AMENDED AND RESTATED SETTLEMENT AGREEMENT
Exhibit 10.75
*** 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.
CONFIDENTIAL
AMENDED AND RESTATED SETTLEMENT AGREEMENT
THIS AMENDED AND RESTATED SETTLEMENT AGREEMENT (this “Agreement”) dated as of November 13,
2009 (the “Effective Date”) is entered into between Medicis Pharmaceutical Corporation, a Delaware
corporation with offices located at 0000 Xxxxx Xxxxxx Xxxx, Xxxxxxxxxx, Xxxxxxx 00000 on behalf of
itself and its Affiliates (collectively, “Medicis”), and Xxxx Laboratories, Inc. (a wholly owned
subsidiary of Teva Pharmaceuticals USA, Inc. (“Teva USA”)), a Delaware corporation with offices
located at 000 Xxxxxx Xxxxxx, Xxxxxxxx, XX 00000 on behalf of itself and its Affiliates
(collectively, “Teva”).
WHEREAS, Medicis and Teva entered into that certain Settlement Agreement (the “Original
Agreement”) effective as of March 18, 2009 (the “Original Effective Date”);
WHEREAS, Medicis and Teva desire to amend and restate the Original Agreement as set forth in
this Agreement;
WHEREAS, Medicis is the owner of the Patent Rights (as defined below);
WHEREAS, Teva filed and owns the ANDA (as defined below) and has manufactured and sold Generic
Product (as defined below) without authorization from Medicis, which manufacture, use, sale, offer
for sale, importation and distribution infringes or induces the infringement of one or more of the
Patent Rights; and
WHEREAS, in consideration for Teva’s agreement to immediately cease manufacturing, using,
selling, offering for sale, importing and distributing Generic Product and stipulate to the
validity of the Patent Rights, Medicis agreed to release Teva from liability arising from the
manufacture and distribution of the Generic Product prior to the Original Effective Date, 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, Medicis and Teva hereby agree that the Original
Agreement is amended and restated in its entirety 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. 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. For clarity, Teva USA hereby represents as
of the Effective Date that Xxxx Laboratories, Inc. is an Affiliate of Teva USA.
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1.2 “AG Date” means the earlier of:
(a) November ***, 2011;
(b) ***; or
(c) ***
1.3 “ANDA” means the Abbreviated New Drug Application #65-485 and any supplements or
amendments thereto.
1.4 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months
ending on March 31, June 30, September 30 and December 31.
1.5 “Calendar Year” means each successive period of twelve (12) months commencing on January 1
and ending on December 31.
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 this Agreement, orally or in written, electronic or tangible form, or otherwise
obtained by the receiving party through observation or examination of the disclosing party’s
operations. Confidential Information includes, but is not limited to, information about the
disclosing party’s financial condition and projections; business, marketing or strategic plans;
sales information, customer lists; price lists; databases; trade secrets; product prototypes and
designs; techniques, formulae, algorithms and other non-public process information.
Notwithstanding the foregoing, Confidential Information of a party shall not include that portion
of such materials, information and data that, and only to the extent, the recipient can establish
by written documentation: (a) is known to the recipient as evidenced by its written records before
receipt thereof from the disclosing party, (b) is disclosed to the recipient free of
confidentiality obligations by a Third Party who has the right to make such disclosure without
obligations of confidentiality, (c) is or becomes part of the public domain through no fault of the
recipient, or (d) the recipient can reasonably establish is independently developed by persons on
behalf of recipient without the use of the information disclosed by the disclosing party.
1.7 “FDA” means the United States Food and Drug Administration or any successor entity
thereto.
1.8 “Generic Product” means, ***.
1.9 [Reserved].
1.10 “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)
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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.
1.11 “Solodyn Products” means the Solodyn® products listed on Exhibit B.
1.12 “Third Party” means any person or entity other than Medicis or Teva.
