LICENSE AND SUPPLY AGREEMENT
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
[##].
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 000 Xxxxxx Xxxxx, Xxxx Xxxxx, Xxxxxxxxxx 00000 (“OMP”), and Rohto
Pharmaceutical Co., Ltd., a Japanese corporation with principal offices at
0-0-0, Xxxxxxx-xxxxx, Xxxxx-xx, Xxxxx 000-0000, Xxxxx (“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.
1.
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DEFINITIONS
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“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.
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“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).
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“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.
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“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).
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2. PRODUCT
AND LICENSE
(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.
(c) Samples.
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.
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(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 31st, June
30th,
September 30th and
December 31st,
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”).
(f) Product
Pricing.
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).
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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
7
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.
(d) Delivery.
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
(a) Development
Fee.
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
8
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).
(b) Royalty
Payments.
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).
(c) Sales
Reports.
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 earlier of (i) the date the Product is shipped, or (ii) the date
of the invoice to the purchaser of the Product. In addition, Rohto
shall supply to OMP within ten (10) days after the end of each calendar month
after First Commercial Sale, a sales report estimating unit sales by sku for
such calendar month.
(d) Timing of Payments;
Taxes.
Rohto
shall pay (i) the first installment of the Development Fee on the execution date
of this Agreement, with other installments to follow as set forth in Section
5(a); (ii) the BiMineral Complex Cost upon BiMineral Complex delivery (as may be
further described in Exhibit A); and (iii)
all royalty payments owed to OMP hereunder in arrears, within sixty (60) days
after the end of each Fiscal Quarter in which such royalty payment
accrued. All payments due to OMP hereunder are exclusive of Taxes
(Rohto shall pay all Taxes in connection with payments made to OMP
hereunder).
(e) Interest.
Subject
to the other terms of this Agreement, any payments not paid by Rohto within the
applicable time period set forth in this Section 5 shall bear interest at a rate
of one and one-quarter percent (1.25%) per month from the due date until paid in
full; provided that in no event shall said annual rate exceed the maximum
interest rate permitted by Applicable Law in regard to such
payments. Such late payment, when made, shall be accompanied by all
interest so accrued. Said interest, and the payment and acceptance
thereof, shall not negate or waive the right of OMP to any other remedy, legal
or equitable, to which it may be entitled because of the delinquency of the
payment.
(f) Accounting.
All
payments hereunder shall be made in the United States in United States
Dollars. Conversion of foreign currency to United States Dollars
shall be made at the conversion rate existing in the United States (as reported
in The Wall Street Journal) on the
last business day of the Fiscal Quarter immediately preceding the applicable
Fiscal Quarter. If The Wall Street Journal ceases to
be published, then the rate of exchange to be used shall be that
9
reported
in such other business publication of national circulation in the United States
as the Parties reasonably agree.
(g) Financial Books and Records
of Sales.
Rohto
shall maintain accurate and complete books and records pertaining to this
Agreement for a period of at least six (6) years (or such longer period as may
correspond to Rohto’s internal records retention policy) after each reporting
period in which Product sales occur. Such books and records shall
show the sales, use and other disposition of Products by Rohto in sufficient
detail to enable the amounts payable to OMP hereunder to be accurately
determined, and otherwise to permit OMP to verify compliance by Rohto with all
obligations under this Agreement. Rohto shall permit its books and
records to be audited, reviewed and copied (“examined” or “examination”) from
time to time by authorized employees of, or attorneys and/or accountants
selected by, OMP with at least ten (10) days advance written notice to Rohto,
but not more frequently than once a year without cause. Such
examination shall be during normal business hours and shall be made at the
expense of OMP, except that if the results of the examination for any
twelve-month period reveal that Rohto has underpaid OMP by an amount exceeding
five percent (5%), then Rohto shall pay the reasonable costs and expenses
incurred by OMP and its representatives in conducting such
examination. Rohto shall immediately pay to OMP any underpayment
revealed by such examination and accrued interest thereon.
6.INSPECTION
OF ROHTO FACILITIES AND RECORDS
Rohto
agrees to permit representatives of OMP and any relevant regulatory or
governmental authority to access at any reasonable time during normal business
hours relevant records, information (and where applicable, to make copies of the
same), personnel and facilities. Rohto shall immediately notify OMP
if any governmental or regulatory authority schedules, or without scheduling
begins, an inspection or audit. Rohto shall make every reasonable
effort to permit OMP to be present at or participate in such inspection or audit
if the same relates directly or indirectly to this Agreement. In
addition, Rohto will immediately provide OMP copies of any correspondence from
or draft communications with (including any notes) government or regulatory
authorities relating directly or indirectly to this Agreement.
7.COMPLAINTS,
ADVERSE EVENT REPORTING AND RECALLS
(a) Complaints
and Adverse Events.
