Exhibit 10.19
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***
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CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY
ASTERISKS) HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
200.83 AND 230.406.
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DEVELOPMENT AND LICENSE
AGREEMENT
between
DOW PHARMACEUTICAL
SCIENCES
and
SKINMEDICA, INC.
This Development and License
Agreement (“ Agreement ”), dated as of June 16,
2003 (“ Effective Date ”), between DOW
PHARMACEUTICAL SCIENCES, a corporation organized under the laws
of the State of California with its principal executive offices at
1330A Redwood Way, Petaluma, California 94954-1169 (“
DOW ”), and SKINMEDICA, INC., a corporation
organized under the laws of the State of Delaware with its
principal executive offices at 5909 Sea Lion Place, Suite H,
Carlsbad, California 92008 (“ SKINMEDICA
”).
RECITALS
WHEREAS, DOW is the owner of patent rights and know-how
relative to the Licensed Product (as defined herein);
WHEREAS, SKINMEDICA desires to obtain from DOW, and DOW
desires to grant to SKINMEDICA, the right to, among other things,
market and sell the Licensed Product in the Field (as defined
below) throughout the Territory (as defined below); and
NOW, THEREFORE,
in consideration of the mutual
promises and covenants hereinafter set forth, and for other good
and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, SKINMEDICA and DOW agree to the foregoing
and as follows:
In addition to terms that are
defined within the body of this Agreement, the following words and
phrases shall have the following meanings:
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1.1
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“
Affiliate ” means, with reference to any Person, any
other Person directly or indirectly controlling, controlled by/or
under common control with such Person, and “control”
means the power to direct the management and policies of a Person,
whether through the ownership of voting securities, by contract or
otherwise.
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1.2
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“
Applicable Laws ” means all laws, treaties,
ordinances, judgments, directives, injunctions, orders of any
court, arbitrator or governmental agency or authority, rules,
regulations, interpretations and authorizations of any
international, national, regional, local or other governmental
body, agency, authority, court or Person having jurisdiction over
or related to the development, registration, manufacture and sale
of the Licensed Product, as may be in effect from time to
time.
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1.3
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“
Development Plan ” means the work plan for continued
development and testing of the Licensed Product attached hereto as
Appendix A , which may be amended from time to time upon
mutual written agreement of the Parties.
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1.4
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“
FDA ” means the United States Food and Drug
Administration or any successor entity.
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1.5
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“
Field ” means the topical treatment of all human
dermatological conditions.
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1.6
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“
Force Majeure Event ” means any action or inaction
which is not reasonably within the control of the Party claiming
the benefit of force majeure, including, without limitation, acts
of God, terrorism, unanticipated government regulations, labor
disputes, floods, fires, civil commotion, embargoes, quotas, any
manufacturing or supply delays by a third party beyond a
Party’s reasonable control or any delays or detention by
customs, health or other government authorities.
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1.7
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“
GAAP ” means United States generally accepted
accounting principles applied on a consistent basis.
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1.8
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“
INDA ” means an Investigational New Drug Application
submitted to the FDA.
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1.9
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“
Launch Date ” means the date of the first commercial
sale of the Licensed Product by SKINMEDICA.
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1.10
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“
Licensed Know-How ” means, except to the extent
published or otherwise known, all proprietary know-how, trade
secrets, unpatented inventions, technical data, manufacturing
processes and knowledge concerning appropriate manufacturing
equipment, formulations, technology and technical information which
are as of the Effective Date or thereafter during the Term owned or
controlled by DOW relative to the Licensed Product in the Field,
but excluding Work Product.
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1.11
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“
Licensed Patent ” means United States Patent No.
6,387,383 titled, ‘Topical low- viscosity gel
composition” issued May 14, 2002 and any extensions or
reissues thereof and any patent in the Territory claiming priority
to the originally filed application from which the ‘383
patent issued or to the progeny of such application, with the
exception of United States Patent No. 6,517,847, which shall not
constitute a Licensed Patent.
