The confidential portions of this exhibit have been omitted and filed separately
with the Securities and Exchange Commission pursuant to a confidential treatment
request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. REDACTED PORTIONS OF THIS EXHIBIT ARE INDICATED BY AN [###].
 
AMENDED AND RESTATED
 
PRODUCT SUPPLY AGREEMENT

This AMENDED AND RESTATED PRODUCT SUPPLY AGREEMENT (the "Agreement"), is
executed this 24th day of August 2009 (the "Effective Date"), between Triax
Pharmaceuticals, LLC, a Delaware limited liability company, having its principal
place of business at 11  Commerce, Cranford, NJ 07016 ("Triax"), and OMP, Inc.,
a Delaware corporation having its principal place of business at 3760 Kilroy
Airport Way, Suite 500, Long Beach, CA 90806 ("OMP"; OMP and Triax, each a
"Party," and collectively, the "Parties").

RECITALS
WHEREAS, Triax develops, manufactures, markets and sells certain topical
products containing Tretinoin;
 
WHEREAS, the Parties are party to that certain Product Supply Agreement dated as
of December 2005 (the “Original Agreement”) whereby Triax granted OMP the
exclusive right to market and sell certain concentrations of Tretinoin bearing
the OMP brand in certain markets, subject to the satisfaction of certain volume
commitments;  and
 
WHEREAS, the Parties deem it to be in their mutual best interests to enter into
this Agreement to amend and restate the Original Agreement in its entirety, and
the Parties hereby agree that the Original Agreement is hereby terminated and
superseded in its entirety by this Agreement.
 
NOW THEREFORE, in consideration of the terms, conditions and mutual covenants
contained herein, the Parties hereto agree as follows:

 
1.       PRODUCTS; PURCHASE ORDERS
 
1.1 Products: Specifications. Triax shall manufacture the following products on
behalf of OMP and sell such products to OMP: Tretinoin 20gram in 0.1%, 0.05% and
0.025% cream concentrations and 15gram in 0.01% and 0.025% gel concentrations
(collectively, the "Products"). Triax shall manufacture the Products according
to the specifications described in Exhibit A (the "Specifications"), which is
hereby incorporated into this Agreement.  At OMP’s request, Triax shall also
sell the 0.0375% and 0.075% Tretinoin cream concentrations as soon as
Triax’s  abbreviated new drug applications (“ANDA”) for such concentrations are
approved by the Federal Food and Drug Administration (“FDA”), as well as any
other Tretinoin concentrations for which Triax receives ANDA approval from the
FDA in the future (collectively, the “Future Products”).  Upon ANDA approval for
any such Future Product and the Parties’ written agreement in accordance with
Section 2.1 below as to the prices to be paid to Triax for such Future Product,
such Future Product shall be included in the definition of “Products” for all
purposes of this Agreement unless otherwise indicated.
 
 

 
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1.2 Purchase Orders. Triax shall agree to manufacture, sell and deliver Products
to OMP in accordance with the terms and conditions of this Agreement. From time
to time and pursuant to Sections 1.4, 1.5, and 1.6, OMP shall place purchase
orders ("Purchase Order(s)") with Triax for the manufacture, sale and delivery
of specific quantities of Products. This Agreement is not a Purchase Order. OMP
shall have no obligation to purchase any Products hereunder until OMP has placed
a Purchase Order, and then only for the quantity of the Products stated in such
Purchase Orders and delivered according to this Agreement. OMP shall use
commercially reasonable efforts to forecast Product demand and Triax shall use
commercially reasonable efforts to provide Product quantities forecasted by OMP
as per Section 1.4 and Section 1.5, unless (and to the extent) Triax notifies
OMP of an inability to provide such quantities due to circumstances outside of
Triax's commercially reasonable control. Such notification must be given within
fifteen (15) days of receipt of such forecast from OMP, and/or within
forty-eight (48) hours of Triax becoming aware of such circumstances.
 
1.3 Exclusivity. OMP shall have exclusive rights to sell the Products in the
physician-dispensed channel in the United States (including all territories of
the United States, the “U.S. Channel”), and on a non-exclusive basis outside the
United States (to the extent the applicable regulatory requirements are
satisfied in each jurisdiction where OMP desires to sell the Products) in every
channel (the “International Channel” and collectively with the U.S. Channel, the
"Channel"); provided, however, that notwithstanding the foregoing, OMP shall
only maintain exclusivity in the U.S. Channel if OMP places Purchase Orders for
at least 100,000 tubes/units of Products (in any combination and from either
Channel) in each calendar year covered by the term of this Agreement; provided
that such minimum volumes shall be pro-rated for the remaining months of 2009
following the Effective Date.   If such minimum volumes are not maintained, all
other rights and obligations of this Agreement will continue on a non-exclusive
basis, beginning on January 1 of the calendar year following the calendar year
in which OMP did not purchase the minimum Purchase Order volume.
 
1.4 Vendor Managed Inventory; Purchase Orders.   Triax will ship Product in
accordance with OMP’s Vendor Managed Inventory (the “VMI Program”) (as such VMI
Program is described in this Section 1.4) and blanket purchase orders issued in
accordance with this Agreement each, a “Purchase Order.”  Under the VMI Program,
OMP will set a calendar quarterly target for the inventory quantity required for
the distribution center(s) at the beginning of each quarter , and will notify
Triax in writing of such targeted quantity.  This quantity is based on sales
requirements, safety stock, and cycle time, and will be subject to the
forecasting, ordering and lead time provisions set forth in Sections 1.5, 1.6
and 3.1 below.  In addition, under the VMI Program, OMP will provide a weekly
report to Triax that includes the OMP part number, description, blanket PO #,
inventory quantity on hand, the maximum quarterly inventory target, the minimum
target for each month of the calendar quarter, and the rolling three month
quarterly forecast. The maximum target level of inventory for the quarter must
be at the OMP distribution center(s) by the first week of the third month of the
calendar quarter, provided that the OMP has submitted corresponding Purchase
Orders to Triax that comply with the Lead Time (as defined in Section 3.1
below). Triax is responsible to use commercially reasonable efforts to ship to
meet those requirements.  Without limiting OMP’s obligations with respect to any
Purchase Orders, OMP is responsible  for the purchase of OMP branded Product
that equals each target set by OMP four (4) month firm portion of forecast;
forecast requirements for non-OMP branded product will be set calendar

 
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quarterly with three (3) month firm portion.  Adjustments are made by OMP to
each forecast based on sales requirements, safety stock, and cycle time.  Triax
shall have the right to review and approve or not approve each Purchase Order
and shall communicate its decision within three (3) business days of its receipt
of such Purchase Order.  Such approval rights shall be exercised by Triax in
good faith.   If Triax approves such Purchase Order, it shall confirm shipment
dates to OMP in writing at the time of its communication approval of such
Purchase Order.  As warranted, OMP shall update its forecast on a monthly basis
or as required by Triax.
 
