Exhibit 10.1
Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
CHILDREN'S MEDICAL CENTER CORPORATION
AND
BOSTON LIFE SCIENCES INC.
INVESTIGATOR: XX. XXXXX XXXXXXXX
TABLE OF CONTENTS
ARTICLE I. DEFINITIONS 4
ARTICLE II. GRANT 8
ARTICLE III. DUE DILIGENCE AND RELATED MATTERS 12
ARTICLE IV. ROYALTIES AND OTHER PAYMENTS 15
ARTICLE V. REPORTS, RECORDS AND RELATED MATTERS 17
ARTICLE VI. PATENT PROSECUTION 19
ARTICLE VII. INFRINGEMENT 20
ARTICLE VIII. UNIFORM INDEMNIFICATION AND INSURANCE PROVISIONS 21
ARTICLE IX. COMPLIANCE WITH LAWS; EXPORT CONTROLS 23
ARTICLE X. NON-USE OF NAMES 23
ARTICLE XI. ASSIGNMENT 23
ARTICLE XII. DISPUTE RESOLUTION AND ARBITRATION 24
ARTICLE XIII. TERM AND TERMINATION 24
ARTICLE XIV. PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS 25
ARTICLE XV. GENERAL PROVISIONS 26
Appendix 1: Existing License Agreements and Existing Technologies 29
Appendix 2: List of Biological Materials (to be provided by Licensee) 30
Appendix 3: Patent Rights 31
Appendix 4: Sponsored Research Agreement 34
Appendix 5: Initial Development Plan 50
Appendix 6: Confidentiality Disclosure Agreement 51
Appendix 7: Diligence Requirements for the Technologies Licensed
Exclusively Under this Agreement 54
2
EXCLUSIVE LICENSE AGREEMENT
This Agreement is made and entered into as of the date last written below (the
Effective Date), by and between CHILDREN'S MEDICAL CENTER CORPORATION, a
charitable corporation duly organized and existing under the laws of the
Commonwealth of Massachusetts and having its principal office at 000 Xxxxxxxx
Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx, 00000, X.X.X. (hereinafter referred to as
"CMCC"), and Boston Life Sciences Inc., a business corporation organized and
existing under the laws of the State of Delaware and having its principal office
at 00 Xxxx Xxxxxx, Xxxxxxxxx, XX, 00000 (hereinafter referred to as "Licensee").
WHEREAS, CMCC is the owner of certain Patent Rights (as that term shall be
defined hereafter) and has the right to grant exclusive licenses under the
Patent Rights, subject only to a royalty-free, nonexclusive license granted to
the United States Government for those inventions and ensuing patents developed
with U.S. Government funding, and certain laws and regulations relating to
Federally-funded projects and institutions;
WHEREAS, in furtherance of its charitable and research missions and those laws
and regulations, CMCC desires to have the Patent Rights utilized to promote the
public interest and to further that goal is willing to grant a license to
Licensee on the terms and conditions described herein;
WHEREAS, Licensee has previously sponsored research in Xx. Xxxxx Xxxxxxxx'x
laboratory at CMCC and has exclusively licensed from CMCC intellectual property
resulting from such sponsored research through the license agreements listed in
Appendix 1 (the "Existing License Agreements" and the "Existing Technologies");
WHEREAS, in consideration of the terms of this Agreement, including without
limitation those intended to hold CMCC harmless from the financial effects of
delay, CMCC has agreed not to terminate the Existing License Agreements;
WHEREAS, Licensee and CMCC have agreed to renegotiate the Existing License
Agreements and have agreed that the obligations of both parties starting on the
Effective Date and going forward will be governed by this License Agreement and
not by Existing License Agreements;
WHEREAS, Licensee desires to continue to sponsor research in the laboratory of
Xx. Xxxxx Xxxxxxxx, in the amounts and conditions specified in the accompanying
Sponsored Research Agreement, and desires to obtain certain rights, as described
herein, to the intellectual property resulting from that Sponsored Research
Program;
WHEREAS Xx. Xxxxxxxx'x technology CMCC 1154 involves the use of a specific
combinatorial treatment to enhance brain rewiring such treatment being a
combination of the [1] activation of the growth program of the neuron (the
"Positive Regulators"); and [2] reduction of the inhibition of axonal growth in
the environment that surrounds the neuron (the "Negative Regulators").
WHEREAS in addition to sponsoring research in Xx. Xxxxxxxx'x laboratory,
Licensee also intends to sponsor research in the laboratory of another CMCC
investigator, Dr. Xxxxxxx Xx,
3
specifically in the area Negative Regulators and desires to obtain certain
rights, as described herein, to the intellectual property resulting from that
sponsored research.
WHEREAS the Licensed Products to be developed by Licensee for therapeutic use
may consist of one or more Positive Regulators, one or more Negative Regulators
or combinations of Positive and Negative Regulators, based on the results of the
sponsored research to be developed both in the laboratory of Xx. Xxxxx Xxxxxxxx
and Dr. Xxxxxxx Xx;
WHEREAS, Licensee has represented to CMCC that Licensee is ready, willing and
able to engage in the commercial development, production, manufacture, marketing
and sale of Licensed Products (as that term shall be defined hereafter) and/or
the use of Licensed Processes (as that term shall be defined hereafter) and that
it will implement a thorough, vigorous and diligent development program as
described in this Agreement;
WHEREAS, Licensee desires to obtain an exclusive license, within a designated
territory and for a prescribed field of use, relating to certain licensed
products and processes within the scope of the Patent Rights, subject to the
terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the promises and the mutual covenants
contained herein, the parties hereto agree as follows:
ARTICLE I. DEFINITIONS
For the purpose of this Agreement, the following words and phrases shall have
the meanings set forth below:
A. "Affiliate" shall mean any company or other legal entity actually
controlling, controlled by or under common control with Licensee. For
purposes of the definition of "Affiliate" the term "control" shall mean:
(i) in the case of a corporate entity, the ability to effect the election
of directors, or in the case of a for-profit entity direct or indirect
ownership of at least a majority of the stock or participating shares
entitled to vote for the election of directors of that entity, in any case
coupled with active managerial involvement and accountability for directing
the business and affairs of that entity; (ii) in the case of a partnership,
the power customarily held by a managing partner to direct the management
and policies of such partnership, provided that such power is actively
exercised; or (iii) in the case of a joint venture, whether in corporate,
partnership or other legal form, a prevailing joint economic interest
coupled with a managerial role entailing active direction, control and
accountability with respect to the business and affairs of the entity.
B. "Analogue Inventions" shall mean inventions conceived and reduced to
practice during the Sponsored Research Program, generally related to the
subject matter described in the claims or specifications of the Patent
Rights, that (i) CMCC owns or has sufficient rights to transfer to
Licensee; (ii) derive from the activities of Xx. Xxxxx Xxxxxxxx and/or
others in his laboratory while at CMCC; (iii) are invented in the
performance of and with funding provided by Licensee under the Sponsored
Research Program; (iv) are not identified for further development by
Licensee as a Licensed Product either directly or through a sublicense in
the accepted Development Plan; (v) are in the same biochemical
4
pathway or are therapeutically active biochemical analogues of products
identified by Licensee for development in the accepted Development Plan;
and (vi) are identified by Licensee as being potential but less desirable
therapeutic alternatives, for the same indications, to identified products
to be developed under the accepted Development Plan, and confirmed as
Analogue Inventions pursuant to Section II.L hereof.
C. "Biological Materials" shall mean the CMCC specific proprietary biological
materials listed in Appendix 2, such list to be provided by Licensee after
discussion with Xx. Xxxxxxxx (including Progeny and Unmodified Derivatives
of those materials, but excluding Modifications except to the extent they
incorporate such materials), which may be updated from time to time upon
mutual written agreement of the Intellectual Property Office of CMCC and
Licensee. For purposes of this definition, Progeny shall mean an unmodified
descendant from the Material, such as a virus from virus, cell from a cell,
or organism from an organism; Unmodified Derivatives shall mean substances
created by the Licensee which constitute an unmodified functional subunit
or product expressed by the original Material (such as subclones of
unmodified cell lines, purified or fractionated subsets of the original
Material, proteins expressed by DNA/RNA, or monoclonal antibodies secreted
by a hybridoma cell line); and Modifications shall mean substances created
by the Licensee which contain or incorporate the Material.
D. "CMCC Multiple Factor Product(s) or Process(es)" shall mean any Licensed
Product(s) or Processes(es) that contains more than one Positive Regulator,
more than one Negative Regulator or a combination of Positive and Negative
Regulators.
E. "Combination Product(s) or Process(es)" shall mean a product or process
that includes a Licensed Product or Licensed Process sold in combination
with another component(s) whose manufacture, use or sale by an unlicensed
party would not constitute an infringement of the Patent Rights licensed in
this Agreement.
F. "Field of Use" shall mean treatment of Central and Peripheral Nervous
System diseases or conditions in humans in the subfields of [**].
G. "First Commercial Sale" shall mean, with respect to each country: (i) the
first sale of any Licensed Product or Licensed Process by Licensee or any
Sublicensee, following approval of such Licensed Product's or Licensed
Process's marketing by the appropriate governmental agency, if any such
approval is necessary, for the country in which the sale is to be made; or
(ii) when governmental approval is not required, the first sale in that
country of the Licensed Product or Licensed Process.
H. "Improvements" shall mean any modification or improvement directed to the
subject matter described in the claims or specifications of the Patent
Rights; (i) which CMCC owns or has sufficient rights to transfer; (ii)
deriving from the activities of Xx. Xxxxx Xxxxxxxx and/or others in his
laboratory while at CMCC; (iii) discovered or invented in the performance
of and with funding under the Sponsored Research Program and within the
scope of said Program. In addition, subject to the same terms (i), (ii) and
(iii) of this Article H, Improvements shall also include any new factors or
targets affecting axon regeneration. Improvements do not include New
Developments.
5
I. "Joint Patent Rights" shall mean patent applications or patents on
inventions made jointly by employees of Licensee and employees of CMCC
during the course of the Sponsored Research Program. The inventorship for
the Joint Patent Rights shall be determined by U.S. patent law.
J. "Know-how" shall mean unpatented manufacturing and scientific information,
including, chemical manufacturing data, toxicological data, pharmacological
data, preclinical data, assays, platforms, formulations, specifications,
and quality control testing data, (i) in the Field of Use; (ii) which CMCC
owns or has sufficient rights to license hereunder; (iii) deriving from the
activities of Xx. Xxxxx Xxxxxxxx and/or others in his laboratory while at
CMCC and prior to the Effective Date or developed under and within the
scope of the Sponsored Research Program; and (iv) that are necessary or
useful and related to the development or manufacture of Licensed Products.
In addition, Know-how shall also include unpatented Improvements.
K. "Licensed Product" shall mean any product or part thereof in the Field of
Use:
1. The manufacture, use or sale of which would infringe any one of the
issued, unexpired claim(s) or any one of the pending claim(s)
contained in the Patent Rights in any country within the Territory. (A
claim of any issued, unexpired Patent Right shall be presumed to be
valid unless and until it has been held to be invalid by a final
judgment of a court of competent jurisdiction from which no appeal can
be or is taken); or
2. The manufacture or use of which uses a "Licensed Process" as that term
shall be defined hereafter; or
3. Is a Licensed Process.
4. Is a CMCC Multiple Factor Product(s) or Process(es)
L. "Licensed Process" shall mean any process that would infringe any one of
the issued, valid, enforceable, unexpired claim(s) or any one of the
pending claim(s) contained in the Patent Rights in any country in the
Territory. A claim of any issued, unexpired Patent Right shall be presumed
to be valid unless and until it has been held to be invalid by a final
judgment of a court of competent jurisdiction from which no appeal can be
or is taken.
M. "Licensee" shall mean Licensee, and successors and assignees permitted by
this Agreement (including Affiliates where they are assignees permitted by
this Agreement).
N. "Net Sales" shall mean the gross sales price billed, invoiced, or received
(whichever occurs first) for sales, leases, or other transfers of Licensed
Products received by Licensee, its Affiliates, its agents, or its
Sublicensees for any Licensed Products to a final customer who will be an
end user of the Licensed Product and is not an Affiliate or Sublicensee,
less (to the extent appropriately documented) the following amounts:
6
(a) credits and allowances for price adjustment, rejection, or return
of Licensed Products previously sold;
(b) rebates, quantity and cash discounts to purchasers allowed and
taken;
(c) amounts for third party transportation, insurance, handling or
shipping charges to purchasers;
(d) taxes, duties and other governmental charges levied on or
measured by the sale of Licensed Products, whether absorbed by
Licensee or paid by the purchaser so long as Licensee's price is
reduced thereby, but not franchise or income taxes of any kind
whatsoever;
(e) for any sale in which the United States government, on the basis
of its royalty-free license pursuant to 35 USC Sec. 202(c) to any
Patent Right, requires that the gross sales price of any Licensed
Product subject to such Patent Right, be reduced by the amount of
such royalty owed Licensor, the amount of such royalty.
