LICENSE AND SETTLEMENT AGREEMENT
Exhibit 10.1
*** 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.
THIS LICENSE AND SETTLEMENT AGREEMENT (this “Agreement”) dated as of May 4, 2010 (the
“Effective Date”) is entered into between Medicis Pharmaceutical Corporation, a Delaware
corporation with an address at 0000 Xxxxx Xxxxxx Xxxx, Xxxxxxxxxx, Xxxxxxx 00000 on behalf of
itself and its Affiliates (collectively, “Medicis”), and Ranbaxy Inc., a Delaware corporation, with
an address at 000 Xxxxxxx Xxxx Xxxx, Xxxxxxxxx, Xxx Xxxxxx 00000 and Ranbaxy Laboratories Limited,
a corporation organized under the laws of the Republic of India with an address at Xxxx 00, Xxxxxx
00, Xxxxxxx (Xxxxxxx) Xxxxx – 122001, on behalf of themselves and their respective Affiliates
(collectively, “Ranbaxy”).
WHEREAS, Medicis is the owner of the Patent Rights (as defined below) and Medicis has asserted
various claims and causes of action against Ranbaxy in an action captioned Medicis Pharmaceutical
Corp. v. Ranbaxy Inc. et al., Civil Action No. 09-CV-435-JJF (consolidated with Medicis
Pharmaceutical Corp. v. Mylan, Inc. et al., Civil Action No. 09-CV-033-JJF), and Medicis
Pharmaceutical Corp. v. Ranbaxy Inc. et al., Civil Action No. 10-120-JJF-MPT (collectively, the
“Litigation”), which are pending in the United States District Court, District of Delaware (the
“Court”); and
WHEREAS, the parties desire to settle the Litigation and Ranbaxy desires to receive, and
Medicis desires to grant to Ranbaxy, (i) a covenant not to xxx, (ii) a royalty-bearing license
under the Patent Rights to develop, make, use, sell, offer for sale, market, promote, distribute,
import and/or otherwise commercialize Current Generic Product and Future Generic Product (as each
term is defined below), and (iii) and a royalty-bearing license under the Patent Rights to develop,
make, use, sell, offer for sale, market, promote, distribute, import and/or otherwise commercialize
Ranbaxy Product (as such term is 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. DEFINITIONS.
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, provided,
however, that for purposes of this Agreement, Daiichi Sankyo Co., Ltd. (“Daiichi”), a corporation
organized under the laws of Japan, and its direct subsidiaries, excluding Ranbaxy, shall not be
considered an Affiliate of Ranbaxy. 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.
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1.2 “Business Day” shall mean any day other than a Saturday, a Sunday or a day on which the
state or federal courts located in the State of Delaware are authorized or obligated by law or
executive order to be closed.
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. The
identity of the Designated Strengths (as defined in Section 1.17) that are not already part of the
public domain shall be the Confidential Information of Medicis until such time that the identity of
such Designated Strength(s) become a part of the public domain.
1.4 “Current Generic Products” means, regardless of whether a product is considered generic
(including, without limitation, authorized generic), branded, private-labeled or otherwise, a
product that is bioequivalent to (or in the case of an authorized generic, the same as) one of the
Current Solodyn Products and has the same strength and dosage form as one of the Current Solodyn
Products.
1.5 “Current Solodyn Products” means the Solodyn® products listed on Exhibit B.
1.6 “Current Strengths Trigger Date” means with respect to a Current Generic Product, on a
Current Generic Product-by-Current Generic Product basis, the earliest of:
(a) November ***, 2011;
(b) ***; or
(c) ***
***
***
1.7 “FDA” means the United States Food and Drug Administration or any successor entity
thereto.
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1.8 “Future Generic Products” means, ***
1.9 “Future Solodyn Products” means (a) the 65 mg and 115 mg dosage strengths of the
Solodyn-branded minocycline products that were previously approved by the FDA under the Medicis
NDA, and (b) all other dosage strengths of the Solodyn-branded minocycline products that are
approved by the FDA under the Medicis NDA after the Effective Date.
1.10 “Future Strengths Trigger Date” means, with respect to a Future Generic Product for which
Ranbaxy has an approved ANDA, on a Future Generic Product-by-Future Generic Product basis, the
earliest of:
(a) ***; or
(b) ***
***
***
1.11 “GAAP” means generally accepted accounting principles in effect in the United States from
time to time, as consistently applied by Ranbaxy.
1.12 “Medicis NDA” means the New Drug Application #50-808 and any supplements or amendments
thereto.
1.13 “Net Profit” means, with respect to a calendar quarter, Net Sales of Current Generic
Product or Future Generic Product, as applicable, during such calendar quarter, less Ranbaxy’s
fully-burdened cost to manufacture such Current Generic Product or Future Generic Product, less
***.
1.14 “Net Sales” means, for the applicable period of calculation, the aggregate gross revenues
derived by or payable to Ranbaxy and its Affiliates from or on account of the sale of Ranbaxy
Product, Current Generic Product and Future Generic Product, less the sum of the following items,
all of which must directly relate to the sale and distribution of Ranbaxy Product, Current Generic
Product, or Future Generic Product: *** (all such amounts determined in accordance with GAAP
applied in a manner consistent with past practices of Ranbaxy). Subsections (a) through (d) shall
be collectively referred to as “Deductions”.
1.15 “Patent Rights” means (a) the patents and patent applications listed on Exhibit A to this
Agreement, (b) all patents and patent applications that (i) claim or cover a Current Solodyn
Product or Future Solodyn Product or the manufacture or use of such product and (ii) Medicis owns
or controls as of the Effective Date or anytime thereafter; (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
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and certificates of invention, together with any reissues, reexaminations, renewals,
extensions or additions thereto.
