*** 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.
LICENSE AND SETTLEMENT
AGREEMENT
THIS LICENSE AND
SETTLEMENT 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 of the Patent Rights (as defined below);
WHEREAS, Medicis
and Impax have entered into that certain Joint Development
Agreement of even date herewith (the “ Joint Development
Agreement ”) pursuant to which Impax is conducting
research and development for a derivative of Medicis’ product
marketed and sold under the trademark Solodyn
® ; and
WHEREAS, in
partial consideration for Impax’s efforts under the Joint
Development Agreement, Impax desires to receive a license under the
Patent Rights and Medicis desires to grant to Impax a license under
the Patent Rights, 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
“AG Term” shall have the meaning set forth in
Section 2.2.2.
1.3
“AG Trigger” means *** .
1.4
“ ANDA ” means an Abbreviated New Drug
Application and any supplements thereto.
1.5
“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.
1.6
“ 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 the
Confidentiality Agreement, this Agreement, the Joint Development
Agreement or the Distribution 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.
1.7
“Confidentiality Agreement” means
***
1.8
“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.
1.9
“ Cost of Sales ” means, on a per Existing
Product or per Generic Subsequent Product basis and for a given
calendar quarter, the sum of the Manufacturing Costs and
Distribution and Sales Costs for such Existing Product or Generic
Subsequent Product sold during such calendar quarter.
1.10
“ Distribution Agreement ” shall have the
meaning set forth in Section 2.2.1.
1.11
“ Distribution and Sales Costs ” means, on a per
Existing Product or per Generic Subsequent Product basis and for a
given calendar quarter, (a) an amount equal to *** and
(b) an amount equal *** ; provided, however, that any
of the foregoing costs that are included within the definition of
“Distribution and Sales Costs” may not be deducted
again when calculating Net Sales.
1.12
“ Existing Product ” means any product
(a) that is a Generic Equivalent of the Solodyn Products,
(b) that is sold pursuant to ANDA #90-024 under Impax’s
control, and (c) the making, using, selling or importation is
covered by one or more Valid Claims.
2
1.13
“ FDA ” means the United States Food and Drug
Administration or any successor entity thereto.
1.14
“Generic Equivalent” means ***
.
1.15
“Generic Subsequent Product” means the
Medicis-authorized generically labeled version of the Subsequent
Product.
1.16
“ Grantback Patents ” means (a) *** ,
(b) all divisions, continuations, continuations-in-part, that
claim priority to, or common priority with, the patent applications
described in clause (a) above or the patent applications that
resulted in the patents described in clause (a) above, and
(c) 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.
1.17
“ Gross Profit ” means, with respect to all
Existing Products or all Generic Subsequent Products in a calendar
quarter, the remainder, if any, that results from Net Sales of
Existing Products or Generic Subsequent Products, as applicable, in
the Territory minus the Cost of Sales of Existing Products or
Generic Subsequent Products, as applicable. With respect to a
product, to the extent such remainder is a negative number, such
loss shall not be due and owing by Medicis, but Impax shall have
the right to offset such loss against any positive remainder for
such product only in the immediately succeeding calendar
quarter.
1.18
“ License Trigger ” means the first to occur of
any of the following:
1.18.4
the third (3rd) anniversary of the Effective Date.
1.19
“ Manufacturing Costs ” means (each of the
following to be determined in accordance with GAAP applied in a
manner consistent with past practices of Impax) (a) the
delivered cost to Impax of a Existing Product or Generic Subsequent
Product for use or sale in the Territory if a Third Party (or
Medicis) is the manufacturer of such Existing Product or Generic
Subsequent Product provided that such Existing Product or Generic
Subsequent Product is provided pursuant to an arms-length and
commercially reasonable agreement, 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
Existing Product for use or sale in the Territory, including the
costs of rejected or failed batches of such Existing 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 Existing
Product; “ Overhead” means all indirect costs of
manufacturing such Existing Product including, without
3
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.
1.20
“ Net Sales ” means, with respect to a given
Existing Product or Generic Subsequent Product, the aggregate gross
price of such Existing Products or Generic Subsequent Products
received by Impax or its sublicensees 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 Existing Products or Generic Subsequent
Products and be determined in accordance with GAAP applied in a
manner consistent with past practices of Impax: (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) sales, valued-added and
other taxes, (c) *** , (d) customs duties, surcharges
and other governmental charges, (e) *** , and (f) ***
. Sales between or among Impax and its Affiliates shall not be
included in Net Sales unless Impax or its Affiliates are the end
user of the Existing Products or Generic Subsequent
Products.
