Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit 10.19
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This Research Collaboration And License Agreement (the "Agreement") is made
by and between The X. X. Xxxxxxx Pharmaceutical Research Institute, a division
of Ortho-XxXxxx Pharmaceutical, Inc., having a business address at U.S. Xxxxx
000, Xxxxxxx, Xxx Xxxxxx 00000 ("PRI") and Dendreon Corporation, having a
business address at 0000 0xx Xxxxxx, Xxxxxxx, Xxxxxxxxxx 00000 ("Dendreon").
Whereas, PRI owns or controls [ * ] technology for [ * ], [ * ] peptide
antigen constructs and related materials; and
Whereas, Dendreon owns or controls dendritic cell technology for Her-2/neu,
[ * ] antigen constructs and related materials; and
Whereas, PRI and Dendreon desire to determine the feasibility of their
respective technologies as immunotherapy products for the treatment of tumors
which express Her-2/neu, including breast cancer, ovarian cancer and colorectal
cancer, with a view toward the possibility of a future collaboration to
determine the feasibility of a such a product made by combining their respective
technologies;
Now Therefore, it is agreed as follows:
1. Purposes. The purposes of this Agreement are to provide for studies of the
PRI Technology and of the Dendreon Technology to determine their feasibility,
respectively, as immunotherapy products for the treatment of tumors which
express Her-2/neu, including breast cancer, ovarian cancer and colorectal cancer
by performing Phase I Clinical Trials, and to consider the feasibility of
combining the PRI Technology and the Dendreon Technology for development and
commercialization of such a product in a future collaboration.
2. Effective Date. This Agreement is effective as of October 1, 2000 (the
"Effective Date").
3. Term. This Agreement is for a term beginning on October 1, 2000 and ending
at 11:59 pm PST on December 31, 2002.
4. Definitions.
4.1 "Affiliate" means, with respect to a Party, any person or entity that
controls, is controlled by, or is under common control with such Party, where
"control" means ownership of fifty percent (50%) or more of the outstanding
voting securities (but only as long as such person or entity meets these
requirements).
1.
4.2 "Clinical Trials" means the clinical studies of human subjects
described in the Collaboration Research Plan.
4.3 "Collaboration" means the work to be performed by the Parties under
this Agreement.
4.4 "Collaboration Research Plan" means the work plan to be performed
under this Agreement as set forth in Schedule A.
4.5 "Confidential Information" means information as defined in Section
7.5.
4.6 "Control or Controlled" means, with respect to Technology, that a
Party owns or has a license to such Technology and has the ability to grant to
the other Party access to or a license or sublicense under such technology
without violating the terms of any agreement with a Third Party at the time of
the grant.
4.7 "Dendreon Patents" means those:
(i) granted patents and patent applications set forth in Schedule B-1,
(ii) Third Party patents set forth in Schedule B-1, and
(iii) any other patent, patent application, and Third Party patent in
which Dendreon, in its sole discretion, may from time to time add to Schedule B-
1, subject to the [ * ], in which Dendreon has a licensable interest, to the
extent such granted patents, patent applications and Third Party patents may
apply in the Field.
4.8 "Dendreon Technology" means the Dendreon Patents and other Technology
that is Controlled by Dendreon and which is appurtenant to Dendreon's antigen
activated dendritic cell product for the treatment of Her-2 positive tumors
(APC8024), Dendreon's Investigational New Drug application for APC8024, and
dendritic cell antigen engineering technology and know-how, cell separation
technology, related materials and know-how specifically germane to the treatment
of Her-2 positive tumors.
4.9 "Developed Technology" means granted patents, patent applications and
other Technology developed in the course of the work under this Agreement,
[ * ].
4.10 "FDA" means the U.S. Food and Drug Administration.
4.11 "Field" means the treatment of cancers which express the Her-2/neu
antigen using Dendreon Technology or PRI Technology directed to the Her-2/neu
antigen as the therapeutic target.
4.12 "FTE" means work hours equivalent to the work performed by one full
time employee working for one year, pursuant to Dendreon's usual and customary
business practices.
4.13 "IND" means Investigational New Drug.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
2.
4.14 "Party" or "Parties" means PRI and/or Dendreon as the context
requires.
4.15 "PRI Patents" means those:
(i) granted patents and patent applications set forth in Schedule B-2,
(ii) Third Party patents set forth in Schedule B-2, and
(iii) any other patent, patent application, and Third Party patent
which PRI, in its sole discretion, may from time to time add to Schedule B-2,
subject to the [ * ], in which PRI has a licensable interest, to the extent such
granted patents, patent applications and Third Party patents may apply in the
Field.
4.16 "PRI Technology" means the PRI Patents and other Technology that is
Controlled by PRI and which is appurtenant to [ * ] for generation of activated
[ * ] against [ * ], [ * ] peptide antigens, related materials and know-how
specifically germane to the treatment of [ * ] tumors.
4.17 "Research Steering Committee" means a committee composed of three PRI
designees and three Dendreon designees, or such other number as the Parties may
agree in writing, whose function is set forth in Section 7.1.
4.18 "Technology" means conceptions, ideas, inventions, processes,
equipment, compositions of matter, genetic material, work plans, improvements,
enhancements, modifications, know-how, methods, techniques, systems, designs,
drawings, plans, specifications, documentation, data, information and other
intellectual property, works of authorship, and products, whether or not
copyrightable, patentable or susceptible to other forms of legal protection.
4.19 "Territory" means all of the countries in the world except [ * ].
4.20 "Third Party" means any party other than PRI and Dendreon.
5. PRI's Responsibilities and Rights.
5.1 License. PRI hereby grants to Dendreon an exclusive, non-assignable
license to the PRI Technology, without the right to sub-license, in the Field in
the Territory, for the sole purpose of conducting the work set forth in the
Collaboration Research Plan during the term of this Agreement; provided however,
PRI shall retain the right to conduct the work set forth in the Collaboration
Research Plan. This license shall automatically terminate upon the expiration or
termination of this Agreement.
5.2 Study Fee. PRI shall pay to Dendreon a study fee in the sum of Three
Million US Dollars (US $3,000,000.00) within [ * ] days after the Effective
Date.
5.3 Milestone Payment. PRI shall pay to Dendreon the sum of One Million US
Dollars (US $1,000,000.00) within [ * ] days after acceptance by the U.S. FDA of
Dendreon's IND application for APC8024 filed with the U.S. FDA under the
Collaboration Research Plan.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
3.
5.4 FTE Reimbursement. PRI shall pay to Dendreon the sum of [ * ] US
Dollars [ * ] for each FTE provided for in the Collaboration Research Plan. PRI
shall pay to Dendreon [ * ] US Dollars [ * ] within [ * ] days after the
Effective Date for FTE reimbursement for the period [ * ] through [ * ].
Thereafter, FTE reimbursement payments shall be made within [ * ] days after
receipt of respective quarterly invoices rendered by Dendreon to PRI.
5.5 Capital Items. PRI shall pay to Dendreon, [ * ] US Dollars [ * ]
within [ * ] days after the Effective Date for purchase by Dendreon on behalf of
PRI of all capital items as provided for in the Collaboration Research Plan.
Dendreon, on behalf of PRI, shall purchase all capital equipment identified in
the Collaboration Research Plan in amounts not to exceed [ * ], and all right,
title and interest to such capital equipment shall be in PRI. At the expiration
or termination of this Agreement, all such equipment shall be shipped by
Dendreon to PRI at such location specified by PRI, f.o.b. site of the equipment,
at PRI's expense.
5.6 Expense Reimbursement. PRI shall pay to Dendreon, within thirty (30)
days after receipt of respective invoices rendered by Dendreon to PRI, amounts
spent by Dendreon for contract costs as provided for in the Collaboration
Research Plan.
5.7 Cooperation. PRI shall, at its expense, cooperate fully in all
respects with Dendreon in the performance of the work under the Collaboration
Research Plan.
5.8 Disclaimer of Warranties. PRI makes NO, AND DISCLAIMS ANY AND ALL
WARRANTIES OR REPRESENTATIONS OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE,
and non-infringement with respect to PRI Technology, except PRI represents that
there is no claim of infringement and that it knows of no infringement with
respect to the PRI Technology as of the Effective Date.
5.9 Indemnity. PRI shall indemnify, defend and hold Dendreon harmless
from and against claims by Third Parties, related expenses, including reasonable
attorney's fees, and for damages payable to Third Parties arising out of or
resulting from PRI's conduct, breach of this Agreement and/or infringement of a
Third Party's patent or other intellectual property that results from Dendreon's
work pursuant to the Collaboration Research Plan under the license granted in
Section 5.1.