1.16 “Ranbaxy NDA” means the New Drug Application seeking approval to market the Ranbaxy
Product ***
1.17 “Ranbaxy Product” means ***
1.18 “Ranbaxy Product Trigger Date” means, with respect to a Ranbaxy Product, the later of
(a) August ***, 2011 or (b) the date of first commercial sale in the United States of such Ranbaxy
Product to a Third Party that is not an Affiliate of Ranbaxy after the FDA has approved the NDA for
such Ranbaxy Product.
1.19 “Third Party” means any person or entity other than Medicis or Ranbaxy.
1.20 “United States” means the United States of America, including its territories and
possessions, but excluding direct sales by Ranbaxy into the Commonwealth of Puerto Rico, provided,
however, that transportation of product to a customer’s warehouse located in the Commonwealth of
Puerto Rico at the direction of such customer located outside of the Commonwealth of Puerto Rico
shall not constitute a direct sale by Ranbaxy.
2. RELEASE; PERMANENT INJUNCTION.
2.1 Prior to Trigger Dates.
(a) Commencing on the Effective Date and continuing until the occurrence of the Current
Strengths Trigger Date for a Current Generic Product, on a Current Generic Product-by-Current
Generic Product basis, Ranbaxy shall not, and shall not directly or indirectly encourage or assist
any Third Party, to sell, offer for sale, distribute, promote, market or otherwise commercialize
such Current Generic Product. ***
(b) Commencing on the Effective Date and continuing until the occurrence of the Future
Strengths Trigger Date for a Future Generic Product, on a Future Generic Product-by-Future Generic
Product basis, Ranbaxy shall not, and shall not directly or indirectly encourage or assist any
Third Party, to sell, offer for sale, distribute, promote, market or otherwise commercialize such
Future Generic Product. ***
(c) Commencing on the Effective Date and continuing until the occurrence of the Ranbaxy
Product Trigger Date for a Ranbaxy Product, on a Ranbaxy Product-by-Ranbaxy Product basis, Ranbaxy
shall not, and shall not directly or indirectly encourage or assist any Third Party, to sell, offer
for sale, distribute or otherwise commercialize such Ranbaxy Product. ***
(d) ***
(e) ***
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2.2 Validity of Patent Rights. Ranbaxy hereby admits that the claims of the Patent
Rights are valid and enforceable ***. Ranbaxy hereby admits that the making, using, offering to
sell, selling, importation and/or distribution into the United States of a Ranbaxy Product, Current
Generic Product or a Future Generic Product, in each case are covered by one or more claims of the
Patent Rights under 35 U.S.C. § 271. The foregoing admission shall be binding on Ranbaxy and
admissible against Ranbaxy in any dispute or litigation between the parties regarding the Patent
Rights, and Ranbaxy will not challenge any such admission. *** Solely with respect to Ranbaxy
Product, Current Generic Product, or Future Generic Product, Ranbaxy shall not assist any Third
Party in an action to invalidate or render unenforceable any of the Patent Rights, and Ranbaxy
shall not disclose any of its proprietary or confidential information relating to the validity or
enforceability of any of the Patent Rights, except to the extent required by court order or other
applicable law.
2.3 Consent Judgment for Permanent Injunction. Upon the Effective Date, Medicis and
Ranbaxy have caused to be completed and executed a Consent Judgment and Permanent Injunction in the
form attached hereto as Exhibit C, and Medicis, with Ranbaxy’s agreement, shall file with and move
the Court within *** following the Effective Date for the entry of the Consent Judgment and
Permanent Injunction. ***
2.4 Mutual Releases. Consistent with the representations, warranties and covenants
made in this Agreement, as of the Effective Date Ranbaxy and each of its predecessors, successors,
parents, subsidiaries, Affiliates, divisions, general partners, limited partners, and assigns
(collectively, the “Ranbaxy Releasees”), fully, finally and forever release, relinquish,
acquit, and discharge Medicis and each of its respective predecessors, successors, parents,
subsidiaries, Affiliates, divisions, general partners, limited partners, and assigns,
(collectively, the “Medicis Releasees”) of and from, and covenant not to xxx, not to assign
to any other entity a right to xxx, and not to authorize any other entity to xxx, any Medicis
Releasee for, any and all claims, counterclaims, defenses, demands, causes of action, suits,
damages, debts, liabilities, obligations, rights, and set-offs of any and all kind or description
whatsoever, including federal or state antitrust or unfair competition law claims relating to the
manufacture, use, sale, offer for sale or distribution of Current Solodyn Products, Future Solodyn
Products, Current Generic Products, Future Generic Products and/or Ranbaxy Products or the
obtaining or enforcing of intellectual property or rights relating to Current Solodyn Products,
Future Solodyn Products, Current Generic Products, Future Generic Products and/or Ranbaxy Products
including costs, expenses, and attorneys’ fees related thereto or arising therefrom (collectively,
“Losses”), known or unknown, suspected or unsuspected, asserted or unasserted, in law or
equity, on which no judgment has yet been rendered, in each case prior to the Effective Date that
could have been, are or were asserted in connection with (i) Ranbaxy’s ANDA for a Current Generic
Product or Future Generic Product, (ii) Ranbaxy’s NDA, or (iii) the Litigation or that arise out
of any claim, counterclaim, affirmative defense, act, transaction, series of transactions, fact,
omission, or matter that could have been, is or was the subject matter of (i) Ranbaxy’s ANDA for a
Current Generic Product or Future Generic Product, (ii) Ranbaxy’s NDA, or (iii) the Litigation
(collectively, “Acts”). Consistent with the representations, warranties and covenants made
in this Agreement, as of the Effective Date, Medicis and each of the other Medicis Releasees,
fully, finally and forever release, relinquish, acquit, and discharge the Ranbaxy Releasees of and
from,
and covenant not to xxx, not to assign to any other entity a right to xxx, and not to
authorize any other entity to xxx, any Ranbaxy Releasee for, any and all Losses, known or unknown,
suspected
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or unsuspected, asserted or unasserted, in law or equity, on which no judgment has yet
been rendered, in each case prior to the Effective Date that could have been, are or were asserted
in, or that arise out of any Acts.