Rohto
shall be responsible for the prompt review, evaluation and documentation of all
complaints relating to any Product in the Territory, with OMP’s reasonable
cooperation. Rohto shall forward to OMP, within five (5) days, and
within 24 hours with respect to reports of serious injury or serious adverse
events, of initial receipt, all complaints received concerning any Product,
including, without limitation, all reports of Product misuse, improper Product
promotion or other Product-related problems. OMP shall reasonably
cooperate with Rohto’s investigation of Product complaints. Rohto
shall be responsible for resolving all Product complaints, at its expense, with
the reasonable cooperation of OMP.
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(b) Recalls.
OMP and
Rohto agree that, if either Party discovers or becomes aware of any fact,
condition, circumstance or event (whether actual or potential) concerning
or
related
to any Product in the Territory that may reasonably require a report, a recall
or market withdrawal of such Product in the Territory, such Party shall promptly
communicate such fact, condition, circumstance or event to the other Party
within twenty-four (24) hours. In the event (i) any governmental
entity or regulatory body requests that a Product be recalled or withdrawn, (ii)
a court of competent jurisdiction orders a Product recall or withdrawal, or
(iii) Rohto (in consultation with OMP) determines that a Product should be
recalled or withdrawn from the market, Rohto shall take all appropriate remedial
actions with respect to such recall or withdrawal of Product (“Remedial
Action”). Rohto shall be responsible for all reporting,
pharmacovigilance reporting and recalls associated with Product in the Channel
in the Territory, and Rohto shall be the primary contact person/ entity for any
communications to any governmental entity, regulatory body, the media and
customers in the Territory concerning the Remedial Action, with OMP’s reasonable
cooperation. If such recalls are necessary because of any event that
listed in Section 9 (b), Rohto shall be solely responsible for, and shall
reimburse OMP for, all costs reasonably incurred as a result of, such Remedial
Action or any Product recalls or market withdrawals, and shall reimburse OMP for
all costs reasonably incurred by OMP in connection with OMP’s reasonable
cooperation, and OMP shall be solely responsible for, and shall reimburse Rohto
for, all costs reasonably incurred as a result of, such Remedial Action if such
recalls are necessary because of any event listed in Section 9 (a). OMP and
Rohto shall discuss and determine how to share the costs incurred as a result of
such Remedial Action if such recalls are necessary because of any event other
than that listed in Section 9 (a) or (b). Rohto shall notify OMP
within forty-eight (48) hours of undertaking a Remedial Action, and the reasons
therefor. The Parties shall cooperate fully with one another to
obtain, but Rohto shall be solely responsible for preparing and submitting, all
information reasonably required by regulatory or governmental authorities
related to the affected Product in the Territory.
8.LIAISONS
The
Parties recognize that good communication between them is important to the
success of this Agreement. To promote such communication, OMP and
Rohto shall each appoint an individual who shall serve as that Party’s liaison
(its “Liaison”) to the
other Party to facilitate good day-to-day communication between the
Parties. Each Party shall notify the other Party in writing of its
designated Liaison, whom it may replace at any time in its discretion (with
notice of such replacement to the other Party).
9.INDEMNIFICATION;
INSURANCE
(a) Indemnification by
OMP.
OMP shall
indemnify, defend and hold harmless Rohto and its directors, officers, employees
and agents (“Rohto
Indemnitees”) from and against any and all Third-Party Claims and
Expenses to the extent that such Third-Party Claims and Expenses arise out of or
result from: (i) any material breach of this Agreement by OMP; or (ii) the
negligence or willful misconduct of OMP or an OMP Indemnitee; provided that OMP
shall have no duty to indemnify, defend or hold harmless any Rohto Indemnitee to
the extent that Rohto caused or contributed to Third-Party Claims and Expenses,
or to the extent that Rohto is obligated to indemnify OMP under Section 9(b);
and provided further that nothing in this Section
11
9(a)
shall create or imply liability for OMP where such liability is expressly
disclaimed or limited under this Agreement.
(b) Indemnification by
Rohto.
Rohto
shall indemnify, defend, and hold harmless OMP and its directors, officers,
employees and agents (“OMP
Indemnitees”) from and against any and all Third-Party Claims and
Expenses to the extent that such Third-Party Claims and Expenses arise out of or
result from: (i) any material breach of this Agreement by Rohto
(including, without limitation, material breach of any of its warranties
hereunder) or other act or omission of Rohto or a Rohto Indemnitee; (ii) the
manufacture, distribution, promotion, marketing ,sale, offer for sale or
labeling of Product, including where such labeling was materially different than
the labeling information furnished by OMP; and/or (iii) the negligence or
willful misconduct of Rohto or a Rohto Indemnitee; provided that Rohto shall
have no duty to indemnify, defend or hold harmless any OMP Indemnitee to the
extent OMP is obligated to indemnify Rohto under Section 9(a).
