Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. SETTLEMENT AND LICENSE AGREEMENT
Exhibit 10.4
CONFIDENTIAL
EXECUTION VERSION
EXECUTION VERSION
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Securities and Exchange Commission. Asterisks denote omissions.
This SETTLEMENT AND LICENSE AGREEMENT (“Agreement”), effective as of the Effective Date (as
defined below), is made by and among Endo Pharmaceuticals Inc., a Delaware corporation having its
principal place of business at 000 Xxxx Xxxxxxxxx, Xxxxxx Xxxx, XX 00000 (“Endo”), Penwest
Pharmaceuticals Co., a Washington corporation having its principal place of business at 0000 Xxxxx
00, Xxxxx 0, Xxxxxxxxx, XX 00000 (“Penwest”), and Impax Laboratories, Inc., a Delaware
corporation having its principal place of business at 00000 Xxxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxx
00000 (“Impax”). Endo, Penwest and Impax are hereinafter collectively referred to as the
“Parties”, and each individually as a “Party”.
RECITALS
WHEREAS, Endo, Penwest and Impax are parties to patent infringement litigations in the United
States District Court for the District of New Jersey (as further defined below, the “New Jersey
Actions”); and
WHEREAS, the Parties seek to resolve the New Jersey Actions without further litigation.
NOW, THEREFORE, in consideration of the covenants, conditions and obligations expressed
herein, and intending to be legally bound thereby, the Parties hereto agree as follows:
ARTICLE I.
DEFINITIONS
DEFINITIONS
Section 1.1. Definitions. The following terms will have the meanings provided below:
“Affiliate” means any person, corporation, company, partnership, joint venture or
other entity controlling, controlled by or under common control with the applicable party. For
such purpose, the term “control” means the holding of fifty percent (50%) or more of the common
voting stock or ordinary shares in, or the right to appoint fifty percent (50%) or more of the
directors of, or otherwise possessing the power to direct or cause the direction of the management
and policies of the said corporation, company, partnership, joint venture or entity.
“Agreement” has the meaning specified in the introductory paragraph hereof.
“ANDA” means an Abbreviated New Drug Application, as defined in 21 U.S.C. 355(j) et
seq., and the regulations promulgated thereunder.
“Commencement Date” means:
(a) with respect to the 5mg, 10mg, 20mg, 30mg and 40mg dosage strengths of the Impax Product
and any future dosage strengths of the Impax Product under the Impax
ANDA for which Impax obtains first applicant status as described in Section 505(j)(5)(B)(iv)
of the FD&C Act, the date that is the earliest of:
(i) January 1, 2013;
(ii) thirty (30) days after the date of a final federal court decision that is no longer
subject to appeal (other than by a petition for writ of certiorari) holding all asserted and
adjudicated claims of the Opana® ER Patents to be (A) invalid or unenforceable in any
lawsuit or (B) non-infringed in a lawsuit involving Endo and/or Penwest in response to a filing by
a Third Party under Section 505(j) of the FD&C Act referencing the Opana® ER Product; and
(iii) the date that the patent information submitted under Section 505(b) of the FD&C Act is
withdrawn by Endo and/or Penwest (21 U.S.C. § 355(j)(5)(D)(i)(I)); and
(b) with respect to the 7.5mg and 15mg dosage strengths of the Impax Product and any future
dosage strengths of the Impax Product under the Impax ANDA for which Impax does not obtain first
applicant status as described in Section 505(j)(5)(B)(iv) of the FD&C Act, the date that is the
earliest of:
(i) January 1, 2013;
(ii) the date of a final federal court decision that is no longer subject to appeal (other
than by a petition for writ of certiorari) holding all asserted and adjudicated claims of the
Opana® ER Patents to be (A) invalid or unenforceable in any lawsuit or (B) non-infringed
in a lawsuit involving Endo and/or Penwest in response to a filing by a Third Party under Section
505(j) of the FD&C Act referencing the Opana® ER Product; and
(iii) the date on which a Third Party commences commercial sale of an FDA approved generic
extended release oxymorphone product that is AB rated to Opana® ER Product, provided that
if such commercial sale is made at risk, and Endo and/or Penwest are successful in causing such
commercial sale to halt, then the Commencement Date will be deemed not to have occurred and Impax
will not launch or continue selling the Impax Product as a result of such commercial sale.
“Covenant Not To Xxx” has the meaning specified in Section 4.1(b).
“Dismissal Date” means the date on which the Stipulation of Dismissal and Order
attached hereto as Appendix A is approved and entered as an order of the court by the court in the
New Jersey Actions.
“DOJ” has the meaning specified in Section 2.1.
“Effective Date” means June 8, 2010.
“Endo” has the meaning specified in the introductory paragraph hereof.
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“Endo Credit” means an amount equal to the product obtained by multiplying (i) the
difference between the [**] and the [**] by (ii) the [**]. For the sake of
clarity, if the difference reflected in clause (i) were [**], then clause (i) would be equal to
[**], and not [**].
“Endo Net Sales” means the gross amounts invoiced by Endo for the sale of Endo
Products by Endo to Third Parties, less deductions customarily deducted by Endo in the ordinary
course in accordance with U.S. generally accepted accounting principles, consistently applied,
throughout the period beginning July 1, 2010 and ending on the day before the Commencement Date.
“Endo Product” means the Opana® ER Products for which Impax has obtained first
applicant status, as described in Section 505(j)(5)(B)(iv) of the FD&C Act.
“Exclusivity Period” has the meaning specified in Section 4.1(c).
“Existing Patents” has the meaning specified in Section 4.1(a).
“FDA” means the United States Food and Drug Administration and any successor agency or
authority thereto.
“FD&C Act” means the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.
“FDB Data” means data maintained by First DataBank, Incorporated relating to the sale
of pharmaceutical drug products in the Territory.
“FTC” has the meaning specified in Section 2.1.
“Impax” has the meaning specified in the introductory paragraph hereof.
“Impax ANDA” means ANDA No. 79-087, and any amendments or supplements thereto.
“Impax Parties” has the meaning specified in Section 4.1(b).
“Impax Product” means any product that (i) is the subject of the Impax ANDA as of the
Effective Date, or (ii) is the subject of the Impax ANDA and which is substantially equivalent to
those products that are the subject of the Impax ANDA as of the Effective Date, including any
future dosage strengths of the product that is the subject of the Impax ANDA as of the Effective
Date. For clarity, a product will be considered “substantially equivalent” to those products that
are the subject of the Impax ANDA as of the Effective Date if regulatory approval of such product
by the FDA would not require the performance of any additional bioequivalence studies (other than
bioequivalence studies required by the FDA for new dosage strengths of or new reference listed drug
descriptions for the product that is the subject of the Impax ANDA as of the Effective Date or any
other changes that do not substantially change the formulation of the products subject to the Impax
ANDA), and if its formulation is substantially the same
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formulation as the products that are the subject of the Impax ANDA as of the Effective Date.
“IMS Data” means data maintained by IMS Health Incorporated relating to the sale of
pharmaceutical drug products in the Territory.
