Home

Intelligence

Services

Subscriptions

News

About Us

Sign In

 

Document Preview

License and Supply Agreement

 

Click "Add to Cart" button to purchase document. 
Documents are emailed immediately after purchase. 
You can also browse documents by
title, category, or company... or click here for help finding documents.

 

Title:

License and Supply Agreement

Entities:

Citibank, NA; Corixa Corp.; Coulter Pharmaceuticals, Inc.; GlaxoSmithKline plc; University of Michigan, Ann Arbor; Cooley Godward LLP; GlaxoSmithKline Inc.

Date:

2003

Size:

Preview shows 9KB of 316KB total

Price:

$80

ID:

#289031

 

 

► Business ► Supply ► License & Supply Agreements
► Financial
► Services ► Legal
► Miscellany ► Universities
► Biotech & Drugs ► Pharmaceutical Preparations
► Biotech & Drugs ► Biological Products

 

 

Start of Preview


         This LICENSE AND SUPPLY AGREEMENT (the "Agreement") is entered into as

of May 27, 2003 (the "Effective Date") between CORIXA CORPORATION, a Delaware
corporation, with its principal place of business at 1124 Columbia Street, Suite
200, Seattle, WA 98104, U.S.A. and its subsidiary Coulter Pharmaceutical, Inc.
(referred to individually as "Corixa Corporation" and "Coulter Pharmaceutical",
respectively, and collectively as "Corixa"), and GLAXOSMITHKLINE INC., a
corporation amalgamated and continued under the laws of Canada, with its
principal place of business at 7333 Mississauga Road North, Mississauga,
Ontario, Canada L5N 6L4 ("GSK Canada"). Both Corixa and GSK Canada are referred
to individually as a "Party" and collectively as the "Parties."

WHEREAS, Corixa has rights to and is developing Bexxar therapy, a
therapeutic antibody product pending FDA approval; and

WHEREAS, GSK Canada possesses development, marketing and distribution
capability for therapeutic products in Canada; and

WHEREAS, Corixa Corporation and GSK Canada entered into a Conditional
Letter of Intent on February 17, 2003 (the "LOI") under which the Parties have
made preparations to register such product in Canada and which is terminated by
the signing of this Agreement; and

WHEREAS, GSK Canada desires to obtain rights to commercialize such
product in Canada for the treatment of humans, and Corixa is willing to grant
such rights on the terms and conditions hereof; and

WHEREAS, GSK Canada desires to obtain finished antibody for such
product from Corixa, and Corixa is willing to provide such antibody on the terms
and conditions hereof; and

NOW THEREFORE, in consideration of the foregoing premises and the
mutual promises, covenants and conditions contained in this Agreement, the
Parties agree as follows:

1. DEFINITIONS

The following terms shall have the following meanings as used in this
Agreement:

1.1 "AFFILIATE" means, with respect to a particular
Party, a person, corporation, partnership, or other entity that controls, is
controlled by or is under common control with such Party. For the purposes of
the definition in this Section 1.1, the word "control" (including, with
correlative meaning, the terms "controlled by" or "under the common control
with") means the actual power, either directly or indirectly through one or more
intermediaries, to direct or cause the direction of the management and policies
of such entity, whether by the ownership of at least fifty percent (50%) of the
voting stock of such entity, or by contract or otherwise.

{PAGE}

1.2 "ANNUAL CLINICAL FTE RATE" shall mean the amount to
be paid by GSK Canada to Corixa for the services of one FTE. The Annual Clinical
FTE Rate will be US[*] per year for calendar year 2003. For each subsequent
calendar year, this rate will be adjusted by the percentage change in the
monthly Consumer Price Index for the immediately preceding December as compared
to the base month of December 2002. The index source will be the Consumer Price
Index published by the Bureau of Labor Statistics of the United States
Department of Labor and covering Seattle, Tacoma and Bremerton (all in the state
of Washington). Should indices covering all of the foregoing areas not be
available, then the national index will be used as the reference.

1.3 "ANNUAL NET SALES" shall mean, with respect to a
particular calendar year, the total Net Sales for such calendar year.

1.4 "BATCH CERTIFICATE" shall mean (a) a certificate
issued by the manufacturer of a lot or batch of a drug that is exported from the
country of manufacture under a mutual recognition agreement, which certificate
includes (i) a detailed description of such drug, (ii) analytical test methods
and results performed on such lot or batch, (iii) addresses of the buildings
where such lot or batch was manufactured, packaged, labeled and tested, (iv) a
master production document for such drug, and (v) certification that Good
Manufacturing Practices were followed; or (b) such other consistent, but more
detailed definition as provided in the Quality Policy Manual.

1.5 "BI PHARMA" SHALL MEAN Boehringer Ingelheim Pharma
KG.

1.6 "BI PHARMA AGREEMENTS" shall mean (a) the Supply
Agreement between Coulter Pharmaceutical and BI Pharma dated November 3, 1998,
as amended by (i) letter agreements dated July 17, 2001 and January 11, 2002 and
(ii) an amendment dated February 24, 2003, and (b) the Contract Research and
Development Agreement between Coulter Pharmaceutical and Dr. Karl Thomae GmbH
dated October 22, 1997.

1.7 "BLA" shall mean a Biologics License Application, as
defined by the regulations promulgated under the FD&C Act and the United States
Public Health Services Act and any supplements thereunder, as amended from time
to time.

1.8 "BUSINESS DAY" OR "BUSINESS DAY" shall mean a day
other than Saturday, Sunday or any day on which banks located in the State of
Washington and/or Ontario are obligated to close. Whenever this Agreement refers
to a number of days, such number shall refer to calendar days unless Business
Days (or business days) are specified.

1.9 "CERTIFICATE OF ANALYSIS" shall mean (a) a
certificate issued by the manufacturer of a lot or batch of a drug, which
certificate (i) certifies that the lot was tested in accordance with Good
Manufacturing Practice and Good Laboratory Practice, (ii) includes the
analytical test results for such lot of drug, (iii) is in conformance with the
applicable NDS, and (iv) states whether such drug is manufactured in accordance
with the Specifications and cGMPs;

----------------------------------
* Confidential Treatment requested.

2.

{PAGE}

or (b) such other consistent, but more detailed definition as provided in the
Quality Policy Manual.

1.10 "CERTIFICATE OF MANUFACTURE" shall mean (a) a
certificate issued by a vendor to a distributor or importer, which certificate
(i) attests that a specific lot or batch of drug has been produced in accordance
with its master production documents, (ii) includes a detailed summary of
current batch documentation, with reference to respective dates of revision,
manufacture and packaging, and (iii) is signed and dated by the quality
assurance department of such vendor; or (b) such other consistent, but more
detailed definition as provided in the Quality Policy Manual.

1.11 "CLINICAL TRIAL" shall mean a trial, conducted by a
Party or a licensee of a Party, in which the Product is administered to humans
for one or more purposes, including, without limitation, with the goal of (a)
generating data to support an application for Regulatory Approval of the
Product, (b) familiarizing physicians with the use of the Product prior to
Initial Approval or (c) generating data in connection with, and familiarizing
physicians with, the use of the Product after Initial Approval.

1.12 "COLD COMPONENT" shall mean two 20ml vials of
Tositumomab and one 3ml vial of Tositumomab.

1.13 "CONFIDENTIAL INFORMATION" shall have the meaning
given such term in Section 9.1.

1.14 "CONTROLLED" means, with respect to any gene,
protein, compound, material, Information or intellectual property right, that
the Party owns or has a license to such gene, protein, compound, material,
Information or intellectual property right and has the ability to grant to the
other Parties access, a license or a sublicense (as applicable) to such gene,
protein, compound, material, Information or intellectual property right on the
terms and conditions set forth herein without violating the terms of any
agreement or other arrangements with any Third Party (or in the case of Corixa,
with SB) existing at the time such Party would first be required hereunder to
grant the other Parties such access, license or sublicense.

 

End of Preview

 

Home        Intelligence        Services        Subscriptions        News        About Us

Contact Us       Terms of Use       Resend Documents       Shopping Cart

Copyright © 2008 The Consus Group LLC