Username:
  
  Password:
  
  

C ONFIDENTIAL — E XECUTED V ERSION

Exhibit 10.9

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

LICENSE AGREEMENT

BY AND AMONG

WYETH, ACTING THROUGH ITS WYETH PHARMACEUTICALS DIVISION;

WYETH PHARMACEUTICALS COMPANY, INC.;

WYETH-WHITEHALL PHARMACEUTICALS INC.;

and

WYETH PHARMACEUTICALS COMPANY

(on the one hand)

AND

TEVA PHARMACEUTICAL INDUSTRIES LTD.

and

TEVA PHARMACEUTICALS USA, INC.

(on the other hand)

January 13, 2006


L ICENSE A GREEMENT

TABLE OF CONTENTS

 

 

 

 

 

 

  

 

  

Page

1.

 

DEFINITIONS.

  

1

 

1.1.

 

“AB Rated”

  

1

 

1.2.

 

“Affiliate”

  

2

 

1.3.

 

“ANDA”

  

2

 

1.4.

 

“Applicable Law”

  

2

 

1.5.

 

“Audit Period”

  

2

 

1.6.

 

“Authorized Generic Product”

  

2

 

1.7.

 

“Business Day” or “business day”

  

2

 

1.8.

 

“Compound”

  

3

 

1.9.

 

“Compound Patent Termination Date”

  

3

 

1.10.

 

“Confidential Information”

  

3

 

1.11.

 

“Cost of Goods Sold”

  

3

 

1.12.

 

“Disclosing Party”

  

3

 

1.13.

 

“FDA”

  

3

 

1.14.

 

“[**]”

  

3

 

1.15.

 

“IR ANDA”

  

3

 

1.16.

 

“IR Entry Date”

  

3

 

1.17.

 

“IR IP”

  

3

 

1.18.

 

“IR New Indication”

  

4

 

1.19.

 

“IR Product”

  

4

 

1.20.

 

“IR Reference Product”

  

4

 

1.21.

 

“Liability”

  

4

 

1.22.

 

“Litigation”

  

4

 

1.23.

 

“MDD”

  

4

 

1.24.

 

“Net Sales”

  

4

 

1.25.

 

“[**]”

  

5

 

1.26.

 

“[**]”

  

5

 

1.27.

 

“[**]”

  

5

 

1.28.

 

“[**]”

  

5

 

1.29.

 

“Other Patent Rights”

  

5

 

1.30.

 

“Patent Rights”

  

5

 

1.31.

 

“Patents In Suit”

  

5

 

1.32.

 

“Product”

  

5

 

1.33.

 

“Profits”

  

5

 

1.34.

 

“Receiving Party”

  

5

 

1.35.

 

“[**]”

  

5

 

1.36.

 

“[**]”

  

5

 

1.37.

 

“[**]”

  

5

 

1.38.

 

“[**]”

  

5

 

1.39.

 

“Settlement Agreement”

  

6

 

1.40.

 

“Settlement Effective Date”

  

6

 

1.41.

 

“Signing Date”

  

6

 

1.42.

 

“Territory”

  

6

 

i


L ICENSE A GREEMENT

 

 

1.43.

 

“Teva DMF”

  

6

 

1.44.

 

“Teva Indemnitees”

  

6

 

1.45.

 

“Third Party”

  

6

 

1.46.

 

“[**]”

  

6

 

1.47.

 

“Transaction Agreements”

  

6

 

1.48.

 

“Valid Claim”

  

6

 

1.49.

 

“Wyeth Indemnitees”

  

6

 

1.50.

 

“Wyeth IP”

  

6

 

1.51.

 

“XR ANDA”

  

6

 

1.52.

 

“[**]”

  

6

 

1.53

 

“XR Entry Date”

  

6

 

1.54.

 

“XR IP”

  

7

 

1.55.

 

“XR New Indication”

  

7

 

1.56.

 

“XR Patent Termination Date”

  

7

 

1.57.

 

“XR Product”

  

7

 

1.58.

 

“XR Reference Product”

  

7

2.

 

RIGHTS GRANTED.

  

7

 

2.1.

 

IR Product Rights

  

7

 

 

2.1.1.

  

Exclusive Commercialization License

  

7

 

 

2.1.2.

  

Manufacturing License

  

8

 

 

2.1.3.

  

Regulatory Licenses and Waivers

  

8

 

 

2.1.4.

  

Preparation for Launch

  

8

 

 

2.1.5.

  

Covenant Not To Sue

  

8

 

 

2.1.6.

  

IR New Indications

  

9

 

2.2.

 

XR Product Rights

  

10

 

 

2.2.1.

  

Exclusive Commercialization License

  

10

 

 

2.2.2.

  

Nonexclusive Commercialization License

  

10

 

 

2.2.3.

  

Manufacturing License

  

10

 

 

2.2.4.

  

Regulatory Licenses and Waivers

  

10

 

 

2.2.5.

  

Limitation on Licenses

  

11

 

 

2.2.6.

  

Preparation for Launch

  

11

 

 

2.2.7.

  

Covenant Not To Sue

  

11

 

 

2.2.8.

  

XR New Indications

  

12

 

2.3.

 

Sales Outside of Licensed Territory

  

12

 

2.4.

 

Retained Rights

  

13

3.

 

CONSIDERATION.

  

13

 

3.1.

 

Payments

  

13

 

 

3.1.1.

  

IR Product

  

13

 

 

3.1.2.

  

XR Product

  

13

 

3.2.

 

[**]

  

14

 

3.3.

 

[**]

  

14

 

3.4.

 

Reports and Payments

  

14

 

3.5.

 

Late Payments

  

14

 

3.6.

 

Taxes

  

14

 

3.7.

 

Record Keeping by Teva; Audits

  

15

 

ii


L ICENSE A GREEMENT

 

 

3.8.

 

Record Keeping by Wyeth; Audits

  

16

4.

 

REGULATORY MATTERS; COMMERCIALIZATION.

  

17

 

4.1.

 

ANDA Approvals

  

17

 

 

4.1.1.

  

IR Product

  

17

 

 

4.1.2.

  

XR Product

  

17

 

4.2.

 

Regulatory Reporting; Pharmacovigilance

  

17

 

 

4.2.1.

  

IR Product

  

17

 

 

4.2.2.

  

XR Product

  

18

 

4.3.

 

Regulatory Approvals

  

18

5.

 

MANUFACTURING.

  

19

 

5.1.

 

Manufacturing Responsibility

  

19

6.

 

INTELLECTUAL PROPERTY.

  

19

 

6.1.

 

Prosecution and Maintenance of Patent Rights

  

19

 

6.2.

 

Enforcement of Patent Rights

  

19

 

6.3.

 

Patent Rights

  

19

 

6.4.

 

Trademarks

  

20

7.

 

CONFIDENTIALITY.

  

20

 

7.1.

 

Nondisclosure and Nonuse Obligations

  

20

 

7.2.

 

Permitted Disclosures

  

21

 

7.3.

 

Return of Confidential Information

  

21

 

7.4.

 

Disclosure of Agreement

  

21

8.

 

REPRESENTATIONS, WARRANTIES AND COVENANTS.

  

22

 

8.1.

 

Representations and Warranties of Both Parties

  

22

 

8.2.

 

Representations and Warranties of Wyeth

  

22

 

8.3.

 

Representation by Legal Counsel

  

22

 

8.4.

 

No Other Warranties

  

22

9.

 

TERM AND TERMINATION.

  

23

 

9.1.

 

Term

  

23

 

9.2.

 

Termination

  

23

 

 

9.2.1.

  

Material Breach

  

23

 

 

9.2.2.

  

Bankruptcy

  

23

 

9.3.

 

Effects of Termination

  

23

 

9.4.

 

Effects of Bankruptcy

  

24

10.

 

OTHER PATENT RIGHTS.

  

24

 

10.1.

 

Licensing or Acquisition of Other Patent Rights

  

24

 

 

10.1.1.

  

Obligation

  

24

 

 

10.1.2.

  

Notice and Consultation

  

24

 

 

10.1.3.

  

Agreements with Third Parties

  

24

 

 

10.1.4.

  

Entry Into Agreements By Teva

  

24

 

10.2.

 

Third Party Claims

  

24

 

iii


L ICENSE A GREEMENT

 

 

 

10.2.1.

  

Notice

  

24

 

 

10.2.2.

  

Cooperation

  

25

 

 

10.2.3.

  

Control of Litigation

  

25

11.

 

INDEMNIFICATION AND INSURANCE.

  

25

 

11.1.

 

Indemnification

  

25

 

 

11.1.1.