1.21
“ Patent Rights ” means (a) the patents and
patent applications listed on Exhibit A to this Agreement, (b)
*** ; (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.
1.22
“ Product ” means any product for which the
making, using, selling or importation is covered by one or more
claims of the Patent Rights.
1.23
“ Solodyn Products ” means the Solodyn products
listed on Exhibit B, as such products are marketed and sold by
Medicis as of the Effective Date in the Territory.
1.24
“ Solodyn Product Patents ” means (a) all
patents and patent applications in the Territory Controlled by
Impax as of the Effective Date that claim or cover a Solodyn
Product or the manufacture or use of a Solodyn Product,
(b) all divisions, continuations and continuations-in-part
(solely to the extent directed to subject matter disclosed in a
patent or patent application described in clause (a) above)
that (i) claim priority to, or common priority with, the
patent applications described in clause (a) above or the
patent applications that resulted in the patents described in
clause (a) above and (ii) claim or cover a Solodyn
Product or the manufacture or use of a Solodyn Product, and
(c) all patents that issue after the Effective Date 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, ***
.
1.25
“ Subsequent Product ” means ***
.
4
1.26
“ Territory ” means the United States of America
including its territories and possessions.
1.27
“ Third Party ” means any person or entity other
than Medicis or Impax.
1.28
“Trade” shall have the meaning set forth in
Section 2.2.1.
1.29
“Valid Claim” means *** .
2.1
License Grant for Existing Product .
2.1.1
Effective only upon the occurrence of the License Trigger, Medicis
hereby grants to Impax a non-exclusive, non-transferable (except as
permitted in Section 8.6) license (without the right to grant
sublicenses except to have made Existing Products on behalf of
Impax) under the Patent Rights to make, have made, use, offer for
sale, sell and import inside the Territory Existing
Products.
2.1.2
Until the occurrence of the License Trigger, Impax shall not, and
shall not directly or indirectly encourage or assist any Third
Party to, develop and/or commercialize any Existing Products in the
Territory; provided, however, that Impax shall not be subject to
the foregoing restriction at any time when there is no Valid Claim
in the Territory claiming the Existing Product or its manufacture
or use.
2.1.3
Nothing in this Agreement shall be construed as creating an
obligation, express or implied, on Medicis to supply any Existing
Product to Impax. Impax shall be solely responsible for
manufacturing, or having manufactured, its supply of Existing
Product.
2.1.5
Each party shall promptly notify the other in writing of the
occurrence of the License Trigger. In addition, Medicis shall keep
Impax apprised of the status of material developments that affect
when the License Trigger occurs, that Impax would not otherwise be
aware of ***. Impax shall notify Medicis in writing at least five
(5) days before Impax initiates commercialization of the
Existing Product if the date of such initiation is anticipated to
be before the License Trigger.
2.2
Subsequent Products; Distribution Agreement .
2.2.1
With respect to the Subsequent Product, and effective only upon the
occurrence of the AG Trigger, Medicis hereby appoints Impax as its
exclusive distributor of the Generic Subsequent Product in the
Territory and authorizes Impax, under the Patent Rights, to market
the Generic Subsequent Product solely to wholesalers, distributors,
retailers, mail order, managed care, and group purchasing
organizations (collectively, the “ Trade ”) in
the Territory, pursuant to a separate distribution and supply
agreement (the “Distribution Agreement” ) to be
entered into between Impax and Medicis.
5
2.2.2
Commencing on the Effective Date, the parties shall negotiate in
good faith the terms of and enter into the Distribution Agreement,
which will contain the following provisions:
