exv10w1






Exhibit 10.1




EXECUTION COPY




SETTLEMENT AGREEMENT




          This
Settlement Agreement, dated as of June 9, 2009 (the “Effective Date”), is by and among
Purdue Pharma L.P., a Delaware limited partnership (on its own behalf and as successor in interest
to The Purdue Pharma Company, a Delaware general partnership), The P.F. Laboratories, Inc., a New
Jersey corporation, and Purdue Pharmaceuticals L.P., a Delaware limited partnership (the foregoing
are individually and collectively referred to as the “Purdue Companies”), and KV Pharmaceutical
Company, a Delaware corporation (together with its Affiliates, “KV”). The Purdue Companies and KV
are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”




WITNESSETH:




          WHEREAS, the Purdue Companies are the owners of United States patent number 5,508,042 (the
“’042 Patent”), and prior to their expiration were the owners of United States patent numbers
5,226,331 (the “’331 Patent”), 5,549,912 (the “’912 Patent”) and 5,656,295 (the “’295 Patent”),
relating to and protecting controlled-release oxycodone products, including the product
OxyContin®, a controlled-release oxycodone product marketed and sold under NDA No.
20-553 (“OxyContin®”);




          WHEREAS, the Purdue Companies and KV are involved in litigation, Civil Action No. 07 Civ.
3972, Civil Action No. 07 Civ. 3973 and Civil Action No. 07 Civ. 4810 (SHS) (collectively, the
“Action”) in the United District Court for the Southern District of New York (the “District Court”)
(Civil Action Nos. 07 Civ. 3972 and 07 Civ. 3973 were originally pending in the United States
District Court for the District of Delaware as Civil Action
No. 07-CV-0032-_ _ _ and 07-CV-0077-_ _ _,
but were transferred by the Judicial Panel on Multidistrict Litigation, In re OxyContin Antitrust
Litigation, Docket No. 1603, as of May 17, 2007), concerning, inter alia, the validity and
enforceability of the ’042 Patent, the ’912 Patent and the ’295 Patent, as well as the infringement
by KV of the ’042 Patent, resulting from KV requesting approval (the “FDA Approval”) from the
United States Food and Drug Administration (the




 









 







“FDA”) of generic versions of OxyContin®
through its submission of Abbreviated New Drug Application (“ANDA”) No. 78-506 (collectively with
all amendments and supplements thereto, the “KV ANDA”);




          WHEREAS, the KV ANDA contains “Paragraph IV” certifications under 21 U.S.C.
§355(j)(2)(A)(vii)(IV) and 21 C.F.R. § 314.94(a)(12)(i)(A)(4) alleging that the ’042 Patent, the
’912 Patent and the ’295 Patent are invalid and unenforceable and therefore cannot be infringed by
KV’s manufacture, use or sale of generic versions of controlled-release oxycodone products,
including OxyContin®, pursuant to the KV ANDA (the “KV Products”), and the Purdue
Companies have disputed such contentions;




          WHEREAS, in the Action, the Purdue Companies have asserted claims against KV and KV has
asserted claims and counterclaims against the Purdue Companies, including violations of federal and
state antitrust and anticompetition laws, which the Parties now seek to resolve without further
litigation; and




          WHEREAS, the KV ANDA has neither tentative approval nor final approval from the FDA and is
currently subject to the limitations on final approval pursuant to 21 U.S.C. §355(j)(5)(B)(iii).




          NOW THEREFORE, for good and valuable consideration, the sufficiency and receipt of which are
hereby acknowledged, the Parties agree as follows:




          1. (a) On the Effective Date, the Purdue Companies and KV are executing and delivering to each
other the following documents:




                    (i) a Patent License Agreement, in the form of Exhibit 1(a)(i) hereto (the “Patent License
Agreement”);



                    (ii) a Distribution and Supply Agreement in the form of Exhibit 1(a)(ii) hereto (the
“Distribution and Supply Agreement”);



                    (iii) a Risk Map License Agreement, in the form of Exhibit 1(a)(iii) hereto;



                    (iv) a Release by the Purdue Companies, in the form of Exhibit 1(a)(iv) hereto (the “Purdue
Release”); and



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                    (v) a Release by KV, in the form of Exhibit 1(a)(v) hereto (the “KV Release”, and, together
with the Purdue Release, the “Releases”).



