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
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Page
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1.
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DEFINITIONS.
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1
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1.1.
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“AB
Rated”
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1
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1.2.
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“Affiliate”
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2
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1.3.
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“ANDA”
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2
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1.4.
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“Applicable Law”
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2
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1.5.
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“Audit
Period”
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2
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1.6.
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“Authorized Generic
Product”
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2
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1.7.
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“Business
Day” or “business day”
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2
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1.8.
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“Compound”
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3
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1.9.
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“Compound
Patent Termination Date”
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3
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1.10.
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“Confidential
Information”
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3
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1.11.
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“Cost of
Goods Sold”
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3
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1.12.
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“Disclosing Party”
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3
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1.13.
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“FDA”
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3
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1.14.
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“[**]”
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3
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1.15.
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“IR
ANDA”
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3
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1.16.
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“IR Entry
Date”
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3
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1.17.
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“IR
IP”
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3
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1.18.
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“IR New
Indication”
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4
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1.19.
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“IR
Product”
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4
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1.20.
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“IR
Reference Product”
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4
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1.21.
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“Liability”
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4
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1.22.
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“Litigation”
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4
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1.23.
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“MDD”
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4
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1.24.
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“Net
Sales”
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4
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1.25.
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“[**]”
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5
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1.26.
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“[**]”
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5
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1.27.
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“[**]”
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5
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1.28.
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“[**]”
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5
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1.29.
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“Other
Patent Rights”
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5
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1.30.
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“Patent
Rights”
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5
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1.31.
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“Patents
In Suit”
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5
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1.32.
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“Product”
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5
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1.33.
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“Profits”
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5
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1.34.
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“Receiving Party”
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5
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1.35.
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“[**]”
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5
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1.36.
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“[**]”
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5
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1.37.
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“[**]”
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5
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1.38.
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“[**]”
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5
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1.39.
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“Settlement Agreement”
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6
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1.40.
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“Settlement Effective
Date”
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6
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1.41.
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“Signing
Date”
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6
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1.42.
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“Territory”
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6
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L ICENSE A GREEMENT
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1.43.
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“Teva
DMF”
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6
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1.44.
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“Teva
Indemnitees”
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6
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1.45.
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“Third
Party”
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6
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1.46.
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“[**]”
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6
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1.47.
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“Transaction Agreements”
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6
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1.48.
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“Valid
Claim”
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6
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1.49.
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“Wyeth
Indemnitees”
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6
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1.50.
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“Wyeth
IP”
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6
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1.51.
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“XR
ANDA”
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6
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1.52.
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“[**]”
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6
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1.53
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“XR Entry
Date”
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6
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1.54.
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“XR
IP”
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7
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1.55.
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“XR New
Indication”
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7
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1.56.
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“XR
Patent Termination Date”
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7
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1.57.
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“XR
Product”
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7
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1.58.
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“XR
Reference Product”
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7
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2.
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RIGHTS
GRANTED.
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7
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2.1.
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IR Product
Rights
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7
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2.1.1.
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Exclusive
Commercialization License
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7
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2.1.2.
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Manufacturing
License
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8
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2.1.3.
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Regulatory
Licenses and Waivers
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8
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2.1.4.
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Preparation for
Launch
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8
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2.1.5.
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Covenant Not To
Sue
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8
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2.1.6.
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IR New
Indications
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9
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2.2.
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XR Product
Rights
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10
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2.2.1.
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Exclusive
Commercialization License
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10
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2.2.2.
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Nonexclusive
Commercialization License
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10
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2.2.3.
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Manufacturing
License
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10
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2.2.4.
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Regulatory
Licenses and Waivers
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10
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2.2.5.
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Limitation on
Licenses
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11
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2.2.6.
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Preparation for
Launch
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11
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2.2.7.
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Covenant Not To
Sue
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11
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2.2.8.
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XR New
Indications
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12
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2.3.