“License” has the meaning specified in Section 4.1(a).
“License Term” has the meaning specified in Section 4.2(a).
“Licensed Patents” has the meaning specified in Section 4.1(a).
“Market Share Profit Factor” means the factor obtained by multiplying [**] (generic
substitution rate) by [**].
“Market Share Profit Value” means the factor obtained by multiplying: [**].
| [**] | [**] | [**] | ||
| [**] |
“NDA” means a New Drug Application, as defined in 21 U.S.C. 355(b) et seq., and the
regulations promulgated thereunder.
“Net Sales” means the gross amount invoiced by or on behalf of Impax for the sale of
Impax Products to Third Parties, less deductions for: (i) normal and customary trade, cash and
quantity discounts actually given, credits, price adjustments or allowances for damaged Impax
Products, returns or rejections of Impax Products, free goods valued at transfer price provided in
lieu of discounts or rebates; (ii) chargeback payments and rebates (or the equivalent thereof)
granted to group purchasing organizations, managed health care organizations or to federal,
state/provincial, local and other governments, including their agencies, or to trade customers and
other price reduction programs customary to the trade or required by law; (iii) freight, shipping
insurance and other transportation expenses directly related to the sale (if actually borne by
Impax without reimbursement from any Third Party); (iv) required sales and distribution
commissions/fees payable to any Third Party providing sales or distribution services to Impax; (v)
sales, value-added and excise taxes, tariffs and duties, surcharges and other taxes and government
charges directly related to the sale, to the extent such items are included in the gross invoice
price and actually borne by Impax without reimbursement from any Third Party (but not including
taxes assessed against the income derived from such sale); (vi) administrative fees, marketing fees
and other similar fees, payments or credits paid to unaffiliated Third Parties customary to the
trade or required by law to the extent such fees, payments and credits are customarily deducted
from gross sales, and (vii) commercially reasonable write-offs for doubtful accounts for Impax
Product sold by or on behalf of Impax. Net Sales shall be determined in all cases in accordance
with U.S. generally accepted accounting principles.
Page 4
“New Jersey Actions” means Endo Pharmaceuticals Inc. and Penwest Pharmaceuticals Co.
v. Impax, Civil Action Nos. 09-831, 09-832 and 09-833 (KSH-PS).
“Opana® ER Generic Product” means any generic version of an Opana® ER Product that is
the subject of an application filed under Section 505(b)(2) or Section 505(j) of the FD&C Act.
“Opana® ER Patents” means U.S. Patents 5,662,933, 5,958,456 and 7,276,250, and any
U.S. patents resulting from any reissue or reexamination thereof.
“Opana® ER Product” means any product marketed and/or sold under the Opana® NDA.
“Opana® NDA” means NDA No. 21-610 and any amendments or supplements thereto.
“Orange Book” means the FDA publication Approved Drug Products with Therapeutic
Equivalence Evaluations.
“Paragraph IV Certification” means a paragraph IV certification under Section
505(j)(2)(A)(vii)(IV) of the FD&C Act (21 U.S.C. § 355(j)(2)(A)(vii)(IV)).
“Party” and “Parties” have the meanings specified in the introductory
paragraph hereof.
“Pending Applications” has the meaning specified in Section 4.1(a).
“Penwest” has the meaning specified in the introductory paragraph hereof.
“Person” means any person, corporation, partnership, joint venture, association,
joint-stock company, trust or unincorporated organization.
“Pre-Impax Amount” means, expressed as a percentage, [**] or (ii) if the Commencement
Date is earlier than January 1, 2013 pursuant to the terms hereof, the [**], divided by the [**].
“Prescription Sales” means for any month, the sum of, for each strength of the Endo
Product, (i) [**] Data multiplied by (ii) [**].
“Quarterly Peak” means the highest Prescription Sales of the Endo Product during any
calendar quarter period from July 1, 2010 through September 30, 2012, or the last day of the full
calendar quarter described in clause (ii) of the defined term Pre-Impax Amount.
“Territory” means the United States of America, its territories, districts,
possessions and commonwealths, including the Commonwealth of Puerto Rico.
Page 5
“Third Party” means any Person other than Impax, Endo, Penwest and their respective
Affiliates.
“Trigger Threshold” means [**] percent ([**]%).
ARTICLE II.
SUBMISSION TO U.S. GOVERNMENT
SUBMISSION TO U.S. GOVERNMENT
Section 2.1. Submission To U.S. Government. The Parties will submit this Agreement
and any ancillary and other related agreements thereto to the Antitrust Division of the United
States Department of Justice (“DOJ”) and the Federal Trade Commission (“FTC”) for
review as promptly as practical after the Effective Date, and in any event within the period
prescribed by the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and other
applicable law. Each of the Parties will use its respective reasonable best efforts to fully
cooperate with any investigation that may ensue as a result of such submission. If any government
investigation or litigation is instituted, each Party will use its respective reasonable efforts to
defend this Agreement and any ancillary and other related agreements thereto in any such
investigation or litigation, and to resist and contest any proposals or efforts to materially alter
the terms thereof so as to permit the Parties to fulfill their obligations under and to obtain the
full benefits contemplated by this Agreement and any ancillary and other related agreements
thereto, including using their reasonable efforts to promptly meet in good faith to renegotiate and
modify this Agreement, provided that such modifications do not materially change the economic value
of the transactions contemplated hereby. Each Party reserves the right to communicate with the FTC
or DOJ regarding such filings as it believes appropriate. Each Party shall keep the other Parties
reasonably informed of such communications and shall not disclose any confidential information of
the other Parties without such other Parties’ consent, which will not be unreasonably withheld or
delayed.
Section 2.2. No Prejudice. If at any time this Agreement or any ancillary or other
related agreements thereto is rendered null and void with respect to the Territory or any portion
thereof by the actions of a Third Party or government entity, it is the intent of the Parties that
(i) no Party will be in any way prejudiced with respect to its claims, causes of action, defenses
and counterclaims in the New Jersey Actions in such jurisdiction or otherwise, (ii) no consent
judgment, order or dismissal entered by a Party pursuant to this Agreement in the Territory or
portion thereof, as applicable, will be deemed an admission on the part of such Party, (iii) the
Parties will be free to assert any and all claims and defenses with respect to the reinstated
portion of the New Jersey Actions in any future litigation, and (iv) the provisions of Section
8.3 shall apply.
ARTICLE III.
SETTLEMENT; DISMISSAL OF ACTION
SETTLEMENT; DISMISSAL OF ACTION
Section 3.1. Required Filings. No later than three (3) days after the Effective Date,
Impax, Endo and Penwest will execute and deliver to the other Parties, or cause their respective
attorneys of record in the New Jersey Actions to execute and deliver to
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the other Parties, the Stipulation of Dismissal and Order attached hereto as Appendix
A, pursuant to which the New Jersey Actions will be dismissed with prejudice and without costs,
and the attorneys for Endo and Penwest shall submit such executed Stipulation of Dismissal and
Order to the court in the New Jersey Actions. If for any reason the court in the New Jersey
Actions does not approve the Stipulation of Dismissal and Order and enter it as an order of the
court, the Parties agree to confer promptly in good faith in an effort to modify the Stipulation of
Dismissal and Order and this Agreement or take such other action as is required to overcome the
court’s objections.
