* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.
COLLABORATION AGREEMENT
This Collaboration Agreement (this "Agreement"), made as of July 1, 2004
(the "Effective Date"), is by and between Advanced Cardiovascular Systems, Inc.,
a corporation organized under the laws of California and having a place of
business at 0000 Xxxxxxxx Xxxxx, Xxxxx Xxxxx, Xxxxxxxxxx 00000 (herein referred
to as "ACS"), and Miravant Medical Technologies, together with its subsidiary,
Miravant Cardiovascular, Inc., both corporations organized under the laws of
Delaware and having places of business at 000 Xxxxxx Xxxxx, Xxxxx Xxxxxxx,
Xxxxxxxxxx 00000 (collectively referred to as "MMT"). ACS and MMT may each be
referred to as a "Party" or, collectively, as the "Parties" in this Agreement.
RECITALS
WHEREAS, ACS is engaged in the design, development, manufacture and
commercialization of medical devices for the diagnosis and treatment of
cardiovascular diseases, and ACS has patented and other proprietary medical
devices and systems for delivery of therapeutic compositions and drugs to
patients;
WHEREAS, MMT is developing photodynamic therapy ("PDT") products using
light activated compositions or drugs and related devices or systems for the
treatment of diseases, such as ophthalmology, dermatology, cardiovascular,
oncology and other conditions and diseases;
WHEREAS, the Parties wish to enter into a business alliance in which they
will collaborate on the development, pre-clinical and clinical investigations of
certain light activated compositions or drugs and related devices or systems for
use in the treatment of cardiovascular diseases, all on the terms and conditions
set forth below; and
WHEREAS, contemporaneously with the execution and delivery of this
Agreement, the Parties are executing and delivering a Securities Purchase
Agreement and a Registration Rights Agreement pursuant to which ACS has agreed
purchase certain MMT preferred stock and to provide certain registration rights
under the Securities Act, the rules and regulations promulgated thereunder and
applicable state securities laws.
AGREEMENT
NOW, THEREFORE, in consideration of the covenants and obligations expressed
herein, and intending to be legally bound, the Parties agree as follows:
ARTICLE 1: DEFINITIONS
1.1 "ACS Indemnitees" has the meaning ascribed to it in Section 11.1.
1.2 "ACS Inventions" has the meaning ascribed to it in Section 9.2.
1.3 "Affiliate" means, with respect to any Party, any corporation or other
business entity, which controls, is controlled by, or is under common control
with such Party. A corporation or other entity shall be regarded as in control
of another corporation or entity if it owns or directly or indirectly controls
at least fifty percent (50%) of the voting stock or other ownership interest of
the other corporation or entity (or alternatively, if not meeting the preceding
and with respect to foreign entities, if it owns the maximum such ownership
interest permitted by law), or if it possesses, directly or indirectly, the
power to direct or cause the direction of the management and policies of the
corporation or other entity or the power to elect or appoint at least fifty
percent (50%) of the members of the governing body of the corporation or other
entity.
1.4 "Agreement" has the meaning ascribed to it in the preamble hereof.
1.5 "Confidential Information" means all proprietary, non-public
information that has commercial value or other utility in a Party's business,
including but not limited to any information, inventions, know-how, biological
materials, chemical compounds, data, pre-clinical data, and materials provided
by one Party to the other pursuant to this Agreement, whether existing or
disclosed in oral, written, graphic, digital, optical, electronic or other form.
1.6 "Effective Date" has the meaning ascribed to it in the preamble hereof.
1.7 "FDA" means the United States Food and Drug Administration and any
successor agency thereto.
1.8 "INDA" means (a) an Investigational New Drug Application, as defined in
the United States Federal Food, Drug and Cosmetic Act, as amended, and the
regulations promulgated thereunder, that is required to be filed with the FDA
before beginning clinical testing of human subjects, or any successor
application or procedure, (b) any foreign counterpart of a United States
Investigational New Drug Application, and (c) all supplements and amendments,
including supplemental Investigational New Drug Applications and related foreign
counterparts, that may be filed with respect to the foregoing.
1.9 "Intellectual Property" means all of the following or their substantial
equivalents or counterparts in any jurisdiction throughout the world: (i)
patents, patent applications and invention disclosures, (ii) trademarks, service
marks, trade dress, trade names, corporate names, logos and Internet domain
names, (iii) copyrights, software and source code and copyrightable works, (iv)
registrations and applications for any registration for any of the foregoing and
(v) trade secrets, know-how, confidential information and inventions.
1.10 "Joint Inventions" has the meaning ascribed to it in Section 9.2.
1.11 "JSC" has the meaning ascribed to it in Section 2.1.
1.12 "Lead Drug" means that certain MMT compound designated as MV0633, or
such other PDT Drug, as the Parties may mutually agree to in writing.
1.13 "MMT Indemnitees" has the meaning ascribed to it in Section 11.2.
1.14 "MMT Inventions" has the meaning ascribed to it in Section 9.2.
1.15 "PDT" has the meaning ascribed to it in the recitals hereof.
1.16 "PDT Device" means those certain non-thermal medical laser devices,
including catheters, that have light sources of any wavelength and associated
equipment designed by MMT to activate the Lead Drug or PDT Drug for the
treatment of cardiovascular disease in the Therapeutic Field.
1.17 "PDT Drug" means those certain light activated compositions or drugs
that are designated as MV0633 and MV0611, including compounds and derivatives of
these compounds that have been, are being, or will be evaluated during the term
of this Agreement by MMT for the treatment of patients within the Therapeutic
Field or that are being developed by MMT during the Term and activated with a
PDT Device for the treatment of patients within the Therapeutic Field. For
clarity, the MMT compound designated as SnET2 is not a PDT Drug under this
Agreement.
1.18 "PDT Technology" means existing and future technology owned or
controlled by MMT that is specifically directed to treating cardiovascular
indications within the Therapeutic Field and necessary for the manufacture, use
or sale of PDT Drug, PDT Device or PDT Therapy, including, without limitation,
materials and processes utilized in production or processing of such PDT Drug,
PDT Device or PDT Therapy, and trade secret information or know-how relating to
such materials and processes.
