Exhibit 10.21
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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 April 15,
2005 (“ Effective Date ”), is entered into by
and between DOW PHARMACEUTICAL SCIENCES, a corporation
organized under the laws of the State of California with its
principal executive offices at 1330 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 Products (as defined herein);
WHEREAS , DOW and SKINMEDICA previously entered into
that certain letter agreement dated as of December 30, 2004 (the
“ Letter Agreement ”) providing for the payment
of certain license and exclusivity fees for the Licensed Products
(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 Products 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:
1. DEFINITIONS
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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“
AB-Rated Generic Substitution Date ” means, with
respect to any Licensed Product, the first day of the first month
in which an AB-rated generic product for such Licensed Product in
the United States as set forth in the “Orange Book” (
i.e ., the A PPROVED D RUG P RODUCTS WITH T HERAPEUTIC E QUIVALENCE E VALUATIONS
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published by
the U.S. Department of Health and Human Services) is substituted by
pharmacies or other dispensers for 17.5% or more of the
prescriptions written in the United States during such calendar
month for such Licensed Product as evidenced by data from IMS
Health or another prescription data service acceptable to both
Parties.
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1.2.
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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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1.3.
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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 Products, as may be in effect from time to
time.
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1.4.
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“
Development Plan ” means the work plan for continued
development and testing of the Licensed Products attached hereto as
Appendix A , which may be amended from time to time upon
mutual written agreement of the Parties.
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1.5.
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“ DOW
Trademark(s) ” means the trademark or trademarks
registered by DOW for its patented aqueous gel technology, and for
use by Dow licensees in association with topical aqueous gel
products covered by the Licensed Patent.
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1.6.
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“
FDA ” means the United States Food and Drug
Administration or any successor entity.
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1.7.
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“
Field ” means the topical treatment of all human
dermatological conditions.
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1.8.
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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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1.9.
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“
GAAP ” means United States generally accepted
accounting principles applied on a consistent basis.
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1.10.
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“
Government Filings ” means, as to each Licensed
Product, the INDA, the NDA, foreign equivalents of the foregoing
and any other applications for government and/or regulatory
approval with respect to such Licensed Product, and any
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information
directly related thereto including without limitation
communications with the relevant Regulatory Authority(ies) together
with the information and data contained therein.
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1.11.
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“
INDA ” means an Investigational New Drug Application
submitted to the FDA.
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1.12.
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“
Launch Date ” means, with respect to any particular
Licensed Product, the date of the first commercial sale of such
Licensed Product in the United States by SKINMEDICA.
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1.13.
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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 (and which DOW has the right to license to
SKINMEDICA pursuant to the terms hereof without breach of any third
party license agreement) necessary or reasonably useful for the
manufacture, use or sale of the Licensed Products in the Field, but
excluding Work Product.
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1.14.
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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 (solely with
respect to those claims entitled to claim priority to the
originally filed application), and any foreign counterparts to any
of the foregoing, including, but not limited to, those patent
applications listed on Schedule 1.13 hereto, with the exception of
United States Patent No. 6,517,847, which shall not constitute a
Licensed Patent.
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1.15.
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“
Licensed Product ” or “ Licensed Products
” means, individually, any of the following, and
collectively, all of the following: (i) the Mometasone Product (or
any substitute pursuant to Section 2.9); (ii) following exercise of
the Option set forth in Section 2.6 of this Agreement, the Third
Steroid Product, and (iii) following exercise of the option set
forth in Section 2.7 of this Agreement, any Other Steroid
Product.
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1.16.
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“
Mometasone Product ” means all forms of a topical
aqueous gel product covered by a Valid Claim of a Licensed Patent
containing mometasone as the sole active pharmaceutical
ingredient.
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1.17.
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“
NDA ” means a New Drug Application or application for
approval to market submitted to the FDA.
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1.18.
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“ Net
Sales ” means the gross amount invoiced by SKINMEDICA for
the sale or other disposition of the Licensed Products in the
Territory (other than with respect to sales or dispositions to end
users outside the United States by SKINMEDICA’s sublicensees
and/or distributors for which payment is to be made pursuant to
Section 4.5), 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 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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1.19.