1.5 Twelve Month Rolling Forecast.    OMP will provide Triax with a rolling
twelve (12)-month forecast (the “Rolling Forecast”) of OMP’s requirement of
Products, and thereafter provide monthly updates to the Rolling Forecast during
the 1st week of each month.  A firm and binding order from OMP is based on each
quarterly forecasted volume for non-OMP branded Products and is based on each
four (4) months of forecasted volume for OMP branded Products (individually the
“firm zone”).  Each firm zone may not be changed by OMP or Triax (unless the
Parties mutually agree otherwise in writing), including through the delivery of
subsequent Rolling Forecasts. The Rolling Forecast sets forth OMP’s anticipated
demand for Products on a monthly basis.  This forecast may be used to help the
manufacturer manage their production lines efficiently and ensure availability
of supply to OMP to achieve the appropriate quarter or four (4) month end
target.  The Rolling Forecast within the firm zone may increase but not
decrease  on a monthly basis depending on the actual unit sales and
adjustments.  If the change is significant or not a quantity that Triax can
meet, OMP and Triax will use their commercially reasonable best efforts to meet
the requested changed requirements.  From time to time after the Effective Date,
the Parties will consider whether, in light of market demand, manufacturing
capacity, inventory levels and other pertinent factors, to revise the schedule
for delivery of forecasts and, if appropriate, the Parties shall negotiate in
good faith to revise such Rolling Forecast or any Purchase Orders(s). Triax
shall secure adequate supply and maintain all Product materials and components
and shall accept and fulfill Purchase Orders placed by OMP in conformance with
the terms of this Agreement.
 
1.6 Quantity Increases; Shipment. At the time purchase forecasts are placed at
the beginning of each quarter in accordance with Section 1.4,  OMP may request,
and Triax will consider in good faith, (i) a maximum quantity by which OMP may
increase the quantity of Products specified in the forecast (which may not be
greater than [XXX]*% of the amount that was specified in the forecast) , and the
period of time from the date of the Purchase Orders within which OMP may order
any such increased quantity; and (ii) a maximum period of time for which OMP may
defer the shipment date specified in the Purchase Orders for all or part of the
Products covered by the Purchase Orders and the period of time from the date of
the Purchase Orders within which OMP may elect any such deferral.
 
1.7 Other Modifications of Purchase Order. Each Purchase Order shall constitute
a binding agreement between Triax and OMP, and the Parties may not modify a
Purchase Order except in writing and upon obtaining the signature of an
authorized representative of each Party.  Any such requests for modifications
shall not be unreasonably withheld or delayed by either Party.  If any
modification of a Purchase Order causes a decrease or reasonably-supported
increase in Triax's manufacturing cost, Triax promptly shall notify OMP prior to
enacting such change and the change, which shall be noted in writing on the
Purchase Order, shall become effective immediately upon the date of such
notification.
 

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1.8 cGMP Quality standards. All Products that Triax sells and delivers to OMP
under this Agreement shall be manufactured, stored, and handled in compliance
with all applicable federal, state, and local laws, regulations, ordinances, and
any other legal requirements, including, without limitation, the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et. seq.  Triax shall document the
reliability and quality of its manufacturing and delivery processes as it
relates to the Products. At the request of OMP, Triax shall deliver in writing
to OMP personnel documentation (consistent with that which would be required by
regulatory agencies to which Triax is subject) which demonstrates the
implementation of these policies in the design, analysis, test and manufacture
of the Products, each in accordance with cGMP and FDA standards to the extent
they are applicable.
 
1.8 Triax's Additional Obligations. Triax shall immediately notify OMP within
twenty-four (24) hours of any adverse or unexpected results or any actual or
potential notice of government action regarding a Product. Triax agrees to
immediately notify OMP of any recall of any Product and to administer and pay
all costs (unless such recall is the result of OMP’s modification of the
recalled Product or OMP’s improper or inadequate storage of such Product at
OMP’s distribution centers, in which event the cost of such recall will be borne
by OMP) associated with any such recall (and any related retrieval and/or
replacement) of any Product.
 
1.9 OMP Marketing. OMP shall throughout the term of this Agreement promote,
market, and sell the Products in all of OMP's active accounts throughout the
United States and, to the extent permitted by law, internationally. Such
activity shall include the development of sales collateral, and incorporation of
the Products into appropriate educational seminars and physician training. OMP
shall submit all sales collateral and printed material referencing the Products
to Triax for its review and approval (not to be unreasonably withheld).
 

1.10  International Registration Requirements.  Subject to the terms of this
Agreement, (i) OMP shall, at its expense, comply with all applicable laws and
regulations of the United States and any international jurisdiction into which
it intends to sell the Products, including but not limited to, export laws and
restrictions and regulations of the United States Department of Commerce or
other United States or foreign agency or authority, and shall not export, or
participate in any transaction which may involve the export or re-export, of any
Product in violation of any such restrictions, laws or regulations; (ii) Triax
will assist OMP in obtaining any required registrations, licenses and permits
for the Products and the marketing, sale and distribution of the Products in
various jurisdictions in the International Channel by supplying such
documentation or information as may be reasonably requested by OMP; and
(iii) for any countries identified to Triax by OMP as being countries in which
OMP intends to market the Products,  OMP will obtain and maintain, at OMP’s sole
cost and expense, during the term of this Agreement all governmental approvals
and licenses necessary to import the Products into such countries.   Unless
otherwise consented to in writing by Triax in connection with an applicable
requirement of law, all registrations, licenses and approvals for the Products
and the distribution of the Products in any jurisdiction in the International
Channel shall be in the name of and shall be solely owned by Triax.  In
addition, OMP will transfer to Triax, at OMP’s sole cost and expense, any
registrations, licenses and approvals then in effect at the time of any
expiration or termination of this Agreement.  OMP shall provide Triax with a
copy of all registrations, licenses and approvals obtained or received for the
Products and distribution of the Products in each jurisdiction in the
International Channel within three (3) business days of OMP’s receipt of each
such registration, license or approval.  In furtherance of, but without
limiting, the foregoing, OMP represents that it has read, understood and will
comply with the anti-bribery provisions of the U.S. Foreign Corrupt Practices
Act.
 