1.19 "PDT Therapy" means a PDT Drug, its related delivery product or
system, and its related light activation product or system that are owned or
controlled by MMT and used for the treatment of a patient within the Therapeutic
Field.
1.20 "Party" and/or "Parties" has the meaning ascribed to it in the
preamble hereof.
1.21 "Patent Prosecution" has the meaning ascribed to it in Section 9.3.
1.22 "Patent Rights" means all existing patents and patent applications and
all patent applications disclosing or claiming any Lead Drug, PDT Drug, PDT
Device or PDT Therapy conceived by a Party during the Term, including any
continuations, continuations-in-part, divisions, provisionals or any substitute
applications, any patent issued with respect to any such patent applications,
any reissue, reexamination, renewal or extension (including any supplemental
patent certificate) of any such patent, and any confirmation patent or
registration patent or patent of addition based on any such patent, and all
foreign counterparts of any of the foregoing.
1.23 "Phase I Trial" means a complete program of one or more human
clinical trials in the United States wherein such program is intended to
initially evaluate the safety and/or pharmacological effect of, or otherwise to
satisfy the requirements of 21 ss.CFR 312.21(a), with respect to a Lead Drug,
PDT Drug, PDT Device or PDT Therapy for a particular condition in patients under
study within the Therapeutic Field.
1.24 "Phase II Trial" means a complete program of one or more human
clinical trials in the United States wherein such program is intended to
initially evaluate the appropriate dose of a drug for effectiveness of, or
otherwise satisfy the requirements of 21 CFR ss.312.21(b), with respect to a
Lead Drug, PDT Drug, PDT Device or PDT Therapy for a particular condition in
patients under study within the Therapeutic Field.
1.25 "Pre-Clinical Development Program" means the collection of
pre-clinical development activities including, without limitation, conducting
all animal studies, good laboratory practices (GLP) animal studies, or other
studies and gathering all data required with respect to non-safety research
studies, early stage drug development, drug metabolism, mechanism of action
analyses, pharmacokinetics, potency, selectivity, safety/toxicology and
manufacturing scale up, which are to be conducted by MMT as it deems necessary
with input from the JSC in order to file an INDA submission with the FDA for a
Lead Drug, PDT Drug, PDT Device or PDT Therapy in the Therapeutic Field.
1.26 "Term" has the meaning ascribed to it in Section 12.1.
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1.27 "Therapeutic Field" means the use of a Lead Drug, PDT Drug, PDT
Device or PDT Therapy for PDT treatment of human cardiovascular diseases
including but not limited to treatment of atherosclerotic vascular disease and
prevention of restenosis as well as other cardiovascular diseases or indications
designated by mutual written agreement of MMT and ACS from time to time in
accordance with the terms of this Agreement. Notwithstanding the foregoing,
Therapeutic Field shall not in any case include hemodialysis graft applications,
arterio-venous access disease, or diseases requiring local (non-intravenous)
SnET2 PDT drug delivery.
1.28 "Third Party" means a person or party other than ACS and MMT.
ARTICLE 2: JOINT COMMITTEE
2.1 Joint Steering Committee. Promptly following the Effective Date,
the Parties shall establish a Joint Steering Committee ("JSC") for the purposes
of collaborating on the development of MMT's Lead Drug, PDT Drug, PDT Device or
PDT Therapy within the Therapeutic Field pursuant to the preliminary development
plan that is attached to this Agreement as Exhibit A, in the manner and to the
extent provided herein. The JSC will be staffed by ACS and MMT employee
appointees, and the total number of JSC members will be eight (8), with four (4)
appointees for each Party, but the number may be adjusted upward or downward by
mutual agreement of the Parties. ACS initial JSC appointees will include one
business development manager, one new ventures research fellow, one new ventures
director and one clinical-regulatory research fellow. MMT's initial JSC
appointees will include one Endovascular Product Team Leader, one
Atherosclerosis Program Manager, one Cardiovascular Program Manager, and one
Director of Corporate Development & Strategic Planning. Either Party may replace
any of one or more of its appointees to the JSC at-will by giving written notice
thereof to the other Party.
2.2 Chairperson. The chairperson of the JSC shall be selected initially
by MMT from among the MMT employee appointees serving on the JSC and shall serve
in such role for one (1) year. After such one year period, the chairperson of
the JSC shall be selected from among the ACS employee appointees then serving on
the JSC, and that person will then serve in such role for one (1) year.
Thereafter, ACS and MMT shall alternate annually in selecting the chairperson of
the JSC from their respective appointees throughout the Term. The Chairperson of
the JSC will be responsible for calling and chairing meetings, developing
meeting agendas, and recording and distributing meeting minutes and directing
future actions of the JSC. The Chairperson of the JSC shall call one (1)
meeting, either face-to-face, video conference, or telephone conference, as
appropriate, for every calendar quarter during the Term or more frequently as
mutually agreed by the Parties.
2.3 Responsibilities of the Joint Steering Committee.
(a) In general, the responsibilities of the JSC will be to
analyze, consult, review and advise MMT, solely on a non-binding, advisory
basis, concerning the research, development, record keeping and other activities
related to any Lead Drug, PDT Drug, PDT Device, PDT Therapy or the Pre-Clinical
Development Program. As part of its responsibilities, the JSC will review and
make non-binding recommendations as necessary from time to time concerning MMT's
Pre-Clinical Development Program and Phase I Trial. Specific review and
consulting activities for JSC include, but are not limited to, (i) recommending
guidelines for staffing physician advisory groups, Pre-clinical Development
Program Plans, and Phase I Trial plans, (ii) discussing project projections,
budgets, tracking reports, and timelines, (iii) reviewing and discussing data
from pre-clinical studies and clinical trials, (iv) recommending additional
research studies beyond Pre-clinical Development Program Plans, (v) recommending
timing of and content for the INDA submission program with respect to any Lead
Drug, PDT Drug, PDT Device or PDT Therapy in the Therapeutic Field, (vi)
recommending content for the clinical readiness review, (vii) analysis of the
Phase I Trial Report, and (viii) recommending how to amend, as needed, the
Pre-clinical Development Program and Phase I Trial plans.