2. RELEASE; PERMANENT INJUNCTION; LICENSE.
2.1 Releases. Teva represents and warrants that, as of the Original Effective Date,
it has only distributed in the United States those units of Generic Product without authorization
from Medicis as set forth on Schedule A (the “Distributed Quantities”), and the Distributed
Quantities are the only infringements of the Patent Rights by Teva with respect to the sale or
offer for sale of Generic Product in the United States. In consideration for the covenants set
forth in this Agreement, and in reliance on the representation and warranty in the preceding
sentence, Medicis hereby as of the Original Effective Date (on behalf of itself, the Medicis
Indemnified Parties, and their predecessors, successors and assigns) irrevocably releases Teva (and
the Teva Indemnified Parties, and their predecessors, successors, assigns, suppliers, purchasers,
customers and patients) from all claims and other Losses arising from the manufacture, use, sale,
offer for sale, importation or distribution of Generic Product prior to the Original Effective Date
(including, without limitation, infringement or induced infringement of any of the Patent Rights by
any of such activities or by filing the ANDA).
2.2 Prior to AG Date. Commencing on the Original Effective Date and continuing until
the occurrence of the AG Date, Teva shall not, and shall not directly or indirectly encourage or
assist any Third Party, on a voluntary basis, to develop, make, use, sell, offer for sale,
distribute, import or otherwise commercialize any Generic Product in the United States, except as
expressly permitted by the terms of this Agreement.
2.3 Validity of Patent Rights. Teva hereby admits that the claims of the Patent
Rights are valid and enforceable. Teva hereby admits that the making, using, offering to sell,
selling, importation and/or distribution into the United States of a Generic Product is covered by
one or more claims of *** under 35 U.S.C. § 271. The foregoing admission shall be binding on Teva
and admissible against Teva in any dispute or litigation between the parties regarding the Patent
Rights, and Teva will not challenge any such admission. Teva agrees that from the Effective Date
forward, Teva shall not assist any Third Party in an action to invalidate or render unenforceable
any of the Patent Rights, except to the extent required by court order or other applicable law.
This Section 2.3 (including, without limitation, those admissions regarding validity and
enforceability) shall apply only to Generic Products (and no other products), and further shall
apply only in the United States.
2.4 Consent Judgment for Permanent Injunction. Upon the Original Effective Date,
Medicis and Teva have caused to be completed, executed and filed with the United States District
Court for the District of Delaware (the “Court”) a Consent Judgment and Permanent Injunction in the
form attached hereto as Exhibit C, and Medicis, with Teva’s agreement, has moved for the entry of
the Consent Judgment and Permanent Injunction by such Court.
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2.5 License Grant.
2.5.1 Medicis hereby grants to Teva a non-exclusive license under the Patent Rights to make,
have made (solely as set forth below), use, sell, offer for sale and import Generic Product in or
for the United States (where “United States” for purposes of this Agreement shall include its
territories and possessions, including, without limitation, the District of Columbia and the
Commonwealth of Puerto Rico (but excluding direct sales of Generic Product into the Commonwealth of
Puerto Rico)) from and after the AG Date (and before the AG Date for reasonable commercial
preparation as contemplated by Section 2.5.2). Neither party shall enter into any agreement in
conflict with any provisions of this Agreement. Teva will have the right to grant sublicenses
under the licenses granted in this Section 2.5.1 solely for its suppliers to make Generic Product
(and for clarity API therefor) for sale only to Teva.
2.5.2 ***
2.5.3 In exchange for the license rights granted in this Section 2.5, Teva agrees that
(a) during the term of this Agreement, Teva shall not make, use, sell, offer for sale, import or
distribute a Generic Product in the United States except for Generic Product in accordance with the
terms of this Agreement, and (b) in the case of an early termination of this Agreement by Medicis
because of a material, uncured breach by Teva, and continuing until the expiration of the last to
expire of any valid and enforceable Patent Rights covering Generic Product, Teva shall not make,
use, sell, offer for sale, import or distribute a Generic Product in the United States.
