEMENT

       

      THIS
        SUPPLY
        AGREEMENT
        (the
“Agreement”) is entered into as of May 18, 2006 (the “Effective Date”), by and
        between ORGANICHEM
        CORPORATION,
        a
        Delaware corporation, with offices at 33 Riverside Avenue, Rensselaer, New
        York
        12144 (“ORGANICHEM”) and NEW
        RIVER PHARMACEUTICALS INC.,
        a
        Virginia corporation, with corporate offices at 1881 Grove Avenue, Radford,
        Virginia 24141 and its designees (“NEW RIVER”).

       

      WHEREAS,
        ORGANICHEM is a contract manufacturer of bulk active ingredients with expertise
        in current Good Manufacturing Practices;

       

      WHEREAS,
        NEW RIVER is a specialty pharmaceutical company engaged in the discovery,
        development and commercialization of novel pharmaceutical products, including
        NRP104;

       

      WHEREAS,
        ORGANICHEM and NEW RIVER (collectively, the “parties”), desire to establish
        mutually agreeable terms for the non-exclusive supply of NRP104 by ORGANICHEM
        to
        NEW RIVER;

       

      WHEREAS,
        ORGANICHEM and NEW RIVER intend to implement this Agreement in connection
        with a
        separate Quality Agreement subject to and incorporating by reference the
        terms
        of this Agreement; and

       

      WHEREAS,
        ORGANICHEM’s manufacturing location for NRP104 is 33 Riverside Avenue,
        Rensselaer, New York 12144;

       

      NOW,
        THEREFORE, in consideration of: (i) ORGANICHEM’s agreement to contract
        manufacture and supply NRP104 to NEW RIVER for the monetary amounts set forth
        in
        this Agreement; (ii) the promises, covenants, agreements and other valuable
        consideration hereinafter set forth, the parties hereby agree as
        follows.

      
        
          
          

        

        
          Page
            1
            of 37

          
            

          

        

        
          
          

        

      

      

      
        	
                ARTICLE
                  1.

              	
                DEFINITIONS.
                  

              

      

       

      As
        used
        in this Agreement, the following words and phrases shall have the meanings
        provided below:

       

      “Act”
        shall
        mean the United States Food, Drug and Cosmetic Act, as amended, and rules
        and
        regulations promulgated thereunder;

       

      “Affiliate”
        means
        any
        individual or entity directly or indirectly controlling, controlled by, or
        under
        common control with such party. For purposes of this definition, “control” means
        the direct or indirect ownership of at least fifty percent (50%) of the
        outstanding voting securities of a party, or the right to control the policy
        decisions of such party;

       

      “Analytical
        Method(s)”
        shall
        mean the following tasks necessary for analytical methods development with
        respect to the API: [***]

       

      “API”
        or “Active Pharmaceutical Ingredient”
        shall
        mean the active pharmaceutical ingredient designated by NEW RIVER as NRP104
        as
        described in the Specifications;

       

      “Applicable
        Laws”
        means
        (a) all applicable U.S. federal, state, and local law, rules, and regulations,
        including, without limitation, the United States Federal Food, Drug and Cosmetic
        Act, as amended, FDA regulations, the Controlled Substances Act, as amended,
        and
        DEA regulations, and (b) all applicable laws, statutes, rules, codes,
        regulations, orders, judgments and/or ordinances of Canada,
        Japan, or any country of the European Union (including any federal, state,
        provincial, or local political subdivision thereof) in which API is
        marketed;

       

      “Certificate
        of Analysis” or “COA”
        shall
        mean the certificate attesting to the attributes for each batch of API delivered
        hereunder in the form contemplated by Section 3.05 of this
        Agreement;

       

      “Certificate
        of Compliance” or
        “COC”
        shall
        mean the certificate stating the batch has been manufactured according to
        the
        relevant guidelines established by the FDA, including cGMP;

      
        
          
          

        

        
          Page
            2
            of 37

          
            

          

        

        
          
          

        

      

      

      “cGMP”
        or “current Good Manufacturing Practices” shall
        mean the current Good Manufacturing Practice regulations and guidelines as
        promulgated by the United States Food and Drug Administration and the equivalent
        regulatory authorities of Canada, Japan, or the European Union, including
        any
        federal, state, provincial, or local political subdivision thereof in which
        API
        is marketed.
        cGMP
        shall
        include but not be limited to 21 CFR Part 210 and FDA Q7A Good Manufacturing
        Practice Guidance for Active Pharmaceutical Ingredients;

      

      “Critical
        Materials” shall
        have the meaning set forth in the Quality Agreement;

       

      “DEA”
        shall
        mean the United States Drug Enforcement Administration;

       

      “Delivery
        Date” shall
        mean the requested delivery date for API supplied under this Agreement, as
        set
        forth in the applicable accepted Purchase Order;

       

      “Drug
        Product”
        shall
        mean any and all pharmaceutical preparations suitable for human use which
        contain API that has been manufactured by ORGANICHEM pursuant to this
        Agreement;

       

      “FDA
        or Food and Drug Administration” shall
        mean the United States Food and Drug Administration, or any successor entity
        thereto;

       

      “Gm”
        shall
        mean grams;

       

      “Improvement
        Program”
        shall
        have the meaning set forth in Section 6.04;

       

      “Intellectual
        Property”
        includes, without limitation, rights in patents, patent applications, formulae,
        trademarks, trademark applications, tradenames, Inventions, copyrights and
        industrial designs, relating specifically to the Manufacture of
        API;

       

      “Invention”
        means
        information relating to any data, innovation, improvement, development,
        discovery, computer program, device, trade secret, method, know-how, process,
        technique or the like, whether or not written or otherwise fixed in any form
        or
        medium, regardless of the media on which it is contained and whether or not
        patentable or copyrightable; 

       

      “Kg”
        shall
        mean kilograms;

      
        
          
          

        

        
          Page
            3
            of 37

          
            

          

        

        
          
          

        

      

      

      “Manufacture”
        and “Manufacturing”
        means
        all steps and activities necessary to produce the API, including the
        manufacturing, processing, quality control, quality assurance, testing, and
        release of the API in compliance with the terms and conditions of this Agreement
        and the Quality Agreement;

       

      “Mutual
        Confidentiality Agreement”
        shall
        mean the Non-Disclosure & Confidentiality Agreement entered into between NEW
        RIVER and Albany Molecular Research, Inc. (on its own behalf and for Organichem)
        with an Effective Date of March 27, 2003;

       

      “NDA”
        or “New Drug Application”
        shall
        mean NEW RIVER’s New Drug Application covering API and filed by NEW RIVER with
        the FDA pursuant to section 505 of the Act;

       

      “Near-Term
        Forecast” shall
        mean the estimated requirements of API for the first [***] [***] of a [***]
        forecast provided by NEW RIVER pursuant to Section 4.01, as set forth on
        such
        forecast;

       

      “Process
        Transfer Plan”
        shall
        have the meaning set forth in Section 9.08;

       

      “Purchase
        Order”
        shall
        mean the NEW RIVER documentation that sets forth the [***], as more fully
        described in Sections 3.01 and 4.02;

      

        “Quality
          Agreement”
          shall
          mean the Quality Agreement between NEW RIVER and ORGANICHEM set forth in
          Appendix
          C
          hereof
          which Appendix is incorporated in and made a part of this
          Agreement;

      

       

      “Raw
        Materials” shall
        mean the materials and ingredients required to be used by ORGANICHEM for
        the
        manufacture of API;

       

      “Regulatory
        Authority(ies)” shall
        mean the FDA as well as other applicable U.S. and foreign
        authorities;

       

      “Services”
        shall
        mean the manufacturing, quality control, quality assurance and stability
        testing, Analytical Methods and related services required for ORGANICHEM
        to
        Manufacture and supply API to NEW RIVER or its designee as contemplated in
        this
        Agreement;

       

      
        
          
          

        

        
          Page
            4
            of 37

          
            

          

        

        
          
          

        

      

       

      “Sourcing
        Date”
        shall
        mean the date of the first delivery of API to NEW RIVER following FDA approval
        of NEW RIVER’s NDA for API;

      

      “Specifications”
        shall
        mean the specifications for API set forth in the Quality Agreement attached
        hereto as Appendix
        C;

       

      “Term”
        shall
        have the meaning set forth in Article 8;

       

      “Validation
        Protocol”
        shall
        mean the validation of lots of API under a validation protocol prepared in
        accordance with the Quality Agreement. 

       

      
        	
                ARTICLE
                  2.

              	
                MANUFACTURE.
                  

              

      

       

      
        	
                2.01

              	
                The
                  parties shall negotiate and agree to a Quality Agreement which
                  shall
                  govern all quality related matters pertaining to each party’s obligations
                  hereunder.

              

      

      

      
        	
                2.02

              	
                During
                  the term and pursuant to the conditions of this Agreement, ORGANICHEM
                  shall provide the Services in accordance with the Specifications,
                  cGMP,
                  the terms of the Quality Agreement, and all Applicable Laws, including,
                  but not limited to, those dealing with occupational safety and
                  health,
                  those dealing with public safety and health, those dealing with
                  protecting
                  the environment, and those dealing with disposal of wastes. During
                  the
                  term of this Agreement, ORGANICHEM shall not Manufacture and/or
                  supply
                  API, or perform any other Services with respect to API, for any
                  person or
                  entity other than NEW RIVER or its
                  designees.

              

      

       

      
        	
                2.03

              	
                ORGANICHEM
                  shall purchase, test and store at no cost to NEW RIVER, a stock
                  of Raw
                  Materials equivalent to a [***] supply of API based upon the most
                  recent
                  forecast provided by NEW RIVER in accordance with Article 4 hereunder.
                  ORGANICHEM shall use and rotate the Raw Material in accordance
                  with its
                  own inventory management policies. Such policies shall be made
                  available
                  to NEW RIVER upon prior written request. ORGANICHEM shall be responsible
                  for obtaining, at its own expense, sufficient quantities of Raw
                  Materials
                  for the Manufacture of API to meet [***] [***] of the most recent
                  Near-Term Forecast. On NEW RIVER’S written request, ORGANICHEM shall
                  notify NEW RIVER of its inventory of Raw Materials and its arrangements
                  for further supply. The parties acknowledge that certain of the
                  Raw
                  Materials may not be immediately available from approved vendors
                  and/or
                  may require government approval prior to their purchase. The parties
                  agree
                  to reasonably cooperate to minimize the impact such lead times
                  or
                  government approvals may have upon ORGANICHEM’s production schedule and,
                  provided that ORGANICHEM
                  has acted in good faith to meet its obligations hereunder, failure
                  to
                  comply strictly with the provisions of this Section 2.03 for reasons
                  beyond its direct control shall not constitute a breach of this
                  Agreement.

              

      

      
        
          
          

        

        
          Page
            5
            of 37

          
            

          

        

        
          
          

        

      

      

      
        	
                2.04

              	
                ORGANICHEM
                  agrees to Manufacture reasonable quantities of analytical reference
                  standards as needed for testing of the API and the Drug Product
                  and to
                  supply them at cost to NEW RIVER for its use or the use by third
                  party
                  suppliers to NEW RIVER or its designee. ORGANICHEM agrees, upon
                  NEW
                  RIVER’s written request,
                  to
                  furnish written procedures for the preparation of the mutually
                  agreed list
                  of analytical reference standards to NEW
                  RIVER.

              

      

       

      
        	
                2.05

              	
                ORGANICHEM
                  shall be responsible for all process and equipment validation and
                  shall
                  take all reasonable steps necessary to pass government inspection
                  by the
                  applicable Regulatory Authority. ORGANICHEM shall be responsible
                  for
                  system suitability confirmation and confirmation of API Analytical
                  Methods
                  as required in this Agreement.

              

      

       

      
        	
                2.06

              	
                In
                  accordance with cGMP, ORGANICHEM shall take all steps necessary
                  to ensure
                  that any API that may be produced by it pursuant to this Agreement
                  shall
                  be free of cross-contamination from any other manufacturing or
                  similar
                  activities and be responsible for validated cleaning and changeover
                  procedures prior to Manufacturing any API for NEW
                  RIVER.

              

      

       

      
        	
                2.07

              	
                ORGANICHEM
                  agrees to Manufacture API for NEW RIVER only at ORGANICHEM’s facilities
                  located at 33 Riverside Avenue, Rensselaer, New York 12144. ORGANICHEM
                  shall not Manufacture the API at a different location without first
                  obtaining the prior written consent of NEW RIVER, which consent
                  shall not
                  be unreasonably delayed or withheld. The cost of any such change
                  in
                  location shall be borne solely by
                  ORGANICHEM.

              

      

       

      
        
          
          

        

        
          Page
            6
            of 37

          
            

          

        

        
          
          

        

      

      

      
        	
                2.08

              	
                ORGANICHEM
                  will use commercially reasonable efforts to obtain all necessary
                  regulatory permissions, permits, and licenses to Manufacture API
                  based on
                  the applicable DEA schedule and [***] of the highest annual volume
                  of API
                  set forth in the Tiered Commercial Quote attached hereto as Appendix
                  A
                  provided that NEW RIVER has furnished to ORGANICHEM all reasonably
                  necessary
                  supporting documentation to permit ORGANICHEM to obtain such regulatory
                  permission, permits, and licenses.

              

      

       

      
        	
                2.09

              	
                ORGANICHEM
                  shall reasonably assist NEW RIVER in preparing and updating any
                  required
                  regulatory submissions and all other documents required by the
                  Regulatory
                  Authorities from NEW RIVER for approval of the API under the terms
                  sent
                  forth in an applicable Statement of Work, which will be mutually
                  agreed
                  upon in writing by NEW RIVER and ORGANICHEM and, upon such mutual
                  agreement, deemed incorporated into this
                  Agreement.

              

      

       

      
        	
                2.10

              	
                ORGANICHEM
                  shall not change the Manufacturing process, the Specifications
                  or the
                  Analytical Methods without the prior written consent of NEW RIVER,
                  which
                  shall not be unreasonably delayed or withheld. ORGANICHEM shall
                  provide
                  NEW RIVER with a detailed written report of all proposed changes
                  to the
                  Manufacturing process, the Specifications, or the Analytical Methods
                  prior
                  to NEW RIVER’s consideration of such request, as covered in the Quality
                  Agreement.

              

      

       

      
        	
                2.11

              	
                Each
                  party agrees to promptly forward to the other party copies of any
                  written
                  communication received by such party from a Regulatory Authority
                  that may
                  be reasonably expected to affect the Manufacture of API as contemplated
                  herein, and shall confer with each other with respect to the best
                  means to
                  comply with any new or modified
                  requirements.

              

      

       

      
        	
                2.12

              	
                If
                  NEW RIVER is required by the Regulatory Authorities to change the
                  Specifications, the Critical Materials, sources of Cirtical Materials
                  or
                  Analytical Methods with respect to API, ORGANICHEM shall use [***]
                  efforts
                  to accommodate such request, and NEW RIVER and ORGANICHEM shall
                  use [***]
                  efforts to agree upon a revised fee for the Services if necessary
                  in
                  respect of such required change.

              

      

       

      
        
          
          

        

        
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            7
            of 37

          
            

          

        

        
          
          

        

      

       

      
        	
                2.13

              	
                If
                  NEW RIVER requests in writing a change in the Manufacturing process,
                  the
                  Specifications, the Critical Materials, source of Critical Materials
                  or
                  Analytical Methods with respect to the API that is not the result
                  of a
                  Regulatory Authority requirement, ORGANICHEM shall use [***] efforts
                  to
                  accommodate such request, and NEW RIVER shall reimburse ORGANICHEM
                  for any
                  reasonable additional costs associated with such
                  change.

              

      

       

      
        	
                2.14

              	
                If
                  ORGANICHEM requests in writing a change in the Manufacturing process,
                  the
                  Specifications, the Critical Materials, source of Critical Materials
                  or
                  Analytical Method with respect to API that is not the result of
                  a
                  Regulatory Authority requirement, NEW RIVER shall use [***] efforts
                  to
                  accommodate such request, provided that any such change shall be
                  at
                  ORGANICHEM’s sole expense, unless otherwise agreed upon in writing by the
                  Parties.

              

      

      

      
        	
                2.15

              	
                Unless
                  otherwise agreed to in writing by the Parties, NEW RIVER shall
                  have the
                  sole responsibility for filing all documents with the FDA and taking
                  any
                  other actions that may be required for the receipt of FDA Approval
                  for the
                  commercial Manufacture of API. ORGANICHEM shall assist NEW RIVER,
                  to the
                  extent consistent with ORGANICHEM’s obligations under this Agreement, to
                  obtain FDA Approval for the commercial Manufacture of API as quickly
                  as
                  reasonably possible.

              

      

       

      
        	
                ARTICLE
                  3.

              	
                PURCHASE
                  ORDERS, TESTING AND SUPPLY. 

              

      

       

      
        	
                3.01

              	
                NEW
                  RIVER shall submit Purchase Orders to ORGANICHEM for all API and
                  related
                  Services requested under this Agreement, which requests may be
                  made by NEW
                  RIVER from time to time at NEW RIVER’s discretion. Each such Purchase
                  Order shall set forth in reasonable detail the quantities of API
                  that are
                  desired by NEW RIVER, any additional Services that may be desired
                  by NEW
                  RIVER, and the desired date of delivery for such API and related
                  Services.
                  NEW RIVER shall not be bound by any obligation that has not been
                  reduced
                  to writing and executed by NEW RIVER. When executed by both parties,
                  such
                  Purchase Order shall become exhibits to and incorporated into,
                  this
                  Agreement. In the event of any difference between the terms and
                  conditions
                  contained in any such Purchase Order and those contained herein,
                  the terms
                  and conditions of this Agreement shall
                  prevail.