 
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2.       PRODUCT PRICES
 
2.1           Price List. The prices for Products purchased hereunder shall be
as specified in Exhibit B (the "Prices") which is hereby incorporated into this
Agreement.   Such price increases shall be effective for all purchase orders
issued on or after the Effective Date.  The Parties will negotiate in good faith
to agree in writing on the Prices for Future Products.  Except as expressly
provided herein, all Prices are fixed through the term of this Agreement in
United States dollars, except changes agreed to in a mutual, signed writing,
including any changes contemplated by Section 1.7.  Triax may also increase
Prices, provided such increases occur no more than once per twelve (12) month
period, and are based on increases in costs demonstrated to OMP's reasonable
satisfaction are the sole result of incremental increases in raw materials,
packaging, labeling design and/or similar costs and the integration of
custom-labeled Product tubes into the manufacturing process. Prices are
exclusive of  shipping charges and inclusive of (i) all applicable local, state
and federal taxes, and (ii) any other costs (including, without limitation,
set-up, testing and tooling costs and non-recurring engineering expenses)
incurred by Triax in connection with the manufacture, sale and delivery of
Products in accordance with this Agreement.
OMP shall also be entitled to volume discounts to the base pricing listed on
Exhibit B, for Product purchased in excess of [XXX]* tubes/units per calendar
year, and to the extent such Product is sold through to OMP's customer's within
a reasonable time of OMP’s  receipt of such Product.  Volume discounts will be
based on calendar year performance and applied to cumulative year-to-date
purchases in excess of   [XXX]* units per year, such that annualized volumes
over [XXX]* units will be sold by Triax to OMP at a [XXX]* % discount to Prices.

 
3.    LEAD TIME, SHIPMENT AND DELIVERY
3.1 Lead Time For Products. It is understood and agreed between the Parties that
Products with OMP-branded packaging must be manufactured in quantities of at
least [XXX] * units per SKU, with OMP paying for the split charge of
approximately $[XXX]* per run.  There will be no minimum batch size requirements
for non-OMP branded Products.  Triax agrees that such Product will have  a
minimum of thirty six (36) months expiration date for OMP branded products and
twenty-three (23) months expiration date for non-OMP branded Products, in each
case from the date of manufacture (and, in the case of the

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* Subject to confidential treatment request

 
5 

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gel, eighteen (18) months expiration date from the date of delivery to
OMP).   In the case of the gel Products, should the dating be short, OMP can
choose to go on back order.  Triax shall deliver all Products to OMP, in
compliance with the terms of this Agreement, within one hundred twenty (120)
days of Triax’s receipt of a Purchase Order ("Lead Time"), unless otherwise
mutually agreed to by the Parties in writing.
 
3.2 Shipment. Triax shall ship all Products purchased under this Agreement
F.O.B. shipping point, to the location specified by OMP in each Purchase Order,
so as to be received by OMP, allowing for normal transit times, in accordance
with the quantities and delivery schedule specified on the corresponding
Purchase Order. If any shipment is late due to Triax's fault, Triax shall ship
the effected Product by such mode of expedited shipment specified by OMP, at
Triax's sole expense. Triax shall cause the delivery of all Products to OMP's
receiving department during normal business hours, unless otherwise directed by
OMP.
 
3.3 Mode of Shipment. The mode of shipment shall in each instance be ground
transportation, unless otherwise specified by OMP on the Purchase Order or
pursuant to late delivery provisions of Section 3.2. In the absence of specific
instructions by OMP, Triax will select the best carrier for shipment at the most
advantageous price.
 
3.4 Risk of Loss/ Insurance. Risk of loss and damage shall pass from Triax to
OMP upon delivery by Triax or the common carrier to OMP's representative at the
F.O.B. shipping point described in Section 3.2 above.
 
3.5 Packaging. Products containing 0.025% cream concentrations shall be packaged
with OMP branded packaging, label design and label copy only until current
packaging inventory has been exhausted. The other current Products (0.1% and
0.05% creams) shall be packaged with OMP branded packaging, label design and
label copy as in effect on the Effective Date("Packaging Specifications").   All
OMP branded Products will use the same packing tubes as then-currently utilized
by Triax in its Tretinoin production.  Notwithstanding the foregoing, once the
remaining 0.025% cream concentration tube inventory is exhausted, all such
packaging for that concentration, and any Future Products shall be in generic
Triax packaging, and there will be no minimum batch size purchase requirements
for any generically branded sku’s.
 
    Packaging Specifications shall comply with all applicable FDA labeling
requirements.
 
3.6 Use of Intellectual Property. Triax shall use any trademarks, trade names,
logos, products names, or labels of OMP, and any derivatives thereof or
intellectual property rights related thereto, solely for purposes of performing
under this Agreement and only in accordance with this Agreement and the
instructions of OMP. This Agreement is not intended to, and shall not be
construed, to result in any transfer of either Party’s intellectual property
rights or related interests, registered or not, domestic or foreign, to the
other Party.

 
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3.7 Payment Terms. The terms of payment for all Products purchased under this
Agreement shall be net thirty (30) days from the date of OMP's receipt of
invoices for Products. Triax shall submit all invoices to OMP's corporate
offices, Attn: Accounts Payable, unless otherwise instructed by OMP.
 
3.8 Delinquent Accounts. All amounts due and owing to Triax hereunder, but not
paid by OMP within fifteen (15) business days of the due date thereof, shall
bear interest in U.S. dollars at the rate of the lesser of: (i) one per cent
(1%) per annum above the then applicable prime interest rate announced by the
Wall Street Journal for 90-day U.S. dollar loans to prime commercial customers
in the United States; or (ii) the maximum lawful interest rate permitted under
applicable California law. Such interest shall accrue on the balance of unpaid
amounts from time to time outstanding from the date on which portions of such
amounts become due and owing until payment thereof in full.
 
3.9 Billing Disputes.

 
(a) In the event that a billing dispute occurs concerning any charges billed to
OMP by Triax, OMP must submit documentation regarding the disputed amount.
Documentation must be submitted to Triax within one hundred twenty (120) days of
OMP's receipt of billing invoice for the Products.
 
