Exhibit 9.01
EXCLUSIVE LICENSE AGREEMENT
---------------------------
This Agreement, effective as of July 17, 2006 (the "Effective Date"),
is between the University of Massachusetts ("University"), a public institution
of higher education of the Commonwealth of Massachusetts as represented by its
Worcester campus, and Advanced Influenza Technologies, Inc. ("Company"), a
subsidiary of UTEK Corporation having corporate headquarters at 0000 X. Xxxx
Xxxxxx, Xxxxx XX 00000.
R E C I T A L S
---------------
WHEREAS, University is owner by assignment of the invention claimed in
the United States Patent Applications listed on Exhibit A relating to the
Medical School's invention disclosure number UMMC04-96 entitled "Influenza
Nucleic Acids, Polypeptides, and Uses Thereof"; and
WHEREAS, Company desires to obtain an exclusive license in the field of
DNA-based vaccines for the prophylaxis and treatment of influenza in humans,
under the rights of University in any patent rights claiming those inventions;
and
WHEREAS, University is willing to grant Company an exclusive license on
the terms set forth in this Agreement;
NOW, THEREFORE, University and Company agree as follows:
1. Definitions.
-----------
1.1. "Affiliate" means any legal entity (such as a corporation,
partnership, or limited liability company) that is controlled by Company. For
the purposes of this definition, the term "control" means (i) beneficial
ownership of at least fifty percent (50%) of the voting securities of a
corporation or other business organization with voting securities or (ii) a
fifty percent (50%) or greater interest in the net assets or profits of a
partnership or other business organization without voting securities.
1.2. "Confidential Information" means any confidential or proprietary
information furnished by one party (the "Disclosing Party") to the other party
(the "Receiving Party") in connection with this Agreement that is specifically
designated as confidential.
1.3. "Field" means plasmid DNA-based vaccines for influenza prophylaxis
and treatment in humans.
1.4. "Licensed Product" means any product that cannot be developed,
manufactured, used, or sold without infringing one or more claims under the
Patent Rights.
1.5. "Net Sales" means the gross amount billed or invoiced on sales by
Company and its Affiliates of Licensed Products, less the following: (i)
customary trade, quantity, or cash discounts to non-affiliated brokers or agents
to the extent actually allowed and taken; (ii) amounts repaid or credited by
reason of rejection or return; (iii) to the extent separately stated on purchase
1 of 14
orders, invoices, or other documents of sale, any taxes or other governmental
charges levied on the production, sale, transportation, delivery, or use of a
Licensed Product which is paid by or on behalf of Company; and (iv) outbound
transportation costs prepaid or allowed and costs of insurance in transit.
In any transfers of Licensed Products between Company and its
Affiliates, Net Sales are calculated based on the final sale of the Licensed
Product to an independent third party. If Company or its Affiliates receive
non-monetary consideration for any Licensed Products, Net Sales are calculated
based on the fair market value of that consideration. If Company or its
Affiliates use or dispose of a Licensed Product in the provision of a commercial
service, the Licensed Product is sold and the Net Sales are calculated based on
the sales price of the Licensed Product to an independent third party during the
same Royalty Period or, in the absence of sales, on the fair market value of the
Licensed Product as determined by the parties in good faith.
1.6. "Patent Rights" means the patent applications listed on Exhibit A
and any divisional, continuation, or continuation-in-part of those patent
applications to the extent the claims are directed to subject matter
specifically described therein as well as any patents issued on these patent
applications and any reissues or reexaminations of those patents, and any
foreign counterparts to those patents and patent applications.
1.7. "Royalty Period" means the partial calendar quarter commencing on
the date on which the first Licensed Product is sold and every complete or
partial calendar quarter thereafter during which either (i) this Agreement
remains in effect or (ii) Company has the right to complete and sell
work-in-progress and inventory of Licensed Products pursuant to Section 8.5.
2. Grant of Rights.
---------------
2.1. License Grant. Subject to the terms of this Agreement, University
grants to Company an exclusive, nontransferable, worldwide, royalty-bearing
license (without the right to sublicense) under its commercial rights in the
Patent Rights to develop, make, have made, use, sell and otherwise commercialize
the Licensed Products in the Field. This license grant to Company by University
hereto shall also include the right to permit a third party or Affiliate
manufacturer to practice or use the Patent Rights to manufacture the Licensed
Products.
2.2. Retained Rights.
---------------
(a) University. University retains the right to make and use the Patent
Rights for academic research, teaching, and non-commercial patient care, without
payment of compensation to Company. University may license its retained rights
under this Section to research collaborators of University faculty members,
post-doctoral fellows, and students for academic research, teaching, and
non-commercial patient care.
(b) Federal Government. To the extent that any invention claimed in the
Patent Rights has been funded by the federal government, this Agreement and the
grant of any rights in Patent Rights are subject to and governed by federal law
as set forth in 35 U.S.C. xx.xx. 201-211, and the regulations promulgated
thereunder, as amended, or any successor statutes or regulations. Company
acknowledges that these statutes and regulations reserve to the federal
government a royalty-free, non-exclusive, non-transferable license to practice
any government-funded invention claimed in the Patent Rights. If any term of
this Agreement fails to conform with those laws and regulations, the relevant
term is an invalid provision and shall be modified by the parties pursuant to
Section 10.11.
(c) Other Organizations. To the extent that any invention claimed in
the Patent Rights has been funded by a non-profit organization or state or local
agency, this Agreement and the grant of any rights in Patent Rights are subject
2 of 14
to and governed by the terms of the applicable research grant. If any term of
this Agreement fails to conform with those terms, the relevant term is an
invalid provision and shall be modified by the parties pursuant to Section
10.11.
3. Company Obligations Relating to Commercialization.
-------------------------------------------------
3.1. Diligence Requirements. Company shall use diligent commercially
reasonable efforts, and shall cause its Affiliates to use diligent commercially
reasonable efforts, to develop Licensed Products and to introduce Licensed
Products into the commercial market. Thereafter, Company and its Affiliates
shall make Licensed Products reasonably available to the public. Specifically,
Company shall fulfill the following obligations:
(a) Within sixty (60) days of the delivery of the optimized flu DNA
vaccine plasmids ready for GMP manufacturing, Company shall furnish University
with a written research and development plan under which Company intends to
develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the delivery of
the optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company
shall furnish University with a written report on the progress of its
commercially reasonable efforts during the prior year to develop and
commercialize Licensed Products, including without limitation research and
development efforts, commercially reasonable efforts to obtain regulatory
approval, marketing efforts, and sales figures. The report shall also contain a
discussion of intended efforts and sales projections for the current year. The
Company shall use its commercially reasonable efforts to achieve the following:
(c) Within two (2) years of the anniversary of the delivery of the
optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall
have filed an IND or equivalent.
(d) Within three (3) years of the anniversary of the delivery of the
optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall
have initiated a Phase I clinical trial.
(e) Within four (4) years of the anniversary of the delivery of the
optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall
have initiated a Phase II clinical trial.
(f) Within eight (8) years of the anniversary of the delivery of the
optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall
have initiated a Phase III clinical trial.
If University determines that Company has not fulfilled its obligations under
this Section 3.1., University shall furnish Company with written notice of the
determination. Within sixty (60) days after receipt of the notice, Company shall
either (i) fulfill the relevant obligation or (ii) negotiate with University a
mutually acceptable schedule of revised diligence obligations, failing which
University may, immediately upon written notice to Company, terminate this
Agreement or convert the exclusive license into a non-exclusive license and
grant additional licenses to third parties to the Patent Rights in the Field.
3.2. Indemnification.
---------------
(a) Indemnity. Company and its Affiliates shall indemnify, defend, and
hold harmless University and its trustees, officers, faculty, students,
employees, and agents and their respective successors, heirs and assigns (the
"Indemnitees"), against any liability, damage, loss, or expense (including
reasonable attorneys fees and expenses of litigation) incurred by or imposed
upon any of the Indemnitees in connection with any claims, suits, actions,
demands or judgments arising out of any theory of liability (including without
limitation actions in the form of tort, warranty, or strict liability and
3 of 14
regardless of whether the action has any factual basis) concerning any product,
process, or service that is made, used, or sold pursuant to any right or license
granted under this Agreement. However, indemnification does not apply to any
liability, damage, loss, or expense to the extent directly attributable to (i)
the negligence or intentional misconduct of the Indemnitees or (ii) the
settlement of a claim, suit, action, or demand by Indemnitees without the prior
written approval of Company
(b) Procedures. The Indemnitees agree to provide Company with prompt
written notice of any claim, suit, action, demand, or judgment for which
indemnification is sought under this Agreement. Company agrees, at its own
expense, to provide attorneys reasonably acceptable to University to defend
against any claim. The Indemnitees shall cooperate fully with Company in the
defense and will permit Company to conduct and control the defense and the
disposition of the claim, suit, or action (including all decisions relative to
litigation, appeal, and settlement). However, any Indemnitee may retain its own
counsel, at the expense of Company, if representation of the Indemnitee by the
counsel retained by Company would be inappropriate because of actual or
potential differences in the interests of the Indemnitee and any other party
represented by that counsel. Company agrees to keep University informed of the
progress in the defense and disposition of the claim and to consult with
University regarding any proposed settlement.