              

      

      
        
          
          

        

        
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            8
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                3.02

              	
                The
                  API ordered for any month may be [***] and ORGANICHEM shall use
                  [***]
                  efforts to [***], except that any Purchase Order submitted by NEW
                  RIVER
                  shall [***] and ORGANICHEM shall
                  [***]

              

      

       

      
        	
                3.03

              	
                Raw
                  Materials and API supplied hereunder shall conform to the Specifications
                  (as set forth in the Quality Agreement) and such conformance shall
                  be
                  verified in accordance with procedures set forth in the Quality
                  Agreement
                  and this Article 3. To the extent that any provision relating to
                  safety or
                  quality control documents or procedures that is
                  set forth in the Specifications or the Quality Agreement conflicts
                  with
                  any provision in this Article 3, the provision in the Specification
                  or
                  Quality Agreement (as the case may be) shall govern and supersede
                  the
                  conflicting provision(s) in this Article
                  3.

              

      

       

      
        	
                3.04

              	
                ORGANICHEM
                  agrees that once the validation of the Manufacturing process has
                  been
                  completed, it will prepare, [***], all analytical reference standards
                  required for its use during the preparation, release testing of
                  Raw
                  Materials, intermediates or finished API. ORGANICHEM will continue
                  to
                  provide for its purposes reasonable quantities of such analytical
                  reference standards throughout the
                  Term.

              

      

       

      
        	
                3.05

              	
                ORGANICHEM's
                  laboratory personnel shall obtain a representative sample from
                  each batch
                  of API produced by ORGANICHEM. In testing API, ORGANICHEM shall
                  assay and
                  analyze such samples in accordance with the agreed upon Analytical
                  Methods, and the Specifications set forth in the Quality Agreement,
                  and
                  shall promptly prepare a CoA / CoC in a format agreed to in writing
                  by the
                  parties. Such CoA / CoC shall identify the batch of API to which
                  it
                  relates. ORGANICHEM shall provide NEW RIVER with a copy of the
                  CoA / CoC
                  containing the address of the Manufacture for each batch upon delivery
                  of
                  such batch in the format required by NEW
                  RIVER.

              

      

       

      
        	
                3.06

              	
                If
                  ORGANICHEM’s analysis or assay indicates that such batch does not meet
                  Specifications, ORGANICHEM shall promptly advise NEW RIVER of its
                  noncompliance. ORGANICHEM shall reasonably cooperate with NEW RIVER
                  to
                  determine the cause of the failure of the API to meet Specifications.
                  ORGANICHEM shall not ship any API hereunder which, as indicated
                  by a
                  sample assay or analysis as set forth above, does not conform to
                  Specifications without the prior written consent of NEW
                  RIVER.

              

      

      
        
          
          

        

        
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            9
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                3.07

              	
                ORGANICHEM
                  shall not rework any batch of API without NEW RIVER’s prior written
                  consent, which consent shall not be unreasonably withheld. All
                  non-specification (out-of-Specification) API not capable of being
                  reworked
                  or reprocessed to meet Specification shall be disposed of by ORGANICHEM.
                  In the event that API does not meet Specifications due to ORGANICHEM’s
                  [***] [***], then ORGANICHEM shall be [***]. In the event that
                  such
                  noncompliance with the Specifications is for any reason other than
                  ORGANICHEM’s [***], the parties shall [***] cooperate to determine
                  [***]

              

      

       

      
        	
                3.08

              	
                ORGANICHEM
                  shall package, label and otherwise prepare for bulk shipment API
                  as
                  outlined in the Quality Agreement, in accordance with the instructions
                  for
                  shipping and packaging included in the applicable Purchase Order,
                  applicable transport regulations and guidelines, and as approved
                  by NEW
                  RIVER or its designee.

              

      

       

      
        	
                3.09

              	
                Each
                  shipment of API hereunder will be shipped to a facility of NEW
                  RIVER or
                  its designee, as designated on a Purchase Order governing such
                  shipment or
                  by subsequent written instruction given by NEW RIVER. ORGANICHEM
                  will
                  include the current Material Safety Data Sheet (“MSDS”), Certificate of
                  Analysis and Certificate of Compliance, as required with each shipment,
                  for API.

              

      

       

      
        	
                3.10

              	
                In
                  the event that, with respect to the [***] period covered by a particular
                  Near-Term Forecast, the quantity of API needed by NEW RIVER shall
                  exceed
                  the amount forecast by NEW RIVER in such Near-Term Forecast, ORGANICHEM
                  shall use [***] efforts to [***] and NEW RIVER shall reasonably
                  cooperate
                  with ORGANICHEM to [***]

              

      

       

      
        	
                3.11

              	
                In
                  the event that ORGANICHEM is unable to provide Services in accordance
                  with
                  the terms of this Agreement, or the Quality Agreement, and such
                  inability
                  subsists or is likely to subsist on a rolling [***] cumulative
                  basis
                  (“Failure Period”), the parties agree to work together in good faith
                  during the Failure Period to resolve the event causing ORGANICHEM’s
                  failure to provide the Services and to procure the continued Services
                  from
                  ORGANICHEM as soon as reasonably practicable following resolution
                  of the
                  event causing the Failure Period.
                  For the avoidance of doubt, failure of ORGANICHEM to use
                  commercially reasonable efforts to obtain sufficient quota for
                  Manufacture
                  of API and/or [***] such that ORGANICHEM is unable to meet its
                  obligations
                  under Section 4.06, or
                  the occurrence of any Quarterly Shortfall or Yearly Shortfall (as
                  defined
                  in Section 4.06), shall deemed to be a failure of ORGANICHEM to
                  provide
                  the Services that has continued beyond the applicable Failure Period
                  set
                  forth in Section 3.12, in response to which NEW RIVER may elect
                  the remedy
                  set forth in Section 3.12.

              

      

      
        
          
          

        

        
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                3.12

              	
                In
                  the event that parties are unable to resolve the event leading
                  to
                  ORGANICHEM’s failure to provide the Services, and such failure continues
                  beyond the Failure Period, then the
                  [***], subject to possible reinstatement as provided in the final
                  sentence
                  of this Section 3.12. If ORGANICHEM is unable to resume providing
                  the
                  Services within the Failure Period, then
                  ORGANICHEM shall: [***] For the avoidance of doubt, NEW RIVER shall
                  not
                  have any right to [***] Subject to NEW RIVER’s termination rights set
                  forth in Section 4.06, NEW RIVER’s
                  [***]

              

      

       

      
        	
                ARTICLE
                  4.

              	
                FORECASTS
                  AND FIRM ORDERS.

              

      

       

      
        	
                4.01

              	
                Within
                  [***] after the Effective Date of this Agreement, NEW RIVER will
                  provide
                  ORGANICHEM with a written, non-binding forecast showing NEW RIVER’s
                  estimated requirements for API, by month, covering a [***] period.
                  Following FDA approval of the first Drug Product, NEW RIVER will
                  issue on
                  the fifteenth (15th)
                  day of every calendar [***] a non-binding forecast update for the
                  next
                  [***] period commencing on the first day of the immediately following
                  quarter.

              

      

       

      
        	
                4.02

              	
                Firm
                  orders for API shall be placed by NEW RIVER in writing (each such
                  writing,
                  a “Purchase Order”) on the [***] day of each [***] month and at a [***]
                  prior to desired delivery date.

              

      

       

      
        	
                4.03

              	
                Provided
                  Purchase Orders are consistent with the most recent Near Term Forecast
                  (i.e., the quantity of API ordered by NEW RIVER for the [***] period
                  covered by a particular Near-Term Forecast does not exceed the
                  amount
                  forecast by NEW RIVER in such Near-Term Forecast, by more than
                  [***] as
                  permitted in Section 3.02) ,
                  ORGANICHEM agrees to accept Purchase Orders from NEW RIVER and
                  ship an
                  amount of API identified in the applicable Purchase Order, up to
                  the [***]
                  Notwithstanding the foregoing, ORGANICHEM will use [***] efforts
                  to meet
                  NEW RIVER’s demand for API in amounts [***], and shall provide, upon NEW
                  RIVER’s written request, written confirmation to NEW RIVER that ORGANICHEM
                  has sufficient Manufacturing capacity to satisfy the most recent
                  Near-Term
                  Forecast. Within [***] after receipt of NEW RIVER’s Purchase Order,
                  ORGANICHEM shall confirm receipt of the Purchase Order and confirm
                  the
                  delivery date of such quantity of API as set forth in the applicable
                  Purchase Order.

              

      

      

      
        
          
          

        

        
          Page
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                4.04

              	
                NEW
                  RIVER may cancel any Purchase Order by providing ORGANICHEM not
                  less than
                  [***] written notice. In the event that NEW RIVER cancels any order
                  for
                  API, NEW RIVER [***] For clarity, in the event NEW RIVER cancels
                  a
                  Purchase Order with less than [***], ORGANICHEM may, at its sole
                  discretion, require that [***]

              

      

       

      
        	
                4.05

              	
                The
                  parties recognize that the manufacture of API involves the use
                  of a
                  substance that is regulated by the DEA. For the purposes of fulfilling
                  its
                  obligations to obtain approval to manufacture such controlled substance,
                  NEW RIVER shall, no later than April 1st
                  of
                  each calendar year of the Term, provide to ORGANICHEM a written
                  estimate
                  of its expected purchases of API from ORGANICHEM during the following
                  calendar year. NEW RIVER shall also promptly notify in writing
                  any
                  significant change in such forecast following the April 1st
                  forecast. The parties agree that ORGANICHEM’s inability to produce API
                  resulting from a failure of NEW RIVER to accurately project NEW
                  RIVER’s
                  requirements for API or failure of DEA to grant such quota or other
                  permissions as may be required by ORGANICHEM to fulfill its obligations
                  hereunder, provided that ORGANICHEM has otherwise made all reasonable
                  efforts to request such permissions in a timely manner, may qualify
                  as a
                  force majeure event pursuant to Article
                  18.

              

      

       

      
        
          
          

        

        
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                4.06

              	
                If
                  [***] of API that is ordered and scheduled for delivery in any
                  one
                  calendar quarter
                  pursuant to applicable accepted Purchase Orders, as established
                  by the
                  applicable Delivery Date,
                  is
                  not delivered in that calendar quarter
                  in
                  accordance with the mutually agreed upon delivery dates
                  (a
                  “Quarterly Shortfall”)
                  then NEW RIVER, in addition to any other rights available to it
                  under this
                  Agreement, may terminate this Agreement on [***] written notice.
                  Similarly, if [***] of API that is ordered and scheduled for delivery
                  in
                  any one calendar year pursuant to applicable accepted Purchase
                  Orders, as
                  established by the applicable Delivery Date, is not delivered in
                  that
                  calendar year in
                  accordance with the mutually agreed upon delievery dates (a
                  “Yearly Shortfall”),
                  then NEW RIVER, in addition to any other rights available to it
                  under this
                  Agreement, may terminate this Agreement on [***]
                  written notice. Termination under this Section 4.06 shall be subject
                  to
                  the provisions of Article 9.

              

      

       

      
        	
                4.07

              	
                [***]

              

      

       

      
        	
                ARTICLE
                  5.

              	
                SHIPPING
                  AND DELIVERY; ACCEPTANCE AND REJECTION.

              

      

       

      
        	
                5.01

              	
                Unless
                  otherwise agreed upon by the parties in writing, NEW RIVER will
                  provide
                  requested shipping and delivery dates at the time firm orders are
                  placed.
                  API Manufactured by ORGANICHEM shall be shipped to NEW RIVER FCA
                  (Incoterms, 2000) Rensselaer, New York via NEW RIVER’s designated
                  carrier.

              

      

       

      
        	
                5.02

              	
                A
                  bill of lading will be furnished to NEW RIVER with respect to each
                  shipment. At the time of shipment, ORGANICHEM represents and warrants
                  that
                  API will be free and clear of any liens or encumbrances placed
                  thereon.

              

      

       

      
        	
                5.03

              	
                ORGANICHEM
                  agrees to ship products hereunder in a timely manner so as to comply
                  with
                  the scheduled Delivery Dates as set forth in the relevant Purchase
                  Orders.

              

      

       

      
        	
                5.04

              	
                NEW
                  RIVER shall notify ORGANICHEM in writing of any loss or damage
                  of API
                  within the following time limits:

              

      

       

      
        	 	
                (a)

              	
                Notification
                  by NEW RIVER to ORGANICHEM of partial loss, damage, defects or
                  non-delivery of any separate part of a consignment shall be made
                  promptly
                  by NEW RIVER after delivery to NEW RIVER, and if loss, damage,
                  defects or
                  partial non-delivery are not evident to NEW RIVER at the time of
                  delivery,
                  such notification by NEW RIVER to ORGANICHEM shall be made no later
                  than
                  [***] after delivery to NEW RIVER or its designee. If a defect
                  is not
                  apparent upon acceptance, NEW RIVER may notify ORGANICHEM up to
                  [***] from
                  receipt of that lot of API.

              

      

      
        
          
          

        

        
          Page
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                (b)

              	
                Notification
                  by NEW RIVER to ORGANICHEM of an entire non-delivery to NEW RIVER
                  of a
                  whole consignment shall be made within [***] from the date NEW
                  RIVER
                  should have received notice of dispatch of such consignment, or
                  within
                  such longer period as may be agreed upon in writing between the
                  parties.

              

      

       

      
        	 	
                (c)

              	
                In
                  the event of such partial or full loss of such consignment, the
                  parties
                  will cooperate to insure that notification and follow-up with the
                  involved
                  ground and air carriers and customs or other warehouses is made
                  in order
                  to determine if such missing delivery can be located. NEW RIVER
                  may assist
                  ORGANICHEM in tracing such shipment and NEW RIVER [***] For such
                  a
                  consignment which has been accepted by such carrier but is not
                  recovered
                  or which is damaged or defective,
                  [***]

              

      

       

      
        	
                5.05

              	
                NEW
                  RIVER or its designee may test each batch of API and may reject
                  any batch
                  delivery which does not conform with the Specifications or with
                  applicable
                  documentation and process requirements as set forth in the Quality
                  Agreement. In testing API, NEW RIVER or its designee shall use
                  the agreed
                  upon Analytical Methods, and the Specifications set forth in the
                  Quality
                  Agreement. NEW RIVER or its designee shall analyze the API (for
                  purposes
                  of determining whether the same meets Specifications) [***] from
                  the date
                  of receipt of the affected API and NEW RIVER shall report any adverse
                  findings, except latent or hidden defects to ORGANICHEM within[***]
                  from
                  such date of receipt. Any such notice of rejection shall be in
                  writing and
                  shall indicate the reasons for such rejection. If no such notice
                  of
                  rejection is received, NEW RIVER shall be deemed to have accepted
                  such
                  delivery of API within [***] of delivery of the
                  batch.

              

      

      
        
          
          

        

        
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                5.06

              	
                After
                  notice of rejection is given, NEW RIVER shall cooperate with ORGANICHEM
                  in
                  determining whether rejection is necessary or justified. ORGANICHEM
                  will
                  evaluate process issues and other reasons for such non-compliance.
                  ORGANICHEM shall respond to NEW RIVER’s written notice of rejection within
                  [***] of receipt, and shall advise NEW RIVER whether it accepts
                  or
                  challenges the basis for the notice of rejection. In the event
                  that the
                  compliance of the API lot cannot be resolved through the mutual
                  agreement
                  of the respective Quality Assurance groups in accordance with the
                  Quality
                  Agreement, then the parties will submit an agreed sample of the
                  API lot to
                  an independent qualified laboratory, mutually agreed upon by NEW
                  RIVER and
                  ORGANICHEM, for analysis and a determination whether, at the time
                  of
                  Manufacture, it complied with the Specifications. Both parties
                  shall be
                  bound by the results of such independent review, [***] Whether
                  or not
                  ORGANICHEM accepts NEW RIVER’s basis for rejection, promptly on receipt of
                  a notice of rejection of a full batch of API, ORGANICHEM shall
                  use [***]
                  efforts at NEW RIVER’s request to [***] Any rejected
                  API not replaced within ninety (90) days shall be deemed to have
                  [***] for
                  the purpose of evaluating ORGANICHEM’s performance under this Agreement
                  (including without limitation the evaluation contemplated by Sections
                  3.11
                  and 4.06). [***]
                  of
                  such batch of API from any of ORGANICHEM’s required safety stock of
                  API
                  or
                  Critical Materials may have the effect of reducing the level of
                  such
                  inventories below
                  those required hereunder. If such [***] is necessary, NEW RIVER
                  will
                  provide ORGANICHEM with [***] (but no more than [***]) in which
                  to
                  replenish such inventories. If the third-party tester rules that
                  the batch
                  meets Specifications, NEW RIVER
                  [***]

              

      

       

      
        	
                5.07

              	
                NEW
                  RIVER may not destroy any batch of API that is subject to disagreement
                  under Section 5.06 until it receives written notification from
                  ORGANICHEM
                  that ORGANICHEM does not dispute that the batch fails to meet
                  Specifications and that ORGANICHEM does not request return of the
                  API.
                  Upon authorization from ORGANICHEM to do so, NEW RIVER shall destroy
                  the
                  API received in the rejected delivery promptly at [***] ORGANICHEM
                  with
                  certification of such destruction. NEW RIVER shall, upon receipt
                  of
                  ORGANICHEM’s request for return, promptly return said API to ORGANICHEM,
                  [***]

              

      

      
        
          
          

        

        
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                ARTICLE
                  6.

              	
                PRICE
                  FOR BULK API. 

              

      

       

      
        	
                6.01

              	
                The
                  price for the supply of API and related Services performed hereunder
                  shall
                  be identified as a cost per Kg delivered to NEW RIVER based on
                  the
                  [***]

              

      

       

      
        	
                6.02

              	
                As
                  part of the cost of the bulk API, ORGANICHEM will provide and maintain
                  bulk stability testing for API and provide NEW RIVER with the related
                  data.

