Exhibit 10.21
MASTER LICENSE AGREEMENT
effective September 16, 0000
xxxxxxx
XXXXXXXXXX XX XXXXXXXX, XXXXXXXXX
and
JDA MEDICAL TECHNOLOGIES, INC.
Table of Contents
Article 1. BACKGROUND ................................................ 1
Article 2. DEFINITIONS ............................................... 1
Article 3. GRANT OF LICENSE; OPTION .................................. 4
Article 4. COMPANY RESPONSIBILITIES .................................. 6
Article 5. CONSIDERATION: PAYMENTS ................................... 8
Article 6. DATA ...................................................... 12
Article 7. PATENT PROSECUTION AND PUBLICATIONS ....................... 12
Article 8. CONFIDENTIALITY ........................................... 14
Article 9. REPORTS AND ACCOUNTING .................................... 16
Article 10. INFRINGEMENT .............................................. 18
Article 11. TERM AND TERMINATION ...................................... 20
Article 12. ASSIGNABILITY ............................................. 22
Article 13. APPLICABLE LAW; WAIVER .................................... 22
Article 14. INTEGRATION AND INTERPRETATION ............................ 22
Article 15. REPRESENTATIONS AND WARRANTIES ............................ 23
Article 16. CLAIMS, INDEMNIFICATION AND INSURANCE ..................... 23
Article 17. ADVERTISING AND PUBLICITY ................................. 25
Article 18. DISPUTE RESOLUTION ........................................ 25
Article 19. MISCELLANEOUS ............................................. 26
Signatures ............................................................ 29
ExhibitA-1 p .......................................................... 30
ExhibitA-2 p .......................................................... 31
Confidential
MASTER LICENSE AGREEMENT
for Instant Microspheres for Microarterial Imaging and Radiotherapy
This Master License Agreement ("Agreement") effective September 16, 2003
("Effective Date") is made by and between the University of Maryland, Baltimore
("UM"), a constituent institution of the University System of Maryland, an
agency of the State of Maryland, having an address at 000 Xxxx Xxxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxx 00000, and JDA Medical Technologies, Inc., a corporation of
Maryland, with its principal place of business at 6501 Autumn Xxxx Xxxxxx,
Xxxxxxxxxxx, Xxxxxxxx 00000 ("Company").
ARTICLE 1. BACKGROUND
1.01 As a public research and education institution, UM is interested in
licensing Patent Rights (as defined below) to benefit the public by development
and marketing of new and useful products and methods.
1.02 Valuable inventions ("inventions"), comprised of the Patent Rights
identified in Exhibit A-1, and generally known as "Instant Microspheres for
Microarterial Imaging and Radiotherapy" [Docket Code: BL2003-028], have been
made by Inventors (as defined below).
1.03 Subject to certain rights retained by the federal government in inventions
resulting from federally supported work, under UM policy UM owns all right,
title, and interest in and to the Inventions, which has been confirmed by the
execution of an assignment to UM from each Inventor.
1.04 Company desires to license the Patent Rights as set forth in this
Agreement.
ARTICLE 2. DEFINITIONS
In this Agreement, the following terms have the meanings set forth in this
Article.
2.01 "Affiliate": any entity which directly or indirectly controls, is
controlled by, or is under common control with Company. "Control" means the
right to exercise more than 50% of the voting rights of a controlled
corporation, limited liability company, or partnership, or the power to direct
or cause the direction of the management or policies of any other controlled
entity.
2.02 "Company Data": Information arising out of or resulting from use of the
Patent Rights made by one or more employees of, or owned by, Company or
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Company's affiliates or Sublicensees, including, without limitation, documents,
drawings, models, designs, data, memoranda, tapes, records, formulae and
algorithms, in hard copy form or in electronic form.
2.03 "Company Improvement": Any invention or discovery arising out of or
resulting from use of the Patent Rights which is or may be patentable or
otherwise protected under law, made by one or more employees of, or owned by,
Company or Company's Affiliates.
2.04 "Confidential Information": Information relating to the subject matter of
the Patent Rights which has not been made public and includes, without
limitation, any documents, drawings, sketches, models, designs, data, memoranda,
tapes, records, formulae and algorithms, given orally, in hard copy form, or in
electronic form, which Company receives from UM or UM Personnel, or UM or UM
Personnel receives from Company.
2.05 "First Commercial Sale": The initial transfer of a Licensed Product for
compensation by Company, an Affiliate or a Sublicensee to a Third Party.
Transfer of a Licensed Product for clinical testing occurring prior to the
issuance of any required regulatory approval for sale does not constitute First
Commercial Sale.
2.06 "Inventors": Xxxxx Line, Xxxxx Van Echo, Xxxxxx Xxxxxxx, Xxxxx Xxxxxxxxxx,
and Xxxxx Xxx.
2.07 "Joint Data": Information arising out of or resulting from use of the
Patent Rights made by one or more employees of, or owned by, Company or
Company's Affiliates, and by one or more UM Personnel, or owned by, UM,
including, without limitation, documents, drawings, sketches, models, design,
data, memoranda, tapes, records, formulae and algorithms, in hard copy or
electronic form..
2.08 "Joint Improvement": Any invention or discovery arising out of or resulting
from use of the Patent Rights which is or may be patentable or otherwise
protected under law, made by one or more employees of, or owned by, Company or
Company's Affiliates, and made by one or more employees of, or owned by, UM.
2.09 "Licensed Field": The use of Patent Rights for all purposes.
2.10 "Licensed Product": Any product which is covered by any claims in the
Patent Rights.
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2.11 "Net Sales": The gross sales revenues and fees billed by Company, an
Affiliate or a Sublicensee, for the sale of Licensed Products, less the sum of
the following:
(a) customary trade, quantity and cash discounts actually allowed and
taken;
(b) sales or use taxes, excise taxes and customs duties and other
governmental charges included in the invoiced amount;
(c) outbound transportation, shipping and insurance, prepaid or allowed, if
separately itemized on the invoice to the customer; and
(d) amounts actually allowed or credited on returns or rejections of
Licensed Products or billing errors.
Net Sales does not include any resales of Licensed Product after its sale by
Company, an Affiliate or a Sublicensee to a Third Party purchaser. In computing
Net Sales, (1) no deductions from gross revenues and fees will be made for
commissions paid to individuals, whether they be with independent sales agencies
or regularly employed on the payroll by Company, its Affiliate(s) or
Sublicensee(s), or for cost of collections, and (2) Licensed Products will be
considered sold when billed out or invoiced, whichever is first.
2.12 "Patent Expenses": All fees and charges of outside patent counsel (whether
or not paid by UM or reimbursed to UM) as well as all costs incurred by UM
(including fees, charges, and costs incurred before the Effective Date) in
connection with the preparation, filing, prosecution, issuance, reissuance,
reexamination, interference, and maintenance of applications for patent or
equivalent protection for the Patent Rights, UM Improvements, and/or Joint
Improvements.
2.13 "Patent Rights": UM's interest in:
(a) U.S. and foreign patent applications and patents listed in Exhibit A-1
as of the Effective Date;
(b) any divisions or continuations, or the foreign equivalent of these, of
the U.S. and foreign patent applications described in (a);
(c) foreign patent applications which are filed as the foreign counterparts
of the U.S. patent applications described in (a), and the foreign
equivalent of divisions or continuations of such foreign patent
applications;
(d) U.S. and foreign patents issuing from the applications described in
(a), (b), and (c); and
(e) any reissues, reexaminations or patent-term extensions, or the foreign
equivalent of these, of U.S. and foreign patents described in (a) or (d).
2.14 "Sublicensee": A person or entity, including an Affiliate, to which Company
sublicenses or transfers all or some of the Patent Rights.
2.15 "Third Party": Any entity or person other than UM, Company, an Affiliate or
a Sublicensee.
2.16 "UM Affiliates": University of Maryland Medical System Corporation,
faculty practice organizations of UM, and the Baltimore Veterans Administration
Medical Center.
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2.17 "UM Data": Information in UM's possession received from Inventors prior to
the Effective Date which is directly related to Patent Rights in the Licensed
Field and reasonably necessary for the practice of the Patent Rights by Company
or an Affiliate or Sublicensee under this Agreement. UM Data includes, without
limitation, documents, drawings, models, designs, data, memoranda, tapes,
records, formulae and algorithms, in hard copy form or in electronic form.
Medical or research information which identifies an individual or which may
reasonably be used to identify an individual is expressly excluded from the
definition of UM Data and may not be disclosed by UM, its officers, employees,
students or agents, to Company, Affiliates, Sublicensees or their officers,
servants or agents.
2.18 "UM Improvement": An invention, modification or discovery made by or more
UM Personnel, or owned by UM, which is directly related to the Patent Rights
in the Licensed Field, the practice of which, if unlicensed, would infringe one
or more claims of the Patent Rights, or which, has a similar structure to the
Patent Rights and performs a similar function to that described in the patent
rights in a better or more economical manner, which is or may be patentable or
otherwise protected under law.
2.19 "UM Personnel": Inventors and the students, trainees, and other persons
working with Inventors, using UM resources, and subject to the UM intellectual
property policy (including any prior or future policy).
2.20 "UM Rights in Improvements": UM Improvements and UM's joint interest in
Joint Improvements.