2.5.4 Teva shall pay to Medicis on a quarterly basis for any Generic Product sold after the AG
Date (and, for clarity, not including any of the Distributed Quantities for which no payments will
be owed Medicis): *** of all Gross Profit resulting from sales of Generic Product made by Teva
within *** of the AG Date (the “Payment Period”) and covered by a valid, issued and enforceable
unexpired Patent Right licensed to Teva under this Agreement, ***.
2.5.5 For the *** period following the expiration of Teva’s obligations to make royalty
payments hereunder, Teva shall permit an independent auditor selected by Medicis, familiar with the
generic pharmaceutical industry and reasonably acceptable to Teva, to have access, (i) during
normal business hours, (ii) upon reasonable prior notice (not more often than *** in any Calendar
Year) and (iii) such access not to unreasonably interfere with the day-to-day operations of Teva,
to those books and records maintained by Teva necessary for Medicis to verify the accuracy of
Teva’s calculation of any Net Sales, and/or Gross Profit; provided that no such independent auditor
shall be retained on a contingency basis. All such information shall be retained on a confidential
basis by such auditor’s firm, and such firm’s use of such information shall be limited to the
aforementioned verification. The fees charged by such auditor shall be paid by Medicis; provided,
however, if the audit discloses that the royalties payable by Teva for the audited period are more
than *** of the royalties actually paid during such period, then Teva shall promptly pay the
reasonable fees and expenses charged by such auditor in addition to any underpayments. Upon Teva’s
request, Medicis shall provide Teva with a copy of the report or other summary of its findings
prepared by such auditor.
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2.5.6 Certain Definitions: For the purposes of this Section 2.5:
(i) “Gross Profit” means, with respect to any Generic Product sold by Teva, Net Sales of such
Generic Product less the Costs of Goods for such Generic Product.
(ii) “Net Sales” means the aggregate gross sales of the amounts invoiced for the sale of
Generic Product by Teva in arm’s length transactions with Third Parties for use in the United
States, less good faith and reasonable estimates for the following: (A) cash discounts, (B)
adjustments on account of ***, (C) returns, shortages or rejected/damaged goods, (D) chargebacks,
and (E) rebates, promotional allowances, administrative fee arrangements, and similar payments to
all direct and indirect customers, including wholesalers and other distributors, buying groups,
health care insurance carriers, pharmacy benefit management companies, health maintenance
organizations, Medicaid or Medicare or similar type programs. In the event that Teva sells Generic
Product as part of a bundle or group sale with other products not covered by this Agreement, and
Teva provides a discount, allowance or rebate to the purchaser of such Generic Product based on the
invoiced prices for all products sold, such discount must be allocated pro rata based on the
selling prices of all such products. Net Sales shall be determined using the accrual method of
accounting determined in a manner consistent with Teva’s practice for its other pharmaceutical
products and in accordance with GAAP consistently applied. Sales of Generic Product by and between
Teva and its Affiliates are not sales to Third Parties and shall be excluded from Net Sales
calculations for all purposes, but the final sale to a Third Party shall be included in Net Sales.
Within ninety (90) days after the end of the Payment Period, the Parties agree to allow for a “true
up” reconciliation (and provide Medicis a written report of such reconciliation) of the deductions
from gross sales of the amounts invoiced for the sale of Generic Product to the extent such
deductions have not already been made during the Payment Period. The “true up” reconciliation
shall be based on actual credits issued and estimates for those incurred related to the reported
invoiced sales, but not yet issued for amounts as outlined in clauses (ii)(A) through (ii)(E) of
this definition of “Net Sales”. If the foregoing reconciliation report shows either an
underpayment or an overpayment to Medicis, Medicis shall pay Teva the amount of the overpayment, or
Teva shall pay Medicis the amount of the underpayment, (whichever shall be applicable) within
thirty (30) days of the date of its receipt of the report.
