| Preview
Full Doc
 | 2000 |
Joint Development, License And Supply Agreement
Joint Development, License And Supply Agreement (112K)
Doc #278564: Click preview link for longer preview.
JOINT DEVELOPMENT, LICENSE
AND SUPPLY AGREEMENT
THIS JOINT DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT (this "Agreement"),
dated as of September 10, 1998, is entered into by and between Inspire
Pharmaceuticals, Inc., a corporation organized and existing under the laws of
the State of Delaware, having offices located at 4222 Emperor Boulevard, Suite
470, Durham, North Carolina 27703, USA ("Inspire"), and Kissei Pharmaceutical
Co., Ltd., a corporation organized under the laws of Japan, having offices
located at 19-48, Yoshino, Matsumoto-City, Nagano-Prefecture, 399-8710, Japan
("Kissei").
PRELIMINARY STATEMENTS
----------------------
A. Inspire owns, and/or has exclusive rights to, the Patents and Know-How
in existence as of the Effective Date relating to the Compound. In addition,
Inspire has the expertise necessary to coordinate the worldwide development and
manufacture of the Product.
B. Kissei has the personnel, facilities and expertise necessary for the
development and commercialization of the Product in the Territory.
C. The Parties wish to collaborate to develop, commercialize and market
the Product, upon the terms and conditions set forth in this Agreement. In
connection therewith, Kissei desires to obtain, and Inspire desires to grant to
Kissei, an exclusive license under the Licensed Technology with respect to the
development and commercialization of the Product in the Territory for
applications in the Field, subject to Inspire's right to manufacture and supply
Finished Product and Delivery Systems for Kissei, all on the terms and
conditions set forth below.
D. Simultaneously with the execution of this Agreement, the Parties are
entering in that certain Stock Purchase Agreement (the "Stock Purchase
Agreement") and documents ancillary thereto, all dated of even date herewith,
pursuant to which Kissei is purchasing shares of Series C Preferred Stock of
Inspire.
NOW, THEREFORE, in consideration of the foregoing Preliminary Statements
and the mutual agreements and covenants set forth herein, the Parties hereby
agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms shall have the meanings set
forth in this Section 1 unless context dictates otherwise:
1
{PAGE}
1.1 "Affiliate," with respect to any Party, shall mean any entity
controlling, controlled by, or under common control with, such Party. For these
purposes, "control" shall refer to (i) the possession, directly or indirectly,
of the power to direct the management or policies of an entity, whether through
the ownership of voting securities, by contract or otherwise, or (ii) the
ownership, directly or indirectly, of at least 50% of the voting securities or
other ownership interest of an entity.
1.2 "Annual Development Plan" shall have the meaning assigned to such term
in Section 4.1(a).
1.3 "Cassette" shall mean a disposable self-contained unit to be filled
with a quantity of Formulated Material sufficient to provide the number of doses
as approved by the Joint Development Committee pursuant to Section 3.2(f) (e.g.,
sufficient for dosing for one week).
1.4 "cGMP" shall mean current Good Manufacturing Practice as defined in
Parts 210 and 211 of Title 21 of the Code of Federal Regulations, as may be
amended from time to time, or any successor thereto.
1.5 "Compound" shall mean the chemical compound designated as INS365,
whose chemical name is P1, P4-Di(uridine 5'-tetraphosphate), and all sodium
salts thereof.
1.6 "Compound Specifications" shall mean the specifications for the
Compound approved by the Joint Development Committee in consideration of the
regulatory requirements in the Territory, as may be amended from time to time.
1.7 "Confidential Information" shall have the meaning assigned to such
term in Section 10.4.
1.8 "Cost of Compound" shall mean Inspire's fully burdened costs
associated with the manufacture of the Compound, as determined pursuant to
Exhibit A.
1.9 "Cost of Delivery Systems" shall mean Inspire's fully burdened costs
associated with the manufacture of the Delivery System, as determined pursuant
to Exhibit A.
1.10 "Cost of Finished Product" shall mean Inspire's fully burdened costs
associated with the manufacture of the Finished Product, including without
limitation, the Cost of Formulated Material and the costs associated with
assembly of the Finished Product, as determined pursuant to Exhibit A.
1.11 "Cost of Formulated Material" shall mean Inspire's fully burdened
costs associated with the manufacture of the Formulated Material, as determined
pursuant to Exhibit A.
-2-
{PAGE}
1.12 "Delivery System" shall mean the novel delivery system designed to
deliver Formulated Material contained within a Cassette to the lungs via
inhalation and to be reusable for at least one year, as approved by the Joint
Development Committee pursuant to Section 3.2(f).