Net Sales also includes the fair market value which shall be mutually
agreed in good faith between the parties of any non-cash consideration
received by Licensee or any Sublicensee for the sale, lease, or transfer of
Licensed Products. Transfer of a Licensed Product within Licensee or
between Licensee and an Affiliate for sale by the transferee shall not be
considered a Net Sale for purposes of ascertaining royalty charges. In such
circumstances, the gross sales price and resulting Net Sales price shall be
based upon the sale of the Licensed Product by the transferee.
O. "New Developments" shall mean inventions and/or technologies (i) discovered
or invented in the performance of the Sponsored Research Program, (ii)
funded by and within the scope of the Sponsored Research Program, (iii) but
not directed to the subject matter specifically described by the
specification or claims of Patent Rights and (iv) is not a new factor or
target affecting axon growth. New Developments do not include Improvements.
P. "Patent Rights" shall mean all of the following intellectual property which
CMCC owns or has rights to during the Term of this Agreement as hereafter
defined, including:
1. The United States and foreign patents and/or patent applications
listed in Appendix 3 attached hereto and incorporated herein by
reference and divisionals and continuations thereof.
2. The United States and foreign patents issued from the applications
listed in Appendix 3 and from divisionals and continuations of those
applications.
3. Claims of United States and foreign continuation-in-part applications,
and of the resulting patents, which are directed to the subject matter
specifically described in the United States and foreign patent
applications described in Appendix 3.
7
4. Claims of all later filed foreign patent applications, and of the
resulting patents, which are directed to the subject matter
specifically described in the United States patent and/or patent
applications described in subparagraphs 1, 2 or 3 of this Article I,
Section P.
5. Any reissues, divisions, amendments or extensions of the United States
or foreign patents described in subparagraphs 1, 2, 3 or 4 of this
Article I, Section O. Patent Rights shall include Improvements upon
Licensee's request if accompanied by an acceptable Development Plan or
an amendment to the Development Plan relating to such Improvements as
described in Section II.A.3 hereof. Subject to Article 11.3. and
Article II. 4. of this Agreement, Patent Rights shall also include
Joint Patent Rights. Notwithstanding the foregoing, Patent Rights does
not include New Developments.
Q. "Sponsored Research Program" shall mean the research program sponsored by
Licensee in the laboratory of Xx. Xxxxx Xxxxxxxx while at CMCC starting at
the effective date, in the amounts and under the conditions specified in
the accompanying Sponsored Research Agreement attached as Appendix 4.
R. "Sublicensee" shall mean a person or entity unaffiliated with Licensee to
whom Licensee has granted an arm's length sublicense under this Agreement.
S. "Territory" shall mean worldwide.
T. "Term" shall have the meaning stated in paragraph A of Article XIII.
ARTICLE II. GRANT
A. Subject to the terms of this Agreement, and conditioned on the faithful
performance by Licensee of its obligations, CMCC hereby grants to Licensee:
1. the worldwide right and exclusive license to make, have made, use,
lease sell and sublicense the Licensed Products, and to practice the
Licensed Processes, in the Territory for the Field of Use to the end
of the Term, unless sooner terminated as provided in this Agreement.
2. a non-exclusive license to Know-how, and a non-exclusive license to
use Biological Materials in connection with Licensee's research and
development of Licensed Products and/or Licensed Processes; provided
that such license shall not include the right to sublicense or
transfer such Know-how or Biological Materials except to contractors
of Licensee for the purpose of carrying out the Development Plan.
3. the right to amend Appendix 3 (the Patent Rights) to add Improvements
at any time during the period the Licensee is supporting the Sponsored
Research Program, upon the acceptance by CMCC of the Development Plan
or an amendment to the Development Plan relating to such Improvements.
8
4. the right to amend Appendix 3 (the Patent Rights) to add Analogue
Inventions at any time during the period the Licensee is supporting
the Sponsored Research Program, upon the acceptance by CMCC of the
Development Plan or an amendment to the Development Plan relating to
such Analogue Inventions, pursuant to Section III (C) below.
5. a [**] exclusive option to a license to any issued or pending patent
claims in the New Developments. The time of the option period for each
New Development begins at the time CMCC notifies Licensee, in writing,
of such New Development. During the option period, CMCC and Licensee
agree to negotiate in good faith to establish the terms of a license
agreement granting Licensee exclusive rights to make, have made, use
and sell New Development licensed products in the area of the licensed
application. Such New Development license agreement shall be
consistent with CMCC's customary license to for-profit third parties
for commercial development, and shall include at least the following
provisions: patent prosecution by CMCC with input from Licensee,
payment by Licensee of all past and future patent prosecution costs,
license fees, royalty payments, a commitment by Licensee and any
sublicensee to exert best efforts to introduce the licensed material
into public use as rapidly as practicable, the right of CMCC to
terminate the license should Licensee not meet specified due-diligence
milestones or make required payments or reports, and indemnity and
insurance provisions satisfactory to CMCC and its insurance carrier.
Before receiving such a license, Licensee shall demonstrate to CMCC
that it has appropriate and sufficient available resources, including
liquid financial resources, management experience, and sufficient
scientific, business and other expertise, and that such resources will
be committed to satisfy its obligations under any license; and agree
with CMCC to a development plan which will be included as a term of
the New Development license agreement. If Licensee and CMCC are unable
to sign a license for the New Development within the [**] option
period, at the end of the [**] option period CMCC shall be free to
license the New Developments to third parties without further
obligation to Licensee. If Licensee decides not to pursue said New
Development at any point before the end of the [**] period, Licensee
agrees to inform CMCC of Licensee's decision and CMCC shall be free to
license the New Developments to third parties without further
obligation to Licensee.
B. Notwithstanding anything above to the contrary, CMCC shall retain a
royalty-free, nonexclusive, right to practice and use, and to license for a
nominal fee (such as shipping and handling charges) to other academic
nonprofit research organizations to practice and/or use the Patent Rights,
Licensed Products and Licensed Processes, for research, educational,
clinical and/or charitable purposes only. CMCC shall use reasonable efforts
to notify Licensee of such sublicenses. Any such sublicense shall
specifically exclude and prohibit commercialization of the Patent Rights
unless the sublicensee enters into an agreement with Licensee on terms
consistent with this Agreement but in other respects agreeable to Licensee
in Licensee's sole discretion.
9
C. In order for CMCC to comply with Article II.A (5) above, Licensee agrees
not to solicit the disclosure of new discoveries directly from Xx. Xxxxxxxx
without the knowledge of the CMCC Intellectual Property Office. If Licensee
receives a disclosure from Xx. Xxxxxxxx, Licensee agrees (i) to inform the
CMCC Intellectual Property Office about the new disclosure as soon as
possible, (ii) to keep such disclosure confidential, and (iii) not to use
such disclosure for any purpose, until the CMCC Intellectual Property
Office has been notified. The parties agree that a representative of the
Intellectual Property Office will be invited to attend the biannual annual
report meetings where Xx. Xxxxxxxx will be disclosing new scientific
information obtained in the Sponsored Research Program to Licensee.
D. Notwithstanding any other provision of this Agreement, the license and any
sublicense shall be subject to the rights of the United States government,
if any, under Public Law 96-517, 97-226, and 98-620, codified at 35 U.S.C.
sec. 200-212 and any regulations promulgated thereunder; the obligations of
CMCC under applicable laws and regulations; and Licensee's warranty to
comply with all applicable laws and regulations.
E. Licensee agrees that pursuant to 35 USC Section 204 Licensed Products
leased or sold in the United States shall be manufactured substantially in
the United States as and to the extent required by applicable laws. Upon
the First Commercial Sale and thereafter, Licensee's annual report to CMCC
shall substantiate Licensee's compliance with this provision.
F. The license granted hereunder shall not be construed to confer any rights
upon Licensee by implication, estoppel or otherwise as to any inventions,
discoveries, know-how, technology or other intellectual property not
described in Paragraph A of this Article.
G. As a condition of the license granted hereunder, Licensee hereby
irrevocably covenants and agrees that it will not, directly or indirectly,
in any respect, use non-public information it has acquired in the course of
prosecution of the Patent Rights from CMCC and/or patent counsel
prosecuting the Patent Rights, or non-public information Licensee has
provided, or recommendations made by Licensee that have been implemented in
whole or in part with respect to prosecution of the Patent Rights, to
challenge the Patent Rights or CMCC's ownership of such rights. Any
assignment or sublicense granted by Licensee shall contain an identical
commitment by the assignee or sublicensee.
H. Nothing in this Agreement shall be construed to limit or constrain CMCC, or
any officer, director, employee, member of its medical staff, or of any
CMCC Affiliate, from continuing to engage in related research; or from the
development of related or unrelated inventions, discoveries, rights or
technology, and from practicing, licensing or sublicensing related or
unrelated intellectual property rights arising from inventions occurring
after the Effective Date of this Agreement; or from academic publication
related thereto; or from entering into agreements and other relationships
with other persons or organizations related to matters not directly and
expressly within the scope of this Agreement or from exercising any rights
whatsoever with respect to the Biological Materials and Licensed Know-how.
10
I. Licensee shall have the right to enter into sublicensing agreements with
respect to any of the rights, privileges, and licenses granted hereunder,
subject to the terms and conditions hereof. CMCC agrees that, in the event
CMCC terminates this Agreement for any reason provided hereafter, CMCC
shall provide to known Sublicensees, no less than sixty (60) days prior to
the effective date of said termination, written notice of said termination
at the address specified by Licensee in the notice provided to CMCC under
paragraph I of this Article. If the Sublicensee may, during that sixty (60)
day period, provide to CMCC notice that the Sublicensee: (i) reaffirms the
terms and conditions of this Agreement as it relates to the rights the
Sublicensee has been granted under the sublicense; (ii) agrees to abide by
all of the terms and conditions of this Agreement applicable to
Sublicensees and to discharge directly all pertinent obligations of
Licensee which Licensee is obligated hereunder to discharge; and (iii)
acknowledges that CMCC shall have no obligations to the Sublicensee other
than its obligations set forth in this Agreement with regard to Licensee.
CMCC agrees that, provided that Sublicensee notice is satisfactory, and
Sublicensee is not in breach of its sublicense, CMCC shall grant to such
Sublicensee license rights and terms equivalent to the sublicense rights
and terms which the Licensee shall have granted to said Sublicensee;
provided that the Sublicensee shall remain a Sublicensee under this
Agreement for a period of at least sixty (60) days following receipt of
notice from CMCC.
J. In any event, Licensee agrees that any sublicense granted by it shall
provide that the obligations to CMCC of Articles II (Grant), V (Reports and
Records), VII (Infringement), VIII (Insurance and Indemnification), IX
(Compliance with Laws; Export Controls), X (Non-Use of Names), XI
(Assignment), XII (Dispute Resolution), XIII (Term and Termination) and XV
(General Provisions) of this Agreement shall be binding upon the
Sublicensee, for the benefit of CMCC, as if it were a party to this
Agreement. In addition, every sublicense shall contain within it
requirements for commercially reasonable due diligence in developing or
exploiting the Patent Rights, or selling Licensed Products, as specifically
applicable, shall obligate Licensee to enforce those provisions consistent
with achieving Licensee's obligations pursuant to this Agreement, and shall
make CMCC a third-party beneficiary of the sublicense, with the right, but
not the obligation, to enforce Licensee's rights in the event Licensee
fails to, provided that CMCC has provided Licensee [**] days written notice
to Licensee of CMCC's intention to do so. Licensee agrees to provide to
CMCC notice of any sublicense granted hereunder and to forward to CMCC a
copy of any and all fully executed sublicense agreements within [**] days
of execution. Licensee further agrees to forward to CMCC annually a copy of
such reports received by Licensee from its Sublicensees during the
preceding [**] month period as shall be pertinent to a royalty accounting
under the applicable sublicense and compliance with the other terms of this
Agreement.
K. Licensee shall advise CMCC in writing of any consideration received from
Sublicensees, and, at CMCC's request, provide such information in an
electronic or other format recognizable by CMCC's data processing systems.
Licensee shall not accept from any Sublicensee anything of value in lieu of
cash payments to discharge sublicensee's payment obligations under any
sublicense granted under this Agreement, without the express written
permission of CMCC, which permission shall not be unreasonably
11
withheld but may take into account a reasonable valuation for purposes of
Licensee's payment obligations to CMCC.