2.5 Filing of Agreement. Within ten (10) business days after the Effective Date, the
Parties shall each submit this Agreement to the U.S. Federal Trade Commission (“FTC”) and
U.S. Department of Justice (the “DOJ”) pursuant to Section 1112 of the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003. The Parties shall promptly in good
faith coordinate the foregoing filings and respond promptly in good faith to any requests for
additional information made by either of such agencies.
3. LICENSE
3.1 License Grants.
3.1.1 Medicis hereby covenants that it will not xxx, assert any claim or counterclaim against,
otherwise participate in any action or proceeding against Ranbaxy or any of its shareholders,
Affiliates, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors,
insurers, or any heirs, administrators, executors, predecessors, successors, or assigns of the
foregoing, or cause or authorize any person or entity to do any of the foregoing, in each case
claiming or otherwise asserting that Ranbaxy’s manufacture, use, sale, offer for sale, or
importation of the Ranbaxy Product, Ranbaxy’s Current Generic Product, and Ranbaxy’s Future Generic
Product to the extent the same is within the scope of the licenses granted under this Agreement
infringes the Patent Rights, provided that Ranbaxy remains in compliance with the terms of this
Agreement.
3.1.2 Subject to the terms and conditions of this Agreement, and effective on the applicable
Current Strengths Trigger Date for each applicable Current Generic Product, Medicis hereby grants
to Ranbaxy and its Affiliates a non-exclusive, non-transferable, non-sublicensable, royalty-bearing
right and license under the Patents Rights to sell, offer for sale, distribute and/or otherwise
commercialize the applicable Current Generic Product in the United States, provided, however, that,
effective as of the Effective Date, Ranbaxy shall have the limited right and license under the
Patent Rights to develop, make, have made, import, store, handle and transport (but not sell or
offer for sale) in the United States amounts of Current Generic Product for Ranbaxy’s good faith
preparation for, and in anticipation of, the applicable Current Strengths Trigger Date, subject to
Ranbaxy’s compliance with the restrictions contained herein until the applicable Current Strengths
Trigger Date. For the sake of clarity, indirect sales of Current Generic Product into the
Commonwealth of Puerto Rico shall not constitute a breach of this Agreement, including, without
limitation, transportation of such Current Generic Product to a customer’s warehouse located in
Puerto Rico at the direction of such customer located outside of the Commonwealth of Puerto Rico.
3.1.3 Subject to the terms and conditions of this Agreement, and effective on the applicable
Future Strengths Trigger Date for each applicable Future Generic Product for which Ranbaxy has an
approved ANDA, Medicis hereby grants to Ranbaxy and its
Affiliates a non-exclusive, non-transferable, non-sublicensable, royalty-bearing right and
license under the Patents Rights to sell, offer for sale, distribute and/or otherwise commercialize
in the
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United States the applicable Future Generic Product for which Ranbaxy has an approved ANDA,
provided, however, that, effective as of the Effective Date, Ranbaxy shall have the limited right
and license under the Patent Rights to develop, make, have made, import, store, handle and
transport (but not sell or offer for sale) in the United States amounts of Future Generic Product
for Ranbaxy’s good faith preparation for, and in anticipation of, the applicable Future Strengths
Trigger Date, subject to Ranbaxy’s compliance with the restrictions contained herein until the
applicable Future Strengths Trigger Date. For the sake of clarity, indirect sales of Future
Generic Product into the Commonwealth of Puerto Rico shall not constitute a breach of this
Agreement, including, without limitation, transportation of such Current Generic Product to a
customer’s warehouse located in Puerto Rico at the direction of such customer located outside of
the Commonwealth of Puerto Rico.
3.1.4 Subject to the terms and conditions of this Agreement, and effective on the Ranbaxy
Product Trigger Date for each applicable Ranbaxy Product, Medicis hereby grants to Ranbaxy,
including it’s Affiliates, a non-exclusive, non-transferable (except in the event of the sale of
all assets related to the Ranbaxy Product or all of the stock of Ranbaxy or an Affiliate which
holds all of the assets related to the Ranbaxy Product), royalty-bearing right and license under
the Patents Rights to sell, offer for sale, distribute and/or otherwise commercialize in the United
States such Ranbaxy Product. For the sake of clarity, indirect sales of Ranbaxy Product into the
Commonwealth of Puerto Rico shall not constitute a breach of this Agreement, including, without
limitation, transportation of such Current Generic Product to a customer’s warehouse located in
Puerto Rico at the direction of such customer located outside of the Commonwealth of Puerto Rico.
3.1.5 Except as provided in Section 3.1.6, during each twelve (12) month period following the
Ranbaxy Product Trigger Date and each anniversary thereof (each a “Ranbaxy Product Year”) until
***, the license provided under Section 3.1.4 shall only grant Ranbaxy rights to sell the aggregate
*** of Ranbaxy Product set forth in the table below, provided, however, that following ***, the
limits on the *** of Ranbaxy Product Ranbaxy can sell under the license provided under
Section 3.1.4 shall no longer apply. During the applicable Ranbaxy Product Year, Ranbaxy shall not
sell or distribute (and shall not authorize or assist any Third Party to sell or distribute)
amounts of Ranbaxy Product in excess of the following aggregate amounts for all Ranbaxy Product.