               (b) On the Effective Date, the Purdue Companies and KV, through their respective attorneys of
record, are executing the Consent Judgment, in the form of Exhibit 1(b) hereto (the “Consent
Judgment”) and each of the Purdue Companies and KV are causing their respective attorneys of record
in the Action to execute and deliver one copy of the Consent Judgment to the attorneys for the
Purdue Companies and one copy of the Consent Judgment to the attorneys for KV, as applicable, to be
held by each of them until submitted to the District Court in accordance with paragraph 3 of this
Settlement Agreement. Unless otherwise expressly set forth herein, as used herein, the term
“Settlement Agreement” shall refer to this Settlement Agreement, and such Settlement Agreement,
together with each of the Exhibits attached hereto, shall be referred to as the “Settlement
Documents.” The term “oxycodone” shall include oxycodone base and any of its salts and “Oxycodone
API” shall mean oxycodone as an active pharmaceutical ingredient. The definitions of the terms
herein apply equally to the singular and plural of the terms defined. Whenever the context may
require, any pronoun will include the corresponding masculine, feminine and neuter forms. The
words “include”, “includes” and “including” will be deemed to be followed by the phrase “without
limitation”. Unless the context requires otherwise, (A) any definition of or reference to any
agreement, instrument or other document herein will be construed as referring to such agreement,
instrument or other document as from time to time amended, supplemented or otherwise modified
(subject to any restrictions on such amendments, supplements or modifications set forth herein or
therein), and (B) the words “herein”, “hereof” and “hereunder”, and words of similar import, will
be construed to refer to this Settlement Agreement in its entirety and not to any particular
provision hereof. For purposes of the Settlement Documents, “Affiliate” means, as to any Party,
any person, firm, trust, partnership, corporation, company or other entity or combination thereof,
which directly or indirectly controls, is controlled by or is under common control with such Party,
provided that for purposes of each of the Settlement Documents, The Purdue Frederick Company Inc.,
a New York corporation (d/b/a The Purdue Frederick Company) shall not be considered



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an “Affiliate” of any of the Purdue Companies. The terms “control” and “controlled” mean ownership of fifty
percent (50%) or more, including ownership by trusts with substantially the same beneficial
interests, of the voting and equity rights of such person, firm, trust, partnership, corporation, company
or other entity or combination thereof or the power to direct the management of such person, firm,
trust, partnership, corporation, company or other entity or combination thereof.




               (c) KV agrees that it will make, have made, use, offer to sell and sell the KV Products only
in accordance with the Patent License Agreement.



               (d) KV agrees that, notwithstanding anything to the contrary set forth in any of the
Settlement Documents, KV will provide the Purdue Companies with at least five (5) business days
advance written notice prior to any initial launch shipment of any of the KV Products.



          2. (a) Within two business days after the Effective Date, the Parties shall comply with the
requirements of Title XI, Subtitle B of the Access to Affordable Pharmaceuticals Act (The Medicare
Prescription Drug Improvement and Modernization Act of 2003, Pub. L. 108-173), as the same may be
amended from time to time (the “Act”), by filing all necessary copies of the Settlement Documents
(the “MMA Filing”) with the Federal Trade Commission (the “FTC”) and the Antitrust Division of the
Department of Justice (“DOJ”) (the FTC and the DOJ each shall be referred to as an “Agency”). The
Parties will use commercially reasonable efforts to coordinate the foregoing filings and any
responses thereto, to make such filings promptly and to respond promptly to any requests for
additional information. Each Party will keep the other Party reasonably informed of any such
communication, provided that neither Party is required to disclose to the other confidential
information concerning such Party that was communicated by such Party to an Agency. Neither Party
will disclose the confidential information of the other Party to an Agency without such other
Party’s prior written consent (not to be unreasonably withheld, conditioned or delayed).




               (b) If, subsequent to the Effective Date, an Agency Objection (as defined below) is raised or
an Agency Action (as defined below) is brought, then the Parties shall in good faith use
commercially reasonable efforts to revise the Settlement Documents in a manner which “reasonably



