***
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 November 26, 2008 (the “ Effective Date
”) is entered into between Medicis Pharmaceutical
Corporation, a Delaware corporation with offices located at 7720
North Dobson Road, Scottsdale, Arizona 85256 on behalf of itself
and its Affiliates (collectively, “ Medicis ”),
and Impax Laboratories, Inc., a Delaware corporation with offices
located at 30831 Huntwood Avenue, Hayward, California 94544 on
behalf of itself and its Affiliates (collectively, “
Impax ”).
WHEREAS, Medicis
is the owner or otherwise has rights to certain patents,
formulations and know-how related to its minocycline products
marketed as of the Effective Date under the trademark
Solodyn ® (the “ Original Products
”);
WHEREAS, Impax has
the expertise and know-how to conduct a joint development program
with Medicis to create a next generation derivative of the Original
Products and to research, develop and commercialize certain generic
drugs, and Impax has certain proprietary intellectual property that
will be useful to Medicis with respect to such next generation
derivative of the Original Products; and
WHEREAS, Medicis
desires to collaborate with Impax regarding the research and
development of (a) the next generation derivative of the
Original Products, and (b) certain generic drugs in exchange
for a share of the Gross Profit (as defined below), 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
“*** NDA” means the following NDA, which was
approved prior to the Effective Date: NDA # *** .
1.2
“ *** NDC ” means the following NDCs: ***
.
1.3
“*** Products” means one or more products that
are generic equivalents of the products that are (a) marketed
under the trademark *** and (b) approved pursuant the
*** NDA or a supplement thereto and/or sold under an
*** NDC, in each case at any strength, dosage or form;
provided that with respect to any obligations on Impax under
Section 5.1.1 or Medicis’ milestone payment obligations
under Sections 6.2(e) or (f), “ *** Product
” shall mean only the *** mg strength.
1.4
“ 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.
1.5
“ ANDA ” means an Abbreviated New Drug
Application and any supplements thereto.
1.6
“ ANDA Product ” means each of the following
products (including any future packaging changes or pack sizes):
(a) the *** Products; (b) the *** Products;
(c) the *** Products; and (d) the ***
Products.
1.7
“Authorized Product” means any product that is
in the same form as a New Product approved under a NDA held by
Medicis or its sublicensee but is relabeled and marketed as a
generic product.
1.8
“ Confidential Information ” means all
non-public materials, information and data concerning the
disclosing party and its operations that is disclosed the
disclosing party to the receiving party pursuant to the
Confidentiality Agreement, this Agreement, the License Agreement or
the Distribution Agreement (as defined in the License 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.
1.9
“Confidentiality Agreement” means the letter
agreement dated February 24, 2008 from David Greenbaum,
counsel for Medicis Pharmaceutical Corporation, to Roger Chin,
counsel for Impax Laboratories, Inc.
1.10
“Control” means with respect to any material,
information, or intellectual property right, that a party
(a) owns such material, information, or intellectual property
right, or (b) has a license or right to use such material,
information, or intellectual property right, in each case with the
ability to grant to the other party access, a right to use, a
license, or a sublicense (as applicable) to such material,
information, or intellectual property right on the terms and
conditions set forth herein, without violating the terms of any
agreement or other arrangement with any Third Party.
2
1.11
“ Cost of Sales ” means, on a per ANDA Product
basis and for a given calendar quarter, the sum of the
Manufacturing Costs, Distribution and Sales Costs, and Third Party
IP Costs for such ANDA Product sold during such calendar
quarter.
1.12
“ Development Plan ” means the plan for the
research and development of the New Product, which plan shall be
consistent with Section 2.1, prepared by the parties and
periodically updated upon mutual written agreement of the
parties.
1.13
“ Development Program ” means the development
program described in Section 2.1.
1.14
“ Diligent Efforts ” means with respect to the
research, development or commercialization of a product, as
applicable, efforts and resources commonly used in the
pharmaceutical industry for a product at a similar stage of
research, development or commercialization, and having similar
market potential. Diligent Efforts shall be determined by taking
into account the characteristics of the product, the technical risk
and stage of research, development, or commercialization of the
product, the cost-effectiveness of efforts or resources applied
towards such product, the competitiveness of alternative Third
Party products that are or are expected to be in the relevant
marketplace, the regulatory and business environment, the
likelihood of achieving the goal of such research or of obtaining
regulatory approval and product reimbursement (as applicable), the
profitability of the product (without taking into account any
payments to be made to other party pursuant to this Agreement) and
the relative potential for product liability exposure. Diligent
Efforts shall be determined on a product and market basis, and it
is anticipated that the level of efforts and resources will change
over time reflecting changes in the status of the product or the
market involved.