|
|
•
|
|
Unless earlier terminated for cause
or by Impax for convenience, the term of any such appointment of
Impax as the exclusive distributor of the Generic Subsequent
Product shall extend from the AG Trigger and remain in effect until
*** (the “AG Term” ).
|
|
|
|
|
|
|
|
•
|
|
Medicis will supply (either itself
or through its Third Party manufacturer) Impax its requirements in
the Territory for the Generic Subsequent Product in finished form;
on such forecasting, invoicing, shipment, delivery, inspection and
payment terms as are agreed upon by the parties and set forth in
the Distribution Agreement; including, without limitation
*** ;
|
|
|
|
|
|
|
|
•
|
|
Medicis will manufacture the Generic
Subsequent Product in accordance with cGMPs and the specifications,
at a transfer price equal to *** ;
|
|
|
|
|
|
|
|
•
|
|
In
exchange for such appointment, Impax agrees that during the term of
the Distribution Agreement, and in the case of termination of the
Distribution Agreement for any reason for a period of ***
after such termination, not to market or launch a Generic
Equivalent of the Subsequent Product in the Territory, or sell to
any Third Party any Generic Subsequent Product if it has reason to
believe that such person intends to sell such product inside the
Territory; the Distribution Agreement will not include any other
limitations on development, submission of regulatory filings or
commercialization by Impax;
|
|
|
|
|
|
|
|
•
|
|
Impax shall pay to Medicis
*** of all Gross Profit resulting from sales of the Generic
Subsequent Product, on a quarterly basis, on such terms as are
agreed by the parties;
|
|
|
|
|
|
|
|
•
|
|
To
the extent that Medicis is required to pay a royalty or other
payment to a Third Party with respect to a license to such Third
Party’s intellectual property to distribute the Generic
Subsequent Product in the Territory, the parties will deduct such
payment from the calculation of Gross Profit ***
;
|
|
|
|
|
|
|
|
•
|
|
Medicis and Impax will each
indemnify the other for third party claims arising from their
actions under the Distribution Agreement and breaches of
representations and warranties; and
|
|
|
|
|
|
|
|
•
|
|
such other terms as the parties may
agree and as are commercially reasonable and usual and customary
for agreements of such type.
|
2.2.3
If the parties do not agree upon the terms of the Distribution
Agreement within sixty (60) days of the Effective Date, then
either party may, by written notification to the other party,
submit the matter to binding “baseball” arbitration to
determine the terms of the Distribution 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
6
arbitrator
shall be neutral and independent of both parties, shall have
significant experience and expertise in distribution and supply
agreements in the generic pharmaceutical industry, and shall have
some experience in mediating or arbitrating issues relating to such
agreements. If the parties cannot agree on such arbitrator within
thirty (30) days of request by a party for arbitration, then
such arbitrator shall be appointed by the American Arbitration
Association, which arbitrator must meet the foregoing criteria.
Within fifteen (15) days after an arbitrator is selected (or
appointed, as the case may be), each party will deliver to both the
arbitrator and the other party a detailed written proposal setting
forth its proposed terms for the Distribution Agreement, which
terms shall not conflict with the terms set forth in
Section 2.2.2 (the “Proposed Terms” of the
party) and a memorandum (the “Support
Memorandum” ) in support thereof, not exceeding ten
(10) pages in length. The parties will also provide the
arbitrator a copy of this Agreement, as may be amended at such
time. Within fifteen (15) days after receipt of the other
party’s Proposed Terms and Support Memorandum, each party may
submit to the arbitrator (with a copy to the other party) a
response to the other party’s Support Memorandum, such
response not exceeding five (5) pages in length. Neither party
may have any other communications (either written or oral) with the
arbitrator other than for the sole purpose of engaging the
arbitrator or as expressly permitted in this Section 2.2.3;
provided that, the arbitrator may convene a hearing if the
arbitrator so chooses to ask questions of the parties and hear oral
argument and discussion regarding each party’s Proposed
Terms. Within sixty (60) days after the arbitrator’s
appointment, the arbitrator will select one of the two Proposed
Terms (without modification) provided by the parties that he or she
believes is most consistent with the intention underlying and
agreed principles set forth in this Agreement and most accurately
reflects industry norms for a transaction of this type. The
decision of the arbitrator shall be final, binding, and
unappealable and the parties shall promptly enter into a
Distribution Agreement having the terms set forth in the Proposed
Terms selected by the arbitrator. For clarity, the arbitrator must
select as the only method to determine the terms of the
Distribution Agreement one of the two sets of Proposed Terms, and
may not combine elements of both Proposed Terms or take any other
action.
2.3.1
Impax hereby grants to Medicis a perpetual, royalty-free,
fully-paid up, non-transferable (except as provided in
Section 8.6), non-exclusive license (with the right to grant
sublicenses through multiple tiers) under the Grantback Patents to
make, have made, use, offer for sale, sell and import Products in
the Territory.
2.3.2
Impax hereby grants to Medicis a perpetual, royalty-free,
fully-paid up, non-transferable (except as provided in
Section 8.6), non-exclusive license (with the right to grant
sublicenses through multiple tiers) under the Solodyn Product
Patents to make, have made, use, offer for sale, sell and import
Solodyn Products in the Territory.
2.4
Validity of Patent Rights . Impax hereby admits that the
following Patent Rights claims are valid and enforceable:
(a) all claims that are in the patents listed on
Exhibit A that issued prior to the Effective Date (not taking
into account any claim amendments filed, before, on or after the
Effective Date, pursuant to a reexamination or reissuance
proceeding) and (b) all claims listed on Exhibit C from
pending patent applications, as such claims were worded as of the
Effective Date and as they may be modified during prosecution of
the underlying application following the Effective Date, but only
to the extent they remain substantially similar.