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addresses” (as that term is defined below) such Agency Objection or Agency Action in a manner which
does not materially change the economic value of the transactions contemplated by the Settlement
Documents for either Party. If such commercially reasonable efforts are not successful, or if
it is not possible to reasonably address such Agency Objection or Agency Action in a manner which
does not materially change the economic value of the transactions contemplated by the Settlement
Documents, then notwithstanding anything herein to the contrary, the Settlement Documents shall
remain in full force and effect, including any revisions that the Parties shall have mutually
agreed upon in writing. Notwithstanding the foregoing, if a final non-appealable judgment is
entered by a court of competent jurisdiction invalidating any of the provisions of paragraphs 5(a),
5(b), 5(c) or 20 of this Settlement Agreement, the Releases or Sections 1, 2 or 3 of the Patent
License Agreement or any of the provisions of Article II or Article IV of the Distribution and
Supply Agreement, then the Settlement Documents shall become null and void and have no legal
effect. For purposes of this paragraph 2(b), (x) the term “Agency Action” shall mean either Agency
has brought a judicial or administrative proceeding against either of the Parties related to the
terms of the Settlement Documents and (y) the term “Agency Objection” shall mean (i) the Director
of the FTC’s Bureau of Competition or a Section Chief of the Antitrust Division of DOJ, as
applicable, or a staff person acting expressly on behalf of any of those individuals, has notified
either Party in writing that the staff of the Agency is recommending that the Agency institute its
own judicial or administrative proceeding against either of the Parties related to the terms of the
Settlement Documents, or (ii) either the Assistant Director or Deputy Assistant Director for
Healthcare Services and Products Division of the FTC’s Bureau of Competition, or another staff
person acting expressly on behalf of any of those individuals (each referred to herein as
“Reviewing Agency Staff”), has notified either of the Parties in writing indicating that the
Reviewing Agency Staff has reviewed the Settlement Documents and stating a specific objection
regarding the possible competitive effects of any of the terms of the Settlement Documents. A
notification from the Reviewing Agency Staff of a decision to commence an investigation regarding
the Settlement Documents without stating a specific objection shall not constitute an Agency
Objection. For purposes of this paragraph 2(b), the Parties shall have “reasonably addressed” any
Agency



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Objection or Agency Action when (a) the FTC (including its Reviewing Agency Staff) has
indicated to the Parties (in writing to either of the Parties or orally to both Parties) that such
Agency Objection has been resolved or if the FTC indicates that it otherwise does not intend to expend substantial
Agency resources in taking further action at such time with respect to the Settlement Documents,
(b) such Agency Objection or Agency Action is withdrawn without any further challenge to the
Settlement Documents, or (c) the Parties mutually agree in writing.



          3. On the Effective Date, counsel for the Purdue Companies and counsel for KV shall jointly
inform the District Court of the execution of this Settlement Agreement. Within two (2) business
days following the Effective Date, counsel for the Purdue Companies or counsel for KV will submit
the fully executed Consent Judgment to the District Court for signing and entry, and will
simultaneously provide the District Court with a copy of the Settlement Documents in camera and to
the extent requested by the District Court, file the Settlement Documents under seal. If for any
reason the District Court does not approve the Consent Judgment and enter it as an order of the
District Court as submitted, the Parties agree to confer promptly in good faith and to use
commercially reasonable efforts to modify the Consent Judgment or take such other action consistent
with the Settlement Documents as is required to overcome the District Court’s objections or
modifications, and to secure entry of the Consent Judgment as submitted or with agreed-upon
modifications, failing which, notwithstanding anything herein to the contrary, (x) the Settlement
Documents shall remain in full force and (y) the Parties agree to take all such actions as may be
reasonably necessary to dismiss the claims of the Parties against each other in the Action without
prejudice; provided, however, that neither of the Parties is under any obligation
to revise the Settlement Documents in a manner which materially changes the economic value of the
transactions contemplated by the Settlement Documents for such Party. The date on which the
Consent Judgment is entered, following the modification of such Consent Judgment, if any, in
accordance with this paragraph 3, or if the Consent Judgment is not entered, the date on which the
Action is dismissed, shall be the “Consent Judgment Date.” In the event that the Settlement
Documents become null and void as provided in paragraph 2 herein, neither the provisions of the
Settlement Documents, nor the Settlement Documents themselves




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(except for the provisions of the Settlement Documents which remain in effect as specified in paragraph 2 hereof), may be offered
into evidence, or be referred to in any testimonial or other evidence, by either
Party or any of their Affiliates at any trial, action or other proceeding pertaining to the
subject matter hereof, nor shall anything herein be construed as an admission or waiver as to any
factual or legal matter by either Party or any of their respective Affiliates.




          4. KV acknowledges and agrees that (a) the ’042 Patent is valid, enforceable and infringed,
and the ’331 Patent, the ’912 Patent and the ’295 Patent (the ’331 Patent, the ’912 Patent and the
’295 Patent being collectively referred to herein as the “Purdue Patents”) were valid and
enforceable and would have been infringed during their respective terms, as to oxycodone products
made, used, sold or offered for sale or imported pursuant to the KV ANDA, and (b) the ’042 Patent
is valid and enforceable, and will be valid and enforceable, in any future causes of action or
litigation involving KV, its successors or assigns, including any other or future causes of action
or litigation respecting different or future products, and the Purdue Patents were valid and
enforceable during their respective terms.