Section 3.2. Impax Sale Commencement Date. Subject to this Section 3.2, Impax
agrees, on behalf of itself and its Affiliates, not to, prior to the applicable Commencement Date,
directly or indirectly market, offer to sell, sell, import, manufacture or have manufactured in or
for the Territory any Opana® ER Generic Product, or directly or indirectly assist or authorize any
Third Party to do any of the foregoing. Impax shall have the right to make commercially reasonable
preparations prior to the Commencement Date as set forth below. Nothing in this Agreement shall
preclude Impax or its Affiliates from manufacturing, having manufactured, importing or marketing
the Impax Products in or for the Territory for a reasonable period of time, as set forth below,
prior to the applicable Commencement Date solely for the purpose of allowing Impax and its
Affiliates to prepare for the commercial sale of such Impax Products for delivery in the Territory
for sale only on and after the Commencement Date pursuant to Section 4.1 or for purposes of
conducting activities protected under 35 U.S.C. § 271(e)(1). A reasonable period of time for
purposes of the foregoing sentence shall be no more than [**] days prior to the anticipated
applicable Commencement Date for the marketing of and offers to sell the Impax Products and a
commercially reasonable period of time prior to the anticipated applicable Commencement Date for
the manufacturing and importing of the Impax Products. Impax will provide notice to Endo and
Penwest as soon as practicable, and in any event prior to launch of the Impax Product, if it
believes that the Commencement Date will be earlier than January 1, 2013. Impax acknowledges and
agrees that Endo and Penwest would be irreparably harmed should Impax breach the first sentence of
this Section 3.2. Nothing in the Agreement shall prohibit or preclude Impax from
exercising its rights under 35 U.S.C. § 271(e)(1).
Section 3.3. No Challenge to Opana® ER Patents. From and after the Effective Date,
Impax agrees, on behalf of itself and its Affiliates, not to, directly or indirectly, challenge the
validity or enforceability of the Licensed Patents with respect to any product that is the subject
of the Impax ANDA or the infringement of the Licensed Patents by the manufacture, use and sale of
any product that is the subject of the Impax ANDA, including by suing, directly or indirectly,
Endo, Penwest or any of their respective Affiliates in any action in any forum seeking an order or
decision that any of the Licensed Patents is invalid or unenforceable with respect to any product
that is the subject of the Impax ANDA or that the manufacture, use or sale of any product that is
the subject of the Impax ANDA does not infringe the Licensed Patents. Further, Impax will not, and
will cause its Affiliates to not, directly or indirectly, participate in or support any such
challenges relating to any Opana® ER Generic Product by any Person. Notwithstanding the foregoing,
nothing herein shall prevent Impax from (a) maintaining the Paragraph IV Certifications contained
in the Impax ANDA, (b) amending the Impax
Page 7
ANDA, such as to include future Opana® ER Product dosages, or a Paragraph IV Certification to
any patents that may be listed in the Orange Book for the Opana® ER Product, or (c) challenging the
Licensed Patents with respect to any product that is not the subject of the Impax ANDA.
Section 3.4. Costs; Dismissals. All dismissals of all claims and counterclaims
specified in Section 3.1 will be without costs to any Party and will include an irrevocable
release by each Party, on behalf of itself and its Affiliates, of all claims for attorneys’ fees.
Each Party will bear its own costs in connection with entering into this Agreement and the
negotiation and submission of the dismissals specified in Section 3.1.
Section 3.5. No Implied Consents. Nothing herein will be deemed to be Endo’s or
Penwest’s consent to or approval of any ANDA or similar application or filing by Impax or any of
its Affiliates in any foreign jurisdiction, or to permit Impax or any of its Affiliates the right
to reference or cross-reference any Endo NDA, Penwest NDA or similar application or filing.
Section 3.6. Releases. (a) Except for the obligations created under this Agreement,
and unless this Agreement is terminated pursuant to Section 8.2, Impax, on behalf of itself
and its Affiliates, predecessors, successors and assigns, and all other Persons claiming by,
through and under them, does hereby fully, finally release and forever discharge, relinquish and
acquit, effective on the Dismissal Date, Endo and Penwest and their respective past and present
Affiliates and their respective, predecessors, successors, assigns and their respective past and
present Affiliates, shareholders, predecessors, successors, assigns, employees, officers,
directors, principals, agents, attorneys, accountants, representatives, insurers, manufacturers,
suppliers, importers, distributors and customers from any and all claims, rights, causes of action,
counterclaims, defenses and liabilities whatsoever that, in each case accrued prior to the
Effective Date, whether based on federal, state, local, statutory or common law or any other law,
rule or regulation, whether known or unknown, (i) that in any way arise out of, or are related to,
any cause of action asserted in the New Jersey Actions; (ii) that relate to the Impax Products and
could have been asserted in the New Jersey Actions now or upon the approval of the Impax Products;
or (iii) that in any way arise out of, or are related to, the marketing or sale of Opana® ER
Products, or the acquisition, listing in the FDA’s Orange Book or enforcement of the Opana® ER
Patents, including without limitation any antitrust or unfair competition claims. Nothing in this
release shall preclude Impax from asserting the invalidity, unenforceability or non-infringement of
the Opana® ER Patents, any continuations, continuations-in-part, or divisionals thereof, and any
patents and patent applications owned or controlled by, or licensed to, Endo or Penwest (or their
respective Affiliates) in any future litigation concerning any product that is not the subject of
the Impax ANDA.
(b) Except for the obligations created under this Agreement, and unless this Agreement is
terminated pursuant to Section 8.2, Endo and Penwest, on behalf of themselves and their
respective Affiliates, predecessors, successors and assigns, and all other Persons claiming by,
through and under them, do hereby fully, finally release and forever discharge, relinquish and
acquit effective on the Dismissal Date, Impax and its
Page 8
predecessors, successors, assigns and their respective past and present Affiliates,
shareholders, predecessors, successors, assigns, employees, officers, directors, principals,
agents, attorneys, accountants, representatives, insurers, manufacturers, suppliers, importers,
distributors and customers from any and all claims, rights, causes of action, counterclaims,
defenses and liabilities whatsoever that, in each case accrued prior the Effective Date, whether
based on federal, state, local, statutory or common law or any other law, rule or regulation,
whether known or unknown, (i) that in any way arise out of, or are related to, any cause of action
asserted in the New Jersey Actions; (ii) that relate to the Impax Products and could have been
asserted in the New Jersey Actions now or upon the approval of the Impax Products, including
without limitation any antitrust or unfair competition claims relating thereto; or (iii) that
relate to any activities in respect of the products that are the subject of the Impax ANDA that
were engaged in by Impax or its Affiliates prior to the Effective Date and that would have given
rise to a claim of infringement of the Licensed Patents. Nothing in this release shall preclude
Endo or Penwest from asserting the Opana® ER Patents, any continuations, continuations-in-part, or
divisionals thereof, and any patents and patent applications owned or controlled by, or licensed
to, Endo or Penwest (or their respective Affiliates) in any future litigation concerning any
product that is not the subject of the Impax ANDA.
