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Collaboration Agreement

 

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Title:

Collaboration Agreement

Entities:

Novartis Pharma AG; Rigel Pharmaceuticals, Inc.; Transgene SA; Stanford University; Cooley Godward LLP

Date:

2000

Size:

Preview shows 28KB of 196KB total

Price:

$83

ID:

#327519

 

 

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                             COLLABORATION AGREEMENT


THIS COLLABORATION AGREEMENT ("Agreement") is entered into as of May
26th, 1999 ("Effective Date") by and between RIGEL PHARMACEUTICALS, INC., a
Delaware corporation ("Rigel") with its offices at 240 East Grand Avenue,
South San Francisco, CA 94080, and NOVARTIS PHARMA AG, a Swiss corporation
("Novartis") with offices at Lichtstrasse 35, CH-4058, Basel, Switzerland
(collectively, "Parties"; individually, a "Party").

RECITALS

WHEREAS, Rigel is a leader in the discovery and validation of
intracellular target molecules involved in the modulation of human disease; and

WHEREAS, Novartis is engaged in the research, development, marketing,
manufacture and distribution of pharmaceutical compounds useful in treating or
preventing human diseases and conditions; and

WHEREAS, Rigel and Novartis desire to enter into a collaborative
relationship to conduct research on intracellular target molecules and to
discover, develop and manufacture pharmaceutical products useful for treating or
preventing diseases associated with human disease; and

WHEREAS, Novartis is purchasing two million (2,000,000) shares of Rigel
Series D Preferred Stock with a total value of US$4 million pursuant to a stock
purchase agreement between the Parties of even date herewith (the "Stock
Purchase Agreement"), and the Parties are further entering into an Equity Option
Agreement pursuant to which Novartis may purchase up to an additional US$10
million in value of Rigel equity;

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

1. DEFINITIONS

As used herein, the following terms (whether used in their singular or
plural form) shall have the following meanings:

"AFFILIATE" shall mean, with respect to a Party to this Agreement, any
other entity, whether de jure or de facto, which directly or indirectly
controls, is controlled by, or is under common control with, such Party. A
business entity or Party shall be regarded as in control of another business
entity if it owns, or directly or indirectly controls, at least fifty percent
(50%) (or such lesser percentage which is the maximum allowed to be owned by a
foreign entity in a particular jurisdiction) of the voting stock or other
ownership interest of the other entity, or if it directly or indirectly
possesses the power to direct or cause the direction of the management and
policies of the other entity by any lawful means whatsoever.


1.
{PAGE}

"AT-NOVARTIS PROJECT" shall mean a Program of Research performed by
Novartis as provided in Section 4.2 hereof.

"B-CELL PROJECT" shall mean the Program of Research directed to the
identification of Novel Validated Targets involved in the process of B-Cell
activation, as the Program of Research is more fully described in Exhibit A-2
hereto.

"COLLABORATION PROJECT" shall mean a Joint Project or an At-Novartis
Project.

"COMMENCEMENT DATE" shall mean the date upon which a Collaboration
Project shall commence as set forth in Exhibit B or as determined pursuant to
the provisions of Section 2.2 hereof.

"COMPOUND SCREENING" shall mean the use of a primary assay for testing
biological or chemical materials, including chemical materials coming out of
high-throughput screening, to determine whether they show pharmaceutically
relevant activity.

"CONFIDENTIAL INFORMATION" shall mean any invention, discovery, patent
application or claim, trade secret, idea, improvement or other work of
authorship, any process, formula, data, program, drawing, information, price,
technique, sample, compound, extract, media, vector and/or cell line and
procedures and formulations for producing any such sample, compound, extract,
media, vector and/or cell line, any process, formula or data relating to any
research project, work in process, future development, engineering,
manufacturing, marketing, servicing, financing or personnel matter relating to a
Party, its present or future products, sales, suppliers, clients, customers,
employees, investors, or business, whether in oral, written, graphic or
electronic form.

"CONTROL" shall mean the possession of the ability to grant a license
or sublicense to know-how or patents without violating the terms of any
agreement or other arrangement with, or the rights of, any Third Party.

"COOPERATION MANAGEMENT COMMITTEE" or "CMC" shall mean the committee
formed pursuant to Section 3.1.

"EXCLUSIVITY TERM" shall have the meaning assigned to it in Section
5.2.

"EXTENSION FEE" shall have the meaning assigned to it in Section 7.5.

"FSC-STATUS" or "Final Selected Compound Status" shall mean the point
at which a Product is declared, following Novartis' standard compound
development procedures, an 'FSC Compound' or equivalent status by Novartis'
Research Management Board or some other similar body, which declaration
authorizes the initiation of preclinical development programs aimed, INTER ALIA,
at the detailed investigation of those toxicological, bioavailability,
pharmacokinetic and formulation parameters whose successful completion will
allow progression of the Product to Phase I Clinical Trials.

"FTE" shall mean the equivalent of a full-time twelve (12) months
(including normal vacations, sick days and holidays) work of a person,
carried out by one or more employees or consultants of a Party, each of whom
devotes all or a portion of his or her time to a Collaboration Project;
provided, however, that each Party understands and agrees that the other
Party retains complete discretion to change the identity, the frequency and
time which


2.
{PAGE}

any individual employee devotes to a Collaboration Project. Scientific work
on or directly related to a Collaboration Project to be performed by a
Party's employees or consultants can include, but is not limited to,
experimental laboratory work, recording and writing up results, reviewing
literature and references, holding scientific discussions, managing and
leading scientific staff, and carrying out Research Cooperation management
duties (including service on the Cooperation Management Committee).

"JOINT INVENTION" shall have the meaning assigned to it in Section 8.1.

"JOINT PROJECT" shall mean a Program of Research which Novartis and
Rigel agree will be conducted collaboratively as provided in Section 4.1 hereof.

"JOINT TECHNOLOGY" shall mean Know-How and Patents conceived or reduced
to practice by at least one employee of Novartis and at least one employee of
Rigel during the course of a Program of Research.

"KNOW-HOW" shall mean any and all tangible or intangible know-how,
trade secret, invention (whether or not patentable), data, pre-clinical and
clinical result, physical, chemical or biological material, and other
information.

"LEAD COMPOUND" shall mean an active compound identified by Rigel in
the course of Compound Screening on the basis of a Novel Validated Target
pursuant to Section 5.6.

"MILESTONE EVENT" shall have the meaning assigned to it in Section 7.2.

"MILESTONE PAYMENT" shall have the meaning assigned to it in Section
7.2.

"NOTICE DATE" shall have the meaning assigned to it in Section 4.1.4
and 4.2.4.

"NOVARTIS KNOW-HOW" shall mean any Know-How that is necessary and
useful in a Program of Research and that Novartis owns or Controls on the
Effective Date, and any replication or any part of such information or material.

"NOVARTIS PATENTS" shall mean all Patents which claim inventions or
discoveries necessary and useful in a Program of Research and that that Novartis
owns or Controls on the Effective Date.

"NOVARTIS TECHNOLOGY" shall mean Novartis Know-How and Novartis
Patents, subject to any limitation contained in the agreements under which
Novartis' rights to the use of such Novartis Technology are derived.

"NOVEL VALIDATED TARGET" shall mean a specific molecule in an
intracellular signaling pathway which, when bound by a specific peptide, changes
in a predetermined way the phenotype of a target cell with a degree of
specificity and in a manner meeting the predetermined validation criteria set by
the CMC for Joint Projects and by Novartis for At-Novartis Projects.

"PATENTS" shall mean all foreign and domestic patents (including,
without limitation, extensions, reexaminations, reissues, renewals and inventors
certificates) and patents issuing from patent applications (including
substitutions, provisionals, divisionals, continuations and
continuations-in-part).


3.
{PAGE}


"PHASE I CLINICAL TRIALS" shall mean first clinical trial where the
Product is applied in healthy human volunteers to test safety of such Product.

"PRODUCT" shall mean a molecule in the various stages of development
from identification in Compound Screening to and including commercialization,
which is useful to diagnose, treat or prevent human diseases or conditions and
whose principal mechanism of action by which it exerts its pharmacological
activity is based upon, derived from or discovered with the use of, a Novel
Validated Target.

"PROGRAM OF RESEARCH" shall mean research utilizing Rigel Technology to
identify specific target molecules and peptides which bind thereto that alter a
selected phenotype of a target cell population, including the use of retroviral
vector and expression systems which express libraries of molecules in target
cells, high-speed fluorescent cell sorting systems to identify the cells in
which the selected phenotype change has occurred and two-hybrid screening assays
to elaborate the intracellular interactions of the specific target molecules and
other means and methods, whether or not utilizing Rigel Technology, appropriate
in a particular program.

"PROGRAM PROPOSAL" shall mean a written description of a Program of
Research specifying in reasonable detail the specific goals of the project
including clinical objectives, target cells to be utilized, desired biologic
endpoints of assays of the target cells, project time frames and resource
requirements.

"PROJECT CONTACT PERSON" shall have the meaning assigned to it in
Section 3.8.

"PROJECT KNOW-HOW" shall mean Know-How developed, conceived or reduced
to practice by a Party in the course of a Collaboration Project.

"PROJECT PATENT" shall mean a Patent claiming Project Know-How.

"PROJECT TECHNOLOGY" shall mean Project Know-How and Project Patents.

"RESEARCH COOPERATION" shall mean the Joint Projects and the
At-Novartis Projects.

"RESEARCH PERIOD" shall mean, for each Joint Project and each
At-Novartis Project, five (5) years commencing as of the corresponding
Commencement Date, subject to earlier termination as permitted hereby.

"RIGEL CORE TECHNOLOGY" shall mean Rigel's proprietary packaging cell
lines (e.g., without limitation, that designated as Phoenix), high-speed
functional genomic screening technology, two-hybrid screening assays, retroviral
vector systems and expression systems that utilize these vectors to express
libraries of molecules in target cells and high speed fluorescent cell sorting
systems and any improvements thereon, and any Patents and Know-How relating
thereto owned or Controlled by Rigel, subject to any limitation contained in the
agreements under which Rigel's rights to the use of such Rigel Core Technology
are derived.

"RIGEL KNOW-HOW" shall mean any Know-How other than Rigel Core
Technology that is useful in a Collaboration Project and that Rigel owns or
Controls on the Effective Date and any replication or any part of such
information or material.


4.
{PAGE}

"RIGEL PATENTS" shall mean all Patents other than Rigel Core
Technology which claim inventions or discoveries useful in a Collaboration
Project and that are owned or Controlled by Rigel on the Effective Date.

"RIGEL TECHNOLOGY" shall mean the Rigel Patents and Rigel Know-How,
subject to any limitation contained in the agreements under which Rigel's rights
to the use of such Rigel Technology are derived.

"SOLE INVENTIONS" shall have the meaning assigned to it in Section 8.1.

"T-CELL PROJECT" shall mean the Program of Research directed to the
identification of Novel Validated Targets involved in the process of T-Cell
activation, as the Program of Research is more fully described in Exhibit A-1
hereto.

"TERM OF AGREEMENT" shall have the meaning assigned to it in Section
11.1.

"TERRITORY" shall mean the entire world.

"THIRD PARTY" shall mean any person or entity other than Novartis,
Rigel and Affiliates of either.

2. SELECTION OF PROJECTS

2.1 NOVARTIS ACCESS TO FIVE PROJECTS. Novartis may have access to up to
five (5) Programs of Research of which at least two (2) will be Joint Projects
and no more than three (3) will be At-Novartis Projects.

2.2 PROPOSAL FOR A PROGRAM OF RESEARCH.

2.2.1 JOINT PROJECTS. A Program of Research for a Joint
Project may be proposed by Novartis or Rigel submitting to the other a Program
Proposal. Within thirty (30) days of receipt of a Program Proposal the receiving
party shall determine whether it has any agreement with a Third Party which
would prevent it from agreeing to conduct pursuant to this Agreement the Program
of Research identified in the Program Proposal and notify the proposing party
accordingly. If the receiving party is free to conduct the Program of Research
pursuant to this Agreement, the Parties shall meet to determine whether they
will agree to conduct such Program of Research pursuant to this Agreement. If
so, the CMC shall meet promptly to prepare a mutually agreeable description of
the Program of Research to be attached as an exhibit to this Agreement, to
specify the number of FTEs which will be utilized, the Commencement Date and the
number of FTEs as well as the resources to be allocated at Novartis. If the
receiving party is not free to conduct the Program of Research pursuant to this
Agreement, neither Party shall have any obligation or liability to the other
with respect to such Program of Research.

2.2.2 AT-NOVARTIS PROJECTS.

(a) Novartis may propose a Program of Research
for an At-Novartis Project by submitting to Rigel a corresponding Program
Proposal.

(b) Novartis shall have the right to proceed
with such Program of Research, unless Rigel notifies Novartis in writing within
thirty (30) days of receipt of a


5.
{PAGE}

Program Proposal (i) that in Rigel's opinion, the Program of Research as
proposed by Novartis is scientifically not feasible, or (ii) that Rigel is
engaged in advanced negotiations with a Third Party regarding a collaboration
on a Program of Research which would conflict with the Program of Research
proposed by Novartis under this Agreement, or (iii) that Rigel has initiated
an internal Program of Research, as evidenced by written records, which would
conflict with the Program of Research proposed by Novartis.

(c) If Rigel provides to Novartis a notice
pursuant to subsection (b)(i) above, the Parties shall meet to discuss and
revise the proposed Program Proposal as appropriate to address Rigel's comments
and suggestions, whereafter Novartis shall have the right to proceed with such
Program of Research based on the revised Program Proposal. If Rigel provides to
Novartis a notice pursuant to subsection (b)(ii) or (b)(iii) above, such Program
of Research may not be pursued by Novartis, and neither Party shall have any
obligation or liability to the other with respect to such Program of Research.

(d) If Novartis has the right to proceed with a
Program of Research as provided in this Section 2.2.2, Novartis will provide to
Rigel a mutually agreeable description of the Program of Research, including the
validation criteria to be applied for determining whether a molecule is a Novel
Validated Target, to be attached as an exhibit to this Agreement which
description shall specify the Commencement Date of the At-Novartis Project.
Thereafter, the Parties will meet promptly to specify the Rigel Technology and
Rigel Core Technology to be transferred and the time of the transfer thereof to
Novartis pursuant to Section 4.2.5 hereof.

2.3 NUMBER AND KIND OF ADDITIONAL PROGRAMS OF RESEARCH. The parties
hereby agree that the Commencement Date of the T-Cell Project shall be the
Effective Date of this Agreement. Subject to Section 2.2, Novartis and Rigel
will add to this Agreement two (2) additional Programs of Research prior to the
first (1st) anniversary of the Effective Date and two(2) Programs of Research
prior to the second (2nd) anniversary of the Effective Date.

2.4 T-CELL PROJECT. Novartis and Rigel hereby agree that the T-Cell
Project is to be conducted as a Joint Project as provided in Section 4.1 and is
one of the Programs of Research referred to in Section 2.1. A mutually agreeable
description of the Program of Research is set forth in Exhibit A-1. The number
of FTEs and the Commencement Date for the T-Cell Project are set forth in
Exhibit B-1.

2.5 B-CELL PROJECT. Novartis hereby acknowledges that Rigel has
proposed the B-Cell Project as the second Joint Project in compliance with
Section 2.2, and that Novartis has no agreement with a Third Party which would
prevent it from agreeing to engage in the B-Cell Project pursuant to this
Agreement. A mutually agreeable description of the Program of Research for the
B-Cell Project is set forth in Exhibit A-2. The number of FTEs and the
Commencement Date for the B-Cell Project are set forth in Exhibit B-2. Novartis
will notify Rigel within ninety (90) days after the Effective Date whether it
agrees that the B-Cell Project shall be conducted as the second Joint Project.
If Novartis does not so agree, Rigel's proposal of the B-Cell Project shall be
considered withdrawn as of the ninety-first (91st) day after the Effective Date
and neither Novartis nor Rigel shall thereafter have any obligation or liability
to the other with respect to the B-Cell Project.

3. RESEARCH COOPERATION GOVERNANCE


6.
{PAGE}

3.1 JOINT COOPERATION COMMITTEE FORMATION. The Research Cooperation
established by this Agreement shall be overseen or monitored, pursuant to the
provisions of Section 3.7 hereof, by a Cooperation Management Committee composed
of an equal number of representatives from each Party (the "Cooperation
Management Committee"). Each Party shall initially designate three (3)
representatives on the CMC within ten (10) business days after the Effective
Date. The addition of further representatives to the CMC, if any, shall occur
pursuant to the provisions of Section 3.3.6 hereof. Each Party may, upon notice
to the other Party, change its representatives to the CMC to allow for the
participation of different research groups within Novartis or Rigel, as the case
may be. The Parties shall agree upon the appropriate qualifications for members
of the CMC. An alternate member designated by a Party may serve temporarily in
the absence of a permanent member of the CMC for such Party. Each Party shall
designate one of its representatives as a Co-Chair of the CMC. Each Co-Chair of
the CMC will be responsible for the agenda and the minutes of alternating CMC
meetings.

