Exhibit 10.49
The
confidential portions of this exhibit have been filed separately
with the Securities and Exchange Commission pursuant to a
confidential treatment request in accordance with Rule 24b-2 of the
Securities and Exchange Act of 1934, as amended. REDACTED
PORTIONS OF THIS EXHIBIT ARE MARKED BY AN [##].
LICENSE AND SUPPLY
AGREEMENT
This License and Supply Agreement (the “
Agreement ”) is effective as of December 4, 2008
(“ Effective Date ”) and is by and between OMP,
Inc., a Delaware corporation with principal offices at 310 Golden
Shore, Long Beach, California 90802 (“ OMP ”),
and Rohto Pharmaceutical Co., Ltd., a Japanese corporation with
principal offices at 1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka
544-8666, Japan (“ Rohto ”). OMP and
Rohto are referred to herein each as a “ Party ”
and collectively as the “ Parties ”.
WITNESSETH
:
WHEREAS , OMP has developed certain BiMineral Collagen
and Elastin enhancing products for cosmeceutical uses;
WHEREAS , Rohto desires to be OMP’s exclusive
licensee in the Territory for Products in the Channel (as each term
is defined in Section 1 hereof), and Rohto desires to assume
responsibilities for manufacturing Products for sale in the Channel
in the Territory;
WHEREAS , OMP desires to grant such exclusive license to
Rohto, and to transfer to Rohto Product manufacturing
responsibilities in the Territory for the Channel, in accordance
with the terms and conditions of this Agreement; and
WHEREAS , in connection with such exclusive license, OMP
shall supply, and Rohto shall purchase, certain related materials
and goods, as set forth herein.
NOW, THEREFORE , subject to the terms and conditions of this
Agreement, and in consideration of the covenants and agreements
hereinafter set forth, as well as other good and valuable
consideration, the receipt and sufficiency of which is acknowledged
by the Parties, the Parties agree as follows.
“ Additional Purchase Orders
” shall have the meaning set forth in Section
3(c).
“ Affiliate ” of a Party
means, for so long as one of the following relationships is
maintained, any corporation or other business entity controlled by,
controlling, or under common control with such Party, with
“control” meaning direct or indirect beneficial
ownership of more than fifty percent (50%) of the voting stock of
such corporation, or more than fifty percent (50%) interest in the
decision-making authority of such other business entity, or a
corporation in which the maximum amount of stock permitted by law
to be held by another entity is beneficially owned by such other
entity.
“ Annual Forecast ” shall
have the meaning set forth in Section 3(c).
“ Applicable Law(s) ” shall
mean all applicable laws, rules, regulations, guidelines and
standards.
“ BiMineral Complex ” (also
known as “ Copper Zinc Malonate ”) shall mean
the mineral complex described and set forth in Exhibit A
hereto, which is used as a raw material in the manufacture of
finished Product.
“ BiMineral Complex Cost ”
shall mean OMP’s fully-burdened cost for BiMineral Complex in
the form delivered to Rohto, including the entire cost for
BiMineral Complex manufacture, finish, design, packaging,
transportation, insurance and any third-party payments, as set
forth in Exhibit A .
“ Channel ” shall mean
consumer sales and distribution channels in which Rohto is
currently engaged: specifically the Drug Stores and Variety Stores
Channel, including mail-order and internet sales activities that
support such Drug Stores and Variety Stores Channel, as well as the
Department Stores Channel, including mail-order and internet sales
activities that support such Department Stores
Channel. Unless agreed to in writing by both parties
separately, the Channel shall not include physician, medical spas,
aesthetic spas and salon, or such similar outlets wherein products
are sold in combination with or in addition to, aesthetic
procedures or services and/or medical procedures.
“ Confidential Information ”
shall have the meaning set forth in Section 16.
“ CPR ” shall have the
meaning set forth in Section 18(b).
“ Department Stores Channel ”
shall mean upscale “department” stores, such as those
operated by Matsuzakaya Co., the Daimaru, Inc., Isetan Co., or
Hankyu Department Stores, Inc.
“ Development Fee ” shall
have the meaning set forth in Section 5(a).