ARTICLE IV.
LICENSE AND COVENANT NOT TO XXX
LICENSE AND COVENANT NOT TO XXX
Section 4.1. License; Covenant Not To Xxx. (a) Subject to the terms and conditions
herein, each of Endo and Penwest, on behalf of itself and its respective Affiliates, hereby grants
to Impax and its Affiliates, effective only on and after the applicable Commencement Date (subject
to Impax’s permitted pre-Commencement Date activities set forth in Section 3.2), and Impax
hereby accepts (on behalf of itself and its Affiliates), a non-transferable (except in accordance
with Section 9.6), non-sublicensable and royalty-free (except as set forth in Section 4.3)
license (the “License”), under the Opana® ER Patents, any continuations, continuations in
part, or divisionals thereof, and any patents and patent applications owned by Endo or Penwest (or
their respective Affiliates) to the extent that Endo and/or Penwest has the right to grant a
sublicense to such patents and applications that cover or could potentially cover the manufacture,
use, sale, offer for sale, importation, marketing or distribution of products (or any components
thereof) that are the subject of the Impax ANDA (the issued patents being the “Existing
Patents” and the patent applications (and any patents issued thereunder) being the “Pending
Applications” and the Existing Patents and Pending Applications being collectively the
“Licensed Patents”), during the License Term, to make, have made, offer to sell, sell, have
sold, market, distribute, import and use the Impax Products solely in or for the Territory.
(b) Each of Endo and Penwest, on behalf of itself and its Affiliates and its officers and
directors, covenants that it will not xxx or assert any claim against, or otherwise participate in
any action or proceeding against Impax or its Affiliates or their successors and permitted assigns
or any of Impax’s suppliers, distributors, wholesalers or customers (collectively, the “Impax
Parties”), or cause or authorize any person or entity to do any of the foregoing, in each case
claiming or otherwise asserting that the
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Settlement and License Agreement
manufacture, use, sale, offer for sale, importation, marketing or distribution of Impax
Products in or for the Territory on or after the applicable Commencement Date (subject to Impax’s
or its Affiliates’ permitted pre-Commencement Date activities set forth in Section 3.2 and
except for any activities in respect of the products that are the subject of the Impax ANDA that
were engaged in by Impax or its Affiliates prior to the Effective Date and that would have given
rise to a claim of infringement of the Licensed Patents) by or on behalf of Impax, infringes the
Licensed Patents or any patents or patent applications licensed to Endo or Penwest (or their
respective Affiliates) that cover or could potentially cover the manufacture, use, sale, offer for
sale, importation, marketing or distribution of products (or any components thereof) that are the
subject of the Impax ANDA, so long as Impax is in compliance with the terms of this Agreement (the
“Covenant Not to Xxx”).
(c) The License granted in this Agreement to Impax is non-exclusive, except as provided in
this Section 4.1(c). Endo and Penwest agree that, for the Exclusivity Period (as defined
below), the License granted to Impax covering the 5mg, 10mg, 20mg, 30mg and 40mg dosage strengths
of the Impax Product, and any future dosage strengths of the Impax Product under the Impax ANDA for
which Impax obtains first applicant status as described in Section 505(j)(5)(B)(iv) of the FD&C
Act, shall be exclusive as to all but (i) the Opana ER® Product and any Opana ER®-branded products
that are not sold as generic products and (ii) generic products covered by agreements executed by
Endo and/or Penwest and a Third Party that holds an ANDA referencing the Opana® ER Product as of or
prior to the Effective Date. The “Exclusivity Period” for each such dosage strength of the
Impax Product is defined as starting on the Commencement Date and ending on the earlier of (x)
12:01 A.M. EST on the day after the 180-day period described in 21 U.S.C. § 355(j)(5)(B)(iv) for
such dosage strength; and (y) 12:01 A.M. EST on the day after the FDA determines that the 180-day
period described in 21 U.S.C. § 355(j)(5)(B)(iv) for such dosage strength has been forfeited by the
occurrence of any event, including those described in 21 U.S.C. § 355(j)(5)(D)(i)(I)-(IV). Prior
to the expiration of the Exclusivity Period, neither Endo nor Penwest nor any of their respective
Affiliates shall (A) sell, offer to sell, import, or distribute any generic version of products
that are the subject of the Opana® NDA, (B) license or authorize any Third Party to sell, offer to
sell, import or distribute any generic version of products that are the subject of the Opana® NDA,
and/or (C) sell or license or authorize under the Opana® ER Patents any Third Party to
sell an Opana® ER Generic Product in or for the Territory, except as provided for herein.
Notwithstanding the foregoing, nothing in this Agreement shall prohibit Endo or Penwest from
entering into bona fide settlements with Third Parties relating to ANDAs filed by such Third
Parties in relation to the Opana® ER Product, which settlements may include licenses and covenants
not to xxx under the Opana® ER Patents; provided, however, that such settlement or any other
agreement entered into by Endo or Penwest with any such Third Party shall not grant any right or
license authorizing such Third Party to make, have made, use, sell, offer to sell, import or
distribute products that are the subject of the Opana® NDA. Following the expiration of the
Exclusivity Period with respect to the dosage strengths referenced above, and at all times with
respect to the 7.5mg and 15mg dosage strengths of the Impax Product and any other dosage strengths
of the Impax Product under the Impax ANDA for which Impax
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Settlement and License Agreement
does not obtain first applicant status as described in Section 505(j)(5)(B)(iv) of the FD&C
Act, the License granted to Impax shall be non-exclusive.
(d) Impax, Endo and Penwest each agrees to negotiate in good faith an amendment to the terms
of the License to any patents which issue from any Pending Applications for the time period
following the Exclusivity Period.
(e) For avoidance of doubt, and notwithstanding anything to the contrary in this Agreement,
the License and Covenant Not To Xxx do not grant to Impax any rights or immunities, or impose on
Impax any restrictions, with respect to any products other than the Impax Products, including any
combination products.
(f) In the event that the Commencement Date has occurred and the License has become effective
due to an at-risk launch by a Third Party of an FDA-approved generic extended release oxymorphone
product that is AB-rated to Opana® ER, and Endo and Penwest are successful in stopping such Third
Party that engaged in such at-risk launch from selling such generic extended release oxymorphone
product in the Territory, Endo and Penwest may, at their discretion, suspend the Commencement Date
upon written notice to Impax, in which case Impax immediately shall, subject to Section
3.2, cease making, using, shipping, distributing, selling and/or offering to sell the Impax
Products until such time as the License becomes effective again due to the triggering of the
Commencement Date, provided that any activities conducted by Impax or any of its Affiliates
prior to such suspension shall remain subject to the License and Covenant Not to Xxx.