(iii) “Cost of Goods” means the fully burdened manufacturing cost (as defined below),
excluding handling losses of the finished product. For purposes of this definition, the term
“fully burdened manufacturing cost” shall mean and comprise the sum of:
(1) The cost of goods produced as determined by Teva in accordance with U.S. GAAP consistently
applied, including ***all to the extent directly attributable and allocable to the manufacture and
supply of Generic Product;
(2) *** and
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(3) Any other costs borne by Teva for transport, customs clearance and storage of Generic
Product (i.e., freight, customs, duty, and transportation related insurance).
2.6 No Licenses. Except as expressly set forth 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.
3. TERM AND TERMINATION.
3.1 Term. Subject to Section 3.2, this Agreement shall expire on the expiration of
the last to expire of the Patent Rights; provided, however, that if 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.
3.2 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 forty-five (45) days after receipt of express written notice
thereof by the non-breaching party.
3.3 Termination for Challenge. Medicis shall have the right to immediately terminate
this Agreement at any time after the Effective Date in the event Teva 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, provided that Medicis has
first provided Teva with thirty (30) days prior written notice of its intent to terminate and Teva
has not ceased contesting or challenging, or ceased supporting or assisting any Third Party to
contest or challenge, Medicis’s ownership of or rights in, or the validity, enforceability or scope
of, any of the Patent Rights within such thirty (30) day period. This Section 3.3 shall apply only
to contests or challenges of the Patent Rights with respect to Generic Products (and no other
products), and further shall apply only in the United States.
3.4 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, 2.3, 2.6, 3.4, 4, 5.4, 6 and 7 shall survive the
expiration or termination of this Agreement. No other provisions shall survive expiration or
termination of this Agreement.
4. CONFIDENTIALITY.
4.1 Confidentiality. For a period of five (5) years following the expiration or
earlier termination of this Agreement, 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
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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.
4.2 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 4.1.
4.3 Litigation and Governmental Disclosure. Each party may disclose Confidential
Information of the other party or the terms of this Agreement 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.
4.4 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; (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. The parties
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acknowledge and agree that the press release(s) set forth on Schedule B was issued on the
Original Effective Date.
5. REPRESENTATIONS AND WARRANTIES.
5.1 Representations.
5.1.1 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.
5.2 Disclaimer of Warranties. Except for those warranties set forth in Section 5.1,
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.
5.3 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 6
(INDEMNIFICATION), OR A BREACH BY TEVA OF SECTIONS 2.2 OR 2.3, 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.
5.4 Equitable Relief. Teva acknowledges and agrees that the obligations and
undertakings of Teva pursuant to Sections 2.2 and 2.3 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 Teva’s breach or threatened breach or
failure to comply with such Sections 2.2 and 2.3 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. Teva 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 2.2 or 2.3 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 Teva an opportunity to cure, in addition to seeking any other remedy
available to Medicis in law or equity. Teva agrees that it shall not challenge any of the
foregoing acknowledgements and agreements concerning injunctive relief in any proceeding brought by
Medicis.
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6. INDEMNIFICATION.
6.1 Teva Indemnification. Teva 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 Teva’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.
6.2 Medicis Indemnification. Medicis shall indemnify, defend and hold harmless Teva,
its directors, managers, members, officers, employees, authorized subcontractors and agents
(collectively the “Teva 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 Teva’s breach of any
representation, warranty or covenant under this Agreement.
6.3 Obligations. A party which intends to claim indemnification under this Section 6
(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 6. 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.
7. GENERAL PROVISIONS.
7.1 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:
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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 Teva: | Teva Pharmaceuticals USA, Inc. | |||
0000 Xxxxxxx Xxxx. | ||||
Xxxxx Xxxxx, XX 00000 | ||||
Attn: President & CEO | ||||
Facsimile: (000) 000-0000 | ||||
With a copy to: | Teva Pharmaceuticals USA, Inc. | |||
0000 Xxxxxxx Xxxx. | ||||
Xxxxx Xxxxx, XX 00000 | ||||
Attn: General Counsel | ||||
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 7.1.