          5. (a) KV agrees that, other than in accordance with all of the terms and conditions of the
Settlement Documents, KV will not, directly or indirectly, alone or in cooperation with any other
person, make, have made, use, sell, ship or offer to sell, import or distribute, or authorize,
permit or solicit others to make, have made, use, sell, ship or offer to sell, import or
distribute, or facilitate in any manner, indemnify others regarding, or participate in the profits
of others arising from, the sale of any controlled-release oxycodone product that is described in
or covered by the KV ANDA or that would infringe any of the claims of the ’042 Patent;
provided, however, that subject to the proviso of paragraph 5(c) and paragraph 20,
the provisions of this paragraph 5(a) shall not apply following the date (the “Terminal Date”)
which is the earliest to occur of (A) the expiration of the ’042 Patent, plus any period of
exclusivity under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Sections 301, et seq.,
including any amendment thereof; and (B) the date on which, following the entry of a judgment in
another case or proceeding after the Effective Date, each and every asserted claim of the ’042
Patent is either (I) unenforceable or (II) invalid; provided, however, that in the
case of either clause (I) or (II) above, the


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mandate affirming the judgment in such other case or proceeding is issued by the United
States Court of Appeals for the Federal Circuit following appeal of such judgment, or the time for appeal from
that judgment has lapsed.




               (b) KV agrees that it will not, directly or indirectly, alone or in cooperation with any other
person, make, have made, use, sell, ship, offer to sell, import or distribute, or authorize, permit
or solicit others to make, have made, use, sell, ship, offer to sell, import or distribute, or
facilitate in any manner, indemnify others regarding, or participate in the profits of others
arising from, the sale of any controlled-release oxycodone product, including 10, 15, 20, 30, 40,
60 and 80 mg dosage strengths, (i) that is substantially as described in the KV ANDA in all foreign
countries in which there is a Patent listed in Exhibit 2 hereto (the “Foreign Patents”), or (ii) in
a foreign country where the making, using, selling or offering for sale, import or distribution of
such product would infringe any of the claims of any of the Foreign Patents in such country;
provided, however, that subject to the proviso of paragraph 5(c) and paragraph 20,
the provisions of this paragraph 5(b) shall not apply on a country-by-country basis following the
date which is the later of (x) (A) the expiration date of the last to expire of the Foreign Patents
and (B) November 25, 2012, and (y) the date on which a court of competent jurisdiction or
applicable patent office enters a final, non-appealable judgment or ruling, providing that with
respect to each and every asserted claim of the Foreign Patents in suit in such country that such
Foreign Patents are unenforceable or invalid.



               (c) Except as provided in paragraphs 5(a) and 5(b) of this Settlement Agreement and consistent
with the proviso of this paragraph 5(c) and paragraph 20 of this Settlement Agreement, nothing set
forth in the Settlement Documents shall be deemed to prevent KV from (i) making, having made,
using, importing, selling or offering for sale any product which does not infringe the Purdue U.S.
Patent Family (as defined in paragraph 6(a)) or Foreign Patents, or (ii) performing any act
protected by 35 U.S.C. § 271(e)(1); provided, however, that nothing set forth in
the Settlement Documents is intended to license or authorize KV to engage in any of the activities
described above in this paragraph 5(c), or otherwise to make, have made, use, import, sell or offer
for sale any product, in any case, unless



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specifically permitted and authorized by Section 1 of the
Patent License Agreement, and the Purdue Companies reserve all of their rights to assert a claim of patent infringement for any of such
activities and seek all remedies available to them at law or in equity with respect to such claim.



               (d) KV shall take all actions reasonably necessary to obtain FDA Approval of the KV ANDA as
soon as reasonably practicable and shall use its commercially reasonable efforts in connection with
such actions; provided that such obligation shall terminate upon the effectiveness of the
Distribution and Supply Agreement. KV acknowledges that it is solely responsible and accepts full
risk for obtaining the FDA Approval of the KV ANDA.



          6. (a) KV agrees that it will not initiate, file, participate, finance, aid, raise a defense
or assist in (i) any action or proceeding that challenges the validity, patentability, priority of
invention or other claim to priority, or enforceability of the ’042 Patent or any of the Purdue
Patents and (ii) any reexamination, protest, observation, comment, opposition, interference or
other action or proceeding in the United States Patent and Trademark Office or any federal court of
the United States challenging the validity, patentability, priority of invention or other claim to
priority, or enforceability of the ’042 Patent or any of the Purdue Patents, or any other patent or
patent application claiming priority to application numbers U.S. 800,549 (filed November 27, 1991),
U.S. 81,302 (filed June 18, 1993) or PCT/US 92/10146 (filed November 25, 1992) (any and all such
’042 Patent, Purdue Patents, other patents and patent applications are collectively referred to
herein as the “Purdue U.S. Patent Family”). The provisions of this paragraph 6(a) shall not apply:
(x) to the extent that KV directly or indirectly engages in conduct pursuant to the order of a
court of competent jurisdiction, which conduct would otherwise be prohibited by this paragraph
6(a), provided that KV has not directly or indirectly initiated or participated in a request that
such court issue such order; or (y) to the extent required by law (excluding pursuant to private
contractual arrangements).