(c) Indemnification Procedure
and Resolution.
Unless
and to the extent otherwise specifically provided herein, an OMP Indemnitee or a
Rohto Indemnitee (“Indemnitee”) that intends to
claim indemnification under Section 9(a) or 9(b) shall notify the other Party
(the “Indemnitor”)
promptly of any Third-Party Claims and Expenses in respect of which the
Indemnitee intends to claim such indemnification, and the Indemnitor shall
assume the defense thereof, at its expense, with counsel of its own choosing;
provided that an Indemnitee shall also have the right to retain its own counsel
at its sole expense, but if (i) the action threatens to restrain or adversely
affect the conduct of the business of the Indemnitee or (ii) independent counsel
to the Indemnitee concludes that there are defenses available to Indemnitee
which are different from, or additional to, and may conflict with those
available to the Indemnitor, the costs, expenses and attorneys’ fees incurred by
the Indemnitee in retaining its own counsel shall be borne by the
Indemnitor. An Indemnitee shall not be entitled to indemnification
under this Section 9 if any settlement or compromise of a Third-Party action is
effected by the Indemnitee without the consent of the Indemnitor. An
Indemnitor shall not (except with the Indemnitee’s prior written approval) enter
into any settlement or compromise of any Third-Party action or consent to the
entry of any judgment or other order with respect to any action that does not
contain, as a part thereof, an unconditional release of the Indemnitee for
liability for all losses, liabilities and expenses that may rise from such
action, or that does contain any injunctive or any other non-monetary relief
that might in any way interfere with the future conduct of business by the
Indemnitee. The failure by the Indemnitee to deliver notice to the
Indemnitor within a reasonable time after the commencement of any such
Third-Party action of which it becomes aware shall relieve such Indemnitor of
any liability to the Indemnitee under this Section 9 only if and to the extent
that the Indemnitor was materially prejudiced thereby. An Indemnitee
and its representatives shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any action covered by this
indemnification.
(d) Insurance.
As of the
First Commercial Sale, each Party shall maintain with reputable insurers general
liability insurance, including products liability coverage, in a minimum amount
per occurrence that is commensurate with industry standards for similar products
(but not less than [ 8* ] Japanese yen per occurrence), that provides coverage
for the Products and the transactions contemplated by this
Agreement. At a minimum, the Parties shall maintain such insurance
coverage required hereunder for the entire Term and, if any such
* Subject to confidential treatment request
12
policy(ies)
shall provide coverage on a claims made basis, the Parties shall be required to
maintain a claims-made policy(ies) providing such coverage for an additional
period of not less than five (5) years following the expiration or termination
of this Agreement (to the extent such policies are reasonably
available). Each policy required hereunder shall name the other Party
as an additional insured with respect to this Agreement. Each Party
shall deliver to the other a certificate from the insurance carrier or broker
evidencing such coverage and the fact that the other Party is named as an
additional insured, and noting any exclusions and agreeing to provide no less
than five (5) days’ prior written notice to the other Party in the event of a
material change in coverage or policy cancellation.
10.WARRANTIES
OF OMP
OMP
hereby warrants as follows:
(a) Organization;
Authority.
OMP is a
corporation duly organized and validly existing in good standing under the laws
of Delaware. OMP has the power and authority, and has taken all
corporate action necessary, to execute, deliver and perform this
Agreement.
(b) Binding
Obligation.
The
execution and delivery of this Agreement by OMP does not, and the performance of
its obligations hereunder will not, violate any provision of the Article of
Incorporation or by-laws of OMP or violate any provisions of, or result in a
breach of any of the terms or provisions of or the acceleration of any of the
obligations under, or constitute a default under, any mortgage, lease,
agreement, instrument, order, arbitration award, judgment or decree to which OMP
is a party or to which OMP or its assets, properties or business are
subject. This Agreement is a valid and binding agreement of OMP
enforceable against it in accordance with its terms (subject to applicable
bankruptcy laws).
(c) No Other
Agreement.
OMP is
not party to any agreement with or obligation to any Third Party or any other
legally binding commitment of any kind or nature whatsoever that conflicts with
the full right and authority of OMP to perform its covenants under this
Agreement.
(d) Patents, Formula and
Know-How.
Exhibit B sets forth
a complete list of Product Patents owned or controlled by OMP in the Territory
which are necessary for making, using, selling, offering for sale and importing
Products in the Channel in the Territory in accordance with this
Agreement. To the best knowledge of OMP’s officers, no lawsuit has
been filed in the Territory against OMP with respect to the Product Patents and
Product Know-How.
