C ONFIDENTIAL — E XECUTED V ERSION
Exhibit 10.9
Confidential Materials omitted
and filed separately with the
Securities and Exchange
Commission. Asterisks denote omissions.
LICENSE AGREEMENT
BY AND AMONG
WYETH, ACTING THROUGH ITS WYETH
PHARMACEUTICALS DIVISION;
WYETH PHARMACEUTICALS COMPANY,
INC.;
WYETH-WHITEHALL PHARMACEUTICALS
INC.;
and
WYETH PHARMACEUTICALS
COMPANY
(on the one hand)
AND
TEVA PHARMACEUTICAL INDUSTRIES
LTD.
and
TEVA PHARMACEUTICALS USA,
INC.
(on the other
hand)
January 13,
2006
L ICENSE A GREEMENT
TABLE OF CONTENTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page
|
|
1.
|
|
DEFINITIONS.
|
|
1
|
|
|
1.1.
|
|
“AB
Rated”
|
|
1
|
|
|
1.2.
|
|
“Affiliate”
|
|
2
|
|
|
1.3.
|
|
“ANDA”
|
|
2
|
|
|
1.4.
|
|
“Applicable Law”
|
|
2
|
|
|
1.5.
|
|
“Audit
Period”
|
|
2
|
|
|
1.6.
|
|
“Authorized Generic
Product”
|
|
2
|
|
|
1.7.
|
|
“Business
Day” or “business day”
|
|
2
|
|
|
1.8.
|
|
“Compound”
|
|
3
|
|
|
1.9.
|
|
“Compound
Patent Termination Date”
|
|
3
|
|
|
1.10.
|
|
“Confidential
Information”
|
|
3
|
|
|
1.11.
|
|
“Cost of
Goods Sold”
|
|
3
|
|
|
1.12.
|
|
“Disclosing Party”
|
|
3
|
|
|
1.13.
|
|
“FDA”
|
|
3
|
|
|
1.14.
|
|
“[**]”
|
|
3
|
|
|
1.15.
|
|
“IR
ANDA”
|
|
3
|
|
|
1.16.
|
|
“IR Entry
Date”
|
|
3
|
|
|
1.17.
|
|
“IR
IP”
|
|
3
|
|
|
1.18.
|
|
“IR New
Indication”
|
|
4
|
|
|
1.19.
|
|
“IR
Product”
|
|
4
|
|
|
1.20.
|
|
“IR
Reference Product”
|
|
4
|
|
|
1.21.
|
|
“Liability”
|
|
4
|
|
|
1.22.
|
|
“Litigation”
|
|
4
|
|
|
1.23.
|
|
“MDD”
|
|
4
|
|
|
1.24.
|
|
“Net
Sales”
|
|
4
|
|
|
1.25.
|
|
“[**]”
|
|
5
|
|
|
1.26.
|
|
“[**]”
|
|
5
|
|
|
1.27.
|
|
“[**]”
|
|
5
|
|
|
1.28.
|
|
“[**]”
|
|
5
|
|
|
1.29.
|
|
“Other
Patent Rights”
|
|
5
|
|
|
1.30.
|
|
“Patent
Rights”
|
|
5
|
|
|
1.31.
|
|
“Patents
In Suit”
|
|
5
|
|
|
1.32.
|
|
“Product”
|
|
5
|
|
|
1.33.
|
|
“Profits”
|
|
5
|
|
|
1.34.
|
|
“Receiving Party”
|
|
5
|
|
|
1.35.
|
|
“[**]”
|
|
5
|
|
|
1.36.
|
|
“[**]”
|
|
5
|
|
|
1.37.
|
|
“[**]”
|
|
5
|
|
|
1.38.
|
|
“[**]”
|
|
5
|
|
|
1.39.
|
|
“Settlement Agreement”
|
|
6
|
|
|
1.40.
|
|
“Settlement Effective
Date”
|
|
6
|
|
|
1.41.
|
|
“Signing
Date”
|
|
6
|
|
|
1.42.
|
|
“Territory”
|
|
6
|
i
L ICENSE A GREEMENT
|
|
|
|
|
|
|
|
|
|
|
1.43.