“ Direct Advertising and Sales
Support ” shall have the meaning set forth in Section
2(e)(i).
“ Disclosing Party ” shall
have the meaning set forth in Section 16.
“ Dispute ” shall mean a
dispute, controversy or claim between the Parties based on or
arising out of (a) this Agreement, (b) any obligation or warranty
hereunder, or (c) the breach or alleged breach thereof.
“ Drug Stores and Variety Stores
Channel ” shall mean (a) stores (i) that are specifically
licensed to sell either prescription medicines or over-the-counter
drugs, and (ii) for which sales of such medicines and drugs are a
primary or significant portion of total store sales (“
Drug Stores ”); and (b) stores that are not licensed
to sell prescription medicines or over-the-counter drugs, but are
otherwise similar to Drug Stores in terms of the type of products
they carry and the consumer demographics that they target for
appeal (“ Variety Stores ”). Variety
Stores sell many kinds of goods including cosmetics, accessories
and other small household or personal items. Examples of
Variety Stores include the Loft and Sony Plaza. Examples
of Drug Stores include Matsumotokiyoshi and Sugi
pharmacy.
“ Extended Term ” shall have
the meaning set forth in Section 13(a).
“ First Commercial Sale ”
shall mean the date of the first arm’s length transaction,
transfer or disposition for value to a Third Party of a Product by
Rohto in the Channel in the Territory.
“ Fiscal Quarter ” shall mean
the three (3) month calendar quarters of each calendar year, as the
context requires.
“ Force Majeure Event ” shall
have the meaning set forth in Section 15.
“ ICC Rules ” shall have the
meaning set forth in Section 18(c).
“ Indemnitee ” shall have the
meaning set forth in Section 9(c).
“ Indemnitor ” shall have the
meaning set forth in Section 9(c).
“ Initial Term ” shall have
the meaning set forth in Section 13(a).
“ Liaison ” shall have the
meaning set forth in Section 8.
“ Net Sales ” shall mean the
gross amount invoiced by Rohto for the sale or other disposition of
Products, less the following deductions, but only to the extent
such deductions are actually paid or allowed in connection with
Products, are specified on documents related to such sale or other
disposition of Products, and are consistent with International
Financial Reporting Standards: (a) customary trade discounts
(including cash and volume discounts), credits and rebates, and
allowances and adjustments for rejections, recalls, returns or
retroactive price reductions; and (b) freight, insurance,
Taxes and/or duties imposed on the sale or disposition.
“ Notice of Breach ” shall
have the meaning set forth in Section 13(b)(i).
“ Notice of Termination ”
shall have the meaning set forth in Section 13(b)(i).
“ OMP Indemnitees ” shall
have the meaning set forth in Section 9(b).
“ Patent Rights ” shall mean
the rights and interests in and to issued patents and pending
patent applications (including inventor’s certificates and
utility models) in the Territory, including all provisionals,
substitutions, continuations, continuations-in-part, divisionals,
supplementary protection certificates, renewals, all letters patent
granted thereon, and all reissues, reexaminations, extensions,
confirmations, revalidations, registrations and patents of addition
thereof, which are owned or controlled by a Party.
“ Prior Agreement ” shall
have the meaning set forth in Section 2(e)(iv).
“ Product(s) ” shall mean
OMP’s BiMineral Collagen and Elastin enhancing product(s) for
eyes, face or body, in cream-based formulation and gel-based
formulation, which is/are manufactured using BiMineral Complex as a
raw material (also known as “ Elastiderm Products
”), as such product(s) are currently marketed in the United
States. All Products under this Agreement shall be
manufactured and sold by Rohto in a form approved by
OMP.
“ Product Know-How ” shall
mean Product formulas and Product manufacturing know-how used by
OMP in the manufacturing of finished Products in the United States
as of the Effective Date, including (without limitation)
information, materials, formulations, manufacturing technology,
trade secrets and data that (a) are owned or controlled by OMP, (b)
have been or are transferred by OMP to Rohto prior to or during the
Term, and (c) are necessary for Rohto’s manufacture, use,
sale, offer for sale, distribution, promotion, and marketing of the
Products in the Channel in the Territory.