(e) BiMineral Complex
Warranty.
At the
time of shipment to Rohto, the BiMineral Complex shall meet the Specifications
in all material respects and have no defect in material, design, and
workmanship.
(i) If a
shipment of BiMineral Complex is not returned to OMP within thirty (30) days of
delivery, Rohto may not return such BiMineral Complex to OMP for any reason
without OMP’s prior written consent; provided that (for the avoidance of doubt)
this shall not limit OMP’s indemnification obligations for Third-Party Claims
and Expenses based on a breach of the BiMineral Complex warranty as provided in
the first sentence of Section 10(e).
13
(ii) To the
best knowledge of OMP’s officers, no lawsuit has been filed against OMP with
respect to the BiMineral Complex.
(iii) EXCEPT
FOR, AND WITHOUT LIMITING, OMP’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 9(a)
WITH RESPECT TO THIRD-PARTY CLAIMS AND EXPENSES ARISING OUT OF OR RESULTING FROM
OMP’S BREACH OF THE BIMINERAL COMPLEX WARRANTY IN THE FIRST SENTENCE OF SECTION
10(e), OMP’S EXCLUSIVE LIABILITY, AND THE EXCLUSIVE REMEDY OF ROHTO, FOR OMP’S
SUPPLY OF DEFECTIVE BIMINERAL COMPLEX SHALL BE REPLACEMENT OF SUCH BIMINERAL
COMPLEX OR CREDIT THEREFOR. The warranty set forth in the first
sentence of Section 10(e) is void to the extent that BiMineral Complex failure
or deficiencies are (A) the result of occurrences, mishandling or modification
during or after shipment to Rohto, or (B) caused by an act or omission of Rohto,
its employees or agents.
11.WARRANTIES
OF ROHTO
Rohto
hereby warrants as follows:
(a) Organization.
Rohto is
a corporation duly organized and validly existing in good standing under the
laws of Japan. Rohto has the power and authority, and has taken all
corporate action necessary, to execute, deliver and perform this
Agreement.
(b) Binding
Obligation.
The
execution and delivery of this Agreement by Rohto does not, and the performance
of its obligations hereunder will not, violate any provision of the certificate
of incorporation or by-laws of Rohto or violate any provisions of, or result in
a breach of any of the terms or provisions of or the acceleration of any of the
obligations under, or constitute a default under, any mortgage, lease,
agreement, instrument, order, arbitration award, judgment or decree to which
Rohto is a party or to which Rohto or its assets, properties or business are
subject. This Agreement is a valid and binding agreement of Rohto
enforceable against it in accordance with its terms (subject to applicable
bankruptcy laws).
(c) No Other
Agreement.
Rohto is
not a party to any agreement with or obligation to any Third Party or any other
legally binding commitment of any kind or nature whatsoever that conflicts with
the full right and authority of Rohto to perform its covenants under this
Agreement.
(d) Compliance with
Laws.
Rohto and
its employees and agents shall comply with all Applicable Law applicable to its
conduct and its respective obligations under this Agreement, including, without
limitation, those applicable to the manufacture, handling, storage, shipment,
export, import, rotation, segregation, advertising, promotion, marketing,
pricing, sale, offer for sale and/or distribution of Products. In
addition, Rohto agrees to comply with, and not to cause OMP to be in violation
of, the Article 18 of Unfair Competition Protection Act in Japan Act, as
amended.
14
(e) Manufacturing
and Sales of Products.
Rohto
shall manufacture Product in accordance with OMP’s written
instructions. All Products manufactured by Rohto shall be free from
defects in materials and workmanship. Product warranties shall be
determined, provided and fulfilled by Rohto (and not by OMP).
(f) Permits.
Rohto
shall obtain and maintain all permits and approvals required for its
manufacturing, sales and Product distribution facilities and
networks.
00.XX
OTHER WARRANTIES; LIMITATION OF LIABILITY
(a) No Other
Warranties.
EXCEPT
ONLY FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, OMP MAKES NO
WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY
STATUTE OR OTHERWISE, AND OMP SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY OF
QUALITY, WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE OR WARRANTY OF NONINFRINGEMENT WITH RESPECT TO PRODUCTS OR
THE BIMINERAL COMPLEX.
(b) Limitations of
Liability.
EXCEPT
ONLY FOR ITS INDEMNIFICATION OBLIGATIONS WITH RESPECT TO THIRD-PARTY CLAIMS AND
EXPENSES UNDER SECTION 9, IN NO EVENT SHALL OMP BE LIABLE TO ROHTO (UNDER ANY
CONTRACT, STRICT LIABILITY, NEGLIGENCE OR OTHER LEGAL OR EQUITABLE THEORY) FOR
ANY INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, OR EXEMPLARY DAMAGES
OF ANY KIND, INCLUDING WITHOUT LIMITATION, LOST PROFITS, REVENUES, OR SALES,
ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
13.TERM
AND TERMINATION
(a) Term.