(c) Insurance. Company and its Affiliates shall maintain insurance or
self-insurance that is reasonably adequate to fulfill any potential obligation
to the Indemnitees, but not less than two million dollars ($2,000,000) for
injuries to any one person arising out of a single occurrence pursuant to any
right or license granted herein and four million dollars ($4,000,000) for
injuries to all persons arising out of a single occurrence pursuant to any right
or license granted herein. Company shall provide University, upon request, with
written evidence of insurance or self-insurance. Company and its Affiliates
shall continue to maintain such insurance or self insurance after the expiration
or termination of this Agreement during any period in which Company or Affiliate
continues to make, use, or sell a product that was envisioned by the license
under this Agreement.
3.3. Use of University Name. In accordance with Section 7.3., Company
and its Affiliates may not use the name "University of Massachusetts" or any
variation of that name in connection with the marketing or sale of any Licensed
Products.
3.4. Marking of Licensed Products. To the extent commercially feasible
and consistent with prevailing business practices, Company shall xxxx and shall
cause its Affiliates to xxxx all Licensed Products that are manufactured or sold
under this Agreement with the number of each issued patent under the Patent
Rights that applies to a Licensed Product.
3.5. Compliance with Law. Company shall comply with, and shall ensure
that its Affiliates comply with, all local, state, federal, and international
laws and regulations relating to the development, manufacture, use, and sale of
Licensed Products. Company expressly agrees to comply with the following:
(a) Company and its Affiliates shall obtain all necessary approvals
from the United States Food & Drug Administration and any similar governmental
authorities of any foreign jurisdiction in which Company or Affiliate intends to
make, use, or sell Licensed Products.
(b) Company and its Affiliates shall comply with all United States laws
and regulations controlling the export of commodities and technical data,
including without limitation all Export Administration Regulations of the United
States Department of Commerce. Among other things, these laws and regulations
prohibit or require a license for the export of certain types of commodities and
technical data to specified countries and foreign nationals. Company hereby
gives written assurance that it will comply with and will cause its Affiliates
to comply with all United States export control laws and regulations, that it
bears sole responsibility for any violation of those laws and regulations by
itself or its Affiliates, and that it will indemnify, defend, and hold
University harmless (in accordance with Section 3.2.) for the consequences of
any violation.
4 of 14
(c) To the extent that any invention claimed in the Patent Rights has
been partially funded by the United States government, and only to the extent
required by applicable laws and regulations, Company agrees that any Licensed
Products used or sold in the United States will be manufactured substantially in
the United States or its territories. Current law provides that if domestic
manufacture is not commercially feasible under the circumstances, University may
seek a waiver of this requirement from the relevant federal agency on behalf of
Company.
4. Consideration for Grant of Rights.
---------------------------------
[ * ]
5 of 14
5. Royalty Reports; Payments; Records.
----------------------------------
5.1. First Sale. Company shall report to University the date of first
commercial sale of each Licensed Product within thirty (30) days after
occurrence in each country.
5.2. Reports and Payments. Within sixty (60) days after the conclusion
of each Royalty Period, Company shall deliver to University a report containing
the following information:
(a) the number of Licensed Products sold to independent third parties
in each country;
(b) the gross sales price for each Licensed Product during the
applicable Royalty Period in each country;
(c) calculation of Net Sales for the applicable Royalty Period in each
country, including a listing of applicable deductions;
(d) total royalty payable on Net Sales in United States dollars,
together with the exchange rates used for conversion; and
If no royalties are due to University for any Royalty Period, the report shall
so state. Concurrent with this report, Company shall remit to University any
payment due for the applicable Royalty Period.