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1.12
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“
Licensed Product ” means all forms of a topical
aqueous gel product containing desonide as the sole active
ingredient.
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1.13
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“
NDA ” means a New Drug Application or application for
approval to market submitted to the FDA.
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1.14
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“ Net Sales ”
means the gross amount invoiced by SKINMEDICA for the sale or other
disposition of the Licensed Product, less the following: (a)
customary quantity, trade, and/or cash discounts, allowances,
chargebacks, rebates and price adjustments or reductions allowed or
given as consistently applied by SKINMEDICA; (b) actual credits,
rebates, or refunds for Licensed Products that are rejected,
returned or destroyed by customers; (c) freight, postage and
shipping expenses to the extent
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included in the gross invoiced
amount and separately itemized on the invoice; and (d) sales and
other excise taxes and duties directly related to the sale, to the
extent included in the gross invoiced amount and separately
itemized on the invoice, all applied in accordance with GAAP. For
purposes of clarity, any Licensed Product delivered to a third
party without charge (e.g., “free goods”) or any
Licensed Product used in any new clinical or marketing-initiated
trial supported by SKINMEDICA without charge to the user shall not
be included in Net Sales.
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1.15
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“
Party ” or “ Parties ” means,
individually, SKINMEDICA or DOW, as the context so requires, and
collectively, SKINMEDICA and DOW.
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1.16
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“
Person ” means any individual, partnership, limited
liability company, association, joint venture or
corporation.
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1.17
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“
SKINMEDICA Trademark(s) ” means any of the trademarks,
service marks or trade names used by SKINMEDICA.
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1.18
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“
Territory ” means the United States, its territories
and possessions.
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1.19
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“
Valid Claim ” means a claim of an issued and unexpired
Licensed Patent which has not: (a) expired or been canceled, (b)
been declared invalid by an unreversed and unappealable or
unreversed and unappealed decision of a court of competent
jurisdiction; or (c) been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise.
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1.20
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“ Work
Product ” means any and all work product created,
gathered or generated by or on behalf of DOW in its performance
under the Development Plan including, without limitation, clinical
data, toxicology data, analytical data, professional opinions,
statistical analysis, clinical results, and analysis of any and all
of the foregoing data.
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2.
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RIGHTS
AND RESTRICTIONS
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2.1
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Subject to the
terms and conditions of this Agreement, DOW hereby grants to
SKINMEDICA an exclusive right and license: (i) under the Licensed
Patent, to make or have made, use, and sell the Licensed Product in
the Field in the Territory; and (ii) to utilize the Licensed
Know-How to make or have made, use, and sell the Licensed Product
in the Field in the Territory (sometimes collectively the “
SKINMEDICA Licenses ”). The foregoing shall not be
construed to limit DOW’s rights to use or practice under the
Licensed Know-How or the Licensed Patent (a) outside the scope of
the SKINMEDICA Licenses or (b) for the purposes of performing its
responsibilities under this Agreement, including the Development
Plan.
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2.2
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SKINMEDICA
shall not have the right to grant sublicenses under this Agreement,
nor to enter into any agreement with a third party for distribution
or promotion of the Licensed Product in the absence of prior
written approval from DOW, which approval shall not be unreasonably
withheld.
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2.3
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During the
Term, neither Party shall undertake clinical or product development
or seek regulatory approval from the FDA with regard to the
Licensed Product in the Field in the Territory prior to FDA
approval except pursuant to the Development Plan or by mutual
agreement of the Parties. In the event SKINMEDICA pursues any such
activities, after FDA approval, SKINMEDICA shall keep DOW
reasonably informed of such activities.
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2.4
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Covenant Not
to Assert . During the
Term, DOW agrees not to assert United States Patent No. 6,517,847
against SKINMEDICA for SKINMEDICA’s exercise of any rights or
its performance of any obligations with regard to the Licensed
Product under this Agreement. This provision shall not be construed
in such a way as to imply any expansion of the SKINMEDICA
Licenses.