              

      

       

      
        	
                6.03

              	
                Beginning
                  [***] after the Sourcing Date, the price of API from ORGANICHEM
                  may be
                  [***] in ORGANICHEM’s direct costs to Manufacture the API, including
                  increases and decreases in the price of (a) Critical Materials,
                  and/or (b)
                  labor; provided, however, that no change in the price of API shall
                  be
                  effective until mutually agreed by the parties in a written amendment
                  to
                  this Agreement. NEW RIVER shall have the right, upon prior written
                  notice
                  to ORGANICHEM, to cause an independent accounting firm to audit
                  ORGANICHEM’s records relevant to any changes in the direct costs to
                  Manufacture the API for the purpose of verifying such changes.
                  [***] Any
                  increase in the price of API that is attributable to any factor
                  other than
                  the costs of Raw Materials (such as labor or other costs or fees
                  that are
                  not directly related to a rise in the cost of a starting material)
                  shall
                  be [***] if any, the percentage change in prices in the [***]

              

      

       

      
        	
                6.04

              	
                ORGANICHEM
                  agrees to use commercially reasonable efforts to identify, target
                  and
                  implement all potential areas of cost reduction relating to the
                  performance of its obligations under this Agreement
                  including:

              

      

       

      
        	 	
                (a)

              	
                a
                  reduction in all costs and expenses associated with the Manufacture
                  of the
                  API including the cost of Raw Materials, Manufacturing overhead,
                  labor,
                  operating costs and the delivery of the
                  Product;

              

      

       

      
        	 	
                (b)

              	
                improvements
                  in the yield of API; and

              

      

       

      
        	 	
                (c)

              	
                reduction
                  of waste associated with the Manufacture of
                  API

              

      

       

      (collectively
        the “Improvement Program”).

       

      Not
        less
        than [***] and upon [***], NEW RIVER and ORGANICHEM agree to discuss objectives
        for the Improvement Program, and to exchange relevant information in their
        possession relating to the Manufacture of API, including details of the cost
        of
        Raw Materials, the cost of the various stages of the Manufacture of API,
        and
        targets for cost reductions in order to pursue and implement the Improvement
        Program. The Parties shall use best efforts to achieve such objectives
        identified for the relevant year.

      
        
          
          

        

        
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                6.05

              	
                The
                  parties shall allocate the benefits of cost reductions and improved
                  efficiencies achieved as the result of the Improvement Program
                  equally
                  between NEW RIVER and ORGANICHEM.

              

      

      

      
        	
                ARTICLE
                  7.

              	
                PAYMENT.
                   

              

      

       

      Payment
        shall be made by NEW RIVER to ORGANICHEM [***] following the date of NEW
        RIVER’s
        receipt of an invoice for API from ORGANICHEM. Each such invoice shall, to
        the
        extent applicable, identify NEW RIVER’s Purchase Order number, product names and
        quantities delivered to NEW RIVER, unit price, Services provided, and the
        total
        amount to be remitted by NEW RIVER.

       

      
        	
                ARTICLE
                  8.

              	
                TERM.
                  

              

      

       

      This
        Agreement enters into effect on the Effective Date and shall remain in full
        force and effect for five (5) years from the Sourcing Date (the “Term”).
        Thereafter, it shall be extended on an annual basis from year to year, unless
        terminated by either party by giving no less than twelve (12) months prior
        written notice to the other party or terminated as provided for under the
        terms
        of Article 9.

       

      
        	
                ARTICLE
                  9.

              	
                TERMINATION.
                  

              

      

       

      
        	
                9.01

              	
                Either
                  party may terminate this Agreement as
                  follows:

              

      

       

      
        	 	
                (a)

              	
                If
                  the other party is unable to pay its debts as they come due, becomes
                  bankrupt or insolvent or enters into liquidation whether compulsory
                  or
                  voluntary, or convenes a meeting of its creditors, or has a receiver
                  appointed for all or part of its assets, or takes or suffers any
                  similar
                  action in consequence of a debt, or ceases for any reason to carry
                  on
                  business,
                  either
                  party may terminate this Agreement by
                  giving the other party [***] prior written notice;
                  or

              

      

      
        
          
          

        

        
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                (b)

              	
                If
                  the other party commits a
                  material breach of this
                  Agreement,
                  including, without limitation, ORGANICHEM’s breach of its obligations
                  under Section 4.06,
                  and
                  if
                  such
                  material
                  breach is not cured within [***] in the case of a breach not reasonably
                  curable within [***], provided that the allegedly breaching party
                  has made
                  commercially reasonable efforts to cure such breach as quickly
                  as
                  possible) after written notice thereof to the party in breach,
                  such notice to include a description of the nature of the breach,
                  then
                  the non-breaching party may terminate this Agreement immediately
                  on
                  written notice to the breaching party following such sixty [***] cure
                  period
                  (as applicable),
                  provided that
                  the material breach continues to exist following such cure
                  period.

              

      

       

      
        	
                9.02

              	
                NEW
                  RIVER may terminate this Agreement
                  on
                  not less than [***] prior written notice to
                  ORGANICHEM only
                  in the event that NEW RIVER fails to obtain approval by the FDA
                  of its NDA
                  for API and it publicly abandons its efforts to obtain such approval
                  or,
                  in the event that the FDA revokes such approval and NEW RIVER publicly
                  discloses that it shall not seek reinstatement of such
                  NDA.

              

      

       

      
        	
                9.03

              	
                If,
                  following the [***]
                  of
                  the Effective
                  Date,
                  NEW RIVER is able to obtain API of equivalent quality and comparable
                  quantities from any third party manufacturer at [***], NEW RIVER
                  shall
                  notify ORGANICHEM in writing and, if
                  requested by ORGANICHEM, produce reasonable written evidence of
                  [***].
                  ORGANICHEM shall have [***] from the date of notice to [***] but
                  if
                  ORGANICHEM does not or cannot do so for any reason within such
                  [***] NEW
                  RIVER shall be entitled, in its absolute discretion to
                  either:

              

      

       

      
        	 	
                (a)

              	
                reduce
                  its [***]
                  under the terms of this Agreement from [***] of its [***] of its
                  [***];
                  or

              

      

       

      
        	 	
                (b)

              	
                terminate
                  this Agreement by giving [***]
                  written notice to ORGANICHEM.

              

      

       

      Any
        such
        termination shall be subject to the provisions of Section 9.05
        and
        other
        applicable provisions hereunder.

      
        
          
          

        

        
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                9.04

              	
                Upon
                  termination, expiration or cancellation of this Agreement for any
                  reason,
                  ORGANICHEM shall cease any ongoing production and take reasonable
                  measures
                  to limit further expenses associated with such ongoing production.
                  Upon
                  termination,
                  expiration or cancellation of this Agreement for any reason by
                  NEW
                  RIVER
                  (other than pursuant to Section 9.01(b)),
                  [***]

              

      

       

      
        	
                9.05

              	
                Upon
                  termination, expiration or cancellation of this Agreement for any
                  reason,
                  any undelivered API and API intermediate produced by
                  ORGANICHEM
                  shall be held by ORGANICHEM [***], and ORGANICHEM shall cooperate
                  with NEW
                  RIVER in the return, resale, disposal, or delivery to NEW RIVER,
                  [***] of
                  such materials as requested by NEW RIVER.
                  Such obligation shall only apply to undelivered API or API intermediate
                  to
                  [***] API or API intermediate pursuant to Section 9.04 or, if the
                  applicable terms of Section 9.04 do not apply, has [***] for
                  API
                  at
                  the [***] for API or
                  for API intermediates
                  at
                  a [***]
                  After such [***],
                  if so requested by NEW RIVER, ORGANICHEM shall store such API and/or
                  API
                  intermediates for no longer than [***] to be negotiated by the
                  parties in
                  good faith. After the end of such [***] (or earlier at NEW RIVER’s
                  election), NEW RIVER shall either accept delivery of such API or
                  API
                  intermediates or provide ORGANICHEM with instructions for the disposal
                  of
                  such materials. Any such shipments or disposal
                  [***]

              

      

       

      
        	
                9.06

              	
                Termination,
                  expiration, or cancellation of this Agreement through any means
                  and for
                  any reason shall not relieve the parties of any obligation accruing
                  prior
                  thereto, including but not limited, to the confidentiality and
                  proprietary
                  ownership provisions herein and the [***], and shall be without
                  prejudice
                  to the rights and remedies of either party with respect to the
                  antecedent
                  breach of any of the provisions of this
                  Agreement.

              

      

       

      
        	
                9.07

              	
                Upon
                  termination,
                  expiration or cancellation of this Agreement for any reason, ORGANICHEM
                  shall promptly return to NEW RIVER any and all materials, technical
                  information, trade secrets and know-how relating to or including
                  any
                  modification to the synthesis of API provided by NEW RIVER to ORGANICHEM
                  hereunder, if requested in writing by NEW RIVER.
                  [***]

              

      

      
        
          
          

        

        
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                9.08

              	
                Following
                  termination, expiration or cancellation of this Agreement for any
                  reason
                  other than NEW RIVER’s insolvency, bankruptcy, or liquidation, should NEW
                  RIVER desire to Manufacture API at a non-ORGANICHEM facility, ORGANICHEM
                  shall (a) grant NEW RIVER or its designee, a [***] under any ORGANICHEM
                  Intellectual Property necessary for the Manufacture of API and
                  performance
                  of the Services (for the avoidance of doubt, such Intellectual
                  Property
                  shall specifically exclude ORGANICHEM’s process for the [***]);
                  and (b) assist NEW RIVER in transferring Manufacturing of the API
                  by
                  providing support for the transfer of the Manufacturing process
                  to NEW
                  RIVER or an organization named by NEW RIVER, pursuant to a plan
                  to be
                  negotiated in good faith and agreed upon by the parties (the “Process
                  Transfer Plan”). Such Process Transfer Plan shall include [***] and shall
                  also include without limitation all documentation relating to process
                  development, Manufacturing procedures, and product-specific procedures
                  referenced in such Manufacturing procedures, test records and technical
                  documents including testing and characterization of API, and any
                  regulatory documents prepared by ORGANICHEM to support the Manufacture
                  of
                  API. ORGANICHEM shall provide NEW RIVER or its designee, at NEW
                  RIVER’s or
                  its designee’s expense, with reasonable assistance and co-operation in the
                  transfer of any know how or technology required for the Manufacture
                  or
                  validation of the Services by such third party in a timely manner.
                  Except
                  in the event of termination of this Agreement pursuant to Section
                  9.01,
                  [***] for Manufacturing transfer activities such as [***]ipping,
                  and
                  [***].

              

      

       

      
        	
                9.09

              	
                Termination,
                  expiration or cancellation of this Agreement for any reason shall
                  not
                  affect the obligations and responsibilities of the parties pursuant
                  to
                  Articles 10, 12, 13, 14 and 17, all of which survive any termination,
                  along with any additional terms in this Agreement necessary to
                  give effect
                  to such provisions (including without limitation any perpetual
                  licenses
                  contained herein).

              

      

       

      
        	
                ARTICLE
                  10.

              	
                ORGANICHEM
                  REPRESENTATIONS, WARRANTIES AND COVENANTS.

              

      

       

      ORGANICHEM
        makes the following assurances, representations, warranties and covenants
        that
        at all times during the Term and any extension of this
        Agreement:

      
        
          
          

        

        
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                10.01

              	
                ORGANICHEM
                  (a) is duly organized, validly existing and in good standing under
                  the
                  laws of the state in which it is organized; (b) has the power and
                  authority and the legal right to own and operate its property and
                  assets,
                  to lease the property and assets it operates under lease, and to
                  carry on
                  its business as it is now being conducted; and (c) is in compliance
                  with
                  all requirements of Applicable Laws with respect to each facility
                  and site
                  to be used in the Manufacture or storage of API, except to the
                  extent that
                  any noncompliance would not materially adversely affect ORGANICHEM’s
                  ability to perform its obligations in compliance with Applicable
                  Laws and
                  the terms set forth under the
                  Agreement.

              

      

       

      
        	
                10.02

              	
                ORGANICHEM
                  (a) has the power and authority and the legal right to enter into
                  the
                  Agreement and to perform its obligations hereunder and thereunder,
                  (b) has
                  the necessary facilities, equipment, know-how, procedures and personnel
                  at
                  its manufacturing site to Manufacture the API in compliance with
                  this
                  Agreement and the Quality Agreement and in sufficient quantities
                  to
                  satisfy its Manufacturing obligations contemplated under this Agreement,
                  (c) shall not alter or otherwise effect any changes requiring FDA
                  approval
                  to any Manufacturing, processing or other component of API, including
                  without limitation, the installation of new or upgraded equipment
                  used in
                  the Manufacture or processing of API, from that utilized on the
                  Effective
                  Date, except in accordance with this Agreement the Quality Agreement,
                  and
                  Applicable Laws, and (d) has taken all necessary action on the
                  part of its
                  officers and directors necessary to authorize the execution and
                  delivery
                  of the Agreement and the performance of its obligations hereunder
                  and
                  thereunder. The Agreement has been duly executed and delivered
                  on behalf
                  of such party, and constitutes a legal, valid, binding obligation,
                  enforceable against such party in accordance with its
                  terms.

              

      

       

      
        	
                10.03

              	
                All
                  necessary licenses, permits, consents, approvals and authorizations
                  of all
                  governmental authorities and other persons required to be obtained
                  by
                  ORGANICHEM in connection with the Agreement have been
                  obtained.

              

      

       

      
        	
                10.04

              	
                The
                  execution and delivery of the Agreement and the performance of
                  ORGANICHEM’s obligations hereunder and thereunder (a) do not conflict with
                  or violate any requirement of Applicable Laws or regulations or
                  any
                  material contractual obligation of ORGANICHEM and (b) do not materially
                  conflict with, or constitute a material default or require any
                  consent
                  under, any material contractual obligation of ORGANICHEM. ORGANICHEM
                  shall
                  not in any event enter into any agreement or arrangement with any
                  other
                  party that would prevent or in any way interfere with ORGANICHEM’s
                  obligations pursuant to this
                  Agreement.

              

      

      
        
          
          

        

        
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                10.05

              	
                The
                  Intellectual Property utilized by ORGANICHEM in connection with
                  the
                  provision of ORGANICHEM’s obligations under this Agreement (i) may be
                  lawfully used as set forth in this Agreement and the Quality Agreement,
                  and (ii) such use does not knowingly infringe any third party
                  rights.

              

      

       

      
        	
                10.06

              	
                ORGANICHEM
                  shall convey good title in any API delivered to NEW RIVER or its
                  designee
                  under this Agreement, and that all such API will be delivered to
                  NEW RIVER
                  or its designee free from any security interest, lien, or other
                  encumbrance.

              

      

       

      
        	
                10.07

              	
                ORGANICHEM
                  shall not in the performance of its obligations under this Agreement
                  use
                  the services of any person debarred or suspended under 21 U.S.C.
§335a(a)
                  or (b). The parties represent that they do not currently have,
                  and
                  covenants that they will not hire, as an officer or an employee
                  any person
                  who has been convicted of a felony under the laws of the United
                  States for
                  conduct relating to the regulation of any drug product under the
                  Federal
                  Food, Drug, and Cosmetic Act.

              

      

       

      
        	
                10.08

              	
                ORGANICHEM
                  is cognizant of current Good Manufacturing Practices as defined
                  herein,
                  that ORGANICHEM shall meet the requirements as provided for in
                  the FDA Q7A
                  Good Manufacturing Practice Guidance for Active Pharmaceutical
                  Ingredients
                  and the provisions of the Quality Agreement, and ORGANICHEM warrants
                  that
                  API delivered hereunder will (i) be Manufactured by ORGANICHEM
                  in
                  compliance with cGMP and other Applicable Laws, (ii) be Manufactured
                  in
                  compliance with the agreed-upon Manufacturing procedures described
                  in the
                  Quality Agreement and (iii) conform to the applicable Specifications
                  set
                  forth in the Quality Agreement hereto at the time of delivery.
                  NEW RIVER’s
                  remedies and ORGANICHEM’s liability with respect to this warranty are set
                  forth below. This warranty is the only warranty made by ORGANICHEM
                  with
                  respect to API delivered hereunder, and may only be modified or
                  amended by
                  a written instrument signed by a duly authorized officer of ORGANICHEM
                  and
                  accepted by NEW RIVER. THE EXPRESS WARRANTY IN THIS SECTION 10.08
                  IS IN
                  LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
                  LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
                  PARTICULAR
                  PURPOSE.

              

      

      
        
          
          

        

        
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                10.09

              	
                Any
                  lot of API delivered to NEW RIVER by ORGANICHEM which does not
                  conform to
                  Specifications and is rejected by NEW RIVER [***] of delivery,
                  does not
                  conform to Specifications as a result of latent or hidden defects,
                  or is
                  otherwise not in compliance with the warranty made in this Section
                  10.09,
                  will, with ORGANICHEM’s [***] efforts, be [***] or, if ORGANICHEM has
                  acknowledged in writing that it is unable to produce conforming
                  API, [***]
                  The remedy of [***] is available only if such nonconformance was
                  not
                  caused by NEW RIVER’s misuse, unauthorized modifications, neglect,
                  improper testing or improper storage, including without limitation
                  storage
                  at inappropriate temperatures, transportation, use beyond any dating
                  provided, by accident, fire or other hazard or other circumstances
                  beyond
                  the reasonable control of ORGANICHEM. THE EXPRESS OBLIGATIONS STATED
                  IN
                  THIS SECTION 10.09 AND ARTICLE 13 ARE IN LIEU OF ALL OTHER LIABILITIES
                  OR
                  OBLIGATIONS OF ORGANICHEM FOR DAMAGES, INCLUDING BUT NOT LIMITED
                  TO LOSS,
                  DAMAGE OR BODILY OR PERSONAL INJURY, DIRECT OR CONSEQUENTIAL, ARISING
                  OUT
                  OF OR IN CONNECTION WITH THE DELIVERY, USE OR PERFORMANCE OF ORGANICHEM’S
                  PRODUCTS.