ARTICLE 3. GRANT OF LICENSE; OPTION
3.01 Subject to rights of the United States that may exist under grants to UM
and pursuant to 35 U.S.C, Section 201 et seq. and all implementing regulations,
and subject to Section 3.02, UM grants to Company, and Company accepts, an
exclusive worldwide license under Patent Rights to make, have made, use, lease,
offer to sell, sell and import the Licensed Products within the Licensed Field
for the term of this Agreement. This license includes the right to grant
sublicenses consistent with this Agreement.
3.02 UM specifically reserves the rights:
(a) to practice under the Patent Rights and make and use the Licensed
Products on a royalty-free basis solely for research and education,
and to license universities, colleges, and other research or
educational institutions to practice under the Patent Rights and make
and use the Licensed Products on a royalty-free basis solely for
research and education;
(b) to provide information and material covered by the Patent Rights to
universities, colleges and other research or educational institutions,
but only for research and educational purposes and uses and not for
any commercial purposes or uses; and
(c) to permit UM Personnel to disseminate and publish scientific findings
from research related to Patent Rights subject to the requirements in
Section 7.05, when appropriate.
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3.03 Company may transfer its rights to an Affiliate consistent with this
Agreement, provided Company is responsible for the obligations of its Affiliate
relevant to this Agreement, including the payment of royalties, whether or not
paid to Company by its Affiliate.
3.04 Company may grant sublicenses consistent with this Agreement, provided
Company is responsible for the obligations of its Sublicensees relevant to this
Agreement, including the payment of royalties, whether or not paid to Company by
its Sublicensees.
3.05 Company will identify its Affiliates and its Sublicensees under this
Agreement to UM by name, address and field of sublicense (both as to geography
and subject matter), and will promptly provide to UM a copy of each sublicense
and a copy of each agreement or document designating or establishing an
Affiliate having the right to use the Patent Rights. Company may redact
information from an agreement or document provided however UM is advised of the
nature of the information redacted, Further, each agreement and document must
contain sufficient information for UM to determine that Company, Affiliates and
Sublicensees are operating in accordance with this Agreement, including the
kinds and amounts of consideration exchanged and the schedule and amount of
payments due to Company.
3.06 This Agreement confers no license or rights by implication, estoppel, or
otherwise under any patent applications of UM other than Patent Rights within
the Licensed Field, regardless of whether such patent applications or patents
are dominant or subordinate to Patent Rights within the Licensed Field. Joint
Improvements and UM Improvements are not considered part of Patent Rights
unless added to Exhibit A-1 by proper amendment of this Agreement.
3.07 If Company accepts from Affiliates or Sublicensees anything of value in
lieu of cash in consideration for any sublicense or other transfer of Patent
Rights or Licensed Products, Company must notify UM in writing within 30 days.
3.08
(a) UM Improvements are owned by UM. Joint improvements are owned jointly
by Company and UM. Company Improvements are owned by Company, subject to a
non-exclusive, non-transferable, irrevocable, and royalty-free license to
UM to practice Company Improvements in any field of use for research or
education but not for commercial purposes.
(b) Subject to rights of other parties sponsoring research at UM, Company
has a first option to enter into a license agreement with UM for UM Rights
in Improvements, within the Licensed Field, so long as (i) this Agreement
is in effect, (ii) Company pays Patent Expenses for UM Rights in
Improvements, and (iii) Company has not notified UM that Company declines
to exercise its option. During the term of this option,
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UM Rights in Improvements will be subject to the same patent prosecution
terms and conditions applicable to Patent Rights under Article 7 of this
Agreement.
(c) Company is responsible for the filing, prosecution, and maintenance of
patent applications for Company Improvements unless Company and UM agree
otherwise in writing.
(d) Company may exercise its option to UM Rights in Improvements by giving
written notice to UM within 60 days after Company receives written notice
from UM of a UM Improvement or Joint Improvement in accordance with Section
3.08(f) below, or within 60 days after Company gives written notice to UM
of a Joint Improvement in accordance with Section 3.08(f) below. Company's
exercise of the option initiates a negotiation period of 120 days. If the
negotiation period ends and Company and UM have not executed an amendment
to this Agreement adding all or a portion of UM Rights in Improvements to
the license, UM will be free to license to others all or a portion of UM
Rights in Improvements not licensed to Company.
(e) The terms of any license to Company for UM Rights in Improvements will
include a reservation of a nonexclusive, non-transferable, irrevocable and
royalty-free license to UM to practice UM Rights in Improvements in any
field of use for research and education but not for commercial purposes.
(1) UM will report promptly to Company in writing each UM Improvement
available for option and each Joint Improvement. Company will report
promptly to UM in writing each Company Improvement and each Joint
Improvement. These reports will be in sufficient detail to determine
inventorship. These reports will be treated as Confidential Information.
Inventorship will be determined in accordance with the patent laws of the
United States.
ARTICLE 4. COMPANY RESPONSIBILITIES
4.01 Company will use commercially reasonable efforts to bring one or more
Licensed Products to market in each country in which Patent Rights are licensed
through a thorough, vigorous and diligent program for exploitation of the Patent
Rights within the Licensed Field. Company's efforts must satisfy the following
milestones:
(a) Company has delivered to UM prior to execution of this Agreement a
research and development plan (the "R&D Plan") reasonably acceptable to UM,
showing the amount of money and time budgeted and planned for technical
development of the Patent Rights, and a proposed commercialization scheme
for the Licensed Products.
(b) Within 90 days after the Effective Date, Company will deliver to UM a
business plan (the "Business Plan") showing the amount of money, number and
kind of personnel, and time budgeted and planned for each phase of
development, clinical studies, marketing, manufacturing, and
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sublicensing of Licensed Products. The Business Plan must include Company's
specific plans to secure financing for commercialization of the Invention.
(c) Company will provide quarterly written reports for the first 3 years
after the Effective Date, and annual written reports thereafter, to UM on
progress against the R&D Plan and the Business Plan, including detailed
technical information on the research and development activities related to
the Licensed Products and marketing analyses and any changes in the R&D
Plan or Business Plan.
(d) To the extent that the Company's responsibility for any aspect of the
R&D Plan or Business Plan is made the responsibility of an Affiliate or
Sublicensee, Company retains its obligations to UM as to this Article as if
Company is solely responsible for that aspect.
(e) Company submits an Investigational Device Exemption for a Licensed
Product to the FDA on or before 3 years after the Effective Date.
(f) Company receives Pre-Market Approval for a Licensed Product on or
before 6 years after the Effective Date.
4.02 Company agrees that any Licensed Products for use or sale in the United
States will be manufactured substantially in the United States in accordance
with the requirements of 35 U.S.C. Section 204 and 37 C.F.R. 401.14(a)(i).
4.03 The use and disclosure of technical information acquired pursuant to this
Agreement and the exercise of Patent Rights granted by this Agreement are
subject to the export, assets, and financial control regulations of the United
States of America, including, without limitation, restrictions under regulations
of the United States that may be applicable to direct or indirect re-exportation
of such technical information or of equipment, produats, or services directly
produced by use of such technical information. Company is responsible for taking
any steps necessary to comply with such regulations.
4.04 Company will ensure that "Patent Pending" or the Patent Rights patent
number or both appears on all Licensed Products, their labels or their
packaging.
4.05 Company represents that, as of the Effective Date, it and its Affiliates
qualify as a small business concern that meet the size standards set forth in 13
CFR Part 121 to be eligible for reduced patent fees. Company must provide
written notification to UM immediately upon Company's learning that Company and
its Affiliates no longer qualify as a small business concern or immediately
after Company sublicenses any part of the Patent Rights to an entity that does
not qualify as a small business concern.
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ARTICLE 5. CONSIDERATION: PAYMENTS
In consideration of the license granted to Company of the Patent Rights
listed in Exhibit A-1 as of the Effective Date:
5.01 Company will pay to UM a non-refundable licensing fee of $10,000.00 which
is not creditable against any other fee, royalty, or payment, and is due not
later than 30 days after the Effective Date.
5.02
(a) Company will pay to UM the following commercial milestone payments as
they are met:
(i) FDA approval of Investigational Device
Exemption for a Licensed Product: $ 25,000.00;
(ii) FDA approval of Pre-Market Approval
Application for a Licensed Product: $ 50,000.00;
(iii) Acquisition of a controlling interest in
Company by a Third Party: $100,000.00;
(iv) Completion of first calendar year in which
Net Sales exceed $5,000,000.00: $200,000.00
(b) If Company receives milestone payments from a Sublicensee for any of
the milestones listed in Section 5.02(a), the share of any milestone payments
paid to UM under Section 5.06(b) may be credited toward the milestone payments
required by Section 5.02(a).
5.03 Except to the extent otherwise provided by Sections 5.06 and 5.07, Company
and its Affiliates will pay to UM a running royalty on Net Sales of Licensed
Products covered by Patent Rights as described in Exhibit A-2. Running royalty
payments are due within 60 days after each June 30 and December 31, along with a
report as required by Section 9.02. If no running royalty is due for any
semi-annual period, Company will so report as required by Section 9.02.
5.04 Company will pay UM minimum annual royalties as set forth below, beginning
with a minimum annual royalty due for the calendar year in which the First
Commercial Sale occurs, if the aggregate of all running royalties due under
Section 5.03 and all other creditable fees or payments due under this Article 5
is less than the minimum annual royalty amount for that year. The minimum annual
royalty for each year is $10,000.00. Company will pay UM the difference between
the minimum annual royalty and the total of running royalties and all other
creditable fees or payments due for that calendar year within 60 days after the
end of that calendar year.
