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Title:

Exclusive License Agreement

Entities:

Santarus, Inc.; The Curators of the University of Missouri; University of Missouri

Date:

2003

Size:

Preview shows 9KB of 116KB total

Price:

$48

ID:

#326804

 

 

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► Biotech & Drugs ► Pharmaceutical Preparations

 

 

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                           EXCLUSIVE LICENSE AGREEMENT

BETWEEN
THE UNIVERSITY OF MISSOURI AND SANTARUS, INC.

This Exclusive License Agreement ("Agreement") is effective as of the
26th day of January 2001 (the "Effective Date"), by and between THE CURATORS OF
THE UNIVERSITY OF MISSOURI, a public corporation organized under the laws of
Missouri, having a principal place of business at 615 Locust Street Building,
Third Floor, Columbia, Missouri 65211-1400 ("the University"), and SANTARUS,
INC. ("Santarus"), a California corporation, having a principal place of
business at 12230 El Camino Real, Suite 300, San Diego, California 92130.

RECITALS

Whereas, certain discoveries useful for the administration of proton
pump inhibitors using pharmaceutically acceptable carriers were made in the
course of research under the direction of Dr. Jeffrey O. Phillips ("Dr.
Phillips") at the University (the "Research") and are claimed in the patents and
patent applications included in the Patent Rights (defined below);

Whereas, Santarus has requested a license of certain rights from the
University to commercialize Licensed Products (defined below) based on such
discoveries;

Whereas, the University is willing to grant such license rights to
Santarus; and

Whereas, the University hereby responds to the request of Santarus by
granting the following rights to Santarus so that the products and other
benefits derived from the Patent Rights can be enjoyed by the general public.

AGREEMENT

Now, therefore, in consideration of the representations and covenants
set forth herein, the payments made hereunder, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
parties agree as follows:

1. DEFINITIONS

Capitalized terms used but not elsewhere defined in this Agreement shall
have the meanings set forth below:

1.1 "AFFILIATE(s)" of either party to this Agreement means any
entity which, directly or indirectly, controls the party, is controlled by the
party, or is under common control with the party ("control" for these purposes
being defined as the actual, present capacity to elect a majority of the
directors or curators, as the case may be, of such entity, or if not, the power
to direct at least *** of the voting rights entitled to elect
directors or curators); provided, however, that in any country where the local
law will not permit foreign equity participation of a majority, then an
"Affiliate" of Santarus will include any company in which Santarus owns or
controls, directly or indirectly, the maximum percentage of such outstanding



1

*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
{PAGE}

stock or voting rights permitted by local law. Each reference to Santarus herein
will be deemed to include its Affiliates.

1.2 "ANDA" means an Abbreviated New Drug Application filed with
the FDA.

1.3 "COMBINATION PRODUCT" means any product which is a Licensed
Product and which also contains other product(s) or component(s) ("Other
Product"), which Other Product (i) is not a Licensed Product; (ii) the sale, use
or import of which, by itself, does not contribute to the infringement of the
Patent Rights; (iii) could be sold separately by Santarus; and (iv) enhances the
market price of the final Licensed Product(s) sold, used or imported by
Santarus. ***

***
***
***

1.4 "FDA" means the United States Food and Drug Administration.

1.5 "FIELD OF USE" means all uses within the Patent Rights.

1.6 "FIRST COMMERCIAL SALE" means the first sale of a Licensed
Product in the country in the Territory, such Licensed Product intended for
administration to a patient for a therapeutic use approved by the FDA or other
similar regulatory agency in a foreign country; provided, however, if approval
by a similar regulatory agency is not required in a particular foreign country,
then such approval shall not be an element of the definition of "First
Commercial Sale."

1.7 "FUNDED RESEARCH" has the meaning set forth in Section 4.16
("Funded Research").

1.8 "IND" means an Investigational New Drug application filed
with the FDA.

1.9 "JOINT VENTURE" means any separate entity established
pursuant to an agreement between a third party and Santarus to constitute a
vehicle for a joint business enterprise, in which the separate entity
manufactures, uses, or sells Licensed Products, or purchases or acquires
Licensed Products from Santarus.

1.10 "LICENSED PRODUCT" shall mean any product that cannot be
manufactured, used or sold without (i) infringing one or more claims under the
Patent Rights (including the claims in pending applications) or (ii) using any
part of the Technical Information not otherwise includable within the Patent
Rights.

1.11 "NDA" means a New Drug Application filed with the FDA.



*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.



2
{PAGE}

1.12 "NET SALES" means the amount invoiced as a result of the
sale of Licensed Products by Santarus, Joint Ventures, and sublicensees to
independent third parties for cash or other forms of consideration in accordance
with generally accepted accounting principles ("GAAP") limited to the following
deductions (if not already deducted from the gross invoice price and at rates
customary within the industry): ***

***
***
***

1.13 " *** LICENSED PRODUCT" means any Licensed Product other
than an *** Licensed Product.

1.14 "NOTICE OF DEFAULT" and "NOTICE OF TERMINATION" have the
meanings set forth in Article 8 ("Term and Termination; Resolution of
Disputes").

1.15 " *** LICENSED PRODUCT" means any Licensed Product that
contains *** .

1.16 "ORAL LIQUID" means a composition intended for oral
administration to a patient comprising any of (i) a liquid solution, (ii) a
solid-in-liquid suspension, and (iii) a powder or other solid formulation
intended to be reconstituted into a liquid solution or a solid-in-liquid
suspension.

1.17 "PATENT METHOD" means any process or method covered by the
claims of a patent application or patent within Patent Rights or the use or
practice of which would constitute in a particular country, but for the license
granted to Santarus pursuant to this Agreement, an infringement of an unexpired
claim of a patent or pending claim of a patent application were it issued as a
claim in a patent within Patent Rights in that country in which the Patent
Method is used or practiced.

1.18 "PATENT RIGHTS" means all United States patents and patent
applications and foreign patents and patent applications, including any
reissues, re-examinations, extensions, substitutions, continuations,
divisionals, and continuation-in-part applications (only to the extent, however,
that claims in the continuation-in-part applications are enabled and
specifically described in the specification of the parent patent application),
based on and including any subject matter claimed in or covered by the United
States patent applications (a) set forth on Exhibit A hereto, and (b) which may
be filed based on the Results of Funded Research.

1.19 "DR. PHILLIPS" means Dr. Jeffrey 0. Phillips.

1.20 "PPI" means a proton pump inhibitor.

1.21 "PRIMARY COUNTRIES" shall mean the following: *** *** .

1.22 "PROPRIETARY INFORMATION" has the meaning set forth in
Section 14.1.



*** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.

 

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