1.15
“ Distribution and Sales Costs ” means, on a per
ANDA Product basis and for a given calendar quarter, (a) an
amount equal to *** % of Net Sales of such ANDA Product
during such quarter, which amount shall serve as an estimate of the
costs for the distribution of such ANDA Product by Impax for use or
sale in the Territory, including freight, insurance and other costs
of shipping such ANDA Product, (b) an amount equal to
*** % of Net Sales of such ANDA Product in the Territory
during such quarter, which amount shall serve as an estimate of the
costs of marketing, selling and promoting such ANDA Product, and
(c) the actual direct cost incurred with respect to ***
.
1.16
“*** NDA” means the following NDA, which was
approved prior to the Effective Date: NDA # *** .
1.17
“ *** NDC ” means the following NDCs: ***
.
1.18
“ *** Products ” means one or more products that
are generic equivalents of the products that are (a) marketed
under the trademark *** and (b) approved pursuant the
*** NDA or a supplement thereto and/or sold under a
*** NDC, in each case at any strength, dosage or form;
provided that with respect to any obligations on Impax under
Section 5.1.1, “ *** Product ” shall mean
only the *** strengths and further provided that
Impax’s obligations under Section 5.1.2 and ***
Product, as defined below.
1.19
“ *** Product ” means the ***
Product.
3
1.20
“ 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 ).
1.21
“ FDA ” means the United States Food and Drug
Administration or any successor entity thereto.
1.22
“ FD&C Act ” means the United States Federal
Food, Drug and Cosmetic Act, as may be amended from time to
time.
1.23
“ Gross Profit ” means, on a per ANDA Product
basis and for a given calendar quarter, the remainder, if any, that
results from Net Sales of such ANDA Product in the Territory minus
the Cost of Sales of such ANDA Product. *** .
1.24
“ Impax 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 or sell the New Product and which Impax Controls as of
the Effective Date or during the term of this Agreement; provided,
however, that the foregoing shall not apply to any trade secret or
other know-how rights in and to all data, information, compositions
or other technology that that (a) is Controlled by an entity
that becomes an Affiliate of Impax as a result of such
entity’s or its Affiliate’s acquisition of Impax and
(b) was Controlled by such entity prior to such
acquisition.
1.25
“ Impax IP Rights ” means the Impax Patent
Rights and Impax Know-How Rights.
1.26
“ Impax Patent Rights ” means all patents and
patent applications (including utility, model and design patents
and certificates of invention) in any country of the world that
claim or cover the New Product or the manufacture or use thereof
and that Impax (but not including any entity that first becomes an
Affiliate of Impax after the Effective Date) Controls as of the
Effective Date or during the term of this Agreement; provided,
however, that the foregoing shall not apply to any patent or patent
application that (a) is Controlled by an entity that becomes
an Affiliate of Impax as a result of such entity’s or its
Affiliate’s acquisition of Impax and (b) was Controlled
by such entity prior to such acquisition.
1.27
“ 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.
1.28
“License Agreement” means the License and
Settlement Agreement between Medicis and Impax dated as of the
Effective Date.
1.29
“ Manufacturing Costs ” means (a) the
delivered cost to Impax of an ANDA Product for use or sale in the
Territory if a Third Party is the manufacturer of such
4
ANDA Product,
or (b) where Impax is itself the manufacturer, the sum of
Materials Costs, labor costs, Overhead and Freight And Taxes
incurred by Impax to produce such ANDA Product for use or sale in
the Territory, including the costs of rejected or failed batches of
such ANDA Product. As used herein, “ Materials
Cost” means Impax’s procurement costs for
(i) raw materials (both active and inactive ingredients), and
(ii) packaging, labeling and storing materials, incurred in
connection with the manufacture, testing, labeling, purchasing and
distribution of such ANDA Product; “ Overhead”
means all indirect costs of manufacturing such ANDA Product
including, without limitation, insurance, inspection, testing,
quality control and quality assurance, depreciation, maintenance
and repair costs, all as determined in accordance with the U.S.
GAAP, and “ Freight And Taxes ” means all
insurance, freight and shipping charges, import taxes and duties
and similar taxes and duties levied by the United States or other
government entity with jurisdiction, and port and loading charges,
all to the extent not already deducted under Distribution and Sales
Costs.
1.30
“ NDA ” means a New Drug Application as defined
in the FD&C Act or FDA Regulations (21 CFR).
