CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO CERTAIN PORTIONS OF
THIS EXHIBIT PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT FILED WITH
THE COMMISSION UNDER RULE 24b-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
COLLABORATIVE ALLIANCE AGREEMENT
THIS COLLABORATIVE ALLIANCE AGREEMENT (the "Agreement") is made as of
June 26, 1998 (the "Effective Date") by and between GENEMEDICINE, INC., a
Delaware corporation ("GENEMEDICINE"), and BIOJECT, INC., an Oregon corporation
("BIOJECT").
RECITALS
WHEREAS, GENEMEDICINE possesses substantial experience and expertise
in gene delivery and gene expression;
WHEREAS, BIOJECT possesses substantial experience and expertise in the
discovery, design and development of needle-free injection devices for the
administration of prophylactic and therapeutic products;
WHEREAS, GENEMEDICINE and BIOJECT wish to engage in a [* * *]
collaborative alliance to validate and co-promote BIOJECT's needle-free
injection devices in combination with GENEMEDICINE's proprietary gene delivery
systems, to seek patent protection for such combined devices and delivery
systems, and to develop and commercialize prophylactic and therapeutic,
non-viral genetic vaccine products using such combined devices and delivery
systems;
WHEREAS, GENEMEDICINE and BIOJECT wish to enter into this Agreement to
establish such collaborative alliance on the terms and subject to the conditions
set forth herein.
NOW, THEREFORE, in consideration of the foregoing recitals and the
mutual covenants and agreements contained herein, the parties hereto, intending
to be legally bound, do hereby agree as follows:
AGREEMENT
ARTICLE 1
DEFINITIONS
1.1 "Affiliate" means an individual, trust, business trust, joint
venture, partnership, corporation, association or any other entity which owns,
is owned by or is under common ownership with a party. For the purposes of this
definition, the term "owns" (including, with correlative meanings, the terms
"owned by" and "under common ownership with") as used with respect to any party,
shall mean the possession (directly or indirectly) of more than 50% of the
outstanding voting securities of a corporation or comparable equity interest in
any other type of entity.
1.2 "BIOJECT Know-How" means all Know-How which is not covered by the
BIOJECT Patent Rights but is necessary or appropriate to develop, manufacture
and commercialize Products in the Field, and which is under the Control of
BIOJECT as of the Effective Date or during the Term, including, without
limitation, Know-How covering BIOJECT's Dermal Devices, Biojectors and other
proprietary NFIDs.
1.3 "BIOJECT Patent Rights" means all Patent Rights necessary or
appropriate to develop, manufacture and commercialize Products in the Field,
which are under the Control of BIOJECT as of the Effective Date or during the
Term, including, without limitation, Patent Rights covering BIOJECT's Dermal
Devices, Biojectors and other proprietary NFIDs, but excluding the Joint Patent
Rights. The BIOJECT Patent Rights as of the Effective Date are set forth on
Exhibit A.
1.4 "BIOJECT Technology" means the BIOJECT Patent Rights and the
BIOJECT Know-How.
1.5 "Biojector" means any BIOJECT NFID designed and used for the
intra-muscular and/or subcutaneous administration of therapeutic products.
1.6 "Collaborative Alliance" means the activities of the parties
carried out in performance of, and the relationship between the parties
established by, this Agreement.
1.7 "Confidential Information" means any confidential information
(including information related to the GENEMEDICINE Technology, the BIOJECT
Technology or any information generated during the course of the Collaborative
Alliance) of a party relating to any use, process, method, compound, research
project, work in process, future development, scientific, engineering,
manufacturing, marketing, business plan, financial or personnel matter relating
to the disclosing party, its present or future products, sales, suppliers,
customers, employees, investors or business, whether in oral, written, graphic
or electronic form. Confidential Information shall not include any information
which the receiving party can prove by competent and contemporaneous written
evidence:
(a) is now, or hereafter becomes, through no act or failure to
act on the part of the receiving party, generally known or available;
(b) is known by the receiving party at the time of receiving such
information, as evidenced by its records;
(c) is hereafter furnished to the receiving party by a Third
Party, as a matter of right and without restriction on disclosure;
(d) is independently developed by the receiving party without
knowledge of, and without the aid, application or use of, the disclosing party's
Confidential Information; or
(e) is the subject of a written permission to disclose provided
by the disclosing party.
1.8 "Contributed Technology" means the GENEMEDICINE Technology or the
BIOJECT Technology, as applicable.
1.9 "Control" means possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party.
1.10 "Corporate Partner" means any company or entity that has
therapeutic or prophylactic product revenues in excess of [* * *] per year.
1.11 "Dermal Device" means any NFID that primarily reproducibly
delivers a drug or drug formulation to the dermis/epidermis.
1.12 "Direct Competitor" means any corporation or entity that is a
direct competitor of GENEMEDICINE in the Field, as set forth on a list developed
by the parties pursuant to Section 4.3 and approved by the Steering Committee
from time to time during the Term.
1.13 "Field" means therapeutic and prophylactic, non-viral genetic
vaccine applications.
1.14 "Gene Delivery System" means any gene delivery system composed of
one or more of the following elements: polymers, cationic lipids, targeting
ligands and endosomal release peptides that control the stability, distribution,
access, recognition, uptake and intracellular trafficking of a plasmid by a
target cell.
1.15 "GENEMEDICINE Know-How" means all Know-How which is not covered
by the GENEMEDICINE Patent Rights but is necessary or appropriate to develop,
manufacture and commercialize Products in the Field, and which is under the
Control of GENEMEDICINE as of the Effective Date or during the Term, including,
without limitation, Know-How covering GENEMEDICINE's proprietary Gene Delivery
Systems.
1.16 "GENEMEDICINE Patent Rights" means all Patent Rights necessary or
appropriate to develop, manufacture and commercialize Products in the Field,
which are under the Control of GENEMEDICINE as of the Effective Date or during
the Term, including, without limitation, Patent Rights covering GENEMEDICINE's
proprietary Gene Delivery Systems, but excluding the Joint Patent Rights. The
GENEMEDICINE Patent Rights as of the Effective Date are set forth on Exhibit B.
1.17 "GENEMEDICINE Technology" means the GENEMEDICINE Patent Rights
and the GENEMEDICINE Know-How.
1.18 "Joint Patent Rights" means all Patent Rights covering all
inventions conceived of and reduced to practice during the Term jointly by
employees or agents of BIOJECT and employees or agents of GENEMEDICINE.
1.19 "Know-How" means all know-how, trade secrets, inventions, data,
processes, techniques, procedures, compositions, devices, methods, formulas,
protocols and information, whether or not patentable, which are not generally
publicly known, including, without limitation, all chemical, biochemical,
toxicological, and scientific research information.
1.20 "NFID" means any needle-free injection device that relates to an
apparatus that is capable of injecting material through and/or to the skin of a
mammal into the tissue by gas and/or mechanical pressure.
1.21 "Patent Rights" means all rights under patents and patent
applications, and any and all patents issuing therefrom (including utility,
model and design patents and certificates of invention), together with any and
all substitutions, extensions (including supplemental protection certificates),
registrations, confirmations, reissues, divisionals, continuations,
continuations-in-part, re-examinations, renewals and foreign counterparts of the
foregoing.
1.22 "Product" means any product comprised of a NFID and a Gene
Delivery System, which is covered by, based on or incorporates both GENEMEDICINE
Technology and BIOJECT Technology.
1.23 "Steering Committee" means the committee established pursuant to
Section 3.1.
1.24 "Term" has the meaning set forth in Section 10.1.
1.25 "Third Party" means any entity other than GENEMEDICINE or BIOJECT
or an Affiliate of GENEMEDICINE or BIOJECT.
ARTICLE 2
SCOPE OF COLLABORATIVE ALLIANCE
2.1 Objectives. During the Term, GENEMEDICINE and BIOJECT will
participate in a [* * *] collaborative alliance to validate and co-promote
BIOJECT's needle-free injection devices in combination with GENEMEDICINE's
proprietary gene delivery systems, to seek patent protection for such combined
devices and delivery systems, and to develop and commercialize prophylactic and
therapeutic, non-viral genetic vaccine products using such combined devices and
delivery systems. Each party will utilize the Contributed Technology to develop
Products in the Field. Products developed under the Collaborative Alliance are
intended to be commercialized by Corporate Partners, in accordance with the
terms and conditions set forth herein.
2.2 [* * *].
(a) During the Term and subject to Section 2.2(b), GENEMEDICINE
hereby agrees that it will not [* * *] a [* * *] using any [* * *] with
GENEMEDICINE's [* * *] in the [* * *]. Notwithstanding the foregoing, in the
event a [* * *] decides to [* * *] (rather than a [* * *]) for a particular
indication (e.g. [* * *]), (i) GENEMEDICINE shall have the right to [* * *] a [*
* *] with such [* * *] to use such [* * *] with GENEMEDICINE's [* * *] for such
indication, and (ii) if GENEMEDICINE [* * *] to any of its [* * *] to such [* *
*] for such indication, BIOJECT shall have the right to [* * *] a [* * *] with a
[* * *], including a [* * *], to use [* * *] with a [* * *] for such indication.
(b) During the Term and subject to Section 2.2(a), BIOJECT hereby
agrees that it will not [* * *] a [* * *] with any [* * *] in the [* * *].
Notwithstanding the foregoing, (i) BIOJECT may [* * *] a [* * *] with a [* * *]
who has an [* * *] established prior to the Effective Date with a [* * *], or
(ii) in the event a [* * *] decides to use either its own [* * *] or a [* * *]
(rather than a [* * *]) for a particular indication, (A) BIOJECT shall have the
right to [* * *] a [* * *] with such [* * *] to use such [* * *] or [* * *] with
[* * *] for such indication, and (B) if BIOJECT [* * *] to its [* * *] to such
[* * *] for such indication, GENEMEDICINE shall have the right to [* * *] a [* *
*] with a [* * *] to use [* * *] with a [* * *] for such indication.
(c) For the avoidance of doubt, it is understood by both parties
that, before either party may [* * *] with a [* * *] (other than a [* * *]) that
has or is contemplating [* * *] in the [* * *], such party must present
information regarding such [* * *] and [* * *] to, and receive approval by, the
Steering Committee.
(d) Neither party shall be entitled to use the Contributed
Technology of the other party in connection with the business relationships
contemplated under this Section 2.2. Notwithstanding the foregoing, except as
specifically provided herein, all activities of the parties outside of the
Collaborative Alliance are outside of the scope of this Agreement, and nothing
herein is intended to limit GENEMEDICINE or its Affiliates from using the
GENEMEDICINE Technology and any Joint Patent Rights or BIOJECT or its Affiliates
from using the BIOJECT Technology and any Joint Patent Rights for other
purposes.
ARTICLE 3
STEERING COMMITTEE
3.1 Formation. The activities of the parties under the Collaborative
Alliance shall be managed by the Steering Committee, which shall be comprised of
two representatives appointed by GENEMEDICINE and two representatives appointed
by BIOJECT. Such representatives shall be senior members of management from each
of the parties. Either party may appoint substitute or replacement members of
the Steering Committee to serve as their representatives upon notice to the
other party. The Steering Committee shall oversee the activities of the parties
under the Collaborative Alliance and shall have the responsibility and authority
to (a) coordinate and monitor the progress of the Collaborative Alliance, (b)
encourage and facilitate communication, cooperation and technology integration
between the parties in the performance of the Collaborative Alliance, (c)
coordinate promotional efforts of the parties to identify, contact and negotiate
with Corporate Partner candidates, (d) determine from time to time during the
Term if any corporation or entity is a Direct Competitor, and (e) evaluate and
approve additional animal and/or human studies that may be financed jointly by
GENEMEDICINE and BIOJECT in the course of the Collaborative Alliance.
3.2 Meetings. The Steering Committee will initially meet at least
three times per year at locations and times to be determined by the Steering
Committee, with the intent of meeting at alternating locations in The Woodlands,
Texas and Portland, Oregon, with each party to bear all travel and related costs
for its representatives. Each meeting shall be chaired by a Steering Committee
member from the host party.
3.3 Decision-Making Process. Each member of the Steering Committee
shall have one vote, and decisions by the Steering Committee shall be made by a
majority vote. Any disagreement among members of the Steering Committee will be
resolved within the Steering Committee based on the efficient achievement of the
objectives of this Agreement. Any disagreement which cannot be resolved by a
majority vote of the Steering Committee shall be referred to the Chief Executive
Officer or President of each of GENEMEDICINE and BIOJECT for resolution under
Article 12. It is the intent of the parties to resolve issues through the
Steering Committee whenever possible and to refer issues to the Chief Executive
Officer or President of each of GENEMEDICINE and BIOJECT only when resolution
through the Steering Committee cannot be achieved. In particular, in the event
the Steering Committee fails to reach a decision as to whether a corporation or
entity is a Direct Competitor, the Chief Executive Officer or President of each
of GENEMEDICINE and BIOJECT shall render a definitive decision within 10
business days after being notified that the Steering Committee has failed to
reach a decision.
ARTICLE 4
ACTIVITIES UNDER THE COLLABORATIVE ALLIANCE
4.1 GENEMEDICINE Contributions. Unless otherwise agreed upon by the
Steering Committee, GENEMEDICINE will conduct, at its own expense, animal
studies involving BIOJECT's NFIDs (including Dermal Devices and Biojectors) in
combination with GENEMEDICINE's proprietary Gene Delivery Systems. GENEMEDICINE
will own all data generated from these studies, which shall be considered
Confidential Information of GENEMEDICINE, but will disclose such data to BIOJECT
solely for the purpose of entering into collaborative business relationships
with Third Parties in accordance with this Agreement.
4.2 BIOJECT Contributions. BIOJECT will supply to GENEMEDICINE NFIDs
(including Dermal Devices and Biojectors) and associated reagents and supplies,
at no cost to GENEMEDICINE, to perform animal studies under the Collaborative
Alliance. BIOJECT will use commercially reasonable and diligent efforts, at its
expense, to assist GENEMEDICINE in the development and enhancement of BIOJECT
NFIDs that are compatible with GENEMEDICINE's proprietary Gene Delivery Systems
(e.g. no or minimal DNA shearing and reproducible performance).
4.3 Initial Meeting. Within 30 business days following the Effective
Date, representatives from each party shall meet at GENEMEDICINE's offices in
The Woodlands, Texas to (a) develop a patent strategy for the Contributed
Technology and (b) develop a list of companies considered Direct Competitors. It
is understood that the list of Direct Competitors may be revised from time to
time to reflect the appropriate Direct Competitors and that the Steering
Committee is responsible for approving any modification to the list of Direct
Competitors.
4.4 [* * *]. GENEMEDICINE will conduct a [* * *] the [* * *] to a [* *
*] known as the [* * *]. GENEMEDICINE and BIOJECT will share equally the costs
and expenses of such [* * *], and will own jointly the [* * *] from the such [*
* *]. The total cost of such [* * *] shall not exceed [* * *].
4.5 Additional Studies. GENEMEDICINE will conduct any additional
animal and/or human studies in the course of the Collaborative Alliance approved
in writing by GENEMEDICINE and BIOJECT. GENEMEDICINE and BIOJECT will share
equally the costs and expenses of any such additional studies, and will own
jointly the data generated from any such studies.
4.6 Funding. Each party will bear all of its own costs and expenses
with respect to the activities performed by such party pursuant to the
Collaborative Alliance (e.g. promotional efforts, manufacture of plasmids and
formulated plasmids, NFIDs and patent costs).