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Sales Outside
of Licensed Territory
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12
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2.4.
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Retained
Rights
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13
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3.
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CONSIDERATION.
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13
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3.1.
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Payments
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13
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3.1.1.
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IR
Product
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13
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3.1.2.
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XR
Product
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13
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3.2.
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[**]
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14
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3.3.
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[**]
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14
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3.4.
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Reports and
Payments
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14
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3.5.
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Late
Payments
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14
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3.6.
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Taxes
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14
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3.7.
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Record Keeping
by Teva; Audits
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15
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L ICENSE A GREEMENT
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3.8.
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Record Keeping
by Wyeth; Audits
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16
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4.
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REGULATORY
MATTERS; COMMERCIALIZATION.
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17
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4.1.
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ANDA
Approvals
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17
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4.1.1.
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IR
Product
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17
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4.1.2.
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XR
Product
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17
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4.2.
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Regulatory
Reporting; Pharmacovigilance
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17
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4.2.1.
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IR
Product
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17
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4.2.2.
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XR
Product
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18
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4.3.
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Regulatory
Approvals
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18
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5.
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MANUFACTURING.
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19
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5.1.
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Manufacturing
Responsibility
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19
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6.
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INTELLECTUAL
PROPERTY.
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19
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6.1.
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Prosecution and
Maintenance of Patent Rights
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19
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6.2.
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Enforcement of
Patent Rights
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19
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6.3.
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Patent
Rights
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19
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6.4.
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Trademarks
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20
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7.
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CONFIDENTIALITY.
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20
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7.1.
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Nondisclosure
and Nonuse Obligations
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20
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7.2.
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Permitted
Disclosures
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21
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7.3.
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Return of
Confidential Information
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21
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7.4.
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Disclosure of
Agreement
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21
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8.
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REPRESENTATIONS, WARRANTIES AND
COVENANTS.
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22
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8.1.
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Representations
and Warranties of Both Parties
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22
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8.2.
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Representations
and Warranties of Wyeth
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22
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8.3.
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Representation
by Legal Counsel
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22
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8.4.
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No Other
Warranties
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22
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9.
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TERM AND
TERMINATION.
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23
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9.1.
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Term
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23
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9.2.
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Termination
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23
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9.2.1.
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Material
Breach
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23
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9.2.2.
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Bankruptcy
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23
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9.3.
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Effects of
Termination
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23
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9.4.
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Effects of
Bankruptcy
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24
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10.
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OTHER PATENT
RIGHTS.
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24
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10.1.
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Licensing or
Acquisition of Other Patent Rights
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24
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10.1.1.
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Obligation
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24
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10.1.2.
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Notice and
Consultation
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24
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10.1.3.
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Agreements with
Third Parties
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24
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10.1.4.
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Entry Into
Agreements By Teva
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24
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10.2.
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Third Party
Claims
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24
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iii
L ICENSE A GREEMENT
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10.2.1.
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Notice
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24
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10.2.2.
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Cooperation
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25
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10.2.3.
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Control of
Litigation
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25
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11.
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INDEMNIFICATION
AND INSURANCE.
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25
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11.1.
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Indemnification
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25
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11.1.1.
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Responsibility
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25
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11.1.2.
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Indemnification
by Wyeth
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25
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11.1.3.
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Indemnification
by Teva
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26
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11.2.
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Insurance
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26
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11.3.
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Limitation of
Liability
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26
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12.
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GOVERNING LAW;
DISPUTE RESOLUTION.
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27
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12.1.
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Governing Law;
Jurisdiction
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27
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12.2.
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Dispute
Resolution
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27
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12.3.
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Injunctive
Relief
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27
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12.3.1.
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Against
Wyeth
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27
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12.3.2.
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Against
Teva
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27
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13.
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MISCELLANEOUS.
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28
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13.1.
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Data
Sources
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28
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13.1.1.