“ Product Patents ” shall
mean the Patent Rights owned or controlled by OMP that are
necessary for Rohto’s manufacture, use, sale, offer for sale,
distribution, promotion, and marketing of the Products in the
Channel in the Territory, as set forth in Exhibit
B.
“ Purchase Order ” shall have
the meaning set forth in Section 3(c).
“ Receiving Party ” shall
have the meaning set forth in Section 16.
“ Regulatory Approval ” shall
mean shall mean any and all approvals (including pricing and
reimbursement approvals), product and establishment licenses,
registrations or authorizations of any kind necessary for the human
testing, manufacture, quality testing, supply, use, storage,
importation, export, transport, marketing and sale of a Product (or
any component thereof) for use in the Channel in the
Territory.
“ Remedial Action ” shall
have the meaning set forth in Section 7(b).
“ Rohto Indemnitees ” shall
have the meaning set forth in Section 9(a).
“ SEC ” shall have the
meaning set forth in Section 16.
“ Specifications ” shall mean
the specifications for BiMineral Complex, as established by OMP and
accepted by Rohto.
“ Taxes ” shall mean sales,
use, import, export, excise, value added and similar taxes, and
customs duties and assessments, however designated, that are
incurred or assessed in connection with the purchase of Product
under this Agreement, or the sale or use of Product or transactions
contemplated under this Agreement, excluding (for the avoidance of
doubt) income tax imposed on a Party.
“ Term ” shall have the
meaning set forth in Section 13(a).
“ Territory ” shall mean the
country of Japan.
“ Third Party ” shall mean an
entity other than Rohto or OMP.
“ Third-Party Claims and Expenses
” shall mean claims, actions, causes of action, liabilities,
losses, costs and expenses (including reasonable attorneys’
fees) incurred thereby or caused thereto arising out of third-party
claims.
“ Volume Target ” shall have
the meaning set forth in Section 2(e)(ii).
(a) Product Rights
and License .
Subject to the
terms and conditions of this Agreement and during the Term, OMP
hereby grants to Rohto (but not to its Affiliates), and Rohto
hereby accepts, an exclusive license under the Product Patents and
Product Know-How (i) to use, manufacture, offer to sell,
sell, distribute, promote, and market the Products in the Channel
in the Territory, and (ii) to develop improvements of the Products
and new products for use in the Channel in the Territory which are
related to the Product Patents and/or Product Know-How; provided
that Rohto shall have no right to grant a sublicense or engage a
subdistributor under the license rights granted to Rohto under this
Agreement. Rohto shall notify OMP of any opportunities
to strengthen OMP’s patent protection for BiMineral Complex
or Products in the Territory, and shall cooperate fully with OMP in
making any filings and seeking any such intellectual property
protection in the name of OMP, including (but not limited to)
providing reasonable assistance to OMP in preparing such patent
applications in the Territory. The seeking and obtaining
of all such intellectual property rights related to BiMineral
Complex or Products shall be the sole and exclusive right and
responsibility of OMP.
(b) Use of
BiMineral Complex to Manufacture Products; No Right to Manufacture
or Sell BiMineral Complex .
Rohto shall have no right hereunder to
manufacture BiMineral Complex, or to use BiMineral Complex for any
purposes other than the use for the purpose of Section
2(a). For the sake of clarity, Rohto shall have no right
to sell or resell BiMineral Complex to any Third Party in or
outside of the Territory. Subject to the terms and
conditions set forth herein, OMP shall be responsible for the
manufacture of all BiMineral Complex used by Rohto for the
manufacture of Product hereunder.
No Product (including, but not limited to,
Product packaging, final Product formulation and appearance, and
changes to Product) shall be distributed, promoted, marketed or
sold by Rohto pursuant to this Agreement without the prior written
approval of the final Product by OMP, such approval shall not be
unreasonably withheld. Rohto shall supply to OMP, in the
quantities reasonably requested by OMP, samples of each of the
Products in finished, packaged commercial form every six (6) months
after First Commercial Sale.