7
Impax hereby
admits that the making, using, offering to sell, selling, and/or
importation into the United States of Impax’s product that is
to be sold pursuant to Impax’s ANDA #90-024 is covered by one
or more claims of United States Patent No. 5,908,838 (not
taking into account any claim amendments filed, before, on or after
the Effective Date, pursuant to a reexamination or reissuance
proceeding) under 35 U.S.C. § 271. The foregoing admission
shall be binding on Impax and admissible against Impax in any
dispute or litigation between the parties regarding the Patent
Rights, and Impax will not challenge any such admission. Impax
shall not receive any rights under this Agreement, and Medicis
shall retain the sole right, to prepare, prosecute, maintain and
enforce the Patent Rights.
2.5
No Implied Licenses . Except as explicitly set forth in this
Agreement, neither party grants to the other party under its
patents or other intellectual property any license, express or
implied. Impax shall not use Medicis’ name or any Medicis
trademarks (including without limitation Solodyn
® ) in connection with the marketing, promotion or
sale of any products without the prior written consent of Medicis
in each instance.
2.6
Releases . Impax has appealed the holding of the United
States District Court for the Northern District of California,
Civil Action No. 3:2008cv00253 to the United States Court of
Appeals for the Federal Circuit, Appeal No. 2008-1373
(collectively, the “ Action ”), in which Impax
challenges the district court’s dismissal of Impax’s
declaratory judgment action regarding the invalidity and
noninfringement of certain of the Patent Rights. In consideration
of the mutual covenants herein and in the Joint Dismissal Agreement
attached hereto as Exhibit D and incorporated herein by
reference Impax hereby releases and agrees to release Medicis from
all claims arising out of the Action. Upon the Effective Date,
Impax and Medicis shall cause to be completed, executed and filed
with the Federal Circuit a stipulated dismissal with prejudice of
the Action, in the form of the Joint Dismissal Agreement attached
hereto as Exhibit D, and to seek entry of such order and
judgment by such Court.
3.
FINANCIAL CONSIDERATIONS.
3.1.1
With respect to the Existing Products, and subject to the terms and
conditions of this Agreement, commencing on the date Impax begins
selling an Existing Product, within sixty (60) days following
the end of each calendar quarter thereafter, Impax shall pay to
Medicis *** of all Gross Profit accrued during such calendar
quarter and arising from Net Sales of such Existing Products during
such quarter. Medicis’ right to receive a share of the Gross
Profit under this Section 3.1.1 shall expire upon ***
.
3.1.2
Impax shall not (a) have any obligation to pay any amounts
pursuant to Section 3.1.1, or (b) be subject to the
restrictions under Section 2.1.2, in each case if there is no
Valid Claim in the Territory at the time of sale of an Existing
Product; provided, however, that if there is at the time of such
sale a pending patent application in the Patent Rights in the
Territory with a published claim which covers such Existing Product
or its manufacture or use and a patent subsequently issues in the
Territory from such patent application that contains such claim or
a claim that is substantially similar to such claim, then Impax
shall pay Medicis within thirty (30) days of receipt from Medicis
of written notice of the issuance of such patent,
8
an amount equal
to *** . If there is no Valid Claim in the Territory and a
patent subsequently issues in the Territory from a patent
application within the Patent Rights and there is a dispute between
the parties regarding whether at least one such subsequently issued
claim covers the Existing Product or its manufacture or use then
upon the submission of a written request of either party to the
other party, such dispute shall be resolved exclusively by binding
arbitration before a single arbitrator, conducted in accordance
with the rules of arbitration of the American Arbitration
Association for commercial disputes (the “Rules”),
except to the extent that such Rules are inconsistent with this
Agreement. Each party shall select one independent, neutral
representative, and shall notify the other party of its selection
of such representative within ten (10) business days after the
written request for binding arbitration. The two
(2) representatives selected by the parties shall then
mutually select, within twenty (20) business days, in
accordance with the Rules, an independent, neutral arbitrator who
is admitted to practice before the United States Patent and
Trademark office and has at least ten (10) years of experience
as a patent attorney in the biotechnology or pharmaceuticals field.