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[**]
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28
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13.1.2.
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IR
Product
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28
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13.1.3.
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XR
Product
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29
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13.1.4.
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Miscellaneous
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30
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13.2.
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Assignment
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30
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13.2.1.
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Assignment by
Teva
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30
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13.2.2.
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Assignment by
Wyeth
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31
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13.2.3.
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Binding Nature
of Assignment
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31
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13.3.
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No
Waiver
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31
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13.4.
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Severability
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31
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13.5.
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Relationship
Between The Parties
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32
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13.6.
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Correspondence
and Notices
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32
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13.7.
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Entire
Agreement; Amendments
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33
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13.8.
|
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Headings;
Defined Terms
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33
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13.9.
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Counterparts
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34
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13.10.
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Further
Actions
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34
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13.11.
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References to
ANDAs and NDAs
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34
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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.
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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.
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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.
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1.5.
|
“Audit
Period” shall have
the meaning set forth in Section 3.7.
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|
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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.
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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.
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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.
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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.
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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.
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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.
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1.12.
|
“Disclosing Party”
shall mean the Party who is
disclosing its Confidential Information to the Receiving
Party.
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1.13.
|
“FDA” shall mean the United States Food and Drug
Administration or any successor agency thereto.
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1.14.
|
“[**]” shall have the meaning [**].
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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.
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1.16.
|
“IR
Entry Date” shall
mean the earlier of (i) June 15, 2006, or (ii) [**]
in which [**] as compared to [**].
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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
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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).
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1.18.
|
“IR
New Indication” shall have the meaning set forth in
Section 2.1.5.
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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.
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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.
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1.21.
|
“Liability” shall have the meaning set forth in
Section 11.1.2.
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1.22.
|
“Litigation” shall mean that certain civil action for patent
infringement brought by Wyeth against Teva in the United States
District Court for the District of New Jersey which is referenced
as Wyeth v. Teva, et al. (Civil Action No. 03-CV-1293(WJM))
and is the subject of the Settlement Agreement.
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1.23.
|
“MDD” shall mean major depressive disorder.
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1.24.
|
“Net
Sales” shall mean
the aggregate gross sales of the amounts invoiced for the sale of
XR Products and IR Products by Teva or any of its Affiliates in
arm’s length transactions with Third Parties (“Gross
Sales”) for use in the Territory, less reasonable estimates
for the following: (i) cash discounts (ii) adjustments on
account of price adjustments, billing adjustments, or shelf stock
adjustments (iii) returns, shortages or rejected/damaged goods
(iv) chargebacks (v) rebates, promotional allowances,
administrative fee arrangements, and similar payments to all direct
and indirect customers, including wholesalers and other
distributors, buying groups, health care insurance carriers,
pharmacy benefit management companies, health maintenance
organizations, Medicaid or Medicare or similar type programs. In
the event that Teva sells XR Product or IR Product as part of a
bundle or group sale with other products not covered by this
Agreement, and Teva provides a discount, allowance or rebate to the
purchaser of such XR Product or IR Product based on the invoiced
prices for all products sold, such discount must be allocated pro
rata based on the selling prices of all such products. Net Sales
shall be determined using the accrual method of accounting
determined in a
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L ICENSE A GREEMENT
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manner consistent with
Teva’s practice for its other pharmaceutical products. Sales
of Product(s) by and between Teva and its Affiliates are not sales
to Third Parties and shall be excluded from Net Sales calculations
for all purposes, it being understood that the sale of a Product by
Teva or any of its Affiliates to a Third Party shall be utilized in
calculating Net Sales under this Agreement.
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1.25.
|
“[**]” shall mean the first day by when both of the
following have occurred: (i) [**], and (ii) Next
Generation XR Product is [**].