(g) Impax will have no right or immunity under the License or the Covenant Not To Xxx to,
market, offer to sell or sell the Impax Products to any Person outside of the Territory or to any
Person that Impax knows, or should reasonably be expected to know, may, directly or indirectly,
market, offer to sell, sell or use any of the Impax Products outside of the Territory.
Notwithstanding the foregoing, nothing herein shall be construed as an admission or waiver as to
any factual or legal matter by any Party or their Affiliates with respect to any products other
than Impax Products, or to any jurisdiction outside of the Territory (including without limitation,
with respect to any ex-U.S. equivalents of any generic oxymorphone products or any ex-U.S. patents
or patent applications.)
Section 4.2. License Term. The term of the License (“License Term”) will
commence on the applicable Commencement Date for each Impax Product and will continue, unless
earlier suspended or terminated pursuant to this Agreement, until the expiration of all claims of
the Licensed Patents.
Section 4.3. Royalties. Impax agrees to pay to Endo a royalty on all Net Sales of
Impax Products (for which dosage strengths Impax has obtained first applicant status, as described
in Section 505(j)(5)(B)(iv) of the FD&C Act) sold by or on behalf of Impax during the Exclusivity
Period. Such royalties shall be calculated as follows: if Endo Net Sales of Endo Products for the
[**], then Impax shall pay to Endo a royalty of [**] percent ([**]%) on Net Sales of Impax Products
(for which dosage strengths Impax has
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Settlement and License Agreement
obtained first applicant status, as described in Section 505(j)(5)(B)(iv) of the FD&C Act)
during the Exclusivity Period. Otherwise, no royalty shall be due. Such royalty shall be paid by
Impax to Endo within ninety (90) days after the end of the Exclusivity Period by wire transfer to
an account specified by Endo in writing to Impax, and shall be accompanied by a written report
specifying in reasonable detail the amount of such Net Sales during the Exclusivity Period and the
royalty payable therefor.
Section 4.4. Endo Credit. If the [**] is less than the [**], then [**] shall pay to
[**] shall pay [**] the amount under this Section 4.4, if any, within ninety (90) days
after [**] with written documentation of all of the amounts referenced in this Section 4.4.
Section 4.5. Steering Committee. Promptly after the Effective Date, the Parties will
form a committee (the “Steering Committee”), equally represented by Endo and Impax, to meet
within forty-five (45) days after the end of each quarter, beginning with the quarter ending June
30, 2010, to determine in good faith [**], if any. In making such
determination, the Steering Committee shall rely on [**], or such other market
data as may be determined by the Steering Committee, and shall agree on the methodology for
calculating [**].
Section 4.6. Opana® ER Patents. As among the Parties, Endo and/or Penwest will have
the sole right, but not the obligation, to prosecute, maintain, enforce and defend the Opana® ER
Patents in its sole discretion. Impax will have no right to prosecute, maintain, enforce or defend
the Opana® ER Patents.
Section 4.7. No Implied Rights. Except as expressly provided in Section 4.1,
Endo and Penwest do not grant to Impax or any of its Affiliates or any other Person any license,
right or immunity, whether by implication, estoppel or otherwise, other than as expressly granted
herein. Impax will not use the name, insignia or symbols of Endo, Penwest or any of their
respective Affiliates for any purpose whatsoever without Endo’s or Penwest’s, as the case may be,
prior written consent. No rights are granted under this Agreement by Endo or Penwest to Impax to
the use of any of Endo’s, Penwest’s or their respective Affiliates’ trademarks, or any other
trademark confusingly similar thereto, and all rights to those trademarks are expressly reserved by
Endo and Penwest, as the case may be. Nothing herein will be deemed to require Endo or Penwest to
provide any know-how or other Confidential Information to Impax.
Section 4.8. Governmental Approvals. Endo and Penwest make no representation that, as
of the Commencement Date, Impax will be able to launch any Impax Products. Impax agrees that,
notwithstanding anything to the contrary herein, it will not sell any Impax Products prior to
obtaining FDA approval to sell the Impax Products. Impax will be solely responsible for, and will
bear all costs involved in, the registration and approval of the Impax Products with any
governmental regulatory agencies.
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Settlement and License Agreement
Section 4.9. Transfers. To the extent Endo, Penwest or any of their respective
Affiliates assign, license, sublicense or otherwise transfer any right, title or interest in or to
the Opana® NDA or the Opana® ER Patents, or any other patents or patent applications or regulatory
exclusivities subject to same, to any Third Party, Endo and Penwest, on behalf of themselves and
their respective Affiliates, will make such assignment, license, sublicense or other transfer
subject to any restrictions or limitations under the License, waivers and Covenant Not To Xxx
granted herein.
Section 4.10. FDA Cooperation. (a) Within five (5) business days of Impax’s request,
Endo shall provide the FDA with written confirmation of the Commencement Date and the license,
covenants and waivers herein, including, where applicable, written confirmation that the
Commencement Date is before January 1, 2013, and including, where applicable, written confirmation
that the restriction specified in the Stipulation of Dismissal and Order does not bar entry by
Impax on a date prior to January 1, 2013. Concurrently with such request, Impax shall provide to
Endo the desired form of written confirmation to be provided to the FDA.
(b) Endo and/or Penwest shall waive any period of regulatory exclusivity to the extent such
exclusivity would preclude or impede the launch of the Impax Product as of the Commencement Date.
Endo and/or Penwest shall provide reasonable cooperation to Impax in connection with such waiver,
including by (i) submitting a mutually agreeable notice to FDA of the existence of such waiver and
(ii) not opposing the approval of Impax Product effective as of the Commencement Date based on any
applicable regulatory exclusivity in force at the time. Such notice will be delivered by Endo to
FDA within five (5) business days of receipt of written request from Impax, provided that
the form of such notice has been agreed to as set forth above, such agreement not to be
unreasonably withheld, delayed or conditioned. For purposes of clarity, nothing in this
Section 4.10(b) is intended to or does accelerate the Commencement Date.
Section 4.11. NDC. Endo shall at all times during the term of this Agreement maintain
(or otherwise not change the status of) the National Drug Code(s) in respect of the Opana® ER
Product until the end of the Exclusivity Period, unless otherwise directed by the FDA.
ARTICLE V.