|
|
“Teva
DMF”
|
|
6
|
|
|
1.44.
|
|
“Teva
Indemnitees”
|
|
6
|
|
|
1.45.
|
|
“Third
Party”
|
|
6
|
|
|
1.46.
|
|
“[**]”
|
|
6
|
|
|
1.47.
|
|
“Transaction Agreements”
|
|
6
|
|
|
1.48.
|
|
“Valid
Claim”
|
|
6
|
|
|
1.49.
|
|
“Wyeth
Indemnitees”
|
|
6
|
|
|
1.50.
|
|
“Wyeth
IP”
|
|
6
|
|
|
1.51.
|
|
“XR
ANDA”
|
|
6
|
|
|
1.52.
|
|
“[**]”
|
|
6
|
|
|
1.53
|
|
“XR Entry
Date”
|
|
6
|
|
|
1.54.
|
|
“XR
IP”
|
|
7
|
|
|
1.55.
|
|
“XR New
Indication”
|
|
7
|
|
|
1.56.
|
|
“XR
Patent Termination Date”
|
|
7
|
|
|
1.57.
|
|
“XR
Product”
|
|
7
|
|
|
1.58.
|
|
“XR
Reference Product”
|
|
7
|
|
|
|
|
2.
|
|
RIGHTS
GRANTED.
|
|
7
|
|
|
2.1.
|
|
IR Product
Rights
|
|
7
|
|
|
|
|
2.1.1.
|
|
Exclusive
Commercialization License
|
|
7
|
|
|
|
|
2.1.2.
|
|
Manufacturing
License
|
|
8
|
|
|
|
|
2.1.3.
|
|
Regulatory
Licenses and Waivers
|
|
8
|
|
|
|
|
2.1.4.
|
|
Preparation for
Launch
|
|
8
|
|
|
|
|
2.1.5.
|
|
Covenant Not To
Sue
|
|
8
|
|
|
|
|
2.1.6.
|
|
IR New
Indications
|
|
9
|
|
|
2.2.
|
|
XR Product
Rights
|
|
10
|
|
|
|
|
2.2.1.
|
|
Exclusive
Commercialization License
|
|
10
|
|
|
|
|
2.2.2.
|
|
Nonexclusive
Commercialization License
|
|
10
|
|
|
|
|
2.2.3.
|
|
Manufacturing
License
|
|
10
|
|
|
|
|
2.2.4.
|
|
Regulatory
Licenses and Waivers
|
|
10
|
|
|
|
|
2.2.5.
|
|
Limitation on
Licenses
|
|
11
|
|
|
|
|
2.2.6.
|
|
Preparation for
Launch
|
|
11
|
|
|
|
|
2.2.7.
|
|
Covenant Not To
Sue
|
|
11
|
|
|
|
|
2.2.8.
|
|
XR New
Indications
|
|
12
|
|
|
2.3.
|
|
Sales Outside
of Licensed Territory
|
|
12
|
|
|
2.4.
|
|
Retained
Rights
|
|
13
|
|
|
|
|
3.
|
|
CONSIDERATION.
|
|
13
|
|
|
3.1.
|
|
Payments
|
|
13
|
|
|
|
|
3.1.1.
|
|
IR
Product
|
|
13
|
|
|
|
|
3.1.2.
|
|
XR
Product
|
|
13
|
|
|
3.2.
|
|
[**]
|
|
14
|
|
|
3.3.
|
|
[**]
|
|
14
|
|
|
3.4.
|
|
Reports and
Payments
|
|
14
|
|
|
3.5.
|
|
Late
Payments
|
|
14
|
|
|
3.6.
|
|
Taxes
|
|
14
|
|
|
3.7.
|
|
Record Keeping
by Teva; Audits
|
|
15
|
ii
L ICENSE A GREEMENT
|
|
|
|
|
|
|
|
|
|
|
3.8.
|
|
Record Keeping
by Wyeth; Audits
|
|
16
|
|
|
|
|
4.
|
|
REGULATORY
MATTERS; COMMERCIALIZATION.
|
|
17
|
|
|
4.1.
|
|
ANDA
Approvals
|
|
17
|
|
|
|
|
4.1.1.