1.31
“ Net Sales ” means, with respect to a given
ANDA Product or New Product, the aggregate gross price of such ANDA
Product or New Product received, in the case of an ANDA Product, by
Impax or its sublicensees or, in the case of a New Product, by
Medicis or its sublicensees (except with respect to a
sublicensee’s sales of Authorized Products), in each case
from unaffiliated retailers, distributors or other customers, less
the sum of the following items, all of which must directly relate
to the sale and distribution of such ANDA Product or New Product
and be determined in accordance with GAAP applied in a manner
consistent with past practices of the applicable party:
(a) returns, credits, rebates, discounts, allowances,
promotional payments, free goods, chargebacks and other price
reduction programs customary to the trade or required by law,
(b) actual packaging, freight and insurance costs incurred in
transporting such New Product in final form to customers (this
clause (b) shall not apply to ANDA Products, for which an
allowance has already been incorporated into Distribution and Sales
Costs), (c) sales, valued-added and other taxes, (d) customs
duties, surcharges and other governmental charges,
(e) administrative fees, marketing fees and other similar
fees, payments or credits paid to unaffiliated third parties
customary to the trade or required by law, and
(f) commercially reasonable write-offs for doubtful accounts.
Sales between or among a party and its Affiliates shall not be
included in Net Sales unless such party or its Affiliates are the
end user of such ANDA Product or New Product, as
applicable.
1.32
“ New Product ” means (a) a product that
(i) contains *** and (ii) is to be developed by
the parties under this Agreement with the goal of achieving the
Target Product Profile, or (b) any other product agreed to in
writing by the parties to serve as a substitute for the product
described in subsection (a) above (in which case the product
descried in subsection (a) shall cease to be a “New
Product”), in each case including any *** .
1.33
“ New Product Technology ” means all
discoveries, inventions, improvements and other technology that is
developed by Impax, Medicis or both in the conduct of the
Development Program.
5
1.34
“ Non-Specific Technology ” means any of the New
Product Technology (including without limitation manufacturing
processes) that is not specific to the New Product.
1.35
“*** NDA” means the following NDA, which was
approved prior to the Effective Date: NDA # *** .
1.36
“ *** NDC ” means the following NDCs: ***
.
1.37
“*** Products” means one or more products that
are generic equivalents of the products that are (a) marketed
under the trademark *** and (b) approved pursuant the
*** NDA or a supplement thereto and/or sold under an
*** NDC, in each case at any strength, dosage or form;
provided that with respect to any obligations on Impax under
Sections 5.1.1 and 5.1.2 and *** strength.
1.38
“ Oral Acne Field ” means the treatment or
palliation of acne (including acne rosacea) through an oral
administration.
1.39
“Regulatory Approval” means, with respect to a
particular regulatory jurisdiction, the approval of a NDA or its
equivalent in such regulatory jurisdiction by the applicable
regulatory authority in such regulatory jurisdiction and such other
regulatory approvals as are required in order to market the New
Product in such regulatory jurisdiction.
1.40
“*** NDA” means the following NDA, which was
approved prior to the Effective Date: NDA # *** .
1.41
“ *** NDC ” means the following NDCs: ***
.
1.42
“*** Products” means one or more products that
are generic equivalents to the products that are (a) marketed
under the trademark *** and (b) approved pursuant the
*** NDA or a supplement thereto and/or sold under a
*** NDC, in each case at any strength, dosage or form;
provided that with respect to any obligations on Impax under
Section 5.1.1 and *** strength.
1.43
“ Steering Committee ” means the committee
composed of representatives of Impax and Medicis described in
Section 2.3 below.
1.44
“ Target Product Profile ” means the product
criteria set forth in Exhibit A.
1.45
“Territory” means the United States of America
including its territories and possessions.
1.46
“Third Party ” means any person or entity other
than Medicis or Impax.
1.47
“Third Party IP Costs” means, on a per ANDA
Product basis and for a given calendar quarter, the royalties and
other payments (including upfront fees and milestone payments) paid
by Impax to a Third Party in consideration for a license or other
rights to
6
intellectual
property necessary or useful for the manufacture, development,
commercialization, use, or sale of such ANDA Product in the
Territory.
1.48
“ Valid Claim ” means a claim in an issued
patent, whether such patent issues before, on or after the
Effective Date, in the Impax Patent Rights or any issued patent
owned by Medicis pursuant to Section 3.3, in each case that
has not: (a) expired or been canceled; (b) been declared
invalid by a decision of a court or other appropriate body of
competent jurisdiction from which no appeal has been timely taken
or may be taken (e.g., as a result of denial of a petition for writ
of certiorari); (c) been admitted to be invalid or
unenforceable through reissue or disclaimer, provided that actions
taken during reexamination shall not, prior to the issuance of a
final certificate of reexamination, be construed as admissions of
invalidity or unenforceability of the claims contained in such
patent prior to the initiation of such reexamination; or
(d) been abandoned.
2.
DEVELOPMENT PROGRAM; STEERING COMMITTEE.