(b) If the dispute is resolved in favor of OMP and OMP has withheld the disputed
amount, no interest credits or penalties will apply. If the dispute is resolved
in favor of OMP and OMP has paid the disputed amount, OMP will be credited with
interest on such amount by Triax at the rate of one percent (1%) per month, from
the date Triax received payment up to and including the date of refund. If the
dispute is resolved in favor of Triax and OMP has paid the disputed amount on or
before the payment due date, no interest credit or penalties will apply.
 
(c) If the dispute is resolved in favor of Triax and OMP has withheld the
disputed amount, any payments withheld pending settlement of the disputed amount
shall bear interest at the rate of one percent (1%) per month, from the payment
Due Date up to and including the date of payment.
 
       (d) If any continuing dispute between the Parties is not resolved within
one hundred twenty (120) days of the due date, after reasonable attempts by OMP
and Triax, the dispute will be referred to the respective executive responsible
for each Party's respective obligations under this Agreement. The executives
will negotiate in good faith to resolve the dispute informally. During the
course of such negotiations, all reasonable requests made by one Party to the
other for information will be honored by the Parties. Both Parties shall
continue performing their respective obligations under this Agreement while the
dispute is being resolved, except to the extent that such obligations are in
dispute, unless and until this Agreement expires or is terminated in accordance
with its terms. If the Parties are unable to resolve such dispute within the
process above then either Party may exercise any remedies, in law or equity,
available to it.
 
4.    PRODUCT INSPECTION AND ACCEPTANCE

 
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4.1 Acceptance Inspection and Testing. OMP shall have the right, at its sole
discretion, to perform acceptance testing and inspection of any shipment of
Products ("Acceptance Testing") to determine whether or not such Products, when
delivered by OMP, conform with the specifications set forth in Exhibit A (the
“Specifications”). Such Acceptance Testing shall take place, at OMP's election,
either on Triax's premises (during normal business hours and upon reasonable
notice to Triax), OMP's premises, or at a location selected by OMP (including
the premises of any customer of OMP). OMP shall have sixty (60) days from
receipt of a shipment of Products to perform such Acceptance Testing ("Initial
Acceptance Testing Period").
 
4.2 Non-Conforming Products. If OMP reasonably determines within the Initial
Acceptance Testing Period that all or any portion of a shipment of Products are
non-conforming with the Specifications, OMP shall provide Triax a notice of
non-conformance and appropriate supporting documentation, and unless Triax
disputes such determination in good faith, Triax shall promptly correct the
defects identified by OMP or supply new Products within thirty (30) days after
receipt of OMP's notice of non-conformance. All costs and expenses associated
with any such correction or replacement, including, without limitation,
transportation charges for return to Triax and subsequent return to OMP, shall
be borne solely by Triax. Upon receipt by OMP of corrected or replaced Products,
OMP shall have an additional sixty (60) day period to conduct Acceptance Testing
("Additional Acceptance Testing Period").  If during such Additional Acceptance
Testing Period, OMP determines that any of the Products are still non-conforming
with the Specifications, Triax shall (unless Triax disputes such determination
in good faith) provide new replacement Products for all non-conforming Products
at Triax's sole cost and expense and OMP shall have a second Additional
Acceptance Testing Period for such replacement Products.    If Triax disputes
any determination by OMP that the Products do not conform with the
Specifications, the Parties shall submit the Products at issue to a
mutually-acceptable, independent testing lab, and the report issued by such
testing lab shall be final and binding on the Parties.  The fees charged by such
testing lab will be paid by the Party whose position is not supported by the
report of the testing lab.  If the testing lab’s report supports the position of
OMP, then Triax shall correct defects or supply new Products as set forth above,
provided that the time period for doing so shall end thirty (30) days after the
date on which the parties receive the testing lab’s report.
 
4.3 No Waiver of Warranty. In no event shall OMP's inspection and acceptance of
any Product pursuant to this Section 4, or the payment for such Product by OMP,
in any way impair or reduce OMP's rights under the warranty provisions of
Section 8 of this Agreement.
 
4.4 Facilities’ Surveys.  Following reasonable notice to Triax, OMP reserves the
right on an annual basis, and for cause as necessary due to any regulatory or
other governmental or quality control issued that may arise,  to review (or have
its agents review), during regular business hours, Triax's manufacturing
facilities and Triax's quality control procedures, both prior to first Product
deliveries and periodically thereafter, in order to assure compliance with the
Specifications and other standard industry practices and procedures.
 
5.      SPECIFICATION AND OTHER CHANGES

 
 
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5.1 Changes in Specifications. All Products shipped by Triax to OMP shall
conform to the existing Specifications at the time of deliver to OMP hereunder.
The Specifications may be amended or otherwise changed from time to time only by
written agreement of Triax and OMP.
 
5.2 OMP Changes. OMP may propose changes to the Specifications, and Triax shall
consider the feasibility of any such proposal. Triax shall, within thirty (30)
days of receipt of OMP's proposal, furnish to OMP in writing its comments
regarding the proposed changes, including an expression of its willingness to
implement the same, the price implications, if any, of the change, and the time
schedule required for implementation.
 
5.3 Change in Source of Parts. Triax promptly shall notify OMP in writing of,
including the reason for, any change in the source (including the addition of
new vendors) of purchased components (including, without limitation, active or
inactive ingredients) for any Products. Upon request, Triax shall provide OMP
with copies of raw ingredient certificates of analysis consistent with past
practice.
 
5.4 Notification of Updates. Triax shall send all updates provided to OMP
pursuant to this Section 5, unless otherwise instructed by OMP, to: OMP, Inc.
3760 Kilroy Airport Way, Suite 500,  Long Beach, California 90806, Attn: Preston
S. Romm, Executive Vice President, Finance, Operations and  Administration &
Chief Financial Officer.
 
5.5 Change Documentation. Triax shall, at its expense, provide OMP with copies
of all change in Specifications documentation or similar documentation issued by
it during the term of this Agreement that affects any Product. Such copies shall
be provided to OMP as soon as practicable, but in no event later than ten (10)
days after issuance by Triax.
 
6.   CONFIDENTIALITY/ PROPRIETARY INFORMATION
 
6.1 Definitions. For purposes of this Agreement, "Trade Secrets" means
information which: (a) derives economic value, actual or potential, from not
being generally known to, and not being readily ascertainable by proper means
by, other persons who can obtain economic value from its disclosure or use; and
(b) is the subject of efforts that are reasonable under the circumstances to
maintain its secrecy. "Confidential Information" means information, other than
Trade Secrets, that is of value to its owner and is treated as confidential.
"Proprietary Information" means Trade Secrets and Confidential Information of
OMP.
 