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2.5
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Non-Compete . During the Term, neither Party shall develop,
manufacture, test, market, sell, or otherwise commercialize any
topical product containing desonide in the Field in the Territory
except as provided herein with regard to Licensed Product;
provided, however, SKINMEDICA may, through an asset or equity
purchase, acquire a line of products from a third party that
includes a commercially-marketed desonide product provided that the
asset value of such desonide product constitutes no more than
twenty-five percent (25%) of the asset value of the entire line of
products so acquired.
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3.
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DEVELOPMENT AND
COMMERCIALIZATION
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3.1
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Project
Coordination . SKINMEDICA
and DOW each shall appoint a project coordinator (each a “
Project Coordinator ”) to coordinate such
Party’s efforts under this Agreement. Each Party shall have
the right to replace its Project Coordinator at any time upon
written notice to the other Party. The DOW Project Coordinator will
administer the Development Plan (and any amendments to the
Development Plan as jointly agreed to by the Parties) and will keep
the SKINMEDICA Project Coordinator informed of material
developments. DOW will promptly respond to any reasonable requests
by the SKINMEDICA Project Coordinator for information concerning
any matters related to the development of the Licensed
Product.
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3.2
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Meetings . The Project Coordinators (and other management
and scientific personnel of the Parties as desired) will meet at a
minimum on a quarterly basis for review of DOW’s progress
under the Development Plan and any other issues deemed useful by
the Parties. Such meetings will be held at DOW’s principal
place of business or telephonically or at such other locations as
the Parties may agree from time to time.
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3.3
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Resolution
of Issues . Either of the
Parties may at any time submit by written notice to the chief
executive officers of the Parties any issue pertaining to the
Development Plan, including, without limitation, any proposed
modification to the Development Plan involving an increase or
decrease in the Development Fee (defined below) pursuant to Section
4.2(c) below. Within *** after receipt of such notice, the chief
executive officers of both Parties shall meet and enter into good
faith negotiations to resolve the issue(s) that were the subject of
such notice. During such negotiations, the Parties shall, to the
extent reasonably possible consistent with prudent
business
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***
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Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
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practices, continue to perform
their respective obligations under this Agreement, subject to the
provisions of Section 3.4. In the event the Parties are unable to
resolve such issue(s) within *** following written submission to
the chief executive officers, either Party may submit the issue to
the dispute resolution process set forth in Section 12
below.
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3.4
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Responsibilities of DOW . In addition to DOW’s other
responsibilities under this Agreement, DOW shall use reasonable
commercial efforts to diligently (i) undertake clinical
development, product development, and other responsibilities set
forth in the Development Plan and this Agreement; (ii) seek
regulatory approval of the Licensed Product from the FDA as set
forth in the Development Plan, it being the intent of the Parties
that a key objective of the Development Plan is the expeditious
clinical development, product development and regulatory approval
of the Licensed Product in the Field in the Territory; and (iii)
evaluate in good faith SKINMEDICA’s suggested changes to the
Development Plan and use reasonable commercial efforts to minimize
costs, if any, associated with any changes to the Development Plan
implemented in accordance with the provisions of this Agreement.
Notwithstanding any other provision of this Agreement, DOW shall be
entitled in its discretion to suspend performance under the
Development Plan at any time when any payment due to DOW hereunder
is more than *** past due.