(b) The JSC shall have such other responsibilities as are
expressly set forth elsewhere in this Agreement or as are assigned to it as
mutually agreed upon by the Parties in writing.
(c) For clarity, MMT shall have the sole and exclusive right
to determine and control all research, development, commercialization and other
activities with respect to any Lead Drug, PDT Drug, PDT Device, PDT Therapy and
PDT Technology.
ARTICLE 3: MMT AND ACS OBLIGATIONS AND RESPONSIBILITIES
3.1 MMT Obligations and Responsibilities.
(a) MMT, through its Pre-Clinical Development Program, will
use commercially reasonable efforts to develop sufficient data concerning the
Lead Drug, PDT Drug, PDT Device, or PDT Therapy to enable MMT to file an INDA
submission with the FDA for such Lead Drug, PDT Drug, PDT Device, or PDT Therapy
in an expeditious and efficient manner.
(b) MMT agrees, in order for the JSC to undertake its
responsibilities, to provide the JSC with its information, data, records and
other documents including but not limited to MMT's comprehensive project plans
and tracking reports related to the Lead Drug, PDT Drug, PDT Device, PDT
Therapy, Pre-Clinical Development Program, and the Phase I Trial.
(c) MMT will use commercially reasonable efforts to i) provide
technical expertise concerning PDT Technology, ii) conduct its activities for
the Pre-Clinical Development Program and Phase I Trial, and (iii) provide data,
results and other related information generated in the course of the
Pre-Clinical Development Program and Phase I Trial to the JSC for review and
comment.
(d) MMT agrees to provide ACS with exclusive access to its
records reflecting inventions, ideas, information or data related to any Lead
Drug, PDT Drug, PDT Device, PDT Therapy or PDT Technology developed in the
course of work done under a Pre-Clinical Development Program and Phase I Trial
and to its records and data that existed prior to this Agreement related to any
PDT Drug. ACS acknowledges that MMT may share such records with its third party
contractors who are performing services for MMT in connection with the Phase I
Trial and who are under a confidentiality obligation with MMT without violating
the exclusive access granted to ACS herein. MMT also agrees to provide ACS with
written quarterly research and development updates as well as pre-clinical
research and clinical research updates in a format that is mutually agreed upon
by the Parties.
3.2 ACS Obligations and Responsibilities. ACS agrees, through its
appointees to the JSC, to (i) provide pre-clinical, clinical and regulatory
advice and consultation to MMT, (ii) offer its business and strategic
perspectives concerning treatment of atherosclerotic vascular disease, and (iii)
provide, in its sole discretion, reasonable advice and consultation concerning
catheter devices and systems for use in, or as used for, PDT Therapy.
ARTICLE 4: EXCLUSIVITY
4.1 Exclusive Collaboration Within The Therapeutic Field. Subject to
any obligations of the Parties herein, each Party agrees that it will not
commence a research, development, or commercialization plan or program, directly
or indirectly in collaboration with any Third Party, for the purpose of
researching, developing, delivering, administering, commercializing or otherwise
exploiting any Lead Drug, PDT Drug, PDT Device or PDT Therapy in the Therapeutic
Field during the Term, unless otherwise mutually agreed to by the Parties in
writing. The Parties acknowledge that this exclusivity obligation does not
prevent ACS or its Affiliates from making equity investments in, licensing or
acquiring PDT technology of any Third Party in the Therapeutic Field.
Notwithstanding the foregoing, MMT shall have the right to have any of the
activities under the Pre-Clinical Development Program and Phase I Trial
conducted on its behalf by Third Party contractors, and except as provided
herein nothing contained herein shall restrict either party's right to research,
discover, develop, manufacture and/or commercialize PDT products and technology
outside the Therapeutic Field.
ARTICLE 5: RIGHT OF FIRST REFUSAL
5.1 ACS's Right Of First Refusal. Upon (i) the completion of the Phase
I Trial as that event is defined in Section 12.1, or (ii) receipt by either
party of notice of termination of this Agreement pursuant to Section 12.2(a),
(b), (c) or (e), ACS shall have a right of first refusal ("ROFR") for a period
of 12 months to participate in any Phase II Trial. ACS participation may
include, but is not limited to, consultation regarding the design, manufacture
or use of light activation catheters or products, providing clinical and
regulatory consultation to MMT, providing funding to MMT for access to the Phase
II Trial data and results, or conducting the Phase II Trial in collaboration
with MMT or independently in the event that MMT would transfer or assign the
INDA to ACS, in each case as mutually agreed in writing by the Parties in
accordance with the process set forth in Section 5.1. ACS shall have thirty (30)
days to decide to exercise its ROFR after receiving written notice from MMT that
it has a bona-fide intention to begin, or that it has a bona-fide intention to
have a third party begin, any Phase II Trial. If ACS exercises its ROFR it shall
notify MMT in writing within such 30 day period. Then, the Parties will have an
additional thirty (30) days from the date of ACS's notice to MMT to exclusively
negotiate and enter into a term sheet concerning ACS participation in the Phase
II Trial. If the Parties execute a term sheet, they agree for a period of at
least sixty (60) days following the date of ACS's notice to MMT to negotiate in
good faith to reach a definitive agreement. In the event that MMT and ACS enter
into a definitive agreement, that agreement shall provide ACS with an option to
obtain a license from MMT to develop and commercialize, or otherwise exploit any
Lead Drug, PDT Drug, PDT Device or PDT Therapy within the Therapeutic Field on
terms to be mutually agreed upon by the Parties. If with respect to the subject
of a particular written notice received by ACS pursuant to this Section 5.1, the
Parties do not execute either the term sheet or the definitive agreement within
the foregoing time periods, then ACS's rights and MMT's obligations under this
Section 5.1 shall terminate, unless extended by mutual agreement or in the event
a delay is caused by the other Party's action or inaction, and MMT may proceed
with its plans for a Phase II Trial as set forth in the notice to ACS.