7.2 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 Teva and Medicis and their respective permitted successors and assigns.
7.3 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.
7.4 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.
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7.5 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; and (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. 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 7.5 shall be void.
7.6 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.
7.7 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.
7.8 Headings, Interpretation. The headings used in this Agreement are for convenience
only and are not part of this Agreement.
7.9 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.
7.10 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]
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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.
XXXX LABORATORIES, INC. | MEDICIS PHARMACEUTICAL CORPORATION | |||||||||
By:
|
By: | |||||||||
Name: | Name: | |||||||||
Title: | Title: | |||||||||
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EXHIBIT A
Patent Rights
Issued Patents (all U.S.)
5,908,838
7,541,347 (issued June 2, 2009 from 11/695,528)
7,544,373 (issued June 9, 2009 from 11/695,539)
7,541,347 (issued June 2, 2009 from 11/695,528)
7,544,373 (issued June 9, 2009 from 11/695,539)
Pending Applications (all U.S.)
11/776,669
11/776,676
11/776,691
11/776,711
11/944,186
11/695,513
11/695,514
11/695,541
12/253,845
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
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, |
) | |||
) | ||||
v. |
) | C.A. No. 09-033 (JJF) | ||
) | ||||
MYLAN INC.; |
) | |||
MATRIX LABORATORIES LTD.; |
) | |||
MATRIX LABORATORIES INC.; |
) | |||
SANDOZ, INC.; and |
) | |||
XXXX LABORATORIES, INC. |
) | |||
) | ||||
Defendants. |
) |
UNOPPOSED MOTION FOR ENTRY OF CONSENT JUDGMENT AND
PERMANENT INJUNCTION AS TO XXXX LABORATORIES, INC.
PERMANENT INJUNCTION AS TO XXXX LABORATORIES, INC.
Plaintiff Medicis Pharmaceutical Corporation (“Medicis”) and Defendant Xxxx Laboratories, Inc.
(“Xxxx”) having met, conferred, and agreed to resolve their dispute upon execution of a separate
Settlement Agreement (“Settlement Agreement”), Medicis respectfully moves for entry of the executed
Consent Judgment and Permanent Injunction submitted herewith. Xxxx does not oppose this motion.
C-1
MORRIS, NICHOLS, ARSHT & XXXXXXX LLP | ||
Xxxx X. Xxxxxxxxxx (#1014) | ||
Xxxxx Xxxxxx Xxxxxx (#2881) | ||
0000 Xxxxx Xxxxxx Xxxxxx | ||
Xxxxxxxxxx, XX 00000-0000 | ||
(000) 000-0000 | ||
Xxxxxxxxxxx@xxxx.xxx | ||
xxxxxxx@xxxx.xxx | ||
Attorneys for Plaintiff | ||
Medicis Pharmaceutical Corporation | ||
OF COUNSEL: |
||
Xxxxxxx X. Xxxxxx |
||
WEIL, GOTSHAL & XXXXXX LLP |
||
000 Xxxxxxx Xxxxxx Xxxxxxx |
||
Xxxxxxx Xxxxxx, XX 00000 |
||
Telephone: (000) 000-0000 |
||
Facsimile: (000) 000-0000 |
||
Xxxxxxxxx Xxxxxxxx Xxxxxxxxxx |
||
Xxxxx Xxxxxx |
||
Xxxxxxxx X. Xx |
||
Xxxxxx Xxxxxx |
||
XXXX, GOTSHAL & XXXXXX LLP |
||
000 Xxxxx Xxxxxx |
||
Xxx Xxxx, XX 00000 |
||
Telephone: (000) 000-0000 |
||
Facsimile: (000) 000-0000 |
||
Dated: November 13, 0000 |
X-0
XX XXX XXXXXX XXXXXX DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
FOR THE DISTRICT OF DELAWARE
MEDICIS PHARMACEUTICAL
|
) | |||||
CORPORATION,
|
) | |||||
) | ||||||
Plaintiff,
|
) | |||||
) | ||||||
v.