***
Upon written request of Medicis, Ranbaxy shall provide to Medicis certification and/or such
information as Medicis requests as reasonably necessary to confirm that any product that Ranbaxy
purports to be a Ranbaxy Product satisfies the definition of “Ranbaxy Product” as set forth in
Section 1.17. By way of example, but not limitation, Medicis shall have the right to request, and
Ranbaxy shall provide, copies of any NDA (or amendment or supplement to an existing NDA) submitted
by Ranbaxy to the FDA with respect to any such purported Ranbaxy Product. All such information
provided by Ranbaxy to Medicis hereunder shall be the Confidential Information of Ranbaxy.
3.1.6 In the event that after the Ranbaxy Product Trigger Date but before the end of ***, a
Third Party *** (“Third Party *** Sale”), the volume limitations set forth in
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section 3.1.5 shall
no longer apply, provided, however, that if such Third Party *** Sale is not pursuant to a license
agreement with, or otherwise under authorization by, Medicis in existence as of the date of such
Third Party *** Sale, the volume limitations set forth in section 3.1.5 shall remain in effect
until at least *** after the date Ranbaxy provides to Medicis written notice of such Third Party
*** Sale if Medicis provides Ranbaxy with written notice within *** after receipt of such written
notice from Ranbaxy regarding the Third Party *** Sale of Medicis’ intent to: (i) seek Judicial
Relief, or (ii) enter into an agreement with the Third Party, in either or both cases to prohibit
further Third Party *** Sales in the United States by the Third Party. In the event that Medicis
obtains Judicial Relief or an agreement with the Third Party, either or both within *** after
receipt of such notice from Ranbaxy regarding the Third Party *** Sale that restrains further Third
Party *** Sales by the Third Party, then for purposes of this Section 3.1.6 no Third Party *** Sale
shall have occurred.
3.2 Prior to Trigger Dates. During the term of this Agreement, subject to
Section 2.1, Ranbaxy shall not sell, offer for sale, market, promote or distribute any Ranbaxy
Product, Current Generic Product or Future Generic Product until, as the case may be, the
applicable Ranbaxy Product Trigger Date, Current Strength Trigger Date or Future Strength Trigger
Date in accordance with the terms of this Agreement.
3.3 ***
3.4 No Licenses. Except as otherwise provided herein, nothing in this Agreement shall
be construed as: (a) an obligation to bring or prosecute actions or suits against Third Parties for
infringement of any patent, whether within the Patent Rights or otherwise; (b) conferring a right
to use in advertising, publicity, promotion or otherwise any trademark or trade name of Medicis; or
(c) granting by implication, estoppel or otherwise, any licenses or rights under the Patent Rights
or any other patents. For the avoidance of doubt, nothing in this Agreement grants to Ranbaxy or
its Affiliates any right to use, and Ranbaxy and its Affiliates shall not use (and shall not
authorize or assist any Third Party to use), the names or trademarks of Medicis (including without
limitation “Medicis” and “Solodyn®”) in connection with the promotion, manufacture, marketing, sale
or distribution of the Ranbaxy Product, except to the extent required by law.
3.5 Right of First Offer.
(a) In the event that Ranbaxy or its Affiliates (i) elect to sell, license or otherwise
transfer to a Third Party any of the rights to the Ranbaxy Product, excluding only a transaction
that consists of the sale of all or substantially all of the assets of Ranbaxy or its Affiliate
holding such rights (unless the only asset or Primary Asset of such Affiliate are rights to the
Ranbaxy Product), or (ii) elect not to launch or elect to otherwise discontinue the sale of Ranbaxy
Product, then Ranbaxy shall notify Medicis in writing. Ranbaxy hereby grants to Medicis for a
period of *** following the date Medicis receives such notice from Ranbaxy (the “Negotiation
Period”), the exclusive right to negotiate with Ranbaxy to exclusively license or acquire such
rights. ***
(b) During the applicable Negotiation Period (i) Ranbaxy shall provide to Medicis such
information and documents (including regulatory and technical information) as
8
reasonably necessary
for Medicis to evaluate the Ranbaxy Product and (ii) the parties shall negotiate in good faith and
attempt to reach mutual agreement on commercially reasonable terms and conditions for such license
or acquisition. If the parties are unable to agree upon such terms and conditions during the
applicable Negotiation Period, then Ranbaxy shall not grant to any Third Party a license or
otherwise sell or transfer such rights on terms and conditions that are more favorable to such
Third Party than those last offered to Medicis unless Ranbaxy first offers to Medicis the right,
for a period of not less than ***, to accept those more favorable terms and conditions and Medicis
fails to accept such terms and conditions during such *** period.
(c) If Ranbaxy sells, licenses or transfers the rights to the Ranbaxy Product to a Third
Party, then such agreement shall be subject to the provisions of Section 2.2 with respect to the
Ranbaxy Product.
4. ROYALTIES
4.1 Payment.
4.1.1 Subject to the terms and conditions of this Agreement, within *** following the end of
each calendar quarter during the term of this Agreement, Ranbaxy shall pay to Medicis in U.S.
dollars (i) a royalty of *** of Net Sales of the Ranbaxy Product during such calendar quarter, (ii)
a royalty of *** of Net Profit of the Current Generic Product during such calendar quarter, and
(iii) a royalty of *** of Net Profit of the Future Generic Product during such calendar quarter.