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“
Other Steroid Product ” means any form of topical
aqueous gel product covered by a Valid Claim of a Licensed Patent,
which product contains as the sole active pharmaceutical ingredient
a steroid selected by SKINMEDICA pursuant to Section
2.7.
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1.20.
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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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1.21.
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“
Person ” means any individual, partnership, limited
liability company, association, joint venture or
corporation.
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1.22.
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“
Regulatory Authority ” means any governmental agency,
administrative agency or commission or other governmental authority
or other instrumentality of the United States or any other country,
or any state, county, city or other political subdivision thereof,
including, without limitation, the FDA and the European Agency for
the Evaluation of Medicinal Drug Products.
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1.23.
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“
SKINMEDICA Trademark(s) ” means any of the trademarks,
service marks or trade names used by SKINMEDICA.
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1.24.
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“
Territory ” means the entire world.
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1.25.
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“
Third Steroid ” means a single active pharmaceutical
ingredient steroid selected by SKINMEDICA in accordance with
Section 2.6 (if any).
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1.26.
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“
Third Steroid Product ” means any form of a topical
aqueous gel product covered by a Valid Claim of a Licensed Patent,
which product contains the Third Steroid as the single active
pharmaceutical ingredient.
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1.27.
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“
United States ” means the United States, its
territories and its possessions, including, without limitation, the
Commonwealth of Puerto Rico.
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1.28.
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“
Valid Claim ” means, on a country-by-country basis, a
claim of an issued and unexpired Licensed Patent or a pending
patent application for a Licensed Patent which has not: (a) expired
or been canceled, (b) been declared invalid by an unreversed and
unappealable or unreversed and unappealed decision (and as to which
the time to appeal has lapsed) of a court of competent
jurisdiction; or (c) been admitted to be invalid or unenforceable
through reissue, disclaimer or otherwise.
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1.29.
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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.
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2. RIGHTS
AND RESTRICTIONS
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2.1.
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Grant of
License. Subject to the
terms and conditions of this Agreement, DOW hereby grants to
SKINMEDICA an exclusive (even as to DOW), sublicensable (as set
forth in Section 2.2 below), royalty-bearing right and license: (i)
under the Licensed Patent, to make, have made, use, sell, have
sold, offer for sale, import and export the Licensed Products in
the Field in the Territory; and (ii) to utilize the Licensed
Know-How to make, have made, use, sell, have sold, offer for sale,
import and export the Licensed Products in the Field in the
Territory (such exclusive licenses 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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Sublicense
Rights . 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 any Licensed Product in the absence of prior written
approval from DOW, which approval shall not be unreasonably
withheld, conditioned or delayed. For the avoidance of doubt, this
Section 2.2 shall not prevent SKINMEDICA’s use of a contract
manufacturer and related sublicense of rights to have made the
Licensed Products. Any sublicense will be subject to the terms of
this Agreement. SKINMEDICA shall at all times remain fully liable
for the performance of its sublicensees, distributors, wholesalers,
dealers and affiliates under any sublicense and will indemnify,
defend and hold harmless DOW from all liabilities, damages, losses,
judgments, costs or expenses (including reasonable attorneys’
fees) arising in any manner from any failure by any such
sublicensee, distributor, wholesaler, dealer or affiliate to comply
with the terms of this Agreement.
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2.3.
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Clinical and
Product Development .
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(a)
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During the term
of the applicable SKINMEDICA License covering a Licensed Product,
(i) DOW shall not undertake clinical or product development or seek
regulatory approval from any Regulatory Authority with regard to
such Licensed Product in the Field in the Territory except pursuant
to the Development Plan or by mutual agreement of the Parties; and
(ii) prior to the approval of the NDA for each such Licensed
Product, SKINMEDICA shall not undertake clinical or product
development or seek regulatory approval from any Regulatory
Authority with regard to such Licensed Product in the Field in the
United States except pursuant to the Development Plan or by mutual
agreement of the Parties.