|
|
IR
Product
|
|
17
|
|
|
|
|
4.1.2.
|
|
XR
Product
|
|
17
|
|
|
4.2.
|
|
Regulatory
Reporting; Pharmacovigilance
|
|
17
|
|
|
|
|
4.2.1.
|
|
IR
Product
|
|
17
|
|
|
|
|
4.2.2.
|
|
XR
Product
|
|
18
|
|
|
4.3.
|
|
Regulatory
Approvals
|
|
18
|
|
|
|
|
5.
|
|
MANUFACTURING.
|
|
19
|
|
|
5.1.
|
|
Manufacturing
Responsibility
|
|
19
|
|
|
|
|
6.
|
|
INTELLECTUAL
PROPERTY.
|
|
19
|
|
|
6.1.
|
|
Prosecution and
Maintenance of Patent Rights
|
|
19
|
|
|
6.2.
|
|
Enforcement of
Patent Rights
|
|
19
|
|
|
6.3.
|
|
Patent
Rights
|
|
19
|
|
|
6.4.
|
|
Trademarks
|
|
20
|
|
|
|
|
7.
|
|
CONFIDENTIALITY.
|
|
20
|
|
|
7.1.
|
|
Nondisclosure
and Nonuse Obligations
|
|
20
|
|
|
7.2.
|
|
Permitted
Disclosures
|
|
21
|
|
|
7.3.
|
|
Return of
Confidential Information
|
|
21
|
|
|
7.4.
|
|
Disclosure of
Agreement
|
|
21
|
|
|
|
|
8.
|
|
REPRESENTATIONS, WARRANTIES AND
COVENANTS.
|
|
22
|
|
|
8.1.
|
|
Representations
and Warranties of Both Parties
|
|
22
|
|
|
8.2.
|
|
Representations
and Warranties of Wyeth
|
|
22
|
|
|
8.3.
|
|
Representation
by Legal Counsel
|
|
22
|
|
|
8.4.
|
|
No Other
Warranties
|
|
22
|
|
|
|
|
9.
|
|
TERM AND
TERMINATION.
|
|
23
|
|
|
9.1.
|
|
Term
|
|
23
|
|
|
9.2.
|
|
Termination
|
|
23
|
|
|
|
|
9.2.1.
|
|
Material
Breach
|
|
23
|
|
|
|
|
9.2.2.
|
|
Bankruptcy
|
|
23
|
|
|
9.3.
|
|
Effects of
Termination
|
|
23
|
|
|
9.4.
|
|
Effects of
Bankruptcy
|
|
24
|
|
|
|
|
10.
|
|
OTHER PATENT
RIGHTS.
|
|
24
|
|
|
10.1.
|
|
Licensing or
Acquisition of Other Patent Rights
|
|
24
|
|
|
|
|
10.1.1.
|
|
Obligation
|
|
24
|
|
|
|
|
10.1.2.
|
|
Notice and
Consultation
|
|
24
|
|
|
|
|
10.1.3.
|
|
Agreements with
Third Parties
|
|
24
|
|
|
|
|
10.1.4.
|
|
Entry Into
Agreements By Teva
|
|
24
|
|
|
10.2.
|
|
Third Party
Claims
|
|
24
|
iii
L ICENSE A GREEMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
10.2.1.
|
|
Notice
|
|
24
|
|
|
|
|
10.2.2.
|
|
Cooperation
|
|
25
|
|
|
|
|
10.2.3.
|
|
Control of
Litigation
|
|
25
|
|
|
|
|
11.
|
|
INDEMNIFICATION
AND INSURANCE.
|
|
25
|
|
|
11.1.
|
|
Indemnification
|
|
25
|
|
|
|
|
11.1.1.
|
|
Responsibility
|
|
25
|
|
|
|
|
11.1.2.
|
|
Indemnification
by Wyeth
|
|
25
|
|
|
|
|
11.1.3.
|
|
Indemnification
by Teva
|
|
26
|
|
|
11.2.
|
|
Insurance
|
|
26
|
|
|
11.3.
|
|
Limitation of
Liability
|
|
26
|
|
|
|
|
12.
