AMENDED AND RESTATED PRODUCT SUPPLY AGREEMENT
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
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 ▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
("Triax"), and
OMP, Inc., a Delaware corporation having its principal place of business at ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("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superseded in its entirety by this Agreement.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.
4
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
5
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.
6
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
8
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. ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, Attn: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇,
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
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
11
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
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
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
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.
15
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
▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇▇▇▇▇▇
▇. ▇▇▇▇▇▇▇▇
Vice
President, General Counsel
and
▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, PhD
Chief
Scientific Officer
16
If to
OMP,
to:
OMP,
Inc
▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇. ▇▇▇
▇▇▇▇
▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇▇
▇. ▇▇▇▇▇▇,
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
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/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇ | |
| ▇▇▇▇▇▇▇ ▇. ▇▇▇▇ | |||
| EVP Operations, Finance and Administration and CFO | |||
| TRIAX PHARMACEUTICALS, LLC | |||
|
|
By:
|
/s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ | |
| ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ | |||
| COO | |||
18
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
|
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
|
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
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]*
22