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(b)
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During the term
of the applicable SKINMEDICA License covering a Licensed Product,
SKINMEDICA may undertake clinical or product development or seek
regulatory approval from FDA in the United States with regard to
any Licensed Product in its sole discretion after approval of the
NDA for such Licensed Product, and may undertake clinical or
product development or seek regulatory approval from any Regulatory
Authority outside the United States for any Licensed Product in its
sole discretion at any time. In the event SKINMEDICA pursues any
such activities with regard to a particular Licensed Product
SKINMEDICA shall keep DOW reasonably informed of such activities
related to each such Licensed Product.
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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
or any other patent rights which may be owned or controlled by DOW
as of the Effective Date against SKINMEDICA based upon
SKINMEDICA’s exercise of the SKINMEDICA Licenses as expressly
permitted 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.
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(a)
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Mometasone . During the term of the SKINMEDICA License for
the Mometasone Product hereunder, neither Party shall develop,
manufacture, have manufactured, test, market, sell, or otherwise
commercialize a topical aqueous gel product containing mometasone
as an active pharmaceutical ingredient in the Field in any country
in the Territory, except as provided herein with regard to Licensed
Products.
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(b)
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Third
Steroid . From and after
SKINMEDICA’s exercise of the Option (as defined in Section
2.6 below) until the expiration of the term of the SKINMEDICA
License for the Third Steroid Product hereunder, neither Party
shall develop, manufacture, have manufactured, test, market, sell,
or otherwise commercialize a topical aqueous gel product containing
the Third Steroid as an active pharmaceutical ingredient in the
Field in any country in the Territory, except (i) as provided
herein with regard to Licensed Products; or (ii) to the extent that
DOW can document it has commenced or contracted to provide prior to
the exercise of the Option by SKINMEDICA, in which case DOW shall
provide prompt notice to SKINMEDICA of such services and the
steroid(s) involved, clinical testing, clinical development or any
non-formulation services for a third party, or the development
(including formulation) of a combination product containing the
Third Steroid and another active pharmaceutical ingredient (whether
a steroid or a non-steroid). This Section 2.5(b) and the SKINMEDICA
License with respect to such Third Steroid shall terminate if
SKINMEDICA does not elect to exercise the Option under Section 2.6
below on or before the Option Deadline, or thereafter ceases
development, or directs DOW to cease development, of a Third
Steroid Product.
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(c)
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Other
Steroids .
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(i)
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Prior to
Exercise of Option to Develop Third Steroid . Until the date that is *** after the Effective
Date (the “ Option Deadline ”), DOW shall not,
directly or indirectly, for itself or any third party, in the Field
in any country in the Territory:
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(A)
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develop,
manufacture, have manufactured, test, market, sell, or otherwise
commercialize any topical aqueous gel product covered by a Valid
Claim of the Licensed Patent containing a steroid as the single
active pharmaceutical ingredient; or
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(B)
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engage in any
formulation activities with respect to any topical aqueous gel
product containing a steroid as the single active pharmaceutical
ingredient (provided, however, that nothing in this Section
2.5(c)(i) shall restrict DOW’s ability to contract for and
provide clinical testing, clinical development or any
non-formulation services to third parties in connection with
formulations provided by third parties);
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except (1) as
provided herein with regard to Licensed Products; or (2) pursuant
to that certain Development and License Agreement between the
Parties dated as of June 16, 2003 (the “ Desonide
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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(ii)
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After
Exercise of Option to Develop Third Steroid .
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(A)
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Exercise of
Option; Payment of Steroid Exclusivity Royalty
. If SKINMEDICA elects to develop a
Third Steroid Product under Section 2.6 below on or before the
Option Deadline, then for so long as SKINMEDICA pays to DOW the
Steroid Exclusivity Royalty (defined below), until the expiration
of the Term of the license for all Licensed Products hereunder, DOW
shall not, directly or indirectly, for itself or any third party,
in the Field in any country in the Territory:
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(1)
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develop,
manufacture, have manufactured, test, market, sell, or otherwise
commercialize any topical aqueous gel product covered by a Valid
Claim of the Licensed Patent containing a steroid as the single
active pharmaceutical ingredient; or
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(2)
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engage in any
formulation activities with respect to any topical aqueous gel
product containing a steroid as the single active pharmaceutical
ingredient (provided, however, that nothing in this Section
2.5(c)(ii) shall restrict DOW’s ability to contract for and
provide clinical testing, clinical development or any
non-formulation services to third parties in connection with
formulations provided by third parties);
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except (x) as
provided herein with regard to Licensed Products; or (y) pursuant
to the Desonide Agreement.
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The term
“ Steroid Exclusivity Royalty ” shall mean with
respect to each complete calendar year commencing after the first
commercial sale of the earlier of the Mometasone Product or the
Third Steroid Product the amount set forth opposite such year
below:
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YEAR
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STEROID
EXCLUSIVITY
ROYALTY
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Year 1
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***
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Year 2
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***
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Year 3
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***
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Year 4
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***
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Year 5
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***
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Year 6
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***
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Year 7
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***
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Year 8
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***
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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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For the
avoidance of doubt, no Steroid Exclusivity Royalty shall be due
prior to the first complete calendar year commencing after the
first commercial sale of the earlier of the Mometasone Product or
the Third Steroid Product.
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The Steroid
Exclusivity Royalty shall be measured as of SKINMEDICA’s
royalty report due under Section 4.6 for the final quarter of the
applicable year, and DOW’s obligations under this subsection
(A) shall apply until it is demonstrated in the royalty report
under Section 4.6 that SKINMEDICA has not paid the Steroid
Exclusivity Royalty for any complete year. In the event the
royalties paid by SKINMEDICA to DOW under Section 4.4 exceed the
Steroid Exclusivity Royalty for any given year, the excess amount
shall be credited to the following years; and in the event
SKINMEDICA’s actual royalty payments under Section 4.4 are
less than the Steroid Exclusivity Royalty for any given year,
SKINMEDICA shall have the option, but not the obligation, to
preserve DOW’s obligations under this subsection (A) by
providing notice of SKINMEDICA’s intention to pay to DOW the
difference between such amounts with the applicable royalty report
and making payment within 30 days thereafter.
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(B)
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Exercise of
Option; Failure to Pay Steroid Exclusivity Royalty
. Notwithstanding subsection (A)
above, if SKINMEDICA elects to develop a Third Steroid
Product
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under Section
2.6 below on or before the Option Deadline, but fails to pay to DOW
the Steroid Exclusivity Royalty, then after the lapse of
DOW’s obligations under subsection (A) above and until the
expiration of the Term of the license for all Licensed Products
hereunder, DOW shall not, directly or indirectly, for itself or any
third party, develop, manufacture, have manufactured, test, market,
sell, or otherwise commercialize any topical aqueous gel product
covered by a Valid Claim of the Licensed Patent containing a
steroid as the single active pharmaceutical ingredient, except (1)
as provided herein with regard to Licensed Products; or (2)
pursuant to the Desonide Agreement. For the avoidance of doubt,
after the lapse of DOW’s obligations under subsection (A)
above, except for a product containing desonide, mometasone or the
Third Steroid, DOW shall not be restricted by this Agreement from
developing any other topical aqueous gel products that are not
covered by a Valid Claim of the Licensed Patent.
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(d)
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Other
Steroid Products . During
the term of a SKINMEDICA License for any Other Steroid Product for
which SKINMEDICA has exercised its rights under Section 2.7 below,
DOW shall not develop, manufacture, have manufactured, test,
market, sell or otherwise commercialize any topical aqueous gel
product which contains that Other Steroid in the territory licensed
to SKINMEDICA, except (A) as provided herein with regard to
Licensed Products; (B) pursuant to the Desonide Agreement; or (C)
to the extent that DOW can document it has commenced or contracted
to provide prior to SKINMEDICA’s exercise of its rights under
Section 2.7 below, in which case DOW shall provide prompt notice to
SKINMEDICA of such services and the steroid(s) involved, clinical
testing, clinical development or any non-formulation services for a
third party.
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(e)
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Non-Steroid
Products or Steroid Combination Products . During the period that SKINMEDICA has an
exclusive license to use, make, have made or sell a Non-Steroid
Product or Steroid Combination Product under any definitive
agreement executed by the parties pursuant to Section 2.8, DOW
shall not develop, manufacture, test, market, sell or otherwise
commercialize any topical aqueous gel product which contains the
same active pharmaceutical ingredient as such Non-Steroid Product
or the same combination of active pharmaceutical ingredients as
such Steroid Combination Product, limited to the territory licensed
to SKINMEDICA, except (A) as provided herein with regard to
Licensed Products; (B)
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pursuant to the
Desonide Agreement; or (C) clinical testing, clinical development
or any non-formulation services for a third party. DOW’s
obligations under this Section 2.5(e) shall automatically terminate
with respect to each Non-Steroid Product or Steroid Combination
Product at the end of the term of the exclusive license for each
such product.
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(f)
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***
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2.6.
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Option for
Third Steroid Product .
At any time on or before the Option Deadline, SKINMEDICA shall have
the option, but not the obligation, to select in its sole
discretion the Third Steroid for development of the Third Steroid
Product by DOW pursuant to this Agreement. DOW shall cooperate with
SKINMEDICA in its due diligence review and evaluation of potential
candidates for development as the Third Steroid Product, including,
but not limited to, providing SKINMEDICA with all available
projections for development cost of such potential candidates.
SKINMEDICA may exercise its option for the Third Steroid Product
hereunder (the “ Option ”) only by giving
written notice to DOW prior to the Option Deadline and specifying
the Third Steroid in reasonable detail. If SKINMEDICA does not
deliver to DOW such written notice by the Option Deadline, then as
of the Option Deadline (i) the SKINMEDICA Licenses shall be deemed
void ab initio with respect to the Third Steroid Product (but not
with respect to the Mometasone Product), (ii) the Parties’
obligations under Sections 2.5 and 2.6 with regard to the Third
Steroid and the Third Steroid Product shall terminate, and (iii)
the right of first refusal set forth in Section 2.8 below shall
terminate. Dow shall have up to *** after SKINMEDICA’s notice
of its intent to exercise the Option to commence development
services for the Third Steroid Product. For the avoidance of doubt,
following the exercise of the Option, and provided further that if
and only if SKINMEDICA has in good faith initiated development of a
Third Steroid Product, Sections 2.7 and 2.8 shall remain in full
force and effect. If at any time following exercise of the Option,
SKINMEDICA directs DOW to cease, or SKINMEDICA ceases, development
of the Third Steroid Product and SKINMEDICA does not select an
alternate steroid product pursuant to Section 2.9 for development
hereunder as a replacement for such Third Steroid Product and
commence development thereof within *** after such cessation, then
SKINMEDICA’s rights under Sections 2.7 and 2.8 shall
immediately terminate. Upon such selection, the alternate steroid
product shall be deemed the Third Steroid Product for purposes of
this Agreement, including this Section 2.6.
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2.7.
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License of
Other Steroid Products .
At any time after the exercise of the Option, SKINMEDICA shall have
the right, but not the obligation, to request that DOW develop one
or more Other Steroid Products pursuant to this Agreement. Upon
SKINMEDICA’s request, DOW shall cooperate with SKINMEDICA in
its due diligence review and evaluation of potential candidates for
development as 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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Other Steroid
Products, including, but not limited to, providing SKINMEDICA with
all available projections for development cost of such potential
candidates. Following exercise of the Option, DOW shall not offer
any steroid product covered by a Valid Claim of the Licensed Patent
for development to any third party without first offering such
steroid to SKINMEDICA subject to the procedures and time periods
set forth in Section 2.8 below, if and only if SKINMEDICA has not
ceased development of the Third Steroid Product.
