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Exhibit 10.19
PRODUCT SUPPLY
AGREEMENT
This PRODUCT SUPPLY AGREEMENT
(the “Agreement”), dated as of December 8, 2005 (the
“Effective Date”), between Triax Pharmaceuticals, LLC,
a Delaware corporation, having its principal place of business at
20 Commerce, Cranford, NJ 07016 (“Triax”), and OMP, a
Delaware corporation having its principal place of business at 310
Golden Shore, Long Beach, California (“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, OMP has successfully
marketed and sold such products in the physician-dispensed channel;
and
WHEREAS, OMP and Triax deem it to be
in their mutual best interests to enter into an agreement whereby
the Parties shall collaborate to incorporate “Obagi”
branding and volume-based incentives to aid OMP in its Tretinoin
product sales efforts.
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: 20mL Tretinoin in 0.1%, 0.05% and 0.025%
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.
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,
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 15 days of receipt of such forecast from OMP,
and/or within 48 hours of Triax becoming aware of such
circumstances.
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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
“Channel”) for the first 12 months of this Agreement
from the Effective Date. Thereafter, OMP shall only maintain
exclusivity in the Channel, if OMP places Purchase Orders for at
least [***] units of Products (in any combination) in each calendar
year covered by the term of this Agreement. 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
Twelve -Month Rolling Forecasts
and Purchase Order Placement . Thirty days prior to the first day of the
first month of each quarter (which quarters shall begin on January
1, April 1, July 1 and October 1 of each year) during the term of
this Agreement, OMP will provide Triax with an estimated forecast
of Product orders for the coming 12 months, including firm Purchase
Orders for the second quarter of each forecast period. OMP will
place additional Purchase Orders as needed throughout each quarter
in advance of the required delivery date thereof allowing for the
Lead Time(s) (as such term is defined below). Triax shall secure
adequate supply and maintain Product materials and components to
the extent such materials and components are not typically provided
by OMP, and shall accept and fulfill Purchase Orders placed by OMP
in conformance with the terms of this Agreement. Triax shall accept
Purchase Order(s) and confirm shipment dates to OMP in writing
within 5 business days of receipt of a Purchase Order(s). As
warranted, OMP shall update its forecast on a monthly basis or as
required.
1.5
Quantity Increases;
Shipment . At the time
that purchase forecasts are placed at the beginning of each quarter
in accordance with Section 1.4, the Parties shall negotiate in good
faith to establish: (i) a maximum quantity by which OMP may
increase the quantity of Products 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.
1.6
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. 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.
1.7
GMP 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.
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THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTION.
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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 GMP and FDA standards to the extent they are
applicable.
1.8
Triax’s Additional
Obligations . Triax shall
immediately notify OMP within 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
associated with any recall, 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. 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.
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. All Prices are fixed through the term of this Agreement
in United States dollars, except changes agreed to in a mutual,
signed writing. Triax may also increase Prices, provided such
increases occur no more than once per 12 month period, and are
based on increases in costs demonstrated to OMP’s reasonable
satisfaction are the sole result of incremental increases in
packaging and labeling design costs and the integration of
custom-labeled Product tubes into the manufacturing process. Prices
are exclusive of delivery charges set forth in Section 3.2 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.
OMP shall also be entitled to volume
discounts to the base pricing listed on Exhibit B, for product
purchased in excess of [***] units per year, and to the extent such
product is sold through to OMP’s customer’s within 90
days of OMP’s receipt of such product. Volume discounts will
be based on calendar year performance and applied to cumulative
quarterly purchases in excess of [***] units per quarter, such that
annualized volumes over[***] units will be sold by Triax to OMP at
a [***] discount to Prices up to [***] units; volumes over [***]
shall be sold Triax to OMP at a [***] discounts to Prices, up to
[***] units; and volumes in excess of [***] shall be sold by Triax
to OMP at a [***] discount to Prices as follows;
THE SYMBOL [***] IS USED TO INDICATE
THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTION.
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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 [***] units per SKU. OMP
shall agree to purchase quantity in its entirety within 12 months
of expiration date, provided such smaller quantity as may be
desired by OMP cannot be accommodated as part of a larger
production run of similar Triax product, and only so long as such
Product has a minimum 2 year expiration date from the date of
manufacture. In any event, OMP shall provide at least a 120 day
lead time from the date of submission of Purchase Orders, and Triax
shall deliver all Products to OMP, and in compliance with the terms
of this Agreement, within 30 days of Triax’s receipt of such
Purchase Orders (“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.
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 . Product shall be packaged under Triax’s
standard label, branding and package design except that OMP shall
have the right, at OMP’s own expense to develop OMP branded
packaging, label design and label copy (“Packaging
Specifications”), and to have Product manufactured with such
“Packaging Specifications”. Triax shall take
commercially reasonable efforts to integrate “Packaging
Specifications” into Triax’s manufacturing processes.
OMP shall submit such Packaging design to Triax for approval as to
compliance with regulatory
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THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTION.
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requirements. Such approval will not be
unreasonably withheld. All OMP branded Products will use the same
packing tubes as currently utilized by Triax in its Tretinoin
production.
Packaging Specifications shall
include the phrase “Manufactured and distributed under
authority of Triax Pharmaceuticals, Inc.” and shall otherwise
comply with all applicable Food and Drug Administration
(“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 or any such
intellectual property rights or related interests, registered or
not, domestic or foreign, to Triax.
3.7
Payment Terms
. The terms of payment for all
Products purchased under this Agreement shall be net 30 days from
the date of OMP’s receipt of 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 10 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 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
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THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
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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 this 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
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”) for conformance with OMP’s specifications
(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 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 Triax shall promptly correct the defects identified by OMP or
supply new Products within 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 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 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.
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 as necessary to review (or have its
agents review), during regular business hours,
Triax’s
THE SYMBOL [***] IS USED TO INDICATE
THAT A PORTION OF THE EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREAT