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ELAN PHARMA INTERNATIONAL LIMITED AND ENTREMED, INC. LICENSE AGREEMENT

License Agreement

ELAN PHARMA INTERNATIONAL LIMITED AND ENTREMED, INC. LICENSE AGREEMENT | Document Parties: ENTREMED INC | ELAN PHARMA INTERNATIONAL LIMITED You are currently viewing:
This License Agreement involves

ENTREMED INC | ELAN PHARMA INTERNATIONAL LIMITED

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Title: ELAN PHARMA INTERNATIONAL LIMITED AND ENTREMED, INC. LICENSE AGREEMENT
Date: 5/10/2006
Industry: Biotechnology and Drugs    

ELAN PHARMA INTERNATIONAL LIMITED AND ENTREMED, INC. LICENSE AGREEMENT, Parties: entremed inc , elan pharma international limited
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Exhibit 10.1

EXECUTION COPY

ELAN PHARMA INTERNATIONAL
LIMITED

AND

ENTREMED, INC.

 

LICENSE AGREEMENT

 

 


 

INDEX

 

 

 

 

 

 

 

1.

 

Definitions and Interpretation

 

 

1

 

2.

 

The License

 

 

7

 

3.

 

Intellectual Property

 

 

8

 

4.

 

Non-Competition

 

 

15

 

5.

 

Registration, Marketing and the Promotion of the Product

 

 

15

 

6.

 

Financial Provisions

 

 

15

 

7.

 

Manufacture and Supply

 

 

18

 

8.

 

Payments, Reports and Audits

 

 

19

 

9.

 

Duration and Termination

 

 

19

 

10.

 

Consequences of Termination

 

 

21

 

11.

 

Warranties, Indemnification and Liability

 

 

22

 

12.

 

Confidentiality

 

 

25

 

13.

 

Miscellaneous Provisions

 

 

26

 

Schedule 1

 

EPIL Patents

 

 

31

 

Schedule 2

 

EntreMed Patents

 

 

39

 

Schedule 3

 

Technological Competitors

 

 

40

 

Schedule 4

 

Commercial Unit Dose Cost of Goods Pricing

 

 

41

 

Schedule 5

 

Key Terms for Manufacturing and Supply Agreement

 

 

42

 

 

 

 

 

 

 

 

i

 


 

THIS LICENSE AGREEMENT is dated January 9, 2006

PARTIES:

(1)

 

ELAN PHARMA INTERNATIONAL LIMITED , a company incorporated under the laws of Ireland, having its registered office at Monksland, Athlone, Co Westmeath, Ireland (“ EPIL ”); and

 

 

 

(2)

 

ENTREMED, INC. , a Delaware corporation, having its principal place of business at 9640 Medical Center Drive, Rockville, MD 20850 (“ EntreMed ”).

BACKGROUND:

(A)

 

EPIL possesses certain proprietary technology as well as proprietary know-how and confidential information used or useful in the manufacture and use of pharmaceutical products containing nanoparticles.

 

 

 

(B)

 

EntreMed possesses certain rights to intellectual property rights covering the Compound (as defined below).

 

 

 

(C)

 

EntreMed wishes to obtain the right to utilize certain EPIL Intellectual Property to commercialize the Product in the Field in the Territory in accordance with the terms and conditions set out below.

 

 

 

(D)

 

Simultaneously with or shortly after the execution of this Agreement, EntreMed intends to enter into a Services Agreement with EDDI, an EPIL Affiliate, that will contain a Development Plan for further research and development of the Product and that will grant EDDI the exclusive right to supply the Product to EntreMed for preclinical, clinical and regulatory purposes.

 

 

 

(E)

 

Following the execution of this Agreement and the Services Agreement, EPIL and EntreMed intend to enter into a Manufacturing and Supply Agreement that will establish the terms by which EPIL or an Affiliate will manufacture and supply to EntreMed its entire requirement of the Product for commercial supply in the Territory.

TERMS:

The Parties agree as follows:

1.

 

DEFINITIONS AND INTERPRETATION

 

 

 

1.1.

 

Definitions . In this Agreement:

 

 

 

 

 

Affiliate ” means any corporation or entity controlling, controlled or under common control with EPIL or EntreMed, as the case may be. For the purposes of this Agreement, “control” means the direct or indirect ownership of more than 50% of the issued voting shares or other voting rights of the subject entity to elect directors, or if not meeting the preceding criteria, any entity owned or controlled by or owning or controlling at the maximum control or ownership right permitted in the country where such entity exists.

 

 

 

 

*

 

The marked portions have been omitted pursuant to a request for confidential treatment and filed separately with the Securities Exchange Commission.

Page 1


 

 

 

Agreement ” means this license agreement (which expression shall be deemed to include its Recitals and Schedules).

 

 

 

 

 

API ” means active pharmaceutical ingredient.

 

 

 

 

 

Business Days ” means Monday to Friday inclusive, excluding any days on which the clearing banks are generally closed in Dublin and/or New York.

 

 

 

 

 

cGMP ” means the then current regulations set forth in 21 C.F.R. Parts 210-211, 820 or 21 C.F.R. Subchapter C (drugs) quality system regulations and the requirements thereunder imposed by the FDA and, as applicable, the equivalent regulations and requirements imposed by other RHAs in the Territory.

 

 

 

 

 

Claims ” means all and any claims (whether successful or otherwise), demands, settlement amounts, losses, liabilities, damages, costs and expenses, including reasonable attorneys’ fees and expenses and legal costs.

 

 

 

 

 

Commercially Reasonable Efforts ” means those efforts of a party which are consistent with those utilised by such party for its own internally developed or in-licensed pharmaceutical products, taking into account all factors that impact the manufacturing, development, marketing and sales of such products, as applicable.

 

 

 

 

 

Compound ” means EntreMed’s proprietary compound 2-methoxyestradiol (2ME2) having the following chemical formula:

 

 

 

 

 

 

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