5.10 Notice of Infringement Claims. PRI shall promptly notify Dendreon of
any claim of infringement of a patent or other intellectual property which is
PRI Technology.
5.11 Audit. PRI may audit and inspect the work being done by Dendreon
under the Collaboration Research Plan and related records at any time following
reasonable notice to Dendreon of PRI's intent to audit and inspect.
6. Dendreon's Responsibilities and Rights.
6.1 License. Dendreon hereby grants to PRI an exclusive non-assignable
license to the Dendreon Technology, without the right to sub-license, in the
Field in the Territory, for the sole purpose of conducting the work set forth in
the Collaboration Research Plan during the term
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
4.
of this Agreement; provided however, Dendreon shall retain the right to conduct
the work set forth in the Collaboration Research Plan. This license shall
automatically terminate upon the expiration or termination of this Agreement.
6.2 Conduct of the Work. Dendreon shall undertake and conduct the work,
including the Clinical Trials, as set forth in the Collaboration Research Plan
in accordance with appropriate standards articulated in current good clinical
practices (GCP), current good manufacturing practices (GMP) and current good
laboratory practices (GLP). Dendreon will use reasonable efforts to carry out
the work in accordance with the Collaboration Research Plan.
6.3 Cooperation. Dendreon shall cooperate fully in all respects with PRI
in the performance of the work under the Collaboration Research Plan.
6.4 Disclaimer of Warranties. Dendreon makes NO, AND DISCLAIMS ANY AND
ALL WARRANTIES OR REPRESENTATIONS OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, and non-infringement with respect to Dendreon Technology, except
Dendreon represents that there is no claim of infringement and that it knows of
no infringement with respect to the Dendreon Technology as of the Effective
Date.
6.5 Insurance. Dendreon shall maintain property and casualty insurance
covering the capital equipment purchased by Dendreon on behalf of PRI in an
amount not less than [ * ] US Dollars [ * ], naming PRI as a loss payee to the
extent of its interest in such capital equipment. Dendreon shall cause its
insurance policies to be endorsed to provide for [ * ] days' prior written
notice to PRI by the insurance carrier of cancellation, expiration or
modification of the insurance policy, and will furnish to PRI certificates of
insurance evidencing the foregoing within ninety (90) days after the Effective
Date.
6.6 Indemnity. Dendreon shall indemnify, defend and hold PRI harmless
from and against claims by Third Parties, related expenses, including reasonable
attorney's fees, and for damages payable to Third Parties arising out of or
resulting from Dendreon's conduct, breach of this Agreement and/or infringement
of a Third Party's patent or other intellectual property that results from PRI's
work pursuant to the Collaboration Research Plan under the license granted in
Section 6.1.
6.7 Notice of Infringement of Claims. Dendreon shall promptly notify PRI
of any claim of infringement of a patent or other intellectual property which is
Dendreon Technology.
7. Mutual Responsibilities and Rights.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
5.
7.1 Research Steering Committee. The Research Steering Committee shall
manage and direct the work under the Collaboration Research Plan and may modify
the Collaboration Research Plan.
7.1.1 Unanimous Decisions. Decisions of the Research Steering
Committee may be made only unanimously, with each of PRI and Dendreon having one
vote.
7.1.2 Expenses. Expenses of the Parties' designees to the Research
Steering Committee shall be borne by [ * ].
7.1.3 Meetings. The Research Steering Committee shall meet at such
times and places as it shall determine at least four times a year.
7.1.4 Advice as to Future Collaboration. Not later than [ * ], the
Research Steering Committee shall advise the Parties in writing as to any view
the committee may have of the feasibility of future collaboration by the Parties
with respect to the Parties' respective separate and/or combined technology. The
Research Steering Committee may include in its advice recommendations as to the
general content of a future research and development plan, clinical studies, and
other terms of a future collaboration.
7.1.5 Program Coordinators. Dendreon and PRI shall each identify one
program coordinator with relevant experience and credentials to coordinate the
efforts of the Research Steering Committee as set forth in this Section 7 (the
"Program Coordinators"). Dendreon and PRI shall designate their respective
Program Coordinators within ten (10) days after the Effective Date and inform
each other of such designation in writing within such time period. Either Party
may replace its Program Coordinator, at its discretion, with another individual
with appropriate experience and credentials. Each Party will promptly provide
written notice to the other if it replaces its Program Coordinator.
The Program Coordinators shall be responsible for: (i) coordinating the
activities of the Research Steering Committee; (ii) conducting and coordinating
reviews of the Collaboration Research Plan; (iii) proposing revisions to the
Collaboration Research Plan to the Research Steering Committee; (iv)
communicating on a regular basis by telephone, facsimile, email, video
conference, internet conferencing and/or in person to review progress, track
schedules, resolve problems and arrange for the exchange of materials or
information necessary for the performance of the Collaboration in accordance
with the Collaboration Research Plan; (v) scheduling Research Steering Committee
meetings and creating agendas therefore mutually acceptable to the Parties; and
(vi) representing the position of their respective Party with respect to
Research Steering Committee decisions and actions.
7.1.6 Establishment of Research Steering Committee. The Parties
shall establish within ten (10) days after the Effective Date the Research
Steering Committee to manage, discuss, oversee, direct, and provide input with
regard to the status, progress and results of the Collaboration. Each Party
shall inform the other of its Research Steering Committee designees in writing
within such time period. The Program Coordinators shall be the co-chairs of the
Research Steering Committee. Subject to the approval of the Program
Coordinators, each Party may invite any of its employees or approved contractors
with relevant experience to attend
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
6.
and participate in Research Steering Committee meetings in a non-voting
capacity. The Program Coordinators shall jointly create written summary reports
reflecting matters discussed, input provided, decisions made and actions taken
at Research Steering Committee meetings, and such reports shall be prepared
promptly after each meeting and provided to the members of the Research Steering
Committee.
7.1.7 Method of Modification of Collaboration Research Plan. Any
modification of the Collaboration Research Plan requested by either Party,
including but not limited to Third Party licenses, shall be made in a written
proposal to the Research Steering Committee. The Research Steering Committee
will determine whether implementing the requested change will result in a delay
in the schedule for the Collaboration or have other impact on the Collaboration.
If the Research Steering Committee unanimously approves the proposed change, the
Collaboration Research Plan will be modified to reflect the change. PRI shall
have no obligation to provide additional funding for the work beyond the amounts
set forth in Schedule A without the prior written approval of PRI.
7.2 Future Collaboration, Right of First Negotiation. Not later than
[ * ], the Parties shall endeavor to agree upon the feasibility of a future
collaboration using their respective separate and/or combined technology,
including potential terms of an agreement with respect thereto, contemplated to
be entered into following completion and evaluation of the Clinical Trials and
to [ * ]. Nothing herein shall [ * ] Agreement.
7.3 Standstill. Each of the Parties agrees that [ * ] it shall not enter
into any negotiations related to a potential agreement for the purpose of
performing [ * ] without the prior written consent of the other Party. Such
negotiations and agreements do not include any Third Party agreement for the
purpose of performing the work under this Agreement.
7.4 Compliance with Laws and Regulations. PRI and Dendreon shall,
respectively, comply with all applicable laws and regulations in the performance
of this Agreement.
7.5 Confidentiality. Except as provided below, and except as provided in
Schedule C, PRI and Dendreon shall maintain the other's proprietary information
in confidence and shall not disclose it to any Third Party and shall use it only
to the extent reasonably necessary to carry out the terms of this Agreement.
Each Party may from time to time during the term of this Agreement disclose (the
"Disclosing Party") to the other Party (the "Receiving Party") certain
information not generally available to the public regarding the Disclosing
Party's business, including PRI Technology, Dendreon Technology, Developed
Technology, information relating to business plans furnished by one Party to the
other, and other information relating to the Collaboration or Field furnished by
one Party to the other in the course of the work under this Agreement
("Confidential Information"). No Confidential Information shall be disclosed to
any officer, employee, agent, or Affiliate of the Receiving Party who does not
have a need to know such information for the purposes described herein or for
conducting the business of the Receiving Party and who is not bound by a written
agreement with the Receiving Party to maintain Confidential Information in
confidence under the terms no less burdensome than those set forth herein. The
obligations set forth in this Section 7.5 shall survive for a period of five (5)
years after the termination or expiration of this Agreement.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
7.
7.5.1 Exceptions to Non-disclosure of Confidential Information. The
Receiving Party may make disclosures of Confidential Information which may be
required by law, regulation, or court or administrative order, provided that the
Receiving Party: (a) uses reasonable efforts to limit the disclosure of
Confidential Information consistent with disclosure requirements; (b) seeks to
obtain the appropriate confidential treatment or a protective order protecting
any further disclosure of Confidential Information; and (c) makes such
reasonable efforts as are reasonably practicable under the circumstances to
allow Disclosing Party to seek the opportunity to protect its Confidential
Information.
7.5.2 Exclusions from Confidential Information. The definition of
Confidential Information will exclude that which is (a) in the public domain at
the time of disclosure hereunder or which subsequently has come within the
public domain other than through breach of this Agreement by the Receiving
Party, (b) lawfully made available to the Receiving Party by an independent
party (and such lawful availability can be properly demonstrated by written
records), (c) already in the Receiving Party's possession at the time of the
initial receipt (and such prior possession can be properly demonstrated by
written records), or (d) independently developed by the Receiving Party without
use of or reliance on the Confidential Information.
7.6 Publication. Neither PRI nor Dendreon shall publish any human
clinical data relating to the Clinical Trials without the prior written consent
of the other Party. Upon such written consent, and with respect to the
publication of any other information relating to the Collaboration, the Party
intending to publish shall provide the other with a copy of the proposed
presentation or publication at least forty-five (45) days prior to submission
for publication or presentation. The Party intending to publish shall, at the
other's request, exclude or delete matter reasonably designated by the other
from the proposed publication or presentation. Notwithstanding the foregoing,
the Parties shall use reasonable efforts to ensure sufficient time prior to any
publication of any data generated during performance of the Collaboration to
allow filing of patent applications.
For Clinical Trials that are performed by a Third Party, Dendreon shall
make a reasonable effort to obtain agreement with the Third Party to not publish
the result of the Clinical Trial without the prior written consent of Dendreon.
In the event that Dendreon does not obtain such agreement with a Third Party,
the Third Party may be permitted to publish the results of the Clinical Trial
actually performed by the Third Party, provided that Dendreon will submit to PRI
drafts of all proposed publications relating to the Clinical Trials, and any
know-how or patent rights relating to such Clinical Trials, at the earliest
possible date, but in any event not less than forty-five (45) days prior to the
submission of said proposed publications for publication or presentation. PRI
shall have the right to advise Dendreon as to the patentability of any invention
disclosed therein, and to request the filing of a patent application. Dendreon
shall prepare and file any such patent application prior to the submission of
the proposed publication for publication or presentation. At the end of such
forty-five (45) day period, the Third Party shall have the right, at its sole
discretion, to submit such proposed publications for publication or
presentation, but [ * ].
Except with respect to [ * ], the foregoing limitations on publication
shall not apply to [ * ].
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
8.
7.7 Publicity. Dendreon and PRI contemplate announcing the execution and
delivery of this Agreement shortly after its signing. However, except as may be
required by law, regulation, or court or administrative order, neither Party
shall originate any publicity, news release or other public announcement or
disclosure, written or oral, whether relating to the performance under or
existence of this Agreement, without the prior written consent of the other
Party, which shall not be unreasonably withheld; provided, however, if public
disclosure is or may be required by law, regulation, or court or administrative
order, the parties shall, as is reasonably practicable under the circumstances,
consult with one another in connection with such disclosure a reasonable time
under the circumstances prior to its release to allow the other Party to comment
thereon. Notwithstanding anything else in this Section 7.7, Dendreon may, after
initial approval of any disclosure by PRI, publicly disclose thereafter such
approved information from time to time. The publicity and disclosures set forth
on Schedule C are approved by the Parties.
7.8 Trade Marks and Trade Names. Neither PRI nor Dendreon is authorized
to use the other's name or xxxx in any advertisement.
7.9 Disposition of Technology Upon Expiration or Termination of This
Agreement.
7.9.1 PRI Technology. Upon expiration or termination of this
Agreement, PRI shall solely have and retain the PRI Technology, and Dendreon
shall have no rights or interest therein.
7.9.2 Dendreon Technology. Upon expiration or termination of this
Agreement, Dendreon shall solely have and retain the Dendreon Technology, and
PRI shall have no rights or interest therein.
7.9.3 Developed Technology. Upon the expiration or termination of
this Agreement, the Parties shall identify with specificity any Developed
Technology and shall [ * ], provided however that (i) PRI shall not be permitted
to use or disclose to any Third Party Developed Technology which was directly
derived from Dendreon Technology without the express written consent of
Dendreon, and (ii) Dendreon shall not be permitted to use or disclose to any
Third Party Developed Technology which was directly derived from PRI Technology
without the express written consent of PRI.
7.10 Patents. The Parties shall [ * ] the expense of filing, prosecuting
and defending patents that claim Developed Technology. In the event of
infringement of Developed Technology by an unauthorized Third Party, the Parties
shall agree on how to xxxxx such infringement. In the event the Parties jointly
litigate any infringement of Developed Technology by a Third Party, the Parties
shall [ * ] in the expenses of such litigation and shall [ * ] in any recovery.
If the Parties do not jointly litigate any infringement of Developed Technology
by a Third Party, either Party may independently litigate such infringement at [
* ] and shall be entitled to [ * ].
7.11 Non-Solicitation of Employees. Neither PRI nor Dendreon shall
directly or indirectly, alone or in concert with others, employ or solicit for
employment any employee of the
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
9.
other Party during the term of this Agreement and for one year after the
termination or expiration thereof.
8. Generally Applicable Provisions.
8.1 Counterparts. This Agreement may be executed in counterparts.
8.2 Entire Understanding. This Agreement represents the entire
understanding between PRI and Dendreon with respect to the subject matter of
this Agreement, and supercedes any implied or expressed agreement or
understanding between them.
8.3 Force Majeure. Neither PRI nor Dendreon shall be liable for failure
to perform under this Agreement if the failure results from a cause beyond the
control of the failing party, such as an act of God, fire, strike, flood, riot
or act of war; provided, that the failing Party shall use reasonable efforts to
avoid or remove such cause, and upon removal shall resume performance.
8.4 No Assignment and Binding on Successors. Except to the extent PRI may
assign its responsibilities and rights hereunder to an Affiliate of PRI
following at least thirty (30) days prior written notice to Dendreon of PRI's
intent to do so, this Agreement and the responsibilities and rights hereunder
undertaken by and granted to the Parties may not be assigned by either Party, or
the work hereunder sub-contracted by Dendreon without the prior written consent
of the other Party, such consent not to be unreasonably withheld. This Agreement
shall be binding on the Parties' respective successors and permitted assigns.
8.5 No Partnership. This Agreement is not intended to make, and shall not
be construed to make, PRI and Dendreon the agent, partner or co-venturer of the
other.
8.6 No Waiver. Failure to enforce at any time for any period any
provision in this Agreement shall not be construed to be a waiver of such
provision or the right to enforce such provision.
8.7 Notices. Notices required by this Agreement shall be in writing and
made by first class mail, postage prepaid, or facsimile.
Notice to be given to PRI, if by mail, shall be addressed to:
The X. X. Xxxxxxx Pharmaceutical Research Institute
U.S. Xxxxx 000
Xxxxxxx, Xxx Xxxxxx 00000 Phone: 000-000-0000
Attention: Chairman, The X. X. Xxxxxxx Pharmaceutical Research
Institute
Or, if by facsimile, to Chairman, at (000) 000-0000
With a copy to:
Office of General Counsel
Xxxxxxx & Xxxxxxx
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
10.
Xxx Xxxxxxx & Xxxxxxx Xxxxx
Xxx Xxxxxxxxx, Xxx Xxxxxx 00000
Fax: 000-000-0000
Phone: 000-000-0000
Invoices should be addressed to:
The X. X. Xxxxxxx Pharmaceutical Research Institute
0000 Xxxxxxxxxx xxx
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: Xx. Xxxxxxx X. Xxxxxxx
Phone: (000) 000-0000
Notice to be given to Dendreon, if by mail, shall be addressed to:
Dendreon Corporation
0000 0xx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Phone: (000) 000-0000
Attention: Xxxxx X. Xxxxx, Executive Vice President
Or, if by facsimile, to Xxxxx X. Xxxxx at (000) 000-0000.
8.8 Surviving Provisions. Sections 5.8, 5.9, 5.10, 5.11, 6.4, 6.6, 6.7,
7.5, 7.6, 7.7, 7.9.3, 7.10, 7.11, 8.7, 8.8, and 10 shall survive the expiration
or termination of this Agreement.
9. Procedure Upon Default. The failure of a Party to pay any amounts when due
hereunder or the failure of a Party to perform any obligation required of it to
be performed hereunder, and the failure to cure within sixty (60) days after
receipt of written notice from the other Party specifying in reasonable detail
the nature of such default, shall be considered an event of default hereunder.
Upon the occurrence of an event of default and the failure to cure during the
sixty (60) days after receipt of notice, either Party may deliver to the other
Party written notice of intent to invoke the provisions of Section 10.
9.1 Termination by PRI. PRI shall have the right to terminate this
Agreement if the result of the arbitration is that there has been a material
breach by Dendreon, by providing written notice of such termination to Dendreon.
Any payment obligations of PRI that have accrued prior to the date of such
notice of termination shall be paid by PRI. PRI shall not be obligated to make
any payments to Dendreon that would accrue after the receipt by Dendreon of
PRI's termination notice.
9.2 Termination by Dendreon. Dendreon shall have the right to terminate
this Agreement, if the result of the arbitration is that there has been a
material breach by PRI, by providing written notice of such termination to PRI.
Any performance obligations of Dendreon that have accrued prior to the date of
such notice of termination shall be completed by Dendreon. Dendreon shall not
have any performance obligations to PRI after the receipt by PRI of Dendreon's
termination notice.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
11.
10. Dispute Resolution and Governing Law. Should any dispute between the
parties arise under this Agreement, PRI and Dendreon, through appropriately
senior persons, shall first meet and attempt to resolve the dispute in face-to-
face negotiations. This meeting shall occur within 30 days after written notice
of a dispute is received by either Party from the other Party.
If no resolution is reached through negotiation, PRI and Dendreon shall,
within 45 days after the first meeting, attempt to settle the dispute by formal
mediation. If the parties cannot agree upon a mediator and the place of
mediation, the mediation shall be administered by the American Arbitration
Association in Seattle, Washington.
If no resolution is reached in mediation, the dispute shall be resolved by
binding arbitration before one arbitrator, administered by the American
Arbitration Association, in accordance with its Commercial Arbitration Rules,
with limited discovery. The arbitrator shall be an attorney who has at least 15
years of experience with a law firm or corporate law department of over 25
lawyers or was a judge of a court of general jurisdiction. The arbitrator shall
issue an award no more than three months after selection of the arbitrator.
The venue and the governing law shall be in and that of San Diego,
California and the State of California, without giving effect to conflict of law
considerations, or Seattle, Washington and the State of Washington, without
giving effect to conflict of law considerations, at the instance of the Party
which is the respondent in the first notice of intent to arbitrate. In no event
shall punitive or exemplary damages, pre-judgment interest, or attorney's fees
be awardable.
Notwithstanding the foregoing dispute resolution and governing law
provisions, PRI and Dendreon shall each retain the right to seek judicial
injunctive and other equitable relief where appropriate.
In Witness Whereof, the Parties have caused this Agreement to be executed
as of the Effective Date.
The X.X. Xxxxxxx Pharmaceutical Dendreon Corporation
Research Institute, a division of
Ortho-XxXxxx Pharmaceutical, Inc.
By: /s/ Per X. Xxxxxxxx By: /s/ Xxxxx X. Xxxxx
------------------------------ --------------------------------
Name: Per X. Xxxxxxxx, M.D., Ph.D. Name: Xxxxx X. Xxxxx, Ph.D.
---------------------------- ------------------------------
Title: President Title: Executive Vice President
--------------------------- -----------------------------
Date: October 6, 2000 Date: October 5, 2000
--- ---
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
12.
Schedule A
XX XXXXXXX PHARMACEUTICAL RESEARCH INSTITUTE (PRI) AND
DENDREON CORPORATION (DENDREON)
COLLABORATION RESEARCH PLAN
[ * ]
(Five pages of text omitted here)
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
A-1.
Schedule B-1
DENDREON PATENTS
[ * ]
(Five page chart omitted here)
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
B1-1.
Schedule B-2
PRI PATENTS
[ * ]
(One page chart omitted here)
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
B2-1.
Schedule C
The following publicity and disclosures are approved:
1. Statement for filing with the U.S. Securities and Exchange Commission in
substantially the form and content attached.
2. Press release in substantially the form and content attached.
3. Reference in Dendreon's web site to this Agreement in substantially the
content of the SEC statement referred to in 1 above and the press release
referenced to in 2 above.
4. Reference in Dendreon's company fact sheets to this Agreement in
substantially the content of the SEC statement referred to in 1 above and
the press release referred to in 2 above.
5. Oral and graphic reference in industry and professional presentations and
presentations and communications with investors, potential investors and
analysts to this Agreement in substantially the content of the SEC
statement referred to in 1 above and the press release referenced to in 2
above.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
1.