  

Responsibility

  

25

 

 

11.1.2.

  

Indemnification by Wyeth

  

25

 

 

11.1.3.

  

Indemnification by Teva

  

26

 

11.2.

 

Insurance

  

26

 

11.3.

 

Limitation of Liability

  

26

12.

 

GOVERNING LAW; DISPUTE RESOLUTION.

  

27

 

12.1.

 

Governing Law; Jurisdiction

  

27

 

12.2.

 

Dispute Resolution

  

27

 

12.3.

 

Injunctive Relief

  

27

 

 

12.3.1.

  

Against Wyeth

  

27

 

 

12.3.2.

  

Against Teva

  

27

13.

 

MISCELLANEOUS.

  

28

 

13.1.

 

Data Sources

  

28

 

 

13.1.1.

  

[**]

  

28

 

 

13.1.2.

  

IR Product

  

28

 

 

13.1.3.

  

XR Product

  

29

 

 

13.1.4.

  

Miscellaneous

  

30

 

13.2.

 

Assignment

  

30

 

13.2.1.

 

Assignment by Teva

  

30

 

 

13.2.2.

  

Assignment by Wyeth

  

31

 

 

13.2.3.

  

Binding Nature of Assignment

  

31

 

13.3.

 

No Waiver

  

31

 

13.4.

 

Severability

  

31

 

13.5.

 

Relationship Between The Parties

  

32

 

13.6.

 

Correspondence and Notices

  

32

 

13.7.

 

Entire Agreement; Amendments

  

33

 

13.8.

 

Headings; Defined Terms

  

33

 

13.9.

 

Counterparts

  

34

 

13.10.

 

Further Actions

  

34

 

13.11.

 

References to ANDAs and NDAs

  

34

 

iv


L ICENSE A GREEMENT

 

LICENSE AGREEMENT

(United States)

This License Agreement (this “Agreement”) is entered into as of January 13, 2006 (the “Effective Date”), by and among Wyeth, acting through its Wyeth Pharmaceuticals Division, having a place of business at 500 Arcola Road, Collegeville, Pennsylvania 19426 (“Wyeth Pharmaceuticals”), Wyeth Pharmaceuticals Company, Inc., having a place of business at Road No. 3, KM. 142.1, Guayama, Puerto Rico 00784 (“WPCI”), Wyeth-Whitehall Pharmaceuticals Inc., having a place of business at Road No. 3, KM. 142.1, Guayama, Puerto Rico 00784 (“Wyeth-Whitehall”) and Wyeth Pharmaceuticals Company, having a place of business at Road No. 3, KM. 142.1, Guayama, Puerto Rico 00784 (“WPC”) on the one hand, and Teva Pharmaceutical Industries Ltd. (“Teva Ltd.”), having a place of business at 5 Basel St. Petach Tikva 49131, Israel and Teva Pharmaceuticals USA, Inc. (“Teva USA”), having a place of business at 1090 Horsham Road, North Wales, PA 19454, on the other hand. Wyeth Pharmaceuticals, WPCI, Wyeth-Whitehall and WPC may be referred to herein collectively as “Wyeth”. Teva Ltd. and Teva USA may be referred to herein collectively as “Teva”. Wyeth and Teva may each be referred to herein individually as a “Party” and collectively as the “Parties”.

WHEREAS, the Parties have agreed to amicably settle patent litigation currently ongoing between them and on October 18, 2005 entered into a Binding Term Sheet (the “Term Sheet”) in connection therewith; and

WHEREAS, in connection with such settlement, Wyeth is willing to grant, and Teva is willing to receive, subject to the terms and conditions set forth in this Agreement, a license to enable Teva to sell certain products in the Territory (as defined below) to its distributors and other customers for ultimate sale to consumers in the Territory; and

WHEREAS, the Term Sheet requires the Parties to negotiate and enter into a number of definitive agreements, including this Agreement.

WHEREAS, the Parties attached a copy of this Agreement to the Settlement Agreement (as defined hereinafter) for submission to the Court (as defined in the Settlement Agreement)] on December 6, 2005.

WHEREAS, subsequent to the approval of this Agreement by the Court as provided in the Settlement Agreement, the Parties have (i) as provided in Section 2.H of the Settlement Agreement, as amended, agreed to a revised Section 13.1 of this Agreement, and (ii) agreed to a revised Section 13.6 of this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants, agreements and stipulations set forth herein, and in the Settlement Agreement (as defined hereinafter),the receipt and legal sufficiency of which are hereby mutually acknowledged, Wyeth and Teva hereby agree as follows:

 

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


L ICENSE A GREEMENT

 

 

1.8.