L. The parties acknowledge that Sponsored Research Program may yield
inventions that provide less desirable therapeutic alternatives to
inventions selected for development by Licensee, and that licensing by CMCC
of such alternatives to other companies could create barriers to the
successful dissemination of the more desirable therapeutics through
adequate security for corporate investment. Therefore, CMCC covenants and
agrees that it will not license to third parties those Analogue Inventions
that have been mutually identified through the following process, and
subject to the following terms:
(a) the Analogue Inventions have been identified in writing in the
Development Plan accepted by CMCC, or a CMCC-accepted amendment
thereof, which shall further describe how the Analogue Inventions
satisfy the criteria described section I (B) hereof;
(b) CMCC has agreed in writing that the proposed Analogue Inventions
satisfy such criteria, which agreement shall not be unreasonably
withheld, or withheld on grounds other than whether the criteria
of Section I (B) are satisfied;
(c) Licensee agrees, in a binding undertaking, that it shall bear any
additional costs, including patent costs, that arise from
continuing to provide patent protection for the Analogue
Inventions;
(d) Licensee remains in continuing compliance with this Agreement,
including without limitation the Development Plan obligations
with respect to the proposed Licensed Product, identified in the
Development Plan or any amendment thereof, to which the Analogue
Invention relates;
(e) Should Licensee desire to develop and sell an Analogue Invention,
it shall seek to do so through an acceptable amendment to its
Development Plan pursuant to Article III hereof.
ARTICLE III. DUE DILIGENCE AND RELATED MATTERS
A. Licensee, upon execution of this Agreement, shall use best efforts in good
faith to bring one or more Licensed Products to market as soon as
practicable, consistent with sound and legal business practices and
judgment, through a vigorous and diligent program for exploitation of the
Patent Rights. Licensee shall use best efforts to obtain all necessary
government approvals for the manufacture, use, sale and distribution of
Licensed Products. Thereafter, Licensee agrees that until expiration or
termination of this Agreement, Licensee shall continue active and diligent
efforts to keep Licensed Products reasonably available to the public, in
quantities sufficient to meet market demand, in the Territory. In the event
Licensee decides not to exploit a licensed Patent Right, or Field of Use,
it shall promptly inform CMCC in writing and shall surrender to CMCC its
license to that Patent Right or Field of Use.
12
B. For the sake of clarity, the parties agree that three levels of diligence
will apply to the technologies described in this Agreement, as further
described in Appendix 7:
1-Group A: Technologies chosen by Licensee or by a sublicensee for
development as a Licensed Product. Subject to the diligence requirement as
per Paragraph III (C) below. This group specifically includes (i)
Technologies in the Existing Agreements listed in Appendix 1; (ii)
Improvements. Group A specifically excludes Analogue Inventions.
2-Group B: Analogue Inventions: Subject to no diligence requirements,
provided that Licensee is in compliance with the provisions of this Article
applicable to the proposed Licensed Product to which the Analogue Invention
relates.
3-Group C: New Developments. Subject to new due diligence requirements
governed by a new license agreement between CMCC and Licensee if Licensee
exercises the option as per Paragraph II A (4) above.
C. The parties acknowledge that Licensee has provided to CMCC prior to the
date of execution of this Agreement a proposed written development plan
("Initial Development Plan") setting forth critical milestones to be
accomplished by Licensee during the term of this Agreement. The Initial
Development Plan is attached hereto as Appendix 5 and is hereby
incorporated herein by reference. No later than [**] from the Effective
Date of this Agreement, Licensee shall provide to CMCC written notice of
which Positive and/or Negative Regulators covered by the Patent Rights,
including any Improvements, Licensee intends to develop into Licensed
Products, and a selection of at least three subfields in the Field of Use.
Such selection will define the technologies in Group A. In addition, such
written notification will include a commercialization development plan
("Development Plan") setting forth the initial indications and markets for
at least one Licensed Product in each one of the chosen subfields. The
parties have agreed that although Licensee is licensing technologies both
from Xx. Xxxxx Xxxxxxxx through this License Agreement and from Dr. Xxxxxxx
Xx through a companion license agreement, Licensee is required to provide
only one Development Plan for both license agreements in each chosen
subfield. Such Development Plan may include technologies (a) only from Xx.
Xxxxxxxx' laboratory; (b) only from Dr. Xxxxxxx Xx'x laboratory; or (c) a
combination of both. The Development Plan will also include: (i)
time-delimited targets for pre-clinical development, clinical trials,
regulatory approval, manufacturing and marketing that represent reasonable
efforts, consistent with industry norms for similar technology and
applications, to bring Licensed Products and Licensed Processes to the
marketplace; and (ii) actual or projected financial resources and/or
strategic alliances that will be required to implement the Development
Plan. The Development Plan and any amendments to the Development Plan shall
be acceptable to CMCC. All rights granted herein to Patent Rights covering
axonal growth factors in this group, either from Xx. Xxxxxxxx' or Dr.
Xxxxxxx Xx'x laboratory, for which Licensee has not submitted a Development
Plan at the third anniversary of the Effective Date shall automatically
revert back to CMCC, without further action from CMCC. CMCC shall be free
to license such rights to a third party without any further obligations to
Licensee.
13
Analogue Inventions: If at any point Licensee decides to develop a Licensed
Product from an Analogue Invention, Licensee shall notify CMCC in writing
of Licensee's desire to amend Appendix 3 of this Agreement to add Analogue
Inventions and present a development plan for such new Licensed Product.
Upon CMCC's approval of this development plan this Analogue Invention will
become part of Patent Rights in Appendix 3.
D. Licensee shall use good faith and diligent efforts to accomplish the
milestones set forth in the Development Plan and to manufacture and
distribute Licensed Products.
E. Notwithstanding anything above to the contrary, CMCC shall not unreasonably
withhold its consent to any revision of the objective(s) set forth in the
Development Plan when requested in writing in advance by Licensee and the
request is supported by evidence reasonably acceptable to CMCC: (i) of
technical difficulties or delays in the clinical studies or regulatory
process that Licensee could not reasonably have been avoided; (ii) Licensee
is proposing and will implement satisfactory and effective means of
addressing such difficulties or delays, including sufficient financial and
technical resources; and (iii) that Licensee, its Affiliates and/or
sublicensees have in good faith made diligent efforts and expended adequate
resources to meet said objective and will continue to do so.
F. In the event Licensee fails to meet the objective(s) set forth in the
Development Plan in a timely manner, CMCC shall notify Licensee thereof in
writing, and Licensee shall have [**] days following such notification to
establish to the reasonable satisfaction of CMCC that (i) it has met such
objective(s); or (ii) a revision to the Development Plan is necessary and
appropriate as contemplated above. In the event Licensee fails to establish
the same to CMCC's reasonable satisfaction, CMCC shall have the right in
its sole discretion to terminate in whole or in part the license granted to
Licensee under this Agreement effective immediately.
G. If, during the course of this Agreement, Licensee makes any discovery or
invention that is not within the scope of the Patent Rights but would not
have been made but for the Patent Rights, Licensed Products or Licensed
Processes licensed hereunder, Licensee shall, as a condition of this
License, confidentially disclose such discovery or invention to CMCC, on
usual and customary terms necessary to protect its patentability or its
confidentiality as a trade secret. CMCC shall have the right to review in
advance of filing any related patent application by or on behalf of
Licensee or any assignee of Licensee, for purposes of evaluating the
relatedness to the Patent Rights. Recognizing that CMCC enters into this
Agreement in furtherance of its charitable academic research mission,
Licensee shall enter into with CMCC a non-exclusive license or permit, as
applicable, including no more than a nominal fee, to practice such
discovery or invention, whether or not patented, solely for CMCC internal
and academic research purposes. In addition, acknowledging that CMCC is a
charitable organization engaged in academic research for the benefit of the
public, Licensee agrees to offer promptly to CMCC and its investigators a
non-exclusive license to practice or use for internal research purposes any
other patent right, other intellectual property right or materials owned or
licensed by Licensee, which could not have been made but for the existence
of the Patent Rights on terms at least as favorable to CMCC as those on
which such right is made available to
14
others; provided however that this provision shall not be construed to
require Licensee to enter into agreements with CMCC or its investigators
where doing so would violate contractual or other legal obligations of
Licensee entered into before the Effective date of this Agreement; nor
shall any such license or permit require CMCC to convey to Licensee its
ownership of intellectual property arising from such license or permit,
although such an agreement may grant Licensee license options on mutually
agreeable terms.
ARTICLE IV. ROYALTIES AND OTHER PAYMENTS
A. For the rights, privileges and exclusive license granted hereunder,
Licensee shall pay to CMCC the following amounts in the manner hereinafter
provided. Unless expressly stated otherwise in this Agreement, periodic
payment obligations listed below shall endure through the Term of this
Agreement, unless this Agreement shall be sooner terminated as hereinafter
provided:
1. Payments for accrued and continuing patent prosecution costs as stated
in Article VI hereof for Patent Rights, Improvements, Analogue
Inventions and New Developments;
2. Licensee shall make the following payments to CMCC upon the occurrence
of the following events ("Milestones"):
(a) $[**] upon [**];
(b) $[**] upon [**];
(c) $[**] after [**];
(d) $[**] upon [**];
For CMCC Multiple Factor Product(s) or Process(es) it is understood
that Licensee shall pay only one set of milestones for each study in
(c) and (d) above.
(e) Running Royalties in an amount equal to [**] percent ([**]%) of
cumulative Net Sales of up to [**] dollars of Licensed Product(s)
used, leased or sold by and/or for Licensee (including its
Affiliates) in all territories and [**] percent ([**]%) of
cumulative Net Sales of over [**] dollars of Licensed Product(s)
used, leased or sold by and/ or for Licensee (including its
Affiliates). These percentages apply to each Licensed Product
regardless of the number of axonal growth factors are used for
each Licensed Product. The same calculation above i.e., [**]
percent ([**]%) of cumulative Net Sales of up to one hundred
million dollars of Licensed Product(s) and [**] percent ([**]%)
of cumulative Net Sales of over [**] dollars of Licensed
Product(s) will apply each time a new Licensed Product is
released for sale, by and/ or for Licensee (including its
Affiliates).
15
The requirement of Licensee to pay CMCC the Royalties above shall
terminate upon the expiration of the last applicable patents in a
Licensed Product in the country or territory where the Licensed
Product(s) are used, leased or sold by and/or for Licensee (including
its Affiliates), provided, however, that after such expiration of the
patent in the applicable country or territory, Licensee shall continue
to pay half of the values described in those paragraphs for use,
leases and/or sales by Licensee (or its Affiliates) in such country or
territory for eight years after the expiration of the applicable
patents in such country or territory.
For the sake of clarity, Licensed Product(s) developed from
Improvements or from Analogue Inventions are subject to the same
payments as Licensed Products from Existing Technologies and subject
to the payments terms of Article IV hereof;
3. For any year in which royalties are not payable or payments are not
being made under the Sponsored Research Program, a license maintenance
fee of [**] dollars ($[**]) shall be payable on each anniversary of
the Effective Date during the exclusive license period of this
Agreement.
4. In the event Licensee has granted sublicenses under this Agreement,
[**] percent ([**]%) of any and all payments received by Licensee from
said sublicensees in consideration of permitting the sublicensee to
practice the Patent Rights, including but not limited to sublicense
issue fees, any lump sum payments, milestone payments, technology
transfer payments or other similar fees shall be paid to CMCC;
provided that with respect to running royalties in connection with a
sublicensee's sales of Licensed Products, Licensee shall pay to CMCC
hereunder an amount equal to the royalty CMCC would have received from
Licensee if such sales had been made by Licensee.
B. No multiple royalties shall be payable because any Licensed Product or
Licensed Process, its manufacture, use, lease or sale are or shall be
covered by more than one Patent Rights patent application or Patent Rights
patent licensed under this Agreement.
C. To the extent that Licensee is necessarily required to obtain, subsequent
to the date of this Agreement, licenses to third party patents or other
intellectual property that dominates or is dominated by the Patent Rights,
in order to practice the Patent Rights or to produce or sell Licensed
Products in a particular country and avoid infringing such third-party
intellectual property, Licensee may deduct from the running royalty due to
CMCC for that country [**] percent ([**]%) of the royalties due on such
third party patents or intellectual property up to an amount equal to [**]
percent ([**]%) of royalties hereunder, provided that such deduction
reflects a pro rata or other fair apportionment among Licensee and other
royalty obligations of Licensee for required licenses and other
intellectual property of Licensee, as documented by Licensee to CMCC's
satisfaction in royalty reports to CMCC.
D. For purposes of calculating royalties, in the event that a Licensed Product
includes both component(s) covered by a claim of a Patent Right ("Patented
Component") and a component which is diagnostically useable or
therapeutically active alone or in a
16
combination which does not require the Patented Component, and such
component is not covered by a claim of a Patent Right ("Unpatented
Component"), then Net Sales of the Combination Product or Combination
Process shall be calculated using one of the following methods:
1. By [**]; or
2. In the event that no such separate sales are made of the Patented
Component(s) or the Unpatented Components during the applicable
accounting period, Net Sales for purposes of determining royalties
payable hereunder shall be calculated by [**]. Such fully allocated
costs shall be determined by using Licensee's standard accounting
procedures, which procedures must conform to standard cost accounting
procedures.