              

      

       

      
        	
                10.10

              	
                All
                  assurances, representations, warranties and covenants contained
                  in this
                  Article 10 shall survive termination of this
                  Agreement.

              

      

       

      
        	
                ARTICLE
                  11.

              	
                INSPECTIONS,
                  RECALLS AND SEIZURES.  

              

      

       

      
        	
                11.01

              	
                The
                  parties shall comply with the Quality Agreement with respect to
                  government
                  and regulatory inspections. At NEW RIVER’s request and expense, ORGANICHEM
                  further agrees to use its best efforts to assist NEW RIVER or its
                  designee
                  in obtaining FDA approval of its NDA with respect to API, as well
                  as
                  approvals from any other government or agency which may be required
                  for
                  the marketing of API in any other country. Notwithstanding the
                  foregoing,
                  NEW RIVER shall not be obligated to [***] ORGANICHEM specifically
                  agrees
                  to cooperate with any inspection by the FDA or other regulatory
                  agency,
                  including but not limited to any inspection prior to approval of
                  NEW
                  RIVER’s NDA. ORGANICHEM shall permit a NEW RIVER representative to review
                  any response it intends to make to the FDA only as it relates specifically
                  to API. When required NEW RIVER shall assist ORGANICHEM in filing
                  such
                  requests as necessary to obtain DEA quotas and permits for the
                  manufacture
                  of API and the appropriate starting
                  materials.

              

      

      
        
          
          

        

        
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                11.02

              	
                Upon
                  prior written request and at mutually agreeable times, ORGANICHEM
                  will
                  permit representatives of NEW RIVER or its designee to observe
                  such
                  Manufacture of API and to have access to any relevant records in
                  connection with such Manufacture as more fully provided in Quality
                  Agreement. Upon reasonable written request to ORGANICHEM, NEW RIVER
                  or its
                  designee shall have the right to have representatives visit ORGANICHEM’s
                  manufacturing facilities during normal business hours to review
                  ORGANICHEM’s manufacturing operations and assess its compliance with cGMP
                  and quality assurance standards and to discuss any related issues
                  with
                  ORGANICHEM’s manufacturing and management
                  personnel.

              

      

       

      
        	
                11.03

              	
                ORGANICHEM
                  shall notify NEW RIVER of any inspections by any governmental agency
                  involving the API. NEW RIVER or its designee reserves the right
                  to be
                  present at ORGANICHEM during any inspection by any governmental
                  agency but
                  does not have the right to be directly involved with the inspection
                  process. NEW RIVER or its designee reserves the right to review
                  any
                  findings by such governmental agency that are communicated to ORGANICHEM
                  and directly related to API, and ORGANICHEM shall allow NEW RIVER
                  to have
                  a reasonable period in which to comment on any response before
                  such
                  response is sent to the governmental
                  agency.

              

      

       

      
        	
                11.04

              	
                The
                  parties shall comply with the Quality Agreement with respect to
                  inspection
                  and audit rights. NEW RIVER may perform an annual Quality or cGMP
                  audit or
                  inspect as necessary as defined in the Quality Agreement. NEW RIVER
                  will
                  provide notification, ORGANICHEM will not refuse so long as the
                  request is
                  reasonable [***] and within normal business hours. All audited
                  data shall
                  be treated as Confidential Information of ORGANICHEM and NEW RIVER
                  or its
                  designee shall not be permitted to remove or copy data without
                  ORGANICHEM’s prior written consent. In accordance with the batch
                  documentation audit schedule outlined in the Quality Agreement
                  and upon
                  NEW RIVER’s written request, ORGANICHEM shall supply NEW RIVER or its
                  designee with copies of ORGANICHEM’s Manufacturing records, including its
                  batch records, for the purposes of assuring product quality and
                  compliance
                  with agreed-upon Manufacturing
                  procedures.

              

      

      
        
          
          

        

        
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                11.05

              	
                ORGANICHEM
                  shall retain samples of API and isolated intermediates for each
                  batch of
                  API for a period of [***] after NEW RIVER’s acceptance of such batch. The
                  sample size shall be [***] to conduct quality control testing.
                  Upon NEW
                  RIVER’s reasonable written request, ORGANICHEM shall provide NEW RIVER
                  or
                  its designee with up to [***] of the retained samples. Such request
                  from
                  NEW RIVER or its designee will fully document the reason(s) why
                  such
                  quantity of retained sample would be
                  needed.

              

      

       

      
        	
                11.06

              	
                The
                  parties shall comply with the Quality Agreement with respect to
                  recall or
                  seizure.

              

      

       

      
        	
                ARTICLE
                  12.

              	
                LIABILITY
                  AND INSURANCE. 

              

      

       

      
        	
                12.01

              	
                Other
                  than for a party’s breach of its obligations under Articles 10 or 14,
                  neither party shall be liable to the other party for any exemplary,
                  special, punitive, incidental or consequential damages. The foregoing
                  provision shall not be construed to limit a party’s indemnification
                  obligations under this Agreement for third party claims which may
                  include
                  consequential, punitive or other types of
                  damages.

              

      

       

      
        	
                12.02

              	
                Each
                  party shall secure and maintain at its own expense during the term
                  of this
                  Agreement and any extension of this Agreement, commercial general
                  liability insurance with
                  an annual aggregate limit of [***]
                  and products liability insurance for up to [***]
                  Upon written request, each party shall furnish
                  the other party with certificates of such commercial general liability
                  and
                  products liability insurance.

              

      

      
        
          
          

        

        
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                12.03

              	
                The
                  liability provisions and insurance obligations set forth in this
                  Article
                  12 shall survive termination of this Agreement, except to the extent
                  such
                  provisions or obligations are explicitly limited to the
                  Term.

              

      

       

      
        	
                ARTICLE
                  13.

              	
                INDEMNIFICATION.
                  

              

      

       

      
        	
                13.01

              	
                Subject
                  to Article 12, NEW RIVER shall indemnify, defend and hold harmless
                  ORGANICHEM (except to the extent ORGANICHEM is obligated to indemnify
                  NEW
                  RIVER as set forth below) against all claims, losses, damages and
                  liabilities, [***] (“NEW RIVER Indemnification Claims”) asserted by a
                  third party, to the extent arising out of or connection
                  with:

              

      

       

      
        	 	
                (a)

              	
                NEW
                  RIVER’s or its designee’s distribution, marketing, sale, and use of Drug
                  Product;

              

      

       

      
        	 	
                (b)

              	
                a
                  breach of NEW RIVER’s representations, warranties and covenants under this
                  Agreement; or

              

      

       

      
        	 	
                (c)

              	
                NEW
                  RIVER’s willful misconduct or
                  negligence.

              

      

       

      ORGANICHEM
        shall not settle any such claim without the prior written approval of NEW
        RIVER.
        NEW RIVER shall have the right, if NEW RIVER so wishes, to retain legal counsel
        of its own choosing, conduct negotiations to settle, settle or to conduct
        any
        litigation arising out of, any such claim. ORGANICHEM shall provide prompt
        written notice of any claim to NEW RIVER and shall cooperate in the defense
        of
        the claim.

       

      
        	
                13.02

              	
                Subject
                  to Article 12, ORGANICHEM shall indemnify, defend and hold harmless
                  NEW
                  RIVER or its designee (except to the extent NEW RIVER is obligated
                  to
                  indemnify ORGANICHEM as set forth above) against all claims, losses,
                  damages, and liabilities [***] (“ORGANICHEM Indemnification Claims”), to
                  the extent arising out of or in connection
                  with:

              

      

       

      
        	 	
                (a)

              	
                any
                  failure of API supplied by ORGANICHEM hereunder to conform to
                  Specifications as outlined in the Quality Agreement when it was
                  delivered
                  to NEW RIVER or its designee’s shipping
                  agent;

              

      

      
        
          
          

        

        
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                (b)

              	
                any
                  failure of API supplied by ORGANICHEM hereunder to be Manufactured
                  in
                  accordance with Applicable Laws, including without limitation,
                  current
                  Good Manufacturing Practices;

              

      

       

      
        	 	
                (c)

              	
                a
                  breach of ORGANICHEM’s representations, warranties and covenants under
                  this Agreement; or

              

      

       

      
        	 	
                (d)

              	
                ORGANICHEM’s
                  willful misconduct or negligence.

              

      

       

      NEW
        RIVER
        shall not settle any such claim without the prior written approval of
        ORGANICHEM, and that ORGANICHEM shall have the right, if it so wishes, to
        retain
        legal counsel of its own choosing, conduct negotiations to settle, settle
        or to
        conduct any litigation arising out of, any such claim. NEW RIVER shall provide
        prompt written notice of any such claim to ORGANICHEM and shall cooperate
        in the
        defense of the claim.

       

      
        	
                13.03

              	
                The
                  indemnification obligations set forth in this Article 13 shall
                  survive the
                  termination of this Agreement.

              

      

       

      
        	
                ARTICLE
                  14.

              	
                CONFIDENTIALITY
                  AND NON-USE. 

              

      

       

      
        	
                14.01

              	
                NEW
                  RIVER and ORGANICHEM agree that the provisions of the Mutual
                  Confidentiality Agreement, which is incorporated herein by reference
                  and
                  made a part of this Agreement, shall apply to all confidential
                  information
                  disclosed by the parties under this Agreement, and that the activities
                  contemplated and carried out under this Agreement shall be deemed
                  to be
                  included within the purpose of the Mutual Confidentiality Agreement,
                  which
                  agreement remains in effect in accordance with its terms, provided
                  however,
                  that in the event the Mutual Confidentiality Agreement expires
                  or is
                  terminated prior to the expiration or termination of this Agreement,
                  the
                  terms of the Mutual Confidentiality Agreement shall continue to
                  govern the
                  parties’ obligations of confidentiality with respect to any confidential
                  or proprietary information disclosed by the parties hereunder,
                  for the
                  term of this Agreement and for [***] thereafter, as though such
                  agreement
                  remained in full force and effect. The parties agree that any confidential
                  or proprietary information that satisfies the requirements of Section
                  5(e)
                  or 5(f) of the Mutual Confidentiality Agreement shall, subject
                  to the
                  remainder of the Mutual Confidentiality Agreement, continue to
                  be
                  considered Confidential Information (as defined therein) for all
                  purposes
                  other than the disclosures specifically contemplated by such
                  sections. In
                  addition, in the event a party desires or is required by law to
                  make a
                  disclosure pursuant to Section 5(e) of the Mutual Confidentiality
                  Agreement, it shall, except where impracticable, give reasonable
                  advance
                  notice to the other party of such disclosure and use best efforts
                  to
                  secure confidential treatment of such information. A copy of the
                  Mutual
                  Confidentiality Agreement is attached hereto as Appendix
                  B.

              

      

      
        
          
          

        

        
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                ARTICLE
                  15.

              	
                INTELLECTUAL
                  PROPERTY. 

              

      

       

      
        	
                15.01

              	
                ORGANICHEM
                  shall promptly disclose to NEW RIVER all Inventions which ORGANICHEM
                  makes, conceives, learns or reduces to practice, either alone or
                  jointly
                  with others, in performing the Analytical Methods or Services under
                  this
                  Agreement.

              

      

       

      
        	
                15.02

              	
                Subject
                  to Section 15.06, ORGANICHEM agrees that all such Inventions and
                  Intellectual Property related thereto are the sole property of
                  NEW RIVER
                  and may be transferred by NEW RIVER to its designee. Notwithstanding
                  anything to the contrary set forth in the Mutual Confidentiality
                  Agreement, such Inventions and Intellectual Property shall be deemed
                  to be
                  the Confidential Information (as defined in the Mutual Confidentiality
                  Agreement) of NEW RIVER.

              

      

       

      
        	
                15.03

              	
                ORGANICHEM
                  shall be permitted to use such Inventions and Intellectual Property
                  related thereto exclusively and strictly for the purpose of carrying
                  out
                  its obligation to Manufacture API. In no event shall ORGANICHEM
                  be
                  permitted to use the Inventions and Intellectual Property for any
                  other
                  purpose or for any other customer of ORGANICHEM without the consent
                  of NEW
                  RIVER, which consent may be withheld for any reason and which consent
                  may
                  be [***] to be agreed upon by the
                  parties.

              

      

       

      
        	
                15.04

              	
                [***].

              

      

       

      
        	
                15.05

              	
                ORGANICHEM
                  shall cooperate with NEW RIVER, and at [***], shall execute any
                  instrument
                  or do such act or thing as may be necessary or desirable to ensure
                  that
                  any such Intellectual Property referred to in Section 15.02 above
                  vest in
                  NEW RIVER.

              

      

      
        
          
          

        

        
          Page
            28 of 37

          
            

          

        

        
          
          

        

      

      

      
        	
                15.06

              	
                All
                  Intellectual Property generated or derived by ORGANICHEM in the
                  course of
                  performing the Services which are not specific to, or dependent
                  upon, API
                  and which have application to manufacturing processes or formulation
                  development of drug products or drug delivery systems shall be
                  the
                  exclusive property of ORGANICHEM (the “Broader Intellectual Property
                  Rights”). ORGANICHEM hereby grants to NEW RIVER a non-exclusive,
                  perpetual, irrevocable, sublicensable, paid-up, royalty-free, transferable
                  license under the Broader Intellectual Property Rights to make,
                  have made,
                  use, import, offer for sale, and sell products containing API (and
                  any
                  intermediates thereof). For the avoidance of doubt, such requirement
                  to
                  license shall not apply to ORGANICHEM’s process for the
                  [***].

              

      

       

      
        	
                ARTICLE
                  16.

              	
                ASSIGNMENT.

              

      

       

      
        	
                16.01

              	
                ORGANICHEM
                  shall not have the right to assign any or all of its rights or
                  obligations
                  under this Agreement without NEW RIVER’s prior written consent, which
                  shall not be unreasonably delayed or withheld. Notwithstanding
                  the
                  foregoing, NEW RIVER’s consent shall not be required in connection with an
                  assignment made by ORGANICHEM to a successor in connection with
                  a merger,
                  consolidation, or a sale of all or substantially all of ORGANICHEM’s
                  assets to a third party; provided, however, ORGANICHEM shall provide
                  NEW
                  RIVER with written notice of such
                  assignment.

              

      

       

      
        	
                16.02

              	
                NEW
                  RIVER shall have the right to assign any or all of its rights or
                  obligations under this Agreement without the consent of ORGANICHEM;
                  provided, however, that NEW RIVER shall provide ORGANICHEM with
                  written
                  notice of such assignment. For clarity, this Agreement shall be
                  assigned
                  by NEW RIVER to any entity to which NEW RIVER may license Drug
                  Product,
                  without the consent of ORGANICHEM.

              

      

       

      
        	
                16.03

              	
                In
                  the event of a permitted assignment pursuant to Article 16, this
                  Agreement
                  shall be binding upon and insure to the benefit of any permitted
                  successors or assigns of the
                  parties.

              

      

      
        
          
          

        

        
          Page
            29 of 37

          
            

          

        

        
          
          

        

      

      

      
        	
                ARTICLE
                  17.

              	
                CHOICE
                  OF LAW; JURISDICTION.  

              

      

       

      The
        provisions of this Agreement shall be governed by and construed in accordance
        with the laws of the State of Delaware, without regard to conflict of laws
        principles.

       

      
        	
                ARTICLE
                  18.

              	
                FORCE
                  MAJEURE. 

              

      

       

      Any
        delay
        in the performance of any of the duties or obligations of either party (except
        the payment of money due hereunder) shall not be considered a breach of this
        Agreement; provided that such delay has been caused by or is the result of
        any
        acts of God, acts of the public enemy, insurrections, riots, embargoes, labor
        disputes, including strikes, lockouts, job actions or boycotts, fires,
        explosions, floods, shortages of energy, government action including to grant
        sufficient quota for Manufacture of API [***], or other unforeseen causes,
        in
        each case provided that such delay is beyond the reasonable control and without
        the fault or negligence of the party so affected. The party so affected shall
        give prompt notice to the other party of such cause, and shall take whatever
        reasonable steps are necessary to relieve the effect of such cause as rapidly
        as
        reasonably possible. In the event that such delay is unacceptable to the
        other
        party or such purchase order specified that time was of the essence, the
        other
        party shall have the right, but not the obligation, to terminate such Purchase
        Order affected by such delay without further liability to the affected party.
        For
        clarity, nothing in this Article 18 shall limit NEW RIVER’s right to exercise
        its rights under this Agreement relating to supply failures, shortfalls,
        or
        disruptions (other than termination of this Agreement for breach), including
        its
        rights under Section 3.12 or Section 4.06.

       

      
        	
                ARTICLE
                  19.

              	
                SEVERABILITY.
                  

              

      

       

      In
        the
        event that any provision of this Agreement is judicially determined to be
        void
        or unenforceable, such provision shall be construed to be separable from
        the
        other provisions of this Agreement and the other provisions of this Agreement
        shall retain full force and effect. Notwithstanding the foregoing, if a
        provision is judicially determined to be void or unenforceable and that
        provision is essential to the purpose of the Agreement such that separating
        that
        provision from the Agreement would frustrate the original purpose of the
        Agreement, then there shall be no separation and the entirety of the Agreement
        shall be deemed void and unenforceable.

      
        
          
          

        

        
          Page
            30 of 37

          
            

          

        

        
          
          

        

      

      

      
        	
                ARTICLE
                  20.

              	
                HEADINGS.
                  