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3.5
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Responsibilities of SKINMEDICA
. In addition to its other
responsibilities under this Agreement, SKINMEDICA agrees to conduct
or have conducted and to pay all costs relative to any
photocarcinogenicity study required by the FDA with regard to the
Licensed Product. With the exception of the photocarcinogenicity
study, SKINMEDICA shall not be required to conduct, have conducted
or to pay the costs of any material additional expanded studies,
data or data analysis required by the FDA beyond those included in
the Development Plan ( “Additional FDA Studies
”) that it reasonably determines are commercially over
burdensome or impracticable. In the event SKINMEDICA elects not to
conduct, have conducted, or pay the costs of any Additional FDA
Studies, SKINMEDICA shall so notify DOW in writing (a “No-Go
Notice”) within *** after notice from the FDA that such
Additional FDA Studies are required, and this Agreement shall
thereupon terminate automatically. In the event that SKINMEDICA
does not give a No-Go Notice within ***: (i) the Additional FDA
Studies to be performed prior to NDA approval will be added to the
Development Plan and the Development Fee owed to DOW by SKINMEDICA
will be increased appropriately in accordance with the procedures
set out in Section 3.3; and (ii) SKINMEDICA shall be required to
conduct or have conducted and to pay all costs relative to all
Additional FDA Studies to be performed after NDA approval, and DOW
will provide such assistance to SKINMEDICA with regard to such
post-NDA-approval Additional FDA Studies as the Parties may
mutually agree in writing.
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(a)
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SKINMEDICA
shall use reasonable commercial efforts to diligently undertake
market development, launch, and sales and marketing activities for
the Licensed Product in the Territory and shall promptly notify DOW
in writing of the
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***
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Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
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Launch Date. In the event
SKINMEDICA does not launch the Licensed Product in the Territory
within *** after FDA approval of the Licensed Product: (i)
SKINMEDICA shall provide DOW notice of delay and the reasons for
the delay; and (ii) SKINMEDICA shall, upon notice to DOW, have the
option of extending the Launch Date by a period of not more than
*** beyond such *** post-FDA-approval period (the “
Extended Period ”).
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(b)
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If, at the end
of the Extended Period, the Launch Date has still not occurred, DOW
shall have the right to terminate this Agreement pursuant to
Section 6.2, provided , however , that if such delay
is due to a Force Majeure Event the provisions of Section 13.4
shall apply. In the event DOW terminates this Agreement after the
conclusion of the Extended Period due to SKINMEDICA’s failure
to launch the Licensed Product and successfully licenses a third
party to commercialize the Licensed Product under the Licensed
Patent in the Field in the Territory, DOW shall pay SKINMEDICA ***
of any license fees and royalty revenue based on sales of the
Licensed Product in the Field in the Territory that are received by
DOW under such third-party license until the aggregate of such
payments to SKINMEDICA totals *** of Development Fees paid to DOW
by SKINMEDICA.
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3.7
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Use of
Subcontractors by DOW .
Subject to SKINMEDICA’s approval, not to be unreasonably
withheld, the Parties understand and agree that DOW shall have the
right to use the services of subcontractors to perform any of its
obligations under the Development Plan.
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3.8
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Manufacture . SKINMEDICA shall be responsible for the
selection of the entity that will manufacture the Licensed Product,
after consultation with DOW. SKINMEDICA shall use its commercially
reasonable efforts to make such selection, by notice in writing to
DOW, as soon as reasonably possible after the Effective Date of
this Agreement. SKINMEDICA understands that any delay in the
selection of the manufacturer may delay the filing of the NDA for
the Licensed Product. DOW shall, at no additional expense to
SKINMEDICA, provide such third party manufacturer and SKINMEDICA
all reasonable assistance in enabling the manufacturer to
manufacture and supply the Licensed Product.
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3.9
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Inspection
Rights . During the Term,
SKINMEDICA and its authorized representatives shall have the right,
during normal business hours and no more often than twice each
calendar year, to inspect DOW’s facilities and review the
testing process and quality control procedures used with regard to
activities under the Development Plan, upon reasonable notice
which, in any event, shall be not less than one (1) week. All such
inspections shall be limited to the portions of such facilities
which are being utilized in the performance of this Agreement or
the Development Plan.
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3.10
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Exchange of
Information . Each Party
will immediately report to the other any information acquired by
such Party concerning any side effect, injury, toxicity
or
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***
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Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
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sensitivity reaction, or any
unexpected incidence, and the severity thereof, associated with any
use of the Licensed Product pursuant to the Development
Plan.
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4.
