***
INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE
ACT OF 1934, AS AMENDED.
JOINT DEVELOPMENT
AGREEMENT
THIS JOINT
DEVELOPMENT AGREEMENT (this “ Agreement ”) dated
as of April 8, 2009 (the “ Effective Date
”) is entered into between Medicis Pharmaceutical
Corporation, a Delaware corporation with offices located at 7720
North Dobson Road, Scottsdale, Arizona 85256 (“
Medicis ”), and Perrigo Israel Pharmaceuticals, Ltd.,
an Israeli Company with offices located at 25 Lehi Street,
B’nei Brak ISRAEL (“ Perrigo
”).
WHEREAS, Perrigo
has the expertise and know-how to conduct a joint development
program with Medicis to research and develop the Product (as
defined below); and
WHEREAS, Medicis
desires to collaborate with Perrigo regarding the research and
development of the Product, all on the terms and conditions of this
Agreement.
NOW, THEREFORE, in
consideration of the foregoing premises and the mutual covenants
herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the
parties hereto agree as follows:
1.1
“ Affiliate ” means, with respect to any entity,
any other entity that directly or indirectly controls, is
controlled by, or is under common control with, such entity. An
entity shall be regarded as in control of another entity if it
owns, or directly or indirectly controls, at least fifty percent
(50%) of the voting stock or other ownership interest of the other
entity, or if it directly or indirectly possesses the power to
direct or cause the direction of the management and policies of the
other entity by any means whatsoever.
1.2
“ Business Day ” means any day other than a
Saturday, Sunday or a day on which banks in Arizona are authorized
or required by law to close.
1.3
“ Confidential Information ” means all
non-public materials, information and data concerning the
disclosing party and its operations that is disclosed by the
disclosing party to the receiving party pursuant to this Agreement,
orally or in written, electronic or tangible form, or otherwise
obtained by the receiving party through observation or examination
of the disclosing party’s operations. Confidential
Information includes, but is not limited to, information about the
disclosing party’s financial condition and projections;
business, marketing or strategic plans; sales information, customer
lists; price lists; databases; trade secrets; product prototypes
and designs; techniques, formulae, algorithms and other non-public
process information. Notwithstanding the foregoing, Confidential
Information of a party shall not include that portion of such
materials, information and data that, and only to the extent, the
recipient can establish by written documentation: (a) is known
to the recipient as evidenced by its written records before receipt
thereof from the disclosing party, (b) is disclosed to the
recipient free of confidentiality obligations by a Third Party who
has the right to make such disclosure without obligations of
confidentiality, (c) is or becomes part of the public
domain
through no
fault of the recipient, or (d) the recipient can reasonably
establish is independently developed by persons on behalf of
recipient without the use of the information disclosed by the
disclosing party.
1.4
“ Development Plan ” means the plan for the
research and development of the Product as set forth on
Exhibit A, and as such plan may be amended, supplemented or
restated from time to time by mutual written agreement of the
parties.
1.5
“ Development Program ” means the development
program described in the Development Plan.
1.6
“ Exclusion Lists ” mean: (a) the HHS/OIG
List of Excluded Individuals/Entities (available through the
Internet at http://www.oig.hhs.gov) ; and (b) the
General Services Administration’s List of Parties Excluded
from Federal Programs (available through the Internet at
http://www.epls.gov ).
1.7
“ FDA ” means the United States Food and Drug
Administration or any successor entity thereto.
1.8
“ FD&C Act ” means the United States Federal
Food, Drug and Cosmetic Act, as may be amended from time to
time.
1.9
“ Ineligible Person ” means a person who:
(a) is currently excluded, debarred, suspended, or otherwise
ineligible to participate in the Federal health care programs or in
Federal procurement or non-procurement programs; or (b) has
been convicted of a criminal offense that falls within the ambit of
42 U.S.C. § 1320a-7(a), but has not yet been excluded,
debarred, suspended, or otherwise declared ineligible.
1.10
“ NDA ” means a New Drug Application as defined
in the FD&C Act or FDA Regulations (21 CFR).
1.11
“ Net Sales ” means the gross price invoiced by
Medicis or its Affiliate to a retailer or distributor for the
Product, as applicable, less the sum of the following items (to the
extent actually incurred or accrued and to the extent not already
deducted in computing the total amount invoiced by Medicis):
(a) credits or allowances actually granted, if any, for
recalls, rejection or return of items previously sold,
(b) rebates and cash discounts actually granted, (c) *** (d)
excise taxes, sales taxes, duties or other taxes imposed upon and
paid with respect to such sales ***, (all such amounts determined
in accordance with GAAP applied in a manner consistent with past
practices). Sales between Medicis and its Affiliates shall not be
included in Net Sales unless such Affiliate is the end user of the
Product.