6.2 Proprietary Information. The Parties agree that any and all Proprietary
Information exchanged prior to this Agreement have been subject to the terms and
conditions of those certain Confidentiality Agreements (including, without
limitation, the confidentiality provisions set forth in the Original Agreement)
as signed between the parties from time to time.  Further, the Parties
acknowledge and agree that any and all Proprietary Information exchanged in the
past and that which may be exchanged from time to time under this Agreement,
shall be under an obligation by the receiving party to maintain the
confidentiality of such information.

 
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6.3 Nondisclosure Requirements. Each party shall hold Proprietary Information of
the other party in strictest confidence and shall not copy, reproduce,
distribute, manufacture, duplicate, reveal, report, publish, disclose, cause to
be disclosed, or otherwise transfer the Proprietary Information to any third
party, or utilize the Proprietary Information for any purpose whatsoever other
than as expressly contemplated by this Agreement or as otherwise mutually agreed
to in writing. Proprietary Information shall only be disclosed to employees,
representatives and consultants of the Parties with a need to know such
information in order to further the intent and purposes of this
Agreement.   Each Party shall cause such employees, representatives and
consultants to comply with the nondisclosure obligations set forth herein and
shall be responsible for any breach of this Agreement by any such employee,
representative or consultant. Each Party shall immediately notify the other
party in writing of any suspected or known breach of the obligations or
restrictions set forth in this Section 6. Each Party shall cooperate with the
other party to prevent, cure and mitigate any harmful or potentially harmful
effects of any suspected or known breach. Notwithstanding the foregoing, any
previously executed Confidentiality Agreements between the Parties shall
continue in full force and effect, provided that to the extent of any
inconsistency or ambiguity between such agreements and this Agreement, this
Agreement shall control and govern in all respects.
 
6.4 Exceptions. The obligations of Section 6.3 shall not apply if and to the
extent that: (i) the Proprietary Information communicated was already known
without obligation to keep such information confidential, at the time of
receipt; (ii) the Proprietary Information communicated was received in good
faith from a third party lawfully in possession thereof and having no obligation
to keep such information confidential; or (iii) the receiving Party establishes
that the Proprietary Information communicated was publicly known at the time of
receipt or has become publicly known other than by a breach of this Agreement.
If the receiving Party is required to disclose all or part of the Proprietary
Information pursuant to any legal requirement of any country which may have
jurisdiction over such Party, such Party shall immediately upon becoming aware
that such disclosure is required, give the other Party notice of the
circumstances in which the disclosure is required and obtain agreement from the
other Party on the extent and timing of such disclosure, and provide assistance
in obtaining any injunction on such disclosure, if applicable.
 
6.5 Publicity. Each Party shall not, without the prior written consent of the
other Party, issue any news releases, advertisements or other promotional
materials that refer to, or otherwise disclose any information relating to, such
other Party, this Agreement, such other Party's business affairs or the
performance of any Purchase Order.  The Parties may make such disclosure of the
existence and terms of this Agreement:  (i) as may be required by the public
reporting obligations or either Party for so long as it is a public reporting
company and (ii) subject to obligations of confidentiality, to potential
acquirers and/or financing sources (and their respective advisors and
representatives).
 
6.6 Proprietary Information. Any OMP Proprietary Information that is or has been
provided to Triax in connection with this Agreement or the negotiation of any
Purchase Order, whether in written form or otherwise, shall remain the sole and
exclusive property of OMP and may not, without the prior written consent of OMP,
be used by Triax for any other purpose, including, without limitation, the

 
10 

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development, marketing or sale of any product or part to any other customer or
any prospective customer of Triax.
 
Any Triax Proprietary Information that is or has been provided to OMP in
connection with this Agreement or the negotiation of any Purchase Order, whether
in written form or otherwise, shall remain the sole and exclusive property of
Triax and may not, without the prior written consent of Triax, be used by OMP
for any other purpose, including, without limitation, the development, marketing
or sale of any product or part to any other customer or any prospective customer
of OMP.
 
6.7 Injunctive Relief. The obligations of the Parties under this Section 6 shall
survive the expiration or termination of this Agreement. OMP and Triax
acknowledge and agree that the extent of damages in the event of a breach of
this Section 6 of the Agreement would be difficult or impossible to ascertain
and that there will be available no adequate remedy at law in the event of any
such breach. Both Parties therefore agree that in the event either Party
breaches any provision of this Section 6, the non-breaching Party shall be
entitled to specific performance and injunctive or other equitable relief, in
addition to any other relief to which it may be entitled at law or in equity.
 
7. TERM AND TERMINATION
 
7.1 Term. This Agreement shall commence as of the date hereof and remain in full
force and effect for a term of [XXX]* years from the Effective Date (the
"Initial Term"). Thereafter, this Agreement shall be renewed automatically for
successive [XXX]* year terms, unless written notice is provided by either party
at least [XXX]* months before the end of the then-current term, in which event
this Agreement shall end on the last day of such term. The Initial Term and any
renewals shall be constitute the "Term."
 
7.2 Termination for Breach. Either Party may terminate this Agreement upon
[XXX]* days' prior written notice to the other Party in the event that the other
Party breaches or fails to fulfill any of its material obligations under this
Agreement (including, without limitation, making deliveries of Products within
the deadlines specified on any Purchase Order in accordance with the applicable
Lead Times, or providing Products that do not meet the Specifications). However,
if during such [XXX]* day notice period the other Party shall have remedied such
failure, this Agreement shall continue in full force and effect as if such
failure had not occurred.
 
7.3 Termination for Other Reasons. This Agreement shall terminate forthwith, at
the option of either Party by written notice to the other Party, if the other
Party ceases to carry on its business or becomes the subject of any proceeding
under state or federal law for the relief of debtors or otherwise becomes
insolvent, bankrupt or makes an assignment for the benefit of creditors, or upon
the appointment of a receiver for the other Party or the reorganization of the
other Party for the benefit of creditors.
 
           7.4 Rights after Termination. Termination of this Agreement by either
Party shall not prejudice the right of it or the other Party to recover any
monies or require performance of any obligations due at the time of such
termination.   In the event of termination of this Agreement Triax shall, at
OMP's
 

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* Subject to confidential treatment request

 
11 

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sole discretion and option, pass title and deliver to OMP completed Products in
its possession meeting the Specifications and that are the subject of current
Purchase Orders, provided that OMP pays a reasonable price not to exceed the
price that would have applied if Triax had delivered such Products according to
the terms of the applicable Purchase Orders.
 