All payments shall be made by wire transfer in US Dollars to such bank account as may be designated
from time-to-time by Medicis in writing to Ranbaxy. In the event that an unaffiliated Third Party
enters the United States market with an AB-Rated generic version of the Ranbaxy Product, then
Ranbaxy shall provide to Medicis written notice of the sale of such AB-Rated generic version of the
Ranbaxy Product by such Third Party. In the event that Medicis is unable to obtain either Judicial
Relief or an agreement with the Third Party, either or both within *** after receipt of such
written notice from Ranbaxy regarding the sale of such AB-Rated generic version of the Ranbaxy
Product that restrains further sales of such AB-Rated generic version of the Ranbaxy Product by the
Third Party in the United States, then if Ranbaxy launches an authorized generic version of the
Ranbaxy Product, the royalty payable on such sales of authorized generic Ranbaxy Product shall be
*** of Net Profit. For the sake of clarity, in the event Ranbaxy launches an authorized generic
Ranbaxy Product but continues to sell a branded Ranbaxy Product, Ranbaxy shall continue to pay a
royalty of *** of Net Sales on sales of branded Ranbaxy Product.
4.1.2 Within *** following the end of each calendar quarter in which the Ranbaxy Product,
Current Generic Product or Future Generic Product is sold during the term of this Agreement,
Ranbaxy shall provide to Medicis a written estimate of the royalty amount that will be payable for
each product for such calendar quarter in accordance with Section 4.1.1. Within *** following the
end of each calendar quarter in which the Ranbaxy Product, Current Generic Product or Future
Generic Product is sold during the term of this Agreement, Ranbaxy shall provide to Medicis a
written report stating the number and description of all Ranbaxy Product, Current Generic Product
or Future Generic Product sold during the relevant calendar
quarter; the gross sales associated therewith; the calculation of Net Sales thereon, including
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without limitation the amount of any Deductions; and the royalties that will be payable for such
calendar quarter in accordance with Section 4.1.1.
4.1.3 Any late payments shall bear interest at the lower of (a) *** per annum, or (b) the
maximum rate allowed by law, commencing on the date payment is due.
4.2 Taxes. Ranbaxy shall be responsible for and may withhold from payments made to
Medicis under this Agreement any taxes required to be withheld by Ranbaxy under applicable law.
Accordingly, if any such taxes are levied on such payments due hereunder (“Withholding Taxes”),
Ranbaxy 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 *** following the applicable tax payment.
4.3 Audit Rights. On no less than *** notice from Medicis, Ranbaxy shall make
available for inspection during normal business hours by an independent auditor selected by Medicis
and reasonably acceptable to Ranbaxy all records, books of account, information and data concerning
(a) Net Sales pursuant to this Agreement for the purpose of an audit to determine the accuracy of
the reports delivered and amounts paid by Ranbaxy pursuant to Section 4.1 and (b) Ranbaxy’s
compliance with Section 3.1.5 of this Agreement. 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. Medicis shall be solely responsible for its
costs in making any such audit, unless Medicis identifies a discrepancy in favor of Ranbaxy in the
calculation of the Net Sales and royalties paid to Medicis under this Agreement in any calendar
year from those properly payable for that calendar year of *** or greater, in which event Ranbaxy
shall be solely responsible for the reasonable cost of such audit and pay Medicis any underpayment.
5. TERM AND TERMINATION.
5.1 Term. Subject to Section 5.2, this Agreement, shall expire on the expiration of
the last to expire of the Patent Rights; provided, however, that if at any time during the Term
there are no valid, issued patents within the Patent Rights, but there are at such time pending
patent applications within the Patent Rights, then subject to the terms and conditions of this
Agreement, the term of this Agreement shall continue for the pendency of such pending patent
applications.
5.2 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 *** after receipt of express written notice thereof by the
non-breaching party. If this Agreement is terminated prior to expiration of the last to expire of
the Patent Rights, Ranbaxy shall not make, have made, use, sell, offer for sale, import or
distribute Ranbaxy Product, Current Generic Product or Future Generic Product until the expiration
of the last to expire of the Patent Rights.
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5.3 Termination for Challenge. Except as expressly permitted in Section 2.2 above,
Medicis shall have the right to immediately terminate this Agreement at any time after the
Effective Date in the event Ranbaxy or any of its Affiliates contests or challenges, or supports or
assists any Third Party to contest or challenge, with the patent office or any court, regulatory
agency or other forum, Medicis’ ownership of or rights in, or the validity, enforceability or scope
of, any of the Patent Rights, solely with respect to Ranbaxy Product, Current Generic Product or
Future Generic Product.
5.4 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 termination,
and the provisions of Sections 2.1, 2.2, 3.3, 4.3, 5.2, 5.4, 6, 7.4, 8 and 9 shall survive the
expiration or termination of this Agreement. No other provisions shall survive expiration or
termination of this Agreement.
6. CONFIDENTIALITY.
6.1 Confidentiality. Until the expiration or earlier termination of this Agreement,
and for a period of *** 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 and the terms of
this 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 or the terms of this Agreement. Without limiting the generality of the
foregoing, Ranbaxy shall not disclose to any Third Party the Designated Strengths that are not part
of the public domain and Ranbaxy shall not use the knowledge of the Designated Strengths that are
not part of the public domain for any purpose (including without limitation, filing an NDA or ANDA,
or filing an amendment or supplement to an existing NDA or ANDA) other than for the sole purpose of
ensuring that the Ranbaxy Products do not have strengths identical to any of the Designated
Strengths. Notwithstanding the foregoing, Ranbaxy may continue ongoing development and shall be
permitted to file an ANDA for any of the Designated Strengths that were identified and/or or were
in development by Ranbaxy prior to the Effective Date, as may be evidenced by the written records
of Ranbaxy.