|
|
GOVERNING LAW;
DISPUTE RESOLUTION.
|
|
27
|
|
|
12.1.
|
|
Governing Law;
Jurisdiction
|
|
27
|
|
|
12.2.
|
|
Dispute
Resolution
|
|
27
|
|
|
12.3.
|
|
Injunctive
Relief
|
|
27
|
|
|
|
|
12.3.1.
|
|
Against
Wyeth
|
|
27
|
|
|
|
|
12.3.2.
|
|
Against
Teva
|
|
27
|
|
|
|
|
13.
|
|
MISCELLANEOUS.
|
|
28
|
|
|
13.1.
|
|
Data
Sources
|
|
28
|
|
|
|
|
13.1.1.
|
|
[**]
|
|
28
|
|
|
|
|
13.1.2.
|
|
IR
Product
|
|
28
|
|
|
|
|
13.1.3.
|
|
XR
Product
|
|
29
|
|
|
|
|
13.1.4.
|
|
Miscellaneous
|
|
30
|
|
|
13.2.
|
|
Assignment
|
|
30
|
|
|
13.2.1.
|
|
Assignment by
Teva
|
|
30
|
|
|
|
|
13.2.2.
|
|
Assignment by
Wyeth
|
|
31
|
|
|
|
|
13.2.3.
|
|
Binding Nature
of Assignment
|
|
31
|
|
|
13.3.
|
|
No
Waiver
|
|
31
|
|
|
13.4.
|
|
Severability
|
|
31
|
|
|
13.5.
|
|
Relationship
Between The Parties
|
|
32
|
|
|
13.6.
|
|
Correspondence
and Notices
|
|
32
|
|
|
13.7.
|
|
Entire
Agreement; Amendments
|
|
33
|
|
|
13.8.
|
|
Headings;
Defined Terms
|
|
33
|
|
|
13.9.
|
|
Counterparts
|
|
34
|
|
|
13.10.
|
|
Further
Actions
|
|
34
|
|
|
13.11.
|
|
References to
ANDAs and NDAs
|
|
34
|
iv
L ICENSE A GREEMENT
LICENSE AGREEMENT
(United States)
This License Agreement (this
“Agreement”) is entered into as of January 13,
2006 (the “Effective Date”), by and among Wyeth, acting
through its Wyeth Pharmaceuticals Division, having a place of
business at 500 Arcola Road, Collegeville, Pennsylvania 19426
(“Wyeth Pharmaceuticals”), Wyeth Pharmaceuticals
Company, Inc., having a place of business at Road No. 3, KM.
142.1, Guayama, Puerto Rico 00784 (“WPCI”),
Wyeth-Whitehall Pharmaceuticals Inc., having a place of business at
Road No. 3, KM. 142.1, Guayama, Puerto Rico 00784
(“Wyeth-Whitehall”) and Wyeth Pharmaceuticals Company,
having a place of business at Road No. 3, KM. 142.1, Guayama,
Puerto Rico 00784 (“WPC”) on the one hand, and Teva
Pharmaceutical Industries Ltd. (“Teva Ltd.”), having a
place of business at 5 Basel St. Petach Tikva 49131, Israel and
Teva Pharmaceuticals USA, Inc. (“Teva USA”), having a
place of business at 1090 Horsham Road, North Wales, PA 19454, on
the other hand. Wyeth Pharmaceuticals, WPCI, Wyeth-Whitehall and
WPC may be referred to herein collectively as “Wyeth”.
Teva Ltd. and Teva USA may be referred to herein collectively as
“Teva”. Wyeth and Teva may each be referred to herein
individually as a “Party” and collectively as the
“Parties”.
WHEREAS, the Parties have agreed to
amicably settle patent litigation currently ongoing between them
and on October 18, 2005 entered into a Binding Term Sheet (the
“Term Sheet”) in connection therewith; and
WHEREAS, in connection with such
settlement, Wyeth is willing to grant, and Teva is willing to
receive, subject to the terms and conditions set forth in this
Agreement, a license to enable Teva to sell certain products in the
Territory (as defined below) to its distributors and other
customers for ultimate sale to consumers in the Territory;
and
WHEREAS, the Term Sheet requires the
Parties to negotiate and enter into a number of definitive
agreements, including this Agreement.