This Article 5 shall survive expiration or termination of this
Agreement except in the event of termination pursuant to Section 12.2(d) hereof.
ARTICLE 6: COSTS
6.1 Pre-Clinical Development Program and Phase I Trial Costs. All costs
and expenses related to research and development of PDT Therapy, MMT's
Pre-Clinical Development Program and Phase I Trial during the Term will be borne
by MMT.
ARTICLE 7: MMT RECORD KEEPING
7.1 Documentation. All tasks conducted by MMT in the course of its
performance under this Agreement shall be completely and accurately recorded,
recorded in reasonably sufficient detail and, where applicable, in good
scientific manner.
7.2 Policies for Maintaining Records. In order to protect the Parties'
Patent Rights under United States law in any inventions conceived or reduced
to practice during or as a result of any work performed by the Parties under
this Agreement, each Party agrees to require, consistent with its existing
policies, its employees to record and maintain all data and information
developed during this Agreement in such a manner as to enable the Parties to
use such records to establish the earliest date of invention and/or diligence
to reduction to practice. At a minimum, such individuals will record all
inventions generated by them in standard laboratory notebooks which are dated
and corroborated by non-inventors on a regular, contemporaneous basis.
ARTICLE 8: CONFIDENTIAL INFORMATION
8.1 Confidentiality Obligations. The Parties agree that, for the Term
and for three (3) years thereafter, either Party that receives Confidential
Information (a "Receiving Party") from the other Party (a "Disclosing Party")
shall keep completely confidential and shall not publish or otherwise disclose
and shall not use for any purpose (except as expressly permitted hereunder)
any Confidential Information furnished to it by the Disclosing Party pursuant
to this Agreement (including, without limitation, know-how), except to the
extent that it can be established by the Receiving Party that such
Confidential Information: (a) was already known to the Receiving Party prior
to the time of disclosure by the Disclosing Party, other than under an
obligation of confidentiality from the Disclosing Party, as shown by written
records; (b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving Party; (c) became
generally available to the public or otherwise part of the public domain after
its disclosure and other than through any act or omission of the Receiving
Party in breach of this Agreement; (d) was subsequently lawfully disclosed to
the Receiving Party by a Third Party without breach of an obligation to the
Disclosing Party; (e) can be shown by written records to have been
independently developed by the Receiving Party without reference to the
Confidential Information received from the Disclosing Party and without breach
of any of the provisions of this Agreement; or (f) is information that the
Disclosing Party has specifically agreed in writing that the Receiving Party
may disclose.
8.2 Written Assurances and Permitted Uses of Confidential Information.
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(a) Each Party shall inform its employees and consultants who
perform work under this Agreement of the obligations of confidentiality
specified in Sections 8.1 and 8.2, and all such persons shall be bound by the
terms of confidentiality substantially similar to those set forth therein.
(b) The Receiving Party may disclose Confidential Information
to the extent the Receiving Party is compelled to disclose such information by
a court or other tribunal of competent jurisdiction; provided however, that in
such case the Receiving Party shall immediately give notice to the Disclosing
Party so that the Disclosing Party may seek a protective order or other remedy
from said court or tribunal. In any event, the Receiving Party shall disclose
only that portion of the Confidential Information that, in the opinion of its
legal counsel, is legally required to be disclosed and will exercise
reasonable efforts to ensure that any such information so disclosed will be
accorded confidential treatment by said court or tribunal.
(c) To the extent it is reasonably necessary or appropriate to
fulfill its obligations and exercise its rights under this Agreement, either
Party may disclose Confidential Information of the other Party to its
Affiliates, on a need-to-know basis, provided that such Affiliates agree in
writing to be bound by the provisions of this Article 8, and keep such
Confidential Information confidential for the same time periods and to the
same extent as such Party is required to keep the Confidential Information
confidential under this Agreement.
8.3 Publication.
(a) MMT shall not publish or present any of the data or
results of the Pre-Clinical Development Program or the Phase 1 Trial until ACS
has completed its review of all materials to be provided to ACS by MMT pursuant
to this Agreement and the Securities Purchase Agreement. In no event shall the
time for ACS to complete its review be less than sixty (60) days after receipt
of such data and/or results by ACS. If MMT receives no response from ACS within
such sixty (60) day period, MMT shall be free to proceed with publication or
presentation of such data or results.
(b) No Party may publish Confidential Information of the other
Party, the use of which is restricted under this Article 8, without the prior
written consent of the other Party.
(c) If the Parties determine that patent protection is
suitable for any results proposed to be published, then no Party may publish
such results without first obtaining prior written approval from patent counsel
in charge of prosecuting that patent application (who shall take into
consideration the absolute novelty requirements of applicable jurisdictions).
8.4 Public Announcements.
(a) Neither Party shall make any public announcement or
disclosure concerning the terms of this Agreement (including its attachments) or
concerning the transactions described herein and therein or the performance of
either Party's rights or obligations under this Agreement, either directly or
indirectly, without first obtaining the prior written approval of the other
Party and its agreement upon the nature, text, and timing of such announcement
or disclosure, which approval and agreement shall not be unreasonably withheld,
conditioned or delayed; provided, however, any disclosure which is required by
law as advised by the disclosing Party's counsel may be made without the prior
approval of the other Party. Notwithstanding the foregoing, MMT may, without
prior approval of ACS, make presentations to shareholders and potential
investors regarding the Pre-Clinical Development Program or Phase I Trial
necessary for such shareholders and potential investors to evaluate securities
purchases in MMT, provided such presentations do not contain ACS Confidential
Information.