               (b) KV agrees that it will not initiate, file, finance, participate, aid, raise a defense or
assist in (i) any action or proceeding that challenges the validity, patentability, priority of
invention or other claim to priority, or enforceability of any of the Foreign Patents, (ii) any
reexamination,



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protest, observation, comment, interference, opposition, or other action or
proceeding in any foreign patent office or court challenging the validity, patentability, priority of invention or other
claim to priority, or enforceability of any of the Foreign Patents, and (iii) any application
seeking compulsory licensing under a claim within the Foreign Patents. The provisions of this
paragraph 6(b) shall not apply on a country-by-country basis (x) following the date which is the
later of: (A) the expiration date of the last to expire of the Foreign Patents and (B) November 25,
2012; (y) to the extent that KV directly or indirectly engages in conduct pursuant to the order of
a court of competent jurisdiction, which conduct would otherwise be prohibited by this paragraph
6(b), provided that KV has not directly or indirectly initiated or participated in a request that
such court issue such order; and (z) to the extent required by law (excluding pursuant to private
contractual arrangements).



               (c) KV will not take any action or waive any right, including (i) the right to assert a
conflict of interest or (ii) rights under a confidentiality agreement or order, which would have
the effect of permitting any of its attorneys of record in the Action to take any action on behalf
of a third party which, if taken by KV, would be prohibited by paragraphs 6(a) or 6(b) of this
Settlement Agreement. The provisions of the immediately preceding sentence shall not apply (x) to
the extent that KV directly or indirectly engages in conduct pursuant to the order of a court of
competent jurisdiction, which conduct would otherwise be prohibited by this paragraph 6(c),
provided that KV has not directly or indirectly initiated or participated in a request that such
court issue such order; or (y) to the extent required by law (excluding pursuant to private
contractual arrangements). KV will not provide to any third party any confidential information or
attorney work product relating to the Action or the KV ANDA, except as required by statute,
ordinance, regulation, court order or compulsory legal process, provided that KV will request
confidential treatment with respect to any confidential information or attorney work product
disclosed pursuant hereto.



          7. The Purdue Companies represent and warrant as of the Effective Date that (a) each of them
has all necessary partnership or corporate, as applicable, power and authority to execute and
deliver the Settlement Documents and to perform its obligations thereunder, (b) the execution,
delivery and




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performance of the Settlement Documents have been duly and validly authorized by each
of them and they are delivering to KV an incumbency certificate simultaneously with the execution of this
Settlement Agreement attesting to the incumbency of each of the officers executing this Settlement
Agreement and the other Settlement Documents on behalf of the Purdue Companies, (c) there is no
other agreement, whether written or oral, among the Parties hereto with respect to the subject
matter of the Settlement Documents other than as set forth herein and therein, and (d) the Purdue
Companies or their Affiliates collectively own all right, title and interest in and to each and
every patent and/or patent application within the Purdue U.S. Patent Family and have not granted or
otherwise transferred to any third party any right to enforce any patent or patent application
included in the Purdue U.S. Patent Family, or any right to practice any patent or patent
application included in the Purdue U.S. Patent Family that would conflict with this Settlement
Agreement. Upon execution and delivery of the Settlement Documents by each of the Purdue
Companies, the Settlement Documents shall constitute the legal, valid and binding agreement of each
of them, enforceable against each of them in accordance with their respective terms and conditions,
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.




          8. KV represents and warrants as of the Effective Date that (a) KV has all necessary
corporate, limited liability company or partnership, as applicable, power and authority to execute
and deliver the Settlement Documents and to perform KV’s obligations thereunder, (b) the execution,
delivery and performance of the Settlement Documents have been duly and validly authorized by KV
and KV is delivering to the Purdue Companies an incumbency certificate simultaneously with the
execution of this Settlement Agreement attesting to the incumbency of each of the officers
executing this Settlement Agreement and the other Settlement Documents on behalf of KV, (c) there
is no other agreement, whether written or oral, among the Parties hereto with respect to the
subject matter of the Settlement Documents other than as set forth herein and therein, (d) KV owns
all right, title and interest in and to the KV ANDA, no other person or entity has any rights under
the KV ANDA, and KV has not otherwise transferred or