3.2 CMC ACTIONS. Actions by the CMC pursuant to this Agreement shall be
taken only with unanimous approval of all of the representatives of the CMC. If
the CMC fails to reach unanimity on a matter before it for decision, the matter
shall be referred for resolution to the designated executives of the Parties
identified in Section 13.2.

3.3 MEETINGS OF THE CMC. The CMC:

3.3.1 shall hold meetings at such times and places as shall be
determined by the CMC (it being expected that meetings will alternate between
one of Novartis' research sites on the one hand and Rigel's head offices on the
other hand) but in no event shall such meetings be held in person less
frequently than once every three (3) months during the entire period during
which the Research Period of at least one Collaboration Project is not yet
expired or terminated;

3.3.2 may conduct meetings in person or by telephone or
video conference;

3.3.3 by mutual consent of the representatives of each Party,
may invite other personnel of either Party to attend meetings of the CMC;

3.3.4 may act without a meeting if prior to such action a
written consent thereto is signed by all members of the CMC;

3.3.5 may form and subsequently disband subcommittees with
appropriate representation from each Party;

3.3.6 may increase or decrease the equal number of CMC
representatives each Party can designate; and

3.3.7 may amend or expand upon the foregoing procedures for
its internal operation by unanimous written consent.

3.4 MINUTES. Subject to the provisions of Section 3.1 hereof, one of
the Co-chairs of the CMC will prepare, within ten (10) business days after each
meeting (whether held in person or by telephone or video conference), the
minutes reporting in reasonable detail the actions taken by the CMC, the status
of each Collaboration Project, the then current list of Novel Validated Targets,
issues requiring resolution and resolutions of previously reported


7.
{PAGE}

issues, which minutes are to be approved by the signature of the CMC Co-Chair
of the other Party.

3.5 SUBCOMMITTEES. Any subcommittee established by the CMC shall have
appropriate representation of each Party and may include representatives of a
Party who are not members of the CMC. Any such subcommittee shall be subject to
the CMC and shall report its activities and actions to the CMC. At the request
of either Party at any time, any such committee shall be dissolved and its
powers and functions returned to the CMC.

3.6 REPORTS. Novartis and Rigel shall each provide written reports at
or before each CMC meeting describing its activities and results under the
Research Cooperation. Such reports shall be in such form and contain such detail
as the CMC shall determine.

3.7 CMC FUNCTIONS AND POWERS. The activities of the Parties under this
Agreement shall be managed by the CMC only to the extent set forth herein
(unless otherwise mutually agreed by the Parties). The CMC shall:

3.7.1 foster the collaborative relationship between the
Parties;

3.7.2 facilitate and monitor the technology transfer under
the Collaboration Projects;

3.7.3 approve the validation criteria for a Novel Validated
Target within sixty (60) days of each Commencement Date;

3.7.4 pursuant to Section 5.4 and provided Novartis has
requested Rigel screening thereunder, approve in advance the criteria for a Lead
Compound identified by Rigel and to be reported to Novartis;

3.7.5 monitor the progress of the research in the Joint
Projects;

3.7.6 monitor the status of At-Novartis Projects to allow
assessment of whether or when a Milestone Payment is due;

3.7.7 review and allocate annual FTEs in the Joint Projects,
within the framework of the contractually agreed funding level;

3.7.8 clear scientific publications relating to the Joint
Projects, and, insofar as containing work from both Parties, relating to
At-Novartis Projects, subject to the review and approval of both Parties
pursuant to Section 10.3;

3.7.9 perform such other functions as elsewhere explicitly
provided in this Agreement and as appropriate to further the purposes of this
Agreement as mutually determined by the Parties.

3.8 PROJECT CONTACT PERSONS. Subject to the CMC, the day-to-day
communication between the Parties and project coordination of each Joint Project
will be performed by two (2) "Project Contact Persons", one to be appointed by
each Party.

3.9 OBLIGATIONS OF PARTIES. Each one of the Parties shall have the
right to inspect the other Party's records through a qualified independent Third
Party, reasonably acceptable to the other Party, to determine whether the other
Party's performance complies with the


8.

 

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