8.      OMP WARRANTY AND INDEMNITY
 
8.1           Warranties. OMP represents and warrants to Triax that: (a) OMP has
full authority to execute and perform this Agreement; (b) this Agreement has
been duly executed and delivered by OMP and constitutes the legal, enforceable
and binding obligation of OMP; (c) OMP's execution and performance of this
Agreement will not conflict with the terms or conditions of any other agreement
or contract to which OMP is a party or is otherwise bound; (d) no approval,
action or authorization by any governmental authority or agency is required for
OMP's execution and performance hereof which has not already been obtained; and
(e) OMP will notify Triax within twenty-four (24) hours of receiving any notice
or upon discovery of any adverse event arising from the sale or use of the
Products.
 
8.2           OMP Indemnification. OMP shall defend, indemnify and hold harmless
Triax and its officers, directors, employees, contractors and agents
(“Indemnitees”) against any and all liabilities, claims, suits, damages, losses,
causes of action, complaints, investigations or expenses (including reasonable
attorneys’ fees and court costs), and all other costs and administrative fees
(“Claims”) to the extent arising from or associated with (i) the negligence or
willful misconduct of OMP, its employees, agents, or contractors (other than
Triax) in the performance of its obligations under this Agreement, including any
adverse events or patient injuries related to any Product not sold for approved
indications, except to the extent covered by the indemnity in Section 9.2 below)
(ii) any marketing or sale of the Products, by or on behalf of OMP in violation
of any applicable law or regulation, except to the extent covered by the
indemnity under Section 9.2 below, (iii) any third party Claim that the OMP
marks infringe a trademark of such party, (iv) a breach of this Agreement by OMP
or (v) any modification of any Product or packaging by OMP.  OMP will pay
resulting costs, damages, court costs, penalties and attorneys' fees finally
awarded, provided Triax promptly notifies OMP in writing of any such Claim. OMP
retains sole and exclusive control of the defense and all related settlement
negotiations, provided OMP shall not settle any claim without the prior written
consent of Triax. Triax shall provide OMP with such assistance, cooperation and
all related information for such defense as Triax may reasonably request.
 
              Notwithstanding the foregoing, OMP shall have no liability for any
claim of infringement to the extent based upon OMP technical and sales
literature and the OMP marks that are not made by OMP or its authorized
representatives
 
              8.3 Survival. The provisions of this Section 8 shall survive the
term and any termination of this Agreement regardless of the cause.
 
9.      TRIAX WARRANTY AND INDEMNITY

 
12 

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9.1 Warranties. Triax represents and warrants to OMP that: (a) Triax has full
authority to execute and perform this Agreement; (b) this Agreement has been
duly executed and delivered by Triax and constitutes the legal, enforceable and
binding obligation of Triax; (c) Triax's execution and performance of this
Agreement will not conflict with the terms or conditions of any other agreement
or contract to which Triax is a party or is otherwise bound; and (d) no
approval, action or authorization by any governmental authority or agency is
required for Triax's execution and performance hereof which has not already been
obtained. Triax further represents and warrants that all Products when delivered
to OMP shall conform in all respects to and shall have been manufactured,
assembled, labeled, packaged, stored, transported and handled in accordance with
the terms and conditions of this Agreement and that such Triax activities fully
comply with all applicable government regulations including, without limitation,
current Good Manufacturing Practices of the FDA.
 
9.2 Triax Indemnification.
 
9.3 Triax shall defend, indemnify and hold harmless OMP and its Indemnitees
against any and all Claims to the extent arising from (i) the negligence or
willful misconduct of Triax, its employees, agents, or contractors (other than
OMP) in the performance of its obligations under this Agreement, (ii) any recall
of any Product (except as set forth in Section 1.8 hereof) (iii) any third party
claims arising from any adverse events or patient injuries related to any
Product so long as it is sold by OMP for approved indications and such claim is
not covered by the indemnity under Section 8.2 above, (iv) any third party Claim
that the Triax Product or marks infringe the patents, trademarks or copyrights
of such party (except in the case of trademark infringement, such infringement
is caused by the use of the “Obagi” name or logo), and (v) a breach of this
Agreement by Triax. Triax will pay resulting costs, damages, court costs,
penalties and attorneys' fees finally awarded, provided OMP promptly notifies
Triax in writing of any such claim. Triax retains sole and exclusive control of
the defense and all related settlement negotiations, provided Triax shall not
settle any claim without the prior written consent of OMP. OMP shall provide
Triax with such assistance, cooperation and all related information for such
defense as Triax may reasonably request. Warranty Notwithstanding Acceptance.
Triax's warranty obligations pursuant to this Section 9 shall remain in full
force and effect with respect to all Products, notwithstanding the Products
meeting acceptance by OMP.
 
9.4 Product Liability Indemnification. Triax agrees to defend, protect,
indemnify and hold harmless OMP and each of its officers, directors, employees
and agents from and against all Product liability and regulatory liability,
including, without limitation, environmental liabilities, and attorney fees
resulting from any claims by third parties for loss, damage or injury (including
death) allegedly caused by any Product purchased under this Agreement (except to
the extent covered by any of the indemnities under Section 8.2 above). OMP
agrees to promptly notify Triax of all such claims, and to permit Triax to
control, at its expense, any negotiation, arbitration or litigation concerning
such claims; provided Triax shall not settle any claim without the prior written
consent of OMP.
 
9.5 Survival. The provisions of this Section 9 shall survive the term and any
termination of this Agreement regardless of the cause.

 
 
13 

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10.           LIMITATION OF LIABILITY
 
10.1 IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR
CONSEQUENTIAL (INCLUDING, WITHOUT LIMITATION, ANY LOSS OF PROFITS OR BUSINESS
OPPORTUNITIES), EXEMPLARY, INCIDENTAL OR INDIRECT OR PUNITIVE DAMAGES OR COSTS
(INCLUDING LEGAL FEES AND EXPENSES) OR LOSS OF GOODWILL OR PROFIT IN CONNECTION
WITH THE SUPPLY, USE OR PERFORMANCE OF THE PRODUCTS PROVIDED HEREUNDER, OR IN
CONNECTION WITH ANY CLAIM ARISING FROM OR RELATED TO THIS AGREEMENT, EVEN IF
SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR COSTS OR IF
THE EXCLUSIVE REMEDIES STATED HEREIN FAIL OF THEIR ESSENTIAL PURPOSE.
 