Unless
earlier terminated in accordance with the provisions of this Agreement, the
initial term of this Agreement shall commence on the Effective Date and shall
continue until the fifth (5th) anniversary of the Effective Date (“Initial
Term”). Prior to the expiration of the Initial Term, this
Agreement may be extended for an additional five (5) year period (“Extended Term”) upon written
mutual agreement of the Parties. The “Term” shall mean the Initial
Term and the Extended Term (if any).
(b) Termination.
Notwithstanding
the foregoing, this Agreement may be terminated as follows.
15
(i) By a
Party for material breach of this Agreement by the other Party, unless the
breaching Party shall have remedied such breach within [ 9* ] (thirty (30) days
if the breach is a failure to pay money) following its receipt of written notice
from the non-breaching Party describing such breach in detail, which notice
shall include a statement of the non-breaching Party’s intent to terminate this
Agreement unless such breach is remedied (“Notice of
Breach”). In the event such breach is not remedied
within [ 10* ] (thirty (30) days if the breach is a failure to pay) from
the breaching Party’s receipt of the Notice of Breach, the non-breaching Party
may terminate this Agreement within ninety (90) days after the end of the
initial cure period (or such longer time period as the Parties may agree in
writing) by sending a notice of termination to the breaching Party (“Notice of
Termination”). This Agreement shall terminate thirty (30) days
following the breaching Party’s receipt of such Notice of
Termination.
(ii) By either
Party by written notice to the other Party, in the event that the other Party
shall go into liquidation, or seek the benefit of any bankruptcy or insolvency
act, or a receiver or trustee is appointed for its property or estate, or it
makes an assignment for the benefit of creditors, whether any of the aforesaid
events be the outcome of the voluntary act of such Party or otherwise, and such
procedures are not terminated within ninety (90) days.
(iii) Upon
written notice to Rohto, OMP may terminate this Agreement in the event that
Rohto challenges in any forum the validity, enforceability, scope or any other
elements of patent rights or other intellectual property rights covering a
Product.
(iv) A Party
may terminate this Agreement as provided in Section 2(e)(iv) or in Section
15.
(c) Termination Rights; Survival
of Obligations.
The
termination of this Agreement for any reason shall be without prejudice to OMP’s
right to receive all payments accrued and unpaid hereunder, and to the remedy of
either Party hereto in respect of any previous breach of any of the covenants
herein contained. Rohto’s payment obligations hereunder, and the
provisions of Section 13(c) and Sections 5, 6, 7, 9, 10, 11, 12, 14 and 16-26,
shall survive termination or expiration of this Agreement, as shall such other
provisions that, by their context, are logically intended to
survive.
14.IP
– OWNERSHIP; DEFENSE; INFRINGEMENT BY THIRD PARTIES
All
intellectual property (including inventions, whether patentable or not, and know
how) identified, discovered, conceived, reduced to practice, generated,
obtained, derived or developed by Rohto that relates to any Product or BiMineral
Complex shall be the sole and exclusive property of OMP. Rohto will
disclose to OMP all such intellectual property and, upon the request of OMP,
assign, and cause its employees and agents to assign, to OMP all rights in such
intellectual property. OMP agrees to utilize such intellectual
property only with its own products. Rohto will not file for any patent rights
or any other protection that might cover any Product, BiMineral Complex or any
similar products utilizing copper and/or zinc and malonic
acid. OMP shall have sole responsibility for the writing,
filing, prosecution, maintenance and defense of all rights covering Product
and/or BiMineral Complex. Rohto shall notify OMP in writing in the
event it becomes aware of any third-party infringement or threatened
infringement of any patent or other intellectual property right (including any
OMP trademark or trade dress) in or to the Product and/or BiMineral
Complex. OMP shall have the exclusive right, in its discretion, to
control any enforcement against such infringement or threatened infringement.
Rohto shall fully cooperate with and provide all assistance to OMP in connection
with OMP’s fulfillment of its obligations under this Section 14.
* Subject to confidential
treatment request
16
15.FORCE
MAJEURE
If either
Party shall be delayed or hindered in, or prevented from, the performance of any
act required hereunder by reason of strike, lockouts, labor troubles,
restrictive governmental or judicial orders or decrees, riots, insurrection,
war, acts of God, inclement weather or other reason or cause reasonably beyond
such Party’s control (each a “Force Majeure Event”), then
performance of such act shall be excused for the period of such Force Majeure
Event. The Party affected by the Force Majeure Event shall provide
notice to the other Party of the commencement and termination of the Force
Majeure Event. Should a Force Majeure Event continue for more than [
11* ], the Party unaffected by the Force Majeure Event may terminate this
Agreement upon prior written notice to the affected Party. Should the
Force Majeure Event equally affect the performance of both Parties, then such
termination shall only be by mutual written agreement of the
Parties.