(d) Development and
Approval .
Rohto shall obtain and maintain (and shall have
the sole right and responsibility for obtaining and maintaining),
at its sole cost and expense (including any fees, commissions or
amounts otherwise payable to any brokers, agents, advisors,
consultants or facilitators that Rohto may retain or engage in
connection with the Regulatory Approvals), all necessary Regulatory
Approvals for Products in the Channel in the
Territory. OMP shall, at its sole cost and expense,
provide technical assistance reasonably requested by Rohto in
obtaining and maintaining Product Regulatory Approvals in the
Channel in the Territory. Rohto shall not conduct
clinical trials or any Product development activities without the
prior written consent of OMP. On request from OMP, Rohto
will permit OMP to access all information, materials or documents
which Rohto has prepared for submission to, or which Rohto has
submitted to, the authorities for obtaining Regulatory Approvals
for each of the Products, provided however, such accessed
information shall not be used by OMP other than for checking
Rohto’s process of the Regulatory Approvals and quality of
Products.
(e) Certain Volume
and Expense Commitments.
(i) During the Term,
Rohto shall provide reasonable advertising, marketing and sales
support for each of the Products, which shall reasonably include,
but not be limited to, expenditures in direct and indirect
advertising, sales commissions/incentives and any sales promotional
activities approximating (but not less than) thirty percent (30%)
or more of Rohto’s Net Sales of Products in the Channel in
the Territory in each calendar year (this level of support shall be
hereinafter referred to as “ Direct Advertising and Sales
Support ”).
(ii) Rohto shall
achieve First Commercial Sale in calendar year
2009. With respect to sales of Products to Third Parties
that are not Rohto Affiliates, Rohto shall achieve annual sales
amounts that equal or exceed [ 1* ] in each trailing twelve
(12)-month period ending March 31 st ,
June 30 th
, September 30
th and December 31 st ,
beginning one (1) year after First Commercial Sale (“
Volume Target ”). The Volume Target may be
adjusted only by written mutual agreement of the
Parties.
(iii) If, during the
Term, the actual Product unit sales volume of Rohto does not meet
or exceed the Volume Target in any such trailing 12-month period,
OMP shall have the right (but not the obligation) to sell
OMP-manufactured and OMP-branded Products in the Aesthetic
Spa/Salon channels in the Territory, whether directly or through a
Third Party.
(iv) Rohto shall be and
remain the exclusive licensee of the Products in the Channel in the
Territory for so long as Rohto achieves the Volume Target in each
trailing 12-month period during the Term. If, in any
trailing 12-month period, the actual Product unit sales volume of
Rohto falls below such Volume Target, and additionally Rohto does
not provide the level of target Direct Advertising and Sales
Support, either Party shall have the right (but not the obligation)
to convert Rohto’s exclusive license rights under this
Agreement to non-exclusive license rights or to terminate this
Agreement. In the event of termination of this Agreement
pursuant to the foregoing sentence, thereafter OMP shall be free to
sell and/or license the Products in the Channel in the Territory;
provided that OMP shall not sell an Obagi-branded product in the
Channel in the Territory for which Rohto has an existing exclusive
contractual right to do so pursuant to the existing Know-How and
Trademark License Agreement between the Parties, dated September
13, 2002, as amended (“ Prior Agreement
”).
The suggested retail price for each Product in
the Channel in the Territory shall be set by Rohto, assuming that
such Product pricing shall reflect appropriate premium brand
pricing. For the avoidance of doubt, Rohto shall have
the sole right to set Product pricing for customers in the Channel
in the Territory, in its sole discretion.
(g) Access to
Clinical Data of OMP .
Rohto shall have the right to use clinical
results and data generated by OMP with respect to Products which
are developed by OMP using the BiMineral Complex technology, but
only to the extent such clinical results and data are lawfully
available for disclosure by OMP in connection with the Products and
are not subject to any confidentiality
requirements. Rohto shall have the right to use such
clinical results and data solely and specifically for obtaining
Government Approvals and promotion of the Products in the Channel
in the Territory (and for no other purposes).