The arbitrator shall resolve such dispute in accordance with this
Agreement and the substantive rules of law (but not the rules of
procedure or conflicts of laws) that would be applied by a federal
court sitting in Arizona, provided that Impax shall have to
demonstrate to the arbitrator by clear and convincing evidence that
the Existing Product or its manufacture or use is not covered by at
least one Valid Claim. The arbitrator shall use best efforts to
issue a final decision within ninety (90) days after being
selected. The final decision of the arbitrator shall be final and
binding upon the parties, solely for purposes of determining
Impax’s obligations under Section 2.1.2 and/or
Impax’s obligations to pay royalties under
Section 3.1.1, but such decision shall have no force or effect
on any other person in accordance with 35 U.S.C. 294 or with
respect to any products other than the Existing Products. If Impax
breaches its obligations under this Section or Section 2.1.2,
Impax hereby agrees that in any subsequent litigation between the
parties Impax shall be subject to a rebuttable presumption of
willful infringement. All negotiations pursuant to this
Section 3.1.2 and the arbitration proceeding and decision of
the arbitrator shall be confidential, treated as a compromise and
settlement negotiation for purposes of applicable rules of
evidence, including without limitation Rule 408 of the Federal
Rules of Evidence. The parties agree that they shall share equally
the cost of the arbitration filing and hearing fees, and the cost
of the representative and the arbitrator. Each party shall bear its
own attorneys’ and expert fees and all associated costs and
expenses. ***.
3.1.3
Each payment made under this Section 3.1 shall be accompanied
by a written report stating the number and description of all
Existing Products sold in the Territory during the relevant
calendar quarter; a detailed breakdown of the Cost of Sales
associated therewith; the gross sales associated therewith; the
calculation of Net Sales thereon, including without limitation the
amount of any deduction provided for in the definition of Net
Sales; and the calculation of Gross Profits therefrom.
3.2
Taxes . Impax shall be responsible for and may withhold from
payments made to Medicis under this Agreement any taxes required to
be withheld by Impax under applicable law. Accordingly, if any such
taxes are levied on such payments due hereunder (“
Withholding Taxes ”), Impax shall (i) deduct the
Withholding Taxes from the payment amount, (ii) pay all
applicable Withholding Taxes to the proper taxing authority, and
(iii) send evidence of the obligation together with proof of
tax payment to Medicis within sixty (60) days following that
tax payment.
9
3.3
Audit Rights . On no less than five (5) business days
notice from Medicis, Impax shall make all such records, books of
account, information and data concerning (i) its sales of
Existing Products pursuant to this Agreement; and (ii) its
manufacture of any Existing Products, or (iii) to the extent
in its possession, the manufacture of Existing Products on behalf
of Impax by its Third Party contract manufacturer, in each case
available for inspection during normal business hours by an
independent auditor selected by Medicis and reasonably acceptable
to Impax for the purpose of an audit to determine the accuracy of
the reports delivered and amounts paid by Impax pursuant to
Section 3.1; provided that Medicis may not request such
inspection more than once in any calendar year unless a discrepancy
has been identified by Medicis and such audit shall be limited to
records, books of account, information and data pertaining to
payments made pursuant to Section 3.1 during the preceding
three years. Upon reasonable belief of discrepancy or dispute,
Medicis’ external auditors shall be entitled to take copies
or extracts from such records, books of account, information and
data (but only to the extent related to the contractual obligations
set out in this Agreement) during any review or audit. Prior to the
initiation of any audit pursuant to this Section 3.3, the
external auditor shall sign a confidentiality agreement with Impax
providing that, as between the external auditor and Impax, such
records, books of account, information and data shall be treated as
Confidential Information of Impax but may be disclosed to Medicis
solely to the extent necessary to document a discrepancy in any
reports delivered and amounts paid by Impax pursuant to
Section 3.1. Medicis shall be solely responsible for its costs
in making any such audit, unless Medicis identifies a discrepancy
in favor of Impax in the calculation of the share of Gross Profit
paid to Medicis under this Agreement in any calendar year from
those properly payable for that calendar year of five percent (5%)
or greater, in which event Impax shall be solely responsible for
the reasonable cost of such audit and pay Medicis any underpayment.
All information disclosed by Impax pursuant to this Section shall
be deemed Confidential Information of Impax.
4.1
Term . Subject to Section 4.2, this Agreement shall
expire on the expiration of the later to occur of (a) the last
to expire of the Patent Rights and (b) the expiration of all
payment obligations of Impax to Medicis hereunder; provided,
however, that if there are no Valid Claims existing in the
Territory, but there are at such time pending patent applications
in the Patent Rights in the Territory, then subject to the terms
and conditions of this Agreement, the term of this Agreement shall
continue for the pendency of such pending applications. The
expiration of this Agreement shall not cause the expiration of the
Distribution Agreement and vice versa.