16.CONFIDENTIALITY
Each
Party (the “Receiving
Party”) acknowledges that all information (written, oral, tangible or
observed), including all scientific, technical, financial and commercial
information, previously disclosed by or obtained (prior to the Effective Date)
from the other Party (the “Disclosing Party”), or
hereafter possessed or obtained by the Receiving Party concerning the business,
manufacturing, products or plans of the Disclosing Party, including, but not
limited to, information relating to the Disclosing Party’s research,
development, manufacturing or marketing methods, plans, issues and difficulties,
financial plans and records, intellectual property protection, and arrangements
or negotiations with suppliers to or customers of, or others having significant
dealings with, the Disclosing Party, shall be deemed to be the Disclosing
Party’s confidential information (“Confidential Information”),
and shall be maintained by the Receiving Party and its employees, agents and
directors in confidence at all times during the Term, and for a period of five
(5) years after this Agreement has expired or been terminated for any reason,
except to the extent necessary for the commercialization of Products or as
otherwise permitted in writing by the Disclosing Party. Without
limiting the foregoing, each of the Parties further agrees to use the same
degree of care concerning the other Party’s Confidential Information as it uses
to protect its own confidential and proprietary technical information to prevent
the unauthorized disclosure to any Third Party of such Confidential
Information. For the avoidance of doubt, all intellectual property
and related information owned by OMP pursuant to Section 14 shall be and remain
Confidential Information of OMP. The terms and existence of this
Agreement shall be deemed the Confidential Information of both
Parties. Rohto acknowledges that OMP will be obligated to file a copy
of this Agreement with the United States Securities and Exchange Commission
(“SEC”). OMP
will seek confidential treatment of those portions of this Agreement which it
deems appropriate under applicable regulations of the SEC.
The
obligations hereunder shall not apply to information:
* Subject to confidential treatment request
17
(a) which
the Receiving Party can demonstrate by its written records was known to it prior
to the date of disclosure by the Disclosing Party; provided that such
information was not obtained by the Receiving Party through wrongful disclosure
by a Third Party which received such information in confidence from the
Disclosing Party;
(b) which
is now in the public knowledge, or becomes public knowledge in the future, other
than by breach of this Agreement by the Receiving Party;
(c) which,
as can be established by the Receiving Party’s written records, is independently
developed by the Receiving Party without benefit of any Confidential Information
received from the Disclosing Party;
(d) which
is lawfully disclosed to the Receiving Party, after the date of disclosure by
the Disclosing Party, by a Third Party on a non-confidential basis;
or
(e) which
is required to be disclosed by Applicable Law or proper legal, governmental or
other competent authority, or which is included in any filing or action taken by
the Receiving Party to obtain or maintain government clearance or approval to
market a Product(s); provided, however, that when permitted by the provisions of
Applicable Law, the Receiving Party shall use its reasonable best efforts to
protect the confidentiality of any Confidential Information of the Disclosing
Party that is submitted to governmental agencies or authorities pursuant to this
Agreement, and; provided further that, with regard to a court order or similar
process, the Party whose Confidential Information is to be disclosed shall be
notified sufficiently in advance of such required disclosure, so that it may
seek a protective order (or equivalent) with respect to such disclosure, with
which the Receiving Party shall fully comply.
17.NOTICES
All
notices, consents and approvals hereunder shall be in writing and shall be
deemed to have been properly given and to be effective on the date of delivery
if delivered in person, by international courier service or by facsimile
transmission (provided that any faxed notice is also sent by international
courier service, and further provided that Notices of Breach or Notices of
Termination shall not be sent by facsimile transmission) to the respective
address or facsimile number provided below, or to such other address or
facsimile number as a Party shall designate by written notice to the other Party
in such manner:
|
If
to Rohto:
|
0-0-0,
Xxxxxxx-xxxxx, Xxxxx-xx
|
|
Xxxxx
000-0000, Xxxxx
|
Attention: Xxxx
Xxxxxxxxx, Ph.D.
Facsimile: 00-0-0000-0000
|
If
to OMP:
|
0000
Xxxxxx Xxxxxxx Xxx,
|
|
Xxxxx
000
|
|
Xxxx
Xxxxx, Xxxxxxxxxx 00000
|
|
Attention: Xxxx
Xxxxxx and Xxxxxxx Xxxx
|
Facsimile: (000)
000-0000
18
|
With
a copy to:
|
Xxxxx
X. Xxxxxx, Esq.
|
|
OMP,
Inc.
|
|
0000
Xxxxxx Xxxxxxx Xxx,
|
|
Xxxxx
000
|
|
Xxxx
Xxxxx, Xxxxxxxxxx 00000
|
|
Facsimile: (000)
000-0000
|
18.DISPUTE
RESOLUTION
(a) Dispute.