* Subject to
confidential treatment request
3. SUPPLY
OF BIMINERAL COMPLEX
(a) Supply of
BiMineral Complex .
Subject to the terms and conditions of this
Agreement, Rohto shall purchase all of its requirements for (i.e.,
its entire supply of) BiMineral Complex exclusively from OMP, and
OMP shall supply and sell BiMineral Complex to Rohto for use in the
Channel in the Territory; provided that OMP may sell BiMineral
Complex to any Third Party in or outside of the Territory if OMP
reasonably believes that such Third Party does not intend to use
such BiMineral Complex to manufacture and/or sell Products for use
in the Channel in the Territory. OMP shall provide the
Specifications to Rohto promptly after the execution of this
Agreement, but OMP shall have no obligation to provide Rohto with
any BiMineral Complex-related know-how or Confidential Information,
including (without limitation) BiMineral Complex manufacturing
know-how. Rohto acknowledges and agrees (i) that it has
received, and during the Term will receive, OMP’s
confidential and proprietary BiMineral Complex-related know-how,
Product Know-How and other OMP Confidential Information (including,
without limitation, OMP Confidential Information related to
BiMineral Complex) in connection with this Agreement, and (ii) that
such delivery by OMP is conditioned on Rohto’s covenant that
Rohto shall not use or exploit, during the Term and for five (5)
years thereafter, BiMineral Complex (or any substantially similar
variation thereof), BiMineral Complex-related know-how, Product
Know-How, or OMP Confidential Information in connection with any
other topical or skin care-related products (other than the
Products in accordance with this Agreement) without the express
prior written approval of OMP.
The BiMineral Complex shall be provided to Rohto
by OMP in accordance with Exhibit A , at the BiMineral
Complex Cost set forth in Exhibit A . The price
of the BiMineral Complex shall increase commercially reasonably,
but no more often than once per calendar year (unless otherwise
mutually agreed by the Parties in writing). Rohto
acknowledges and agrees that OMP is the only qualified supplier of
the BiMineral Complex for the manufacture of Products
hereunder. The foregoing BiMineral Complex Cost payments
shall be in addition to any other payments Rohto is obligated to
pay hereunder, including those set forth in Section
5. Rohto shall order from OMP at least 25 kg of
BiMineral Complex before December 31, 2008.
(b) Initial
BiMineral Complex Forecast .
Within thirty (30) days after the Effective
Date, the Parties shall agree upon an initial one (1)-year forecast
of Rohto’s BiMineral Complex requirements.
(c) Subsequent
BiMineral Complex Forecasts and Purchase Orders .
Not less than sixty (60) days prior to the first
business day of every Fiscal Quarter following the four Fiscal
Quarters covered by the initial 1-year forecast of Rohto’s
BiMineral Complex requirements, Rohto shall submit to OMP a rolling
quarterly forecast of its BiMineral Complex requirements covering
the subsequent four (4) Fiscal Quarters (each an “ Annual
Forecast ”). Each Annual Forecast shall set
forth in detail Rohto’s requirements for BiMineral Complex,
and each Annual Forecast shall be accompanied by written purchase
orders for the first two Fiscal Quarters within such Annual
Forecast (each, a “ Purchase Order
”). With respect to these accompanying Purchase
Orders, the Purchase Order for the first Fiscal Quarter shall be
firm, non-cancelable and binding on Rohto, and the Purchase Order
for the second Fiscal Quarter shall be firm, non-cancelable and
binding on Rohto, unless the second Fiscal Quarter Purchase Order
is modified by Rohto by written notice to OMP; provided that such
written notice is received by OMP at
least sixty
(60) days prior to the scheduled delivery date for such modified
Purchase Order; and further provided that the difference between
the forecasted Purchase Order and the modified Purchase Order for
the second Fiscal Quarter shall not exceed ten percent (10%) of the
forecasted Purchase Order. From time to time, Rohto may
place additional Purchase Orders with OMP for BiMineral Complex,
either in writing or by electronic or other ordering processes
established and mutually approved by Rohto and OMP (“
Additional Purchase Order(s) ”), and OMP shall use its
commercially reasonable efforts to attempt to fill such Additional
Purchase Orders, but OMP shall not be in breach of this Agreement
should it fail to do so in case that OMP does such
effort.