E. Royalty payments shall be paid in United States dollars in Boston,
Massachusetts, or at such other place as CMCC may reasonably designate
consistent with the laws and regulations controlling in any foreign
country. If the currency conversion shall be required in connection with
the payments of royalties or other amounts hereunder, the conversion shall
be made by using the exchange rate prevailing at Bank of America on the
last business day of the calendar quarterly reporting period to which such
royalty payments relate.
F. Payment of royalties specified in this Article shall be made by Licensee to
CMCC within forty-five (45) days after March 31, June 30, September 30 and
December 31 each year during the Term of this Agreement covering the
quantity of Licensed Products sold by Licensee during the preceding
calendar quarter. The last such payment shall be made within forty-five
(45) days after termination of this Agreement. The royalty payments set
forth in this Agreement shall, if overdue, bear interest until payment at a
per annum rate of four percent (4%) above the prime rate in effect at Bank
of America, Boston, on the due date. The payment of such interest shall not
foreclose CMCC from exercising any other rights it may have as a
consequence of the lateness of any payment.
ARTICLE V. REPORTS, RECORDS AND RELATED MATTERS
A. Licensee shall keep, and shall require its Affiliates and Sublicensees to
keep, full, true and accurate books and records, including books of account
in accordance with generally accepted accounting principles, in sufficient
detail to enable CMCC to determine Licensee's compliance with this
Agreement, including diligence with respect to development, and the royalty
and other amounts payable to CMCC under this Agreement. Said books and
records, including books of account, shall be kept at Licensee's principal
place of business or the principal place of business of the appropriate
division of Licensee to which this Agreement relates. Said books and the
supporting data shall be retained for at least six (6) years following the
end of the calendar year to which they pertain.
B. CMCC shall have the right to inspect, copy and audit, on five (5) days
notice, the books described above from time to time to verify the reports
provided for herein or compliance
17
in other respects with this Agreement. CMCC or its agents shall perform
such inspection, copying and auditing at CMCC's expense during Licensee's
regular business hours.
C. Until the later of First Commercial Sale of a Licensed Product or the last
development milestone, and for such later periods as CMCC shall by written
request from time to time require, Licensee shall provide to CMCC, at least
annually, reasonable detail regarding the activities of Licensee and
Licensee's Affiliates and Sublicensees relative to achieving the objectives
set forth in the Development Plan in a timely manner, including but not
limited to, reports of financial expenditures to achieve said objectives;
research and development activities; names, addresses and actions of all
Sublicensees and affiliates; the progress of obtaining regulatory
approvals, with appropriate documentation (including, without limitation,
applications, reports, and planning documents submitted to the Food and
Drug Administration); strategic alliances and manufacturing, sublicensing
and marketing efforts. Licensee shall also report more frequently, but no
more than quarterly, at CMCC's written request.
D. After first commercial sale, within [**] days ([**]) after the end of each
calendar quarter, Licensee shall deliver to CMCC, at Licensee's expense,
true and accurate reports for the said preceding quarter, giving such
particulars of the business conducted by Licensee, its Affiliates and its
Sublicensees under this Agreement as shall be pertinent to CMCC determining
compliance with this Agreement, including a royalty accounting hereunder
and to verify Licensee's activities with respect to achieving the
objectives of the Development Plan described in Article III above. These
reports shall, at CMCC's request, be provided by Licensee in an electronic
or other format compatible with CMCC's data processing and/or license
management systems. Reports shall include at least the following:
1. Number of Licensed Products and Licensed Processes manufactured and
sold.
2. Total Net Sales for Licensed Products and Licensed Processes sold, by
country.
3. Accounting for all Licensed Products and Licensed Processes sold.
4. Applicable deductions.
5. Total royalties payable to CMCC.
6. Names and addresses of all Sublicensees of Licensee.
7. Payments received by Licensee from Affiliates and Sublicensees.
8. Licensed Products manufactured and sold to the U.S. Government. No
royalty obligations shall arise from sales or use by, for or on behalf
of the U.S. Government in view of a royalty-free, nonexclusive license
that may heretofore have been granted to the U.S. Government.
9. Royalties and Fees received from Sublicensees.
18
10. A listing, with brief descriptions, of any intellectual property
arising from or related to Licensee's or any Sublicensee's practice of
the Patent Rights.
E. On or before the [**] day following the close of Licensee's fiscal year,
Licensee shall provide CMCC with Licensee's certified financial statements
for the preceding fiscal year, including without limitation all statements
reflecting profits and losses from operations, cash balances, and any
management letter.
F. Licensee acknowledges that policies of CMCC, Harvard Medical School and
affiliated organizations, relating to, inter alia, conflicts of interest
and intellectual property, may affect certain direct and indirect
arrangements between inventors and Licensee or related organizations.
During the Term of this Agreement, Licensee shall notify CMCC in writing at
least 30 days before Licensee, or any affiliate of Licensee, or any
organization owned, controlled or influenced by a substantial shareholder
(>5%), officer or director of Licensee, enters into any agreement other
than this License with or involving the inventor(s) of the Invention, or
their family, relatives or members or staff of their laboratories, whether
relating to sponsored research, consulting, board membership, securities,
or otherwise. Licensee's notice to CMCC shall include a detailed
description of all proposed terms and conditions. Licensee shall not enter
into such an agreement if it would violate such policies unless the terms
and conditions of the agreement have been duly approved pursuant to such
policies.
ARTICLE VI. PATENT PROSECUTION
A. CMCC shall apply for, seek prompt issuance of, and maintain during the term
of this Agreement the Patent Rights set forth in Appendix 1. The
specifications of any such patent application and any patent issuing
thereon shall state, to the extent applicable, "This invention was made
with government support under [contract] awarded by [Federal agency]. The
government has certain rights in this invention." The prosecution, filing
and maintenance of all Patent Rights, including Improvements, Analogue
Inventions, and New Developments applications and patents shall be the
primary responsibility of CMCC in its sole discretion, except that Licensee
shall have reasonable opportunities to advise CMCC and shall cooperate with
CMCC in the preparation, filing, prosecution and maintenance of the Patent
Rights, and New Developments applications and patents if such applications
and patents are optioned or licensed to Licensee. CMCC reserves the sole
right to make all final decisions with respect to the preparation, filing,
prosecution and maintenance of such patent applications and patents.
B. Licensee shall reimburse CMCC for all patent costs, past, present and
future incurred by CMCC for the preparation, filing, prosecution and
maintenance of patents underlying the Patent Rights, including Improvements
and Analogue Inventions, and New Developments if such New Developments are
optioned to Licensee. Unpaid patent costs accrued under the Existing
Agreements are currently approximately $[**]. Licensee shall pay such
current costs within [**] days of the Effective Date of this Agreement.
Upon request of CMCC, and only upon such CMCC request, Licensee agrees to
have CMCC's patent counsel directly xxxx Licensee and Licensee shall
directly pay such invoices in compliance with such counsel's customary
business terms, but in any event within thirty
19
(30) days. If Licensee elects to no longer pay the expenses of a patent
application or patent included within Patent Rights, Licensed Products or
Licensed Processes, Licensee shall notify CMCC not less than [**] days
prior to such action and shall thereby surrender its rights under such
patent or patent application. Such notice shall not relieve Licensee from
responsibility to reimburse CMCC for patent-related expenses incurred prior
to the expiration of the [**] day notice period (or such longer period
specified in Licensee's notice). CMCC shall then be free to license its
rights to that patent or patent application to any other party on any other
terms.
C. In the event CMCC elects, in its sole discretion, not to pursue, maintain
or retain a particular Patent Right licensed to Licensee hereunder, then
CMCC shall so notify Licensee and, subject to the rights of the United
States government and any other contractual obligations to research
sponsors, CMCC may, in its sole discretion, and on such terms if any that
the parties may negotiate, authorize Licensee to assume the filing,
prosecution and/or maintenance of such application or patent at Licensee's
expense. In such event, CMCC shall provide to Licensee any authorization
necessary to permit Licensee to pursue and/or maintain such Patent Right,
on such economic and other terms as the parties shall mutually agree.
ARTICLE VII. INFRINGEMENT
A. Licensee and CMCC shall each inform the other promptly in writing of any
alleged infringement by a third party of the Patent Rights in the Field of
Use within the scope of this Agreement and of any available evidence
thereof.
B. During the Term of this Agreement, CMCC shall have the right, but shall not
be obligated, to prosecute at its own expense any infringement of the
Patent Rights and, in furtherance of such right, Licensee hereby agrees
that CMCC may include Licensee as a party plaintiff in any such suit,
without expense to Licensee. The total cost of any such infringement action
commenced or defended solely by CMCC shall be borne by CMCC. CMCC shall
keep any recovery or damages for past infringement derived therefrom.
C. If within [**] months after having been notified of any alleged
infringement, CMCC shall have been unsuccessful in persuading the alleged
infringer to desist and shall not have brought and shall not be diligently
prosecuting an infringement action, or if CMCC shall notify Licensee of its
intention not to bring suit against any alleged infringer then, Licensee
shall have the right, but shall not be obligated, to prosecute at its own
expense any infringement of the Patent Rights, provided, however, that such
right to bring such an infringement action shall remain in effect only for
so long as the license granted hereunder remains exclusive. No settlement,
consent judgment or other voluntary final disposition of the suit may be
entered into without the consent of CMCC, which consent shall not be
unreasonably withheld. Licensee shall indemnify CMCC against any order for
costs that may be made against CMCC in such proceedings.
D. In the event Licensee shall undertake the enforcement and/or defense of the
Patent Rights by litigation pursuant to paragraph C of this section,
Licensee may withhold up to [**] percent ([**]%) of the payments otherwise
thereafter due to CMCC under Article IV
20
above and apply the same toward reimbursement of up to [**] percent ([**]%)
of Licensee's expenses, including reasonable attorney's fees, in connection
therewith. Any recovery of damages by Licensee for each such suit shall be
applied first in satisfaction of any unreimbursed expenses and legal fees
of CMCC and Licensee relating to such suit and next toward reimbursement of
CMCC for any payments under Article IV past due or withheld and applied
pursuant to this Article VII. The balance remaining from any such recovery
shall be divided equally between Licensee and CMCC.
E. In the event that a declaratory judgment action alleging invalidity or
noninfringement of any of the Patent Rights shall be brought against
Licensee, CMCC, at its option, shall have the right, within [**] days after
commencement of such action, to intervene and participate in the defense of
the action at its own expense.
F. In any infringement suit which either party may institute to enforce the
Patent Rights pursuant to this Agreement, the other party hereto shall
cooperate in all reasonable respects and, to the extent reasonably
possible, have its employees testify when requested and make available
relevant records, papers, information, samples, specimens, and the like.
G. Licensee shall during the exclusive period of this Agreement have the sole
right subject to the terms and conditions hereof to sublicense any alleged
infringer for future use of the Patent Rights to the extent licensed by
this Agreement. Any upfront fees paid to Licensee as part of such a
sublicense shall be shared between Licensee and CMCC as they were
receivables under this Agreement.
ARTICLE VIII. UNIFORM INDEMNIFICATION AND INSURANCE PROVISIONS
A. Licensee shall indemnify, defend and hold harmless CMCC, its corporate
affiliates, current or future directors, trustees, officers, faculty,
medical and professional staff, employees, students and agents and their
respective successors, heirs and assigns (the "Indemnitees"), against any
claim, liability, cost, damage, deficiency, loss, expense or obligation of
any kind or nature (including without limitation reasonable attorneys' fees
and other costs and expenses of litigation) incurred by or imposed upon the
Indemnitees or any one of them in connection with any claims, suits,
actions, demands or judgments arising out of any theory of product
liability (including, but not limited to, actions in the form of tort,
warranty, or strict liability) concerning any product, process or service
made, used or sold pursuant to any right or license granted under this
Agreement.
B. Licensee's indemnification under Article VIII, Paragraph A above shall not
apply to any liability, damage, loss or expense to the extent that it is
directly attributable to the negligent activities, reckless misconduct or
intentional misconduct of the Indemnitees.
C. Licensee agrees, at its own expense, to provide attorneys reasonably
acceptable to CMCC to defend against any actions brought or filed against
any party indemnified hereunder with respect to the subject of indemnity
contained herein, whether or not such actions are rightfully brought.
21
D. Beginning at the time as any such product, process or service is being
commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by Licensee or by a sublicensee, Affiliate or agent
of Licensee, Licensee shall, at its sole cost and expense, procure and
maintain commercial general liability insurance in amounts not less than
$2,000,000 per incident and $2,000,000 annual aggregate and naming the
Indemnitees as additional insureds. Such commercial general liability
insurance shall provide (i) product liability coverage and (ii) contractual
liability coverage for Licensee's indemnification under Article VIII,
Paragraphs A through C of this Agreement. If Licensee elects to self-insure
all or part of the limits described above (including deductibles or
retentions which are in excess of $250,000 annual aggregate), such
self-insurance program must be acceptable to CMCC and the Risk Management
Foundation of the Harvard Medical Institutions, Inc. The minimum amount of
insurance coverage required under this Article VIII, Paragraph D, shall not
be construed to create a limit of Licensee's liability with respect to its
indemnification under Article VIII, Paragraphs A through C of this
Agreement.