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PAYMENT
TERMS . Subject to
the terms and conditions of this Agreement, SKINMEDICA shall make
the following payments:
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4.1
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License
Fee . Within five (5)
business days following the Effective Date, SKINMEDICA shall pay
DOW *** (the “ License Fee” ), which shall be
non-refundable.
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(a)
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SKINMEDICA
shall pay DOW *** (the “ Initial Development Fee
”) in installments as follows:
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INSTALLMENT AMOUNT
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DATE
DUE
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***
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***
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(b)
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SKINMEDICA
shall pay DOW an additional development fee in the amount specified
by the FDA as a user fee, estimated to be approximately Six Hundred
Thousand Dollars ($600,000) (the “ FDA Development
Fee” ), due and payable at least *** prior to the
scheduled submission of the NDA. Provided that SKINMEDICA has paid
the FDA Development Fee to DOW, DOW shall be responsible for
payment of the user fee to the FDA at the time of FDA
submission.
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(c)
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As the
development process is by its nature unpredictable, the Development
Fees set out above represent the Parties’ good-faith estimate
of applicable development costs and will be modified in the event
of changed circumstances, which shall include, but not be limited
to, significant cost under or overruns
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***
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Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
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(i.e., greater than *** in any
six-month period), and, subject to the provisions of Section 3.5,
any Additional FDA Studies included in the Development
Plan.
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(d)
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DOW shall
provide sufficient information to SKINMEDICA regarding the actual
expenditures related to the Development Plan in order for
SKINMEDICA to determine if cost under or overruns under the
Development Plan and to determine whether, in its opinion, any
Development Fees should be adjusted upwards or downwards in
accordance with the procedure set forth in Section 3.3.
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(e)
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In the event
any payments hereunder are due on a United States federal holiday
or weekend, such payments shall be due on the immediately following
business day.
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4.3
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Milestone
Payments . SKINMEDICA
shall pay DOW, within *** following SKINMEDICA’s receipt of
written notice from DOW certifying that the applicable milestone
has occurred, the following non-refundable milestone
payments:
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(a)
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Filing of an
NDA – ***.
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(b)
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Approval of the
NDA by the FDA – ***.
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Upon SKINMEDICA’s request, DOW
shall provide SKINMEDICA with any information reasonably requested
by SKINMEDICA so as to permit SKINMEDICA to confirm that the
applicable milestone has occurred.
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(a)
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SKINMEDICA
shall pay to DOW royalties equal to *** of all Net Sales of the
Licensed Product. Payment of such royalties shall be made on a
quarterly basis by the 15th day of May, August, November, and
February each year on Net Sales occurring during the immediately
preceding calendar quarter. For example, payment of royalties will
be due by the 15 th day of May on Net Sales occurring
during the first calendar quarter (January through March) of the
same year.
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(b)
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On February
15 th of each year after the calendar
year in which date occurs which is *** after NDA approval of the
Licensed Product (such calendar year being hereinafter referred to
as the “first royalty year”), SKINMEDICA Shall pay DOW
a minimum annual royalty of *** (“ Minimum Annual
Royalty” ). The first Minimum Annual Royalty payment
shall be prorated based on the number of the days remaining in the
first royalty year after the date which is, *** after NDA approval
of the Licensed Product. In the event the royalties payable by
SKINMEDICA to DOW based on Net Sales occurring in any calendar year
is less than the Minimum Annual Royalty (as prorated for the first
royalty year), SKINMEDICA shall pay the difference between the
royalties
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***
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Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
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payable to DOW and the Minimum
Annual Royalty on February 15 th of the following calendar year. In
the event the royalties payable by SKINMEDICA to DOW based on Net
Sales occurring in any calendar year is more than the Minimum
Annual Royalty (as prorated for the first royalty year), SKINMEDICA
shall owe no additional payment for that calendar year pursuant to
the Minimum Annual Royalty.