Subject to the terms and conditions of this
Agreement, OMP shall deliver to Rohto the BiMineral Complex, using
its commercially reasonable efforts to make such delivery in a
manner that meets the quantity ordered and the delivery dates
specified in Rohto’s Purchase Orders. In
Rohto’s name and at Rohto’s risk and expense, OMP will
deliver BiMineral Complex in accordance with standard operating
procedures established by OMP and approved by Rohto, such approval
not to be unreasonably withheld, delayed or
conditioned. OMP’s delivery of BiMineral Complex
to Rohto shall be Ex Works (Incoterms 2000) OMP’s place of
manufacture. Title to all BiMineral Complex shall remain
in OMP until the BiMineral Complex Cost for the relevant shipment
of BiMineral Complex is received by OMP. Risk of loss
shall pass to Rohto upon delivery of BiMineral Complex at
OMP’s place of manufacture. Shipment to Rohto of
BiMineral Complex (including import of BiMineral Complex into the
Territory) shall be the sole responsibility of Rohto, at
Rohto’s expense.
4.PRODUCT
LABELING, PRODUCT LITERATURE
Final Product image, brand use, positioning and
packaging manufactured by Rohto will be subject to OMP’s
prior written approval on an annual basis, which approval shall not
be unreasonably withheld. To the extent that Rohto
materially alters any Product packaging, and/or reintroduces new or
upgraded Products that are based on the Products approved by OMP
hereunder, all such changes also will be subject to OMP’s
prior written approval, which approval also shall not be
unreasonably withheld. The package label for Products
sold by Rohto pursuant to this Agreement shall, to the extent
permitted by Applicable Law, reflect OMP’s Product Patents or
variations thereof acceptable to OMP. All printed
material related thereto shall be agreeable to both Parties and
acceptable under Applicable Law.
5.PAYMENT
FROM ROHTO
In consideration of the costs and fees incurred
by OMP prior to the Effective Date in connection with the
development of the Copper Zinc Malonate technology, Rohto shall pay
to OMP a non-refundable, development fee (“ Development
Fee ”) in an amount of [ 2* ], which shall be paid to OMP
in five installments of [ 3* ] per year. The first such
installment payment shall be due on the Effective Date, and each
remaining installment payment shall be due on each subsequent
anniversary of the Effective Date during the Initial Term; provided
that, if this Agreement should be terminated by either Party under
Section
* Subject to
confidential treatment request
2(e)(iv), or by
OMP under Section 13(b)(i), 13(b)(ii) or 13(b)(iii), before all
five installments have been paid to OMP, then any unpaid
installment payments shall become due and payable ten (10) days
before the effective termination date (so that OMP will receive a
total of [ 4* ] pursuant to this Section 5(a), even in the event of
early termination).
In consideration of the grant by OMP to Rohto of
the exclusive license and rights set forth in Section 2(a) herein,
Rohto shall pay to OMP a royalty equal to [ 5* ] of Net Sales of
Products sold or distributed by Rohto during the one (1) year
period following the Effective Date. Thereafter, such
royalty rate shall decrease by [ 6* ] on each subsequent
anniversary of the Effective Date during the next four (4)
consecutive years, until the royalty rate payable to OMP reaches [
7* ] of Net Sales of Products sold or distributed by Rohto (which
shall occur on the fourth anniversary of the Effective
Date).
Within thirty (30) days after the end of each
Fiscal Quarter, Rohto shall deliver a written report to OMP that
sets forth, for such Fiscal Quarter, the type and number of
Products sold or otherwise disposed of by Rohto; sales prices for
each type of Product; the applicable royalty rate payable under
this Agreement; the total royalty payable to OMP; the applicable
exchange rate used to convert payments owed under this Section 5 to
United States Dollars; and other significant metrics as requested
by OMP. For purposes of determining when a sale of any
Product occurs under this Agreement, the sale shall be deemed to
occur on the e