CONFIDENTIALITY
CONFIDENTIALITY
Section 5.1. Publicity. No Party or any of its Affiliates or representatives may make
any press release or public announcement concerning the existence or terms of this Agreement
without the other Parties’ prior written consent, except for subsequent disclosure of information
which is substantially similar to publicly available information that has previously been disclosed
as permitted by this Section 5.1 or by Section 5.2. The terms of this Agreement,
and all confidential information exchanged by the Parties during the course of the negotiations of
the transactions contemplated hereby (“Confidential Information”), will remain strictly
confidential, and neither the contents of this Agreement, the subject matter hereof or the
Confidential Information will be, directly or
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Settlement and License Agreement
indirectly, discussed with or disclosed to any Third Party, other than those employees,
officers, directors and advisors of each Party who need to know such information for the sole
purpose of effecting the intent of this Agreement and who agree to keep such information
confidential and who agree to be bound by the terms of this Article V to the same extent as
if they were parties hereto, provided that this Agreement may be disclosed to governmental
authorities as contemplated by Section 2.1, and this Agreement and the Confidential
Information may be disclosed as permitted by Section 5.2 and in connection with pending
litigation over the Opana® ER Product and/or Opana® ER Patents. If a Party
is contacted by any media outlets or press regarding the New Jersey Action, such Party may confirm
that the New Jersey Actions have been settled without disclosing any terms of this Agreement or the
terms of this settlement except to the extent permitted under this Section 5.1.
Section 5.2. Required Disclosure. If a Party concludes in good faith that it is
required by applicable law, FDA rule or requirement, rules or regulations promulgated by the U.S.
Securities and Exchange Commission or any other governmental authority, regulatory agency or
self-regulatory body, or legal proceeding or order by a court of competent jurisdiction to disclose
the terms of this Agreement, the Party required to make such disclosure will (a) endeavor to obtain
confidential treatment of the terms of this Agreement; and (b) include in such disclosure only the
information that, after consultation with counsel, such Party believes is required to be disclosed.
ARTICLE VI.
REPRESENTATIONS AND WARRANTIES
REPRESENTATIONS AND WARRANTIES
Section 6.1. Representations as to Endo and Penwest. Each of Endo and Penwest hereby
represents and warrants to Impax as of the Effective Date as follows:
(a) it has the corporate power and authority to execute and deliver this Agreement and to
perform its obligations hereunder, and the execution, delivery and performance of this Agreement
has been duly and validly authorized by it. Upon execution and delivery of this Agreement by it,
this Agreement will constitute a legal, valid and binding agreement, enforceable in accordance with
its terms, subject to bankruptcy, insolvency, reorganization, moratorium or other similar laws
affecting the enforceability of creditors’ rights generally and other general equitable principles
which may limit the right to obtain certain remedies;
(b) neither the execution and delivery of this Agreement, nor consummation of the transactions
contemplated herein requires it to obtain any permits, authorizations or consents from any
governmental body or from any other person, firm or corporation other than such permits,
authorizations or consents as it has already obtained;
(c) it has the right to grant to Impax the License and the Covenant Not To Xxx;
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Settlement and License Agreement
(d) it has not assigned or otherwise transferred to any Person any of its claims, rights,
causes of action, counterclaims or defenses that are covered by the release granted under
Section 3.6(b); and
(e) it has not licensed or authorized any Third Party or Affiliate to sell, offer to sell,
import or distribute any generic version of products that are the subject of the Opana® NDA.
Section 6.2. Representations as to Impax. Impax represents and warrants to Endo and
Penwest as of the Effective Date as follows:
(a) Impax has the corporate power and authority to execute and deliver this Agreement and to
perform its obligations hereunder, and the execution, delivery and performance of this Agreement
has been duly and validly authorized by Impax. Upon execution and delivery of this Agreement by
Impax, this Agreement will constitute a legal, valid and binding agreement of Impax, enforceable in
accordance with its terms, subject to bankruptcy, insolvency, reorganization, moratorium or other
similar laws affecting the enforceability of creditors’ rights generally and other general
equitable principles which may limit the right to obtain certain remedies;
(b) neither the execution and delivery of this Agreement nor consummation of the transactions
contemplated herein requires Impax to obtain any permits, authorizations or consents from any
governmental body or from any other person, firm or corporation;
(c) to its knowledge, Impax has produced to Endo and Penwest in the New Jersey Actions a full
and complete copy of the Impax ANDA, including all amendments and supplements thereto, as of the
Effective Date; and
(d) Impax has not assigned or otherwise transferred to any Person any of its claims, rights,
causes of action, counterclaims or defenses that are covered by the release granted under
Section 3.6(a).
Section 6.3. Disclaimer. ENDO AND PENWEST ARE LICENSING THE LICENSED PATENTS TO IMPAX
ON AN “AS IS” BASIS. ENDO AND PENWEST MAKE NO WARRANTIES EITHER EXPRESS OR IMPLIED OF ANY KIND,
AND HEREBY EXPRESSLY DISCLAIM ANY WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND AS TO THE
LICENSED PATENTS AND THE SUBJECT OF ANY LICENSE OR COVENANT NOT TO XXX HEREUNDER, INCLUDING BUT NOT
LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY, FITNESS, ADEQUACY OR SUITABILITY FOR A PARTICULAR
PURPOSE, USE OR RESULT, AND ANY WARRANTIES OF FREEDOM OF INFRINGEMENT OF ANY PATENTS, COPYRIGHTS,
TRADE SECRETS OR OTHER PROPRIETARY RIGHTS. NEITHER ENDO, PENWEST, NOR ANY EMPLOYEE OR AGENT OF
EITHER OF THEM, SHALL HAVE ANY LIABILITY TO IMPAX, OR ITS AFFILIATES, OR ANY OTHER PERSON ARISING
OUT OF THE USE OF THE LICENSED PATENTS, INCLUDING TO THE LACK OF MERCHANTABILITY, INADEQUACY OR
UNSUITABILITY OF THE LICENSED
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Settlement and License Agreement
PATENTS FOR ANY PARTICULAR PURPOSE OR TO PRODUCE ANY PARTICULAR RESULT, OR FOR ANY LATENT
DEFECTS THEREIN. ENDO AND PENWEST AND THEIR AFFILIATES, EMPLOYEES, AGENTS, OFFICERS AND DIRECTORS
SHALL NOT BE LIABLE IN ANY WAY WHATSOEVER FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES SUFFERED BY IMPAX OR ANY THIRD PARTY IN CONNECTION WITH THIS AGREEMENT, INCLUDING LOST
PROFITS OR BUSINESS REVENUE OR OTHER ECONOMIC LOSS OF ANY KIND WHATSOEVER, WHETHER OR NOT SUCH
DAMAGES ARE FORESEEABLE OR ENDO, PENWEST OR THEIR AFFILIATES, EMPLOYEES, AGENTS, OFFICERS OR
DIRECTORS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
ARTICLE VII.
INDEMNITY
INDEMNITY
Indemnification. Impax will indemnify and defend Endo, Penwest and their respective
Affiliates and the directors, officers and employees of Endo, Penwest and any such Affiliates, and
hold each of them harmless from and against any and all claims, suits, losses, liabilities, damages
and expenses (including reasonable attorneys’ fees and costs and the costs of enforcing this
indemnity) incurred by any of them arising from or occurring as a result of any claims, demands,
actions and other proceedings of a Third Party, whether for any actual or alleged product defect,
product liability or other related claims, relating to any Impax Product. Any indemnitee that
intends to claim indemnification under this Article VII promptly will notify Impax in
writing of each claim in respect of which the indemnitee or any of its Affiliates, or their
directors, officers or employees intend to claim such indemnification, provided that the
failure to provide such notice shall not release Impax from its obligations under this Article
VII except to the extent that Impax is actually and materially prejudiced thereby. The
indemnitee under this Section and its Affiliates, officers, directors, employees and agents will
reasonably cooperate with Impax and its legal representatives, at Impax’s expense, in the
investigation and defense of any claim or loss covered by this indemnification.
