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LICENSE AGREEMENT

Content License Agreement

LICENSE AGREEMENT | Document Parties: 1090 Horsham Road, North Wales, PA | Teva Pharmaceutical Industries Ltd | Wyeth Pharmaceuticals Company, Inc | Wyeth Teva Ltd | WYETH-WHITEHALL PHARMACEUTICALS INC You are currently viewing:
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1090 Horsham Road, North Wales, PA | Teva Pharmaceutical Industries Ltd | Wyeth Pharmaceuticals Company, Inc | Wyeth Teva Ltd | WYETH-WHITEHALL PHARMACEUTICALS INC

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Title: LICENSE AGREEMENT
Governing Law: New Jersey     Date: 4/30/2009
Industry: Major Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: 1090 horsham road  north wales  pa , teva pharmaceutical industries ltd , wyeth pharmaceuticals company  inc , wyeth teva ltd , wyeth-whitehall pharmaceuticals inc
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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


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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

 

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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

 

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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

 

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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

 

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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:

 

1.

DEFINITIONS.

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


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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.

 

 

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 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.

 

 

1.23.

“MDD” shall mean major depressive disorder.

 

 

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

 

4


L ICENSE A GREEMENT

 

 

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.

 

 

1.25.

“[**]” shall mean the first day by when both of the following have occurred: (i) [**], and (ii) Next Generation XR Product is [**].

 

 

1.26.

“[**]” shall mean [**], in each case, [**] from Wyeth [**].

 

 

1.27.

“[**]” shall have the meaning [**].

 

 

1.28.

“[**]” shall have the meaning [**].

 

 

1.29.

“Other Patent Rights” shall mean those Patent Rights owned or controlled by a Third Party that, [**] after the Settlement Effective Date, [**].

 

 

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.

 

 

1.31.

“Patents In Suit” shall mean U.S. Patents 6,274,171 B1, 6,403,120 B1, and 6,419,958 B2.

 

 

1.32.

“Product” shall mean the IR Product and/or the XR Product, as the context requires.

 

 

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.

 

 

1.34.

“Receiving Party” shall mean the Party who is receiving Confidential Information from the Disclosing Party.

 

 

1.35.

“[**]” shall mean gross sales of [**].

 

 

1.36.

“[**]” shall mean [**] in any way and [**] directly or indirectly, [**] marketed as a generic product [**].

 

 

1.37.

“[**]” shall mean the date on which a [**] is [**], provided that [**], then [**] hereunder.

 

 

1.38.

“[**]” shall mean [**] in any way [**] which [**] and is marketed as a generic product [**].

 

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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.

 

 

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.

 

 

1.42.

“Territory” shall mean the United States and its territories and possessions.

 

 

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.

 

 

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.

 

 

1.46.

[**] :

[**] 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.

 

 

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.

 

 

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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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.

RIGHTS GRANTED.

 

 

2.1.

IR Product Rights.

 

 

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.

 

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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

 

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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 [**]

 

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2.2.

XR Product Rights.

 

 

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

 

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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


 
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