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Development, Commercialization and License Agreement

 

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Title:

Development, Commercialization and License Agreement

Entities:

Cima Labs Inc.; Dr. Reddy’s Laboratories Ltd.

Date:

2003

Size:

Preview shows 10KB of 148KB total

Price:

$61

ID:

#296685

 

 

► Licensing ► Licenses ► Commercializ. ► Development, Commercialization & License Agreements
► Biotech & Drugs ► Pharmaceutical Preparations

 

 

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DEVELOPMENT, COMMERCIALIZATION AND LICENSE AGREEMENT
BETWEEN
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
AND
CIMA LABS INC.

This DEVELOPMENT, COMMERCIALIZATION AND LICENSE AGREEMENT (the
"Agreement"), effective as of June 26, 2003 (the "Effective Date"), by and
between [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.***], a Delaware corporation and
wholly owned subsidiary of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***], maintaining
its offices at [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] ("[***CONFIDENTIAL
TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***]"), and CIMA LABS INC., a Delaware Corporation,
maintaining offices at 10000 Valley View Road, Eden Prairie, MN 55344-9361
("CIMA").

In consideration of the rights conferred and the obligations assumed herein, and
intending to be legally bound, the parties agree as follows:

1. DEFINITIONS

As used in this Agreement, the following capitalized terms shall have
the meanings set out below:

1.1. "Affiliate(s)" shall mean, in relation to either party hereto,
any entity or person which directly or indirectly controls, is
controlled by, or is under common control by a party. The term
"control" for purposes of this definition shall mean the right
to exercise more than fifty percent (50%) of the voting rights
of an entity, or the power to direct or cause the direction of
the management or policies, or to direct, select, or appoint
officers or directors of the entity.

1.2. "[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]
Confidential Information" has the meaning ascribed to it in
Section 9.1

1.3. "CIMA Competitor" shall mean any entity or person principally
engaged in the business of licensing, formulation, development
and manufacturing of fast Oral Disintegrating Tablets and
listed on Schedule 1.3 hereto and as such schedule may be
amended by mutual agreement from time to time.

{PAGE}

1.4. "CIMA Confidential Information" has the meaning ascribed to it
in Section 9.2.

1.5. "CIMA Licensed Patents" shall mean the patents and patent
applications owned or Controlled by CIMA and/or its Affiliates
that claim Licensed Product, the DuraSolv(R) Technology, the
PakSolv(R) Technology and/or the OraSolv(R) Technology as
related to Licensed Product, and its manufacture, its
packaging, or its use, its import or its sale and including
any extension, reissue, renewal, reexamination or
continuation-in-part of such patents or patent applications.
CIMA Licensed Patents shall include Developed Intellectual
Property. CIMA Licensed Patents shall not include any Work
Product. The initial list of CIMA Licensed Patents is set
forth on Schedule 1.5.

1.6. "CIMA Technical Information" shall mean (a) techniques and
data, including ideas, inventions (including patentable
inventions, but excluding inventions covered by CIMA Licensed
Patents), practices methods, knowledge, know-how, trade
secrets, skill, experience, documents, apparatus, test data,
including pharmacological, toxicological and clinical test
data, analytical and quality control data, manufacturing,
patent data or descriptions relating to Licensed Product,
including, but not limited to, those that relate to
DuraSolv(R)Technology, PakSolv(R)Technology and/or
OraSolv(R)Technology, owned or Controlled by CIMA and/or its
Affiliates and (b) chemical formulations, compositions of
matter, product samples and assays relating to Licensed
Product, including, but not limited to, those that relate to
DuraSolv(R)Technology, PakSolv(R)Technology and/or
OraSolv(R)Technology, owned or Controlled by CIMA and/or its
Affiliates. CIMA Technical Information shall include Developed
Intellectual Property. CIMA Technical Information shall not
include any Work Product.

1.7. "CIMA Licensed Technology" shall mean CIMA Licensed Patents
and CIMA Technical Information.

1.8. "Control or Controlled" in the context of intellectual
property rights shall mean rights sufficient to allow a grant
of such rights to a party, including by license.

1.9. "Developed Intellectual Property" shall mean any and all
intellectual property rights, including but not limited to,
inventions, whether patentable or not, and know-how arising
out of the performance of the Work Plan. Developed
Intellectual Property shall not include any party's
intellectual property existing as of the Effective Date.

1.10. "Development Specifications" shall mean the development goals
for the sensory, physical and functional parameters for the
Licensed Product as set forth in Schedule 1.10.

{PAGE}

1.11. "DuraSolv(R)Technology" shall mean the fast-dissolving drug
delivery system generally described in U.S. Patents 6,024,981
and 6,221,392 and PCT Published Application No. WO 98/46215.

1.12. "Exclusive Field" shall mean any product containing
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***].

1.13. "FDA" shall mean the United States Food and Drug
Administration, or any successor thereto.

1.14. "Field" shall mean the treatment of all human conditions.

1.15. "Good Clinical Practice" shall mean the then current standards
for clinical trials for pharmaceuticals, as set forth in the
United States Federal Food, Drug and Cosmetic Act and
applicable regulations promulgated thereunder, as amended from
time to time.

1.16. "Good Laboratory Practice" shall mean the then current
standards for laboratory activities for pharmaceuticals, as
set forth in the United States Federal, Food, Drug and
Cosmetic Act and applicable regulations promulgated
thereunder, as amended from time to time.

1.17. "Good Manufacturing Practice" shall mean the then current
standards for manufacture of pharmaceuticals, as set forth in
the United States Federal, Food, Drug and Cosmetic Act and
applicable regulations promulgated thereunder, as amended from
time to time.

1.18. "Licensed Product" shall mean oral disintegrating tablets
containing [***CONFIDENTIAL TREATMENT REQUESTED, PORTION
OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***] and all improvements and line extensions
thereof.

1.19. "Net Sales" shall mean, for the applicable period, the gross
amount invoiced by [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.***] or its sublicensees for the sale or
other disposition of Licensed Product, less customary
adjustments from gross sales to net sales as determined in
accordance with U. S. Generally Accepted Accounting Principles
as consistently applied by [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***], including but not
limited to: (a) customary quantity, trade and/or cash
discounts, allowances, chargebacks, rebates and price

 

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