SEC STATEMENT
September 29, 2000
On October ____, 2000 we entered into a Research Collaboration And License
Agreement with The X.X. Xxxxxxx Pharmaceutical Institute (PRI), a division of
Ortho-XxXxxx Pharmaceutical, Inc.
The agreement provides for studies of PRI technology and of our technology
to determine their respective feasibility as immunotherapy products for the
treatment of a variety of cancers, including breast, ovarian, and colorectal
cancers. The research plan, covering a defined territory and field, will be
performed jointly by Dendreon and PRI. It will involve at least two Phase I
clinical trials of human subjects performed by Dendreon.
Under the agreement, PRI will pay us a study fee and a milestone payment at
the initiation of clinical trials under our Investigational New Drug
application, to be filed with the U.S. Food and Drug Administration, for
APC8024, our proprietary antigen activated dendritic cell product. The agreement
also provides in part that PRI will fund the research plan by paying us for our
research effort. PRI will receive exclusive access to the work and its results
and an exclusive right to negotiate with us during the term of the agreement
regarding further activities in the territory and field covered by the
agreement.
The agreement provides that during the course of this collaboration, PRI
and we will endeavor to agree upon terms for future collaboration using PRI's
and our respective separate and/or combined technologies.
Work under the agreement is scheduled to begin in 2000.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
2.
Xxxxx Xxxxxxx
Communications/Investor Relations
(206) 256-4545 ext. 1500
xxxxxxxx@xxxxxxxx.xxx
Dendreon Announces Collaboration with The X.X. Xxxxxxx Pharmaceutical Research
Institute in Development of Immunotherapy for Cancer
- leader in cancer vaccines to advance research and development activities
Seattle, WA (October 2000) - Dendreon Corporation (Nasdaq: DNDN) today
announced the signing of a strategic collaboration agreement for the advancement
of cancer immunotherapies with The X.X. Xxxxxxx Pharmaceutical Research
Institute (PRI), a member of the Xxxxxxx & Xxxxxxx family of companies (NYSE:
JNJ).
The Collaboration will provide the opportunity for Dendreon and PRI to pool
products and technologies to develop optimal immunotherapies, including
dendritic cell-based vaccine therapy for the treatment of a variety of cancers,
including breast, ovarian and colorectal cancers. The collaboration will also
involve a pooling of products and technologies which may be developed by the
companies.
"PRI is a strong partner for Dendreon Corporation," said Xxxxx Xxxxx, Ph.D.,
Chief Scientific Officer of Dendreon. "PRI's innovation in biotechnology,
coupled with Dendreon's leadership in the cancer immunotherapy arena, provides a
significant validation for this important area of clinical development and a
strong groundwork for our future research and development activities."
Under the terms of the agreement, PRI will provide financial support for
research and development activities to be carried out by Dendreon. Dendreon will
also be responsible for clinical testing.
Immunotherapy treatments aim to harness the natural power of the immune system
to fight against diseases such as cancer. Avoiding the harsh side effects
associated with other forms of treatment, immunotherapies may offer new hope to
patients.
Dendreon Corporation (xxx.xxxxxxxx.xxx) is dedicated to the discovery and
development of novel products for the treatment of cancer through its innovative
manipulation of the immune system. Dendreon is focused on the development of
therapeutic cancer vaccines through the use of antigen discovery, antigen
engineering and dendritic cell technologies. Dendreon's vaccine for the
treatment of prostate cancer, Provenge(TM), is in Phase III clinical trials and
its vaccine for the treatment of multiple myeloma, Mylovenge(TM), is in Phase II
clinical trials.
Except for historical information contained herein, this news release contains
forward-looking statements that are subject to risks and uncertainties that may
cause actual results to differ materially from the results discussed in the
forward-looking statements, particularly those inherent in the process of
discovering, developing and commercializing drugs that are safe and effective
for use as human therapeutics. Factors that may cause such a difference include
risks
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
3.
related to Dendreon's limited operating history, risks associated with
completing our clinical trials, and dependence on the efforts of third parties,
and our dependence on intellectual property. Further information on the factors
and risks that could affect Dendreon's business, financial condition and results
of operations, are contained in Dendreon's SEC Reports, including Dendreon's
Form 10-Q and Form S-1 Registration Statement, No. 333-31920, which are
available at xxx.xxx.xxx.
# # #
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
4.