              

      

       

      All
        titles and captions in this Agreement are for convenience purposes only and
        shall not be of any force or substance.

       

      
        	
                ARTICLE
                  21.

              	
                USE
                  OF NAMES. 

              

      

       

      Except
        as
        expressly required pursuant to the Act, neither party will without the prior
        written consent of the other:

       

      
        	 	
                (a)

              	
                use
                  in advertising, publicity, promotional premiums or otherwise, any
                  trade
                  name, trademark, trade device, service mark, symbol, or any abbreviation,
                  contraction or simulation thereof owned by either party, or
                  

              

      

       

      
        	 	
                (b)

              	
                represent,
                  either directly or indirectly, that any product or service of one
                  party is
                  a product or service of the other
                  party.

              

      

       

      
        	
                ARTICLE
                  22.

              	
                INDEPENDENT
                  CONTRACTOR. 

              

      

       

      Each
        party is acting under this Agreement as an independent contractor and not
        as the
        agent or employee of the other party. Each party understands and agrees that
        it
        has no authority to assume any obligation on behalf of the other party and
        that
        it shall not hold out to third parties that it has any authority to act on
        the
        other party’s behalf except as expressly permitted herein. Each party shall be
        responsible for its own expenses relating to its performance under this
        Agreement and shall not incur expenses for the other party’s account unless
        expressly authorized by this Agreement or subsequent written
        agreements.

       

      
        	
                ARTICLE
                  23.

              	
                WAIVER.
                  

              

      

       

      No
        waiver
        or modification of any of the terms of this Agreement shall be valid unless
        in
        writing and signed by an authorized representative of both parties hereto.
        Failure by either party to enforce any rights under this Agreement shall
        not be
        construed as a waiver of such rights nor shall a waiver by either party in
        one
        or more instances be construed as constituting a continuing waiver or as
        a
        waiver in other instances.

      
        
          
          

        

        
          Page
            31 of 37

          
            

          

        

        
          
          

        

      

      

      
        	
                ARTICLE
                  24.

              	
                PUBLIC
                  DISCLOSURE. 

              

      

       

      Neither
        party shall disclose to any third party or originate any publicity, news
        release
        or public announcement, written or oral, whether to the public or the press,
        or
        otherwise, referring to the terms of this Agreement, including its existence,
        the subject matter to which it relates, the performance under it or any of
        its
        specific terms and conditions, except by such announcements as are:

       

      
        	 	
                (a)

              	
                mutually
                  agreed upon by the parties in writing;
                  or

              

      

       

      
        	 	
                (b)

              	
                in
                  the opinion of counsel for the party making such announcement are
                  required
                  by law or regulation. If a party believes a public announcement
                  to be
                  required by law or regulation with respect to this Agreement, it
                  will give
                  the other party such notice as is reasonably practicable and an
                  opportunity to comment upon the
                  announcement.

              

      

       

      
        	
                ARTICLE
                  25.

              	
                NOTICES.
                  

              

      

       

      Unless
        otherwise specified herein, all notices required or permitted to be given
        under
        this Agreement shall be in writing and shall be delivered either personally
        or
        by facsimile, and promptly confirmed, if sent by facsimile, by registered
        or
        certified mail or courier service. Notices may also be sent by registered
        or
        certified mail, return receipt requested, or by courier service. All notices
        shall be to the receiving party at such party’s address set forth below, or at
        such other address as may from time-to-time be furnished by similar notice
        by
        either party. Any notice sent by registered, certified mail or courier service
        or by facsimile if promptly confirmed as aforesaid shall be deemed to have
        been
        given when mailed.

      

        
          	 	
                  If
                    to ORGANICHEM:

                

        

        

        
          	 	
                  Vice
                    President & General Manager

                

        

        
          	 	
                  Organichem
                    Corporation

                

        

        
          	 	
                  33
                    Riverside Avenue

                

        

        
          	 	
                  Rensselaer,
                    NY 12144

                

        

        
          	 	
                  Fax
                    Number (518) 433-7719

                

        

      

       

      
        	 	
                With
                  a copy to:

              

      

      

      
        	 	
                Director,
                  Contracts, Licensing, & Legal
                  Affairs

              

      

      
        	 	
                Albany
                  Molecular Research, Inc.

              

      

      
        	 	
                21
                  Corporate Circle

              

      

      
        	 	
                Albany,
                  NY 12203-5154

              

      

      
        	 	
                Fax
                  Number (518) 464-0289

              

      

      
        
          
          

        

        
          Page
            32 of 37

          
            

          

        

        
          
          

        

      

      

      
        	 	
                If
                  to NEW RIVER:

              

      

       

      
        	 	
                Krish
                  S. Krishnan

              

      

      
        	 	
                CFO
                  & COO

              

      

      
        	 	
                NEW
                  RIVER Pharmaceuticals Inc.

              

      

      
        	 	
                1881
                  Grove Ave

              

      

      
        	 	
                Radford,
                  VA 24141

              

      

      
        	 	
                Fax
                  Number (540) 633-7939

              

      

      

      or
        to
        such other address as the addressee shall have last furnished in writing
        to the
        addresser.

       

      
        	
                ARTICLE
                  26.

              	
                ENTIRE
                  AGREEMENT. 

              

      

       

      
        	
                26.01

              	
                This
                  Agreement (including, without limitation, the Appendices hereto)
                  constitutes the entire Agreement between the parties concerning
                  the supply
                  of API by ORGANICHEM to NEW RIVER, and supersedes all written or
                  oral
                  agreements or understandings with respect thereto; provided, however,
                  that
                  the Mutual Confidentiality Agreement shall survive the execution
                  of this
                  Agreement; shall continue to govern all matters regarding Confidential
                  Information; and remain in full force and effect in accordance
                  with its
                  stated terms and conditions.

              

      

       

      
        	
                26.02

              	
                Neither
                  party shall claim any amendment, modification, nor release from
                  any
                  provision hereof unless such an amendment is in writing signed
                  by an
                  authorized representative of each
                  party.

              

      

      
        
          
          

        

        
          Page
            33 of 37

          
            

          

        

        
          
          

        

      

       

      IN
        WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
        by
        their duly authorized representatives.

       

      ACKNOWLEDGED,
        ACCEPTED AND AGREED TO:

       

      
        	
                 NEW
                  RIVER PHARMACEUTICALS INC.

              	 
	 	 	 
	 	 	 
	
                By:

              	  
/s/ 
                Krish S. Krishnan	 
	 	 	 
	
                Name:

              	  
Krish
                S. Krishnan	 
	
                (Print/Type)

              	 
	 	 	 
	
                Title:

              	  
Chief
                Financial Officer / Chief Operating Officer	 
	 	 	 
	
                Date:

              	  
May
                18, 2006	 

      

      

       

      
        	
                ACKNOWLEDGED,
                  ACCEPTED AND AGREED TO:

              	 
	 	 	 
	
                ORGANICHEM
                  CORPORATION

              	 
	 	 	 
	 	 	 
	
                By:

              	  
/s/ 
Thomas
                E. D'Ambra,
                PhD.	 
	 	 	 
	
                Name:

              	  
Thomas
                E. D'Ambra, PhD.	 
	
                (Print/Type)

              	 
	 	 	 
	
                Title:

              	  
President,
                Chairman and Chief Executive Officer	 
	 	 	 
	
                Date:

              	  
May
                22, 2006	 

      

       

      
        
          
          

        

        
          Page
            34 of 37

          
            

          

        

        
          
          

        

      

      Appendix
        A - [***]

      
        	
                [***]

                 

              	
                [***]

              	
                [***]

              
	
                [***]

                 

              	
                [***]

              	
                [***]

              
	
                [***]

                 

              	
                [***]

              	
                [***]

              
	
                [***]

                 

              	
                [***]

              	
                [***]

              
	
                [***]

                 

              	
                [***]

              	
                [***]

              

      

       

      
        
          
          

        

        
          Page
            35 of 37

          
            

          

        

        
          
          

        

      

      APPENDIX
        B
        - Mutual Confidentiality Agreement. 

       

      Dated
        March 27, 2003

      
        
          
          

        

        
          Page
            36 of 37

          
            

          

        

        
          
          

        

      

      APPENDIX
        C
        - Quality Agreement. 

      
        
          
          

        

        
          Page
            37 of 37

          
            

          

        

        
          
          

        

      

      
         

      

      ACTIVE
        PHARMACEUTICAL INGREDIENT (API) QUALITY AGREEMENT

      

      BETWEEN

      

      NEW
        RIVER PHARMACEUTICALS INC.

      

      AND

      

      ORGANICHEM
        CORPORATION

       

      
        
          
          

        

        
          1

          
            

          

        

        
          
          

        

      

      QUALITY
        AGREEMENT

      

      

      CONTENTS

      
        	
                1.

              	
                PARTIES

              	
                4

              
	
                2.

              	
                QUALITY
                  AGREEMENT

              	
                4

              
	
                3.

              	
                ADMINISTRATIVE
                  INFORMATION

              	
                4

              
	
                4.

              	
                API

              	
                4

              
	
                5.

              	
                DURATION
                  OF AGREEMENT

              	
                4

              
	
                6.

              	
                JURISDICTION

              	
                4

              
	
                7.

              	
                CONFIDENTIALITY

              	
                5

              
	
                8.

              	
                SECURITY

              	
                5

              
	
                9.

              	
                SUPPLY

              	
                5

              
	 	
                9.1

              	
                Premises

              	
                5

              
	 	
                9.2

              	
                API
                  Specification and Master Production Records

              	
                5

              
	 	
                9.3

              	
                GMP
                  Guidelines

              	
                6

              
	 	
                9.4

              	
                Materials

              	
                6

              
	 	
                9.5

              	
                Master
                  Production Record Approval

              	
                7

              
	 	
                9.6

              	
                Production

              	
                7

              
	 	
                9.7

              	
                Methodology

              	
                7

              
	 	
                9.8

              	
                Standard
                  Operating Procedure

              	
                7

              
	 	
                9.9

              	
                Dates
                  of Manufacture and Expiration

              	
                7

              
	 	
                9.10

              	
                Manufacturing
                  and Equipment Data

              	
                7

              
	
                10.

              	
                QUALITY
                  ASSURANCE

              	
                8

              
	 	
                10.1

              	
                QC
                  of Materials

              	
                8

              
	 	
                10.2

              	
                API
                  Testing

              	
                8

              
	 	
                10.3

              	
                Release
                  Procedures

              	
                8

              
	 	
                10.4

              	
                Documentation

              	
                9

              
	 	
                10.5

              	
                Sampling

              	
                9

              
	 	
                10.6

              	
                Stability

              	
                10

              
	 	
                10.7

              	
                Deviations
                  and Investigations

              	
                10

              
	 	
                10.8

              	
                Rejection
                  of API

              	
                11

              
	 	
                10.9

              	
                Dispute
                  Resolution

              	
                11

              
	 	
                10.10

              	
                Regulatory
                  Inspection

              	
                11

              
	 	
                10.11

              	
                Regulatory
                  Actions at NEW RIVER

              	
                12

              
	 	
                10.12

              	
                Regulatory
                  Investigations

              	
                12

              
	 	
                10.13

              	
                Manufacturing
                  Audits

              	
                12

              
	 	
                10.14

              	
                Right
                  to Audit

              	
                12

              
	 	
                10.15

              	
                Product
                  Complaints, Recall

              	
                13

              
	 	
                10.16

              	
                Compliance
                  Deficiencies 

              	
                13

              
	
                11.

              	
                CHANGE
                  MANAGEMENT

              	
                13

              

      

       

      
        
          
          

        

        
          2

          
            

          

        

        
          
          

        

         

      

      
        	
                12

              	
                API
                  PROCESS VALIDATION

              	
                13

              
	 	
                12.1

              	
                Process

              	
                13

              
	 	
                12.2

              	
                Cleaning
                  Validation

              	
                14

              
	 	
                12.3

              	
                Equipment,
                  Computer, Facility, and Utilities Qualification

              	
                14

              
	 	
                12.4

              	
                Laboratory
                  Qualifications

              	
                14

              
	
                13

              	
                PRODUCT
                  QUALITY REVIEW AND ANNUAL REPORTS

              	
                14

              
	 	
                13.1

              	
                Product
                  Quality Review

              	
                14

              
	 	
                13.2

              	
                Annual
                  Reports

              	
                14

              
	
                14.

              	
                STORAGE
                  AND SHIPPING

              	
                14

              
	 	
                14.1

              	
                Storage

              	
                14

              
	 	
                14.2

              	
                Packing
                  and Labeling for Transit

              	
                15

              
	 	
                14.3

              	
                Shipment
                  of API to NEW RIVER or Third Party

              	
                15

              

      

      
        	
                15.

              	
                CONTRACTUAL
                  AGREEMENT

              	
                16

              
	 	
                APPENDIX
                  I

              	
                Quality
                  Assurance Responsibility Matrix

              	 
	 	
                APPENDIX
                  II

              	
                List
                  of Contacts

              	 
	 	
                APPENDIX
                  III

              	
                NRP104
                  Drug Substance Specifications and Approved Raw Materials Sources
                  

              	 
	 	
                APPENDIX
                  IV

              	
                Batch
                  Release Documentation 

              	 
	 	
                APPENDIX
                  V

              	
                Batch
                  Document Audit Schedule

              	 

      

       

      
        	
                1.

              	
                PARTIES

              

      

      

      This
        AGREEMENT is effective as of May 18, 2006, by and between NEW RIVER
        PHARMACEUTICALS INC., a Virginia corporation having its principal offices
        at
        1881 Grove Avenue, Radford, Virginia 24141 (hereinafter referred to as “NEW
        RIVER”) and ORGANICHEM CORPORATION, a Delaware corporation having its principal
        offices at 33 Riverside Avenue, Rensselaer, New York 12144 (hereinafter referred
        to as “ORGANICHEM”).

      

      
        	
                2.

              	
                QUALITY
                  AGREEMENT

              

      

      

      
        	 	
                2.1

              	
                This
                  agreement defines the roles and responsibilities of ORGANICHEM
                  for
                  services or materials supplied to NEW RIVER or affiliates, for
                  Commercial
                  Distribution or Clinical Trial use to ensure compliance with applicable
                  current Good Manufacturing Practice (cGMP) and ICH Q7A guidelines.
                  This
                  agreement is supplemental to and shall be incorporated within and
                  constitute a part of the API Supply Agreement entered into between
                  NEW
                  RIVER and ORGANICHEM. The provisions of this Agreement are intended
                  to be
                  supplemental to and not in derogation from the terms of the API
                  Supply
                  Agreement and provisions contained herein shall be treated as supplemental
                  to the API Supply Agreement and in particular but without limitation
                  in
                  relation to the application, compliance, verification and implementation
                  of cGMP. Capitalized expressions used in this Agreement shall have
                  the
                  meaning ascribed thereto in the API Supply
                  Agreement.

              

      

       

      
        
          
          

        

        
          3

          
            

          

        

        
          
          

        

      

      
        	
                3.

              	
                ADMINISTRATIVE
                  INFORMATION

              

      

      

      A
        Responsibilities Matrix covering the responsibilities of the quality assurance
        functions is found in Appendix I. This matrix is intended to supplement the
        document and the Quality Agreement will have jurisdiction over any discrepancies
        between the two. Contact names will be provided from both sites for key
        functional areas. Contact names are provided in Appendix II and may be updated
        as needed upon written notice of a Party.

      

      
        	
                4.

              	
                API

              

      

      

      The
        API
        is described in the schedule of the API Supply Agreement to which this Agreement
        is appended and as outlined within the specifications attached as Appendix
        III.

      

      
        	
                5.

              	
                DURATION
                  OF AGREEMENT

              

      

      

      This
        Agreement shall commence on execution thereof by both parties and subject
        to the
        following provisions of this clause shall expire or terminate in respect
        of any
        API Supply Agreement on the expiry or termination of that agreement. Any
        section
        of this agreement which has a predefined retention, survival or maintenance
        period, for example raw data storage, product complaints and sample retention,
        shall survive the termination of this contract for the period defined in
        the
        appropriate section. The agreement cannot be modified except with the written
        approval of both parties. Specifications and Master Batch Records may be
        modified with written authorization from designated representatives of both
        companies.

      

      
        	
                6.

              	
                JURISDICTION

              

      

      

      In
        case
        of a disagreement on analytical test results between parties, such disputes
        will
        be resolved in accordance with the terms of the API Supply Agreement. For
        batches with an out-of-specification result, ORGANICHEM’s out-of-specification
        SOP will be followed to determine suitability for batch release. ORGANICHEM
        may
        ship API to the Finished Product manufacturer when the API has been released
        by
        ORGANICHEM’s internal procedures.

       

      
        
          
          

        

        
          4

          
            

          

        

        
          
          

        

      

      

      
        	
                7.

              	
                CONFIDENTIALITY

              

      

      

      Both
        parties will treat as confidential all data supplied by the other in connection
        with the manufacture of the API in accordance with the API Supply
        Agreement.

      

      
        	8.	
                SECURITY

              

      

      

      ORGANICHEM
        has and will maintain controlled access to the facility through a security
        card
        key or similar system.

      

      
        	
                9.

              	
                SUPPLY

              

      

      

      
        	 	
                9.1

              	
                Premises

              

      

      

      
        	 	
                9.1.1

              	
                ORGANICHEM
                  will manufacture, package, and/or test the API at the Plant and
                  will not
                  use or transfer at a later date any of the manufacturing, packaging
                  or
                  testing operations for the API (s) to third parties or other sites
                  without
                  the prior written agreement of NEW RIVER Quality
                  Assurance.