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1.26.
|
“[**]” shall mean [**], in each case, [**] from Wyeth
[**].
|
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1.27.
|
“[**]” shall have the meaning [**].
|
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1.28.
|
“[**]” shall have the meaning [**].
|
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|
1.29.
|
“Other
Patent Rights” shall mean those Patent Rights owned or
controlled by a Third Party that, [**] after the Settlement
Effective Date, [**].
|
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1.30.
|
“Patent Rights”
shall mean all patents and patent
applications, including all provisional applications,
substitutions, continuations, continuations-in-part, divisions, and
renewals, all patents granted thereon, and all patents-of-addition,
reissues, reexaminations, extensions and extended exclusivities
(including supplementary protection certificates and pediatric
extensions) or restorations by existing or future extension or
restoration mechanisms.
|
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1.31.
|
“Patents In Suit”
shall mean U.S. Patents 6,274,171
B1, 6,403,120 B1, and 6,419,958 B2.
|
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1.32.
|
“Product” shall mean the IR Product and/or the XR Product,
as the context requires.
|
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1.33.
|
“Profits” shall mean, with respect to any Product sold by
Teva or any of Teva’s Affiliates, Net Sales of such Product
less the Costs of Goods Sold for such Product.
|
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|
1.34.
|
“Receiving Party”
shall mean the Party who is
receiving Confidential Information from the Disclosing
Party.
|
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|
1.35.
|
“[**]” shall mean gross sales of [**].
|
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|
1.36.
|
“[**]” shall mean [**] in any way and [**] directly or
indirectly, [**] marketed as a generic product [**].
|
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|
1.37.
|
“[**]” shall mean the date on which a [**] is [**],
provided that [**], then [**] hereunder.
|
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|
1.38.
|
“[**]” shall mean [**] in any way [**] which [**] and
is marketed as a generic product [**].
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L ICENSE A GREEMENT
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1.39.
|
“Settlement Agreement”
shall mean that certain Settlement
and Release Agreement entered into by the Parties and dated
November 2, 2005.
|
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1.40.
|
“Settlement Effective
Date” shall mean
the date on which all of the Settlement Conditions set forth in the
Settlement Agreement have occurred such that this Agreement and the
settlement becomes effective as provided in the Settlement
Agreement.
|
|
|
1.41.
|
“Signing Date”
shall mean October 18,
2005.
|
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|
1.42.
|
“Territory” shall mean the United States and its territories
and possessions.
|
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|
1.43.
|
“Teva
DMF” shall mean the
drug master file submitted by Teva to the FDA on December 2,
2002 relating to the manufacture of venlafaxine hydrochloride and
identified as DMF No. 16281.
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1.44.
|
“Teva
Indemnitees” shall
have the meaning set forth in Section 11.1.2.
|
|
|
1.45.
|
“Third
Party” shall mean
any person or entity other than Wyeth, Teva or any of their
respective Affiliates.
|
[**] provided, however , that
such [**]
|
|
1.47.
|
“Transaction Agreements”
shall mean this Agreement and the
Settlement Agreement.
|
|
|
1.48.
|
“Valid
Claim” shall mean
either (a) a claim of an issued and unexpired Patent Right
which has not been revoked or held unenforceable or invalid by a
decision of a court or other governmental agency of competent
jurisdiction, which revocation or holding is unappealable or
unappealed within the time allowed for appeal, and which has not
been disclaimed, denied or admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise, or (b) a claim of
a pending application for a Patent Right which claim was filed in
good faith and has not been abandoned or finally disallowed without
the possibility of appeal or refiling of said
application.