5.05
(a) Company and its Affiliates will pay running royalties on a country by
country basis as provided in Section 5.03 for Net Sales in each country of
Licensed Products covered under Patent Rights in that country, until
disallowance, expiration or invalidation of all claims in the Patent Rights
of that country that cover the Licensed Products.
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(b) Except as provided in Section 11.01, on a country by country basis, if
a claim of any patent comprising the Patent Rights is invalidated by a
court of competent jurisdiction from which no appeal is taken, or from
which no further appeal can be taken, UM agrees that it will not terminate
this Agreement but will terminate only the future obligations of Company
pursuant to Article 5 with respect to Licensed Products made under the
invalidated claim(s) and not covered by other claim(s) of the Patent
Rights.
5.06 For Licensed Products sold by a Sublicensee that is not an Affiliate,
Company will pay to UM:
(a) 25% of all royalties received by Company and its Affiliates from the
Sublicensee's Net Sales.
(b) 25% of all licensing, up-front, milestone or other payments received by
Company from the Sublicensee in consideration of its rights as Sublicensee;
and
(c) 25% of the fair market value of non-cash consideration received by
Company under the Sublicensee's license agreement. Non-cash consideration
may be accepted by Company only with UM's prior written approval. If a
Sublicensee's license agreement provides fair market value in cash or non-
cash consideration for the Sublicensee's use of Patent Rights and, in
addition, provides that Company will receive other funds for separate,
reasonable consideration (e.g., payment for Company research, or for the
purchase of Company stock at market price), no royalty is due with respect
to the Sublicensee's payment of such other funds. The fair market value of
non-cash consideration is the greater of the fair market value determined
as of the effective date of the sublicense agreement or the date of
transfer of the non-cash consideration to the Company.
For any sublicense executed by Company (or an Affiliate) and the
Sublicensee two or more years after the Effective Date, the 25% rates specified
in (a), (b) and (c) of this Section 5.06 will be reduced to 15%. Payments under
this Section 5.06 are due within 60 days after each June 30 and December 31,
along with a report as required by Section 9.02.
5.07
(a) In the event that Company or an Affiliate or a Sublicensee is required
to license one or more technologies of a Third Party in order to make, have
made, use, lease, offer to sell, sell or import Licensed Products or to
practice or otherwise make use of the Patent Rights, and is required to pay
a royalty to one or more Third Parties, Company or its Affiliate may deduct
from royalties due to UM 50% of the royalty paid to the Third Party(ies),
but in no event may the royalties due to UM be reduced by more than 50% as
a result of licenses from Third Parties.
(b) In sublicense agreements, Company will not permit Sublicensees that are
not Affiliates to deduct more than 50% of royalties due to Company as a
result of licenses from Third Parties.
5.08
(a) No multiple fees or royalties are payable because any Licensed Product,
its manufacture, use, sale, or lease is or will be covered
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by more than one patent application or patent licensed under this Agreement
as part of Patent Rights.
(b) The aggregate reduction of royalties on Net Sales as a result of
applicability of Sections 5.06 and 5.07 will not exceed 50% of royalties as
calculated with no reduction of royalties on Net Sales as permitted by
those Sections.
5.09
(a) Royalties are payable from the country in which they are earned and are
subject to foreign exchange regulations then prevailing in the country.
Royalty payments must be paid to UM in United States Dollars by check(s)
drawn to the order of UM or by electronic funds transfers to an account
designated by UM. To the extent sales may have been made by Company, its
Affiliates or Sublicensees in a foreign country, those royalties will be
determined first in the currency of the country in which the royalties are
earned, and then converted to their equivalent in United States Dollars.
The buying rates of exchange for converting the currencies involved into
the currency of the United States quoted by the Xxxxxx Guaranty Trust
Company of New York, New York, averaged on the last business day of each of
6 consecutive calendar months constituting the semi-annual period in which
the royalties were earned, will be used to determine any such conversion.
Company will bear any loss of exchange or value or pay any expenses
incurred in the transfer or conversion to U.S. dollars.
(b) To the extent that statutes, laws, codes, or government regulations
(including currency exchange regulations) prevent or limit royalty payments
to UM by Company, its Affiliates or its Sublicensees with respect to Net
Sales received in any country, Company will render to UM annual reports of
sales of Licensed Products in such country. All monies due and owing UM as
provided in the annual reports at UM's option (1) will be deposited
promptly by Company, its Affiliates or its Sublicensees, as the case may
be, in a local bank in such country in an account to be designated by UM in
writing, or (2) will be paid promptly to UM or deposited in its account, as
directed in writing by UM in any other country where the payment or deposit
is lawful under the currency restrictions.
5.10 If Company sells Licensed Products to its Affiliates or Sublicensees for
subsequent resale, no royalty will be due on the sales to Affiliates or
Sublicensees, but royalty will be calculated and paid on the resale of the
Licensed Product to a Third Party. If Company sells Licensed Products to an
Affiliate, Sublicensee, or Third Party in a non-arm's length transaction, and
the Licensed Products are not subsequently resold, the selling price of the
Licensed Products is deemed to be the selling price that would have been
received in an arm's length transaction, based on sales of products of similar
quantity and quality on or about the UMe of such transaction, or, in the
absence of such sales, based upon reasonable pricing practices in Company's
industry.
5.11 Interest is due on any payments to UM required by any Section of this
Agreement that are more than 30 days late. Also, interest is due on any
underpayments of royalties or other amounts payable to UM under this Agreement.
The interest rate is 10% simple interest per annum accruing from the due date.
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5.12 If Joint Improvements and/or UM Improvements are added to Patent Rights by
amendment of Exhibit A-1, the amendment will specify whether and how the terms
of Sections 5.01 to 5.06 are applied to the Patent Rights. There is no
presumption that Joint Improvements or UM Improvements will be licensed upon
the terms and conditions originally provided in those Sections.
5.13 Within 90 days after the Effective Date of this Agreement, Company will
grant UM 664,028 founders shares in Company (10% of total authorized shares) for
and in consideration of this Agreement. Founders shares issued to UM will have
the same rights as those issued to other founders. Company acknowledges that UM
may transfer any or all of its Company shares to another individual or entity at
any time. Company agrees to fully cooperate with UM and to take all actions
necessary to complete the prompt transfer of such Company shares in accordance
with UM's instructions and subject to any restrictions on voting, sale,
transfer, or other matters required by UM. Any document(s) and issued or
reissued stock certificates necessary to accomplish a transfer of Company shares
by UM will be executed by Company and delivered to UM within 30 days after
Company's receipt of UM's request.
5.14 UM's share of total equity in Company will not be diluted to less than 10%
of total authorized shares prior to Company raising $250,000 in paid-in capital.
Shares issued by Company as incentive stock options under an employee stock plan
will not be considered in determining whether UM owns less then 10% of issued
stock, provided that stock options under such plan do not exceed 30% of
authorized shares.
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ARTICLE 6. DATA
6.01 Company Data is owned by Company. Joint Data is owned jointly by Company
and UM. UM Data is owned by UM.
6.02 To the extent permitted by law, UM will keep Company Data and Joint Data
confidential in accordance with Article 8, and Company will keep UM Data and
Joint Data confidential in accordance with Article 8. Any information that would
identify human research subjects or patients will be maintained confidentially
by UM and Company to the extent permitted by law.
6.03 While this Agreement is in effect and Company is pursuing commercialization
efforts, Company will have the right to use UM Data and Joint Data in and for
regulatory filings on behalf of Company or its Affiliates, and UM will have the
right to use Company Data and Joint Data for research purposes. If this
Agreement is terminated or if Company abandons its commercialization efforts,
UM will have (a) the exclusive right to use UM Data and (b) the non-exclusive
right to use Joint Data, for research purposes, and for regulatory filings
related to Patent Rights, and to authorize others to do so, subject to Article
8.
ARTICLE 7. PATENT PROSECUTION AND PUBLICATIONS
7.01
(a) UM is responsible for filing any patent applications for the Patent
Rights, UM Improvements, and Joint Improvements. The scope of patent
coverage within Patent Rights, UM Improvements, or Joint Improvements will
not be significantly modified by UM without prior review by Company, but
any modification will not require the approval of Company, and Company will
not control the prosecution of applications for patents for Patent Rights,
UM Improvements, or Joint Improvements.
(b) Company may approve outside patent counsel chosen by UM, which approval
must not be withheld or delayed unreasonably.
(c) UM will provide Company with copies of all substantive communications
received from and filed with the U.S. Patent and Trademark Office in
connection with the prosecution of patent applications for which Company
pays Patent Expenses.
(d) UM is not liable for any loss, in whole or in part, of a patent term
extension granted by the U.S. Patent and Trademark Office on a patent
issuing under Patent Rights, even if such loss resulted from the acts or
omissions of UM, UM Personnel or UM's patent counsel.
7.02
(a) UM will invoice Company for Patent Expenses incurred by UM prior to and
after the Effective Date with respect to U.S. patents and patent
applications. Company will pay the invoice in full to UM within 30 days
after the date of UM's invoice. Company's failure to pay an invoice on time
will result in interest charges in accordance with Section 5.11 as well as
loss of input into patenting decisions until such UMe as Company pays all
outstanding invoices for Patent Expenses. Additionally, Company's failure
to pay an invoice within 90 days after date of invoice will result in
termination of Company's option rights under Section 3.08.