6.2 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 6.1.
6.3 Litigation and Governmental Disclosure. Each party may disclose Confidential
Information of the other party to the extent such disclosure is reasonably necessary
11
for prosecuting or defending litigation or complying with a court order or applicable law,
governmental regulations or investigation, provided that if a party is required by court order, 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.
6.4 Publicity. Except as expressly authorized hereunder, neither party shall make any
publicity releases, interviews or other 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 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 (or the applicable
ex-U.S. equivalent); (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.
7. REPRESENTATIONS AND WARRANTIES.
7.1 Representations.
7.1.1 Each party hereby represents and warrants as of the Effective Date 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.
7.1.2 ***
7.1.3 ***
12
7.1.4 ***
7.1.5 ***
7.1.6 ***
7.2 Disclaimer of Warranties. Except for those warranties set forth in Section 7.1,
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.
7.3 Limitation of Liability. WITH THE EXCEPTION OF DAMAGES RESULTING FROM A PARTY’S
BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER THIS AGREEMENT OR ITS OBLIGATIONS UNDER SECTION 8
(INDEMNIFICATION), OR A BREACH BY RANBAXY OF SECTIONS 2.1 OR 2.2, 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.
7.4 Equitable Relief. Ranbaxy acknowledges and agrees that the obligations and
undertakings of Ranbaxy pursuant to Sections 2.1 and 2.2 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 Ranbaxy’s breach or threatened breach or
failure to comply with such Sections 2.1 and 2.2, solely with respect to the Ranbaxy’s Current
Generic Product and Future Generic Product, 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. Ranbaxy further acknowledges and agrees that Medicis shall have the
right, solely with respect to Ranbaxy’s Current Generic Product and Future Generic Product, to
apply to any court of competent jurisdiction for an injunction order restraining any breach or
threatened breach of Sections 2.1 or 2.2 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, in addition to seeking any other remedy available to Medicis in law or equity, provided,
however, that with respect to the Ranbaxy Product, Medicis shall have the right to apply to any
court of competent jurisdiction for an injunction order restraining any demonstrated breach of
Section 2.1 or 2.2 and specifically enforcing the terms and provisions of such Sections of this
Agreement, subject to the posting of a bond or security, in addition to seeking any other remedy
available to Medicis at law or equity, and provided, further, that Medicis shall only have the
right to apply for an injunction or equitable relief, or otherwise assert damages, against Ranbaxy
with respect to the applicable Ranbaxy Product alleged to be the subject of a breach.
13
8. INDEMNIFICATION.
8.1 Ranbaxy Indemnification. Ranbaxy 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) Ranbaxy’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, ***
8.2 Medicis Indemnification. (a) Medicis shall indemnify, defend and hold harmless
Ranbaxy, its Affiliates, directors, managers, members, officers, employees, authorized
subcontractors and agents (collectively the “Ranbaxy 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 Ranbaxy’s breach of any representation, warranty or covenant under this Agreement.
8.3 Obligations. A party which intends to claim indemnification under this Section 8
(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 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 8. 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.
9. GENERAL PROVISIONS.
9.1 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:
14
If to Medicis:
|
Medicis Pharmaceutical Corporation 0000 Xxxxx Xxxxxx Xxxx Xxxxxxxxxx, Xxxxxxx 00000 Attn: Chief Executive Officer Facsimile: 480-291-5175 |
|
with a copy to:
|
Medicis Pharmaceutical Corporation 0000 Xxxxx Xxxxxx Xxxx Xxxxxxxxxx, Xxxxxxx 00000 Attn: General Counsel Facsimile: 000-000-0000 |
|
If to Ranbaxy:
|
Ranbaxy Laboratories Limited Corporate Office, Xxxx 00, Xxxxxx 00 Xxxxxxx -000000 (Xxxxxxx), Xxxxx Attn: Head – Global Legal Facsimile: |
|
With a copy to:
|
Ranbaxy Inc. 000 Xxxxxxx Xxxx Xxxx Xxxxx 0000 Xxxxxxxxx, Xxx Xxxxxx 00000 Attn: Legal Department Facsimile: (000) 000-0000 |
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 9.1.
9.2 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 Ranbaxy and Medicis and their respective permitted successors and
assigns.
9.3 Waiver. None of the provisions of this Agreement 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.
9.4 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.
15
9.5 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; (ii) in the case of a
merger, consolidation, change in control or sale of all or substantially all of the assets related
to this Agreement, or (iii) in the case of a merger, consolidation, change in control or sale of
all or substantially all of the assets or stock of Ranbaxy or an Affiliate, provided further that
with respect to Ranbaxy, any such Affiliate or Third Party agrees to be bound by the terms and
conditions of this Agreement including, without limitation, the provisions of Section 2.2. No
assignment shall be valid unless the permitted assignee(s) assumes all obligations of its assignor
under this Agreement. No assignment shall relieve any party of responsibility for the performance
of its obligations hereunder. Any purported assignment in violation of this Section 9.5 shall be
void.
9.6 Governing Law. In any action brought regarding the validity, construction and
enforcement of this Agreement, it shall be governed in all respects by the laws of the State of
Delaware, without regard to the principles of conflicts of laws. The federal and state courts in
the State of Delaware shall have jurisdiction over the parties hereto in all matters arising
hereunder and the parties hereto agree that the venue with respect to such matters will be a state
or federal court in the State of Delaware.