4.7 Mutual Responsibilities; Cooperation. Each party shall use
commercially reasonable and diligent efforts to perform its responsibilities
under the Collaborative Alliance. As used herein, the term "commercially
reasonable and diligent efforts" will mean, unless the parties agree otherwise,
those efforts consistent with the exercise of prudent scientific and business
judgment, as applied to other products of similar scientific and commercial
potential within the relevant product lines of the parties. Upon reasonable
advance notice, each party agrees to make its employees and non-employee
consultants reasonably available at their respective places of employment to
consult with the other party on issues arising during the Collaborative Alliance
and in connection with any request from any regulatory agency, including,
without limitation, regulatory, scientific, technical and clinical testing
issues.
4.8 Availability of Resources. Each party will maintain laboratories,
offices and all other facilities reasonably necessary to carry out the
activities to be performed by such party pursuant to the Collaborative Alliance.
4.9 Disclosure; Reports. Each party shall make available and disclose
to the other party promptly after the Effective Date all GENEMEDICINE Know-How
or BIOJECT Know-How, as applicable, known by such party as of the Effective
Date. During the Term, (a) each party will share all research data and results
with the other party promptly after such data and results become available, and
(b) the parties will exchange, at a minimum, quarterly written reports (with
copies to the Steering Committee) presenting a meaningful summary of the
activities performed by such party pursuant to the Collaborative Alliance. In
addition, on reasonable request by a party, the other party shall make
presentations of its activities under this Agreement to inform such party of the
details of the work performed under this Agreement during the Term. Know-How and
other information disclosed by one party to the other party pursuant hereto may
be used only in accordance with the rights granted under this Agreement.
ARTICLE 5
GRANT OF LICENSES
5.1 Research License to BIOJECT. Subject to the terms and conditions
of this Agreement and during the Term, GENEMEDICINE grants to BIOJECT a
royalty-free, worldwide, non-exclusive, non-sublicensable, non-transferable
license under the GENEMEDICINE Technology for the sole purpose of performing its
duties and obligations under the Collaborative Alliance.
5.2 Research License to GENEMEDICINE. Subject to the terms and
conditions of this Agreement and during the Term, BIOJECT grants to GENEMEDICINE
a royalty-free, worldwide, non-exclusive, non-sublicensable, non-transferable
license under the BIOJECT Technology for the sole purpose of performing its
duties and obligations under the Collaborative Alliance.
ARTICLE 6
CORPORATE PARTNERING
6.1 Co-Promotion. The parties agree to co-promote Products in the
Field resulting from the Collaborative Alliance to Corporate Partners. To this
end, the parties will use commercially reasonable and diligent efforts to
identify, contact and negotiate with Corporate Partners. The Steering Committee
shall direct and coordinate such efforts of the parties. The parties will use
commercially reasonable and diligent efforts to ensure that joint presentations
are provided to each Corporate Partner. In the event that a party is unable to
attend a presentation to a Corporate Partner, such party's role in the
Collaborative Alliance will be acknowledged during the presentation. BIOJECT and
GENEMEDICINE will develop a mutually acceptable standard promotional package
that either party may present to a Corporate Partner.
6.2 Business Proposals; Negotiations. Following the presentation
described in Section 6.1 and upon request by a Corporate Partner for a business
proposal relating to a Product in the Field, [* * *] shall (a) [* * *] a
business proposal to present to such Corporate Partner, (b) submit such business
proposal to such Corporate Partner, and (c) [* * *] with such Corporate Partner
[* * *]; provided, however, that (i) [* * *] all negotiations with such
Corporate Partner, and (ii) any agreement with a Corporate Partner that [* * *]
shall be subject to [* * *]. Under all circumstances, the terms and conditions
of any agreement to be entered into by the parties with a Corporate Partner will
be subject to the approval of both parties. In any event, the parties agree to
evaluate in good faith each negotiation and to devise a negotiating strategy
that is mutually acceptable to the parties.
6.3 [* * *]. The parties anticipate that each party's [* * *] will be
licensed to a Corporate Partner as [* * *]. However, subject to Section 2.2, in
the event that a Corporate Partner [* * *] of [* * *], [* * *] may negotiate and
enter into a business relationship with such Corporate Partner with respect to
[* * *].
6.4 BIOJECT Support Services. In the event any of BIOJECT's NFIDs
(including Dermal Devices and Biojectors) are sold to, or purchased by, a
Corporate Partner for use with GENEMEDICINE's proprietary Gene Delivery Systems,
BIOJECT shall provide support services, at its expense, to GENEMEDICINE in
accordance with BIOJECT's standard practices.
ARTICLE 7
PATENT RIGHTS AND INFRINGEMENT
7.1 Ownership of Patent Rights. Ownership of inventions conceived of
or reduced to practice in the course of the Collaborative Alliance shall be
determined in accordance with the rules of inventorship under United States
patent laws. BIOJECT shall own all BIOJECT Technology and all inventions
conceived of and reduced to practice in the course of the Collaborative Alliance
during the Term solely by its employees and agents, and all patent applications
and patents claiming such inventions. GENEMEDICINE shall own all GENEMEDICINE
Technology and all inventions conceived of and reduced to practice in the course
of the Collaborative Alliance during the Term solely by its employees and
agents, and all patent applications and patents claiming such inventions. All
Joint Patent Rights shall be owned jointly by BIOJECT and GENEMEDICINE;
provided, however, that, during the Term, BIOJECT shall not license to any
Direct Competitor any Joint Patent Rights claiming methods of use of a NFID
conceived of or reduced to practice in the course of the Collaborative Alliance.