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2.8.
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Right of
First Refusal for Non-Steroid Products and Steroid Combination
Products.
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(a)
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If at any time
during the term of this Agreement, DOW or any of its Affiliates
develops or acquires any rights to, or plans to offer a license
with respect to, any topical aqueous gel compound or other product
(other than a product containing ***) with application in the Field
and covered by a Valid Claim of a Licensed Patent (a “
Non-Steroid Product or Steroid Combination Product ”),
DOW shall offer, or cause its applicable Affiliate to offer, to
SKINMEDICA such rights upon terms and conditions developed in good
faith by DOW. Such offer shall be made in the form of a written
term sheet, describing the rights and all economic terms in
reasonable detail (the “Offer”). DOW shall cooperate
with SKINMEDICA in its due diligence review of such Non-Steroid
Product or Steroid Combination Products, including, but not limited
to, providing SKINMEDICA with all available projections for
development costs of such potential candidates. SKINMEDICA shall
have *** to negotiate the material terms of the licensing of the
applicable candidate for development by giving DOW written notice
of such election and *** to enter into the definitive agreement
related to such licensing. During such combined *** period, both
SKINMEDICA and DOW shall conduct any such negotiations in good
faith.
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(b)
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Subject to the
non-compete provisions in Section 2.5 above, in the event
SKINMEDICA does not exercise its right to negotiate with DOW, or
the Parties otherwise fail to enter into a definitive agreement
within the combined *** period set forth in Section 2.8(a) above,
DOW or its Affiliate, as applicable, shall then have the right to
offer the same rights to any other third party on terms that are
consistent with (or more expensive or onerous than, from the third
party’s perspective) those offered to SKINMEDICA by DOW in
the Offer or, if applicable, the last draft of a definitive
agreement proposed by DOW to SKINMEDICA in the Parties’ good
faith negotiations.
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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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(c)
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In the event
that DOW enters into any definitive agreement with a third party
with respect to a development candidate that was the subject of an
Offer to SKINMEDICA in accordance with the foregoing, DOW shall
provide SKINMEDICA with written confirmation signed by an officer
of DOW certifying that DOW has complied with the provisions of this
Section 2.8.
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(d)
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DOW’s
obligations under this Section 2.8 shall terminate as set forth in
Section 2.6 above.
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2.9.
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Right of
Substitution regarding Mometasone and Third Steroid
Products . In the event
SKINMEDICA determines that the continued development of the
Mometasone Product and/or the Third Steroid Product hereunder is
not commercially viable, taking into account market potential,
stage of development, product life, the alternative products in the
marketplace and the likelihood of regulatory approval, among other
things, SKINMEDICA may, within thirty (30) business days of its
determination, select another steroid as a substitute for
development hereunder, without payment of license and exclusivity
fees (other than those not already paid pursuant to Section 4.1) by
giving written notice to DOW, provided , however , if
DOW in compliance with the terms of this Agreement has entered into
a development or other agreement with any third party with respect
to SKINMEDICA’s proposed substitute steroid (“ Prior
Agreement ”) prior to receipt of SKINMEDICA’s
written notice of its selection of a substitute steroid under this
Section 2.9, DOW shall not be deemed in breach of this Agreement by
virtue of the performance of its obligations or the exercise of its
rights under the Prior Agreement, and provided
further , that DOW’s performance of its obligations
under this Agreement with respect to a substitute steroid shall be
subject to any restrictions or other terms of that Prior Agreement.