4.2
Termination for Cause . Either party may terminate this
Agreement upon or after the material breach of any material
provision of this Agreement by the other party if the other party
has not cured such breach within thirty (30) days after
receipt of express written notice thereof by the non-breaching
party. Any termination of this Agreement by Medicis for material
uncured breach by Impax shall give rise to a right of Medicis also
to terminate the Distribution Agreement; however, any breach of the
Distribution Agreement will not be automatically deemed a breach of
this Agreement.
4.3
Effect of Expiration or Termination . Expiration or
termination of this Agreement shall not relieve the parties of any
obligation accruing prior to such expiration or
10
termination,
and the provisions of Sections 2.3, 2.4, 2.6, 3.3 (until
expiration of the three (3) year period set forth therein),
4.3, 5, 7 and 8 shall survive the expiration or termination of this
Agreement.
5.1
Confidentiality . Until the last to expire of this
Agreement, the Joint Development Agreement or the Distribution
Agreement, and for a period of five (5) years following the
expiration or earlier termination hereof or thereof, except with
respect to any Confidential Information constituting a trade secret
in which case the receiving party’s obligation continues in
perpetuity, provided such receiving party has been informed as to
the status of such Confidential Information as a trade secret, each
party shall maintain in confidence all Confidential Information
disclosed by the other party (including all Confidential
Information disclosed under the Confidentiality Agreement), and
shall not use, grant the use of or disclose to any Third Party the
Confidential Information of the other party other than as expressly
permitted hereby. Each party shall notify the other promptly upon
discovery of any unauthorized use or disclosure of the other
party’s Confidential Information.
5.2
Permitted Disclosures . Either party may disclose
Confidential Information of the disclosing party (a) on a
need-to-know basis, to such party’s directors, officers and
employees to the extent such disclosure is reasonably necessary in
connection with such party’s activities as expressly
authorized by this Agreement, and (b) to those agents and
consultants, and contract manufacturers who need to know such
information to accomplish the purposes of this Agreement
(collectively, “ Permitted Recipients ”);
provided such Permitted Recipients are bound to maintain such
Confidential Information in confidence at least to the same extent
as set forth in Section 5.1.
5.3
Litigation and Governmental Disclosure . Each party may
disclose Confidential Information of the other party to the extent
such disclosure is reasonably necessary for prosecuting or
defending litigation, complying with a court order or applicable
law, governmental regulations or investigation, provided that if a
party is required by law or regulation to make any such disclosure
of the other party’s Confidential Information it will give
reasonable advance notice to the other party of such disclosure
requirement and will use good faith efforts to assist such other
party to secure a protective order or confidential treatment of
such Confidential Information required to be disclosed.
5.4
Limitation of Disclosure . The parties agree that, except as
otherwise may be required by applicable laws, regulations, rules or
orders, including without limitation the rules and regulations
promulgated by the United States Securities and Exchange
Commission, or any regulations of any national securities exchange,
and except as may be authorized in Section 5.5, no information
concerning this Agreement and the transactions contemplated herein
shall be made public by either party without the prior written
consent of the other.
5.5
Publicity . Neither party shall make any publicity releases,
interviews or other non-confidential dissemination of information
concerning this Agreement or its terms, or either party’s
performance hereunder, to communication media, financial analysts
or others without the prior written approval of the other party,
which approval shall not be unreasonably
11
withheld,
delayed or conditioned. Notwithstanding anything to the contrary in
this Agreement, the parties understand and agree that either party,
may, if so required, disclose some or all of the information
included in this Agreement or other Confidential Information of the
other party (a) in order to comply with its obligations under
the law, including the United States Securities Act of 1933 and the
United States Securities Exchange Act of 1934; (b) in order to
comply with the listing standards or agreements of any national or
international securities exchange or The NASDAQ Stock Market or New
York Stock Exchange or other similar laws of a governmental
authority; (c) to respond to an inquiry of a governmental
authority or regulatory authority as required by law; or
(d) in a judicial, administrative or arbitration proceeding.
In any such event the party making such disclosure shall
(i) provide the other party with as much advance notice as
reasonably practicable of the required disclosure,
(ii) cooperate with the other party in any attempt to prevent
or limit the disclosure, and (iii) limit any disclosure to the
specific purpose at issue. In connection with any filing of a copy
of this Agreement with the Securities and Exchange Commission, the
filing party shall endeavor to obtain confidential treatment of
economic and trade secret information, and shall keep the other
party informed as the planned filing (including, but not limited to
providing the other party with the proposed filing reasonably in
advance of making the planned filing) and consider the requests of
the other party regarding such confidential treatment.