              

      

      

      
        	 	
                9.1.2

              	
                ORGANICHEM
                  will ensure at all times that the premises and equipment comprising
                  the
                  Plant used to manufacture/supply the API comply with current regulatory
                  requirements, applicable cGMP’s, ICH Q7A, and are in accordance with the
                  documentation approved by NEW RIVER Quality
                  Assurance.

              

      

      

      
        	 	
                9.2

              	
                API
                  Specification and Master Production
                  Records

              

      

      

      
        	 	
                9.2.1

              	
                ORGANICHEM
                  will manufacture, package, and test the API in accordance with
                  and subject
                  to the terms of the API Supply Agreement against the most recent
                  version
                  of the Specifications and Master Batch Record (in process, release
                  and
                  shelf-life/regulatory) and formula of the API listed in Appendix
                  III. API
                  Specifications will be approved by the NEW RIVER QA Department
                  or
                  designee. A list of authorized signatures will be provided by NEW
                  RIVER.

              

      

      

      
        	 	
                9.2.2

              	
                ORGANICHEM
                  will evaluate and/or qualify suppliers through QA and Purchasing
                  evaluation which verifies compliance by the supply company with
                  cGMP (if
                  applicable) and specifications, where appropriate, an on-site audit
                  of the
                  manufacturing site may be required if mutually agreed to in the
                  Master
                  Supply Agreement. Critical Material supplies are identified as
                  [***].
                  ORGANICHEM will be limited to those qualified suppliers. Any change
                  from
                  these Critical Material suppliers will be handled through Critical
                  Material change control procedures, and must be first approved
                  by NEW
                  RIVER Quality Assurance or designee. ORGANICHEM will be responsible
                  to
                  qualify these Critical Material suppliers according to ORGANICHEM
                  SOPs.

              

      

       

      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

      

       

      
        	 	
                9.2.2.1

              	
                Chemical
                  Component Specification

              

      

      

      If
        ORGANICHEM has the responsibility in the API Supply Agreement for providing
        Raw
        Material, ORGANICHEM will obtain (from approved ORGANICHEM suppliers as defined
        in the appropriate Regulatory documentation) and test raw materials to the
        full
        Specification unless a supplier Certificate of Analysis (COA) is available
        from
        an approved supplier. Then provided ORGANICHEM has provided a reasoned
        justification for the application for reduced standards for review by NEW
        RIVER,
        reduced testing following ORGANICHEM’S SOP may be applied. Any reference
        standards for testing that are supplied by NEW RIVER or its Affiliates must
        be
        accompanied by a COA listing expiration date and any correction factors that
        need to be applied.

      

      If
        raw
        material is provided by NEW RIVER, ORGANICHEM will obtain and test raw materials
        to the full specification unless a Certificate of Analysis (COA) is available,
        then provided ORGANICHEM has provided a reasoned justification for the
        application for reduced standards for review by NEW RIVER, reduced testing
        after
        approval by NEW RIVER may be applied.

      

      At
        NEW
        RIVER’s request, ORGANICHEM will provide confirmation that all [***] raw
        materials purchased by ORGANICHEM for the manufacture of API have a [***]
        certificate of compliance from the supplier.

      

      
        	 	
                9.2.2.2

              	
                Label
                  Component Specifications

              

      

      

      ORGANICHEM
        will provide copies of Master labels that meet all appropriate GMP, Regulatory
        and Shipping requirements applicable to the NEW RIVER API for approval by
        NEW
        RIVER QA. Any modifications to the Label and or Label copy will be submitted
        to
        NEW RIVER QA for approval prior to use.

      

      
        	 	
                9.2.2.3

              	
                Packaging
                  Component Specifications

              

      

      

      ORGANICHEM
        will obtain product contact packaging components (from approved ORGANICHEM
        suppliers as defined in the appropriate Regulatory documentation) and test
        packaging components to the full Specification unless a qualified supplier
        COA
        is available from a certified supplier.

      

      
        	 	
                9.3

              	
                GMP
                  Guidelines

              

      

      

      Any
        applicable API license or pharmacopoeia or formulatory requirements applicable
        to the Manufacture of APIs shall be complied with in addition to cGMP, Q7A,
        and
        Specifications.

      

      
        	 	
                9.4

              	
                Materials

              

      

      

      
        	 	
                9.4.1

              	
                Materials
                  Procured by ORGANICHEM

              

      

      

      
        
          
          

        

        
          6

          
            

          

        

        
          
          

        

      

       

      ORGANICHEM
        is responsible for ensuring that all raw materials procured for use in the
        product are in full compliance with the specifications. Raw materials are
        given
        a retest date upon the satisfactory completion of all initial testing. Retesting
        will be performed at defined time intervals to ensure the chemical and physical
        stability of the raw materials unless NEW RIVER provides an official expiration
        date. NEW RIVER QA or designee must approve any program that allows retesting
        of
        raw materials through annual on-site audit.

      

      
        	 	
                9.4.2

              	
                Materials
                  Provided by NEW RIVER

              

      

      

      Raw
        materials provided by NEW RIVER may require acceptance testing by ORGANICHEM
        to
        confirm that the product is in full compliance with the Specifications. Where
        acceptance testing is to be performed by ORGANICHEM to ensure full compliance
        with Specifications then ORGANICHEM shall undertake such acceptance testing
        as
        is agreed. Should this testing be performed by NEW RIVER it will be the
        responsibility of NEW RIVER for ensuring that these raw materials are in
        full
        compliance with the Specifications. ORGANICHEM is responsible for ensuring
        that
        all materials are used correctly, have the correct identity by testing identity
        on receipt, and have the relevant COA required for the Batch.

      

      
        	 	
                9.5

              	
                Master
                  Production Record Approval

              

      

      

      ORGANICHEM
        may transcribe the information into its own format and must obtain written
        approval from NEW RIVER QA or designee for each document version before
        manufacturing. NEW RIVER will have [***] to provide approval, unless otherwise
        mutually agreed to. If NEW RIVER approval is not received within the mutually
        agreed upon timeframe, then ORGANICHEM will give NEW RIVER notification that
        ORGANICHEM intends to proceed with the execution of the procedure in [***]
        without NEW RIVER approval.

      

      
        	 	
                9.6

              	
                Production

              

      

      

      
        	 	
                9.6.1

              	
                The
                  API will be manufactured in accordance with the manufacturing and
                  packaging procedures set forth in the API Monograph and Master
                  Production
                  Record.

              

      

      

      
        	 	
                9.7

              	
                Methodology

              

      

      

      ORGANICHEM
        will test using the approved methodology listed in the NEW RIVER QA approved
        API
        Monograph.

      

      
        	 	
                9.8

              	
                Standard
                  Operating Procedures

              

      

      

      ORGANICHEM
        is responsible for maintaining any Standard Operating Procedures (SOPs) required
        to make the API in accordance with cGMPs, ICH Q7A, and as described in the
        NDA
        or Compendial documentation as well as any other regulatory
        requirements.

      

      
        	 	
                9.9

              	
                Dates
                  of Manufacture and Retest

              

      

      
        
          
          

        

        
          7

          
            

          

        

        
          
          

        

      

      

      
        	 	
                9.9.1

              	
                Date
                  of Manufacture

              

      

      

      ORGANICHEM
        will allocate the Date of Manufacture based on ORGANICHEM written procedures,
        reviewed by NEW RIVER during annual on-site audit.

      

      
        	 	
                9.9.2

              	
                Retest
                  Date

              

      

      

      NEW
        RIVER
        will provide the appropriate Retest Date information (for ORGANICHEM review)
        based upon available stability data.

      

      
        	 	
                9.10

              	
                Manufacturing
                  Equipment and Supporting Data

              

      

      

      ORGANICHEM
        shall maintain all equipment used in the manufacturing, packaging, testing
        and
        supply of API hereunder in good operating condition and shall maintain the
        Facility and such equipment in accordance with applicable current Good
        Manufacturing Practices (21 CFR Parts 210 and 211), ICH Q7A, specification,
        applicable laws, rules and regulations. As deemed appropriate, equipment
        shall
        be qualified prior to use by performing Installation Qualification, Operation
        Qualification and Performance Qualification (as applicable) using protocols
        in
        accordance with all applicable laws, rules and regulations.

      

      Equipment
        and instruments used to produce or test the API or components thereof shall
        be
        calibrated, where appropriate, at suitable intervals in accordance with an
        established written program.

      

      ORGANICHEM
        is responsible for safe keeping and retention of records of machine usage
        (previous API produced in non-dedicated machinery), cleaning, any
        maintenance/calibration performed, API batch numbers and certification,
        in-process results and parameters, and test results in accordance with and
        shall
        perform all functions in accordance with legal and regulatory
        requirements.

      

      

      
        	
                10.

              	
                QUALITY
                  ASSURANCE AND CONTROL

              

      

      

      
        	 	
                10.1

              	
                QC
                  of Materials

              

      

      

      
        	 	
                10.1.1

              	
                Quality
                  control of Materials supplied by ORGANICHEM will be undertaken
                  by
                  ORGANICHEM in accordance with all applicable SOPs and meet ICH
                  Q7A or
                  applicable requirements. All Critical Raw Materials will be evaluated
                  in
                  accordance with the approved
                  Monograph.

              

      

      

      
        	
              	10.2	
                API
                  Testing

              

      

      

      
        	 	
                10.2.1

              	
                APIs
                  and packaging components:

              

      

      ORGANICHEM
        will ensure that all materials used are in compliance with the
        Monograph.

      
        
          
          

        

        
          8

          
            

          

        

        
          
          

        

      

      

      
        	 	
                10.2.2

              	
                ORGANICHEM
                  will perform all API testing using the Specifications, and methods
                  of
                  analysis listed in Appendix III or the latest version approved
                  by NEW
                  RIVER.

              

      

      

      
        	 	
                10.3

              	
                Release
                  Procedures

              

      

      

      A
        list of
        documents issued to facilitate batch release is provided in Appendix
        IV.

      

      
        	 	
                10.3.1

              	
                API

              

      

      ORGANICHEM
        is responsible for ensuring and certifying that the API has been made according
        to applicable cGMPs and the specifications/procedures documented in the Master
        Batch Record. This includes a complete and thorough review of the executed
        batch
        records.

      

      
        	 	
                10.3.2

              	
                Certificate
                  of Conformity/Analysis

              

      

      ORGANICHEM’s
        QA Representative will sign a Certificate of Conformity/Analysis confirming
        that
        the API has been manufactured, packaged, tested, in accordance with cGMP,
        appropriate regulations and meets the requirements of the Master Batch Record
        and Specification. A copy of this documentation will be sent to NEW RIVER
        as
        generated during release of the batch prior to shipment. ORGANICHEM will
        issue a
        Certificate of Analysis and Certificate of Conformance containing the lot
        number, date of release, date of manufacture, retest date, compound name,
        and
        testing results. A copy of the COA and COC will be forwarded to NEW RIVER
        as
        generated during Batch Release prior to shipment. An additional copy of the
        COA
        and COC will be sent with the shipment. ORGANICHEM will send a copy of the
        packing list with pertinent shipping information to NEW RIVER at the same
        time
        the material leaves the ORGANICHEM facility.

      

      
        	 	
                10.3.3

              	
                Executed
                  batch records will be requested by NEW RIVER QA or designee for
                  periodic
                  review independent of batch investigations conducted for batch
                  or testing
                  difficulties. The planned frequency of New River full review of
                  batch
                  records will be outlined in Appendix V. ORGANICHEM will supply
                  requested
                  documents within [***] of completion of ORGANICHEM internal batch
                  release.

              

      

      

      
        	 	
                10.3.4

              	
                NEW
                  RIVER Confirmatory Testing

              

      

      NEW
        RIVER
        or its affiliates may perform confirmatory testing to validate ORGANICHEM’S
        data.

      

      
        	 	
                10.4

              	
                Documentation

              

      

      

      
        	 	
                10.4.1

              	
                Requests
                  for Full Documentation

              

      

      ORGANICHEM
        agrees to supply NEW RIVER or its Affiliates with copies of any manufacturing,
        packaging, testing, or stability data within [***] of request.

      

      
        	 	
                10.4.2

              	
                ORGANICHEM
                  will retain, at minimum, batch production records, quality control
                  testing
                  records, all records of shipments of the API from ORGANICHEM, all
                  validation data and other documentation relating to the API for
                  [***] or
                  the time periods required by applicable laws and regulations with
                  respect
                  to the API plus one year. ORGANICHEM will retain, at minimum batch
                  packaging documents for [***] [***] materials were last used in
                  the
                  packaging or labeling of API.

              

      

      
        
          
          

        

        
          9

          
            

          

        

        
          
          

        

      

      

      
        	 	
                10.4.2.1

              	
                ORGANICHEM
                  shall supply the documentation outlined in Appendix V for the “Batch
                  Document Audit Schedule” as outlined for both routine and regulatory or
                  validation batches. Copies of the documents and records required
                  to
                  complete the NEW RIVER batch review will be made at ORGANICHEM’s expense
                  and supplied in a timely manner as for NEW RIVER to complete the
                  review
                  and release (where applicable) of the drug substance (API), as
                  quickly as
                  possible, but not to exceed [***] of ORGANICHEM internal batch
                  release.

              

      

      

      
        	 	
                10.4.2.2

              	
                ORGANICHEM
                  shall make such records and data available for review by NEW RIVER
                  at
                  ORGANICHEM’s facility during the annual compliance
                  audit.

              

      

      

      
        	 	
                10.4.3

              	
                NEW
                  RIVER may review the ORGANICHEM document retention policy during
                  annual
                  on-site audit. Upon termination or expiration of this Agreement
                  or prior
                  to destruction of any records, whichever occurs first, ORGANICHEM
                  will
                  upon NEW RIVER’s written request and at NEW RIVER’s expense, make copies
                  of such records and data for NEW
                  RIVER.

              

      

      

      
        	 	
                10.5

              	
                Sampling

              

      

      

      
        	 	
                10.5.1

              	
                Retain
                  Samples - Raw Materials

              

      

      ORGANICHEM
        will retain samples of the raw materials where possible or reasonable given
        the
        chemistry of the material for a time period as defined in ORGANICHEM’s
        procedures. ORGANICHEM will retain samples of the active ingredient for a
        minimum of five years or at least one year beyond the expiry period of the
        API.
        The amount of sample retained will be [***] required to carry out all of
        the
        tests required to determine of the material meets its specifications, with
        the
        exception of Sterility and Pyrogen testing, if applicable. (CFR
        211.170a)

      

      
        	 	
                10.6

              	
                Stability

              

      

      

      
        	 	
                10.6.1

              	
                Routine
                  Stability Program

              

      

      

      
        	 	
                10.6.1.1

              	
                ORGANICHEM
                  is responsible for maintaining a routine stability testing program
                  for the
                  API, and will provide a stability report to NEW RIVER annually
                  or on
                  reasonable request intervals. Stability samples will be tested
                  [***] of
                  the target stability pull date or as indicated per the approved
                  stability
                  protocol. Completed testing data will be provided to NEW RIVER
                  [***] of
                  the request.

              

      

      

      
        	 	
                10.6.1.2

              	
                NEW
                  RIVER is responsible to provide or approve a stability indicating
                  method
                  to support the Routine Stability
                  Program.

              

      

      

      
        	 	
                10.6.1.3

              	
                The
                  stability program will be in compliance with any license commitments
                  as
                  notified by NEW RIVER. At a minimum one lot of each API, in each
                  package
                  type (largest to smallest, as applicable) will be placed on stability
                  each
                  year unless otherwise agreed to in writing by ORGANICHEM, NEW RIVER
                  and
                  FDA. The stability program will comply with ICH guidelines. The
                  stability
                  protocol or any changes must be approved by NEW RIVER QA or
                  designee.

              

      

      
        
          
          

        

        
          10

          
            

          

        

        
          
          

        

      

      

      
        	 	
                10.6.2

              	
                Development
                  Stability Program

              

      

      ORGANICHEM
        will be responsible for performing any development stability required to
        support
        the API. If that development stability is to support projects initiated by
        ORGANICHEM, then ORGANICHEM will develop, execute and write reports for the
        program. Stability samples will be tested [***] of the target stability pull
        date. All protocols for such work must be approved by NEW RIVER.

      

      
        	 	
                10.6.3

              	
                Stability
                  Failures

              

      

      Any
        confirmed problems or out-of-specification results which arise as a result
        of or
        during any of the stability programs will be communicated verbally [***]
        and in
        writing [***] to NEW RIVER Quality Assurance. ORGANICHEM will supply NEW
        RIVER’s
        Quality Assurance department with stability results [***] of receiving a
        written
        request.

      

      
        	 	
                10.7

              	
                Deviations
                  and Investigations

              

      

      

      
        	 	
                10.7.1

              	
                Deviations

              

      

      Any
        deviation from the process during Manufacture must be carefully explained
        and
        documented in the batch records, justified and approved by ORGANICHEM’s quality
        management and production management, and included in the documentation
        package.

      

      
        	 	
                10.7.1.1

              	
                Any
                  “planned” or “un-planned” process deviations affecting a Regulatory Filing
                  and/or Process Validation will be fully documented and investigated
                  according to ORGANICHEM procedures. Any such deviations will be
                  reviewed
                  with NEW RIVER’s QA Representative prior to batch
                  release.

              

      

      

      NOTE:
        A
        deviation is defined as any anomalous event that may occur during the processing
        of a Batch that is a departure from the specifications, and approved procedures
        or validated processes filed in the NDA. Planned deviations are considered
        those
        that occur before a process step is executed and when a batch can be interrupted
        to consider the ramifications of the proposed process or batch instruction
        deviation.

      

      
        	 	
                10.7.2

              	
                Failure
                  Investigations

              

      

      ORGANICHEM
        is responsible for investigating any test result or in-process test which
        fails
        to meet Specification. Each investigation will be reviewed and approved by
        ORGANICHEM’s designated Quality person. The investigation must document that any
        failure has not jeopardized the safety, efficacy or quality of the API. NEW
        RIVER must be notified in writing promptly but within 5 working days of the
        confirmed failing test result.