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assigned any of its rights under the KV ANDA,
(e) KV has not transferred or assigned any of its rights or claims with respect to the Action, (f) KV does not have any other pending ANDA relating to
controlled-release oxycodone products and has no current plans to file any other ANDA relating to
any such product, (g) KV is not subject to or aware of an order of a court of competent
jurisdiction of the type referred to in paragraph 6(a)(x), paragraph 6(b)(y) or paragraph 6(c)(x)
hereof, (h) KV is not a party to or bound by a contractual arrangement of the type referred to in
paragraph 6(a)(y), paragraph 6(b)(z) or paragraph 6(c)(y) hereof, (i) the only dosage strengths for
which KV has requested FDA Approval under the KV ANDA are 10, 15, 20, 30, 40, 60 and 80 mg., (j) no
Affiliate of KV has offered to sell, sold, marketed, shipped, distributed or imported any KV
Products, (k) KV has not appointed any third party to make, have made, use, offer to sell, sell,
ship, distribute or import the KV Products and (l) KV has not offered to sell, sold, marketed,
shipped, distributed or imported the KV Products to third parties for resale by such third parties
for and on behalf of KV. Upon execution and delivery of the Settlement Documents by KV, the
Settlement Documents shall constitute the legal, valid and binding agreements of KV, enforceable
against it in accordance with their respective terms and conditions, 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. KV shall be liable for (i) any breach of the provisions of the Settlement
Documents by any of its Affiliates and (ii) any failure by KV to cause its Affiliates to comply
with the Settlement Documents.




          9. Except as (a) required by statute, ordinance or regulation, (b) required pursuant to
compulsory legal process, (c) necessary for the exercise of the rights granted to the Parties under
the Settlement Documents, (d) expressly permitted under this paragraph 9, (e) set forth in the
press releases attached hereto as Exhibit 9(e) to be issued by the respective Parties at 7:00 AM
EDT on the day following the Effective Date, or as otherwise agreed to by the Parties, or (f) set
forth in the Current Report on Form 8-K attached hereto as Exhibit 9(f), none of the Purdue
Companies, KV, or any of their respective Affiliates will publicly announce or otherwise disclose
to any third party any of the terms of the Settlement Documents, without the prior written approval
of the other Party. Except as set forth




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above in paragraphs 9(e) and (f), the Parties will only release public announcements of the execution of
the Settlement Documents in forms to be mutually agreed to by the Parties, provided if a Party
is disclosing information relating to the Settlement Documents because it is required to do so to
comply with statutory, regulatory or legal process requirements, including its reporting
requirements under the Securities Exchange Act of 1934, as amended, or any national securities
exchange on which it is listed, which may include the aggregate financial effects of the different
options under the Settlement Documents on KV’s financial condition, but shall not include specific
timing, pricing or units, such Party intending to make such disclosure shall give the other Party
at least two (2) business days prior notice in writing of the text of the intended disclosure,
unless such statutory, regulatory or legal process requirements would require earlier disclosure,
in which event, the notice shall be provided as early as practicable. A disclosing Party agrees to
request confidential treatment with respect to the terms of the Settlement Documents and to use
commercially reasonable efforts to have redacted such provisions of the Settlement Documents as the
Parties may agree from any copies filed pursuant to such statutory, regulatory or legal process
requirements. If either Party determines that it will be required to file the Settlement Documents
as provided above, promptly after the giving of notice by such Party as contemplated above, the
Parties will use commercially reasonable efforts to agree on those provisions of the Settlement
Documents that the Parties will seek to have redacted as provided above. Notwithstanding anything
to the contrary above, (i) the Purdue Companies may disclose the terms of the Settlement Documents
to (x) present, former or future co-promoters of controlled-release oxycodone products who have a
legitimate business reason to know such terms, subject to all such co-promoters keeping the terms
of the Settlement Documents confidential, and (y) third parties in connection with patent
litigation involving the Purdue U.S. Patent Family or the Foreign Patents or in connection with
settlement discussions and agreements with alleged infringers of the Purdue U.S. Patent Family or
the Foreign Patents, subject to all such third parties keeping the terms of the Settlement
Documents confidential, and (ii) each Party may disclose the terms of the Settlement Documents to
its respective Affiliates, insurers,


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lenders, attorneys and accountants, subject to such Affiliates, insurers, lenders, attorneys and accountants being bound by confidentiality
obligations.