5.3. Payments in United States Dollars. All payments due under this
Agreement are payable in United States dollars. Conversion of foreign currency
to United States dollars shall be made at the conversion rate existing in the
United States (as reported in the Wall Street Journal) on the last working day
of the calendar quarter preceding the applicable Royalty Period. Payments shall
be without deduction of exchange, collection, or other charges.
5.4. Payments in Other Currencies. If by law, regulation, or fiscal
policy of a particular country, conversion into United States dollars or
transfer of funds of a convertible currency to the United States is restricted
or forbidden, Company shall give University prompt written notice of the
restriction, within the sixty-day payment deadline described in Section 5.2.
Company shall pay any amounts due University through whatever lawful methods
University reasonably designates. However, if University fails to designate a
payment method within thirty (30) days after University is notified of the
restriction, Company may deposit payment in local currency to the credit of
University in a recognized banking institution selected by Company and
identified by written notice to University, and that deposit fulfills all
obligations of Company to University with respect to that payment.
5.5. Records. Company shall maintain and shall cause its Affiliates to
maintain complete and accurate records of Licensed Products that are made, used,
sold, or performed under this Agreement and any amounts payable to University in
relation to Licensed Products, which records shall contain sufficient
information to permit University to confirm the accuracy of any reports
delivered to University under Section 5.2. The relevant party shall retain
records relating to a given Royalty Period for at least three (3) years after
the conclusion of that Royalty Period, during which time University shall have
the right, at its expense, to cause its internal accountants or an independent,
certified public accountant to inspect records during normal business hours for
the sole purpose of verifying any reports and payments delivered under this
Agreement. The accountant may not disclose to University any information other
than information relating to accuracy of reports and payments delivered under
this Agreement. The parties shall reconcile any underpayment or overpayment
6 of 14
within thirty (30) days after the accountant delivers the results of the audit.
If any audit performed under this Section reveals an underpayment in excess of
ten percent (10%) in any Royalty Period, Company shall bear the full cost of the
audit. University may exercise its rights under this Section only once every
year and only with reasonable prior notice to Company.
5.6. Late Payments. Any payments by Company that are not paid on or
before the date payments are due under this Agreement bear interest, to the
extent permitted by law, at one and one half percent (1.5%) per month calculated
based on the number of days that payment is delinquent.
5.7. Method of Payment. All payments under this Agreement should be
made to the "University of Massachusetts" and sent to the address identified
below. Each payment should reference this Agreement and identify the obligation
under this Agreement that the payment satisfies.
5.8. Withholding and Similar Taxes. Royalty payments and other payments
due to University under this Agreement may not be reduced by reason of any
withholding or similar taxes applicable to payments to University.
6. Patents and Infringement.
------------------------
6.1. Responsibility for Patent Rights. University has primary
responsibility at the expense of Company for the preparation, filing,
prosecution, and patent maintenance of all Patent Rights, using patent counsel
reasonably acceptable to Company. University shall consult with Company as to
the preparation, filing, prosecution, and patent maintenance of all Patent
Rights reasonably prior to any deadline or action with the United States Patent
& Trademark Office or any foreign patent office and shall furnish Company with
copies of relevant documents reasonably in advance of consultation.
6.2. Cooperation. Company shall cooperate fully in the preparation,
filing, prosecution, and patent maintenance of all Patent Rights. Cooperation
includes, without limitation, (a) promptly executing all papers and instruments
or requiring employees of Company to execute papers and instruments as
reasonable and appropriate to enable University to file, prosecute, and maintain
Patent Rights in any country; and (b) promptly informing the University of
matters that may affect the preparation, filing, prosecution, or maintenance of
Patent Rights (such as, becoming aware of an additional inventor who is not
listed as an inventor in a patent application).
6.3. Payment of Expenses.
-------------------
(a) Within thirty (30) days of the Effective Date, Company will pay
University nineteen thousand three hundred ninety eight dollars and ninety nine
cents ($19,398.99) to reimburse University for its actual expenses incurred as
of the Effective Date in connection with obtaining the Patent Rights, which
amount shall be payable together with the Company's payment pursuant to Section
4.1. To clarify, this Exclusive License Agreement does not require the payment
of license maintenance fees.