In such event, DOW shall cooperate with SKINMEDICA in its due
diligence review and evaluation of potential candidates for
development as the substitute Licensed Product, including, but not
limited to, providing SKINMEDICA with all available projections for
development cost of such potential candidates. The Parties shall
agree on a development plan and budget promptly thereafter for such
substitute Licensed Product. Notwithstanding anything in this
Agreement to the contrary, (i) from and after the selection of a
substitute development product for the Mometasone Product all
references herein to the “Mometasone Product” shall be
deemed to refer to such substitute product, and the noncompete
provisions set forth in Section 2.5(a) above applicable to
mometasone shall terminate and shall apply instead to such
substitute steroid, and (ii) from and after the selection of a
substitute development product for the Third Steroid and the Third
Steroid Product all references herein to the “Third
Steroid” and the “Third Steroid Product” shall be
deemed to refer to such substitute steroid and substitute product,
respectively, and the noncompete provisions set forth in Section
2.5(b) above applicable to the original Third Steroid shall
terminate and shall apply instead to
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such substitute
steroid. Notwithstanding anything else in this Agreement,
SKINMEDICA shall only be entitled to one (1) substitution for each
of the Mometasone Product or the Third Steroid Product, and further
substitutions shall not be permitted hereunder.
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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
Products.
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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 ***.
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(d) 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
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
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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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approval of the
Licensed Products 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
Products in the Field in the United States; (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; (iv) following
the exercise of the Option, agree to develop the Third Steroid
Product on terms to be negotiated between the Parties in good faith
and implement a separate written Development Plan for such Third
Steroid Product; and (v) upon SKINMEDICA’s request, agree to
(1) develop one or more Other Steroid Products consistent with
Section 2.7 on terms and conditions to be negotiated between the
Parties in good faith (including, without limitation, development
fees, milestone payments, royalty payments and other fees, and
supplements or changes to the Development Plan, but excluding
additional exclusivity fees) and (2) implement a separate written
Development Plan for such Other Steroid Product. For any
responsibilities set forth in the current Development Plan for
which DOW has in-house capability as of the Effective Date, such
responsibilities shall be performed directly by DOW except as
otherwise agreed in writing by the Parties. 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
. 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, whether pre-or post-marketing approval, 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 with respect to any particular Licensed Product, 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 the SKINMEDICA License with respect
to such Licensed Product 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 (iii) 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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***
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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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3.6.
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Commercialization .
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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 Products in the United States and shall promptly
notify DOW in writing of each Launch Date. In the event SKINMEDICA
does not launch a particular Licensed Product in the United States
within *** after FDA approval of such 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 for the applicable Licensed
Product has still not occurred, subject to any rights which may
have previously been granted to one or more third parties by
SKINMEDICA, DOW shall have the right to terminate the SKINMEDICA
Licenses with regard to such Licensed Product in the Territory,
provided , however , that if such delay is due to a
Force Majeure Event the provisions of Section 13.4 shall
apply.
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3.7.
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Use of
Subcontractors by DOW .
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. Except as set forth below,
such subcontractor shall be subject to SKINMEDICA’s prior
written approval, not to be unreasonably withheld (and if no
written approval or rejection has been received by DOW within ***
after DOW’s written request therefore, SKINMEDICA shall be
deemed to have approved the same). Notwithstanding the foregoing,
no approval shall be required (as long as the service provided is
part of an activity that was identified in the Development Plan)
for DOW subcontracting out any (1) services to any subcontractor
totaling less than ***, or (2) purity testing, preservative
testing, raw material release testing, and other analytical testing
that DOW routinely subcontracts to outside vendors. Any permitted
subcontractor shall be bound by confidentiality obligations at
least as restrictive as those set forth in Section 8
below.
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3.8.
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Manufacture . SKINMEDICA shall be responsible for the
selection of the entity(ies) that will manufacture each 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 with respect to the Mometasone Product, and as soon
as reasonably possible after the selection of the Third Steroid
Product and as soon as
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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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reasonably
possible after the selection of each Other Steroid Product.
SKINMEDICA understands that any delay in the selection of the
manufacturer may delay the filing of the NDA for the applicable
Licensed Product. DOW shall, at no additional expense to
SKINMEDICA, provide each such third party manufacturer and
SKINMEDICA all reasonable assistance in enabling the manufacturer
to manufacture and supply each Licensed Product during the
development, scale up, validation stages and product launch
stages.
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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 ***. All such
inspections shall be limited to the portions of such facilities
which are being utilized in the perf
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