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OPTION and LICENSE AGREEMENT

Option Agreement

OPTION and LICENSE AGREEMENT | Document Parties: Sanquin Blood Supply Foundation | Seattle Genetics, Inc You are currently viewing:
This Option Agreement involves

Sanquin Blood Supply Foundation | Seattle Genetics, Inc

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Title: OPTION and LICENSE AGREEMENT
Governing Law: Washington     Date: 3/13/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

OPTION and LICENSE AGREEMENT, Parties: sanquin blood supply foundation , seattle genetics  inc
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Exhibit 10.53

Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [***]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.

OPTION and LICENSE AGREEMENT

This Option and License Agreement (this “Agreement”), is entered into as of July 5, 2001 (the “Effective Date”) by and between Sanquin Blood Supply Foundation for the purpose of this agreement acting through her division CLB-Research and Development, formed under the laws of the Netherlands (hereinafter referred to as “CLB”) and Seattle Genetics, Inc., a Delaware corporation (hereinafter referred to as “SGI”).

RECITALS

A. CLB owns intellectual property rights relating to certain antibodies directed toward CD70 described in this Agreement;

B. SGI desires to acquire access to the antibodies for research and development purposes and an option to a worldwide exclusive license to the antibodies.

C. CLB is willing to provide SGI with access to the antibodies and to grant SGI an option to acquire a worldwide exclusive license in accordance with the terms and conditions set forth in this Agreement.

AGREEMENT

The parties hereto agree as follows:

1. Definitions

Affiliate ” shall mean any corporation or other business entity controlled by, controlling, or under common control with another entity, with “control” meaning direct or indirect beneficial ownership of more than fifty percent (50%) of the voting stock of such corporation, or more than a fifty percent (50%) interest in the decision-making authority of such other unincorporated business entity; and a corporation in which the maximum amount of stock permitted by law to be held by another entity is beneficially owned by such other entity.

Antibodies ” shall mean the antibodies identified on Exhibit A and any other antibodies directed toward human and murine CD70 that are owned or controlled by CLB now or in the future.

Antibody Technology ” shall mean all rights to the Antibodies including, but not limited to:

(a) the patents and patent applications currently existing or filed hereafter covering the Antibodies, including any addition, continuation, continuation-in-part or division thereof or any substitute application therefor; and


(b) all trade secrets and other information , including but not limited to present and future techniques, inventions, discoveries, developments, practices, methods, formulations, specifications, processes, apparatus, knowledge, know-how, skill, biological materials, design data, pharmacological, toxicological and clinical test data, sequence data, analytical and quality control data, manufacturing data and all other information and data relating to the Antibodies including, the hybridoma cell line expressing each Antibody;

provided, however, that Antibody Technology shall not include trade secrets and other information that is specifically and solely related to the Reagents Programme.

Approval ” shall mean all approvals, licenses, registrations and authorizations of all governmental agencies in a country necessary for the manufacture, use or sale of a Licensed Product in the applicable country.

Confidential Information ” shall have the meaning assigned thereto in Section 11.

First Commercial Sale ” shall mean, with respect to any Licensed Product, the first sale for use or consumption by the general public of such product in any country following Approval, or otherwise permitted, by the governing health authority of such country. “First Commercial Sale” shall not include the sale of any Licensed Product for use in clinical trials or research.

License ” shall have the meaning assigned thereto in Section 4.2.

Licensed Products ” shall mean any product incorporating the Antibodies or derived from the Antibodies or their sequences.

Net Sales ” shall mean the amount actually received by SGI or its Affiliates or sublicensees for the sale to an unaffiliated third party of a Licensed Product, less the following deductions for amounts actually incurred related to the sale:

(a) [***]

(b) [***].

In the event that a Licensed Product is sold as part of a Combination Product (as defined below), the Net Sales from the Combination Product, for the purposes of determining royalty payments, shall be determined by [***].

As used above, the term “ Combination Product ” shall mean any pharmaceutical product which comprises a Licensed Product and any other active compounds and/or ingredients.

Net Sales shall not include transfer of Licensed Products at or below cost by or on behalf of SGI in connection with research or clinical trials.

 

[***]

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Option ” means the option granted by CLB to SGI pursuant to the provisions of Section 4.1 hereof to obtain the licenses under Section 4.2 hereof.

Option Period ” means, the period commencing as of the Effective Date and continuing for a period of [***] unless terminated earlier pursuant to the provisions of Section 4.1 below.