       

      
        
          
          

        

        
          11

          
            

          

        

        
          
          

        

      

      

      
        	 	
                10.7.3

              	
                ORGANICHEM
                  will notify NEW RIVER in writing as soon as reasonably possible
                  but [***]
                  of any batch of API rejected by
                  ORGANICHEM.

              

      

      

      
        	 	
                10.7.4

              	
                ORGANICHEM
                  will notify NEW RIVER forthwith if any problems are discovered
                  that may
                  impact API batch(s) previously shipped to NEW RIVER or its affiliates
                  identifying the batches in
                  question.

              

      

      

      
        	 	
                10.7.5

              	
                Some
                  deviations/failures may require that additional testing, stability,
                  or
                  validation be conducted. This work will be performed by ORGANICHEM
                  as
                  agreed by both parties.

              

      

      

      
        	 	
                10.8

              	
                Rejection
                  of API

              

      

      

      
        	 	
                10.8.1

              	
                Investigation
                  of Problems

              

      

      NEW
        RIVER
        or its affiliates will notify ORGANICHEM of any problems thought to be due
        to
        manufacture or stability, which are found during the finish dose manufacture
        of
        the product. When requested by NEW RIVER, ORGANICHEM will promptly perform
        investigations for these problems. Investigation reports will be forwarded
        to
        NEW RIVER as required.

      

      
        	 	
                10.9

              	
                Dispute
                  Resolution

              

      

      In
        the
        event that a dispute arises between ORGANICHEM and NEW RIVER or its affiliates
        in the analysis of the API, the resolution will proceed in stages. The first
        stage requires direct communication between analysts from both parties to
        determine that the methods of analysis are the same and are being executed
        in
        the same manner at both sites. Second, carefully controlled and split samples
        should be sent from one site to another in an attempt to reach an agreement.
        Should there be a failure to achieve resolution, analysts from both parties
        will
        be required to meet to work through the analysis of a mutually agreeable
        sample.
        If these actions fail to achieve resolution, and only after these avenues
        have
        been exhausted, will the parties apply the terms of the API Supply Agreement
        regarding resolution of API.

      

      
        	 	
                10.10

              	
                Regulatory
                  Inspections

              

      

      NEW
        RIVER’s Vice President of Product Development or designate will be notified as
        soon as reasonably possible of any Regulatory Inspections related to NEW
        RIVER
        API, and ORGANICHEM will permit a representative from NEW RIVER to be present
        on
        site for consultation, if requested by NEW RIVER. ORGANICHEM will notify
        NEW
        RIVER of any requests for information, notices of violations, or other
        communication from FDA relating directly to NEW RIVER API.

      

      
        	
              	10.11	
                Regulatory
                  Actions at NEW RIVER

              

      

      NEW
        RIVER
        or its affiliates will notify ORGANICHEM of any regulatory actions on the
        API
        that may impact ORGANICHEM. Additionally, NEW RIVER will immediately forward
        any
        regulatory correspondence on the APIs to ORGANICHEM.

      

      

      
        	 	
                10.12

              	
                Regulatory
                  Investigations

              

      

      ORGANICHEM
        is responsible for supporting all batch record investigations associated
        with
        regulatory actions. NEW RIVER will be notified of any such events
        [***]

       

      
        
          
          

        

        
          12

          
            

          

        

        
          
          

        

      

      
        	 	
                10.13

              	
                Manufacturing
                  Audits (MA)

              

      

      

      
        	 	
                10.13.1

              	
                ORGANICHEM
                  will allow and support one routine quality audit by NEW RIVER per
                  calendar
                  year per facility.

              

      

      

      
        	 	
                10.13.2

              	
                ORGANICHEM
                  will allow and support additional audits as requested by NEW RIVER
                  (for
                  cause only),
                  and as mutually agreed to by ORGANICHEM, to address specific quality
                  problems related to the API or in direct response to FDA requirements,
                  for
                  circumstances where NEW RIVER and ORGANICHEM reasonably believe
                  that
                  significant quality and/or compliance issues
                  exist.

              

      

      

      
        	 	
                10.13.3

              	
                Correspondence.
                  Each Party shall promptly notify the other Party of, and shall
                  provide
                  such other Party with copies of, any correspondence and other
                  documentation received or prepared by the notifying Party in connection
                  with any of the following events:

              

      

      

      
        	 	
                10.13.3.1

              	
                Receipt
                  of a 483 Observation Letter or “Warning Letter” from the FDA or any other
                  regulatory authority or any relevant foreign equivalent outside
                  the USA in
                  connection with the Manufacture, packaging, testing, storage or
                  security
                  of the API;

              

      

      

      
        	 	
                10.13.3.2

              	
                Any
                  field alert, recall, market withdrawal or correction of any Batch
                  of the
                  API; or

              

      

      

      
        	 	
                10.13.3.3

              	
                Any
                  regulatory comments relating to the Manufacture of the API requiring
                  a
                  response or action by the notifying
                  Party.

              

      

      

      
        	 	
                10.14

              	
                Right
                  to Audit

              

      

      

      
        	 	
                10.14.1

              	
                NEW
                  RIVER or its affiliate’s representatives will be escorted at all times by
                  ORGANICHEM personnel.

              

      

      

      
        	 	
                10.14.2

              	
                Audit
                  Procedures

              

      

      

      
        	 	
                10.14.2.1

              	
                An
                  exit meeting will be held with representatives from ORGANICHEM
                  and NEW
                  RIVER to discuss significant audit
                  observations.

              

      

      

      
        	 	
                10.14.2.2

              	
                NEW
                  RIVER will provide a written report of all observations [***] to
                  ORGANICHEM. [***] of audit report receipt, ORGANICHEM will provide
                  a
                  written response to all findings that details corrective action
                  to be
                  implemented. ORGANICHEM will follow-up to ensure that all corrective
                  actions are implemented.

              

      

       

      
        	 	
                10.15

              	
                Product
                  Complaints, Recall

              

      

      

      
        	 	
                10.15.1

              	
                Product
                  Complaints

              

      

      NEW
        RIVER
        Quality Assurance or its affiliates shall maintain complaint files with respect
        to the API in accordance with cGMP’s. NEW RIVER or its affiliates are
        responsible for receiving and initially investigating any API complaints
        and
        will notify ORGANICHEM of any complaint that may impact the API quality.
        ORGANICHEM will investigate any API complaints and provide a report to NEW
        RIVER
        promptly but [***] from receipt. The investigation shall be completed in
        accordance with all cGMP regulations and any other applicable regulations.
        NEW
        RIVER shall have responsibility for reporting all complaints relating to
        the API
        to the FDA and any other regulatory authority, including, but not limited
        to,
        complaints relating to the Manufacture of the API. NEW RIVER shall have the
        responsibility for reporting all complaints relating to adverse drug experience
        (ADE) reports.

       

      
        
          
          

        

        
          13

          
            

          

        

        
          
          

        

      

      

      
        	 	
                10.15.2

              	
                Product
                  Recall

              

      

      NEW
        RIVER
        or its affiliates are responsible for instituting a product recall due to
        any
        defect considered sufficiently serious. NEW RIVER will notify ORGANICHEM
        of any
        recall that may be due to the manufacture of the API. ORGANICHEM will work
        with
        NEW RIVER and its affiliates to investigate and coordinate the recall.
        ORGANICHEM will provide a rapid initial response and a full report
        [***].

      

      
        	 	
                10.16

              	
                Compliance
                  Deficiencies

              

      

      

      Should
        ORGANICHEM become aware of any issues that could affect the quality, safety,
        identity or efficacy of any NEW RIVER API produced at their facility, ORGANICHEM
        will notify NEW RIVER in writing [***].

      

      
        	
                11.

              	
                CHANGE
                  MANAGEMENT

              

      

      

      Master
        Production Records and the API Monograph will be approved by both NEW RIVER’s
        Quality Assurance Department and ORGANICHEM’s Quality Assurance Department. No
        changes to the above documents may be implemented without the signed
        authorization from an authorized member of the NEW RIVER Quality Assurance
        Department. All required regulatory approvals will be obtained prior to
        implementation. Variations to established production procedures may be initiated
        by either party, but must be agreed to in writing by the authorized members
        of
        the Quality Assurance Departments of both companies before
        implementation.

      

      
        	
                12.

              	
                API
                  AND PROCESS VALIDATION

              

      

      

      
        	 	
                12.1

              	
                Process

              

      

      ORGANICHEM
        is responsible for ensuring that the manufacturing process is validated.
        The
        validation should ensure that the process is capable of consistently achieving
        the API acceptance Specification. ORGANICHEM will not use any validation
        protocol or issue a report unless NEW RIVER technical personnel have first
        reviewed and provided comment (as appropriate). NEW RIVER will review all
        protocols and validation reports [***]

      

      
        	 	
                12.2

              	
                Cleaning
                  Validation

              

      

      ORGANICHEM
        is responsible for ensuring that adequate cleaning is carried out between
        batches of different APIs to prevent cross-contamination. NEW RIVER may review
        (on-site during the annual compliance audit) ORGANICHEM’s overall or Master
        Cleaning Validation Program, which may include equipment logs, cleaning
        validation SOPs, equipment cleaning procedures or SOPs, analytical method
        specificity, rationale for equipment release criteria and classifications
        of
        other products or raw materials used in the same equipment.

      
        
          
          

        

        
          14

          
            

          

        

        
          
          

        

      

      

      
        	 	
                12.3

              	
                Equipment,
                  Computer, Facility, and Utilities
                  Qualification

              

      

      ORGANICHEM
        is responsible for the safe and efficient working of all equipment, computer,
        utility, and facility qualification activities associated with the API including
        maintenance. ORGANICHEM is also responsible for the validation and qualification
        of all equipment, computer, and utilities associated with the API.

      

      
        	 	
                12.4

              	
                Laboratory
                  Qualification

              

      

      ORGANICHEM
        is responsible for ensuring that any contract laboratories used are compliant
        with cGMPs and are qualified in all of the methodology associated with the
        API.
        If analytical work is performed at ORGANICHEM, then NEW RIVER will also provide
        any existing analytical documentation to assist in methods transfer or methods
        validation. ORGANICHEM will not use any validation protocol or issue a report
        unless NEW RIVER technical personnel have first reviewed and provided comment
        (as appropriate). NEW RIVER will review all protocols and reports [***] [***].
        In addition, if analytical work is not performed at ORGANICHEM’s site,
        ORGANICHEM may elect to perform an audit on vendors to be used for analytical
        testing. Should ORGANICHEM decide to sub-contract out any analytical testing,
        prior approval from NEW RIVER QA or designee will be required.

      

      
        	
                13.

              	
                PRODUCT
                  QUALITY REVIEW AND ANNUAL
                  REPORTS

              

      

      

      
        	 	
                13.1

              	
                Product
                  Quality Review

              

      

      ORGANICHEM
        will perform a product quality review according to ICH Q7A (section 2.5)
        and
        will provide to NEW RIVER, upon request, a summary of what is required by
        NEW
        RIVER for a CMC section of an annual report (as per CDER’s Guidance for
        Industry, “Format and Content for the CMC Section of an Annual Report).

      

      
        	 	
                13.2

              	
                Annual
                  Reports

              

      

      NEW
        RIVER
        is responsible for preparing any Annual Report as required by applicable
        regulations, including 21 CFR 314.7 (g)(3), 314.81 (b)(2), and/or 601.12
        (d),
        (f)(3). [***] before the Annual Report due date, NEW RIVER shall request
        in
        writing from ORGANICHEM any information in addition to ORGANICHEM’s Annual
        Report that ORGANICHEM may possess that may be useful in NEW RIVER’s preparation
        of its Annual Report.

      

      
        	
                14.

              	
                STORAGE
                  AND SHIPPING

              

      

      

      
        	 	
                14.1

              	
                Storage

              

      

      ORGANICHEM
        will ensure that during storage of the API that there is no possibility of
        deterioration, interference, theft, material contamination or admixture with
        any
        other materials. NEW RIVER will provide details of any labeling requirements
        and
        container sealing and integrity.

      

      
        	 	
                14.2

              	
                Packing
                  and Labeling for Transit

              

      

      The
        API
        will be suitably packed for transit, each pallet or outer container being
        labeled in accordance with the approved specifications.

       

      
        
          
          

        

        
          15

          
            

          

        

        
          
          

        

      

       

      
        	 	
                14.3

              	
                Shipment
                  of API to NEW RIVER or Third Party

              

      

      Only
        approved, finished (unless required by NEW RIVER), labeled API will be shipped
        by ORGANICHEM to NEW RIVER or a Third Party as indicated on a Purchase Order.
        Any shipment of API from ORGANICHEM that is unapproved or under quarantine
        requires prior written consent by NEW RIVER’s Quality Unit. This authorization
        will be on a lot by lot basis.

      
        
          
          

        

        
          16

          
            

          

        

        
          
          

        

      

      

      
        	
                15.

              	
                CONTRACTUAL
                  AGREEMENT

              

      

      

      Established
        at NEW RIVER PHARMACEUTICALS INC., 1881 Grove Avenue, Radford, Virginia
        24141

       

       

      For
        and
        on behalf of NEW RIVER PHARMACEUTICALS INC.:

       

       

      
        	
                  
                  

              	 	
                
                

              	 	 
	
                 
                  

              	 	 	 	 
	
                NAME

              	 	
                TITLE

              	 	
                SIGNATURE

              

      

       

       

      For
        and
        on behalf of ORGANICHEM CORPORATION:

       

       

      
        	
                 
                  

              	 	
                 
                  

              	 	 
	
                 
                  

              	 	 	 	 
	
                NAME

              	 	
                TITLE

              	 	
                SIGNATURE

              

      

       

      
        
          
          

        

        
          17

          
            

          

        

        
          
          

        

      

      APENDIX
        I

      Quality
        Assurance Responsibilities Matrix

       

      
        
          
          

        

        
          18

          
            

          

        

        
          
          

        

      

       

      Responsibilities
        Matrix

      

      ORGANICHEM
        is responsible for all the operations that are marked with "X" in the column
        titled "ORGANICHEM" and NEW RIVER is responsible for all the operations that
        are
        marked with "X" in the column titled "NEW RIVER." The designated party that
        does
        not have the primary responsibility, however will need to cooperate. Reference
        to QA or MSA correlates the location of this responsibility to the body of
        the
        Quality Agreement (Section or Appendix) or the Master Services Agreement
        (MSA)
        location.

      

      Administrative
        or Overall

       

      
        	 	 	
                Reference
                  QA or MSA

              	
                NEW
                  RIVER

              	
                ORGANICHEM

              
	
                1.

              	
                Manufacture
                  and package API according to the Specifications.

              	
                QA
                  Appendix III

              	 	
                X

              
	
                2.

              	
                Permit
                  cGMP audits of all relevant premises, procedures and documentation
                  by NEW
                  RIVER (once annually or for cause) and permit inspection by regulatory
                  authorities.

              	
                QA
                  Section 10.10 to 10.13

              	 	
                X

              
	
                3.

              	
                Will
                  not subcontract any of the work to a third party without prior
                  written
                  consent of NEW RIVER.

              	
                QA
                  Section 9.1 and 12.4

              	 	
                X

              
	
                4.

              	
                Provide
                  a summary upon request by NEW RIVER for the annual update to the
                  CMC
                  section.

              	
                QA
                  Section 13.1

              	 	
                X

              
	
                5.

              	
                Provide
                  copies of information and correspondence necessary to support the
                  Annual
                  Report when requested by NEW RIVER.

              	
                QA
                  Section 13.2

              	 	
                X

              
	
                6.

              	
                Notify
                  and obtain approval from NEW RIVER before initiating any proposed
                  changes
                  to the Master Production Records and API Monograph that may affect
                  the
                  API.

              	
                QA
                  Section 11

              	 	
                X

              
	
                7.

              	
                NEW
                  RIVER will have [***] to provide such approval of Master Batch
                  Records and
                  API Monograph (unless otherwise mutually agreed to). NEW RIVER
                  approval
                  will not be unreasonably withheld.

              	
                QA
                  Section 9.5

              	
                X

              	 
	
                8.

              	
                Notify
                  and obtain approval from ORGANICHEM of any proposed changes to
                  the
                  process, materials, testing, or Specifications that may affect
                  the API.
                  ORGANICHEM approval will not be unreasonably withheld.

              	
                QA
                  Section 11

              	
                X

              	 
	
                9.

              	
                Notify
                  NEW RIVER promptly of receipt of any FDA Form 483's, warning letters
                  or
                  the like from regulatory agencies relating specifically to: (i)
                  the API;
                  (ii) the supply of API. ORGANICHEM reserves the right to respond
                  to such
                  regulatory agencies without approval, if, in the reasonable opinion
                  of
                  ORGANICHEM’S counsel, it is required to do so.

              	
                QA
                  Section 10.13.3

              	
                (X)

              	
                X

              
	
                10.

              	
                Notify
                  NEW RIVER [***] of any regulatory authority requests for samples,
                  batch
                  documentation, or other information related specifically to the
                  API.

              	
                QA
                  Section 10.12

              	 	
                X

              
	
                11.

              	
                Conduct
                  operations in compliance with applicable cGMP regulations.

              	
                QA
                  Section 2.1 & 9.1.2Article 2 of MSA

              	 	
                X

              
	
                12.

              	
                Investigate
                  all complaints related to the Manufacturing of the API.

              	
                QA
                  Section 10.15

              	
                X

              	
                (X)

              
	
                13.

              	
                Investigate
                  all Manufacturing complaints at NEW RIVER’S request.

              	
                QA
                  Section 10.15

              	 	
                X

              
	
                14.