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|
|
1.49.
|
“Wyeth
Indemnitees” shall
have the meaning set forth in Section 11.1.3.
|
|
|
1.50.
|
“Wyeth
IP” shall mean the
IR IP and the XR IP.
|
|
|
1.51.
|
“XR
ANDA” shall mean
ANDA No. 76-565 filed with the FDA by Teva, which ANDA seeks
approval to market the XR Product.
|
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|
1.52.
|
“[**]” shall mean the first day when [**]
|
|
|
1.53.
|
“XR
Entry Date” shall
mean the earlier of (i) July 1, 2010, [**]
|
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L ICENSE A GREEMENT
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|
1.54.
|
“XR
IP” shall mean the
IR IP, plus (i) U.S. Patent Nos. 5,916,923, 6,274,171,
6,403,120, 6,419,958, and 6,444,708, (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 XR
Product (including Compound to the extent necessary to manufacture
XR Product), and (iii) all U.S. Patent Rights, claiming
(directly or indirectly) priority to such U.S. patents and U.S.
Patent Rights identified in clause (i) and (ii) or any of
the applications to which any such U.S. patents 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 XR Product
(including Compound to the extent necessary to manufacture XR
Product).
|
|
|
1.55.
|
“XR
New Indication” shall have the meaning set forth in
Section 2.2.7.
|
|
|
1.56.
|
“XR
Patent Termination Date” shall mean the date on which there are no more
Valid Claims of U.S. Patent Rights contained in the [**] contained
herein, [**].
|
|
|
1.57.
|
“XR
Product” shall mean
once-daily extended release capsule, which capsule 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 XR Reference Product (in any dosage strength) in the
Territory. For the sake of clarity, XR Product shall not include XR
Reference Product.
|
|
|
1.58.
|
“XR
Reference Product” shall mean the once-daily extended release
capsule containing, as its sole active ingredient, venlafaxine
hydrochloride equivalent to either 37.5mg, 75mg or 150mg of
venlafaxine (or other approved dosage strengths) which capsule is
marketed in the Territory by Wyeth or any of its Affiliates or
licensees as Effexor® XR under NDA No. 20-699.
|
|
|
2.1.1.
|
Exclusive
Commercialization License. Effective as of the IR Entry Date, Wyeth hereby
grants to Teva and its Affiliates an exclusive, non-transferable
(except to the extent permitted in Section 13.2) license,
without the right to grant sublicenses, under the IR IP, to use,
offer for sale, sell, import and have imported IR Products, solely
for sale to their distributors and customers in the Territory for
ultimate resale by such distributors and customers to consumers for
use in the Territory. From the Signing Date until the Compound
Patent Termination Date, neither Wyeth nor any of its Affiliates
will market, sell, supply, distribute or manufacture any Authorized
Generic Product of IR Reference Product (in any dosage strength),
or license, grant a waiver or otherwise authorize or cause or allow
any Third Party to do the same, for sale in the Territory. The
license granted under this Section 2.1.1 shall remain in
effect until such time as there are no more Valid Claims contained
in the IR IP.
|
7
L ICENSE A GREEMENT
|
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2.1.2.
|
Manufacturing License. Effective as of the IR Entry Date, Wyeth hereby
grants to Teva and its Affiliates a non-transferable (except to the
extent permitted in Section 13.2) license, without the right
to grant sublicenses, under all IR IP and those foreign
counterparts to the IR IP in the territories next specified, to
manufacture and have manufactured IR Products (including Compound
to the extent necessary to manufacture IR Products) in the United
States, [**] the license set forth in this sentence [**], but if
outside the Territory, only for the importation of such IR Products
and Compound (solely for the purposes of manufacturing IR Products)
into the Territory and the other activities in the Territory
permitted by the license granted in Section 2.1.1. The license
granted under this Section 2.1.2 shall remain in effect until
such time as there are no more Valid Claims contained in the IR
IP.
|
|
|
2.1.3.