Any
Dispute arising out of or relating to this Agreement, including the breach,
termination or validity thereof, shall be resolved in accordance with the
procedures set forth in this Section 18, which shall be the sole and exclusive
procedure for the resolution of any such Dispute.
(b) Mediation.
The
Parties shall endeavor to resolve any Dispute by mediation under the
International Institute for Conflict Prevention and Resolution (“CPR”) Mediation Procedure then
currently in effect. Unless the Parties agree otherwise, the mediator
will be selected from the JAMS panel of neutrals. If the Dispute is
not resolved within thirty (30) days of a Party’s written request for mediation,
there is no further obligation to mediate.
(c) Arbitration.
Any
Dispute that remains unresolved thirty (30) days after a written request for
mediation made pursuant to subsection (b) shall be finally resolved by
arbitration under the Rules of Arbitration of the International Chamber of
Commerce then currently in effect (“ICC Rules”) by three
independent and impartial arbitrators of whom each party shall select one
arbitrator as provided in the ICC Rules and thereafter those two arbitrators
shall together select the third arbitrator, who shall not be of the same
nationality as either of the parties and shall be an experienced business
attorney with a background in licensing and distribution
agreements. If the party-appointed arbitrators fail to agree on the
third arbitrator within thirty (30) days that arbitrator shall be appointed in
accordance with the ICC Rules. The arbitrators must render their
award by the application of the substantive laws of New York without giving
effect to principles of conflicts of laws. The place of arbitration
shall be New York, NY , USA, and the language of the arbitration and submissions
and proceedings shall be English. Judgment upon the award rendered by
the arbitrators may be entered by any court having jurisdiction
thereof.
(d) Interim
Relief.
Despite
the foregoing, nothing in this Section 18 shall prevent either Party from
seeking temporary equitable relief (including injunctive relief) from any court
of competent jurisdiction, pending selection of the arbitrator(s) and the
arbitrator(s)’ commencement of proceedings, when such interim relief is
appropriate to preserve a Party’s rights under this Agreement pending
arbitration (for example, the enforcement of the confidentiality provisions of
this Agreement). The arbitrator(s) shall be authorized, in their
discretion, to continue, terminate or modify any such interim relief upon
commencing the arbitration proceedings.
19
19. ENTIRE
AGREEMENT; AMENDMENTS
This
Agreement, constitutes the entire agreement between the Parties and supersedes
all prior agreements, understandings, representations, and statements, if any,
regarding the subject matter hereof, whether oral or written. No
amendment or modification of this Agreement shall be valid and binding upon the
Parties unless made in writing and signed on behalf of each of such Parties by
their respective authorized officers.
20.GOVERNING
LAW
This
Agreement shall be governed by and construed in accordance with the laws of New
York without giving effect to principles of conflicts of law.
21.SEVERABILITY
OF PROVISIONS
If any
provision of this Agreement shall be held to be illegal, invalid or
unenforceable by a court, arbitrator or other authority of competent
jurisdiction, the Parties shall endeavor to replace it with another provision
that will as closely as possible reflect their original intention. The validity,
legality and enforceability of the remaining provisions shall not in any way be
affected or impaired thereby.
22.WAIVER
OF DEFAULT
Failure
of either Party at any time to require performance of any provision of this
Agreement shall not affect the right to require full performance thereof at any
time thereafter. The waiver of any default under this Agreement by either Party
shall not constitute a waiver of any of its rights for any subsequent
default.
23.ASSIGNMENT
This
Agreement shall be binding upon and inure to the benefit of the Parties hereto
and their respective successors and assigns. Except as provided
below, neither Party may assign this Agreement (by operation or law or
otherwise) without the prior written consent of the other
Party. Notwithstanding the foregoing, OMP shall have the right, with
written notice to Rohto, to assign this Agreement to any Affiliate of OMP
without Rohto’s consent, so long as such Affiliate is not a direct competitor of
Rohto in the Territory. Furthermore, Rohto’s consent shall not be
required in connection with a transfer (including by assignment) to a
non-Affiliate Third Party of OMP’s rights and/or obligations under this
Agreement incident to a merger, consolidation, reorganization or acquisition of
substantially all the assets of, or a controlling interest in, OMP, so long as
such successor Third Party is not a direct competitor of Rohto in the
Territory.