(b) The Party desiring to make any public announcement shall
provide the other Party with a written copy of the proposed announcement at
least five (5) days prior to public release to allow such other Party to comment
upon such announcement prior to public release. The Party receiving the proposed
announcement shall have five (5) days to provide comments to the Party desiring
to make said public announcement. If the Party receiving the proposed
announcement fails to provide comments to the Party desiring to make the
announcement within five (5) days, the receiving Party is deemed to forego its
ability to provide comments and the Party desiring to make the announcement
shall be allowed to publicly release said announcement.
(c) In addition, MMT may file a copy of this Agreement with
the U.S. Securities and Exchange Commission in connection with any public
offering of MMT's securities or regular reporting obligations as a public
company. In connection with any such filing, MMT will attempt to obtain
confidential treatment of economic and trade secret information for which such
treatment is reasonably available in accordance with applicable laws and
regulations.
ARTICLE 9: PATENTS AND INTELLECTUAL PROPERTY
9.1 Existing Rights Retained. MMT shall retain all of its ownership
interests in its Intellectual Property, as such exist as of the Effective Date
and ACS shall retain all of its ownership interests in its Intellectual
Property, as such exist as of the Effective Date. Except as specifically
provided in this Agreement or in the Securities Purchase Agreement, nothing in
this Agreement shall be construed to transfer ownership of any Intellectual
Property existing as of the Effective Date from one Party to the other Party,
and neither Party grants any license, express or implied, under its Intellectual
Property (including without limitation Patent Rights) to the other Party.
9.2 Inventions. Inventorship of inventions, whether patentable or not,
that are conceived or reduced to practice during the Term in the course of the
performance of activities pursuant to this Agreement shall be determined in
accordance with U.S. patent laws for determining inventorship. Ownership of such
inventions, as between the Parties, shall be determined as follows:
(a): MMT shall solely own all inventions and materials
conceived solely by MMT or its employees, agents, or consultants during the Term
which result from the performance of its obligations under this Agreement ("MMT
Inventions").
(b) ACS shall solely own all inventions and materials
conceived solely by ACS or its employees, agents, or consultants during the Term
which result from the performance of ACS' obligations under this Agreement ("ACS
Inventions").
c) Each Party shall own an undivided interest in all
inventions and materials conceived jointly by employees, agents, or consultants
of both Parties during the Term which result from the performance of the
Parties' obligations under this Agreement ("Joint Inventions"). Either Party may
exploit its interest in and to the Joint Inventions independent of the other
Party, without accounting to such other Party.
9.3 Patent Prosecution of Patent Rights. The right to control matters
of (a) deciding to file, preparing, filing and prosecuting patent applications
(including reissue, continuing, divisional, and substitute applications and any
foreign counterparts thereof); (b) maintaining any Patent Rights; and (c)
managing any interference or opposition proceedings relating to the foregoing
((a), (b) and (c) collectively, "Patent Prosecution"), and responsibility for
all costs and expenses associated with such Patent Prosecution covering any MMT
Inventions or ACS Inventions, shall be the sole and exclusive right of the Party
owning such invention. If any Joint Inventions are conceived or reduced to
practice under this Agreement, the Parties will mutually agree upon the
responsibilities for the Patent Prosecution of such Joint Inventions and the
allocation of corresponding costs and expenses.
9.4 Option to MMT Inventions. MMT agrees to provide ACS with a complete
written disclosure of all MMT Inventions arising from the advice and
consultation provided to MMT by ACS pursuant to Section 3.2(iii) hereof within
thirty (30) days from the date MMT becomes aware of such MMT Invention. ACS
shall have up to a one (1) year option period, commencing upon ACS's receipt of
a disclosure, to obtain a license from MMT to such MMT Inventions under
commercially reasonable terms and conditions as are mutually agreed upon by the
Parties and including royalty provisions that shall not exceed five percent (5%)
of the net sales of any licensed products.
9.5 Cooperation. With respect to all MMT Inventions, ACS Inventions and
Joint Inventions that are the subject of this Agreement and the subject of
Patent Prosecution, each Party shall:
(a) execute all further assignments and other instruments to
document their respective ownership consistent with this Article 9 as reasonably
requested by the other Party;
(b) make its employees, agents and consultants reasonably
available to the other Party (or to the other Party's authorized attorneys,
agents or representatives), to the extent reasonably necessary to enable the
appropriate Party hereunder to undertake Patent Prosecution;
c) cooperate, if necessary and appropriate, with the other
Party in gaining patent term extensions;
(d) endeavor in good faith to coordinate its efforts under
this Agreement with the other Party to minimize or avoid interference with the
Patent Prosecution of the other Party's patent applications; and
(e) require its employees, agents and consultants engaged in
any work performed under this Agreement to agree in writing to assign all
Intellectual Property created, conceived or reduced to practice in connection
therewith to their respective employer, and the Parties shall ensure that each
such employee, agent and consultant has signed such a written agreement before
any work performed under this Agreement commences.
ARTICLE 10: REPRESENTATIONS AND WARRANTIES
10.1 Authority. Each Party represents and warrants that as of the
Effective Date it has the full right, power and authority to enter into this
Agreement and that this Agreement has been duly executed by each Party and
constitutes a legal, valid and binding obligation of each Party, enforceable in
accordance with its terms.
10.2 Commercially Reasonable Efforts. MMT represents and warrants that
it will use good faith commercially reasonable efforts, consistent with sound
business judgment, to perform the activities for which it is responsible under
the Pre-Clinical Development Program and Phase I Trial.
10.3 Intellectual Property.
(a) MMT represents and warrants that it owns or controls the
rights necessary to grant the rights granted to ACS under this Agreement.
(b) MMT represents and warrants that as of the Effective Date,
there is no pending lawsuit or threatened lawsuit against it asserting that
any Lead Drug, PDT Drug, PDT Device or PDT Therapy or that the manufacture,
use, sale, offer for sale or import of a Lead Drug, PDT Drug, PDT Device or
PDT Therapy infringes upon or misappropriates any Intellectual Property of any
Third Party.