E. Licensee shall provide CMCC with written evidence of such insurance upon
request of CMCC. Licensee shall provide CMCC with written notice at least
fifteen (15) days prior to the cancellation, non-renewal or material change
in such insurance. Notwithstanding any other term of this Agreement, if
Licensee does not obtain replacement insurance providing comparable
coverage within such fifteen (15) day period, CMCC shall have the right to
terminate this Agreement effective at the end of such fifteen (15) day
period without notice of any additional waiting periods.
F. Licensee shall maintain such commercial general liability insurance during
(i) the period that any such product, process or service is being
commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by Licensee or by a sublicensee, Affiliate or agent
of Licensee and (ii) a reasonable period after the period referred to
above, which in no event shall be less than fifteen (15) years.
G. The provisions of this Article VIII shall survive expiration or termination
of this Agreement.
H. CMCC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION,
ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR ANY EXPRESS OR
IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF
NON-INFRINGEMENT, WITH RESPECT TO ANY MATTER WITHIN THE SCOPE OF THIS
AGREEMENT, INCLUDING WITHOUT LIMITATION ANY WARRANTY WITH RESPECT TO THE
PATENT RIGHTS, LICENSED PRODUCTS, OR ANY PATENT, TRADEMARK, SOFTWARE, TRADE
SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR DATA LICENSED OR
OTHERWISE PROVIDED TO LICENSEE HEREUNDER, AND HEREBY DISCLAIMS THE SAME.
22
ARTICLE IX. COMPLIANCE WITH LAWS; EXPORT CONTROLS
Licensee shall comply with all applicable laws and regulations, including,
without limitation, statutes and regulations affecting drug testing,
development, marketing and distribution; laws and implementing regulations
of the Department of Commerce governing intellectual property in
federally-funded inventions; and Export Administration Regulations of the
United States Department of Commerce issued pursuant to the Export
Administration Act of 1979 (50 App. U.S.C. Section 2401 et. seq.). Licensee
understands and acknowledges that transfer of certain technical data,
computer software, laboratory prototypes and other commodities is subject
to United States laws and regulations controlling their export, some of
which prohibit or require a license for the export of certain types of
technical data, to certain specified countries. CMCC neither represents
that a license shall not be required, nor that if required, it shall be
issued. Licensee hereby agrees and gives written assurance that it will
comply with all United States laws and regulations, and any applicable
similar laws and regulations of any other country, controlling the export
of commodities and technical data, that it will be solely responsible for
any violation of such by Licensee and/or its Affiliates and/or
Sublicensees, and that it will defend and hold CMCC, its affiliates and
their officers, directors, employees, agents, and medical staff harmless in
the event of any legal action of any nature occasioned by such violation,
and any action by any governmental agency or authority, or any other party,
relating to any asserted illegality or regulatory violation in the
development, production, approval, marketing, sale, storage, manufacture,
distribution, export or commercialization of Licensed Products or Licensed
Processes.
ARTICLE X. NON-USE OF NAMES
Licensee represents and agrees that it will not use the name, names, logos
or trademarks of the CMCC or any of its corporate affiliates, nor the name
or photograph or other depiction of any employee or member of the staff of
CMCC or such affiliates, nor any adaptation of any of the foregoing, in any
advertising, promotional, or sales literature without, in each case, prior
written consent from CMCC and from the individual staff member, employee,
or student if such individual's name, photograph or depiction is used.
Notwithstanding the above, Licensee may state that it is licensed by CMCC
under one or more patents and/or applications consistent with this
Agreement, and Licensee may comply with disclosure requirements of all
applicable laws relating to its business, including United States and state
security laws. In addition, Licensee may refer to publications by employees
of Licensor in the scientific literature.
ARTICLE XI. ASSIGNMENT
CMCC may assign this Agreement at any time without the prior consent of
Licensee. Except as otherwise provided herein, this Agreement is not
assignable or delegable, in whole or in part, by Licensee without the prior
written consent of CMCC, which consent shall not be unreasonably withheld,
acting through an authorized designee, and any purported assignment
otherwise shall be void and of no effect.
23
ARTICLE XII. DISPUTE RESOLUTION AND ARBITRATION
A. Any and all claims, disputes or controversies arising under, out of, or in
connection with this Agreement, which have not been resolved by good faith
negotiations between the parties shall be resolved by final and binding
arbitration in Boston, Massachusetts, in accordance with the rules then
obtaining applicable to the appointment of a single arbitrator of the
American Health Lawyers Association, or in the event such arbitration is
not then available under those rules, the rules of the American Arbitration
Association ("AAA"). All expenses and costs of the arbitrators and the
arbitration in connection therewith will be shared equally, except that
each party will bear the costs of its prosecution and defense, including
without limitation attorneys fees and the production of witnesses and other
evidence. Any award rendered in such arbitration shall be final and may be
enforced by either party.
B. Notwithstanding the foregoing, nothing in this Agreement shall be construed
to waive any rights or timely performance of any obligations existing under
this Agreement, including without limitation Licensee's obligations to make
royalty and other payments, and also, unless CMCC has terminated the
License, Licensee's obligation to continue due diligence and development
obligations. Notwithstanding any other provision of this Agreement,
Licensee agrees that it shall not withhold or offset such payments, and
agrees that Licensee's sole remedy for alleged breaches by CMCC is pursuant
to this Article XII.
ARTICLE XIII. TERM AND TERMINATION
A. The Term of this Agreement shall be fifteen (15) years or the life of the
last expiring Patent Right, whichever period is the longer term.
B. Notwithstanding Article XII of this Agreement, CMCC may terminate this
Agreement immediately upon the bankruptcy, insolvency, liquidation,
dissolution or cessation of operations of Licensee; or the filing of any
voluntary petition for bankruptcy, dissolution, liquidation or winding-up
of the affairs of Licensee; or any assignment by Licensee for the benefit
of creditors; or the filing of any involuntary petition for bankruptcy,
dissolution, liquidation or winding-up of the affairs of Licensee which is
not dismissed within ninety (90) days of the date on which it is filed or
commenced; or upon any final judicial or administrative determination that
this Agreement violates, or if continued would violate, in a substantial
manner, any provision of the Federal Internal Revenue Code, applicable
rights of the United States or obligations of CMCC under Title 15 of the
United States Code, or other Federal or State laws applicable to CMCC; or
in the circumstances providing for immediate termination described in
Article III of this Agreement.
C. CMCC may terminate this Agreement upon thirty (30) days prior written
notice in the event of Licensee's failure to pay to CMCC (including without
limitation patent costs, and payments due under the annexed Sponsored
Research Agreement) or royalties due and payable hereunder in a timely
manner, unless Licensee shall make all such payments to CMCC within said
thirty (30) day period. Notwithstanding Article XII of this
24
Agreement, upon the expiration of the thirty (30) day period, if Licensee
shall not have made all such payments to CMCC, the rights, privileges and
licenses granted hereunder shall terminate without further action by CMCC.
D. Except as otherwise provided in Paragraphs B and C above, and
notwithstanding Article XII of this Agreement, in the event that Licensee
shall default in the performance of any obligations under this Agreement or
under the Sponsored Research Agreement, and the default has not been
remedied to CMCC's satisfaction within sixty days (60) after the date of
notice in writing of such default, CMCC may by written notice to Licensee
terminate this Agreement effective immediately or upon such date as CMCC,
in its sole discretion, shall designate in such notice.
E. Licensee shall have the right to terminate this Agreement at any time upon
six (6) months' prior written notice to CMCC, upon payment by Licensee of
(1) all amounts due CMCC through the effective date of termination
including the amounts due under the Sponsored Research Agreement and (2) a
termination fee of $50,000.
F. Upon termination of this Agreement for any reason, nothing herein shall be
construed to release either party from any obligation that matured prior to
the effective date of such termination.
G. If Licensee terminates this Agreement due to adverse results in clinical or
other testing of Licensed Products or Licensed Processes, Licensee shall
make available to CMCC, for purposes of its evaluation of the future
viability of the technology, a summary of such results together with copies
of any government-mandated reports, such as FDA safety reports, made in
connection with the decision to terminate development.
H. Upon or before the effective date of any termination by CMCC or Licensee,
Licensee shall return or destroy all Biological Materials, and certify in
writing to CMCC that it has done so. Licensee hereby consents to an
injunction to compel compliance with this section, in the event it has
failed to comply, and shall reimburse CMCC for all costs and fees of any
litigation undertaken by CMCC to enforce this provision.
ARTICLE XIV. PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS
All notices, reports and/or other communications made in accordance with
this Agreement shall be sufficiently made or given if delivered by hand,
delivered by facsimile (with mechanical confirmation of transmission), or
sent by overnight receipted mail, postage prepaid, or by reasonable,
customary and reliable commercial overnight carrier in general usage, and
addressed as follows:
In the case of CMCC:
Chief Intellectual Property Officer
Intellectual Property Office
Children's Hospital Boston
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
25
Payments shall be transmitted by reliable means to the same addressee,
payable to Children's Hospital Boston.
Wire transfers for CMCC can be made directly to:
Bank Name: Bank of America, 000 Xxxxxxx Xxxxxx, Xxxxxx, XX
ABA#: 000000000
Account name: [**]
Bank Account Number: [**]
Attention: Xxxxx Xxxxxx (phone 000-000-0000)
Reference: Intellectual Property Office
In the case of Licensee:
Chief Financial Officer
Boston Life Sciences, Inc.
00 Xxxx Xxxxxx
Xxxxxxxxx, XX 00000
or such other address as either party shall notify the other in writing.
NOTICE SHALL BE EFFECTIVE UPON RECEIPT.
ARTICLE XV. GENERAL PROVISIONS
A. All rights and remedies hereunder will be cumulative and not alternative.
This Agreement shall be construed and governed by the laws of the
Commonwealth of Massachusetts.
B. This Agreement may be amended only by written agreement signed by the
parties.
C. It is expressly agreed by the parties hereto that CMCC and Licensee are
independent contractors and nothing in this Agreement is intended to create
an employer relationship, joint venture, or partnership between the
parties. No party has the authority to bind the other.
D. This Agreement constitutes the entire agreement between the parties with
respect to the subject matter hereof and supersedes all proposals,
representations, negotiations, agreements and other communications between
the parties, whether written or oral, with respect to the subject matter
hereof. Where inconsistent with the terms of any contemporaneous related
agreements (such as sponsored research agreements), terms in this Agreement
shall control. The Existing License Agreements are hereby terminated; this
Agreement shall govern the rights and obligations of the parties that shall
hereafter arise with respect to all matters within the scope of this
Agreement; and, as to matters heretofore arising, the parties agree that
the execution of this Agreement satisfies any mutual obligations between
them, including without limitation any obligations arising under the
development plan required by the Existing License Agreements.
Notwithstanding the foregoing, the Existing Licensing Agreements shall
continue to govern any action or proceeding by third parties based in
claims that arose and accrued
26
before the Effective Date, unless by joint written agreement the parties
agree that this agreement shall control. The parties mutually aver that no
such third party action is known to either.
E. The only provision in common between this Agreement and the companion
license agreement with Dr. Xxxxxxx Xx is that Licensee may submit only one
Development Plan for both agreements. All other provisions shall be defined
for each license agreement and provisions from one agreement shall not
govern provisions in the companion agreement.
F. The parties agree that Improvements and Analogue Inventions discovered
under Xx. Xxxxxxxx Sponsored Research Program shall not be considered
improvements and analogue inventions under Dr. Xxxxxxx Xx'x license
agreement; improvements and analogue inventions discovered under Dr.
Xxxxxxx Xx'x sponsored research program shall not be considered
Improvements and Analogue Inventions under this Agreement.
G. If any provisions of this Agreement shall be held to be invalid, illegal or
unenforceable, the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be impaired thereby.
H. This Agreement may be executed in any number of counterparts, each of which
shall be deemed an original as against the party whose signature appears
thereon, but all of which taken together shall constitute but one and the
same instrument.
I. The failure of either party to assert a right to which it is entitled, or
to insist upon compliance with any term or condition of this Agreement,
shall not constitute a waiver of that right or excuse a similar subsequent
failure to perform any such term or condition by the other party.
J. Licensee agrees to xxxx any Licensed Products sold in the United States
with all applicable United States patent numbers. All Licensed Products
shipped to or sold in other countries shall be marked in such a manner as
to conform with the patent laws and practices of the country of manufacture
or sale.
K. Each party hereto agrees to execute, acknowledge and deliver such further
instruments as may be necessary or appropriate to carry out the purposes
and intent of this Agreement.
L. The paragraph headings contained in this Agreement are for reference
purposes only and shall not in any way affect the meaning or interpretation
of this Agreement.
M. The signatories below each warrant that he or she is duly authorized to
execute this Agreement.