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(b) With respect to the filing and prosecution of foreign patent
applications specified by Company in accordance with Section 7.04, Company
will pre-pay or directly pay charges and fees, including attorneys' fees,
at UM's option.
(c) If Company does not license UM Improvements or UM's rights in Joint
Improvements, Company will have no obligation under Section 3.08(b) to pay
Patent Expenses related to the UM Improvements or Joint Improvements
incurred by UM for patent filing and prosecution activities occurring more
than 60 days after Company's option is terminated or expires as provided in
Section 3.08. UM will act in good faith to minimize the Patent Expenses
incurred between receipt of notice and the end of the 60 day period.
(d) If this Agreement is terminated for any reason other than expiration in
accordance with Section 11.01, Company will have no obligation to pay
Patent Expenses related to Patent Rights or UM Rights in Improvements
incurred by UM for patent filing and prosecution activities occurring more
than 60 days after termination. UM will act in good faith to minimize the
Patent Expenses incurred between receipt of notice of termination and the
end of the 60 day period.
7.03 Company and UM will cooperate to limit the Patent Expenses while ensuring
that the Patent Rights cover all items of commercial interest and importance. UM
is solely responsible for making decisions regarding scope and content of U.S.
and foreign applications to be filed under Patent Rights and prosecution of the
applications. UM will give Company reasonable opportunity to advise UM. Company
will cooperate with UM in the prosecution, filing, and maintenance of any patent
applications. UM will advise Company promptly as to all material developments
with respect to the applications. Copies of all papers received and filed in
connection with prosecution of applications will be provided promptly to Company
to enable it to advise UM thereon, but only as to those countries designated by
Company pursuant to Section 7.04.
7.04
(a) UM will file patent applications for Inventions and UM Rights in
Improvements in Japan and Canada, the European States (defmed as "EP" on
the international application form of the Patent Cooperation Treaty), and
additional countries specified by Company in accordance with this section.
Company will specify in writing to UM the additional foreign countries in
which patent applications are to be filed and prosecuted. Company will
specify such additional countries no later than 60 days before the national
phase filing deadline for the pertinent patent application. UM will cause
foreign filings to be made by UM's patent counsel, subject to Company's
payment of Patent Expenses as set forth in Section 7.02. If Company gives
at least 60 days prior written notice to UM, Company may elect to
discontinue support for Patent Expenses in any country other than the
United States, Japan, Canada and the European States. Company will be
responsible for reasonable Patent Expenses incurred in that 60 day period
with respect to the country or countries where Company is ceasing support.
From and after UM's receipt of Company's notice, Company's rights in Patent
Rights and UM Rights in Improvements will terminate with respect to the
country or countries where Company is ceasing support, and Company will
execute such documents as reasonably may be requested by UM to confirm
termination of Company's rights.
(b) UM may elect to file and prosecute patent applications, solely at its
own expense, in foreign countries not listed in Section 7.04(a) or not
specified by Company. If UM so elects, UM will notify Company of such
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election. Company shall notify UM in writing within 30 days if it agrees to
support the relevant Patent Expenses in any such country. In the event
Company declines to support the relevant Patent Expenses or Company does
not timely respond to UM's notice, Company will have no right to approve
UM's patent counsel, and no license rights with respect to Patent Rights in
those countries, and no option rights with respect to UM Rights in
Improvements in those countries.
7.05 In order to safeguard Patent Rights and UM Rights in Improvements, UM
will request that UM Personnel not disseminate or publish any results or
otherwise publicly disclose the results of research performed by UM Personnel
relating to the Patent Rights within the Licensed Field and subject to the
license(s) or option granted to Company under this Agreement unless any
materials containing those results are first submitted to Company for review,
comment, and consideration of appropriate patent action. UM will request that
UM Personnel submit such materials relating to a planned written publication or
other public disclosure to Company for review at least 60 days prior to the date
of the planned submission for written publication. Company will advise UM
within 30 days after receipt of the materials whether patent applications should
be filed in connection with obtaining or maintaining Patent Rights related to
the materials submitted by UM. UM will request UM Personnel to delay written
publication or public disclosure up to a maximum of 90 days after the date
Company receives the materials to enable UM to file, at Company's expense, any
patent applications recommended by Company.
ARTICLE 8. CONFIDENTIALITY
8.01 It may be necessary for either party to disclose to the other certain
Confidential Information. Disclosures by UM are deemed to refer to disclosures
by any UM Personnel. Disclosures by Company are deemed to refer to disclosures
by Company officers, directors, employees or agents. Confidential Information
may be disclosed only in accordance with the provisions of this Article.
8.02 Except as hereafter specifically authorized in writing by the disclosing
party, the receiving party will not disclose or use the Confidential Information
for a period of 5 years after the date of receipt of Confidential Information.
8.03 These obligations of non-disclosure and nonuse do not apply to any
Confidential Information which the receiving party can demonstrate by reliable
written evidence:
(a) was generally available to the public at the time of disclosure to the
receiving party; or
(b) was already in the possession of the receiving party at the time of
the disclosure, other than pursuant to a confidential disclosure agreement
between the parties and not due to any unauthorized act by the receiving
party; or
(c) was developed by the receiving party prior to the disclosure; or
(d) the receiving party is required by law to disclose.
8.04 These obligations of non-disclosure and nonuse will not continue to apply
to any Confidential Information which the receiving party can demonstrate by
reliable written evidence.
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(a) has become generally available to the public other than through a
breach of this Agreement by the receiving party after disclosure;
(b) has been acquired by the receiving party on a nonconfidential basis
from any third party having a lawful right to disclose it to the receiving
party; or
(c) corresponds to information developed by the receiving party independent
of and with no reliance upon the disclosing party's Confidential
Information.
8.05 Each party will use that level of care to prevent the use or disclosure of
the other party's Confidential Information as it exercises in protecting its own
Confidential Information.
8.06 All Confidential Information will be clearly marked as confidential by the
disclosing party and, if not in written or tangible form when disclosed, will be
indicated as confidential upon disclosure and then summarized in writing and so
marked as confidential within 30 days after disclosure to the receiving party.
8.07 Notwithstanding the foregoing, Company, its Affiliates and its Sublicensees
are permitted to disclose and use the Confidential Information to the extent
reasonably necessary to exercise Company's license or sublicenses hereunder,
provided that any disclosure is made subject to confidentiality restrictions
consistent with those accepted by Company in this Agreement.
8.08 UM is an educational institution with standards and practices for
protection of Confidential Information which differ from Company's standards and
practices. By this Agreement UM undertakes to use reasonable efforts to protect
the confidentiality of Company's Confidential Information. Company agrees that,
provided such efforts are made, it will not seek to hold UM or UM Personnel
liable in the event of disclosure of Company's Confidential Information.
8.09 The records of UM are subject to the Maryland Access to Public Records Law
(Title 10, Subtitle 6, Part III, State Government Article, Annotated Code of
Maryland).
This Agreement and its Exhibits (whether or not made park of this Agreement) are
public records of UM under the Act. Reports to UM, as provided in Article 9,
are public records of UM. Confidential Information of Company contained in this
Agreement (and its Exhibits) and any other Confidential Information of Company
received by UM is not subject to disclosure in response to a request under the
Act if the Confidential Information is determined to be confidential financial
information, confidential commercial information, or trade secret information as
provided in Section 10-617(d) of the Act. Company asserts that any Confidential
Information of Company provided to UM under this Agreement is confidential
financial or commercial information, or trade secret information, not subject to
disclosure under the Act. Unless UM determines on the advice of counsel that
such position is not reasonable, UM agrees to assert this position in response
to any request for public records applicable to Company's Confidential
Information, and to promptly notify Company upon receipt of such a request.
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8.10 Upon termination of this Agreement for any reason other than those set
forth in Section 11.01 or a material breach by UM, Company will return to UM
all material which is Confidential Information of UM, together with all copies
and other forms of reproduction, except that a single archive copy may be kept
in Company's legal files. Each party agrees that termination of this Agreement
does not alter the 5 year obligation of confidentiality set forth in Section
8.02.
ARTICLE 9. REPORTS AND ACCOUNTING
9.01 During the term of this Agreement and for 5 years after its termination,
Company will keep, and require each Affiliate and Sublicensee to keep, complete,
true, and accurate records containing all the particulars that may be necessary
to enable royalties payable to UM to be determined, and permit these records to
be inspected at any time during regular business hours, upon reasonable notice,
by an independent auditor appointed by UM for this purpose and acceptable to
Company who will report to UM only the amount of royalty payable under this
Agreement. This audit will be at UM's expense unless the audit shows an
underpayment in amounts due to UM in relation to amounts paid to UM by 5% or
more for any semi-annual period (as defined in Section 9.02) subject to audit,
in which case the audit expense will be borne by Company.
9.02 Within 60 days after each June 30 and December 31, Company will deliver to
UM a true and accurate report, giving particulars of the business conducted by
Company, its Affiliates and its Sublicensees, if any, in the preceding
semi-annual period that are pertinent to any accounting for royalties, fees, or
other payments under this Agreement. These reports will be certified as correct
by an authorized officer of Company and will include at least the following
information for the semi-annual period:
(a) number of Licensed Products manufactured and sold by Company and by
each Affiliate and each Sublicensee;
(b) total xxxxxxxx for Licensed Products sold by Company and by each
Affiliate and by each Sublicensee;
(c) accounting for all Licensed Products used or sold;
(d) deductions as provided in Section 2.11; and
(e) names and addresses of all Affiliates and Sublicensees of Company.