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4.5
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Reporting
Obligations . With
respect to all royalty payments due to DOW under this Agreement,
SKINMEDICA shall provide, with each such royalty payment, a
quarterly report setting forth the following
information:
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(a)
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the total gross
amount invoiced by SKINMEDICA for the sale or other disposition of
the Licensed Product during the applicable calendar
quarter;
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(b)
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the type and
amount of adjustments from gross invoiced amounts to Net Sales of
the Licensed Product during the applicable calendar
quarter;
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(c)
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the total Net
Sales of the Licensed Product during the applicable calendar
quarter;
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(d)
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the calculation
of royalties payable, with sufficient detail to enable DOW to
determine whether such calculation is in compliance with the
provisions of this Agreement; and
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(e)
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the total
royalties due.
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4.6
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Financial
Audit Rights .
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(a)
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SKINMEDICA
shall keep and maintain at its principal executive offices records
of all payments and proceeds which provide evidence supporting the
calculation of royalties due to DOW under this Agreement (the
“ SKINMEDICA Records ”). SKINMEDICA Records
shall be open to inspection by an independent certified public
accountant selected by DOW and reasonably acceptable to SKINMEDICA
at a mutually agreeable time during normal business hours within
three (3) years after the termination of the calendar year to which
such SKINMEDICA Records relate. This audit right shall be exercised
only once during any calendar year.
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(b)
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DOW shall keep
and maintain at its principal executive office records relating to
costs under the Development Plan ( “DOW Records
”). DOW Records shall be open to inspection by an independent
certified public accountant, selected by SKINMEDICA and reasonably
acceptable to DOW, at a mutually agreeable time during normal
business hours within three (3) years after the termination of the
calendar year to which such DOW Records relate. This audit right
shall be exercised only once during any calendar year.
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(c)
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The Party
conducting the audit shall bear the expense of any such audit
unless the audit reveals that errors have resulted which in the
aggregate require payment by the audited Party in an amount equal
to *** or more of the total amount due in any calendar year. In
such event, the audited Party shall bear the reasonable costs of
the audit and shall, not later than *** following delivery of a
demand for payment from the other Party, pay any such amounts
due.
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(d)
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The terms of
this Section 4.6 shall survive the expiration or termination of
this Agreement for any reason.
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4.7
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Taxes . All payments due hereunder shall be paid in
full, without deduction of taxes or other fees which may be imposed
by any government.
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4.8
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Currency . All payments to be made hereunder shall be
computed and made in United States Dollars.
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4.9
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Interest. Any amount owed by SKINMEDICA under this
Agreement that is not received by DOW on or before the date due
shall bear interest at the rate of *** per month for each month or
partial month after payment is due until payment is
made.
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5.
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REPRESENTATIONS, WARRANTIES AND OTHER
COVENANTS
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5.1
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Representations, Warranties and Other Covenants
of Each Party . Each of
the Parties represents, warrants and covenants to the other
that:
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(a)
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it is not
debarred, nor will it use in any capacity in performing its
obligations under this Agreement, the services of any Person
debarred;
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(b)
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it is validly
existing and in good standing under the laws of the state of its
incorporation;
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(c)
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the execution
of this Agreement has been duly authorized by all necessary
corporate action in accordance with all Applicable Laws;
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(d)
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it has the
power and authority to execute and deliver this Agreement and
perform its covenants, duties and obligations described in this
Agreement; and
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(e)
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this Agreement
is a valid, legal and binding obligation upon such
Party.
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5.2
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Representations, Warranties and Other Covenants
of DOW . DOW represents,
warrants and covenants to SKINMEDICA that:
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(a)
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DOW has the
right, power and authority to grant the SKINMEDICA Licenses in
accordance with the terms and conditions of this
Agreement;
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***
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Portions of
this page have been omitted pursuant to a request for Confidential
Treatment and filed separately with the Commission.
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(b)
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prior to the
Effective Date, DOW has not granted to any third party any rights
or licenses and has not otherwise taken any action that conflicts
with or materially and adversely affects the rights granted to
SKINMEDICA under this Agreement and will not grant any such
rights
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