Notwithstanding the provisions of this Section 10.1, this Agreement shall not
limit the liability of either Party for personal injury, including death,
arising from the gross negligence or willful misconduct of such Party or its
employees acting in the scope of their employment.

 
11.           MISCELLANEOUS PROVISIONS
 
11.1 Relationship of Parties. Neither this Agreement nor any Purchase Order
executed pursuant to this Agreement shall be deemed to create or constitute a
partnership, joint venture or business organization of any kind or nature
whatsoever between Triax and OMP.
 
11.2 Order of Precedence. In the event of a dispute between the Parties with
respect to the terms and conditions of any Purchase Order, the order of
precedence in interpreting any such terms and conditions shall be as follows:
(i) information (other than the Terms and Conditions) printed on the Purchase
Order; (ii) the terms of this Agreement; and (iii) the Specifications. In the
event of any conflict between the Terms and Conditions printed on a Purchase
Order and the provisions of this Agreement, the terms of this Agreement shall
prevail.
 
11.3 Entire Agreement. This Agreement (including the exhibits hereto) together
with any Confidentiality Agreements sets forth the entire agreement between the
Parties and supersedes any prior agreements or understanding, written or oral,
relating to the subject matter of this Agreement.   The Parties agree that the
Original Agreement is hereby terminated and is superseded by this Agreement as
of the Effective Date.  Nothing in this Agreement, whether expressed or implied,
is intended to confer any rights or remedies under or by reason of this
Agreement on any persons other than the Parties to this Agreement and to their
respective successors and assigns.  This Agreement may not be amended unless the
amendment is in writing and signed by authorized representatives of both
Parties.
 

 
11.4 Remedies: Waiver. The remedies provided herein shall be cumulative and in
addition to any other remedies available at law or in equity. Any waiver or
delay in the exercise by either Party of any of its rights under this Agreement
shall not be deemed to prejudice such Party's right of termination or
enforcement for any further, continuing or other breach by the other Party.

 
14 

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11.5 Force Majeure.  A Party shall not be liable for delay or failure to
perform, in whole or in part, by reason of contingencies beyond  its reasonable
control, and the other party shall not have the right to terminate this
Agreement as a result thereof, whether such contingency is herein specifically
enumerated or not, including among others, acts of God, war, acts of war,
revolution, civil commotion, riots, acts of public enemies, blockage or embargo,
delays of carriers, car shortage, fire, explosion, breakdown of equipment,
strike, lockout, labor dispute, casualty or accident, earthquake, epidemic,
flood, cyclone, tornado, hurricane or other windstorm, delays of vendors or
other contingencies interfering with production or with customary or usual means
of transportation, or by reason of any law, order, proclamation, regulation,
ordinance, demand, requisition or requirement or any other act of any
governmental authority, local, state or federal, including court orders,
judgments or decrees, or any other cause whatsoever, whether similar or
dissimilar to those above affected; provided, however, that the Party so
affected shall promptly give notice to the other Party whenever such contingency
or other act becomes reasonably foreseeable and shall use its reasonable best
efforts to overcome the effects of the contingency as promptly as possible.
 
11.6 Severability. If any term or provision of this Agreement or the application
thereof to any person or circumstance shall be invalid or unenforceable, to any
extent, the remainder of this Agreement, or the application of such term or
provision to persons or circumstances other than those as to which it is held
invalid or unenforceable, shall not be affected thereby, and each term and
provision of this Agreement shall be valid and enforced to the fullest extent
permitted by law.
 
11.7 Dispute Resolution. Any claim, controversy or dispute which arises between
the Parties, their agents, employees, officers, directors or affiliates
("Dispute") which the Parties are unable to settle through consultation and
negotiation may be mediated under the Commercial Mediation Rules of the American
Arbitration Association ("AAA") by a mutually acceptable mediator. Any Dispute
which cannot be resolved through negotiation or mediation shall be resolved by
binding arbitration as provided in this Section 11.7. The arbitrability of
claims shall be determined under the Federal Arbitration Act, 9 USC Secs. 1-16.
Notwithstanding the foregoing, the Parties may cancel or terminate this
Agreement in accordance with its terms and conditions without being required to
follow the procedures set forth in this Section 11.7.
 
    A single arbitrator engaged in the practice of law, who is knowledgeable
about the subject matter of this Agreement and the matter in Dispute, shall
conduct the arbitration under the rules of the AAA then in effect, except as
otherwise provided herein. The arbitrator shall be selected in accordance with
AAA procedures from a list of qualified people maintained by the AAA. The
arbitration shall be conducted in New York, New York and all expedited
procedures prescribed by the AAA rules shall apply. The laws of New York shall
govern the construction and interpretation of this Agreement.   The arbitrator's
decision and award shall be final, conclusive and binding, and judgment may be
entered upon it in accordance with applicable law in any court having
jurisdiction thereof.
 
   Either Party may request from the arbitrator injunctive relief to maintain
the status quo until such time as the arbitration award is rendered or the
Dispute is otherwise resolved. The arbitrator shall not have authority to award
punitive damages. Each Party shall bear its own costs and attorneys' fees, and
the Parties shall share equally the fees and expenses of the mediator and
arbitrator.

 
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    If any Party files a judicial or administrative action asserting claims
subject to arbitration, as prescribed herein, and another Party successfully
stays such action and/or compels arbitration of said claims, the Party filing
said action shall pay the other Party's costs and expenses incurred in seeking
such stay and/or compelling arbitration, including reasonable attorneys’ fees.
 
    Triax agrees that in the event of any Dispute between the Parties, it will
continue to provide Products without interruption. OMP agrees that in the event
of any Dispute between the Parties, it will continue to pay for Products
delivered by Triax under this Agreement.
 
11.8 Toxic Materials. Nothing used in the manufacture of the Products and
components thereof covered by this Agreement shall contain any materials or
chemicals not approved for the intended use of the Products. Triax warrants that
all packaging material furnished under this Agreement (including any Purchase
Order) and all packaging associated with material furnished under this Agreement
were not manufactured using and do not contain chlorofluorocarbons, including
polystyrene foam manufactured through a process using any of the following
blowing agents: CFC-111, CFC-112, CFC-113, CFC-114 or CFC-115. Triax shall
defend, indemnify and hold OMP and its officers, directors, employees,
contractors, and agents harmless from any liability, fine, penalty, or costs
(including, without limitation, reasonable attorney fees) incurred by OMP or any
of its directors, officers, employees, contractors, or agents to any third party
or governmental agency arising out of OMP's good faith reliance upon said
warranty.
 