7.2 Prosecution and Maintenance of Patent Rights.
(a) GENEMEDICINE shall be responsible, at its own expense, for
the filing, prosecution and maintenance of all patent applications and patents
within the GENEMEDICINE Patent Rights and any inventions conceived of and
reduced to practice in the course of the Collaborative Alliance during the Term
solely by its employees and agents. BIOJECT shall be responsible, at its own
expense, for the filing, prosecution and maintenance of all patent applications
and patents within the BIOJECT Patent Rights and any inventions conceived of and
reduced to practice in the course of the Collaborative Alliance during the Term
solely by its employees and agents. Each party shall consider in good faith the
requests and suggestions of the other party with respect to strategies for
filing, prosecuting and maintaining such patent applications and patents. The
inventing party shall keep the other party informed of progress with regard to
the filing, prosecution, maintenance, enforcement and defense of patents
applications and patents subject to this Section 7.2(a). In the event that
either party desires to abandon any patent application or patent within the
Patent Rights of such party, or if such party later declines responsibility for
any such patent application or patent, such party shall provide reasonable prior
written notice to the other party of such intention to abandon or decline
responsibility, and the other party shall have the right, at its own expense, to
file, prosecute, and maintain such patent application or patent.
(b) The Steering Committee shall determine which party shall be
responsible for the filing, prosecution and maintenance of patent applications
and patents within the Joint Patent Rights on a case by case basis, with the
understanding that it is the parties' intent that GENEMEDICINE will be
responsible for the filing, prosecution and maintenance of patent applications
and patents within the Joint Patent Rights related to gene delivery and gene
expression and BIOJECT will be responsible for the filing, prosecution and
maintenance of patent applications and patents within the Joint Patent Rights
related to NFIDs. In the event that a party responsible for the filing,
prosecution and maintenance of any patent application or patent within the Joint
Patent Rights desires to abandon such patent application or patent, or if such
party later declines responsibility for such patent application or patent, such
party shall provide reasonable prior written notice to the other party of its
intention to abandon or decline responsibility, and the other party shall have
the right, but not the obligation, to prepare, file, prosecute, and maintain any
such patent application or patent within the Joint Patent Rights. The parties
shall share equally the costs of filing, prosecuting and maintaining patents or
patent applications within the Joint Patent Rights.
7.3 Cooperation of the Parties. Each party agrees to cooperate fully
in the preparation, filing, and prosecution of any Patent Rights under this
Agreement. Such cooperation includes, but is not limited to:
(a) executing all papers and instruments, or requiring its
employees or agents, to execute such papers and instruments, so as to effectuate
the ownership of Patent Rights set forth in Section 7.1 and to enable the other
party to apply for and to prosecute patent applications in any country; and
(b) promptly informing the other party of any matters coming to
such party's attention that may affect the preparation, filing, or prosecution
of any such patent applications.
7.4 Enforcement Rights.
(a) Infringement of Third Party Rights. GENEMEDICINE and BIOJECT
shall promptly notify the other in writing of any allegation by a Third Party
that the activity of either of the parties in connection with the Collaborative
Alliance infringes or may infringe the intellectual property rights of such
Third Party. GENEMEDICINE shall have the right to control the defense of any
claims with respect to the GENEMEDICINE Technology at its own expense and by
counsel of its own choice. BIOJECT shall have the right to control the defense
of any claims with respect to the BIOJECT Technology at its own expense and by
counsel of its own choice. In the event that such matter includes claims with
respect to the Joint Patent Rights, the party responsible for prosecution and
maintenance of the applicable Joint Patent Rights under Section 7.2(b) shall
have the right to control the defense of such claims by counsel of its own
choice and the parties shall share equally the costs with respect thereto. If
either party fails to proceed in a timely fashion with regard to the defense of
any claims with respect to the Contributed Technology, the other party shall
have the right to control any such defense of such claim at its own expense and
by counsel of its own choice, and such party shall have the right, at its own
expense, to be represented in any such action by counsel of its own choice.
Neither party shall have the right to settle any patent infringement litigation
under this Section 7.4(a) in a manner that diminishes the rights or interests of
the other party or obligates the other party to make any payment or take any
action without the consent of such other party.
(b) Infringement by Third Parties. GENEMEDICINE and BIOJECT shall
promptly notify the other in writing of any alleged or threatened infringement
of any patent included in the GENEMEDICINE Patent Rights, the BIOJECT Patent
Rights or the Joint Patent Rights of which they become aware. GENEMEDICINE shall
have the right to institute, prosecute and control any action or proceeding with
respect to infringement of any patent included in the GENEMEDICINE Patent Rights
at its own expense and by counsel of its own choice. BIOJECT shall have the
right to institute, prosecute and control any action or proceeding with respect
to infringement of any patent included in the BIOJECT Patent Rights at its own
expense and by counsel of its own choice. In the event any patent included in
the Joint Patent Rights is infringed by a Third Party, the party responsible for
prosecution and maintenance of the applicable Joint Patent Rights under Section
7.2(b) shall have the right to institute, prosecute and control any action or
proceeding with respect to such patent, and the parties shall share equally in
the expenses thereof. With respect to infringement of any patent included in the
Patent Rights of either party, if such party fails to bring an action or
proceeding within (a) 60 days following the notice of alleged infringement or
(b) 10 days before the time limit, if any, set forth in the appropriate laws and
regulations for the filing of such actions, whichever comes first, the other
party shall have the right to bring and control any such action at its own
expense and by counsel of its own choice, and such party shall have the right,
at its own expense, to be represented in any such action by counsel of its own
choice. In the event a party brings an infringement action, the other party
shall cooperate fully, including if required to bring such action, the
furnishing of a power of attorney. Neither party shall have the right to settle
any patent infringement litigation under this Section 7.4(b) in a manner that
diminishes the rights or interests of the other party without the consent of
such other party. Except as otherwise agreed to by the parties as part of a cost
sharing arrangement, any recovery realized as a result of such litigation, after
reimbursement of any litigation expenses of GENEMEDICINE and BIOJECT, shall
belong to the party who brought the action.
