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Development Collaboration Agreement

 

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Title:

Development Collaboration Agreement

Entities:

Dynavax Technologies Corp.; Regents of the University of California; BioSeek, Inc.

Date:

2003

Size:

Preview shows 8KB of 48KB total

Price:

$39

ID:

#193858

 

 

► Licensing ► Collaboration ► Development & Collaboration Agreements
► Biotech & Drugs ► Pharmaceutical Preparations

 

 

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DEVELOPMENT COLLABORATION AGREEMENT

This Development Collaboration Agreement ("AGREEMENT") is made and
effective as of June 10, 2003 (the "EFFECTIVE DATE"), by and between BioSeek,
Inc., a California corporation, having a place of business at 863-C Mitten Road,
Burlingame, California 94010 ("BIOSEEK") and Dynavax Technologies Corporation, a
Delaware corporation, having a place of business at 717 Potter Street, Suite
100, Berkeley, California 94710 ("DYNAVAX").

BACKGROUND

A. BioSeek has developed certain technology known as BioMAP
Technology (as defined below) that is used to perform, among other things,
biofunctional characterization of genes and potential therapeutic compounds, as
further described in this Agreement;

B. Dynavax is engaged in research and development of certain
proprietary compounds for potential human therapeutic use, as further described
in this Agreement;

C. Dynavax and BioSeek desire that BioSeek apply the BioMAP
Technology to analyze and characterize the activity of certain compounds with
the objective of advancing the development of such compounds, and the parties
desire to enter into this Agreement to enable them to engage in such activities.

Now, therefore, in consideration of the mutual covenants and conditions
contained herein, and intending to be legally bound, the parties agree as
follows:

1. DEFINITIONS.

(a) "AFFILIATE" means, with respect to a particular party,
another person that controls, is controlled by or is under common control with
such party. For the purposes of the definition in this Section 1(a), 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.

(b) "BioMAP TECHNOLOGY" means BioSeek's proprietary human
cell-based model systems technology as more fully described in Exhibit 1(b).

(c) "CONFIDENTIAL INFORMATION" means, in the case of Dynavax,
information disclosed by Dynavax to BioSeek concerning the identity of the
Provided TZP Compounds, their development status, results of preclinical assays
and requirements for their handling and safety ("DYNAVAX CONFIDENTIAL
INFORMATION"), and in the case of BioSeek, information disclosed to Dynavax
concerning the BioMAP Technology or otherwise related to BioSeek's performance
of the Program ("BioSEEK CONFIDENTIAL INFORMATION"), that, in either case, if
disclosed in tangible form is marked "Confidential" or with other similar
designation to indicate its confidential or proprietary nature, or if disclosed
orally is indicated orally to be confidential or proprietary by the disclosing
party at the time of disclosure and is confirmed in writing as confidential or
proprietary by the disclosing party within a reasonable time after such
disclosure.

(d) "DERIVATIVE" means any compound that is derived from
another compound. As used in this Section 1(d), a compound shall be considered a
"Derivative" of a precursor compound if it either:

(1) is actually synthesized in a chemical synthesis
program based on the precursor compound; or

1
{PAGE}

(2) is actually synthesized based on
structure-activity data relating to the precursor
compound; or

(3) was made in the course of further advancing one
or more precursor compounds toward
commercialization; or

(4) is included within the scope of any claim of a
patent application or patent which also claims
one or more precursor compounds and/or compounds
described in (1) through (3) above.

(e) "DYNAVAX PARTNER" means a third party with whom Dynavax
has entered into a Partnering Agreement.

(f) "FDA" means the United States Food and Drug
Administration.

(g) "IND" means an Investigational New Drug application, as
defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated
thereunder, for initiating clinical trials in the United States.

(h) "NET SALES" means the total amount invoiced to
non-Affiliate third parties on sales of TZP Products by Dynavax, Dynavax's
Partners, and the Affiliates and sublicensees of each, less the following
reasonable and customary deductions allowed to the buyer against the invoiced
amount: (i) trade, cash and quantity discounts; (ii) amounts for claims,
allowances or credits for returns; and (iii) prepaid freight, sales taxes,
duties and other governmental charges (including value added tax) on particular
sales, but excluding what is commonly known as income taxes, in each case if
charged separately on the invoice and paid by the customer. For the removal of
doubt, Net Sales shall not include sales to Dynavax, Dynavax's Partners, and the
Affiliates and sublicensees of each for resale; however, sales to such entities
shall be treated as Net Sales at list price. A "sale" shall also include a
transfer or other disposition for consideration other than cash, in which case
such consideration shall be valued at the fair market value thereof.

(i) "NOVEL MARKER" means a measurement or profile of a
biological or biochemical analyte that indicates the activity of one or more of
the TZP Compounds in a manner that is relevant to a mechanism of action of such
TZP Compound in a particular disease state, which measurement or profile has not
been, as of the date it is identified by BioSeek, or by Dynavax based on the
Profiling Results, (i) disclosed as a marker for such purpose in the public
domain as a result of prior publication or use, or (ii) identified as a marker
for such purpose by Dynavax without use of any Profiling Results, which Dynavax
shall have the burden of demonstrating with competent evidence.

(j) "PARTNERING AGREEMENT" means any agreement, arrangement or
understanding between Dynavax and a third party under which Dynavax grants to
the third party, directly or indirectly, any right or option to market, sell,
distribute or otherwise commercialize a TZP Product in any geographic territory.

(k) "PHASE III TRIAL" means that portion of the clinical
studies for the FDA submission and approval process which provides for trials of
a product on sufficient numbers of patients to establish the safety and efficacy
of such product to support regulatory approval in the proposed therapeutic
indication as more fully defined in 21 C.F.R. Section 312.21(c).

(l) "PROFILING RESULTS" means the profiling information
regarding the Provided TZP Compounds obtained as a result of BioSeek's

 

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