2.1
Overview . The goal of the Development Program is to develop
the New Product. Each party’s obligations under the
Development Program shall be as set forth in this Section 2.1
or as agreed in writing by the parties after the Effective Date.
Each party shall use commercially reasonable efforts to timely
conduct its obligations under the Development Programs in
accordance with the Development Plan. Subject to Medicis’
payment of the amount set forth in Section 6.1, each party
shall bear its own costs to conduct its obligations under the
Development Program. Impax shall use commercially reasonable
efforts to use its proprietary technology in existence as of the
Effective Date to formulate a product that meets or approaches the
Target Product Profile and to perform standard in vitro analytic
testing upon such resulting New Product to determine whether it
meets the Target Product Profile criteria. Without limiting the
generality of the foregoing, Impax shall perform no more than three
(3) in vivo pharmacokinetic studies upon such New Product to
determine whether it meets the Target Product Profile criteria.
Impax shall also provide a reasonable amount of technical advice to
Medicis with respect to pre-clinical manufacturing scale up work
for the New Product. For clarity, Impax shall not have any
obligation to (i) perform more than three (3) in vivo
pharmacokinetic studies in the course of performing the Development
Program, (ii) perform any manufacturing scale up work for the
New Product, (iii) manufacture the New Product for clinical (except
for the 3 pharmacokinetic studies described above) or commercial
use, (iv) make any filings with the FDA or any other
regulatory agency with respect to the New Product, (v) conduct
any clinical trials for the New Product (except for the 3
pharmacokinetic studies described above) or (vi) conduct any
commercialization-related activities with respect to the New
Product. Impax shall not incorporate any know-how, patented
technology or other intellectual property Controlled by Impax into
the New Product, the New Product Technology or the manufacturing
process therefor without notifying Medicis in writing. If Medicis
notifies Impax in writing, within thirty (30) days of
Impax’s notice, that Medicis, based on its freedom to operate
analysis, has a good faith concern that the use of such know-how,
technology or intellectual property with respect to the New Product
may infringe the intellectual property of a Third Party, then the
parties will discuss such matter and, if such discussion does not
reasonably resolve Medicis’ concern, then Medicis will notify
Impax in writing within thirty (30) days of such discussion
and Impax, following receipt of such notice, will not incorporate
such know-how, technology or intellectual property into the New
Product.
7
2.2
Amendment of Development Plan . The Development Plan may be
amended from time to time by mutual written agreement of the
parties or by the Steering Committee pursuant to Section
2.3.1.
2.3.1
Composition of the Steering Committee . The Steering
Committee shall foster the collaborative relationship between the
parties and shall in particular monitor the progress of the
Development Program and Impax’s progress with respect to the
ANDA Products. The Steering Committee shall be comprised of two
(2) named representatives of Impax and two (2) 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
but shall use commercially reasonable efforts to maintain stability
of Steering Committee representation. The Steering Committee shall
not have the power to amend the terms of this Agreement but shall
have the power to change the Development Plan upon agreement of at
least one (1) representative of the Steering Committee from
each party.
2.3.2
Meetings . The Steering Committee shall meet not less than
four (4) times each calendar year, on such dates and at such
times and places as agreed to by Impax and Medicis, alternating
between Scottsdale, Arizona and Hayward, California or such other
locations as the parties shall agree, including without limitation
via teleconference. At such meetings, the Steering Committee shall
discuss the progress of the Development Program and set priorities
therefor.
2.3.3
Committee Actions . Any approval, determination or other
action agreed to by all of the members of the Steering Committee
present at the relevant Steering Committee meeting shall be the
approval, determination or other action of the Steering Committee;
provided, however, that at least one (1) representative of
each party is present at such meeting, and that such approval,
determination or other action is documented in (a) a writing
signed by a representative of each party at such meeting or
(b) the approved minutes for such meeting. The Steering
Committee also may act by unanimous written consent without a
meeting or between meetings.
2.3.4
Steering Committee Minutes and Reports . One representative
of each party shall be designated to take minutes of each Steering
Committee meeting. Within fifteen (15) days following each
Steering Committee meeting during the term of the Agreement, the
Steering Committee shall prepare and provide to each party a
reasonably detailed written report which shall summarize the
outcome of the meeting.
2.3.5
Term . The term of the Steering Committee shall commence on
the Effective Date and continue until Impax has completed its
obligations under the Development Plan.
2.4
Records . Impax 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
8
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
with respect to New Product Technology and the development and
commercialization of the New Product.
2.5
Reports . Within thirty (30) days following the end of
each calendar quarter during the term of the Development Program,
Impax 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.
3.1
Research License . During the term of the Development
Program, Medicis hereby grants to Impax a fully paid,
non-exclusive, non-transferable (except as permitted in
Section 11.6) license (without the right to grant
sublicenses), under all patents, know-how
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