N. The parties agree that during the course of this Agreement, each may come
into possession of confidential and/or proprietary materials or information
through intentional or accidental disclosure by the other. The parties
agree to preserve the confidentiality of all such information known to be
confidential or proprietary, unless the disclosing party consents in
writing, or unless the confidentiality of the material is lost through
other parties not under obligations to preserve its confidentiality.
Licensee and CMCC have
27
signed a mutual Confidentiality Agreement shown in Appendix 6 which is
incorporated to the Agreement by reference.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date last
written below.
CHILDREN'S MEDICAL CENTER LICENSEE
CORPORATION
By: /s/ Xxxxxx Xxxxxxx By: /s/ Xxxx X. Xxxxxx
----------------------------------- ----------------------------------
Name: Xxxxxx Xxxxxxx Name: Xxxx X. Xxxxxx
Title: Director of Licensing Title: President and Chief Operating
Officer
Date: May 10, 2006 Date: May 10, 2006
28
Appendix 1: Existing License Agreements and Existing Technologies
Existing License Agreements(CMCC
Existing Technologies CMCC case number)
--------------------- --------- --------------------------------
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
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Appendix 2: List of Biological Materials (to be provided by Licensee)
30
Appendix 3: Patent Rights
CMCC REF. NO. PATENT/APPLICATION SERIAL NUMBER FILING DATE FILING COUNTRY TITLE
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CMCC REF. NO. PATENT/APPLICATION SERIAL NUMBER FILING DATE FILING COUNTRY TITLE
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CMCC REF. NO. PATENT/APPLICATION SERIAL NUMBER FILING DATE FILING COUNTRY TITLE
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[**] [**] [**] [**] [**]
33
Appendix 4: Sponsored Research Agreement
CHILDREN'S HOSPITAL SPONSORED RESEARCH AGREEMENT
THIS AGREEMENT is entered into this 10th day of May, 2006, by and between
CHILDREN'S HOSPITAL BOSTON, a charitable corporation duly organized and existing
under the laws of the Commonwealth of Massachusetts and having a principal place
of business located at 000 Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx ("CHB") and
Boston Life Sciences Inc., a business corporation duly organized and existing
under the laws of Delaware and having a principal place of business located at
00 Xxxx Xxxxxx, Xxxxxxxxx XX 00000 ("Sponsor").
WHEREAS, Sponsor has entered into a license agreement as of May 10th, 2006,
(the "License Agreement") with CHB; and
WHEREAS, in order to further the objectives of developing and making
certain inventions or technology available to benefit the public, the License
Agreement requires Sponsor to undertake a Research Program; and
WHEREAS, the Research Program is of mutual interest and benefit to Sponsor
and CHB, will further the research and development objectives of Sponsor, and
will further the biomedical and research missions of CHB in a manner consistent
with its status as a non-profit, tax-exempt, teaching hospital and research
organization; and
WHEREAS, Sponsor therefore desires to provide to CHB research funding to
support the Research Program, subject to the terms and conditions stated herein;
and
WHEREAS, Xx. Xxxxx Xxxxxxxx ("Principal Investigator") is a duly qualified
investigator at CHB, who has agreed to conduct the research program as Principal
Investigator at CHB;
NOW, THEREFORE, the parties hereby agree as follows:
1. Research Study and Program
(a) Subject to the terms and conditions of this Agreement, CHB agrees to
use reasonable efforts to cause the Principal Investigator to conduct
the Research Program entitled "Mechanisms of axon regeneration"
("Research Program") in accordance with Appendix A attached hereto and
incorporated herein by reference. The detailed research program plan
("Research Program Plan") shall be determined and mutually agreed upon
by the parties from time to time during the term of this Agreement.
The various Research Program Plans shall be appended to Appendix A and
shall become a part of this Agreement by reference. The Research
Program shall be conducted at CHB by the Principal Investigator and by
such additional research staff working under the Principal
Investigator's supervision as the Principal Investigator shall
reasonably determine in consultation with CHB.
(b) The parties understand that, given the nature and stage of academic
research and the technology licensed in the License Agreement, the
precise course of the
34
research can not be predicted or guaranteed, and that the Principal
Investigator must act with substantial discretion in defining and
redefining the methods of the Research Program from time to time in
his or her sole discretion, subject to the overall purpose of the
Research Program and development milestones and objectives expressed
in the License Agreement.
(c) The parties intend that the Program will be conducted during the
period from April 1, 2006, to March 31, 2009 ("Period of
Performance"), but recognize that it may be necessary to amend this
time period, by mutual written agreement among all parties, because of
matters arising during the course of the research, such as changes in
government regulations, adverse events, and matters outside the
parties' control. In the absence of such a written amendment affecting
duration, the authority of Principal Investigator to expend funds for
the Program in the attached Budget for the Program shall terminate the
later of March 31, 2009 or sixty (60) days following the date the
Principal Investigator sends the Final Program Report to Sponsor.
(d) Subject to paragraph (b) above, any substantial alteration or
amendment to the parameters of the Research Program as expressed in
Appendix A must be approved in writing by CHB, the Principal
Investigator and the Sponsor before being implemented. CHB and Sponsor
will promptly agree to changes required by law, regulations, and
government policies. If an alteration or amendment increases costs,
CHB and Sponsor agree to negotiate in good faith to increase Sponsor's
funding, and Sponsor shall in any event cover all increased costs
caused by Sponsor-initiated or government-required changes and
inflation, including with respect to institutional costs.
(e) Unless otherwise expressly stated in the Research Program, or
otherwise agreed in writing, Sponsor will supply to Principal
Investigator without charge any reagants, test articles, or compounds
identified in Appendix B without any further materials transfer
agreement, and in the event such an agreement is entered into, its
terms shall be subordinate and superceded by the terms of this
Agreement in all respects where inconsistent. Sponsor will timely
comply with all laws and regulations applicable to it in its capacity
as a research sponsor, and will meet any other Sponsor obligations as
described in the License and this Agreement for the Principal
Investigator's conduct of the Research Program. Sponsor will promptly
inform, in writing, both CHB and Principal Investigator of any new
information relevant to Principal Investigator's or CHB's conduct of
the Research Program, including for example any changes in study
design, Sponsor discoveries relevant to the Program, and suspensions
or debarments of other institutions or co-investigators under the
Protocol.
(f) Sponsor acknowledges that the Principal Investigator is engaged in
certain other research projects as listed in Appendix C attached
hereto and that such projects, as well as any projects unrelated to
the subject matter hereof, are not subject to this Agreement and are
explicitly excluded from the scope of the Program.
35
2. Funding and Payments
(a) The anticipated Budget for the Research Program is attached as
Appendix B. The Budget is designed to include all of CHB's and
Principal Investigator's costs in conducting the research under the
Research Program. Sponsor agrees, subject to the terms and conditions
of this Agreement, to timely provide CHB funds in an amount equal to
the payments described in the Budget according to the schedule for
payment described therein. In the absence of an express schedule for
payments in the Budget, Sponsor's payments to CHB shall be made (1) in
advance for equipment and other purchases and hires if so indicated on
Exhibit C; (2) upon any milestones indicated in Exhibit B; (3) within
thirty days of receipt for a CHB invoice, for expenses payable only
upon invoice; and (4) otherwise quarterly to arrive at CHB no later
than the end of each calendar quarter. Payments received more than 30
days late shall bear interest at the rate of 1.5% per month.
(b) Payment of all sums due hereunder shall be made when due by check
payable as follows:
Children's Hospital Boston
Research Finance
X.X. Xxx 000000
Xxxxxx, XX 00000-0000
Please reference Investigator and research title.
The check shall be accompanied by an explanation of the amount
paid, with a copy to (a) Manager, Clinical Sponsored Research,
Office of Sponsored Programs, and (b) the Principal Investigator.
(c) All funds received from Sponsor become the property of CHB and shall
be allocated by CHB pursuant to institutional and valid departmental
policies, including with respect to indirect costs, and otherwise at
the sole discretion of the Principal Investigator. Consistent with
paragraph 1(c) above, the Principle Investigator shall without prior
approval of the Sponsor be free to reallocate funds from one line item
to another within categorical limits stated in the Budget for any
year, and from year to year, subject only to policies and procedures
of CHB, as necessary to meet the objectives of the Program. If funding
for any year is not completely expended during that year, the balance
remaining shall be rolled forward and added to the next year's total
funded amount.
(d) Any equipment purchased as part of the Research Program shall be owned
by CHB, shall be physically located at CHB and shall remain the
property of CHB following completion of the Research Program. Any
unexpended balance received in connection with the Research Program
shall be retained and allocated by CHB for support of further
research, education and other academic purposes pursuant to CHB and
valid departmental policies.
36
(e) CHB's taxpayer identification number is [**]. Sponsor's taxpayer
identification number is [**].
(f) Nothing contained herein shall be construed as requiring CHB or the
Principal Investigator or any CHB research staff to work on any
project or process which is prohibited by law or by any international
treaty to which the United States of America is a party, or which may
be harmful or detrimental to public health, patient safety or good
clinical care, or which may be considered to be immoral, or which
violates requirements or conditions of the institutional animal care
and use committee, or institutional review board, as applicable.
3. Information and Reports
(a) CHB agrees that Sponsor shall be advised of the progress of the
Research Program in the form of biannual oral reports and an annual
written report under the supervision of the Principal Investigator
reviewing such progress, during the Period of Performance as specified
in Article I. The parties agree that Sponsor shall invite a
representative from the CHB Intellectual Property Office to such
biannual oral presentations. Unless otherwise stated in the Research
Program, Principal Investigator will submit a final written report for
the Research Program, in a mutually agreeable form, to Sponsor within
[**] days of final completion of all research described in the
Research Program, as amended. Sponsor waives any claim for breach,
including with respect to the subject matter and comprehensiveness of
reports or research status, that could have been avoided through its
exercise of reasonable oversight and prompt communication of any
concerns to CHB and the Principal Investigator with an opportunity to
cure.
(b) Upon reasonable notice and written request, Principal Investigator
will provide accurate status and conflict-of-interest information to
the extent required for Sponsor financial disclosures,
securities-related disclosures, and other statements required by law.
(c) Sponsor or its reasonable designees may visit CHB sites at reasonable
and mutually agreeable times, with reasonable frequency not to exceed
once per quarter during normal business hours, to observe the progress
of the research and review data and results. All such visits shall be
pre-arranged with Principal Investigator. All such visitors shall be
subject to applicable CHB policies concerning identification,
on-premises behavior, and related matters.
(d) All medical/scientific and other communications, reports and notices
shall be delivered by hand, by facsimile or sent by first class,
express or overnight mail postage prepaid, or by a recognized reliable
private carrier (e.g. Federal Express) and addressed as follows:
37
If to Sponsor: Xx. Xxxx Xxxxxx
Boston Life Sciences, Inc.
00 Xxxx Xx.
Xxxxxxxxx, XX 00000
If to CHB: Xx. Xxxxx Xxxxxxxx
Children's Hospital Boston
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
In addition, all such communications arising out of Articles 8, 9, 10 and
11 shall be copied to:
Manager of Corporate Sponsored Research
Children's Hospital Boston
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
(e) All reports submitted to Sponsor under this article 4, whether verbal
or in writing shall be held in confidence by Sponsor, unless otherwise
agreed in writing by CHB and Sponsor.
4. Publications
Sponsor acknowledges that CHB is an academic medical center and that the
Principal Investigator and her/his collaborators and trainees shall be free
to publish the background, methods and results of their research without
restraint or improper influence, in accordance with the highest academic
and publication standards. Solely in order to permit Sponsor an opportunity
to determine if a patentable invention(s) or Sponsor confidential
information is therein disclosed, CHB agrees to use reasonable efforts to
cause the Principal Investigator, and by acknowledging this Agreement the
Principal Investigator accepts her/his obligation, to (i) provide to
Sponsor at least thirty days in advance of submission to a journal a
substantially complete manuscript that includes Program-related data; (ii)
provide notice to Sponsor no later than five working days before submission
for publication or to a conference of any substantially final abstract
reporting on the Program, (with a copy to Sponsor upon request); and (iii)
notify Sponsor thirty days in advance of any conference at which the
results of the Program will be presented without abstract. Sponsor agrees
to hold all such submissions and information in confidence. Sponsor agrees
to notify CHB and the Principal Investigator promptly if any action is
necessary to delete Sponsor confidential information or to secure patent
protection for a patentable invention(s) disclosed in any such material.
Sponsor has no other right to request alteration or deletion of any portion
of the material. CHB will include, in any publication of the results of the
Research Program, acknowledgment of Sponsor's financial support of the
Program. The Principal Investigator shall have the opportunity to
contribute as an author to any publication in which Sponsor participates
arising from the Research Program.