ARTICLE VIII.
TERMINATION
TERMINATION
Section 8.1. Term. The term of this Agreement will commence on the Effective Date
and, unless terminated in accordance with this Agreement, will continue through the License Term.
Section 8.2. Termination. Endo and Penwest each may terminate this Agreement upon
written notice effective immediately if (i) Impax or any of its Affiliates breaches the first
sentence of Section 3.2, (ii) Impax or any of its Affiliates challenges the validity or
enforceability of the Licensed Patents with respect to any product that is the subject of the Impax
ANDA, or the infringement of the Licensed Patents by any product that is the subject of the Impax
ANDA, or if Impax or any of its Affiliates participates in or supports, directly or indirectly, any
such challenges with respect to any Opana® ER Generic Product by any Third Party, except
Impax shall be permitted to maintain the
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Settlement and License Agreement
Paragraph IV Certifications contained in the Impax ANDA, or (iii) Impax or any of its
Affiliates makes, has made, uses, offers for sale, sells or imports in the Territory, directly or
indirectly, any Opana® ER Generic Product or assists or authorizes any Third Party to do
any of the foregoing prior to the Commencement Date, subject to Impax’ allowed pre-Commencement
Date activities outlined in Section 3.2 and except for any such activities relating to
products that are the subject of the Impax ANDA that were engaged in by Impax or its Affiliates
prior to the Effective Date and that would have given rise to a claim of infringement of the
Licensed Patents. For the sake of clarity, nothing in this Section 8.2(b) shall permit
termination if Impax asserts the invalidity, unenforceability or non-infringement of the Licensed
Patents in any future litigation concerning any product that is not the subject of the Impax ANDA.
A termination of this Agreement by one Party shall be deemed to be a termination of this
Agreement as to all Parties.
Section 8.3. Effect of Termination. If this Agreement is terminated pursuant to
Section 8.2, (a) Endo and Penwest will have the right to recommence or refile the New
Jersey Actions; (b) each Party consents, with respect to any such refiled New Jersey Actions, to
(i) the exclusive jurisdiction of the United States District Court for the District of New Jersey,
and irrevocably and unconditionally waives any objection to the laying of venue in such court or
that the New Jersey Actions has been brought in an inconvenient forum, and (ii) waive any statute
of limitations defenses in connection with such recommenced or refiled New Jersey Actions; (c) the
License and Covenant Not To Xxx automatically and immediately will terminate; and (d) Impax would
have the right to defend itself on any basis, including challenging the validity and enforceability
of the Opana® ER Patents or the non-infringement thereof. Termination or expiration of this
Agreement shall not release any Party from liability (in an action at law or otherwise) for any
obligations, liabilities or damages incurred prior to such termination and arising out of a breach
of any of its representations, warranties, covenants or agreements set forth in this Agreement.
Section 8.4. Survival. Sections 2.2, 3.4, 3.5, 3.6,
6.1, 6.2, 6.3, 8.3, 8.4 and Articles I, V
and VII will survive the expiration or termination of this Agreement.
ARTICLE IX.
MISCELLANEOUS
MISCELLANEOUS
Section 9.1. Governing Law; Jurisdiction. The validity and interpretation of this
Agreement and the legal relations of the Parties to it will be governed exclusively by the internal
laws, and not the law of conflicts, of the State of New Jersey.
Section 9.2. Notices. All notices, requests and other communications hereunder will
be in writing, will be addressed to the receiving Party’s address set forth below or to such other
address as a Party may designate by notice hereunder, and will be either (a) delivered by hand, (b)
made by facsimile transmission (to be followed with written confirmation by the delivering Party),
(c) sent by private courier service providing evidence of receipt, or (d) sent by registered or
certified mail, return receipt
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Settlement and License Agreement
requested, postage prepaid. The addresses and other contact information for the Parties are
as follows:
| For Impax: | Impax Laboratories, Inc. 000 Xxx Xxxxxxx Xxxx. Xxxxxxxx, XX 00000 Facsimile No.: (000) 000-0000 Attn: Xxxxx Xxxxxxx, President, Generic Division |
|||
| with a copy (which shall not constitute notice) to: |
Impax Laboratories, Inc. 00000 Xxxxxxxx Xxxxxx Xxxxxxx, XX 00000 Facsimile No.: (000) 000-0000 Attn: Xxxxxxxx Xxxxxxx, Vice President, Intellectual Property |
|||
| For Endo: | Endo Pharmaceuticals Inc. 000 Xxxx Xxxxxxxxx Xxxxxx Xxxx, XX 00000 Facsimile No.: (000) 000-0000 Attn: President |
|||
| with a copy to: | Endo Pharmaceuticals Inc. 000 Xxxx Xxxxxxxxx Xxxxxx Xxxx, XX 00000 Facsimile No.: (000) 000-0000 Attn: Chief Legal Officer |
|||
| For Penwest: | Penwest Pharmaceuticals Co. 0000 Xxxxx 00 Xxxxx 0 Xxxxxxxxx, XX 00000 Attn: President & CEO |
or to such other addresses as will have been subsequently furnished by written notice to the other
Parties.
Section 9.3. Entire Agreement; Waiver. This Agreement, including the Appendix
attached hereto, together with the Development Agreement between Endo and Impax, dated as of the
date hereof, contains the entire agreement between the Parties with respect to the subject matter
hereof and supersedes all prior drafts or understandings. No change, modification, amendment or
waiver of any obligation, term or provision contained herein will be valid or enforceable unless
the same is reduced to writing and
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Settlement and License Agreement
signed by a duly authorized representative of each of the Parties to be bound hereby. The
waiver by a Party to this Agreement of a breach of any provision set forth herein or of any right
contained herein will not operate as or be construed as a continuing waiver or a waiver of any
subsequent breach or right granted herein.
Section 9.4. Counterparts. This Agreement may be executed in counterparts, each of
which will be deemed be an original, but all of which together will constitute one agreement.
Section 9.5. No Third Party Beneficiaries. Except as expressly provided herein,
nothing is intended or will be construed to confer upon any person or entity other than the Parties
hereto and their successors or assigns, any rights or remedies under or by reason of this
Agreement.
Section 9.6. Assignment. This Agreement will be binding upon and inure to the benefit
of the Parties and their permitted successors and assigns. This Agreement and the rights granted
herein may not be assigned or transferred (whether by contract, operation of law or otherwise) by
any Party without the prior written consent of the other Parties, provided that this
Agreement shall be assignable by a Party (a) to an Affiliate or (b) in connection with the sale of
all or substantially all of the assets of the business of such Party to which this Agreement
relates, and provided further that (i) the Party whose assets are being sold
notifies the other Parties of any such assignment of this Agreement in writing (including the
identity of the assignee) and (ii) the purchaser of those assets provides written confirmation that
it agrees to assume all of the assigning Party’s obligations hereunder. The covenants, rights and
obligations of each Party under this Agreement shall remain binding upon such Party notwithstanding
any assignment or transfer of this Agreement by such Party as permitted by this Section
9.6, and also shall inure to the benefit of and be binding upon any permitted assignee or
transferee of this Agreement.