6.
REPRESENTATIONS AND WARRANTIES.
6.1.1
Each party hereby represents and warrants to the other party that
(a) the person executing this Agreement is authorized to
execute this Agreement; (b) this Agreement is legal and valid
and the obligations binding upon such party are enforceable by
their terms; and (c) the execution, delivery and performance
of this Agreement does not conflict with any agreement, instrument
or understanding, oral or written, to which such party may be
bound, nor violate any law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over
it.
6.1.2
Medicis hereby represents and warrants to Impax that, as of the
Effective Date, *** .
6.2
Compliance with Law . Impax shall comply with all applicable
laws and regulations with respect to obtaining regulatory approval
for the sale of Existing Products and its manufacture, sale and
commercialization of Existing Products.
6.3
Disclaimer of Warranties . Except for those warranties set
forth in Section 6.1, neither party makes any warranty,
written, oral, express or implied, with respect to this Agreement.
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED
BY BOTH PARTIES.
6.4
Limitation of Liability . WITH THE EXCEPTION OF DAMAGES
RESULTING FROM A PARTY’S BREACH OF ITS CONFIDENTIALITY
OBLIGATIONS
12
UNDER THIS
AGREEMENT OR ITS OBLIGATIONS UNDER SECTION 7 (INDEMNIFICATION), OR
A BREACH BY IMPAX OF SECTION 2.1.2 OR SECTION 2.4, UNDER NO
CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE FOR LOSS OF USE OR
PROFITS OR OTHER COLLATERAL, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR
PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT, WHETHER SUCH
CLAIMS ARE FOUNDED IN TORT OR CONTRACT.
6.5
Equitable Relief . Impax acknowledges and agrees that the
obligations and undertakings of Impax pursuant to
Sections 2.1.2 and 2.4 of this Agreement are reasonable and
necessary to protect the legitimate interests of Medicis, that
Medicis would not have entered into this Agreement in the absence
of such provisions, and that Impax’s breach or threatened
breach or failure to comply with such Sections 2.1.2 or 2.4
shall cause Medicis significant and irreparable harm, the amount of
which shall be extremely difficult to estimate and ascertain, and
for which money damages shall not be adequate. Impax further
acknowledges and agrees that Medicis shall have the right to apply
to any court of competent jurisdiction for an injunction order
restraining any breach or threatened breach of Sections 2.1.2
or 2.4 of this Agreement and specifically enforcing the terms and
provisions of such Sections of this Agreement, without the
necessity of posting any bond or security or giving Impax an
opportunity to cure, in addition to seeking any other remedy
available to Medicis in law or equity. Impax agrees that it shall
not challenge any of the foregoing acknowledgements and agreements
concerning injunctive relief in any proceeding brought by
Medicis.
7.1
Impax Indemnification . Impax shall indemnify, defend and
hold harmless Medicis, its directors, managers, members, officers,
employees, authorized subcontractors and agents (collectively the
“ Medicis Indemnified Parties ”) from and
against any and all liabilities, obligations, penalties, judgments,
disbursements of any kind and nature, losses, damages, costs and
expenses (including, without limitation, reasonable
attorney’s fees and costs) (collectively,
“Losses” ) incurred as a result of any claims,
demands, actions or other proceedings by a Third Party against an
Indemnified Party to the extent arising out of
(a) Impax’s manufacture or sale of any Existing Product
pursuant to this Agreement; or (b) Impax’s breach of any
representation, warranty or covenant under this Agreement, except
to the extent that such Losses arise out of Medicis’ breach
of any representation, warranty or covenant under this
Agreement.
7.2
Medicis Indemnification . Medicis shall indemnify, defend
and hold harmless Impax, its directors, managers, members,
officers, employees, authorized subcontractors and agents
(collectively the “ Impax Indemnified Parties ”)
from and against any and all Losses incurred as a result of any
claims, demands, actions or other proceedings by a Third Party
against an Indemnified Party to the extent arising out of
Medicis’ breach of any representation, warranty or covenant
under this Agreement, except to the extent that such Losses arise
out of Impax’s breach of any representation, warranty or
covenant under this Agreement.
7.3
Obligations . A party which intends to claim indemnification
under this Section 7 (the “Indemnified
Party” ) shall promptly notify the other party (the
“Indemnifying Party” ) in writing of any claim,
demand, action, or other proceeding in respect of which the
Indemnified Party intends to claim such indemnification; provided,
however, that failure to
13
provide such
notice within a reasonable period of time shall not relieve the
Indemnifying Party of any of its obligations hereunder except to
the extent the Indemnifying Party is prejudiced by such failure.