38
5. Confidential Information.
(a) The parties acknowledge that as part of the scientific collaboration
between Sponsor, CHB and the Principal Investigator in connection with
the Research Program, each party, and the Principal Investigator, may
convey confidential and proprietary information and trade secrets
("Confidential Information."). For the term of the Agreement and three
years thereafter, each party agrees to take reasonable steps
calculated to ensure the confidential treatment of any information,
including appropriate policies, educating involved staff, employees,
and agents on their confidentiality obligations. Subject to the
provisions of Article 5, with respect to the Principal Investigator
and related investigatory staff, associates and trainees, CHB's
obligations shall be met by (i) advising the Principal Investigator
and his/her associates, co-workers and staff not to publicly divulge,
disseminate, publish or otherwise disclose any Sponsor Confidential
Information without Sponsor's prior written consent, which consent
shall not be unreasonably withheld, except as permitted by Article 5;
(ii) to request the Principal Investigator to limit access to Sponsor
Confidential Information to those of his/her associates, co- workers
and staff who have a need for such Sponsor Confidential Information in
connection with the Program, and (iii) to request the Principal
Investigator to return to Sponsor any documents, drawings, sketches,
designs, products or samples containing Sponsor Confidential
Information, together with any copies thereof, promptly upon
termination of this Agreement or upon Sponsor's request therefore.
(b) Sponsor acknowledges and agrees that none of the information described
in paragraph (a) above will be considered Sponsor Confidential
Information under this Agreement unless Sponsor has disclosed it in
writing to CHB or Principal Investigator and clearly marked it as
confidential, or embodied any verbal disclosure within thirty (30)
days of such verbal disclosure by a writing from Sponsor confirming
such disclosure and indicating that such disclosure is confidential.
In addition, Sponsor Confidential Information shall not include CHB or
Principal Investigator data generated by CHB or the Principal
Investigator or their agents or employees in connection with the
Program, nor does it include information regarding background and
methods needed to satisfy applicable standards of peer review
publications. Nor shall Sponsor Confidential Information include
information which is public knowledge, or which becomes public
knowledge through no fault of CHB or the Principal Investigator; was
already known to or in the possession of CHB or Principal
Investigator; information provided to CHB or Principal Investigator in
good faith by third parties whose possession or disclosure did not
result from a confidentiality breach or breach of this Agreement;
information independently developed by CHB, the Principal
Investigator, or any other CHB investigator, employee or staff member
or appointee. Confidential Information which is required to be
disclosed by law (including patent applications), order or binding
process; or information which would jeopardize patient safety or the
provision of high quality health care to patients or research subjects
if not disclosed, may be disclosed, in which case
39
such disclosure shall be limited to those parties requesting or in
need of the information.
(c) Notwithstanding any term to the contrary, Sponsor agrees that it shall
not hereafter disclose to CHB any information which is Sponsor
Confidential Information: (i) except to the extent necessary for
Sponsor to fulfill its obligations under this Agreement; or (ii)
unless the Principal Investigator has requested such information and
CHB has agreed in writing to accept such disclosure. All other
information and communications between Sponsor and CHB shall be deemed
to be provided to CHB by Sponsor on a non-confidential basis or within
terms.
(d) Sponsor agrees that neither CHB nor Principal Investigator shall be
liable to Sponsor or to any third party claiming by or through Sponsor
for any unauthorized disclosure or use of Sponsor Confidential
Information which occurs despite CHB's compliance with its obligations
under this Agreement.
6. Intellectual Property
In accordance with CHB policies, the Principal Investigator is obligated to
report inventions and discoveries to the CHB Intellectual Property Office
through a Technology Disclosure Form. Within 60 days of receipt of a
substantially complete Technology Disclosure Form disclosing a potentially
patentable invention, the CHB Intellectual Property Office shall
confidentially disclose the invention to Sponsor as well the status of
CHB's current intentions, if any, concerning preparing a patent
application.
(a) Any patentable invention or other discovery conceived or first reduced
to practice solely by CHB or CHB personnel in the performance of the
Research Program shall be owned by CHB, and CHB shall have the sole
right to determine whether CHB shall file patent applications thereon
and CHB shall have the right to determine disposition of any patents
or other rights resulting therefrom subject to Articles II, III and
VI, inclusive, of the License Agreement. By virtue of the License
Agreement, and according to the terms of Articles, II, III and VI of
the License Agreement, Sponsor may:
(i) amend Appendix 3 of the License Agreement to add Analogue
Inventions (as defined in the License Agreement and included in
Appendix D of this Sponsored Research Agreement), at any time
during the period the Licensee is supporting the Sponsored
Research Program, and
(ii) amend Appendix 3 of the License Agreement to add Improvements (as
defined in the License Agreement and included in Appendix D of
this Sponsored Research Agreement), at any time during the period
the Sponsor is supporting the Sponsored Research Program, upon
acceptance by CMCC of the development plan or an amendment to the
development plan relating to such Improvements.
Additionally, Sponsor has a [**] exclusive option to a license to any
patented New Developments (as defined in the License Agreement and included
in Appendix D of this
40
Sponsored Research Agreement), pursuant to Articles II, III and VI of the
License Agreement.
(b) Any patentable invention conceived or first reduced to practice
jointly by CHB or CHB personnel and Sponsor or Sponsor personnel in
the performance of the Program shall be owned jointly by Sponsor and
CHB, and the parties shall determine the filing and disposition of any
patents or other rights resulting therefrom subject to Articles II,
III and VI of the License Agreement, inclusive, of the License
Agreement. By virtue of the License Agreement, and according to the
terms of Articles, II, III and VI of the License Agreement, Sponsor
may:
(i) amend Appendix 3 of the License Agreement to add Analogue
Inventions, at any time during the period the Licensee is
supporting the Sponsored Research Program, and
(ii) amend Appendix 3 of the License Agreement to add Improvements, at
any time during the period the Sponsor is supporting the
Sponsored Research Program, upon acceptance by CMCC of the
development plan or an amendment to the development plan relating
to such Improvements.
Additionally, Sponsor has a [**] exclusive option to a license to any
patented New Developments, pursuant to Articles II, III and VI of the
License Agreement.
(c) This Agreement does not affect the property rights of either party in
effect before the Program has been commenced, or any intellectual
property rights unrelated to the Program.
7. Indemnification
(a) Sponsor shall indemnify, defend and hold harmless Principal
Investigator and CHB and its affiliates and their respective trustees,
directors, officers, medical and professional staff, employees, and
agents and their respective successors, heirs and assigns (the
"Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorney's fees and expenses of litigation)
incurred by or imposed upon the Indemnitees or any one of them in
connection with any claims, suits, actions, demands or judgments
arising out of the Program occurring to any person as a result of his
or her involvement in the Research Program or research related to the
Research Program, including without limitation any action relating to
product liability, misrepresentation of risks in the Program or
informed consent documentation, or negligent design of the Program.
(b) Sponsor's indemnification under (a) above shall not apply to any
liability, damage, loss or expense to the extent that it is directly
attributable to (i) the negligent activities, reckless misconduct or
intentional misconduct of the Indemnitees; or (ii) failure of the
Indemnitees to substantially adhere to the terms of the Program.
41
(c) Sponsor agrees, at its own expense, to provide attorneys reasonably
acceptable to CHB to defend CHB and/or Principal Investigator against
any actions brought or filed against any party indemnified hereunder
with respect to the subject of indemnity contained herein, whether or
not such actions are rightfully brought. Where any are co-defendants,
Sponsor, Principal Investigator and CHB shall coordinate the defense
of such action.
(d) NEITHER CHB NOR PRINCIPAL INVESTIGATOR MAKES ANY WARRANTY, EXPRESS OR
IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO ANY SERVICE OR ARTICLE SUPPLIED BY CHB OR
PRINCIPAL INVESTIGATOR IN CONNECTION WITH THIS PROGRAM, NOR WITH
RESPECT TO ANY PATENT, TRADEMARK, TRADE SECRET, KNOW-HOW, TANGIBLE
RESEARCH PROPERTY, INFORMATION OR DATA PROVIDED TO SPONSOR HEREUNDER,
AND HEREBY DISCLAIMS THE SAME.
8. Termination
This Agreement may be terminated upon the occurrence of any of the
following events:
(a) CHB may terminate this Agreement immediately upon the bankruptcy,
insolvency, liquidation, dissolution or cessation of operations of
Sponsor; or the filing of any voluntary petition for bankruptcy,
dissolution, liquidation or winding-up of the affairs of Sponsor; or
any assignment by Sponsor for the benefit of creditors; or the filing
of any involuntary petition for bankruptcy, dissolution, liquidation
or winding-up of the affairs of Sponsor which is not dismissed within
ninety (90) days of the date on which it is filed or commenced; or
upon a judicial or administrative determination that this Agreement,
or any part of it, substantially jeopardizes the charitable
characterization of CHB under laws of the Commonwealth of
Massachusetts or the exemption of CHB from taxation under the Internal
Revenue Code; or upon the determination of the CHB Institutional
Review Board that the institution's participation in the Program must
terminate, or that conditions for IRB approval have not be met.
(b) CHB may terminate this Agreement immediately in the event Sponsor
engages in criminal, unprofessional or fraudulent conduct, or is
convicted or sanctioned by any governmental agency in connection with
illegal or unethical conduct.
(c) CHB may terminate this Agreement upon sixty (60) days prior written
notice in the event of any material breach by Sponsor of any material
term or condition hereof, if such breach is not cured within said
sixty (60) day notice period; provided, however, that where Sponsor
fails to make payments required hereunder, CHB may terminate this
Agreement upon thirty (30) days prior written notice provided such
breach is not cured within said thirty (30) day notice period together
with payment of applicable interest.
42
(d) Sponsor may also terminate this Agreement upon sixty (60) days prior
written notice of material breach by CHB or the Principal Investigator
if such breach is not cured within that sixty (60) day period.
(e) Unless precluded by the terms of the License Agreement, either party
may also terminate this Agreement at any time upon six (6) months'
notice to CHB.
9. Effect of Termination
(a) Except as otherwise provided herein, termination of this Agreement
shall not be construed to release either party from any obligation
which has matured prior to the effective date of the termination, nor
shall it terminate the obligations of Article 7 and 8 of this
Agreement, and Sponsor shall pay within 30 days after the termination
date all Budgeted costs accrued by CHB or the Principal Investigator
up to the date of termination. In the event termination requires CHB
or the Principal Investigator to terminate the employment of any
staff, or the cancellation of any related services or other contracts,
or the payment of any research subject expenses, Sponsor shall pay the
reasonable and necessary costs of effecting such termination or
cancellation, including any employee severance expenses. In the event
such staff cannot reasonably be terminated promptly, Sponsor will
support their salary continuation until they can be reassigned,
provided that CHB makes reasonable efforts to accomplish such
reassignment. Sponsor shall also reimburse CHB and Principal
Investigator, as the case may be, for any non-cancelable obligations.
(b) No termination by Sponsor shall be effective prior to Sponsor's
completion of the funding of expenses incurred under the Research
Program and Sponsor's express obligations under the License Agreement.
(c) Notwithstanding anything herein to the contrary, in the event Sponsor
terminates this Agreement, or any renewal thereof, without Cause
(hereinafter, cause is the right to discontinue sponsorship in
response to non-performance of a material duty or responsibility due
herein by CHB or the Principal Investigator or, delivery of fraudulent
data by CHB or the Principal Investigator "Cause") or in the event CHB
terminates this Agreement, or any renewal thereof, pursuant to any of
paragraphs (a), (b), or (c) of Article 9, CHB shall be under no
further obligation to grant to Sponsor any further options or licenses
hereunder and CHB may terminate this License and/or any licenses or
options granted to Sponsor prior to the date of any such termination.
(d) Termination of the Sponsored Research Agreement and the License
Agreement shall not relieve the Sponsor of development and funding
obligations stated in the License Agreement.
10. Use of Names
Except as otherwise required by law, and as provided herein with respect to
publication, CHB and Sponsor each agree not to use or cite in any manner
the name, logos or
43
trademarks of each other or any of their corporate affiliates, nor the name
or photograph or other depiction of any employee or member of the staff of
either party or such affiliates, nor any adaptation of any of the
foregoing, in any advertising, promotional, or sales literature without, in
each case, prior written consent from that party and from the individual if
such individual's name, photograph or depiction is used.
11. Assignment
This Agreement is not assignable by Sponsor or CHB, in whole or in part,
without the express written consent of the other party, and any attempt to
do so shall be void unless agreed to in writing by the parties. In the
ordinary course of business, Sponsor may endeavor to assign its interests
in this Agreement to a business successor, approval for which shall not be
unreasonably withheld by CHB.
12. General Provisions
(a) All rights and remedies hereunder will be cumulative and not
alternative, and this Agreement shall be construed and governed by the
laws of the Commonwealth of Massachusetts.
(b) CHB and Sponsor are independent contractors and nothing in this
Agreement is intended to create an employer/employee relationship,
joint venture, or partnership between the parties. Neither party has
the authority to bind the other.