Phase II Clinical Trial ” shall mean a human clinical trial for which a primary endpoint is a preliminary determination of efficacy in patients with the disease being studied as required in 21 C.F.R. §312, or a similar clinical study prescribed by the regulatory authorities in a country other than the United States. Any well-controlled study intended to provide the substantial evidence of efficacy necessary to support the filing of an approvable marketing applications (such as a combined Phase II Clinical Trial/ Phase III Clinical Trial, or any Phase III Clinical Trial in lieu of a Phase II Clinical Trial) (a “ Pivotal Study ”) shall automatically be deemed to have reached Phase II status. A Phase II Clinical Trial shall be deemed to have commenced when the first patient in the study has been enrolled.

Phase III Clinical Trial ” shall mean a human clinical trial, the principal purpose of which is to establish safety and efficacy in patients with the disease being studied as required in 21 C.F.R. §312, or similar clinical study prescribed by the regulatory authorities in a country other than the United States. A Phase III Clinical Trial shall also include any other human clinical trial intended as a Pivotal Study, whether or not such study is a traditional Phase III Clinical Trial. A Phase III Clinical Trial shall be deemed to have commenced when the first patient has been enrolled in a Pivotal Study.

Reagents Programme ” shall mean any kits or reagents for in vitro diagnostic and research use, currently and prospectively listed and offered for sale in CLB’s standard Immune Reagents Product List.

2. Delivery of Antibodies and Hybridomas . CLB shall deliver to SGI 5 mg of each of the Antibodies, and hybridomas for each within [***] following the Effective Date.

3. Use of Antibodies . As of the Effective Date, CLB grants to SGI a non-exclusive, non-sublicensable, worldwide license to use the Antibodies solely for research purposes. SGI shall use the Antibodies in compliance with all applicable federal, state and local laws and regulations. No other license with regards to the Antibodies shall be granted or implied unless and until the Option is exercised by SGI.

4. Option and License Grant .

4.1 Option Grant and Exercise . Subject to the terms of this Agreement, CLB hereby grants to SGI and its Affiliates an Option to acquire the License set forth in Section 4.2 below with respect to the Antibodies and Antibody Technology. At any time during the Option Period, SGI may provide written notice to CLB that it wishes to acquire such License for the

 

[***]

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


Antibodies and Antibody Technology. SGI shall be able to terminate the Option for any reason by giving [***] advance written notice to CLB during the Option Period.

4.2 License Grant . If (i) SGI elects to exercise its Option to acquire a License with respect to the Antibody Technology pursuant to Section 4.1 and (ii) SGI pays the Option exercise fee pursuant to Section 6.1.2 below, then subject to the terms and conditions of this Agreement, and commencing as of the date that SGI has both (i) so informed CLB in writing of such Option exercise and (ii) paid the Option exercise fee, CLB is automatically deemed to grant, and in such event hereby grants, to SGI, a worldwide, exclusive, non-transferable, royalty-bearing license, with the right to sublicense, to develop, make, have made, import, have imported, use, offer for sale, sell or otherwise distribute Licensed Products (a “License”). The date upon which a License is granted with respect to the Antibody Technology under this Section 4.2 is referred to herein as the “ License Date ”.

5. Reservation . The License granted in Section 4.2 is subject to rights reserved by CLB to [***] .

6. Payments

6.1 Option Fees .

6.1.1. SGI shall pay CLB a fee of [***].

6.1.2. SGI shall pay CLB a fee of [***].

6.1.3. SGI shall pay CLB a maintenance fee of [***].

6.2 License Fee . SGI shall pay CLB a license fee of [***].

6.3 Milestone Payments . Within [***] following the occurrence of each of the events specified below for the first Licensed Product only, SGI shall pay to CLB the following amounts:

 

Milestone

  

Payment

1. [***]

  

[***]

2. [***]

  

[***]

3. [***]

  

[***]

 

[***]

Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


6.4 Royalties

6.4.1 SGI shall pay CLB a royalty equal to [***] on Net Sales of Licensed Products, commencing with the First Commercial Sale of a Licensed Product.

6.4.2 Royalties shall be calculated on a [***] basis and shall be due and payable within [***] after the end of such calendar quarter. Such royalties shall be calculated on the Net Sales in the local currency of each country, and converted into U.S. Dollars and paid in U.S. Dollars, on the basis of the [***]. SGI shall withhold any taxes on such royalties as required by law.

6.4.3 SGI shall furnish to CLB a written report which includes financial information relevant to the calculation of royalties, including the relevant, current standard list prices. Such reports shall be due together with the royalty payments under


 
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