(b) Within thirty (30) days after University invoices Company, Company
shall reimburse University for all patent-related expenses incurred by
University pursuant to Section 6.1. Company may elect, upon sixty (60) days
written notice to University, to cease payment of the expenses associated with
obtaining or maintaining patent protection for one or more Patent Rights in one
or more countries. If Company elects to cease payment of any patent expenses,
Company loses all rights under this Agreement with respect to the particular
Patent Rights in the particular country or countries.
7 of 14
6.4. Infringement.
------------
(a) Notification of Infringement. Each party agrees to provide written
notice to the other party promptly after becoming aware of any infringement of
the Patent Rights.
(b) Company Right to Prosecute. So long as Company remains the only
licensee of the Patent Rights in the Field, Company may, under its own control
and at its own expense, prosecute any third party infringement of the Patent
Rights in the Field or, together with licensees of the Patent Rights in other
fields (if any), defend the Patent Rights in any declaratory judgment action
brought by a third party which alleges invalidity, unenforceability, or
infringement of the Patent Rights. Prior to commencing any action, Company shall
consult with University and shall consider the views of University regarding the
advisability of the proposed action and its effect on the public interest.
Company may not enter into any settlement, consent judgment, or other voluntary
final disposition of any infringement action under this Subsection without the
prior written consent of University, which consent may not be unreasonably
withheld or delayed. Any recovery obtained in an action under this Subsection
shall be distributed as follows: (i) each party shall be reimbursed for any
expenses incurred in the action (including the amount of any royalty payments
withheld from University as described below); (ii) as to ordinary damages,
Company shall receive an amount equal to its lost profits or a reasonable
royalty on the infringing sales (whichever measure of damages the court
applied), less a reasonable approximation of the royalties that Company would
have paid to University if Company had sold the infringing products and services
rather than the infringer; and (iii) as to special or punitive damages, the
parties shall share equally in any award. Company may offset a total of fifty
percent (50%) of any expenses incurred under this Subsection against any royalty
payments due to University under this Agreement. However, royalty payments under
Article 4 may never be reduced by more than fifty percent (50%) in any Royalty
Period.
(c) University as Indispensable Party. University shall permit any
action under this Section to be brought in its name if required by law, provided
that Company and its Affiliates shall hold University harmless from, and if
necessary indemnify University against, any costs, expenses, or liability that
University may incur in connection with the action.
(d) University Right to Prosecute. If Company fails to initiate an
infringement action within a reasonable time after it first becomes aware of the
basis for the action, or to answer a declaratory judgment action within a
reasonable time after the action is filed, University may prosecute the
infringement or answer the declaratory judgment action under its sole control
and at its sole expense, and any recovery obtained shall be given to University.
(e) Cooperation. Both parties shall to cooperate fully in any action
under this Section 6.6. which is controlled by the other party, provided that
the controlling party reimburses the cooperating party promptly for any costs
and expenses incurred by the cooperating party in connection with providing
assistance.
7. Confidential Information; Publications; Publicity.
-------------------------------------------------
7.1. Confidential Information.
------------------------
(a) Designation. Confidential Information that is disclosed in writing
shall be marked with a legend indicating its confidential status (such as,
"Confidential" or "Proprietary"). Confidential Information that is disclosed
orally or visually shall be documented in a written notice prepared by the
Disclosing Party and delivered to the Receiving Party within thirty (30) days of
the date of disclosure. The notice shall summarize the Confidential Information
disclosed to the Receiving Party and reference the time and place of disclosure.
8 of 14
(b) Obligations. For a period of five (5) years after disclosure of any
portion of Confidential Information, the Receiving Party shall (i) maintain
Confidential Information in confidence, except that the Receiving Party may
disclose or permit the disclosure of any Confidential Information to its
trustees or directors, officers, employees, consultants, and advisors who are
obligated to maintain the confidential nature of Confidential Information and
who need to know Confidential Information for the purposes of this Agreement;
(ii) use Confidential Information solely for the purposes of this Agreement; and
(iii) allow its trustees or directors, officers, employees, consultants, and
advisors to reproduce the Confidential Information only to the extent necessary
for the purposes of this Agreement, with all reproductions being Confidential
Information.