9.03 With each report submitted in accordance with Section 9.02, Company must
pay to UM the royalties, fees, or other payments due and payable under this
Agreement for the semi-annual period covered by the report. If no royalties,
fees or other payments are due, Company will so report.
9.04 UM is a unit of the government of the State of Maryland. Where Company, an
Affiliate or a Sublicensee is required to report and withhold for taxation
revenues paid to UM as licensor, Company, the Affiliate or the Sublicensee will
assert that UM is exempt from the tax by virtue of its governmental status. If
the Company, Affiliate, or Sublicensee nevertheless is required to withhold tax,
any tax required to be withheld will be paid promptly by Company or its
Affiliates and its Sublicensees for and on behalf of UM to the appropriate
governmental authority, and Company will furnish UM with proof of payment
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of the tax together with official or other appropriate evidence issued by the
competent governmental authority sufficient to enable UM to support a claim for
tax credit or refund with respect to any sum so withheld. Any tax required to be
withheld on payments by Company to UM will be an expense of and be borne solely
by UM, and Company's royalty payment(s) to UM following the withholding of the
tax will be decreased by the amount of such tax withholding. Company will
cooperate with UM in the event UM elects to seek, at its own expense,
administrative or judicial determination of tax exemption.
9.05 During the implementation of the R&D Plan and Business Plan described in
Section 4.01, and if requested by UM, Company will allow UM to inspect, at any
time during regular business hours and upon reasonable notice, all Company
correspondence to and from any pertinent U.S. regulatory agency and any foreign
equivalent.
9.06 Company will report to UM within 30 days after occurrence, each of the
following:
(a) submission of Investigational Device Exemption;
(b) submission of Pre-Market Approval Application;
(c) approval of Pre-Market Approval Application; and
(d) First Commercial Sale.
ARTICLE 10. INFRINGEMENT
10.01 UM and Company agree to notify each other promptly of each infringement
or possible infringement of the Patent Rights of which either party becomes
aware.
10.02 Company may (a) bring suit in its own name, at its own expense, and on its
own behalf for infringement of presumably valid claims in the Patent Rights
licensed to Company; (b)in any such suit, enjoin infringement and collect for
its use damages, profits, and awards of whatever nature recoverable for such
infringement; and (c) settle any claim or suit for infringement of the Patent
Rights. Company may not compel UM to initiate or join in any such suit for
patent infringement. Company may request UM to initiate or join in any such
suit if necessary to avoid dismissal of the suit. If UM is made a party to any
such suit, Company will reimburse and indemnify UM for any costs, expenses, or
fees which UM incurs as a result of UM's joinder. In all cases, Company agrees
to keep UM reasonably apprised of the status and progress of any litigation.
10.03 If an infringement action or a declaratory judgment action alleging
invalidity or non-infringement of any of the Patent Rights is brought against
Company or raised by way of counterclaim or affirmative defense in an
infringement suit brought by Company under Section 10.02, Company may (a) defend
the suit in its own name, at its own expense, and on its own behalf for
presumably valid claims in the Patent Rights; (b)in any such suit, ultimately
enjoin infringement and collect for its use, damages, profits, and awards of
whatever nature recoverable for such infringement; and (c) settle any claim or
suit for damages or a declaratory judgment involving the Patent Rights. Company
may not compel UM to initiate or join in any such suit. Company may request UM
to initiate or join in any such suit if necessary to avoid dismissal of the
suit. If UM is made a party to any such suit,
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Company will reimburse and indemnify UM for any costs, expenses, or fees which
UM incurs as a result of UM's joinder. In all cases, Company agrees to keep UM
reasonably apprised of the status and progress of any litigation.
10.04 Company will not settle any action described in Section 10.02 or 10.03
without first obtaining the consent of UM, which consent will not be withheld
or delayed unreasonably. In any action under Sections 10.02 or 10.03, the
expenses of Company and UM, including costs, fees, attorney fees, and
disbursements, will be paid by Company. Up to 50% of such expenses may be
credited against the running royalties payable to UM under Article 5 under the
Patent Rights in the country in which such suit is filed. If 50% of such
expenses exceed the amount of running royalties payable by Company in any
royalty year, the expenses in excess may be carried over as a credit on the same
basis in succeeding royalty years. Any recovery of compensatory damages made by
Company, through court judgment or settlement, will be treated as Net Sales and
royalties will be paid by Company to UM in accordance with Article 5. Any other
recovery made by Company, through court judgment or settlement, first will be
applied to reimburse UM for running royalties withheld as a credit against
litigation expenses and then to reimburse Company for its litigation expense.
Any remaining recoveries will be shared equally by Company and UM.
10.05 UM will cooperate fully with Company in connection with any action under
Sections 10.02 or 10.03. UM agrees to provide prompt access to all necessary
documents and to render reasonable assistance in response to requests by
Company.
10.06 UM has a continuing right to intervene in a suit initiated by Company
under Section 10.02 or in a declaratory judgment action involving the Patent
Rights brought against Company under Section 10.03. In either case, if UM
chooses to intervene, UM will be responsible for its litigation expenses and
will be entitled to all recoveries which it obtains for itself as a result of
its intervention.
10.07 If Company desires to initiate a suit for patent infringement under
Section 10.02, Company will notify UM in writing within 90 days after giving or
receiving notice of infringement under Section 10.01. If Company fails to notify
UM of its intent to initiate suit within the 90 day period or if Company
notifies UM that it does not intend to initiate suit, UM may initiate suit at
its own expense. In such case, UM is entitled to all recoveries from such
action.
10.08 If an infringement action or a declaratory judgment action alleging
invalidity or non-infringement of any of the Patent Rights is brought against
Company or raised by way of counterclaim or affirmative defense in an
infringement suit brought by Company as described in Section 10.02, Company will
notify UM whether Company intends to respond in opposition to such legal action
within 10 days after Company's receipt of notice of the filing of such action.
If Company fails to notify UM of its intent to respond in opposition to such
legal action within the 10 day period, or if Company notifies UM that it does
not intend to oppose the action, UM may respond to the legal action at UM's
expense. In such case, UM is entitled to all recoveries from such action.
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10.09 Company will cooperate fully with UM in connection with any action
described in Sections 10.07 or 10.08. Company agrees to provide prompt access to
all necessary documents and to render reasonable assistance in response to
requests by UM.
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ARTICLE 11. TERM AND TERMINATION
11.01 Unless sooner terminated in accordance with any of the succeeding
provisions of this Article 11, this Agreement will continue in full force and
effect until the disallowance, expiration, or invalidation of the last Patent
Right anywhere which is licensed under this Agreement.
11.02 Should Company fail to pay UM any sum due and payable under this
Agreement, UM may terminate this Agreement on 60 days written notice, unless
Company pays UM within the 60 day period all delinquent sums together with
interest due and unpaid. Upon expiration of the 60 day period, if Company has
not paid all sums and interest due and payable, the rights, privileges, and
licenses granted under this Agreement terminate.
11.03 Prior to the First Commercial Sale of a Licensed Product to a Third Party,
Company is considered diligent with regard to development of a Licensed Product
as long as Company updates and reports progress against the R&D Plan and
Business Plan described in Section 4.01 and as long as Company: continues to
provide the necessary financial and other resources which are required to
maintain progress in accomplishing the R&D Plan, as it relates to Licensed
Products; conducts or enables others to conduct the activities required to
maintain scheduled progress in accomplishing the Business Plan, as it relates to
Licensed Products; and meets the deadlines for filing an. Investigational Device
Exemption and receiving Pre-Market Approval as provided in Section 4.01.
11.04 If UM declares Company not diligent in development or sales of Licensed
Product based upon the criteria set forth in Section 11.03, then UM may
terminate this Agreement upon 30 days written notice. The withholding by a
regulatory agency of marketing approval in spite of Company's diligent effort to
obtain such approval may not be the basis for UM to declare Company not
diligent.
11.05 Except as set forth in Sections 11.02, 11.04, or 19.03, in the event that
any provision of this Agreement is breached by Company, any Affiliate or any
Sublicensee, UM may terminate this Agreement and any sublicenses granted
hereunder upon 90 days written notice to Company. However, if the breach is
corrected within the 90 day period and UM is reimbursed for all damages directly
resulting from the breach, this Agreement and any sublicenses will continue in
full force and effect and UM will so notify the Company is writing.
11.06 Company may terminate this Agreement at any time by giving UM 30 days
written notice of termination, and upon payment to UM of all payments maturing
through the effective date of the termination and all Patent Expenses invoiced
by UM within 30 days after the effective date of the termination.
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11.07 Expiration or termination of this Agreement does not relieve either party
of any obligation for payment and reporting which arises before expiration or
termination including obligations under Articles 5 and 9. Articles 10, 15, 16,
17, and 18 and Sections 5.13, 5.14, 6.03, 11.08, 11.09, 11.10, 11.11, 11.12, and
19.11 will survive expiration or termination. Article 8 and Sections 9.01 and
19.02 will survive expiration or termination and will expire in accordance with
their terms. Other sections of this Agreement will be effective after expiration
or termination where that intent is clear from the content of those sections.
11.08 Upon termination of this Agreement for any reason, any Sublicensee not in
default may seek a license from UM.