20
24.INDEPENDENT
CONTRACTOR
Each
Party hereto shall be and remain an independent contractor, and nothing herein
shall be deemed to constitute the Parties as partners or joint
venturers. Further, neither Party shall have any authority to act, or
attempt to act, or represent itself, directly or by implication, as an agent of
the other or in any manner assume or create, or attempt to assume or create, any
obligation on behalf of or in the name of the other, nor shall either be deemed
the agent of the other.
00.XXXXX
RELEASES
No public
announcement or press release with respect to the subject matter of this
Agreement shall be made or issued, directly or indirectly, by either Party
without first obtaining the prior written approval of the other
Party. A Party shall be permitted to make public announcements or
press releases concerning this Agreement as required by Applicable Law
(including, but not limited to, the requirements of any stock exchange,
quotation system, or over-the-counter system on which the Party’s securities are
traded), or as otherwise deemed advisable by a Party’s legal advisors, provided
that a copy of all such releases shall be provided to the other
Party. Neither Party shall use the other’s name in any sales
promotion, advertising or other form of publicity without the prior approval of
such Party, except as specifically permitted in this Agreement.
26.COUNTERPARTS
This
Agreement may be executed by original or facsimile signature in one or more
counterparts with the same effect as if both Parties had signed the same
document. All such counterparts shall be deemed an original, shall be
construed together, and shall constitute one and the same
instrument.
[Remainder
of page is intentionally left blank]
21
IN WITNESS WHEREOF, the
Parties have executed this Agreement as of the Effective Date.
OMP, INC. | ||||
By:
/s/ XXXXX XXXXXXX
|
|
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Xxxxx
Xxxxxxx
|
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Title: President
& Chief Executive Officer
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ROHTO PHARMACEUTICAL CO., LTD. | ||||
By:
/s/ XXXXX XXXXXX
|
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Xxxxx
Xxxxxx
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President
& Chief Executive Officer
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22
EXHIBIT
A
BiMineral
Complex
The
BiMineral Complex to be supplied by OMP to Rohto under this Agreement is the
reacted active, Copper Zinc Malonate. The BiMineral Complex is
prepared in two concentrates, one prepared for a cream-based formulation and one
prepared for a gel-based formulation.
Cream-based
concentrate:
Per the
current formulation used by OMP, the Eye Cream uses approximately 0.375g per 15g
unit of Product. The Eye Cream liquid 40X reacted copper zinc
malonate will be supplied in sanitary polyolefin drums. Appropriate
MSDS and chemical analysis for Cu, Zn , pH and microbial quality will be
supplied with each lot of BiMineral Complex delivered to Rohto.
The
Purchase Orders placed by Rohto shall be in multiples of 10 or 25kg (each 10kg
is sufficient quantity for producing approximately 26000 Eye Cream units per the
OMP formulation). The price for the 40X concentrate custom made for
the Eye Cream is [ 12* ]/kg.
Gel-based
concentrate:
Per the
current formulation used by OMP, the Eye Gel uses approximately 0.30g per 15g
unit of Product. The gel base liquid is a 40X concentrate (due to the
manufacturing difference and pH adjustments required in the gel). As
above, appropriate chemical analysis and MSDS will be provided.
The
Purchase Orders placed by Rohto shall be in multiples of 10 or 25kg (each 10kg
is sufficient quantity for producing approximately 33000 Eye Gel units per the
OMP formulation). The price for the 40X concentrate custom made for
the Eye Gel is [ 13* ]/kg.
Delivery of Purchase
Orders:
Written
purchase orders for the Eye Cream liquid 40X concentrate and for the Eye Gel
liquid 40X concentrate shall be placed by Rohto directly with OMP at
least 60 days prior to the desired delivery date.
23
EXHIBIT
B
Product
Patents
U.S. Patents
Pending
1. U.S.
Patent
Number [
14*]
2. U.S.
Patent
Number [
15* ]
3. U.S.
Patent
Number [
16* ]
4. U.S.
Patent
Number [
17* ]
Japan Patents
Pending
Reference:
1169-36 CIP (Copper Zinc Malonate)
|
||||
Title:
Chemical Compositions and Methods of Making Them
|
||||
Country
|
Application
No.
|
Patent
No.
|
Filing
Date
|
Status
|
JAPAN
|
[
18* ]
|
2/3/06
|
||
[
19* ]
|
12/29/06
|
|||
[
20* ]
|
1/29/07
|
Laid
Open No.
P2007-204479A
on
8/16/07; Awaiting Office Action
|
||
Reference:
1169-37 PCT
|
||||
Title:
Anti-aging Treatment Method using Copper Zinc
Composition
|
||||
Country
|
Application
No.
|
Patent
No.
|
Filing
Date
|
Status
|
Need
to specify Japan
|
[
21* ]
|
2/3/06
6/14/06
|
Response
to OA
Due
12/16/08
|
|
* Subject to confidential treatment request
24