11.9 Notices. All notices, demands, approvals, requests or other communications
which may be or are required to be given, served or sent by either Party to the
other, shall be in writing and shall be delivered personally, by certified mail,
return receipt requested, or by telegraphic, telex, facsimile or cable
communication at the address set forth below, or, as to each Party, at such
other address as shall be designated by such Party in a written notice to the
other Party:
 
If to Triax, to:
 

Triax Pharmaceuticals, LLC
11 Commerce Drive, First Floor
Cranford, NJ 07016
Attn:  Salvatore J. Vitiello
Vice President, General Counsel

                and

Keith Rotenberg, PhD
Chief Scientific Officer

 
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If to OMP, to:                           
OMP, Inc
3760 Kilroy Airport Way, Ste. 500
Long Beach, CA 90806
Attn:  Laura B. Hunter,
Vice President & General Counsel.
                    
                     
 
11.10 Assignment. Neither Party shall, without the written consent of the other
not to be unreasonably withheld , with such other party waiving the right to
renegotiate the terms of this Agreement at such time, assign or transfer this
Agreement or any rights or obligations hereunder (i) provided, however, that
without the consent of the non-            assigning Party, this Agreement may
be assigned by either Party to (i) any of its affiliates, and (ii) any person or
entity (other than a direct competitor with respect to the Products) that
acquires all or substantially all of the assets of such Party to which this
Agreement relates.
 
11.11 Counterparts. This Agreement may be executed in counterparts, all of which
shall be considered one and the same agreement and shall become effective when
one or more counterparts have been signed by each of the Parties and delivered
to the other Party, it being understood that all Parties need not sign the same
counterpart.
 
11.12 Further Assurances. Each Party hereto agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
 
(signature page follows; page 20 intentionally omitted)

17 
 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed
by their respective authorized representatives as of the date first above
written.

  OMP, INC          
 
By:
/s/ Preston S. Romm       Preston S. Romm       EVP Operations, Finance and
Administration and CFO          

  TRIAX PHARMACEUTICALS, LLC          
 
By:
/s/ Leonard L. Mazur       Leonard L. Mazur       COO          

 

 

 
18 

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Exhibit A
Product Specifications

Tretinoin Cream Specifications (0.1%, 0.05%, & 0.025%)
Test
Shelf Life Specification
 Description
Off-white to pale yellow, homogenous cream with a characteristic waxy odor and a
smooth texture
 Specific Gravity
0.90-1.05
 pH (10% Solution)
3.5-4.9
 Viscosity
16,225-43,650 cps
 Minimum Fill :
S1-10 Tubes
 
Avg. NLT 100% of label, Indv. NLT 90%.  Not a stability requirement
S2-30 Tubes
Avg. NLT 100% of label, Indv. NLT 90%.  Not a stability requirement
 Tretinoin Assay, L= 0.1% w/w
90.0%-120% L (Sample from two mixed tubes, head middle, crimp)
 Tretinoin Homogeneity, L=0.1% w/w (Tier 1)
90.0%-120.0% L head,  middle, crimp:
Tier 1
No homogeneity value outside of 90.0%-130.0% L with RSD NMT 6.0%
Tier 2
If tier 1 not met, test 2 additional tubes at head, middle, and crimp:
90.0%-120.0%L
Tier 1 and Tier 2
NMT 2 Homogeneity values outside of 90.0%-120.0%L for Tier 1 and tier 2, No
homogeneity value outside of 90.0-130.0% L with RSD NMT 7.8%
 Identification -  Tretinoin HPLC
Positive (retention time of sample compares to std). Not a stability testing
requirement
 Isotretinoin Content
NMT 5.0% of Tretinoin content
 Limit of 4-Oxotretinoin
NMT 0.7% of Tretinoin content
 Limit of 5,6-Epoxitretinoin
NMT 1.2% of Tretinoin content
Single Other Related Substances
NMT 0.5% of Tretinoin content
Total other Related Substances
NMT 1.0% of Tretinoin content
Microbial Limits Assay (MLA)
a. Total Aerobic Count
b. Total yeasts & Molds
c. Pseudomonas aeruginosa
d. Staphlococcus aureus
e.  E. coli
f. Salmonella species
g. Objectionable Organisms
 
 
NMT 100 cfu/g
NMT 100 cfu/g
Absent per 10 g
Absent per 10 g
Absent per 10 g
Absent per 10 g
Absent per 10 g
 Antimicrobial Effectiveness testing
Pass

 
 
19

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Tretinoin Gel Specification (0.025%)
Test
Shelf Life
Description
Yellow, translucent gel with a characteristic odor
Viscosity
RVT #6 at 10 RPM
45,000-95,000 cps
Tretinoin ID
Matches Standard. Not a stability requirement
Tretinoin Content,
L= 0.025% w/w
90.0%-130% L (Sample from two mixed tubes, head middle, crimp)
Isotretinoin Content
NMT 5.0% of Tretinoin content
Single Related Substance Content
NMT 1.5% Area of Active
Total Other Related Substances
NMT 2.0% Area of Active
BHT Content
0.045% - 0.055% W/W
Ethyl Alcohol Content
83-95% W/W
 Minimum Fill
S1-10 Tubes
 
Avg. NLT 100% of label Indv NLT 90%. Not a stability requirement
S2-30 Tubes
Avg. NLT 100% of label Indv NLT 90%. Not a stability requirement
Package  Integrity
Pass
Weight Loss
NMT 2%

 
20

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Tretinoin Gel Specification (0.025%)
Test
Shelf Life
Microbial Limits Assay (MLA)
a. Total Count
b. Pathogens
 
 
 
NMT 100 cfu/g
Absent
Antimicrobial Effectiveness testing
Pass

 
21

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Exhibit B
 
Product Pricing
 

 

 
Product
Description                                                                                        Price
 
Tretinoin 0.025%
Cream                                                                              
 [XXX]*
 
Tretinoin 0.05%
Cream                                                                                  [XXX]*
 
Tretinoin 0.1%
Cream                                                                                    [XXX]*
 
Tretinoin 0.025%
Gel                                                                                    
[XXX]*
 
Tretinoin 0.01%
Gel                                                                                      
[XXX]*

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* Subject to confidential treatment request

 
22 

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