|
Regulatory
Licenses and Waivers. Wyeth hereby grants to Teva a non-transferable
(except to the extent permitted in Section 13.2) license or
waiver (as applicable), without the right to grant sublicenses,
under any regulatory exclusivities that Wyeth or any of its
Affiliates has for the IR Products in the Territory, but only to
the extent required for Teva and its Affiliates to exercise in full
the licenses contained in Sections 2.1.1 and 2.1.2 and the covenant
not to sue contained in Section 2.1.5 (as may be expanded
under Section 2.1.6). Such license or waiver will be exclusive
for the same period of time as the corresponding license, and shall
remain in effect until such time as there are no more Valid Claims
subject to the licenses contained in Sections 2.1.1 or 2.1.2 or the
covenant not to sue contained in Section 2.1.5 (as may be
expanded under Section 2.1.6).
|
|
|
2.1.4.
|
Preparation
for Launch. The licenses
contained in Sections 2.1.1 to 2.1.3 (other than any license to
sell or distribute the IR Products) may be exercised up to [**]
before the IR Entry Date to enable Teva and its Affiliates to
undertake reasonably necessary preparations to sell IR Product for
use in the Territory as of the IR Entry Date (but not before),
provided, however , that solely with respect to
manufacturing and shipping to Teva or its Affiliates or Third Party
warehouses under Teva’s or Teva’s Affiliates’
control launch amounts of IR Product, the licenses contained in
Sections 2.1.1 to 2.1.3 may be exercised [**] thereafter. Wyeth
will notify Teva as soon as practicable of the expected and actual
occurrence of the IR Entry Date. Teva shall not sell or distribute
IR Product before the IR Entry Date.
|
|
|
2.1.5.
|
Covenant Not To
Sue. From such time as
Teva and its Affiliates may exercise the licenses contained in
Sections 2.1.1 to 2.1.4 with respect to the IR Products (including
Compound for the purposes of manufacturing IR Products), Wyeth
hereby covenants that Wyeth and its Affiliates will
|
8
L ICENSE A GREEMENT
|
|
not sue, or cause or support any
licensee or other Third Party to sue, any of Teva or its
Affiliates, their manufacturers and importers, or their
distributors and customers or their consumers, claiming that the
manufacture, use, sale, offer for sale or importation of IR
Products (including Compound for the purposes of manufacturing IR
Products), within the scope of permitted activities covered by such
licenses, infringes any Patent Rights which
|
|
|
(i)
|
are not
included in the IR IP but are owned or controlled (and with respect
to controlled, with the right to grant at least a covenant not to
sue, [**] as of the Signing Date or thereafter by Wyeth or any of
its Affiliates, and
|
|
|
(ii)
|
cover
(a) the compositions or formulations of IR Reference Product
or IR Product or Compound for the purposes of manufacturing IR
Product, or any of their use (including product-by-process claims),
or (b) manufacture of IR Product or Compound by or on behalf
of Teva or any of its Affiliates using manufacturing processes that
(x) are identified or described in the IR ANDA or the Teva DMF
as they exist on the Signing Date, or are materially the same
thereto, and (y) were conceived prior to the Settlement
Effective Date,
|
provided, however
, that this covenant not to sue
shall not extend to any Valid Claim claiming any
(A) manufacturing process used or useful for IR Reference
Product, IR Product or Compound for the purposes of manufacturing
IR Products, other than those expressly identified in clause
(ii)(b) above, or (B) subject to Section 2.1.6, IR New
Indication. The foregoing covenant not to sue shall remain in
effect until such time as there are no more Valid Claims contained
in Patent Rights subject to such covenant not to sue. For sake of
clarity, the foregoing covenant not to sue shall be in addition to
and shall not limit any of the licenses provided for in Sections
2.1.1 to 2.1.4. Wyeth will impose the foregoing covenant not to sue
on any Third Party to which Wyeth or any of its Affiliates may
assign, license or otherwise transfer any Patent Rights subject to
the foregoing covenant not to sue.
|
|
2.1.6.