9.7 Severability. If any term or provision of this Agreement shall for any reason be
held invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other term or provision hereof, and this Agreement shall be
interpreted and construed as if such term or provision, to the extent the same shall have been held
to be invalid, illegal or unenforceable, had never been contained herein.
9.8 Headings, Interpretation. The headings used in this Agreement are for convenience
only and are not part of this Agreement.
9.9 Attorneys’ Fees. The prevailing party shall be entitled to attorneys’ fees and
its litigation or related expenses in any suit or proceeding with respect to the interpretation or
enforcement of this Agreement.
9.10 Counterparts. The Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument.
[Remainder of this page intentionally blank]
16
IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their
duly-authorized representatives effective as of the Effective Date.
| RANBAXY LABORATORIES LIMITED | MEDICIS PHARMACEUTICAL CORPORATION | |||||
By:
|
By: | |||||
| Name: |
Name: |
|||||
| Title: |
Title: |
|||||
| RANBAXY INC. | ||||||
By: |
||||||
| Name: |
||||||
| Title: |
||||||
EXHIBIT A
Patent Rights
| Issued Patents (all U.S.) | Pending Applications (all U.S.) | |
| 5,908,838 | 11/166,817 | |
| 7,541,347 | 11/776,669 | |
| 7,544,373 | 11/776,676 | |
| 11/776,691 | ||
| 11/776,711 | ||
| 11/944,186 | ||
| 11/695,513 | ||
| 11/695,514 | ||
| 11/695,541 | ||
| 12/253,845 |
A-1
EXHIBIT B
Current Solodyn Products
| PRODUCT | NDC | |
| 00000-0000-00 | ||
| Solodyn 45mg | 00000-0000-00 | |
| 00000-0000-00 | ||
| Solodyn 90mg | 00000-0000-00 | |
| 00000-0000-00 | ||
| Solodyn 135mg | 00000-0000-00 |
B-1
EXHIBIT C
Consent Judgment for Permanent Injunction
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
FOR THE DISTRICT OF DELAWARE
MEDICIS PHARMACEUTICAL CORPORATION,
|
) | |||||
Plaintiff,
|
) | |||||
| C.A. No. 09-033 (JJF)(LPS) | ||||||
v.
|
) | C.A. No. 09-435 (JJF) | ||||
| (Consolidated) | ||||||
RANBAXY INC.; and
|
) | |||||
RANBAXY LABORATORIES LTD.
|
) | |||||
ET AL.
|
) | |||||
Defendants.
|
) | |||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
MEDICIS PHARMACEUTICAL CORPORATION,
|
) | C.A. No. 10-120 (JJF)(MPT) | ||||
Plaintiff,
|
) | |||||
v.
|
) | |||||
RANBAXY INC.; and
|
) | |||||
RANBAXY LABORATORIES LTD.
|
) | |||||
Defendants.
|
) | |||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
| ) | ||||||
CONSENT JUDGMENT AND PERMANENT INJUNCTION
AS TO RANBAXY
AS TO RANBAXY
This matter is before the Court on the unopposed motion of Plaintiff Medicis Pharmaceutical
Corporation (“Medicis”) and Defendants Ranbaxy Inc. and Ranbaxy Laboratories Ltd. (collectively
referred to herein as “Ranbaxy”).
C-1
WHEREAS, this Consent Judgment and Permanent Injunction as to Ranbaxy concerns only Medicis’s
claims against Ranbaxy and Ranbaxy’s counterclaims against Medicis in C.A. No. 09-435 (JJF) (which
has been consolidated with C.A. No. 09-033 (JJF)), and C.A. No. 10-120 (JJF) (collectively referred
to herein as the “Litigations”).
WHEREAS, Medicis requests that this Consent Judgment and Permanent Injunction as to Ranbaxy be
entered in the above-captioned cases, and Ranbaxy does not oppose Medicis’s request.
WHEREAS,
Medicis owns United States Patent No. 5,908,838 (“the ’838 patent”).
WHEREAS, Ranbaxy submitted Abbreviated New Drug Application No. 91-118 (“Ranbaxy ANDA”) to the
FDA under 21 U.S.C. § 355(j) seeking to obtain approval to commercially manufacture and sell
generic minocycline HCl extended release tablets in its 135 milligram (“mg”) strength for the
treatment of acne.
WHEREAS, Ranbaxy submitted a supplement or amendment to the Ranbaxy ANDA (“Ranbaxy ANDA
Supplement/Amendment”) to the FDA under 21 U.S.C. § 355(j) seeking to obtain approval to
commercially manufacture and sell generic minocycline HCl extended release tablets in its 45 mg and
90 mg strengths for the treatment of acne.
WHEREAS, in these Litigations, Medicis alleged that Ranbaxy infringed one or more of claims 3,
4, 12, and 13 of the ’838 patent under 35 U.S.C. § 271(e)(2) by virtue of Ranbaxy’s submission of
the Ranbaxy ANDA and the Ranbaxy ANDA Supplement/Amendment to the FDA.
C-2
WHEREAS, in these Litigations, Medicis alleged that it would be irreparably harmed if Ranbaxy
is not enjoined from infringing or actively inducing or contributing to infringement of one or more
of claims 3, 4, 12, and 13 of the ’838 patent.
WHEREAS, in these Litigations, Medicis requested that this Court enter a permanent injunction
enjoining Ranbaxy from infringing the ’838 patent.
WHEREAS, Medicis and Ranbaxy have reached an agreement to finally settle these Litigations as
set forth in this Consent Judgment and Permanent Injunction as to Ranbaxy and a separate
confidential License and Settlement Agreement (“Settlement Agreement”) which is contemporaneously
and separately being executed.