11.09 Upon and effective as of the date of expiration or termination of this
Agreement, Company, upon UM's request, will transfer to UM a non-exclusive,
non-transferable, irrevocable and royalty-free license with the right to
sublicense others granting UM the right to practice Company Improvements in any
field of use for research and education but not for commercial purposes.
11.10 Upon the effective as of the date of termination of this Agreement for any
reason, Company, upon UM's request, will grant to UM any and all rights to
trademarks and tradenames associated only with Licensed Products. Any written
document(s) necessary to accomplish a transfer of these rights will be executed
by Company and delivered to UM within 30 days after Company's receipt of UM's
request.
11.11 Upon expiration or termination of this Agreement for any reason, at UM's
request, Company will provide UM with a copy of Company Data and Joint Data.
11.12 Upon the expiration or termination of all or part of the license rights of
Company under this Agreement, and at UM's request, Company will execute a
document acknowledging the license rights that have expired or terminated.
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ARTICLE 12 ASSIGNABILITY
12.01 Company may assign this Agreement to an Affiliate or to a successor to all
or substantially all of the Company's assets or business to which this Agreement
relates. Company may not otherwise assign or transfer this Agreement without the
prior written consent of UM, which will not be unreasonably withheld.
12.02 UM may assign this Agreement to a successor-in-interest but UM may not
otherwise assign or transfer this Agreement without the prior written consent of
Company, which will not be unreasonably withheld.
ARTICLE 13. APPLICABLE LAW; WAIVER
13.01 This Agreement is made and construed in accordance with the laws of the
State of Maryland without regard to choice of law issues, except that all
questions concerning the construction or effect of patents will be decided in
accordance with the laws of the country in which the particular patent concerned
has been granted.
13.02 Company submits itself to the jurisdiction of the State courts of the
State of Maryland and Federal courts within the State of Maryland for purposes
of any suit relating to this Agreement, and further agrees that any action
against UM relating to this Agreement will be initiated by Company only in a
court of competent jurisdiction in Baltimore City, Baltimore County, or Xxxxxx
County, Maryland.
13.03 UM and Company waive their rights to trial by jury as to any litigation
between them relating to this Agreement.
ARTICLE 14. INTEGRATION AND INTERPRETATION
14.01 This Agreement, together with any Exhibits specifically referenced and
attached, embodies the entire understanding between Company and UM. There are no
contracts, understandings, conditions, warranties or representations, oral or
written, express or implied, with reference to the subject matter of this
Agreement that are not merged in this Agreement.
14.02 This Agreement is negotiated as an arm's-length business transaction.
Draftsmanship will not be taken into account in construing the Agreement.
14.03 If any condition or provision in any article of this Agreement is held to
be invalid or illegal or contrary to public policy by a court of competent
jurisdiction from which there is no appeal, this Agreement will be construed as
though the provision or condition did not appear. The remaining provisions of
this Agreement will continue in full force and effect.
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ARTICLE 15. REPRESENTATIONS AND WARRANTIES
15.01 UM hereby represents that to the knowledge of the executing UM officer, as
of the date of execution by the officer, (a) as confirmed by assignments from UM
Personnel who are known to be Inventors, UM has full right, title, and interest
in and to the Patent Rights identified in Exhibit A-1 (subject to any rights of
the United States under grants to UM and pursuant to 35 U.S.C. Section 201 et
seq and all implementing regulations); (b) the Patent Rights identified in
Exhibit A-1 are not the subject matter of any currently pending litigation
involving UM, and UM has not been informed of any related litigation
contemplated either by UM or any Third Party; and (c) UM is unaware that any
person disputes inventorship or ownership of Patent Rights as described in this
Agreement. UM warrants that the officer of UM executing this Agreement is
authorized to do so on behalf of UM. UM EXPRESSLY DISCLAIMS ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, AND PATENT
VALIDITY, WITH RESPECT TO PATENT RIGHTS.
15.02 Company hereby represents and warrants to UM that: (a) Company has full
legal right, power and authority to execute, deliver and perform its obligations
under this Agreement; (b) the execution, delivery and performance by Company of
this Agreement do not contravene or constitute a default under any provision of
applicable law or of any agreement, judgment, injunction, order, decree, or
other instrument binding upon Company; and (c) the officer of the Company
executing this Agreement has been authorized by the Company's board of directors
or governing body to execute this Agreement as the act of the Company.
ARTICLE 16. CLAIMS, INDEMNIFICATION AND INSURANCE
16.01 UM and its officers and employees acting within the scope of their
employment by UM are subject to the Maryland Tort Claims Act ("the Act"), Title
12, Subtitle 1, State Government Article, Annotated Code of Maryland, which
permits claims in tort against the State of Maryland under certain circumstances
and subject to limits provided by law. In order to file a claim under the Act, a
claimant must submit a written claim to the Treasurer of the State of Maryland
or a designee of that office within one year after the injury to the person or
property that is the basis of the claim. Company warrants and represents that at
least 30 days prior to a Licensed Product entering a clinical investigation as
defined in 21 CFR 56, Company will acquire comprehensive liability and property
damage insurance coverage in the minimum amounts of$ 1,000,000 per claim and
$3,000,000 aggregate, applicable to bodily injury, property damage, and product
liability claims. Company warrants that the comprehensive liability and property
damage insurance that Company will purchase will cover contractually assumed
liabilities referred to in Section 16.02, and Company will maintain such
coverage throughout the remaining term of this Agreement. During the period from
the execution of this Agreement up to 30 days before entering a clinical
investigation as defined in 21 CFR 56, Company will maintain liability insurance
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at limits to sufficiently cover its obligations under this Agreement and such
insurance will cover contractually assumed liabilities referred to in Section
16.02. A certificate evidencing the required insurance coverage will be
delivered to UM: (i) at or before execution of this Agreement; (ii) each time
there is a change in Company's insurance coverage; (iii) each time Company's
insurance coverage is renewed; and (iv) prior to a Licensed Product entering a
clinical investigation as defined in 21 CFR 56. Company agrees to require its
insurance carriers) to notify UM within 15 days prior to cancellation of
Company's insurance coverage. If Company does not secure liability insurance
written on an occurrence basis, but instead secures liability insurance written
on a claims-made basis, Company warrants that it will purchase extended
reporting coverage or otherwise provide insurance satisfying its obligations
hereunder for a period of not less than three years following termination of
this Agreement.
16.02 (a) Company will defend, indemnify, and hold harmless UM, UM Personnel,
UM Affiliates, the University System of Maryland, the State of Maryland, and
their regents, officers, employees, students, and agents (each individually a
"UM Party" and all, collectively "UM Parties") against any and all claims,
costs or liabilities, including attorney's fees and court costs at trial and
appellate levels, for any loss, damage, personal injury, or loss of life:
(i) caused by the actions of Company, its Affiliates, or Sublicensees,
or their officers, servants, or agents, or Third Parties acting on
behalf of or under authorization from Company, its Affiliates or
Sublicensees, in the performance of this Agreement;
(ii) arising out of use of licensed Patent Rights by Company, its
Affiliates, or Sublicensees or their officers, servants, or agents, or
by any Third Party acting on behalf of or under authorization from
Company, its Affiliates, or Sublicensees; or
(iii) arising out of use by a UM Party of products, processes, or
protocols developed either by Company, its Affiliates, or Sublicensees
or their officers, servants, or agents, or by Third Parties acting on
behalf of or under authorization from Company, its Affiliates or
Sublicensees, in the performance of this Agreement, unless the claim,
cost, or liability is attributable solely to the negligence of a UM
Party
(b) Company's agreement to defend, indemnify and hold harmless a UM Party
is conditioned upon:
(i) UM promptly notifying Company in writing after UM receives notice
of any claim, and
(ii) the UM Party seeking indemnification fully cooperating with
Company in the defense of the claim.
(c) Company's agreement to defend, indemnify and hold harmless a UM Party
will not apply to any claim, cost, or liability attributable to the
negligent act or willful misconduct of the UM Party.
16.03 UM and Company further agree that nothing in this Agreement will be
interpreted as:
(a) a denial to either party of any remedy or defense available to it under
the laws of the State of Maryland;
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(b) the consent of the State of Maryland or its agents and agencies to be
sued; or
(c) a waiver of sovereign immunity or any other governmental immunity of
the State of Maryland and UM beyond the extent of any waiver provided by
law.
ARTICLE 17. ADVERTISING AND PUBLICITY
17.01 Neither party will use the name of the other or any of its employees or
personnel, or any adaptation thereof, in any advertising, promotional, or sales
literature without prior written consent obtained from the other party. Either
party may publicize the fact that the parties have made this Agreement.
ARTICLE 18. DISPUTE RESOLUTION
18.01 If a dispute between the parties related to this Agreement arises, either
party, by notice to the other party, may have the dispute referred to the
parties' respective officers designated below, or their successors, for
attempted resolution by good faith negotiations within 30 days after the notice
is received. The designated officers are as follows:
For Company: Chief Financial Officer
For UM: Vice President, Research and Development
In the event the designated officers are not able to resolve the dispute
within this 30 day period, or any agreed extension, they will confer in good
faith with respect to the possibility of resolving the matter through mediation
with a mutually acceptable Third Party or a national mediation organization. The
parties agree that they will participate in any mediation sessions in good faith
in an effort to resolve the dispute in an informal and inexpensive manner. All
expenses of the mediator will be shared equally by the parties. Any applicable
statute of limitations will be tolled during the pendency of a mediation
initiated under this Agreement. Evidence of anything said or any admission made
in the course of any mediation will not be admissible in evidence in any civil
action between the parties. In addition, no document prepared for the purpose
of, or in the course of, or pursuant to, the mediation, or copy thereof, will be
admissible in evidence in any civil action between the parties. However, the
admissibility of evidence will not be limited if all parties who participated in
the mediation consent to disclosure of the evidence.