10.4 No Conflicts. Each Party represents and warrants that the
execution, delivery and performance of this Agreement does not conflict with,
or constitute a breach or default under any of its charter or organizational
documents, any law, order, judgment or governmental rule or regulation
applicable to it, or any material agreement, contract, commitment or
instrument to which it is a party.
10.5 No Existing Third Party Rights. Each Party represents and warrants
that its obligations under this Agreement are not encumbered by any rights
granted by such Party to any Third Parties that are or may be inconsistent
with the rights or options granted in this Agreement.
10.6 Disclaimer Of Warranties. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS AND EXTENDS NO WARRANTIES OR
CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED
TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
NON-INFRINGEMENT.
ARTICLE 11: INDEMNIFICATION
11.1 Indemnification by MMT. MMT shall indemnify, defend and hold ACS,
its Affiliates and their permitted contractors and agents, employees, officers
and directors (the "ACS Indemnitees") harmless from and against any and all
liability, damage, loss, cost or expense (including reasonable attorneys'
fees) arising out of Third Party claims or lawsuits related to (a) MMT's
performance of its obligations under this Agreement, (b) a breach by MMT of
any of its covenants, representations or warranties set forth in this
Agreement, or (c) the design, manufacture, use or sale by MMT of a Lead Drug,
PDT Drug, PDT Device or PDT Therapy; provided, however, all of the foregoing
is only to the extent such claims or suits do not result from a breach of any
of the provisions of this Agreement, negligence or willful misconduct of any
of the ACS Indemnitees. Upon the assertion of any such claim or suit, ACS
shall promptly notify MMT thereof and MMT shall appoint counsel reasonably
acceptable to the affected ACS Indemnitees to represent such ACS Indemnitees
with respect to any claim or suit for which indemnification is sought.
Affected ACS Indemnitees shall not settle any such claim or suit without the
prior written consent of MMT, unless such ACS Indemnitees shall have first
waived their rights to indemnification hereunder.
11.2 Indemnification by ACS. ACS shall indemnify, defend and hold MMT,
its Affiliates and their permitted contractors and agents, employees, officers
and directors (the "MMT Indemnitees") harmless from and against any and all
liability, damage, loss, cost or expense (including reasonable attorneys'
fees) arising out of Third Party claims or lawsuits related to (a) ACS'
performance of its obligations under this Agreement, or (b) a breach by ACS of
any of its covenants, representations or warranties set forth in this
Agreement; provided, however, all of the foregoing is only to the extent that
such claims or suits do not result from a breach of any of the provisions of
this Agreement, negligence or willful misconduct of the MMT Indemnitees. Upon
the assertion of any such claim or suit, MMT shall promptly notify ACS thereof
and ACS shall appoint counsel reasonably acceptable to the affected MMT
Indemnitees to represent such MMT Indemnitees with respect to any claim or
suit for which indemnification is sought. Affected MMT Indemnitees shall not
settle any such claim or suit without the prior written consent of ACS, unless
such MMT Indemnitees shall have first waived their rights to indemnification
hereunder.
11.3 Insurance. Each Party shall maintain insurance with respect to its
activities hereunder. Such insurance shall be in such amounts and subject to
such deductibles as the Parties may agree based upon standards prevailing in the
industry at the time. ACS acknowledges that MMT does not have product liability
insurance as of the Effective Date of this Agreement and that ACS is not
requiring MMT to obtain such product liability insurance.
ARTICLE 12: TERM AND TERMINATION
12.1 Term. This Agreement shall commence on the Effective Date and,
unless terminated pursuant to Section 12.2, shall terminate in its entirety four
(4) months after the delivery of the Phase I Trial data and results to ACS,
provided that ACS has reviewed the clinical data and results of the Phase I
Trial. If ACS has not completed its review, this Agreement shall be extended at
the request of ACS for no longer than one year after the completion of the Phase
I Trial. For the purpose of this Agreement, the completion of the Phase I Trial
is defined as the time when all patients enrolled in the trial have been
followed-up according to the trial protocol and any additional FDA required
follow-up and when all Phase I Trial clinical reports and data have been
provided to ACS. The period of time from the Effective Date until termination is
the "Term."
12.2 Termination.
(a) The failure by a Party to comply with any of the material
obligations contained in this Agreement shall entitle the other Party to give
notice to have the default cured. If such default is not cured within sixty (60)
days after the receipt of such notice or diligent steps are not taken to cure if
by its nature such default could not be cured within sixty (60) days, then the
notifying Party shall be entitled, without prejudice to any of its other rights
conferred on it by this Agreement, and in addition to any other remedies that
may be available to it, to terminate this Agreement in its entirety; provided,
however, that such right to terminate shall be stayed in the event that, during
such sixty (60) day period, the Party alleged to have been in default shall
have: (a) initiated a dispute resolution proceeding in accordance with Article
13, below, with respect to the alleged default, and (b) diligently and in good
faith cooperated in the prompt resolution of such proceeding.
(b) Either Party may terminate this Agreement in the event the
other Party at any time becomes insolvent or makes a general assignment for the
benefit of creditors, or if a petition in bankruptcy, or any reorganization is
commenced by, against or in respect of such other party and that petition is not
stayed or dismissed within thirty (30) days.
(c) ACS may terminate this Agreement upon seven (7) days
written notice to MMT upon the assignment of this Agreement by MMT to a direct
competitor of ACS or its Affiliates including, but not limited to, Xxxxxxx and
Xxxxxxx, Boston Scientific Corporation, Medtronic, Inc., Xxxxxx Laboratories or
such Third Parties as otherwise confirmed in writing by ACS, from time to time,
as being an ACS direct competitor.