WHEREAS, the Parties attached a copy
of this Agreement to the Settlement Agreement (as defined
hereinafter) for submission to the Court (as defined in the
Settlement Agreement)] on December 6, 2005.
WHEREAS, subsequent to the approval
of this Agreement by the Court as provided in the Settlement
Agreement, the Parties have (i) as provided in
Section 2.H of the Settlement Agreement, as amended, agreed to
a revised Section 13.1 of this Agreement, and (ii) agreed
to a revised Section 13.6 of this Agreement.
NOW, THEREFORE, in consideration of
the mutual covenants, agreements and stipulations set forth herein,
and in the Settlement Agreement (as defined hereinafter),the
receipt and legal sufficiency of which are hereby mutually
acknowledged, Wyeth and Teva hereby agree as follows:
As used in this Agreement, the
following terms, whether used in the singular or plural, shall have
the following meanings:
|
|
1.1.
|
“AB
Rated” shall mean
“therapeutically equivalent” as evaluated by FDA,
applying the definition of “therapeutically equivalent”
set forth in the Preface to the current edition of the FDA
publication “APPROVED DRUG PRODUCTS WITH THERAPEUTIC
EQUIVALENCE EVALUATIONS” (the “Orange Book”), as
such requirements may be amended in the future.
|
L ICENSE A GREEMENT
|
|
1.2.
|
“Affiliate” shall mean with respect to any person or entity,
any other person or entity which controls, is controlled by or is
under common control with such person or entity. A person or entity
shall be regarded as in control of another entity if it owns or
controls at least fifty percent (50%) of the equity securities
of the subject entity entitled to vote in the election of directors
(or, in the case of an entity that is not a corporation, for the
election of the corresponding managing authority), provided
, however , that if local law restricts foreign ownership,
control shall be established by both (i) having direct or
indirect ownership of the maximum ownership percentage that may,
under such local law, be owned by foreign interests and
(ii) having the power to direct and control the management and
policies of such foreign entity, and provided further ,
however , that the term “Affiliate” shall not
include subsidiaries or other entities in which a Party or its
Affiliates owns a majority of the ordinary voting power necessary
to elect a majority of the board of directors or other governing
board, but is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer in
effect.
|
|
|
1.3.
|
“ANDA” shall mean an Abbreviated New Drug Application
as defined in the U.S. Federal Food, Drug and Cosmetic Act, as
amended, and all applicable regulations promulgated
thereunder.
|
|
|
1.4.
|
“Applicable Law”
shall mean all applicable provisions
of all statutes, laws, rules, regulations, administrative codes,
ordinances, decrees, orders, decisions, guidance documents
(including FDA guidance documents), injunctions, awards judgments,
and permits and licenses of or from governmental authorities
relating to the use or regulation of the subject item.
|
|
|
1.5.
|
“Audit
Period” shall have
the meaning set forth in Section 3.7.
|
|
|
1.6.
|
“Authorized Generic
Product” shall mean, with respect to IR
Reference Product or XR Reference Product (in any dosage strength),
as applicable, any product marketed or sold by or under license,
waiver or other actual or effective authorization of, or supplied
by or on behalf of, Wyeth or any of Wyeth’s Affiliates or
licensees, as IR Reference Product or XR Reference Product, as
applicable, as a generic in the Territory (other than by Teva or
Teva’s Affiliates pursuant to this Agreement) not under the
Effexor ® trademark.
|
|
|
1.7.
|
“Business Day” or “business
day” shall mean
any day other than a day which is a Saturday, a Sunday or a day on
which banks in New York City, New York or Israel are authorized or
obligated by law or executive order to not open or remain
closed.
|
2
L ICENSE A GREEMENT
|
|
1.8.
|
“Compound” shall mean venlafaxine hydrochloride and any
form thereof including polymorphs and solvates, and other
pharmaceutically acceptable salts of venlafaxine and any form
thereof including polymorphs and solvates.
|
|
|
1.9.