(c) Exceptions. The obligations of the Receiving Party under Subsection
7.1.(b) above do not apply to the extent that the Receiving Party can
demonstrate that Confidential Information (i) was in the public domain prior to
the time of its disclosure under this Agreement; (ii) entered the public domain
after the time of its disclosure under this Agreement through means other than
an unauthorized disclosure resulting from an act or omission by the Receiving
Party; (iii) was already known or independently developed or discovered by the
Receiving Party without use of the Confidential Information; (iv) is or was
disclosed to the Receiving Party at any time, whether prior to or after the time
of its disclosure under this Agreement, by a third party having no fiduciary
relationship with the Disclosing Party and having no obligation of
confidentiality with respect to the Confidential Information; or (v) is required
to be disclosed to comply with applicable laws or regulations or with a court or
administrative order, provided that the Disclosing Party receives reasonable
prior written notice of the disclosure.
(d) Ownership and Return. The Receiving Party acknowledges that the
Disclosing Party (or a third party entrusting its own information to the
Disclosing Party) owns the Confidential Information in the possession of the
Receiving Party. Upon expiration or termination of this Agreement, or at the
request of the Disclosing Party, the Receiving Party shall return to the
Disclosing Party all originals, copies, and summaries of documents, materials,
and other tangible manifestations of Confidential Information in the possession
or control of the Receiving Party, except that the Receiving Party may retain
one copy of the Confidential Information in the possession of its legal counsel
solely for the purpose of monitoring its obligations under this Agreement.
7.2. Publications. University and its employees are free to disclose
publicly (through journals, lectures, or otherwise) the results of any research
relating to the Field or the subject matter of the Patent Rights, except as
otherwise provided by written agreement between University and Company (e.g., a
sponsored research agreement).
7.3. Publicity Restrictions. Company and its Affiliates may not use the
name of University or any of its trustees, officers, faculty, students,
employees, or agents, or any adaptation of their names, or any terms of this
Agreement in any public announcement or disclosure without the prior written
consent of University, with such consent not to be unreasonably withheld. The
foregoing notwithstanding, Company may disclose that information without the
consent of University in any prospectus, offering memorandum, or other document
or filing required by applicable securities laws or other applicable law or
regulation, provided that Company provides University at least ten (10) days
prior written notice of the proposed text for the purpose of giving University
the opportunity to comment on the text.
9 of 14
8. Term and Termination.
--------------------
8.1. Term. This Agreement commences on the Effective Date and remains
in effect until the expiration of all issued patents within the Patent Rights,
unless earlier terminated in accordance with the provisions of this Agreement.
8.2. Voluntary Termination by Company. Company may terminate this
Agreement for any reason upon ninety (90) days prior written notice to
University. Upon voluntary termination by Company, University will be given
copies of Confidential Information that may be useful for the further
commercialization of Licensed Products.
8.3. Termination for Default. If either party commits a material breach
of its obligations under this Agreement and fails to cure that breach within
sixty (60) days after receiving written notice of the breach, the other party
may terminate this Agreement immediately upon written notice to the party in
breach. If the alleged breach involves nonpayment of any amounts due University
under this Agreement, Company has only one opportunity to cure a material breach
for which it receives notice as described above. Any subsequent material breach
by Company will entitle University to terminate this Agreement immediately upon
written notice to Company, without the sixty-day cure period.
8.4. Force Majeure. Neither party is responsible for delays resulting
from causes beyond its reasonable control, including without limitation fire,
explosion, flood, war, strike, terrorist attack, or riot, provided that the
nonperforming party uses commercially reasonable efforts to avoid or remove
those causes of nonperformance and continues performance under this Agreement
with reasonable dispatch whenever the causes are removed.
8.5. Effect of Termination. The following provisions survive the
expiration or termination of this Agreement: Articles 1 and 9; Sections 3.2.,
3.5., 4.1, 5.2. (obligation to provide final report and payment), 5.5., 6.3.,
6.4., 7.1., 7.3., 8.2., 8.4., and 10.9. Upon the early termination of this
Agreement, Company and its Affiliates may complete and sell any work-in-progress
and inventory of Licensed Products that exist as of the effective date of
termination, provided that (a) Company is current in payment of all amounts due
University under this Agreement, (b) Company pays University the applicable
royalty on sales of Licensed Products in accordance with the terms of this
Agreement, and (c) Company and its Affiliates complete and sell all
work-in-progress and inventory of Licensed Products within six (6) months after
the effective date of termination. During this six month period, the license
grant to Company shall revert to a non-exclusive license and Company's rights
shall be limited to the enumerated activities.