(d) ACS may terminate this Agreement upon sixty (60) days
written notice if it determines, using reasonable business judgment and good
faith, that the data or results reported to ACS and generated either during or
after the Pre-Clinical Development Program or Phase I Trial fail to demonstrate
either safety or efficacy, do not support further development of a Lead Drug,
PDT Drug, PDT Device or PDT Therapy, or would lead to a significant delay in
regulatory approval or commercialization of a Lead Drug, PDT Drug, PDT Device or
PDT Therapy.
(e) ACS may immediately terminate this Agreement by providing
written notice of termination to MMT in the event that MMT fails to meet the
conditions that are needed to be satisfied in order to obligate ACS to make
either the interim or final investments that are set out in Sections 6.4 and 6.5
of the Securities Purchase Agreement executed by the Parties contemporaneously
with this Agreement, or in the event ACS does not make an investment due to one
of the events in Section 6.6 of the Securities Purchase Agreement. In the event
ACS provides MMT with such written notice, this Agreement shall automatically
terminate and the parties rights with respect to data collected prior to the
Effective Date of this Agreement and to data generated pursuant to this
Agreement shall be as set forth in Section 12.3(d), (e) and (f) hereof.
* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.
12.3 Effect of Termination.
(a) Upon receipt of written notice of termination by either
party pursuant to Section 12.2(a) or (b) of this Agreement, then the party
receiving notice shall immediately forfeit and transfer to the party giving
notice all rights to all pre-clinical and clinical data developed or generated
under this Agreement relating to the Lead Drug or other PDT Drug.
(b) Upon receipt of written notice of termination from ACS pursuant to
Section 12.2(c) of this Agreement, * .
(c) Upon receipt of written notice of termination from ACS pursuant to
Section 12.2(d) of this Agreement, * .
(d) Upon receipt of written notice of termination from ACS under Section
12.2(e) of this Agreement because MMT has failed to satisfy any of its
obligations under Section 6.4(a) or (b) of the Securities Purchase Agreement, *
..
(e) Upon receipt of written notice of termination from ACS under Section
12.2(e) of this Agreement because MMT has failed to satisfy any of its
obligations under Section 6.4(d) or 6.5(d) of the Securities Purchase Agreement,
* .
(f) Upon receipt of written notice of termination from ACS under Section
12.2(e) of this Agreement because MMT has failed to satisfy any of its
obligations under Section 6.4(c), (e), (f) or (g) or 6.5(a), (b), (c), (e), (f)
or (g) of the Securities Purchase Agreement, * .
12.4 Survival Of Obligations. The termination or expiration of this
Agreement shall not relieve the Parties of any obligations accruing prior to
such termination, and any such termination shall be without prejudice to the
rights of either Party against the other. The provisions of Articles 8, 9, 10,
11 and 13 shall survive any termination of this Agreement, and Article 5 shall
survive as provided in such Article 5.
ARTICLE 13: DISPUTE RESOLUTION
13.1 Dispute Resolution Process. Both Parties understand and appreciate
that their long term mutual interest will be best served by affecting a rapid
and fair resolution of any claims or disputes concerning the obligations or
terms of this Agreement. Therefore, both Parties agree to use their commercially
reasonable best efforts to resolve all such disputes as rapidly as possible on a
fair and equitable basis.
13.2 Executive Dispute Resolution. If any dispute or claim arising
under this Agreement cannot be readily resolved by the Parties, then the Parties
agree to refer the matter to their respective ACS and MMT executive officers, or
their designees, for review and a non-binding resolution. A copy of the terms of
this Agreement, agreed upon facts (and areas of disagreement), and concise
summary of the basis for each Party's contentions will be provided to both
executive officers who shall review the same, confer and attempt to reach a
mutual resolution of the dispute. If the Parties fail to resolve the dispute at
the executive officer level, then the Parties agree to refer the matter to their
respective ACS and MMT executives at the corporate office level, or their
designees, for review and a non-binding resolution. If the Parties fail to
resolve the dispute at the corporate officer level, the Parties may pursue other
available legal processes to resolve the dispute.
ARTICLE 14: MISCELLANEOUS PROVISIONS
14.1 Injunctive Relief. The Parties acknowledge that (i) the covenants
and the restrictions contained in of this Agreement are an inducement to the
other Party to enter into this Agreement and are necessary and required for the
protection of the Parties, (ii) such covenants relate to matters that are of a
special, unique and extraordinary character that give each of such covenants a
special, unique and extraordinary value, and (iii) a breach of any of such
covenants may result in irreparable harm and damages to a Party in an amount
difficult to ascertain and which cannot be adequately compensated by a monetary
award. Accordingly, in addition to any of the relief to which any Party may be
entitled under this Agreement, at law or in equity, such Party shall be entitled
to seek temporary and permanent injunctive relief from any breach or threatened
breach of such covenants without proof of actual damages that have been or may
be caused to such Party by such breach or threatened breach. In the event an
action for injunctive relief is brought by a Party, the other Party waives any
right to require the Party bringing such action to post any bond or other
security with the court in connection therewith.
14.2 Governing Law. This Agreement shall be governed by and construed
in accordance with the laws of the State of California, without giving effect to
the principles of conflict of laws thereof.
14.3 Assignment. This Agreement shall be binding upon and inure to the
benefit of MMT and ACS and their respective successors and permitted assigns.
Neither Party shall be permitted to assign its rights or obligations hereunder
without the prior written consent of the other Party hereto, except that either
Party shall have the right to assign or otherwise transfer all of its rights and
obligations hereunder (i) to an Affiliate, or (ii) in connection with a sale of
all or substantially all of its business or assets, whether by merger, sale of
stock, sale of assets, or otherwise, in each case and (iii) provided that all
rights and obligations under this Agreement are assigned or transferred together
in their entirety and provided further that such assignment or transfer shall
not relieve the assigning/transferring Party from fulfilling any of its
obligations to the other Party.
14.4 Compliance With Laws. Each Party shall comply with all applicable
laws and regulations in connection with its performance of its obligations and
exercise of its rights under this Agreement. Each Party shall furnish to the
other Party any information reasonably requested or required by that Party
during the Term to enable that Party to comply with the requirements of any
applicable United States or foreign federal, state and/or government agency.