|
“Compound Patent Termination
Date” shall mean
the date on which there are no more Valid Claims of U.S. Patent
No. 4,535,186 that, but for the licenses contained herein,
would be infringed by the manufacture, use, sale, offer for sale or
importation of IR Product.
|
|
|
1.10.
|
“Confidential
Information” shall
mean any and all confidential information regarding, related to, or
associated with the Compound, any Product, the IR Reference
Product, the XR Reference Product, the Wyeth IP and/or this
Agreement (other than the terms and conditions hereof, which shall
be subject to Section 7.4) that (i) is disclosed by the
Disclosing Party to the Receiving Party or otherwise obtained by
the Receiving Party from the Disclosing Party as of and after the
Signing Date or before the Signing Date in connection with the
Litigation or settlement thereof or (ii) was disclosed by or
on behalf of the Disclosing Party to the Receiving Party or the
Receiving Party’s attorneys in connection with the
Litigation, whether or not covered by a protective order or other
similar order issued with respect thereto.
|
|
|
1.11.
|
“Cost
of Goods Sold” shall mean, as applicable, (i) the costs
incurred by Teva in manufacturing IR Products sold by Teva or its
Affiliates in the Territory under this Agreement, provided,
however , [**], or (ii) the costs incurred by Teva in
manufacturing XR Products sold by Teva or its Affiliates in the
Territory under this Agreement (including all applicable [**]). In
calculating costs incurred in manufacturing IR Products or XR
Products only those cost elements described in Exhibit 1.11 shall
be included.
|
|
|
1.12.
|
“Disclosing Party”
shall mean the Party who is
disclosing its Confidential Information to the Receiving
Party.
|
|
|
1.13.
|
“FDA” shall mean the United States Food and Drug
Administration or any successor agency thereto.
|
|
|
1.14.
|
“[**]” shall have the meaning [**].
|
|
|
1.15.
|
“IR
ANDA” shall mean
ANDA No. 76-690 filed with the FDA by Teva, which ANDA seeks
approval to market the IR Product.
|
|
|
1.16.
|
“IR
Entry Date” shall
mean the earlier of (i) June 15, 2006, or (ii) [**]
in which [**] as compared to [**].
|
|
|
1.17.
|
“IR IP”
shall mean (i) Patent Rights
under U.S. Patent No. 4,535,186, (ii) all other U.S.
Patent Rights owned or controlled as of the Signing Date or as of
the Settlement Effective Date by Wyeth or any of its Affiliates
that, but for the licenses contained herein, would be infringed by,
the manufacture, use, sale, offer for sale or importation of any IR
Product (including Compound to the extent
|
3
L ICENSE A GREEMENT
|
|
necessary to manufacture IR
Product), and (iii) all U.S. Patent Rights, claiming (directly
or indirectly) priority to such U.S. patent and U.S. Patent Rights
identified in clause (i) and (ii) or any of the
applications to which any such U.S. patent or U.S. Patent Rights
claim (directly or indirectly) priority, that, but for the licenses
contained herein, would be infringed by the manufacture, use, sale,
offer for sale or importation of any IR Product (including Compound
to the extent necessary to manufacture IR Product).
|
|
|
1.18.
|
“IR
New Indication” shall have the meaning set forth in
Section 2.1.5.
|
|
|
1.19.
|
“IR
Product” shall mean
the immediate release tablet, which tablet contains venlafaxine
hydrochloride as its sole active ingredient and is marketed by Teva
or any of its Affiliates as a generic product AB Rated to IR
Reference Product (in any dosage strength) in the Territory. For
the sake of clarity, IR Product shall not include any IR Reference
Product.
|
|
|
1.20.
|
“IR
Reference Product” shall mean the immediate release tablet
containing, as its sole active ingredient, venlafaxine
hydrochloride equivalent to either 25mg, 37.5mg, 50mg, 75mg or
100mg of venlafaxine (or other approved dosage strengths) which
tablet is marketed in the Territory by Wyeth or any of its
Affiliates or licensees as Effexor® under NDA
No. 20-151.
|
|
|
1.21.
|
“Liability” shall have the meaning set forth in
Section 11.1.2.
|
|
|
1.22.
|
“Litigation” shall mean that certain
|

|