1.13 "Delivery System Specifications" shall mean the specifications for
the Delivery System approved by the Joint Development Committee in consideration
of the regulatory requirements in the Territory, as may be amended from time to
time.
1.14 "Development Coordinator/Liaison" shall have the meaning assigned to
such term in Section 4.4(a).
1.15 "Effective Date" shall mean the date of this Agreement.
1.16 "Executive Officers" shall have the meaning assigned to such term in
Section 3.4(b).
1.17 "Field" shall mean the treatment (but not the diagnosis) of
respiratory diseases in humans, excluding otitis media and sinusitis.
1.18 "Finished Product" shall mean the Formulated Material: (i) loaded
into a Cassette, for use with a Delivery System, or (ii) contained in a
vial/nebule for use with standard nebulizers.
1.19 "Finished Product Specifications" shall mean the specifications for
the Finished Product approved by the Joint Development Committee in
consideration of the regulatory requirements in the Territory, and such other
packaging and labeling specifications as are agreed upon by the Joint
Development Committee or the Parties, as the case may be, for the Finished
Product, as may be amended from time to time.
1.20 "First Commercial Sale" shall mean, with respect to any Product, the
first sale for use or consumption by the general public of such Product in the
Territory after all required NDA Approvals have been granted, or, if such sale
is otherwise permitted, by the Regulatory Authority in the Territory.
1.21 "Formulated Material" shall mean any inhalation formulation of any
product containing the Compound as an active ingredient.
1.22 "Formulated Material Specifications" shall mean the specifications
for the Formulated Material approved by the Joint Development Committee in
consideration of the regulatory requirements in the Territory, as may be amended
from time to time.
1.23 "FTE" shall mean a full-time equivalent employee of Inspire assigned
to conduct coordination/liaison activities pursuant to Section 4.4, including
scientists, professionals or the like, but excluding non-technical, non-
professional personnel such as secretarial staff. As used herein,
-3-
{PAGE}
a "full-time equivalent" shall mean a full-time person, or in the case of less
than a full- time dedicated person, a full-time, equivalent person year, based
upon a total of 1,880 hours per year of work related to such activities.
1.24 "Improved Analog" shall mean any dinucleotide P2Y2 receptor agonist
which has utility as an inhalation product for use in the Field.
1.25 "IND" shall mean any filing made with the Regulatory Authority in the
Territory for initiating clinical trials in the Territory with respect to the
Product.
1.26 "Invention" shall mean any new or useful process, manufacture,
compound or composition of matter relating to the Compound or the Product
(including, without limitation, the formulation, delivery or use thereof),
whether patentable or unpatentable, or any improvement thereof, that is
conceived or first reduced to practice or demonstrated to have utility during
the term of, and in connection with, the Joint Development Program.
1.27 "Joint Development Committee" shall have the meaning assigned to such
278564
|
Inspire Pharma
As referenced in this Joint Development, License And Supply Agreement:
Inspire
Pharmaceuticals, Inc – SUPPLY AGREEMENT
THIS JOINT DEVELOPMENT, LICENSE AND SUPPLY AGREEMENT (this "Agreement"),
dated as of September 10, 1998, is entered into by and between Inspire
Pharmaceuticals, Inc ., a corporation organized and existing under the laws of
the State of Delaware, having offices located at 4222 Emperor Boulevard, Suite
470,
_____________
Inspire Pharmaceuticals, Inc – experiences associated
therewith that are known to the other Party, each Party shall report:
-19-
{PAGE}
(i) In the case of Inspire, to:
Inspire Pharmaceuticals, Inc .
4222 Emperor Boulevard, Suite 470
Durham, North Carolina 27703
USA
Attention: Patricia Edgar, Ph.D., Director, Regulatory
Affairs
Facsimile No.: (919) 941-
_____________
Inspire Pharmaceuticals, Inc – Party for which
such notice is intended, at the address set forth for such Party below:
(i) In the case of Inspire, to:
Inspire Pharmaceuticals, Inc .
4222 Emperor Boulevard, Suite 470
Durham, North Carolina 27703
USA
Attention: Christy L. Shaffer, Ph.D.
Facsimile No.: (919) 941-9797
-36-
{
_____________
INSPIRE PHARMACEUTICALS, INC – the Parties has caused this Agreement to be
executed by its duly authorized representative as of the day and year first
above written.
INSPIRE PHARMACEUTICALS, INC .
By: /s/ David J. Drutz
-----------------------------------
David J. Drutz, M.D., Vice Chairman
KISSEI PHARMACEUTICALS CO., LTD.
By:/s/ Mutsuo Kanzawa
-------------------------------
Mutsuo Kanzawa,
_____________
dt 211707
;
| Kissei Pharmaceutical Co., Ltd.
|