|
) | C.A. No. 09-033 (JJF) | ||||
) | ||||||
MYLAN INC.;
|
) | |||||
MATRIX LABORATORIES LTD.;
|
) | |||||
MATRIXLABORATORIES INC.;
|
) | |||||
SANDOZ, INC.; and
|
) | |||||
XXXX LABORATORIES, INC.
|
) | |||||
) | ||||||
Defendants.
|
) |
CONSENT JUDGMENT AND PERMANENT INJUNCTION
AS TO XXXX LABORATORIES, INC.
AS TO XXXX LABORATORIES, INC.
This matter is before the Court on the unopposed motion of Plaintiff Medicis Pharmaceutical
Corporation (“Medicis”) and Defendant Xxxx Laboratories, Inc. (“Xxxx”).
WHEREAS, this Consent Judgment and Permanent Injunction as to Xxxx concerns only Medicis’s
claims against Xxxx and Xxxx’x counterclaims against Medicis in this civil action no. 09-033-JJF
(referred to herein as the “Litigation”).
WHEREAS, Medicis requests that this Consent Judgment and Permanent Injunction as to Xxxx be
entered in the above-captioned case, and Xxxx does not oppose Medicis’s request.
WHEREAS, Medicis owns United States Patent No. 5,908,838 (“the ’838 patent”).
C-3
WHEREAS, Xxxx submitted Abbreviated New Drug Application No. 65-485 (“Xxxx’x XXXX”) 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 for the treatment of acne.
WHEREAS, in the Litigation, Medicis alleged that Xxxx 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 Xxxx’x submission of Xxxx’x
XXXX to the FDA.
WHEREAS, in this Litigation, Medicis alleged that it would be irreparably harmed if Xxxx 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 this Litigation, Medicis requested that this Court enter a permanent injunction
enjoining Xxxx from infringing the ’838 patent.
WHEREAS, Medicis and Xxxx have reached an agreement to finally settle the Litigation as set
forth in this Consent Judgment and Permanent Injunction as to Xxxx and a separate Settlement
Agreement (“Settlement Agreement”) which is contemporaneously and separately being executed.
WHEREAS, final settlement of the Litigation will help Medicis and Xxxx avoid the substantial
uncertainty and risks involved with prolonged litigation.
WHEREAS, final settlement of this Litigation will permit Medicis and Xxxx to save litigation
costs, as well as adhere to the judicially recognized mandate that encourages the settlement of
litigation whenever possible.
C-4
WHEREAS, final settlement of the Litigation serves the public interest by saving judicial
resources and avoiding the risks to each of Medicis and Xxxx associated with infringement.
WHEREAS, Medicis and Xxxx each consent to personal jurisdiction in Delaware for purposes of
enforcing the Settlement Agreement.
IT IS HEREBY ORDERED, DECREED, and ADJUDGED as follows:
1. The Court has jurisdiction over Medicis and Xxxx and the subject matter of this Litigation.
2. Xxxx acknowledges Medicis’s ownership and standing to xxx for infringement of United States
Patent No. 5,908,838 (“the ’838 patent”).
3. Xxxx acknowledges that the ’838 patent is valid and enforceable, as described more fully in
the Settlement Agreement.
4. Xxxx acknowledges that it has infringed the ’838 patent under 35 U.S.C. § 271(e)(2) and
that Medicis did not authorize the manufacture, use, sale, offer for sale, importation and
distribution of the product described in Xxxx’x XXXX.