Section 9.7. Irreparable Harm. Each Party acknowledges and agrees that, in the event
of any threatened or actual breach by it of the first sentence of Section 3.2, Section
3.3 or Article V, the other Parties will suffer immediate and irreparable injury not
fully compensable by monetary damages and for which the other Parties may not have an adequate
remedy at law. Accordingly, each Party agrees that if one of the other Parties institutes an
action or proceeding to enforce any provisions of this Agreement, such other Party or Parties will
be entitled to seek injunctive or other equitable relief as may be necessary or appropriate to
enjoin, prevent or curtail any such breach or threatened breach. The foregoing will be in addition
to and without prejudice to such other rights as each Party may have under this Agreement, at law
or in equity.
Section 9.8. Expenses. Each Party will pay its own expenses incurred in connection
with its negotiation of this Agreement and the consummation of the transactions contemplated
hereby.
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Settlement and License Agreement
Section 9.9. Headings. The headings contained in this Agreement are for convenience
of reference only and will not affect the meaning or interpretation of this Agreement.
Section 9.10. Construction. References to any NDA or ANDA in this Agreement include,
unless expressly indicated otherwise, all replacements and successors and all amendments and
supplements to the foregoing. The term “including” means “including, without limitation,” and
“herein”, “hereof”, and “hereunder” refer to this Agreement as a whole.
[Remainder of page left blank]
Page 20
IN WITNESS WHEREOF, the Parties have executed this Agreement on the date first above written.
| ENDO PHARMACEUTICALS INC. | ||||
By:
|
/s/ Xxxxx X. Xxxxxxx | |||
| Name and Title: Xxxxx X. Xxxxxxx, President & CEO | ||||
| Date: June 7, 2010 | ||||
| PENWEST PHARMACEUTICALS CO. | ||||
By:
|
/s/ Xxxxxxxx X. Good | |||
| Name and Title: Xxxxxxxx X. Good, President & CEO | ||||
| Date: June 8, 2010 | ||||
| IMPAX LABORATORIES, INC. | ||||
By:
|
/s/ Xxxxxx X. Xxxx, Xx. | |||
| Name and Title: Xxxxxx X. Xxxx, Xx., SVP-CFO | ||||
| Date: June 8, 2010 | ||||
Settlement and License Agreement
APPENDIX A
STIPULATION OF DISMISSAL AND ORDER
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
DISTRICT OF NEW JERSEY
ENDO PHARMACEUTICALS INC.
|
) | |||||||
and PENWEST PHARMACEUTICALS CO., |
) | |||||||
| ) | ||||||||
| Plaintiffs, | ) | |||||||
| ) | C.A. No. 09-831-KSH-PS | |||||||
v.
|
) | C.A. No. 09-832-KSH-PS | ||||||
| ) | C.A. No. 09-833-KSH-PS | |||||||
IMPAX LABORATORIES, INC.,
|
) | |||||||
| ) | ||||||||
| Defendant. | ) ) ) |
WHEREAS, plaintiffs allege that Penwest Pharmaceuticals Co. (“Penwest”) is the assignee and
owner of U.S. Patents 5,662,933, 5,958,456 and 7,276,250 (the “Asserted Patents”), and that Endo
Pharmaceuticals Inc. (“Endo”) is an exclusive licensee of the Asserted Patents in the relevant
field of use pursuant to a strategic alliance agreement with Penwest;
WHEREAS, defendant Impax Laboratories, Inc. (“Impax”) has submitted to the U.S. Food and Drug
Administration Abbreviated New Drug Application No. 79-087 (“Impax ANDA”) for approval to market
and sell generic oxymorphone HCl extended-release tablets; and
WHEREAS, Endo, Penwest and Impax have entered into a Settlement and License Agreement, dated
as of June 8, 2010 (“Settlement and License Agreement”), pursuant to which the parties have
resolved the above-referenced action and Plaintiffs have granted to Impax a license under the
Asserted Patents in the United States.
NOW, THEREFORE, Endo, Penwest and Impax stipulate that:
Settlement and License Agreement
| 1. | Impax, its Affiliates and their respective officers, agents, servants, employees and attorneys will not, until the applicable Commencement Date (as defined in the Settlement and License Agreement), engage in the manufacture, use, marketing, offer for sale, or sale in the United States, or importation into the United States, of any generic version of the Opana® ER product, except that (a) Impax shall be permitted to manufacture and market (but not use or sell) such products for a reasonable period of time prior to the applicable Commencement Date solely for the purpose of selling such products only on or after the Commencement Date, as set forth in the Settlement and License Agreement, and (b) Impax may conduct, directly or indirectly, any activities protected under 35 U.S.C. § 271(e)(1). The foregoing shall terminate automatically upon the applicable Commencement Date for each product as defined in the Settlement and License Agreement. | ||
| 2. | Pursuant to Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure, plaintiffs, Endo, Penwest and Impax hereby stipulate and agree that the above actions C.A. Nos. 09-831, 09-832 and 09-833 -KSH-PS, including all claims, counterclaims and affirmative defenses between Plaintiffs and Impax, are dismissed with prejudice, except as provided for in sections 2.2 and 8.3 of the Settlement and License Agreement. | ||
| 3. | Each party shall bear its own costs, expenses and attorneys’ fees in connection with the above-referenced actions. | ||
| 4. | The parties waive any right of appeal from this Stipulation of Dismissal and Order. | ||
| 5. | The Court retains jurisdiction over this Stipulation of Dismissal and Order, and the interpretation of the Settlement and License Agreement as it pertains to this Stipulation of Dismissal and Order, in the event of any dispute concerning it. |
Settlement and License Agreement
IT IS SO ORDERED, this day of , 2010.
| Xxx. Xxxxxxxxx X. Xxxxxx, U.S.D.J. |
Stipulated as to form and entry:
Dechert llp
|
||||||
Attorneys for Plaintiffs Endo
Pharmaceuticals, Inc. and Penwest
Pharmaceuticals, Co.
|
Attorneys for Defendant and Counterclaim Plaintiff Impax Laboratories, Inc. |
By:
|
/s/ Xxxxxx X. Xxxxx | By: | ||||
| Xxxxxx X. Xxxxx 000 Xxxxxxxx Xxxxxx Xxxxx 000 Xxxxxxxxx, XX 00000 Telephone: (000) 000-0000 Xxxxxx X. Xxxxx XXXXXXX LLP Xxxx Centre 0000 Xxxx Xxxxxx Xxxxxxxxxxxx, XX 00000-0000 Telephone: (000) 000-0000 |
||||||