26
ARTICLE 19. MISCELLANEOUS
19.01 No license or right is granted by implication or otherwise with respect to
any patent application or d by either party, unless specifically set forth in
this Agreement.
19.02 Company, its Affiliates, Sublicensees, subcontractors and agents will not
knowingly employ or directly or indirectly, any person working in the Licensed
Field, or involved in negotiating ti Dn behalf of UM, while the person is
employed by UM or for 2 years thereafter, unless UM mpany with prior written
consent of the UM President to the employment or compensation by Company.
"Compensation" includes but is not limited to: cash, stock, stock option or
stock purchase consulting agreements, gifts, grants, stipends, loans,
perquisites, promises of future employment or any other form of consideration or
agreement executed between a UM employee and Company, its ublicensees,
subcontractors or agents. "Employment" includes both uncompensated and
compensated service to Company. The Maryland Public Ethics Law, Title 15, State
Government Article, Code of Maryland, may apply to a decision by the UM
President in regard to such matter.
This Section is not intended to prevent Inventors from owning stock of
Company received by a distribution of licensing revenues under the University
System of Maryland Intellectual Property Policy. As Company stockholders,
Inventors may receive dividends and enjoy other benefits of ship, subject to any
terms and conditions UM or Company may require in order to satisfy
27
conflict of interest concerns. Should UM terms and conditions be relevant to
the relationship of Company to Inventors, as shareholders, UM will advise
Company of them. This provision is not intended to prevent Company from placing
any restrictions upon Inventors' stock that may be necessary to satisfy federal
or state laws or regulations applicable to Company or to development of Licensed
Products.
19.03 Company will provide written notice to UM prior to the filing of a
petition in bankruptcy if Company intends to file a voluntary petition, or, if
known by Company through statements or letters from a creditor or otherwise, if
a Third Party intends to file an involuntary petition in bankruptcy against
Company. Notice will be given at least 75 days before the planned filing or, if
such notice is not feasible, as soon as Company is aware of the planned filing.
Company's failure to perform this obligation is deemed to be a material
prepetition incurable breach under this Agreement not subject to the 90-day
notice requirement of Section 11.05, and UM is deemed to have terminated this
Agreement 75 days prior to the filing of the bankruptcy petition.
19.04 If Company conducts clinical trials of a Licensed Product, it will give
full consideration to use UM or the University of Maryland Medical System
Corporation as a site for clinical trials, subject to agreement on terms and
conditions, including compensation, negotiated in good faith.
19.05 Neither party is liable for failure or delay in performing any of its
obligations under this Agreement if the failure or delay is required in order to
comply with any governmental regulation, request or order, or necessitated by
other circumstances beyond the reasonable control of the party so failing or
delaying, including but not limited to Acts of God, war (declared or
undeclared), insurrection, fire, flood, accident, labor strikes, work stoppage
or slowdown (whether or not such labor event is within the reasonable control of
the parties), or inability to obtain raw materials, supplies, power or equipment
necessary to enable a party
28
to perform its obligations. Each party will: (a) promptly notify the other party
in writing of an event of force majeure, the expected duration of the event and
its anticipated effect on the ability of the party to perform its obligations;
and (b) make reasonable efforts to remedy the event of force majeure.
19.06 All notices, consents and other communications required or allowed under
this Agreement must be in writing and are effective upon receipt: (a) when
delivered by hand; or (b) when received by the addressee after being mailed by
registered or certified mail (air mail if mailed overseas), return receipt
requested; or (c) when received by the addressee, by delivery service (return
receipt requested), in each case addressed to the party at its address set forth
below (or to another address that a party may later designate by notice to the
other party):
If to UM: Director, Technology Commercialization Office of Research
and Development University of Maryland, Baltimore 000
Xxxx Xxxxxxx Xxxxxx, Xxxxx 000 Xxxxxxxxx, Xxxxxxxx
0000 1-1602
Copy to: University Counsel
University of Maryland, Baltimore
000 Xxxx Xxxxxxx Xxxxxx, Xxxxxx Xxxxx Xxxxxxxxx,
Xxxxxxxx 0 0000-0000
If to Company: Chief Financial Officer
29
JDA Medical Technologies, Inc. 0000 Xxxxxx Xxxx Xxxxxx
Xxxxxxxxxxx, XX 00000
19.07 This Agreement, including Exhibits, may not be amended, nor may any right
or remedy of either party be waived, unless the amendment or waiver is in
writing and signed by a duly authorized representative of each party.
19.08 A failure or delay by a party in exercising any of its rights or remedies
under this Agreement does not constitute a waiver of the rights or remedies, nor
does any single or partial exercise of any right or remedy preclude any other or
further exercise thereof or the exercise of any other right or remedy. The
rights and remedies of the parties provided in this Agreement are cumulative and
not exclusive of any rights or remedies provided by law.
19.09 UM and Company are not (and nothing in this Agreement may be construed to
constitute them as) partners, joint venturers, agents, representatives or
employees of the other, nor is there any status or relationship between them
other than that of independent contractors. Neither party has any responsibility
nor liability for the actions of the other party except as specifically provided
in this Agreement. Neither party has any right or authority to bind or obligate
the other party in any manner or make any representation or warranty on behalf
of the other party.
19.10 Unless otherwise provided, all costs and expenses incurred in connection
with this Agreement will be paid by the party which incurs the cost or expense,
and the other party has no liability for such cost or expense.
30
19.11 This Agreement is not intended to create, and does not create, enforceable
legal rights as a third party beneficiary or through any other legal theory on
the part of any University Personnel or any other person except as otherwise
provided by Section 16.02.
19.12 This Agreement is signed in duplicate originals. The headings used in this
Agreement are for convenience of reference only and do not affect the meaning or
construction of this Agreement.
19.13 If UM offers incubator space for rent to licensees of UM technologies
following the opening of the 15MB Health Sciences Research Park, UM will offer
Company a reasonable amount of space at terms comparable to those offered by UM
to similarly situated companies.
19.14 UM will cooperate with Company's reasonable requests for UM participation
in Company's ftmdraising, regulatory and business development activities. This
agreement does not create personal obligations on the part of any of the
Inventors or other UM Personnel. Company, upon UM's request, will reimburse UM
for any out of pocket expenses it may incur in connection with such activities
(e.g., travel expenses; duplication of materials or media).
The parties have caused this Agreement to be executed by their duly authorized
representatives on the dates indicated below.
31
UNIVERSITY OF MARYLAND
BALITMORE
BY: /s/ Xxxxx X. Xxxxxx WITNESS: /s/ Xxxxx Cra?????
-------------------------------- -------------------------
Xxxxx X. Xxxxxx, X.X., D.Xxxx
Date: 2-19-04 Date: 2/19/04
----------------------------- ----------------------------
JDA MEDICAL - CHOOMS, INC.
BY: /s/ Xxxx Xxxxxx ATTEST: /s/ ???????
------------------------------- --------------------------
Xxxx Xxxxxx
Chief Financial Officer
Date: ??????????????? Date: 2/23/04
----------------------------- ----------------------------
32
Confidential
EXHIBIT A-
1: PATENT RIGHTS
United States Patent Application Serial Number 60/479,832
Date Filed: 6/20/2003
Title: "Instant microspheres for microarterial imaging and radiotherapy"
Inventors: Line, Van Echo, Kennedy, Ghandehari, and Nan Docket
Code: BL-2003-028
Patent applications and patents described in Section 2.15(b), (c), or (d) will
be added to Exhibit A-1 through an amendment in accordance with Section 19.07.
UM Acknowledged Date ????????
Company Acknowledged ______________ Date ______________
33
Confidential
EXHIBIT A-2: ROYALTY RATES
United States Patent Application Serial Number 60/479,832 2.5%
Date Filed: 6/20/2003
Title: "Instant microspheres for microarterial imaging and radiotherapy"
Inventors: Line, Van Echo, Kennedy, Ghandehari, and Nan Docket Code:
XX-0000-000
XX Acknowledged Date ????????
Company Acknowledged ______________ Date ______________
34
Exhibit 10.21 Continued
AGREEMENT AND CONSENT
This Agreement and Consent (this "Agreement") by and between University of
Maryland, Baltimore, a constituent institution of the University System of
Maryland (which is a public corporation and an instrumentality of the State of
Maryland) ("UMB"), and JDA Medical Technologies, Inc., a Maryland corporation
("Company"), is made this __ day of July, 2006.
The parties hereby agree as follows:
ARTICLE 1. RECITALS
1.01 Pursuant to the Master License Agreement dated September 16, 2003 by
and between UMB and Company (the "MLA"), UMB granted to Company an exclusive
worldwide license under certain Patent Rights to make, have made, use, lease,
offer to sell, sell and import the Licensed Products within the Licensed Field
for the term set forth in the MLA.