1.12
“ Perrigo Know-How Rights ” means all trade
secret and other know-how rights in and to all data, information,
compositions and other technology (including, but not limited to,
formulae, procedures, protocols, techniques and results of
experimentation and testing) which are necessary or useful to make,
use, develop, sell or seek regulatory approval to market the
Product and which Perrigo has an ownership or (sub)licensable
interest as of on or after the Effective Date.
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1.13
“ Perrigo IP Rights ” means the Perrigo Patent
Rights and Perrigo Know-How Rights.
1.14
“ Perrigo Patent Rights ” means (a) the
patents and patent applications listed on Exhibit B, (b) all
patents and patent applications in any country of the world that
claim or cover the Product or the manufacture or use thereof in
which Perrigo has an ownership or (sub)licensable interest as of on
or after the Effective Date, (c) all divisions, continuations,
continuations-in-part, that claim priority to, or common priority
with, the patent applications described in clauses (a) and
(b) above or the patent applications that resulted in the
patents described in clauses (a) and (b) above, and
(d) all patents that have issued or in the future issue from
any of the foregoing patent applications, including utility, model
and design patents and certificates of invention, together with any
reissues, renewals, extensions or additions thereto.
1.15
“ Product ” means *** product, as described in
the Development Plan to be prepared by the parties.
1.16
“ Product Technology ” means all discoveries,
inventions, improvements and other technology that specifically
relates to the Product and is conceived or reduced to practice by
Perrigo, Medicis or both in the conduct of the Development
Program.
1.17
“ Royalty Term ” means the period commencing on
the date of first commercial sale of the first Product and expiring
*** thereafter.
1.18
“ Steering Committee ” means the committee
composed of representatives of Perrigo and Medicis described in
Section 2.3 below.
1.19
“ Third Party ” means any person or entity other
than Medicis, Perrigo or their respective Affiliates.
1.20
“ Valid Claim ” means ***
2.
DEVELOPMENT PROGRAM; STEERING COMMITTEE.
2.1
Overview . Perrigo timely conduct the Development Program in
accordance with the Development Plan. Perrigo shall bear its own
costs to conduct the Development Program.
2.2
Amendment of Development Plan . The Development Plan may be
amended from time to time, only upon recommendation of the Steering
Committee and upon mutual written agreement of Medicis and
Perrigo.
2.3
Steering Committee . The Steering Committee shall foster the
collaborative relationship between the parties and shall in
particular have the oversight and responsibility to review and give
recommendations regarding the progress of the Development Program.
The Steering Committee shall be comprised of three (3) named
representatives of Perrigo and three (3) named representatives
of Medicis. Each party shall appoint its respective representatives
to the Steering Committee from time to time, and may substitute one
or more of its representatives, in its sole discretion, effective
upon notice to the other party of such change
3
but shall use
commercially reasonable efforts to maintain stability of Steering
Committee representation. As provided in Section 2.6, for each
calendar quarter during the term of the Development Program,
Perrigo shall provide to the Steering Committee a report that
details the progress and results of the Development Program. The
Steering Committee shall review such report and make
recommendations regarding changes to the Development Program. No
such changes shall be binding unless the Development Plan has been
amended by the parties as required herein. The term of the Steering
Committee shall commence on the Effective Date and continue until
the date when Perrigo has completed all of its obligations under
the Development Plan.
2.4
Conflict . In the event that the terms of the Development
Plan are inconsistent with the terms of this Agreement, this
Agreement shall control, unless otherwise explicitly agreed to in
writing by the parties. The Development Plan shall be incorporated
herein by reference and made a part of this Agreement.
2.5
Records . Perrigo shall maintain complete and accurate
records of all work it conducts under the Development Program and
all results, data and developments made in connection therewith.
Such records shall be complete and accurate and shall fully and
properly reflect all work done and results achieved in the
performance of the Development Program in sufficient detail and in
good scientific manner appropriate for patent and regulatory
purposes. Medicis shall have the right to review and copy such
records (including raw data and scientific notebooks) at reasonable
times to the extent necessary for Medicis to exercise its rights
under this Agreement.
2.6
Reports . Within thirty (30) days following the end of
each calendar quarter during the term of the Development Program,
Perrigo shall prepare and deliver to Medicis a written summary
report which shall describe the research performed to date under
the Development Program and all results, analysis and conclusions
thereof.
3.
INTELLECTUAL PROPERTY/MARKETING.
3.1
Research License . During the term of the Development
Program, Medicis hereby grants to Perrigo a non-exclusive license
(without the right to grant sublicenses) under Medicis’
patents, know-how and other intellectual property rights for the
sole purpose of conducting the Development Program.