9. Dispute Resolution.
------------------
9.1. Procedures Mandatory. The parties agree to resolve any dispute
arising out of or relating to this Agreement solely by means of the procedures
set forth in this Article, and that these procedures constitute legally binding
obligations that are an essential provision of this Agreement. However, all
procedures and deadlines specified in this Article may be modified by written
agreement of the parties. If either party fails to observe the procedures of
this Article, as modified by their written agreement, the other party may bring
an action for specific performance in any court of competent jurisdiction.
9.2. Dispute Resolution Procedures.
-----------------------------
(a) Negotiation. In the event of any dispute arising out of or relating
to this Agreement, the affected party shall notify the other party, and the
parties shall attempt in good faith to resolve the matter within ten (10) days
after the date of notice (the "Notice Date"). Any disputes not resolved by good
10 of 14
faith discussions shall be referred to senior executives of each party, who
shall meet at a mutually acceptable time and location within thirty (30) days
after the Notice Date and attempt to negotiate a settlement.
(b) Mediation. If the matter remains unresolved within sixty (60) days
after the Notice Date, or if the senior executives fail to meet within thirty
(30) days after the Notice Date, either party may initiate mediation upon
written notice to the other party, whereupon both parties shall engage in a
mediation proceeding under the then current CPR Institute for Dispute Resolution
("CPR") Model Procedure for Mediation of Business Disputes, except that specific
provisions of this Section override inconsistent provisions of the CPR Model
Procedure. The mediator will be selected from the CPR Panels of Neutrals. If the
parties cannot agree upon the selection of a mediator within ninety (90) days
after the Notice Date, then upon the request of either party, the CPR shall
appoint the mediator. The parties shall attempt to resolve the dispute through
mediation until one of the following occurs: (i) the parties reach a written
settlement; (ii) the mediator notifies the parties in writing that they have
reached an impasse; (iii) the parties agree in writing that they have reached an
impasse; or (iv) the parties have not reached a settlement within one hundred
twenty (120) days after the Notice Date.
(c) Trial Without Jury. If the parties fail to resolve the dispute
through mediation, or if neither party elects to initiate mediation, each party
may pursue any other remedies legally available to resolve the dispute. However,
the parties expressly waive the right to a jury trial in the legal proceeding
under this Section.
9.3. Preservation of Rights Pending Resolution.
-----------------------------------------
(a) Performance to Continue. Each party shall continue to perform its
obligations under this Agreement pending final resolution of any dispute arising
out of or relating to this Agreement. However, a party may suspend performance
of its obligations during any period in which the other party fails or refuses
to perform its obligations.
(b) Provisional Remedies. Although the procedures specified in this
Article are the exclusive procedures for resolution of disputes arising out of
or relating to this Agreement, either party may seek a preliminary injunction or
other provisional equitable relief if, in its reasonable judgment, that action
is necessary to avoid irreparable harm to itself or to preserve its rights under
this Agreement.
(c) Statute of Limitations. The parties agree that all applicable
statutes of limitation and time-based defenses (such as, estoppel and laches)
are tolled while the procedures set forth in Subsections 9.2 (a) and 9.2(b) are
pending. The parties shall take any actions necessary to effectuate this result.
10. Miscellaneous.
-------------
10.1. Representations and Warranties. University represents that its
employees have assigned to University their entire right, title, and interest in
the Patent Rights and that it has authority to grant the rights and licenses set
forth in this Agreement. UNIVERSITY MAKES NO OTHER WARRANTIES CONCERNING THE
PATENT RIGHTS INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Specifically, University
makes no warranty or representation (a) regarding the validity or scope of the
Patent Rights, (b) that the exploitation of the Patent Rights or any Licensed
Product will not infringe any patents or other intellectual property rights of a
third party, and (c) that any third party is not currently infringing or will
not infringe the Patent Rights
10.2. Compliance with Law and Policies. Company agrees to comply with
applicable law and the policies of University in the area of technology transfer
and shall promptly notify University of any violation that Company knows or has
reason to believe has occurred or is likely to occur. The University policies
11 of 14
currently in effect at the Worcester campus are the Intellectual Property
Policy, Policy on Conflicts of Interest Relating to Intellectual Property and
Commercial Ventures, and Policy on Faculty Consulting and Outside Activities.