1.02 Company proposes to enter into a merger transaction (the "Merger")
with BestNet Communications Corporation ("BestNet") and Oncologix Corporation
("Oncologix"), pursuant to an Agreement of Merger and Plan of Reorganization
dated July ___, 2006 (the "Merger Agreement"). Company represents and warrants
that a true and complete copy of the Merger Agreement has been submitted to UMB,
and no provision of the Merger Agreement has been amended, modified, or waived.
1.03 If the merger is closed on the terms and conditions set forth in the
Merger Agreement, UMB hereby consents to the Merger and to the assignment to and
assumption by Oncologix of the MLA in connection therewith.
1.04 In order to allow Company to close the Merger, the parties agree to
amend the MLA as set forth below. The parties have also agreed as to certain
other matters as set forth below
1.05 All capitalized terms not defined or re-defined herein shall have the
meaning otherwise given in the MLA.
ARTICLE 2. COMPANY RESPONSIBILITIES
2.01 Section 4.01(e) of the MLA is hereby deleted and in its place is
inserted the following:
"(e) On or before September 16, 2008, (a) Company (or a duly
authorized Sublicensee in any country other than the U.S.) submits an
Application for an Investigational Device Exemption ("IDE") for a Licensed
Product to the FDA, or any foreign equivalent, or (b) Company (or a duly
authorized Sublicensee in any country other than the U.S.) commences a
Clinical Trial of a Licensed Product. For purposes of this License
Agreement, "Clinical Trial" shall mean a human clinical trial of a Licensed
Product to that would satisfy the requirements of 21 C.F.R. ss.812.1 et
seq., or its foreign equivalents. A Clinical Trial shall be considered to
have commenced when the Licensed Product has been administered to the first
subject in the study."
2.02 Section 4.01(f) of the MLA is hereby deleted and in its place is
inserted the following:
"(f) Company receives Pre-Market Approval for a Licensed Product on or
before September 16, 2011."
2.03 A new Section 4.01(g) is added to the MLA, as follows:
"(g) Pursuant to an Agreement of Merger and Plan of Reorganization
dated July ___, 2006 (the "Merger Agreement") by and among BestNet
Communications Corporation ("BestNet"), Oncologix Corporation
("Oncologix"), Company, and certain shareholders of Company, BestNet shall
provide at least $4,000,000 in funding for the operations of Oncologix. It
is acknowledged that $350,000 of said amount has already been furnished by
way of an advance to the Company. The balance of $3,650,000 shall be
deposited for the account of Oncologix as follows: (i) $400,000 at the
Closing (as defined in the Merger Agreement); (ii) $250,000 on the last day
of each of the five successive months following the month in which the
Closing occurs; (iii) the remaining balance on the last day of the sixth
month after the Closing occurs; whereupon (iv) a certain Convertible
Promissory Note issued to BestNet by Company on or about March 23, 2006 in
the principal sum of $350,000 shall, together with any liability of the
Company for accrued interest thereunder, be canceled and extinguished. Such
funds shall be used solely for the purposes set forth in the Merger
Agreement."
ARTICLE 3. MILESTONE PAYMENTS
3.01 Section 5.02(a) of the MLA is hereby deleted and in its place is
inserted the following:
"(a) Company will pay to UMB the following commercial milestone
payments within thirty (30) days following the satisfaction of each
milestone:
(i) The first to occur of (a) commencement of a Clinical Trial
for a Licensed Product in any country other than the U.S.,
or (b) filing with FDA of an IDE for a Licensed Product:
$25,000.00;
(ii) Three (3) months following FDA approval of an IDE for a
Licensed Product: $50,000.00;
(iii) Receipt of the first Pre-Market Approval by the FDA for a
Licensed Product: $50,000.00;
(iv) Acquisition of a controlling interest in Company by a Third
Party (other than pursuant to the Merger Agreement):
$100,000.00;
(v) Completion of the first calendar year in which Net Sales
exceed $5,000,000.00: $200,000.00."
ARTICLE 4. COMPANY SHARES
4.01 In addition to the 664,028 founders shares issued to UMB pursuant to
the MLA, immediately prior to the closing of the Merger Company shall issue to
UMB an additional 42,248 shares of Company's common stock. Those additional
shares shall be converted into two hundred thousand (200,000) shares of BestNet
common stock (the "Additional Shares") upon closing of the Merger.
4.02 BestNet shall use its best efforts (subject only to approval by the
U.S. Securities and Exchange Commission) to cause the Additional Shares to be
registered (as defined in the Merger Agreement) during the period commencing six
(6) months after the closing of the Merger and ending twenty-four (24) months
thereafter. Such registration shall be at the sole expense of BestNet, and shall
be made regardless of any condition or requirement under the Merger Agreement
(including without limitation the requirement of Section 5.2.1 that the request
for registration be made by a certain percentage of holders, or that the
anticipated aggregate net offering price of the registrable securities exceed a
certain value).
4.03 A new Section 5.15 is added to the MLA, as follows:
"UMB understands and acknowledges that the shares issued pursuant to
this Agreement are "restricted securities" under federal and state
securities laws insofar as they have not been registered under the
Securities Act of 1933, as amended ("1933 Act"), or the securities laws of
any other jurisdiction, that they may not be resold or transferred without
compliance with the registration or qualification provisions of the 1933
Act or applicable federal and state securities laws of any state or other
jurisdiction or an opinion of counsel that an exemption from such
registration and qualification requirements is available."
4.04 If the Merger is closed in accordance with the terms of the Merger
Agreement, UMB acknowledges and agrees that it shall not be entitled to any
protection against dilution of UMB's founders shares under Section 5.14 of the
MLA.
ARTICLE 5. INDEMNIFICATION.
5.01 Section 16.02(a) of the MLA is hereby deleted and in its place is
inserted the following:
"16.02 (a) Company will defend, indemnify, and hold harmless UM, UM
Personnel, UM Affiliates, the University System of Maryland, the State of
Maryland, and each of their respective current and future regents,
directors, trustees, officers, faculty, medical and professional staff,
employees, students, trainees, and agents, and their respective successors,
heirs, and assigns (each individually a "UM Party" and all, collectively
"UM Parties") against any claim, liability, cost, damage, deficiency, loss,
expense or obligation of any kind or nature (including without limitation
reasonable attorneys' fees, expert witness fees, court costs and other
costs and expenses of litigation at trial and appellate levels) incurred by
or imposed upon Indemnitees or any one of them in connection with any
claims, suits, actions, demands or judgments:
(i) Arising out of the actions or omissions of Company, its
Affiliates, or Sublicensees, or their directors, officers, employees, or
agents, or any Third Party acting on behalf of or under authorization from
Company, its Affiliates, or Sublicensees;
(ii) Arising out of use of the Patent Rights by Company, its
Affiliates, or Sublicensees or their directors, officers, employees, or
agents, or by any Third Party acting on behalf of or under authorization
from Company, its Affiliates, or Sublicensees;
(iii) Arising out of use by a UM Party of products, processes, or
protocols developed either by Company, its Affiliates, or Sublicensees or
their directors, officers, employees, or agents, or by Third Parties acting
on behalf of or under authorization from Company, its Affiliates or
Sublicensees, provided the use was consistent with any instructions,
protocols, or supervision provided or approved by Company or a Sublicensee,
unless the claim, cost, or liability is attributable solely to the
negligence of a UM Party;
(iv) Arising out of any theory of product liability (including
without limitation actions in the form of tort, warranty, or strict
liability) concerning any Licensed Product or any other product, process or
service made, used, or sold pursuant to any right or license granted under
this License Agreement; or
(v) Arising out of any actions or omissions of Fountain
Pharmaceuticals, Inc., a Delaware corporation, its affiliates,
sublicensees, or assignees, or any of their directors, officers, employees,
or agents, whether in connection with the License Agreement dated June 12,
2006 or otherwise."
ARTICLE 6. WAIVERS.
6.01 UMB hereby waives any default or breach of the MLA by Company
through and including the date of closing of the Merger. UMB acknowledges and
aggress that it shall not have any rights or remedies (including without
limitation the right to terminate the MLA) as a result of any default or breach
of the MLA by Company through and including the date of closing of the Merger.
6.02 UMB hereby waives the commercial milestone payment of $100,000.00,
which would have been due upon closing of the Merger pursuant to Section
5.02(a)(iii) of the MLA.
ARTICLE 7. RATIFICATION
7.01 Except as specifically modified above, the MLA is hereby ratified,
affirmed, and is in full force and effect.
ARTICLE 8. COUNTERPARTS.
8.01 This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
ARTICLE 9. CONDITION PRECEDENT.
9.01 This Agreement shall not be effective unless and until the closing of
the Merger. This Agreement shall be null and void if the Merger is not closed by
July 31, 2006.
ARTICLE 10. GOVERNING LAW.
10.01 This Agreement is made and shall be construed in accordance with the
laws of the State of Maryland, without regard to the principles of conflicts of
laws.
[Signature Page Follows]
IN WITNESS WHEREOF, UMB and Company have executed and delivered this
Agreement as of the date first above written.
UNIVERSITY OF MARYLAND, BALTIMORE JDA MEDICAL TECHNOLOGIES, INC.
By: By:
------------------------------------- --------------------------
Its: Its:
------------------------------------ -------------------------
Agreed and accepted:
BESTNET COMMUNICATIONS CORPORATION
By:
------------------------------------
Its:
-----------------------------------
ONCOLOGIX CORPORATION
By:
------------------------------------
Its:
-----------------------------------