ARTICLE 8
CONFIDENTIALITY; PUBLICATIONS
8.1 Nondisclosure. During the Term and for a period of three years
thereafter, each party shall maintain all Confidential Information of the other
party as confidential and shall not disclose any such Confidential Information
to any Third Party or use any such Confidential Information for any purpose,
except (a) as expressly authorized by this Agreement, (b) as required by law,
rule, regulation or court order (provided that the disclosing party shall use
commercially reasonable efforts to obtain confidential treatment of any such
information required to be disclosed), or (c) to its Affiliates, employees,
agents, consultants and other representatives to accomplish the purposes of this
Agreement, so long as such persons are under an obligation of confidentiality no
less stringent than as set forth herein. Each party may use such Confidential
Information only to the extent required to accomplish the purposes of this
Agreement. Each party shall use at least the same standard of care as it uses to
protect its own Confidential Information to ensure that its Affiliates,
employees, agents, consultants and other representatives do not disclose or make
any unauthorized use of the other party's Confidential Information. Each party
will promptly notify the other party upon discovery of any unauthorized use or
disclosure of the other party's Confidential Information.
8.2 Publications. Each party recognizes that the publication of papers
regarding results of the research and development activities performed pursuant
to the Collaborative Alliance, including oral presentations and abstracts, may
be beneficial to both parties provided such publications are subject to
reasonable controls to protect Confidential Information. In particular, it is
the intent of the parties to maintain the confidentiality of any Confidential
Information included in any foreign patent application until such foreign patent
application has been published. Accordingly, each party shall have the right to
review and approve any paper proposed for publication by the other party,
including oral presentations and abstracts, which utilizes data generated from
the Collaborative Alliance and/or includes Confidential Information of the other
party. Before any such paper is submitted for publication, the party proposing
publication shall deliver a complete copy to the other party at least 45 days
prior to submitting the paper to a publisher. The receiving party shall review
any such paper and give its comments to the publishing party within 30 days of
the delivery of such paper to the receiving party. With respect to oral
presentation materials and abstracts, the parties shall make reasonable efforts
to expedite review of such materials and abstracts, and shall return such items
as soon as practicable to the publishing party with appropriate comments, if
any, but in no event later than 30 days from the date of delivery to the
receiving party. The publishing party shall comply with the other party's
request to delete references to such other party's Confidential Information in
any such paper and agrees to withhold publication of same for an additional 180
days to permit the parties to obtain patent protection, if either of the parties
deem it necessary, in accordance with the terms of this Agreement.
Notwithstanding the foregoing, GENEMEDICINE shall have the right to present and
publish all studies using a NFID performed prior to the Effective Date, and
BIOJECT shall have the right to present and publish all studies using BIOJECT's
NFID with a Direct Competitor's Gene Delivery System performed prior to the
Effective Date.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 Corporate Power. Each party hereby represents and warrants that
such party is duly organized and validly existing under the laws of the state of
its incorporation and has full corporate power and authority to enter into this
Agreement and to carry out the provisions hereof.
9.2 Due Authorization. Each party hereby represents and warrants that
such party is duly authorized to execute and deliver this Agreement and to
perform its obligations hereunder.
9.3 Binding Obligation. Each party hereby represents and warrants that
this Agreement is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by such party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
9.4 Limitation on Warranties. Nothing herein shall be construed as a
representation or warranty by either party to the other that any Contributed
Technology under the Control of such party is valid, enforceable, or not
infringed by any Third Party, or that the practice of such rights does not
infringe any intellectual property right of any Third Party. Neither party makes
any warranties, express or implied, concerning the success of the Collaborative
Alliance or the commercial utility of any Products.
9.5 Disclaimer of Warranties. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY
OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
9.6 Limitation of Liability. NEITHER PARTY SHALL BE ENTITLED TO
RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES IN CONNECTION WITH THE COLLABORATIVE ALLIANCE.
9.7 Mutual Indemnification. Each party hereby agrees to save, defend,
indemnify and hold harmless the other party and its officers, directors,
employees, consultants and agents from and against any and all losses, damages,
liabilities, expenses and costs, including reasonable legal expense and
attorneys' fees ("Losses"), to which the indemnified parties may become subject
as a result of any claim, demand, action or other proceeding by any Third Party
to the extent such Losses arise out of, or are based upon, the use of an
indemnifying party's Contributed Technology by the indemnified party or its
Affiliates, except to the extent such Losses result from the gross negligence or
willful misconduct of the party claiming a right of indemnification under this
Section 9.7. In the event either party seeks indemnification under this Section
9.7, it shall inform the other party of a claim as soon as reasonably
practicable after it receives notice of the claim, shall permit the other party
to assume direction and control of the defense of the claim (including the right
to settle the claim solely for monetary consideration), and shall cooperate as
requested (at the expense of the other party) in the defense of the claim.