14.5 Further Assurances. At any time or from time to time following the
date of this Agreement, each Party shall, at the request of the other Party and
to the extent reasonably necessary to fulfill the express intent hereof, (i)
deliver or cause to be delivered to the requesting Party any records, data or
other documents consistent with the provisions of this Agreement, (ii) duly
execute and deliver, or cause to be duly executed or delivered, all such
consents, assignments, documents or further instruments of transfer or license
as required by this Agreement, and (iii) take or cause to be taken all such
actions, in each case as the requesting Party may reasonably deem necessary in
order for the requesting Party to obtain the full benefits of this Agreement and
the transactions contemplated hereby.
14.6 Severability. In the event that any provision of this Agreement is
determined to be invalid or unenforceable by a court of competent jurisdiction,
the remainder of this Agreement shall remain in full force and effect without
said provision. In such event, the parties shall in good faith attempt to
negotiate a substitute clause for any provision declared invalid or
unenforceable, which substitute clause shall most nearly approximate the intent
of the Parties in agreeing to such invalid provision, without itself being
invalid.
14.7 Waivers and Amendments; Preservation of Remedies. This Agreement
may be amended, modified, superseded, canceled, renewed or extended, and the
terms and Therapeutic Fields hereof may be waived, only by a written instrument
signed by the Parties or, in the case of a waiver, the Party waiving compliance.
No delay on the part of any Party in exercising any right, power or privilege
hereunder shall operate as a waiver thereof, nor shall any waiver on the part of
any Party of any right, power or privilege hereunder, nor any single or partial
exercise of any right, power or privilege hereunder, preclude any other or other
exercise thereof hereunder. The rights and remedies herein provided are
cumulative and are not exclusive of any rights or remedies which any Party may
otherwise have at law or in equity.
14.8 Headings. The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are included merely for convenience of
reference only and shall not affect its meaning or interpretation.
14.9 Counterparts. This Agreement may be executed in any number of
counterparts, each such counterpart shall be deemed to be an original instrument
and which together shall constitute one instrument.
14.10 Successors. This Agreement shall inure to the benefit of and be
binding upon each of the Parties and their respective permitted successors and
assigns.
14.11 Notices. All notices, requests, demands, claims, and other
communications hereunder shall be in writing and shall be deemed to have been
duly given if delivered personally, by telecopy (receipt confirmed), sent by
nationally recognized overnight courier or mailed by registered or certified
mail (return receipt requested and postage prepaid), to the parties at the
addresses set forth below (or at such other address for such party as shall be
specified by like notice). All such notices and other communications shall be
deemed to have been given and received (i) in the case of personal delivery, on
the date of such delivery, (ii) in the case of delivery by telecopy, on the date
of such delivery, (iii) in the case of delivery by nationally recognized
overnight courier, on the second business day following the date when sent, and
(iv) in the case of mailing, on the fifth business day following such mailing.
if to MMT:
Miravant Medical Technologies
000 Xxxxxx Xxxxx
Xxxxx Xxxxxxx, XX 00000
Attention: Xxxx X. Xxxxxxxx
Facsimile: (000) 000-0000
with copy (which will not constitute notice) to:
Xxxxxxxx Xxxxxx Xxxxxxx & Hampton, LLP
000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxxx, XX 00000
Attention: Xxxxxx X. Xxxx, Esq.
Facsimile: (000) 000-0000
with copy (which will not constitute notice) to:
Wilson, Sonsini, Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, XX 00000
Attention: Xxxx Xxxxxxxx, Esq.
Facsimile: (000) 000-0000
If to ACS:
Advanced Cardiovascular Systems, Inc.
0000 Xxxxxxxx Xxxxx
Xxxxx Xxxxx, Xxxxxxxxxx 00000
Attention: General Counsel
Facsimile: (000) 000-0000
14.12 No Consequential Damages. IN NO EVENT SHALL EITHER PARTY OR ANY
OF ITS RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER PARTY OR ANY OF ITS
AFFILIATES FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER
IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE,
INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS OR REVENUE, OR CLAIMS OF
CUSTOMERS OF ANY OF THEM OR OTHER THIRD PARTIES FOR SUCH OR OTHER DAMAGES.
14.13 Independent Contractor. Neither Party shall be construed to be a
partner, joint venturer, franchisee, employee, principal, agent, representative
or participant of or with the other for any purpose whatsoever. Neither Party
has any right or authority to assume or to create any obligation or
responsibility, express or implied, on behalf of or in the name of the other
Party in any manner.
14.14 Complete Agreement. This Agreement, together with its Exhibits,
constitutes the entire agreement, both written and oral, among the Parties with
respect to the subject matter hereof, and all prior agreements respecting the
subject matter hereof, either written or oral, expressed or implied.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be
executed by their respective duly authorized officers as of the Effective Date,
each copy of which shall for all purposes be deemed to be an original.
MIRAVANT MEDICAL TECHNOLOGIES:
By: /s/ Xxxx X. Xxxxxxx
-----------------------------------------------------
Name: Xxxx X. Xxxxxxx
Title: Chief Executive Officer
MIRAVANT CARDIOVASCULAR, INC.
By: /s/ Xxxx X. Xxxxxxxx
-----------------------------------------------------
Name: Xxxx X. Xxxxxxxx
Title: Chief Financial Officer
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
By: /s/ Xxxx X. Xxxxxx
-----------------------------------------------------
Name: Xxxx X. Xxxxxx
Title: Vice President, Finance and Business Development
[Signature Page to the Collaboration Agreement]
EXHIBIT A
PRELIMINARY DEVELOPMENT PLAN
The following chart outlines the planned clinical development activities,
responsibilities, and currently estimated timelines. Timelines may be revised as
program progresses.
*
* Portions denoted with an asterisk have been omitted and filed separately with
the Securities and Exchange Commission pursuant to a request for confidential
treatment.