The Indemnified Party shall permit the Indemnifying Party, at its
discretion, to settle any such action, claim or other matter.
Notwithstanding the foregoing, the Indemnifying Party shall not
enter into any settlement that would adversely affect the
Indemnified Party’s rights hereunder, or impose any
obligations on the Indemnified Party in addition to those set forth
herein, in order for it to exercise such rights, without the
Indemnified Party’s prior written consent, which shall not be
unreasonably withheld or delayed. No such action, claim or other
matter shall be settled without the prior written consent of the
Indemnifying Party, which shall not be unreasonably withheld or
delayed. The Indemnified Party shall reasonably cooperate with the
Indemnifying Party and its legal representatives in the
investigation and defense of any claim, demand, action, or other
proceeding covered by the indemnification obligations of this
Section 7. The Indemnified Party shall have the right, but not
the obligation, to be represented in such defense by counsel of its
own selection and at its own expense.
8.1
Notices . All notices hereunder shall be delivered by
facsimile (confirmed by overnight delivery), or by overnight
delivery with a reputable overnight delivery service, to the
following address of the respective parties:
|
|
|
|
|
|
|
Medicis
Pharmaceutical Corporation
7720 North Dobson Road
Scottsdale, Arizona 85256
Attn: Chief Executive Officer
Facsimile: 480-291-5163
|
|
|
|
|
|
|
|
Medicis
Pharmaceutical Corporation
7720 North Dobson Road
Scottsdale, Arizona 85256
Attn: General Counsel
Facsimile: 480-291-5163
|
|
|
|
|
|
|
|
Impax
Laboratories, Inc.
30831 Huntwood Avenue
Hayward, California 94544
Attn: President, Generics Division
Facsimile: 510-471-1595
|
|
|
|
|
|
|
|
Impax
Laboratories, Inc.
30831 Huntwood Avenue
Hayward, California 94544
Attn: Legal Department
Facsimile: 510-476-2092
|
Notices shall be
effective on the day of receipt. A party may change its address
listed above by notice to the other party given in accordance with
this Section 8.1.
14
8.2
Entire Agreement . The parties hereto acknowledge that this
Agreement sets forth the entire agreement and understanding of the
parties and supersedes all prior written or oral agreements or
understandings with respect to the subject matter hereof. No
modification of any of the terms of this Agreement, or any
amendments thereto, shall be deemed to be valid unless in writing
and signed by an authorized agent or representative of both parties
hereto. No course of dealing or usage of trade shall be used to
modify the terms and conditions herein. This Agreement shall be
binding on each of Impax and Medicis and their respective permitted
successors and assigns.
8.3
Bankruptcy . All rights granted under this Agreement by
Medicis to Impax are and shall be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to
“intellectual property” as defined under
Section 101(52) of the US. Bankruptcy Code. The parties agree
that Impax, as a licensee of such rights under this Agreement,
shall retain and may fully exercise all of its rights and elections
under the U.S. Bankruptcy Code, subject to performance by Impax of
its pre-existing obligations under this Agreement.
8.4
Waiver . None of the provisions of this Agreement (including
the Exhibits hereto) shall be considered waived by any party hereto
unless such waiver is agreed to, in writing, by authorized agents
of such party. The failure of a party to insist upon strict
conformance to any of the terms and conditions hereof, or failure
or delay to exercise any rights provided herein or by law shall not
be deemed a waiver of any rights of any party hereto.
8.5
Obligations to Third Parties . Each party warrants and
represents that this Agreement does not conflict with any
contractual obligations, expressed or implied, undertaken with any
Third Party.
8.6
Assignment . Neither party shall assign this Agreement or
any part hereof or any interest herein (whether by operation of law
or otherwise) to any Third Party (or use any subcontractor) without
the written approval of the other party; provided, however, that
either party may assign this Agreement without such consent
(i) to any Affiliate; and (ii) in the case of a merger,
consolidation, change in control or sale of all or substantially
all of the assets of the Relevant Business Unit of the party
seeking such assignment or transfer and such transaction relates to
the business or assets covered by this Agreement and the resulting
entity assumes all of the obligations under this Agreement. For the
purposes of this Section 8.6, the “Relevant Business
Unit” shall mean, with respect to Impax, the generics
division of Impax, and with respect to Medicis, the medical
dermatology division of Medicis.
|