ARTICLE 10
TERM AND TERMINATION
10.1 Term. This Agreement shall begin on the Effective Date and shall
continue for 18 months from the Effective Date, unless extended or terminated
earlier by mutual written agreement of the parties (the "Term"). The parties
agree to meet and evaluate whether to extend the Term under mutually acceptable
terms at least 60 days prior to the end of the Term.
10.2 Termination for Cause. Either party may terminate this Agreement
prior to the expiration of the Term upon the occurrence of any of the following:
(a) Upon or after the bankruptcy, insolvency, dissolution or
winding up of the other party (other than dissolution or winding up for the
purposes of reconstruction or amalgamation);
(b) Upon or after the breach of any material provision of this
Agreement by the other party if the breaching party has not cured such breach
within 30 days after written notice thereof by the non-breaching party; or
(c) Upon or after the transfer or sale of all or substantially
all of the business of the other party to which this Agreement relates, whether
by merger, sale of stock, sale of assets or otherwise, except to an Affiliate,
following 60 days' prior written notice to the other party.
10.3 Effect of Expiration or Termination.
(a) Expiration or termination of this Agreement shall not relieve
the parties of any obligation accruing prior to such expiration or termination.
Except as set forth below or elsewhere in this Agreement, the obligations and
rights of the parties under Sections 7.1, 8.1, 9.4, 9.5, 9.6, 9.7 and 10.3 and
Articles 1, 12 and 13 shall survive expiration or termination of this Agreement.
(b) Upon termination of this Agreement by GENEMEDICINE pursuant
to Section 10.2, Section 2.2(b) shall survive for a period of 18 months from the
Effective Date. Upon termination of this Agreement by BIOJECT pursuant to
Section 10.2, Section 2.2(a) shall survive for a period of 18 months from the
Effective Date.
(c) Upon expiration or termination of this Agreement, each party
shall cease all activities under the Collaborative Alliance, except for
activities required for each party to fulfill its obligations under any
agreement with a Corporate Partner; provided, however, that BIOJECT will have a
non-exclusive, worldwide, fully-paid, irrevocable license to use information
generated from animal and/or human studies involving BIOJECT's NFIDs (including
Dermal Devices and Biojectors) in combination with GENEMEDICINE's proprietary
Gene Delivery Systems in the course of the Collaborative Alliance to enter into
collaborative business relationships with Third Parties.
(d) Upon expiration or termination of this Agreement and for a
period of six months thereafter, each party will use commercially reasonable
efforts to include the other party in any collaborative agreement with any Third
Party in the Field. Notwithstanding the foregoing, a party may proceed with a
collaborative agreement with a Third Party without obligation to the other party
if such Third Party does not wish to enter into a collaborative agreement with
the other party.
(e) In the event of the bankruptcy, insolvency, dissolution or
winding up of a party (other than dissolution or winding up for the purposes of
reconstruction or amalgamation), all rights of such party in the Joint Patent
Rights shall hereby be assigned to the other party to this Agreement, or, if
such assignment is prohibited, such party shall hereby grant to such other party
an exclusive, worldwide, fully-paid, irrevocable license to the Joint Patent
Rights.
ARTICLE 11
PUBLICITY
11.1 Publicity Review. BIOJECT and GENEMEDICINE will jointly discuss
and agree, based on the principles of Section 11.2, on any statement to the
public regarding the execution and the subject matter of this Agreement or any
other aspect of this Agreement, except with respect to disclosures required by
law or regulation. Within 30 days following the Effective Date, the parties
shall issue a joint press release. Neither party shall use the name of the other
party in any public statement, prospectus, annual report, or press release
without the prior written approval of the other party, which may not be
unreasonably withheld or delayed; provided, however, that either party may use
the name of the other party in any public statement, prospectus, annual report,
or press release without the prior written approval of the other party, if such
party is advised by counsel that such disclosure is required to comply with
applicable law.
11.2 Standards. In the discussion and agreement referred to in Section
11.1, the principles observed by BIOJECT and GENEMEDICINE will be accuracy, the
requirements for confidentiality under Section 8.1, the advantage a competitor
of BIOJECT or GENEMEDICINE may gain from any public or Third Party statements
under Section 11.1, the requirements of disclosure under any securities laws or
regulations of the United States, including those associated with public
offerings, and the standards and customs in the pharmaceutical industry for such
disclosures by companies comparable to BIOJECT and GENEMEDICINE.
ARTICLE 12
DISPUTE RESOLUTION
12.1 Disputes. The parties recognize that disputes as to certain
matters may from time to time arise which relate to either party's rights and/or
obligations hereunder. It is the objective of the parties to establish
procedures to facilitate the resolution of such disputes in an expedient manner
by mutual cooperation and without resort to litigation. To accomplish this
objective, the parties agree to follow the procedures set forth in this Section
12.1 if and when such a dispute arises between the parties.