              	
                Notify
                  other party promptly of receipt of information meeting NDA Field
                  Alert
                  criteria as defined in 21 CFR 314.81(b)(1).

              	
                QA
                  Section 10.13.3

              	
                X

              	
                X

              
	
                15.

              	
                Initiate
                  NDA Field Alert reports.

              	
                QA
                  Section 10.13.3

              	
                X

              	 
	
                16.

              	
                Initiate
                  and manage Drug Product recalls.

              	
                QA
                  Section 10.15.2

              	
                X

              	 
	
                17.

              	
                Timely
                  liaise with Regulatory Authorities for approval, maintenance, and
                  updating
                  of marketing approval.

              	
                QA
                  Section 10.10 to 10.16

              	
                X

              	 

      

      

      
        
          
          

        

        
          19

          
            

          

        

        
          
          

        

         

      

      	(b)  	
              Validation
                and Process Testing Activities

            

      

      
        	 	 	
                Reference
                  QA or MSA

              	
                NEW
                  RIVER

              	
                ORGANICHEM

              
	
                1.

              	
                Establish
                  applicable master validation plans.

              	
                QA
                  Section 12

              	 	
                X

              
	
                2.

              	
                Maintain
                  a validation program for the API.

              	
                QA
                  Section 12.1

              	
                (X)

              	
                X

              
	
                3.

              	
                Qualify
                  (IQ/OQ) facilities, utilities, laboratory equipment and process
                  equipment.

              	
                QA
                  Section 12.3

              	 	
                X

              
	
                4.

              	
                Calibrate
                  instrumentation and qualify computer systems used in the Manufacture
                  and
                  testing of the API.

              	
                QA
                  Section 12.3

              	 	
                X

              
	
                5.

              	
                Prepare
                  all Validation Protocols and reports for Manufacturing and packaging
                  operations.

              	
                QA
                  Section 12.1

              	 	
                X

              
	
                6.

              	
                Review
                  NRP104 process validation plan, Validation Protocols, and reports
                  for
                  Manufacturing and packaging of the API. Provide comments and feedback
                  as
                  applicable.

              	
                QA
                  Section 12.1

              	
                X

              	 
	
                7.

              	
                Approve
                  NRP104 process validation plan, and Validation Protocols and reports
                  for
                  Manufacturing and packaging of the API.

              	
                QA
                  Section 12.1

              	 	
                X

              
	
                8.

              	
                Maintain
                  appropriate equipment cleaning procedures and cleaning validation
                  program.

              	
                QA
                  Section 12.2

              	 	
                X

              
	
                9.

              	
                Provide
                  toxicological information to be used in the development of a cleaning
                  program.

              	
                QA
                  Section 12.2

              	
                X

              	 
	
                10.

              	
                Assure
                  analytical test methods for finished API have been adequately validated
                  for use at Organichem.

              	
                QA
                  Section 12.4

              	
                (X)

              	
                X

              

      

      

      
        
          
          

        

        
          20

          
            

          

        

        
          
          

        

         

      

      	(c)  	
              Raw
                Materials

            

      

      
        	 	 	
                Reference
                  QA or MSA

              	
                NEW
                  RIVER

              	
                ORGANICHEM

              
	
                1.

              	
                Provide
                  all Batch Records (including Master Batch Records) including Bill
                  of
                  Materials.

              	
                QA
                  Section 9.2

              	 	
                X

              
	
                2.

              	
                ORGANICHEM
                  to qualify and approve all Raw Material suppliers and ensure cGMP
                  compliance where applicable. Critical material suppliers considered
                  will
                  be identified and changes to these approved Specifications will
                  be routed
                  through NEW RIVER and associated change control. NEW RIVER approval
                  of
                  said changes will not be reasonably withheld (attached hereto as
                  Schedule
                  C).

              	
                QA
                  Section 9.2.2

              	
                (X)

              	
                X

              
	
                3.

              	
                Analyze
                  and release API to NEW RIVER or assigned third party.

              	
                QA
                  Section 9.0

              	 	
                X

              
	
                4.

              	
                Retain
                  reference sample of API for a [***] past the expiry date or such
                  longer
                  period required by law.

              	
                QA
                  Section 10.5.1

              	 	
                X

              
	
                5.

              	
                Procure
                  Raw Materials (including Certificates of Analysis and Certificates
                  of
                  Compliance, where applicable).

              	
                QA
                  Section 9.4

              	 	
                X

              
	
                6.

              	
                Analyze
                  and release Raw Materials.

              	
                QA
                  Section 9.4

              	 	
                X

              
	
                7.

              	
                Retain
                  reference samples (non hazardous) of Raw Materials for a period
                  as defined
                  by ORGANICHEM procedures. Maintain all testing records for raw
                  materials
                  (hazardous and non hazardous) for [***].

              	
                QA
                  Section 10.5.1

              	 	
                X

              
	
                8.

              	
                At
                  NEW RIVER’S request, confirm that all [***] Raw Materials purchased by
                  ORGANICHEM for the Manufacture of API have a [***] certificate
                  of
                  compliance from the Raw Material supplier.

              	
                QA
                  Section 9.2.2.1

              	 	
                X

              

      

      

      
        
          
          

        

        
          21

          
            

          

        

        
          
          

        

         

      

      	(d)  	
              Bulk
                Manufacture

            

      

      
        	 	 	
                Reference
                  QA or MSA

              	
                NEW
                  RIVER

              	
                ORGANICHEM

              
	
                1.

              	
                Create,
                  control, issue and execute Master Batch Record (production
                  instructions).

              	
                QA
                  Section 9.2

              	 	
                X

              
	
                2.

              	
                Approve
                  master production and packaging instructions (New River shall have
                  [***]
                  provide approval, unless otherwise agreed upon).

              	
                QA
                  Section 9.5

              	
                X

              	
                X

              
	
                3.

              	
                Document,
                  investigate, and resolve deviations affecting a Regulatory filing
                  from
                  approved Manufacturing instructions or Specifications.

              	
                QA
                  Section 10.7.1

              	
                (X)

              	
                X

              

      

      

      	(e)  	
              Packaging

            

      

      
        	 	 	
                Reference
                  QA or MSA

              	
                NEW
                  RIVER

              	
                ORGANICHEM

              
	
                1.

              	
                Provide
                  Specifications for packaging components.

              	
                QA
                  Appendix III

              	
                (X)

              	
                X

              
	
                2. 

              	
                Provide
                  labeling text (label, pallet etc.) Specifications.

              	
                QA
                  Section 9.2.2.2

              	 	
                X

              
	
                3. 

              	
                Create,
                  control, issue, and execute master packaging record (may be part
                  of master
                  production instructions).

              	
                QA
                  Section 9.2

              	 	
                X

              
	
                4. 

              	
                Approve
                  master packaging record (may be part of master production instructions)
                  (NEW RIVER shall have [***] [***] to provide approval, unless otherwise
                  agreed upon).

              	
                QA
                  Section 9.5

              	
                X

              	
                X

              
	
                5. 

              	
                ORGANICHEM
                  to assure that “product contact” packaging components meet all cGMP
                  requirements (as applicable).

              	
                QA
                  Section 9.2.2.3

              	 	
                X

              
	
                6. 

              	
                Provide
                  test methods for packaging components.

              	
                QA
                  Section 9.2.2.3

              	 	
                X

              
	
                7. 

              	
                Procure
                  packaging components.

              	
                QA
                  Section 9.2.2.3

              	 	
                X

              
	
                8. 

              	
                Analyze
                  and release packaging components (as applicable).

              	
                QA
                  Section 9.2.2.3

              	 	
                X

              
	
                9. 

              	
                Maintain
                  records and evidence on the testing of packaging/labeling materials
                  for
                  [***] after the materials were last used in the packaging/labeling
                  of the
                  API.

              	
                QA
                  Section 10.4

              	 	
                X

              
	
                10. 

              	
                Document,
                  investigate, and resolve any deviation from approved packaging
                  instructions or specifications.

              	
                QA
                  Section 10.7

              	 	
                X

              

      

      

      
        
          
          

        

        
          22

          
            

          

        

        
          
          

        

         

      

      	(f)  	
              Testing
                & Release of Finished Drug Substance

            

      

      
        	 	 	
                Reference
                  QA or MSA

              	
                NEW
                  RIVER

              	
                ORGANICHEM

              
	
                1. 

              	
                Provide
                  API Specifications.

              	
                QA
                  Appendix III

              	
                (X)

              	
                X

              
	
                2. 

              	
                Supply/develop
                  analytical test methods specific to API.

              	
                QA
                  Section 9.7

              	
                (X)

              	
                X

              
	
                3. 

              	
                Test
                  finished API. Issue CoA/CoC.

              	
                QA
                  Appendix IV

              	 	
                X

              
	
                4. 

              	
                Maintain
                  all batch records for a minimum of [***] past API expiry or retest
                  date.

              	
                QA
                  Section 10.4

              	 	
                X

              
	
                5. 

              	
                Supply
                  copies of all batch records to NEW RIVER upon request.

              	
                QA
                  Section 10.4.1 and Appendix V

              	 	
                X

              
	
                6. 

              	
                Notify
                  NEW RIVER QA of confirmed Out-Of-Specification results within
                  [***]

              	
                QA
                  Section 10.7.2

              	 	
                X

              
	
                7. 

              	
                Resolve
                  Out-Of-Specifications results and supply Investigation Report with
                  Batch
                  Documentation.

              	
                QA
                  Section 10.7.2

              	 	
                X

              
	
                8. 

              	
                Retain
                  reference samples of drug substance for a [***] past retest or
                  expiration
                  date.

              	
                QA
                  Section 10.5.1

              	 	
                X

              

      

      

      	(g)  	
              Stability
                Testing

            

      

      
        	 	 	
                Reference
                  QA or MSA

              	
                NEW
                  RIVER

              	
                ORGANICHEM

              
	
                1.

              	
                Provide
                  stability testing protocol for finished API.

              	
                QA
                  Section 10.6

              	
                (X)

              	
                X

              
	
                2.

              	
                Store
                  stability samples according to ICH conditions.

              	
                QA
                  Section 10.6

              	 	
                X

              
	
                3.

              	
                Assure
                  that a validated stability indicating assay is being performed
                  for
                  stability testing.

              	
                QA
                  Section 10.6

              	
                X

              	
                (X)

              
	
                3.

              	
                Qualify
                  or transfer stability indicating assay.

              	
                QA
                  Section 10.6

              	 	
                X

              
	
                4.

              	
                Perform
                  stability testing [***] of stability pull or as indicated per approved
                  site SOP or approved Stability Protocol.

              	
                QA
                  Section 10.6

              	 	
                X

              
	
                5.

              	
                Notify
                  NEW RIVER of any confirmed stability failure for API supplied to
                  NEW RIVER
                  [***].

              	
                QA
                  Section 10.6

              	 	
                X

              

      

       

      
        
          
          

        

        
          23

          
            

          

        

        
          
          

        

      

       

      APENDIX
        II

      List
        of Contacts

      (Name,
        [***])

       

       

      
        	
                ISSUE

              	
                NEW
                  RIVER or Affiliates

              	
                ORGANICHEM

              
	
                Product
                  Release

              	
                Suma
                  Krishnan

                [***]

              	
                Karen
                  Matteo

                [***]

              
	
                Investigations

              	
                Cheryl
                  Zwirgzdas

                [***]

              	
                Karen
                  Matteo

                [***]

              
	
                Stability

              	
                Cheryl
                  Zwirgzdas

                [***]

              	
                Kristin
                  Schmitz

                [***]

              
	
                Regulatory
                  Inspections

              	
                Suma
                  Krishnan

                [***]

              	
                Patricia
                  Ellis

                [***]

              
	
                Complaints

              	
                Suma
                  Krishnan

                [***]

              	
                Gary
                  Klee

                [***]

              
	
                Change
                  Management

              	
                Cheryl
                  Zwirgzdas

                [***]

              	
                Karen
                  Matteo

                [***]

              
	
                Audits

              	
                Cheryl
                  Zwirgzdas

                [***]

              	
                Stephen
                  Fordham

                [***]

              
	
                Regulatory
                  Affairs

              	
                Suma
                  Krishnan

                [***]

              	
                Gary
                  Klee

                [***]

              
	
                Emergency

              	
                Cheryl
                  Zwirgzdas

                [***]

              	
                Karen
                  Matteo

                [***]

              

      

       

      
        
          
          

        

        
          24

          
            

          

        

        
          
          

        

      

       

      APPENDIX
        III

      NRP104
        Drug Substance and Packaging Specifications

      And

      Approved
        Critical Raw Material and Product Contact Packaging Component
        Suppliers

      
        
          
          

        

        
          25

          
            

          

        

        
          
          

        

      

      

      Product
        Name: NRP104

      

      Replaces: July
        20,
        2004

      Effective: November
        18, 2005

      

      
        
          

          

        

      

      [***]

      

      SPECIFICATIONS:

      

      [***]

       

      
        
          
          

        

        
          26

          
            

          

        

        
          
          

        

      

       

      ORGANICHEM
        CORP. BULK CHEMICAL PACKAGING SPECIFICATIONS

      

      [***]

      
        	
                PRODUCT
                  IDENTIFICATION:

                 

                NRP104

              	
                PRODUCTION
                  PACKAGING SPECIFICATIONS

              	
                MATERIALS
                  PACKAGING SPECIFICATION

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              

      

      
        
          
          

        

        
          27

          
            

          

        

        
          
          

        

      

       

      
        	
                Critical
                  Material

              	
                Suppliers

              
	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              

      

       

      
        
          
          

        

        
          28

          
            

          

        

        
          
          

        

      

       

      APPENDIX
        IV

      Release
        Documentation

      

      All
        Batches

      The
        release documentation will include a Certificate of Analysis (COA) and a
        Certificate of Conformance (COC).

      List
        of
        all batch deviations planned and unplanned.

      

      A
        Certificate of Analysis (COA)

      This
        document will list the following:

      
        	
                ·

              	
                The
                  API Name

              

      

      
        	
                ·

              	
                The
                  Batch/Control Number

              

      

      
        	
                ·

              	
                The
                  Date of Manufacture

              

      

      
        	
                ·

              	
                All
                  Analytical Test Results

              

      

      
        	
                ·

              	
                All
                  Microbiological Test Results (as
                  applicable)

              

      

      
        	
                ·

              	
                Issue
                  Date

              

      

      
        	
                ·

              	
                Retest
                  Date

              

      

      
        	
                ·

              	
                Approval
                  Signature

              

      

       

      A
        Certificate of Conformance (COC)

      This
        document will attest to the fact that the batch of API was made in accordance
        with all applicable regulations, licenses, and company policies statement
        confirming that the batch record has been reviewed and approved by ORGANICHEM’s
        Quality Assurance.

      

      The
        above
        certificates will be signed by ORGANICHEM’s authorized personnel.

       

      
        
          
          

        

        
          29

          
            

          

        

        
          
          

        

      

       

      APPENDIX
        V

      

      Batch
        Document Audit Schedule

      

      

      The
        primary responsibility for batch document review resides with Organichem.
        New
        River has every confidence in Organichem’s expertise and ability to review and
        approve batch documents as part of the release of API to New River or it’s
        affiliates. However to demonstrate this [***]. This will supplement the annual
        cGMP audit, or any other investigations related to quality or batch
        incidents.

      

      The
        following table outlines the plans for New River or it’s affiliates review of
        batch documentation:

      

      
        	 	
                [***]

              	
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                [***]

              
	
                [***]

              	
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                [***]

              	
                [***]

              

      

       [***]

      
        
          
          

        

        
          30

          
            

          

        

        
          
          

        

      

       

      APPENDIX
        D
        - List of Schedules. 

       

      Schedule
        A: Bill of Materials

       

      Schedule
        B: Exclusive Component Purchasing Summary for Key or Critical raw
        materials

       

      Schedule
        C: Shipping Logistics Protocol

      
        
          
          

        

        
          31

          
            

          

        

        
          
          

        

      

      Schedule
        A: Bill of Materials

      

      The
        materials required to produce one [***] of NRP104 are summarized in the table
        below:

      

      
        	
                Raw
                  Material

              	
                ORGANICHEM

                Item
                  Code #

              	
                Estimated

                Required
                  Mass

              
	
                [***]

              	
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                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
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                [***]

              	
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                [***]

              
	
                [***]

              	
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                [***]

              
	
                [***]

              	
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                [***]

              
	
                [***]

              	
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                [***]

              	
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                [***]

              
	
                [***]

              	
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                [***]

              	
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                [***]

              
	
                [***]

              	
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                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              	
                [***]

              

      

      
        
          
          

        

        
          32

          
            

          

        

        
          
          

        

      

      Schedule
        B: Exclusive Component Purchasing Summary for Key or Critical

      Raw
        Materials.

      

      The
        materials determined to be critical and therefore requiring NEW RIVER
        participation in the change control process. These items are summarized in
        the
        table below:

      

      
        	
                Critical
                  Material

              	
                ORGANICHEM

                Item
                  Code #

              
	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              
	
                [***]

              	
                [***]

              

      

       

      
        
          
          

        

        
          33

          
            

          

        

        
          
          

        

      

      Schedule
        C: Shipping Logistics Protocol

      

      All
        materials must be properly classified, packaged, labeled and shipped according
        to all applicable national governmental regulations. A packing list and
        appropriate certificates of analysis must be included with each shipment.
        Shipments shall be made using carriers identified by NEW RIVER according
        to FCA
        Rensselaer shipping terms. Materials shall be shipped according to NEW RIVER’s
        written instructions as specified on the purchase order and any third party
        recipients shall require contact information including name, phone number
        and
        extension, and delivery address. Copies of all relevant shipping documents
        and
        Certificates of Analysis shall be provided to NEW RIVER.

      
         

         

        34

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