WHEREAS, final settlement of these Litigations will help Medicis and Ranbaxy avoid the
substantial uncertainty and risks involved with prolonged litigations.
WHEREAS, final settlement of these Litigations will permit Medicis and Ranbaxy to save
litigation costs, as well as adhere to the judicially recognized mandate that encourages the
settlement of litigation whenever possible.
WHEREAS, final settlement of these Litigations serves the public interest by saving judicial
resources and avoiding the risks to each of Medicis and Ranbaxy associated with infringement.
WHEREAS, Medicis and Ranbaxy each consent to personal jurisdiction in Delaware for purposes of
enforcing the Settlement Agreement.
C-3
IT IS HEREBY ORDERED, DECREED, and ADJUDGED as follows:
1. The Court has jurisdiction over Medicis and Ranbaxy and the subject matter of these
Litigations.
2. Ranbaxy acknowledges Medicis’s ownership and standing to xxx for infringement of United
States Patent No. 5,908,838 (“the ‘838 patent”).
3. Ranbaxy acknowledges that the ’838 patent is valid and enforceable, as described more fully
in the Settlement Agreement.
4. Ranbaxy acknowledges that the making, using, offering to sell, selling importation and/or
distribution of the products that described in the Ranbaxy ANDA and the Ranbaxy ANDA
Supplement/Amendment are covered by one or more claims of the ’838 patent under 35 U.S.C. § 271 and
that Medicis did not authorize the manufacture, use, sale, offer for sale, importation and
distribution of the product described in the Ranbaxy ANDA and the Ranbaxy ANDA
Supplement/Amendment.
5. As described more fully in the Settlement Agreement, Ranbaxy and its affiliates are
permanently enjoined as of the date hereof from infringing the ’838 patent by the manufacture, use,
offer to sell, sale, importation, or distribution of any current products, or future products
having the same strength and dosage form of the current Solodyn® products, that are the subject of
the Ranbaxy ANDA and the Ranbaxy ANDA Supplement/Amendment that is not pursuant to a license
granted by Medicis, and from inducing others to infringe the ’838 patent by inducing others to
manufacture, use, offer to sell, sale, import, or distribute any current products, or future
products having the same strength and dosage form of the current Solodyn® products, that are the
subject of the Ranbaxy ANDA and the Ranbaxy ANDA Supplement/Amendment that is not pursuant to a
license granted by Medicis.
C-4
6. Medicis acknowledges that Ranbaxy will maintain its paragraph IV certification pursuant to
21 C.F.R. § 314.94(a)(12)(v), as described more fully in the Settlement Agreement.
7. All claims and counterclaims in these Litigations are hereby dismissed without prejudice.
8. Except as provided in the Settlement Agreement, each side shall bear its own costs.
9. This Court shall retain jurisdiction over Ranbaxy and Medicis for the purpose of enforcing
the terms of this Consent Judgment and Permanent Injunction and over any matters related to or
arising from the interpretation or enforcement of the Settlement Agreement or any legal or
equitable claim concerning the Settlement Agreement.
IT IS
SO ORDERED, DECREED AND ADJUDGED this ___ day of April, 2010 by:
The Xxxxxxxxx Xxxxxx X. Xxxxxx Xx. |
||
United States District Judge Agreed to: |
||
MORRIS, NICHOLS, ARSHT & XXXXXXX LLP
|
POTTER XXXXXXXX & XXXXXXX LLP | |
Xxxx X. Xxxxxxxxxx (#1014)
|
Xxxxxxx X Xxxxxxx (#2246) | |
Xxxxx Xxxxxx Xxxxxx (#2881)
|
Xxxxx X. Xxxxx (#3983) | |
0000 Xxxxx Xxxxxx Xxxxxx
|
Hercules Plaza, 0xx Xxxxx | |
Xxxxxxxxxx, XX 00000-0000
|
0000 Xxxxx Xxxxxx Xxxxxx | |
(000) 000-0000
|
Xxxxxxxxxx, XX 00000 | |
xxxxxxxxxxx@xxxx.xxx
|
(000) 000-0000 | |
xxxxxxx@xxxx.xxx
|
xxxxxxxx@xxxxxxxxxxxxxx.xxx xxxxxx@xxxxxxxxxxxxxx.xxx |
|
Attorneys for
|
Attorneys for Ranbaxy Inc. and |
C-5
Medicis Pharmaceutical Corporation
|
Ranbaxy Laboratories Ltd. | |
OF COUNSEL:
|
OF COUNSEL: | |
Xxxxxxx X. Xxxxxx
|
Xxxxx X. Xxxx | |
XXXX, GOTSHAL & XXXXXX LLP
|
Xxxxx X. Xxxxxx | |
000 Xxxxxxx Xxxxxx Xxxxxxx
|
Xxxxx Xxxx | |
Xxxxxxx Xxxxxx, XX 00000
|
XXXXXXX XXXXXXXX & XXXX LLP | |
(650) 802-3000
|
000 Xxxxx Xxxxxx | |
| Xxx Xxxx, XX 00000 (000) 000-0000 |
||
Xxxxxxxxx Xxxxxxxx Xxxxxxxxxx Xxxxxxxx X. Xx Xxxxxxxx Xxxxxxxxx Xxxxxxxx Xxxxxx Xxxxxxxxx Xxxxx XXXX, GOTSHAL & XXXXXX LLP 000 Xxxxx Xxxxxx Xxx Xxxx, XX 00000 (000) 000-0000 |
C-6