          10. This Settlement Agreement, including the obligations of the Parties under the Consent
Judgment and the other Exhibits hereto, is binding upon and shall inure to the benefit of each
Party hereto, and each of its successors and permitted assigns. KV may not assign, transfer,
license or otherwise convey in any other form (by way of merger, acquisition, statute, operation of
law or otherwise), in whole or in part, any of its rights or obligations under this Settlement
Agreement or the KV ANDA (an “Assignment”) without the prior written consent of the Purdue
Companies, which consent may be withheld in the sole discretion of the Purdue Companies;
provided, however, that no such Assignment shall in any manner limit or impair the
obligations of KV hereunder; and provided further, however, that any party that
acquires this Settlement Agreement or the KV ANDA as a result of such Assignment will thereby
become subject to the terms and conditions of this Settlement Agreement. If notwithstanding the
above, there is a Change of Control of KV, this Settlement Agreement shall be deemed to be assigned
and each person or entity directly or indirectly controlling KV and each Affiliate of such person
or entity shall become subject to the terms and conditions of this Settlement Agreement and shall
agree in writing to be bound hereby and KV shall remain primarily liable for the performance of all
its obligations under this Settlement Agreement and for causing its assignees to act in a manner
consistent herewith. For purposes of this paragraph 10, “Change of Control” shall mean the
transfer or disposition (including by way of merger, acquisition, consolidation, sale of stock,
sale of assets, operation of law or otherwise), directly or indirectly, of more than 50% of the
total assets, equity interests, or voting power of KV. Any Assignment, attempted Assignment or
assignment of the rights hereunder by KV in contravention of the provisions of this paragraph 10
shall be void and shall have no force or effect. In the event that the Purdue Companies (or any of
their respective successors and assigns) sell or assign (other than in connection with the grant of
a security interest), the ’042 Patent to any other person or entity, such person or entity shall
agree to assume the obligations of the Purdue Companies under the Settlement Documents in writing
as a condition to such acquisition.




14









 








          11. The Settlement Documents set forth the entire agreement and understanding among the
Parties hereto as to the subject matter hereof and supersede all other documents, oral consents or
understandings, if any, made between the Purdue Companies and KV (excluding any agreements or
stipulations endorsed by court order) before the Effective Date with respect to the subject matter
hereof. None of the terms of the Settlement Documents shall be amended or modified except in a
writing signed by each of the Parties hereto. The Parties acknowledge that there have been a
number of drafts of the Settlement Documents exchanged between them prior to the Parties’ agreement
on the final version of the Settlement Documents which have been executed by them. The Parties
expressly agree that these drafts have been superseded by the executed Settlement Documents and
shall not be used in any dispute between the Parties as evidence with respect to interpreting the
meaning of any provision of this Settlement Agreement.




          12. Any term or provision of the Settlement Documents which is invalid or unenforceable in any
jurisdiction shall, as to that jurisdiction, be deemed reformed to the extent required to make such
term or provision valid or enforceable in the manner most closely reflecting the Parties’
intentions as reflected in the Settlement Documents (provided that any such reformation can be
achieved without material change to the economic value of the transactions contemplated by the
Settlement Documents), and shall not render invalid or unenforceable the remaining terms and
provisions of the Settlement Documents in such jurisdiction or in any other jurisdiction, except as
expressly provided in paragraphs 2 or 3 of this Settlement Agreement.




          13. This Settlement Agreement, and the rights and obligations created hereunder, shall be
governed by and interpreted according to the substantive laws of the State of New York without
regard to its choice of law or conflicts of law principles.




          14. Any notice required under this Settlement Agreement shall be in writing and shall be given
(and shall be deemed to be duly given upon receipt) by delivery in person, by facsimile or by
registered or certified mail (postage prepaid, return receipt requested) to the respective Parties
at the following addresses (or at such other address for a Party as shall be specified by like
notice):




15









 







If to any of the Purdue Companies:



Purdue Pharma L.P.

One Stamford Forum

201 Tresser Boulevard

Stamford, CT 06901-3431

Attention: General Counsel

Fax No.: (203) 588-6204



with a copy to:



Chadbourne & Parke LLP

30 Rockefeller Plaza

New York, NY 10112

Attention: Stuart D. Baker

Fax No.: (212) 489-7130



If to KV:



KV Pharmaceutical Company

2503 South Hanley Road

St. Louis, Missouri 63144

Attention: Paul Brady

Fax No.: (314) 644-2419



with a copy to:



Locke Lord Bissell & Liddell

3 World Financial Center

New York, New York 10281-2101

Attention: John F. Sweeney

Fax No.: (212) 303-2754



Each of the Purdue Companies hereby agrees that Purdue Pharma L.P. (or any other Purdue Company
authorized by the Purdue Companies pursuant to the next sentence to provide consents on their
behalf under this Settlement Agreement) shall be authorized to provide (and to determine whether or
not to provide) any and all consents on behalf of each of them under this Settlement Agreement and
shall not take any action inconsistent with such authorization. The Purdue Companies may, at any
time upon written notice to KV as provided above, replace Purdue Pharma L.P. (or any replacement
thereof) with any other Purdue Company who they agree shall be authorized to provide consents on
behalf of each of the Purdue Companies under this Settlement Agreement.




16









 








          15. A waiver by any Party of any term or condition of this Settlement Agreement in any one
instance shall not be deemed or construed to be a waiver of such term or condition for any other
instance in the future (whether similar or dissimilar) or of any subsequent breach of this
Settlement Agreement. All rights, remedies, undertakings, obligations and agreements contained in
this Settlement Agreement shall be cumulative and none of them shall be a limitation of any other
remedy, right, undertaking, obligation or agreement of any of the Parties.