|
IR New
Indications. Wyeth shall
notify Teva reasonably in advance of listing any Patent Rights on
the Orange Book for IR Reference Product. If Wyeth or any of its
Affiliates has or obtains any rights to Patent Rights claiming any
additional, new or supplemental indication (other than MDD or an
equivalent of MDD) for IR Reference Product not already approved as
of the Signing Date (an “IR New Indication”), and any
such Patent Rights are listed in the Orange Book for IR Reference
Product, Wyeth hereby extends the covenant not to sue provided in
Section 2.1.5 to such Patent Rights [**]
|
9
L ICENSE A GREEMENT
|
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2.2.1.
|
Exclusive
Commercialization License. Effective as of the XR Entry Date, subject to
Section 2.2.5 below, Wyeth hereby grants to Teva and its
Affiliates an exclusive non-transferable (except to the extent
permitted in Section 13.2) license, without the right to grant
sublicenses, under the XR IP, to use, offer for sale, sell, import
and have imported XR Products, solely for sale to their
distributors and customers in the Territory for ultimate resale by
such distributors and customers to consumers for use in the
Territory. Such exclusive license will expire [**] after the XR
Entry Date. From the Signing Date until the foregoing exclusive
license expires, neither Wyeth nor any of its Affiliates will
market, sell, distribute or manufacture any Authorized Generic
Product of XR Reference Product (in any dosage strength), or
license, grant a waiver or otherwise authorize or cause or allow
any Third Party to do the same, for sale in the
Territory.
|
|
|
2.2.2.
|
Nonexclusive
Commercialization License. Effective immediately upon expiration of the
exclusive license granted under Section 2.2.1, subject to
Section 2.2.5 below, Wyeth hereby grants to Teva and its
Affiliates a non-exclusive non-transferable (except to the extent
permitted in Section 13.2) license, without the right to grant
sublicenses, under the XR IP, to use, offer for sale, sell, import
and have imported XR Products, solely for sale to their
distributors and customers in the Territory for ultimate resale by
such distributors and customers to consumers for use in the
Territory. The license granted under this Section 2.2.2 shall
remain in effect until such time as there are no more Valid Claims
contained in the XR IP.
|
|
|
2.2.3.
|
Manufacturing License. Effective as of the XR Entry Date, Wyeth hereby
grants to Teva and its Affiliates a non-transferable (except to the
extent permitted in Section 13.2) license, without the right
to grant sublicenses, under the XR IP and those foreign
counterparts to the XR IP in the territories next specified, to
manufacture and have manufactured XR Products (including Compound
to the extent necessary to manufacture XR Products) in the United
States, [**] the license set forth in this sentence [**], but if
outside the Territory, only for the importation of such XR Products
and Compound (for the purposes of manufacturing XR Products) into
the Territory and the other activities in the Territory permitted
by the licenses granted in Section 2.2.1 and 2.2.2. Such
license shall be exclusive for the [**] after the XR Entry Date and
thereafter shall be nonexclusive. The license granted under this
Section 2.2.3 shall remain in effect until such time as there
are no more Valid Claims contained in the XR IP.
|
|
|
2.2.4.
|
Regulatory Licenses and
Waivers. Wyeth hereby
grants to Teva a non-transferable (except to the extent permitted
in Section 13.2) license or waiver (as applicable), without
the right to grant sublicenses, under any regulatory exclusivities
that Wyeth or any of its Affiliates has for the XR
|
10
L ICENSE A GREEMENT
|
|
Products in the Territory, but
only to the extent required for Teva and its Affiliates to exercise
in full the licenses contained in Sections 2.2.1 to 2.2.3 and the
covenant not to sue contained in Section 2.2.7 (as may be
expanded under Section 2.2.8). Such license or waiver will be
exclusive and non-exclusive for the same period of time as the
corresponding license, and shall remain in effect until such time
as there are no more Valid Claims subject to the licenses contained
in Sections 2.2.1, 2.2.2 or 2.2.3 or the covenant not to sue
contained in Section 2.2.7.
|
|
|
2.2.5.
|
Limitation
on Licenses. If the XR
Entry Date [**] the licen
|
|