5. Xxxx and its affiliates, including, but not limited to, Teva Pharmaceuticals USA, Inc.
(“Teva”), 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 Xxxx’x XXXX 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
C-5
distribute any current products, or future products having the same strength and dosage form
of the current Solodyn® products, that are the subject of Xxxx’x XXXX that is not pursuant to a
license granted by Medicis.
6. All claims and counterclaims in this Litigation are hereby dismissed without prejudice.
7. The parties are hereby ordered to comply with the terms of the Settlement Agreement.
8. Each party shall bear its own costs and attorneys’ fees.
9. This Court shall retain jurisdiction over Xxxx 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 by any third party.
IT IS SO ORDERED, DECREED AND ADJUDGED this day of March, 2009 by:
The Xxxxxxxxx Xxxxxx X. Xxxxxx Xx. |
||
United States District Judge |
C-6
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) | |
MORRIS, NICHOLS, ARSHT & XXXXXXX LLP
|
D. Xxx Xxxxxxxxx-Xxxxxx (#4646) | |
0000 Xxxxx Xxxxxx Xxxxxx
|
Hercules Plaza, 0xx Xxxxx | |
Xxxxxxxxxx, XX 00000-0000
|
0000 X. 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 Medicis Pharmaceutical Corporation
|
xxxxxxxxxx-xxxxxx@xxxxxxxxxxxxxx.xxx | |
OF COUNSEL:
|
Attorneys for Xxxx Laboratories, Inc. | |
Xxxxxxx X. Xxxxxx
|
OF COUNSEL: | |
WEIL, GOTSHAL & XXXXXX LLP |
||
000 Xxxxxxx Xxxxxx Xxxxxxx
|
Xxxxxx X. Xxxxxx | |
Xxxxxxx Xxxxxx, XX 00000
|
Xxxxxx X. Xxxxx | |
Telephone: (000) 000-0000
|
Xxxxxxx X. Xxxxxxx | |
Facsimile: (000) 000-0000
|
Xxxxxxx X. Xxxxx | |
Xxxx X. Xxxxxxxx | ||
Xxxxxxxxx Xxxxxxxx Xxxxxxxxxx
|
XXXXXXX XXXX & XXXXXXXXX LLP | |
Xxxxx Xxxxxx
|
000 Xxxxxxx Xxxxxx | |
Xxxxxxxx X. Xx
|
Xxx Xxxx, XX 00000 | |
Xxxxxx Xxxxxx
|
Telephone: (000) 000-0000 | |
WEIL, GOTSHAL & XXXXXX LLP
|
Facsimile: (000) 000-0000 | |
000 Xxxxx Xxxxxx |
||
Xxx Xxxx, XX 00000 |
||
Telephone: (000) 000-0000 |
||
Facsimile: (000) 000-0000 |
C-7
SCHEDULE A
Distributed Quantities
45mg (30tab/bottle) — *** bottles
45mg (100tab/bottle) — *** bottles
90mg (30tab/bottle) — *** bottles
90mg (100tab/bottle) — *** bottles
135mg (30tab/bottle) — *** bottles
135mg (100tab/bottle) — *** bottles
SCHEDULE B
Press Release(s)
[Medicis/Teva] today announced they have agreed to terminate all legal disputes between them
relating to SOLODYN® (minocycline HCl, USP) Extended Release Tablets. Pursuant to an agreement
entered into between the parties, Teva has confirmed that Medicis’ patents relating to SOLODYN® are
valid and enforceable, and cover Teva’s activities relating to its generic product under
Abbreviated New Drug Application (ANDA) #65-485. As part of the settlement, Teva has agreed to
immediately stop all further shipments of generic SOLODYN®. Medicis has agreed to release Teva
from liability arising from any prior sales of its generic SOLODYN®, which were not authorized by
Medicis.
Under the terms of the Settlement Agreement, Teva has the option to market its generic versions of
SOLODYN® 45mg, 90mg and 135mg under the SOLODYN® intellectual property rights belonging to Medicis
commencing in November 2011, or earlier under certain conditions. Additional terms were not
disclosed.