10.3. Tax-Exempt Status. Company acknowledges that University, as a
public institution of the Commonwealth of Massachusetts, is an exempt
organization under the United States Internal Revenue Code of 1986, as amended.
Company also acknowledges that certain facilities in which the licensed
inventions were developed may have been financed through offerings of tax-exempt
bonds. If the Internal Revenue Service determines, or if counsel to University
reasonably determines, that any term of this Agreement jeopardizes the
tax-exempt status of University or the bonds used to finance University
facilities, the relevant term is invalid and shall be modified in accordance
with Section 10.11.
10.4. Counterparts. This Agreement may be executed in one or more
counterparts, each of which is an original, and all of which together are one
instrument.
10.5. Headings. All headings are for convenience only and do not affect
the meaning of any provision of this Agreement.
10.6. Binding Effect. This Agreement is binding upon and inures to the
benefit of the parties and their respective permitted successors and assigns.
10.7. Assignment. This Agreement may not be assigned by either party
without the prior written consent of the other party, such consent not to be
unreasonably withheld. University hereby agrees that it would be unreasonable to
withhold consent to the assignment of this Agreement to any third party that
acquires all of the voting securities of Company.
10.8. Amendment and Waiver. This Agreement may be amended,
supplemented, or otherwise modified only by means of a written instrument signed
by both parties. Any waiver of any rights or failure to act in a specific
instance relates only to that instance and is not an agreement to waive any
rights or fail to act in any other instance.
10.9. Governing Law. This Agreement shall be governed by and construed
in accordance with the laws of the Commonwealth of Massachusetts irrespective of
any conflicts of law principles. The parties may only bring legal action that
arises out of or in connection with the Agreement in the Massachusetts Superior
Court in Suffolk County.
10.10. Notice. Any notices required or permitted under this Agreement
shall be in writing, shall specifically refer to this Agreement, and shall be
sent by recognized national overnight courier, or registered or certified mail,
postage prepaid, return receipt requested, to the following addresses:
12 of 14
If to University:
Office of Technology Management
University of Massachusetts Medical School
000 Xxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
Attention: Xxxxx X. XxXxxxxx, Ph.D, Executive Director
If to Company:
Advanced Influenza Technologies, Inc.
0000 X. Xxxx Xxxxxx
Xxxxx, XX 00000
Attention:
Xxxx Xxxxxxx, President
A party may change its contact information immediately upon written notice to
the other party in the manner provided in this Section.
10.11. Severability. If any provision of this Agreement is held invalid
or unenforceable for any reason, the invalidity or unenforceability does not
affect any other provision of this Agreement, and the parties shall negotiate in
good faith to modify the Agreement to preserve (to the extent possible) their
original intent. If the parties fail to reach a modified agreement within sixty
(60) days after the relevant provision is held invalid or unenforceable, then
the dispute shall be resolved in accordance with the procedures set forth in
Article 9. While the dispute is pending resolution, this Agreement shall be
construed as if the provision were deleted by agreement of the parties.
10.12. Entire Agreement. This Agreement constitutes the entire
agreement between the parties with respect to its subject matter and supersedes
all prior agreements or understandings between the parties relating to its
subject matter.
The parties have caused this Agreement to be executed by their duly
authorized representatives as of the Effective Date.
UNIVERSITY OF MASSACHUSETTS ADVANCED INFLUENZA TECHNOLOGIES, INC.
By:__________________________________ By:__________________________________
Xxxxx X. XxXxxxxx, Ph.D. Xxxx Xxxxxxx
Executive Director, Office of President
Technology Management
Date: ____________________ Date: ___________________
13 of 14
EXHIBIT A
List of Patent Rights
---------------------
University invention disclosure UMMC04-96 entitled "Influenza Nucleic Acids,
Polypeptides, and Uses Thereof" as embodied in Patent Applications 60/655,979;
11,362,617; and PCT/US2006/006701 and naming Xxxx Xx and Xxxxxx Xxxx as
inventors.
14 of 14