(c) This Agreement, together with the License Agreement, constitutes the
entire agreement between the parties with respect to its subject
matter and supersedes all other proposals, representations, promises,
understandings, negotiations and other communications between the
parties, including Sponsor and the Principal Investigator, whether
written or oral, with respect to the Research Program, test articles,
the Principal Investigator's research (unless embodied in a separate
and unrelated agreement), and any other related matter. There are no
undisclosed or unincorporated additional or conflicting terms or
conditions. This Agreement may be amended only by written agreement
signed by all parties.
(d) If any provisions of this Agreement shall be held to be invalid,
illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions of this Agreement shall not be impaired
thereby.
(e) The failure of either party to assert a right to which it is entitled,
or to insist upon compliance with any term or condition of this
Agreement, shall not constitute a waiver of that right or excuse a
similar subsequent failure to perform any such term or condition by
the other party.
(f) This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original as against the party whose signature
appears thereon, but all of which taken together shall constitute one
and the same instrument.
44
(g) The signatories below each warrant that he or she is duly authorized
to execute this Agreement.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date
first written above.
CHILDREN'S HOSPITAL BOSTON SPONSOR
BY: /s/ Xxxxxxx X. Xxxxxxxx BY: /s/ Xxxx X. Xxxxxx
--------------------------------- ------------------------------------
Xxxxxxx X. Xxxxxxxx, Ph.D. Xxxx X. Xxxxxx, V.M.D., Ph.D.
TITLE Vice President, Research TITLE: President
Administration DATE: May 10, 2006
DATE: 5-16-06
PRINCIPAL INVESTIGATOR ACKNOWLEDGEMENT:
Re: PROGRAM: Mechanisms of Axon Regeneration.
AGREEMENT DATED: _______________
I have read and hereby agree to the terms of the referenced Sponsored Research
Agreement.
BY: /s/ Xxxxx Xxxxxxxx
---------------------------------
Principal Investigator,
Children's Hospital Boston
TITLE: Associate Professor of Neurosurgery
DATE: 5/16/06
45
APPENDIX A: PROGRAM
[**]
46
APPENDIX B: BUDGET AND PAYMENT SCHEDULE
I. Budget
$[**] per year for a period of three years beginning on the effective date of
this Agreement.
II. Payment Schedule
To be paid in equal installments. The first payment is to be due within thirty
(30) days of the Effective Date of this Agreement, subsequent payments due
quarterly from the effective date.
47
APPENDIX C: List of research projects NOT covered by the Research Program.
[**]
48
APPENDIX D
"Analogue Inventions" shall mean inventions conceived and reduced to practice
during the Sponsored Research Program, generally related to the subject matter
described in the claims or specifications of the Patent Rights, that (i) CMCC
owns or has sufficient rights to transfer to Licensee; (ii) derive from the
activities of Xx. Xxxxx Xxxxxxxx and/or others in his laboratory while at CMCC;
(iii) are invented in the performance of and with funding provided by Licensee
under the Sponsored Research Program; (iv) are not identified for further
development by Licensee as a Licensed Product either directly or through a
sublicense in the accepted Development Plan; (v) are in the same biochemical
pathway or are therapeutically active biochemical analogues of products
identified by Licensee for development in the accepted Development Plan; and
(vi) are identified by Licensee as being potential but less desirable
therapeutic alternatives, for the same indications, to identified products to be
developed under the accepted Development Plan, and confirmed as Analogue
Inventions pursuant to Section II.M hereof.
"Improvements" shall mean any modification or improvement directed to the
subject matter described in the claims or specifications of the Patent Rights;
(i) which CMCC owns or has sufficient rights to transfer; (ii) deriving from the
activities of Xx. Xxxxx Xxxxxxxx and/or others in his laboratory while at CMCC;
(iii) discovered or invented in the performance of and with funding under the
Sponsored Research Program and within the scope of said Program. In addition,
subject to the same terms (i), (ii) and (iii) of this Article I.H., Improvements
shall also include any new factors or targets affecting axon regeneration.
Improvements do not include New Developments.
"New Developments" shall mean inventions and/or technologies (i) discovered or
invented in the performance of the Sponsored Research Program, (ii) funded by
and within the scope of the Sponsored Research Program, (iii) but not directed
to the subject matter specifically described by the specification or claims of
Patent Rights and (iv) is not a new factor or target affecting axon growth. New
Developments do not include Improvements.
* Definitions come from the License Agreement to which is herein referred.
* Sponsor = Licensee
* CHB = CMCC
49
Appendix 5: Initial Development Plan
As per Article III, Paragraph C, of the companion License Agreements
(Agreements) entered into by Boston Life Sciences, Inc. (Licensee), and
Children's Medical Center Corporation of Boston (CMCC) for the certain
intellectual property derived in the laboratories of Drs. Xxxxxxxx and He, BLSI
hereby provides "a proposed written development plan ("Initial Development
Plan") setting forth critical milestones to be accomplished by Licensee during
the term of this Agreement," which said Initial Development Plan is appended to
the License Agreements as Appendix 5.
The technologies from the Xxxxxxxx and He laboratories pertaining to Positive
Regulators and Negative Regulators, respectively, which are subject to the
Agreements represent early stage technologies that potentially may be useful in
commercial applications of axon regeneration and functional recovery of
disorders of the central and/or peripheral nervous system. Because these
technologies are at early stages, part of the initial efforts under the Initial
Development Plan will entail the research to be carried out under the Sponsored
Research Agreements, as defined in Appendix 4 of the Agreements and incorporated
herein by reference. Additionally, Licensee will continue to work on its
existing programs pertaining to the pre-clinical and clinical development of the
Positive Regulator inosine, currently being assessed for its potential in stroke
recovery, and the Positive Regulator Oncomodulin for its potential in recovery
from optic nerve injury and/or diseases of the retina.
At present, Licensee believes that, pending the success of the research to be
carried out in the Sponsored Research Agreements and the results of Licensee's
own efforts, within [**] years from the effective date of Agreements, Licensee
will initiate [**]. Within [**] years from the effective date of the proposed
master license agreement, Licensee will initiate [**]. Within [**] years from
the effective date of the proposed master license agreement, initiate [**].
Within [**] years from the effective date of the proposed master license
agreement, initiate [**]. Overall, Licensee anticipates that Licensed Products
will address at least three subfields in the Field of Use.
50
Appendix 6: Confidentiality Disclosure Agreement
This mutual confidentiality agreement (the "Agreement") is made as of the last
date of signature below, between the following "Parties":
I. BOSTON LIFE SCIENCES, INC., a Delaware corporation having a principal
place of business at 00 Xxxx Xxxxxx, Xxxxxxxxx, XX 00000, and each of
its subsidiary companies (together referred to as "BLSI"); and
II. CHILDREN'S HOSPITAL BOSTON, having a place of business at 000 Xxxxxxxx
Xxxxxx, Xxxxxx, XX 00000, and each of employees, affiliates, and
representatives (collectively referred to as the "ORGANIZATION").
AGREEMENT INFORMATION:
Agreement Purpose: To discuss collaborations and exchange information on
axon regeneration technologies, and research,
clinical, and commercial uses thereof as well as the
prospects for a comprehensive sponsored research and
licensing program
Confidentiality Period: Five (5) years beginning the last date of signing of
the Agreement
CONTACT INFORMATION:
BLSI Boston Life Sciences, Inc.
Address: 00 Xxxx Xxxxxx
Xxxxxxxxx, XX 00000
Name: Xxxx Xxxxxx, VMD, Ph.D., MBA
Telephone (000) 000-0000
Facsimile: (000) 000-0000
Email: xxxxxxx@xxxxxxxxxxxxxxxxxx.xxx
Organization Children's Hospital Boston
Address: 000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Name: Xxxxxxxxx X. Xxxxxxxx, Ph.D., MBA
Telephone (000) 000-0000
Facsimile: (000) 000-0000
Email: xxxxxxxxx.xxxxxxxx@xxxxxxxxx.xxxxxxx.xxx
1. The following terms and conditions (the Agreement) shall apply to
Confidential Information exchanged between BLSI and ORGANIZATION, in
connection with the Agreement Purpose further outlined below.
(a) Each Party intends to discuss certain matters relating to axon
regeneration and further, relating to the following proprietary
information (the "Subject Matter"): any and all information relating
to axon regeneration research programs in the laboratories of Drs.
Xxxxx Xxxxxxxx and Xxxxxxx Xx, and research, clinical, and commercial
uses thereof.
(b) Each Party may obtain certain confidential commercial, scientific, and
technical information and data on or related to the Subject Matter
(such information and data together with any information derived there
from, the "Information"). Information shall be subject to the terms of
this Agreement if it is either: (a) disclosed in writing and marked
"Confidential", or (b) if not disclosed in writing, then identified as
confidential when first disclosed and/or summarized in a writing that
is marked "Confidential" and delivered to the receiving Party within
thirty (30) days of such first disclosure.
51
2. Each Party hereby agrees as follows with respect to the Information
provided to it by the other Party:
(a) Such Information shall only be used to determine whether the Parties
will entertain joint activities relating to the Subject Matter and in
connection with such activities. Each Party shall not use the
Information for any other purpose without the prior written consent of
the Party that provided such Information.
(b) Each Party shall treat all Information as confidential and the
exclusive property of the other Party, and shall not disclose any of
the Information to any third party without first obtaining the written
consent of the Party which provided such Information.
(c) Each Party further agrees to take all practicable steps to ensure that
the Information shall not be used by the receiving Party's directors,
officers or employees, except on like terms of confidentiality as
aforesaid, and that it is kept fully private and confidential by them.
(d) If, by mistake, disclosed information includes any identifiable
patient information, the recipient will immediately, upon discovering
such information, or at discloser's request, return it (or any
copies).
(e) The above provisions of confidentiality shall not apply to that part
of the Information which a Party is able to demonstrate by documentary
evidence:
(i) was fully in its possession prior to receipt from the other
Party; or
(ii) was in the public domain at the time of receipt from the other
Party; or
(iii) became part of the public domain through no fault of the
receiving Party, its representatives, directors, officers or
employees; or
(iv) was lawfully received by such Party from some third party having
a right of further disclosure; or
(v) was developed by the receiving Party completely independently as
evidenced by tangible records; or
(vi) required to be disclosed by applicable law or court order or
other valid legal process provided that the Party gives the
other Party prompt written notice of the requisite disclosure
to enable the other Party to seek a protective order or other
appropriate remedy and/or waive compliance with the terms of
this Agreement.
(f) The Confidential Information shall not be deemed to be in the public
domain merely because any part of the Confidential Information is
embodied in general disclosures or because individual features,
components or combinations thereof are published or otherwise known to
the public.
3. Each Party agrees that, at the other Party's request, it shall return to
the other Party all parts of the Information provided by the other Party in
documentary form and shall return or
52
destroy any copies thereof made by such Party, its representatives,
directors, officers or employees, except that each Party's legal counsel
may retain one copy of such documents for determination of any continuing
obligations or record keeping purposes.
4. Nothing herein contained shall be deemed to grant to either party any
rights, title, interest or licenses under any patent applications or
patents or under any know-how, technology or inventions.
5. Each Party acknowledges that disclosure of the Information or use of the
Information contrary to the provisions of this Agreement may cause
irreparable harm for which damages at law may not be an adequate remedy,
and each party agrees that the provisions of this Agreement prohibiting
disclosure or use of the Information contrary to the provisions hereof may
be specifically enforced by a court of competent jurisdiction.
Notwithstanding any rights or remedies provided for herewith, each party
retains all rights to seek injunctive relief to prevent or stop the
unauthorized use or disclosure of Information.
6. All information is provided "AS IS" and without any warranty whatsoever,
whether express, implied or otherwise, including but not limited to any
warranties regarding accuracy, completeness, performance or
non-infringement of third party rights or merchantability or fitness for a
particular purpose and each Party agrees that the disclosing Party shall
have no liability whatsoever to the receiving party resulting from the use
of the Information provided.
7. This Agreement supersedes all prior agreements, written or oral, between
the Parties relating to the Subject Matter. This Agreement may not be
modified, changed or discharged, in whole or in part, except by an
agreement in writing signed by the Parties hereto. This Agreement will be
binding upon and inure to the benefit of the Parties hereto and their
respective heirs, successors and assigns.
8. The confidentiality and non-use obligations under this Agreement shall
expire on the fifth (5th) anniversary starting from the last date of
signing of this Agreement.
Signed for and on behalf of Signed for and on behalf of
BOSTON LIFE SCIENCES, INC. ORGANIZATION
/s/ Xxxx X. Xxxxxx /s/ Xxxxxx X. Xxxxxxxx
------------------------------------- ----------------------------------------
Signature Xxxx X. Xxxxxx, VMD, Ph.D., Signature Xxxxxx X. Xxxxxxxx
MBA Title: Chief Intellectual Property
Title: President and COO Officer
Date: 12-02-05 Date: Nov. 30, 2005
53
Appendix 7: Diligence Requirements for the Technologies Licensed Exclusively
Under this Agreement
Group License Diligence Payments
----- ------- --------- --------
[**] [**] [**] [**]
[**] [**] [**] [**]
[**] [**] [**] [**]
54