“Compound” shall mean venlafaxine hydrochloride and any form thereof including polymorphs and solvates, and other pharmaceutically acceptable salts of venlafaxine and any form thereof including polymorphs and solvates.

 

 

1.9.

“Compound Patent Termination Date” shall mean the date on which there are no more Valid Claims of U.S. Patent No. 4,535,186 that, but for the licenses contained herein, would be infringed by the manufacture, use, sale, offer for sale or importation of IR Product.

 

 

1.10.

“Confidential Information” shall mean any and all confidential information regarding, related to, or associated with the Compound, any Product, the IR Reference Product, the XR Reference Product, the Wyeth IP and/or this Agreement (other than the terms and conditions hereof, which shall be subject to Section 7.4) that (i) is disclosed by the Disclosing Party to the Receiving Party or otherwise obtained by the Receiving Party from the Disclosing Party as of and after the Signing Date or before the Signing Date in connection with the Litigation or settlement thereof or (ii) was disclosed by or on behalf of the Disclosing Party to the Receiving Party or the Receiving Party’s attorneys in connection with the Litigation, whether or not covered by a protective order or other similar order issued with respect thereto.

 

 

1.11.

“Cost of Goods Sold” shall mean, as applicable, (i) the costs incurred by Teva in manufacturing IR Products sold by Teva or its Affiliates in the Territory under this Agreement, provided, however , [**], or (ii) the costs incurred by Teva in manufacturing XR Products sold by Teva or its Affiliates in the Territory under this Agreement (including all applicable [**]). In calculating costs incurred in manufacturing IR Products or XR Products only those cost elements described in Exhibit 1.11 shall be included.

 

 

1.12.

“Disclosing Party” shall mean the Party who is disclosing its Confidential Information to the Receiving Party.

 

 

1.13.

“FDA” shall mean the United States Food and Drug Administration or any successor agency thereto.

 

 

1.14.

“[**]” shall have the meaning [**].

 

 

1.15.

“IR ANDA” shall mean ANDA No. 76-690 filed with the FDA by Teva, which ANDA seeks approval to market the IR Product.

 

 

1.16.

“IR Entry Date” shall mean the earlier of (i) June 15, 2006, or (ii) [**] in which [**] as compared to [**].

 

 

1.17.

“IR IP” shall mean (i) Patent Rights under U.S. Patent No. 4,535,186, (ii) all other U.S. Patent Rights owned or controlled as of the Signing Date or as of the Settlement Effective Date by Wyeth or any of its Affiliates that, but for the licenses contained herein, would be infringed by, the manufacture, use, sale, offer for sale or importation of any IR Product (including Compound to the extent

 

3


L ICENSE A GREEMENT

 

 

necessary to manufacture IR Product), and (iii) all U.S. Patent Rights, claiming (directly or indirectly) priority to such U.S. patent and U.S. Patent Rights identified in clause (i) and (ii) or any of the applications to which any such U.S. patent or U.S. Patent Rights claim (directly or indirectly) priority, that, but for the licenses contained herein, would be infringed by the manufacture, use, sale, offer for sale or importation of any IR Product (including Compound to the extent necessary to manufacture IR Product).

 

 

1.18.

“IR New Indication” shall have the meaning set forth in Section 2.1.5.

 

 

1.19.

“IR Product” shall mean the immediate release tablet, which tablet contains venlafaxine hydrochloride as its sole active ingredient and is marketed by Teva or any of its Affiliates as a generic product AB Rated to IR Reference Product (in any dosage strength) in the Territory. For the sake of clarity, IR Product shall not include any IR Reference Product.

 

 

1.20.

“IR Reference Product” shall mean the immediate release tablet containing, as its sole active ingredient, venlafaxine hydrochloride equivalent to either 25mg, 37.5mg, 50mg, 75mg or 100mg of venlafaxine (or other approved dosage strengths) which tablet is marketed in the Territory by Wyeth or any of its Affiliates or licensees as Effexor® under NDA No. 20-151.

 

 

1.21.

“Liability” shall have the meaning set forth in Section 11.1.2.

 

 

1.22.

“Litigation” shall mean that certain


This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more