12.2 Procedures. If any dispute arises between the parties relating to
the interpretation, breach or performance of this Agreement or the grounds for
the termination thereof, and the parties cannot resolve the dispute within 30
days of a written request by either party to the other party, the parties agree
to hold a meeting, attended by the Chief Executive Officer or President of each
party, to attempt in good faith to negotiate a resolution of the dispute prior
to pursuing other available remedies. If, within 60 days after such written
request, the parties have not succeeded in negotiating a resolution of the
dispute, such dispute shall be submitted to final and binding arbitration under
the then current commercial rules and regulations of the American Arbitration
Association ("AAA") relating to voluntary arbitrations. The arbitration
proceedings shall be held in Wilmington, Delaware. The arbitration shall be
conducted by one arbitrator, who is knowledgeable in the subject matter at issue
in the dispute and who will be selected by mutual agreement of the parties or,
failing such agreement, shall be selected in accordance with the AAA rules. Each
party shall initially bear its own costs and legal fees associated with such
arbitration. The prevailing party in any such arbitration shall be entitled to
recover from the other party the reasonable attorneys' fees, costs and expenses
incurred by such prevailing party in connection with such arbitration. The
decision of the arbitrator shall be final and binding on the parties. The
arbitrator shall prepare and deliver to the parties a written, reasoned opinion
conferring its decision. Judgment on the award so rendered may be entered in any
court having competent jurisdiction thereof.
ARTICLE 13
MISCELLANEOUS
13.1 Assignment. Except as expressly provided hereunder, neither this
Agreement nor any rights or obligations hereunder nor a party's interest in the
Joint Patent Rights may be assigned or otherwise transferred by either party
without the prior written consent of the other party, which consent shall not be
unreasonably withheld; provided, however, that either party may assign this
Agreement and its rights and obligations hereunder without the other party's
consent (a) to an Affiliate, (b) in connection with the transfer or sale of all
or substantially all of the assets relating to the subject matter of this
Agreement to another party, or (c) in the event of a merger or reorganization of
such party with or into another party, and, in the event of such assignment, the
assigning party shall provide written notice to the other party within 30 days
after such assignment. In the event of such transaction, however, intellectual
property rights (including Know-How) of a party to such transaction other than
one of the parties to this Agreement (the "Acquiring Party"), shall not be
included in the Contributed Technology licensed hereunder. Notwithstanding the
foregoing, any such assignment to an Affiliate shall not relieve the assigning
party of its responsibilities for performance of its obligations under this
Agreement. The rights and obligations of the parties under this Agreement shall
be binding upon and inure to the benefit of the successors and permitted assigns
of the parties. Any assignment not in accordance with this Agreement shall be
void.
13.2 Force Majeure. Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party, including, but not limited to,
fire, floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party.
13.3 Governing Law. This Agreement shall be governed by, and construed
and enforced in accordance with, the laws of the State of Delaware, as such laws
are applied to contracts entered into and to be performed entirely within the
State of Delaware by Delaware residents, and the laws of the United States.
13.4 Waiver. Except as specifically provided for herein, the waiver
from time to time by either of the parties of any of their rights or their
failure to exercise any remedy shall not operate or be construed as a continuing
waiver of same or of any other of such party's rights or remedies provided in
this Agreement.
13.5 Notices. All notices and other communications provided for
hereunder shall be in writing and shall be mailed by first-class, registered or
certified mail, postage paid, or delivered personally, by overnight delivery
service or by facsimile, computer mail or other electronic means, with
confirmation of receipt, addressed as follows:
If to GENEMEDICINE: GENEMEDICINE, INC.
8301 New Trails Drive
The Woodlands TX 77381-4248
Attn: President
Phone No. (281) 364-1150
Fax No. (281) 364-0858
If to BIOJECT: BIOJECT, INC.
7620 S.W. Bridgeport Road
Portland, Oregon 97224
Attn: President
Phone No. (503) 639-7221
Fax No. (503) 624-9002
Either party may by like notice specify or change an address to which notices
and communications shall thereafter be sent. Notices sent by facsimile, computer
mail or other electronic means shall be effective upon confirmation of receipt,
notices sent by mail or overnight delivery service shall be effective upon
receipt, and notices given personally shall be effective when delivered.
13.6 Severability. In case any provision of this Agreement shall be
invalid, illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions shall not in any way be affected or impaired thereby.
13.7 Independent Contractors. It is expressly agreed that GENEMEDICINE
and BIOJECT shall be independent contractors and that the relationship between
the two parties shall not constitute a partnership or agency of any kind.
Neither GENEMEDICINE nor BIOJECT shall have the authority to make any
statements, representations or commitments of any kind, or to take any action,
which shall be binding on the other party, without the prior written consent of
the other party.
13.8 Entire Agreement; Amendment. This Agreement (including the
Exhibits attached hereto) sets forth all of the covenants, promises, agreements,
warranties, representations, conditions and understandings between the parties
hereto with respect to the subject matter hereof and supersedes and terminates
all prior agreements and understandings between the parties. There are no
covenants, promises, agreements, warranties, representations conditions or
understandings, either oral or written, between the parties other than as set
forth herein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the parties hereto unless reduced to writing and
signed by the respective authorized officers of the parties.
13.9 Headings. The captions contained in this Agreement are not a part
of this Agreement, but are merely guides or labels to assist in locating and
reading the several Articles hereof.
13.10 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed in duplicate by their duly authorized officers as of the date first
above written.
BIOJECT, INC. GENEMEDICINE, INC.
By: /s/ James O'Shea By: /s/ Norman Hardman
Name: James O'Shea Name: Norman Hardman
Title: President and Chairman, Title: President and COO
Chief Executive Officer
EXHIBIT A
BIOJECT PATENT RIGHTS
PATENT NUMBER COUNTRY ISSUE DATE
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[* * *]
EXHIBIT B
GENEMEDICINE PATENT RIGHTS