3.2
License Grant . Perrigo hereby grants to Medicis a
worldwide, perpetual, irrevocable exclusive license (with the right
to grant sublicenses through multiple tiers) under the Perrigo IP
Rights to make, have made, use, offer for sale, sell and import the
Product. For avoidance of doubt, the exclusive license is strictly
limited to the Product and does not cover rights to the Perrigo IP
Rights for any product other than the Product. The foregoing
license shall survive the termination or expiration of the term of
the Agreement for any reason.
3.3
Product Technology . Perrigo shall promptly disclose to
Medicis all Product Technology. Medicis shall solely own all right,
title and interest in and to the Product Technology and all patent
and other intellectual property rights therein. Perrigo hereby
assigns to Medicis all of its right, title and interest in and to
the Product Technology and all patent and
4
other
intellectual property rights therein. Perrigo shall perform, during
and after the term of this Agreement, all acts that Medicis
reasonably deems necessary or desirable to permit and assist
Medicis, at Medicis’ expense, in obtaining, perfecting and
enforcing the full benefits, enjoyment, rights and title throughout
the world in the Product Technology and all patent and other
intellectual property rights therein. If Medicis is unable for any
reason to secure Perrigo’s signature to any document required
to file, prosecute, register or memorialize the assignment of any
rights to the Product Technology as provided under this Agreement,
Perrigo hereby irrevocably designates and appoints Medicis and
Medicis’ duly authorized officers and agents as
Perrigo’s agents and attorneys-in-fact to act for and on
Perrigo’s behalf and instead of Perrigo to take all lawfully
permitted acts to further the filing, prosecution, registration,
memorialization of assignment, issuance and enforcement of such
rights, all with the same legal force and effect as if executed by
Perrigo. The foregoing is deemed a power coupled with an interest
and is irrevocable. Medicis shall have the world-wide right to
control the drafting, filing, prosecution, maintenance and
enforcement of patents covering the Product Technology and shall be
fully responsible for related costs.
3.4
No Implied Licenses . Except as explicitly set forth in this
Agreement, neither party grants to the other party any license,
express or implied, under its patents or other intellectual
property.
3.5
Marketing of Product . Medicis shall have the sole right to
make, use, sell, distribute, market, exploit or otherwise
commercialize the Product. Perrigo acknowledges and agrees that,
except as otherwise provided under this Agreement it shall have no
right to and it shall not (and shall not assist any third party
to), make, have made, use, sell, distribute, market, exploit or
otherwise commercialize the Product.
3.6
Regulatory Matters . Medicis shall have the exclusive
responsibility, at its sole discretion, for all preclinical,
clinical, regulatory and commercialization activities regarding the
Product, including without limitation marketing, pricing,
promotion, strategy, reimbursement, branding, distribution, and
sale. Medicis shall bear its own costs in connection with any such
activities, including the costs for conducting all pre-clinical and
clinical studies. ***
4.1 Terms of Supply Agreement . Commencing on the date the
Product NDA has been submitted to the FDA (the “ Supply
Date ”), the parties shall negotiate in good faith the
terms of and enter into a commercial supply agreement, which shall
contain the following provisions:
4.1.1
For a period of three (3) years following approval of the NDA
for the Product, Medicis would exclusively purchase from Perrigo,
and Perrigo would exclusively supply to Medicis all of
Medicis’ Product requirements in the United States, subject
to Medicis’ right to qualify alternative manufacturers for
the Product.
4.1.2
Perrigo would be responsible for manufacture, delivery and supply
of the Products.
5
4.1.3
Medicis would have the option to procure an alternative
manufacturer and supplier for the Products in the event Perrigo has
a material supply interruption or otherwise failed to supply
Medicis’ requirements of Product.
4.1.4
Perrigo would cooperate and assist in the transfer of all necessary
technical information to qualify the alternative manufacturer and
in the event of a material supply interruption, would cooperate and
assist with the orderly transition of the manufacture of Products
to the alternative manufacturer.
4.1.5
The price for the Product would be *** of Perrigo’s direct
cost to manufacture the Product, calculated in accordance with
GAAP.
4.2
Arbitration . If the parties are unable to agree upon the
terms of the supply agreement described in Section 4.1 within
sixty (60) days after the Supply Date, then either party may,
by written notification to the other party, submit the matter to
binding “baseball” arbitration to determine the terms
of such supply agreement as follows. Promptly following receipt of
such notice, the parties shall meet and discuss in good faith and
agree on an arbitrator to resolve the issue, which arbitrator shall
be neutral and independent of both parti
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