          16. Each of the Parties agrees that in executing the Settlement Documents and in accepting the
consideration provided for herein, each of the Parties does so with full knowledge of any and all
rights that each of the Parties may have with respect to the controversies herein compromised.
Each of the Parties affirms that it is not relying and has not relied upon any representation or
statement made by any of the other Parties with respect to the facts involved in said controversies
or with regard to each of the Parties’ legal rights or asserted legal rights, except as set forth
in paragraphs 7 and 8 hereof, and except as set forth in any representation or warranty in the
Patent License Agreement or the Distribution and Supply Agreement, as the case may be. Each of the
Parties hereby assumes the risk of any mistake of fact or legal right with regard to said
controversies or with regard to any of the facts or legal rights that are now unknown to such
Party, except with respect to any breach of paragraphs 7 and 8 hereof, and except as set forth in
any representation or warranty in the Patent License Agreement or the Distribution and Supply
Agreement, as the case may be.




          17. Each of the Parties agrees that it has received independent legal advice from its
attorneys with respect to the rights and asserted rights arising out of the controversies between
the Parties relating to the Purdue U.S. Patent Family, the Foreign Patents and the Action. Each of
the Parties further agrees that it and its counsel have had adequate opportunity to make whatever
investigation or inquiry they may have deemed necessary or desirable in connection with the subject
matter of this Settlement Agreement, prior to the execution hereof.




          18. If KV breaches, in any material respect, any provision of paragraphs 1(c), 1(d), 4, 5(a),
5(b) or 6 of this Settlement Agreement, or Sections 1 or 2(a) of the Patent License Agreement, in




17









 







addition to any other remedy the Purdue Companies may have at law or in equity, the Purdue
Companies, upon a showing of such breach, shall be entitled to a preliminary injunction to prevent
the continuance of such breach, without the requirement of the posting of a bond.




          19. This Settlement Agreement may be executed in counterparts (including by facsimile or other
electronic transmission), and each fully executed counterpart shall be deemed an original of this
Settlement Agreement.




          20. Except for the rights, agreements and covenants specifically granted pursuant to this
Settlement Agreement, no other right, written or oral license, covenant not to sue, waiver or
release of future infringement or other written or oral authorization is or has been granted or
implied by this Settlement Agreement. Furthermore, and for the avoidance of doubt, no activity by
KV with respect to the making, having made, using, offering to sell, selling, shipping,
distributing or importing of any (a) KV Product and (b) any other pharmaceutical product or
ingredient, shall constitute an authorized sale under this Settlement Agreement unless, in the case
of (a) above, it is expressly permitted and authorized under Section 1 of the Patent License
Agreement or Section 2.1 of the Distribution and Supply Agreement, as applicable; and no
determination that any patent rights of the Purdue Companies in the ‘042 Patent or any other
intellectual property have been terminated or exhausted may be based on any activity by KV
whatsoever unless and solely to the extent that such activity relates to a sale of KV Products
expressly permitted and authorized under Section 1 of the Patent License Agreement or Section 2.1
of the Distribution and Supply Agreement, as applicable.




[Remainder of this page intentionally left blank]




18









 









Settlement Agreement Signature Page




          IN WITNESS WHEREOF, each of the Parties has caused this Settlement Agreement to be executed as
of the date first written above by its duly authorized officer or agent.




	 	 	 	 	 
	PURDUE PHARMA L.P.

(on its own behalf and as successor

in interest to The Purdue Pharma Company)

 	 	 
	By:  	Purdue Pharma Inc., its general partner

 	 	 
	By:  	/s/
Edward B. Mahony	 	 
	 	Name: 	Edward B. Mahony	 	 
	 	Title: 	EVP,
CFO & Treasurer	 	 
	 
	THE P.F. LABORATORIES, INC.

 	 	 
	By:  	/s/
Edward B. Mahony	 	 
	 	Name: 	Edward B. Mahony	 	 
	 	Title: 	EVP,  CFO & Treasurer	 	 
	 
	PURDUE PHARMACEUTICALS L.P.

 	 	 
	By:  	Purdue Pharma Inc., its general partner

 	 	 
	By:  	/s/
Edward B. Mahony	 	 
	 	Name: 	Edward B. Mahony	 	 
	 	Title: 	EVP,  CFO & Treasurer	 	 
	 
	KV PHARMACEUTICAL COMPANY

 	 	 
	By:  	/s/
Paul T. Brady	 	 
	 	Name: 	Paul T. Brady	 	 
	 	Title: 	Corporate
Vice President, B.D.