LICENSE AGREEMENT (as amended)
Exhibit
10.8
Portions
herein identified by [***] have been omitted pursuant to a request for
confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934.
A complete copy of this document has been filed separately with the Securities
and Exchange Commission.
(as
amended)
This
Agreement (hereinafter referred to as this "Agreement"), effective as of
this
April 19, 2005, is entered into by and between the UNIVERSITY OF SOUTH FLORIDA
RESEARCH FOUNDATION, INC., a corporation not for profit under Chapter 617
Florida Statutes, and a direct support organization of the University of
South
Florida (“University”) pursuant to section 1004.28 Florida Statutes, having its
principal office at 0000 Xxxx Xxxxxx Xxxxxx, Xxxxx, Xxxxxxx 00000, X.X.X.
(hereinafter referred to as “Licensor”), and GREENWICH THERAPEUTICS, INC. a
corporation duly organized and existing under the laws of the State of Delaware
with head quarters at 000 Xxxxxxx Xxxxxx, 00xx
Xxxxx,
Xxx Xxxx, XX 00000 (the "Company").
WHEREAS,
Licensor is the exclusive licensee under certain “Patent Rights” (as later
defined herein) relating to Triciribine
a/k/a Triciribine Monphosphate a/k/a Tricyclic Nucleoside a/k/a API-2 for
inhibition of AKT
with
antitumor activity in cancer cells overexpressing AKT
(the
“Technology”)
and has
the right to grant sublicenses under said Patent Rights;
WHEREAS,
Licensor desires to have the Patent Rights utilized in the public interest
and
is willing to grant a license thereunder; and
WHEREAS,
Company intends to develop, produce, manufacture, market and/or sell products
similar to the “Licensed Product(s)” (as later defined herein) and is willing to
commit itself to a diligent program of exploiting the Patent Rights so that
public utilization shall result therefrom; and
WHEREAS,
Company desires to obtain a license under the Patent Rights upon the terms
and
conditions hereinafter set forth.
NOW,
THEREFORE, in consideration of the premises and the mutual covenants contained
herein, the parties hereto agree as follows:
ARTICLE
1 - DEFINITIONS
For
the
purposes of this Agreement, the following words and phrases shall have the
following meanings:
1.1 "Affiliate"
shall mean, with respect to any Entity (as hereinafter defined), any Entity
that
directly or indirectly controls, is controlled by, or is under common control
with such Entity.
1.1.1 “Control”
shall mean, for this purpose, direct or indirect control of more than fifty
percent (50%) of the voting securities of an Entity or, if such Entity does
not
have outstanding voting securities, more than 50% of the directorships or
similar positions with respect to such Entity.
1.1.2 “Entity”
shall mean any corporation, association, joint venture, partnership, trust,
business, individual, or any other organization that can exercise independent
legal standing.
1.2
|
"Company"
shall mean Greenwich Therapeutics, Inc.,
a
Delaware corporation.
|
1.3
|
“Field
of Use” shall mean all uses.
|
1.4 "Improvements"
shall mean any modification of a Licensed Process or Licensed
Product or any inventions (whether patentable or not), information and data,
in
the Field of Use that, created or derived during the term of this Agreement,
the
manufacture use or sale of which would be commercially important or necessary
in
the practice of, or would infringe an issued or pending claim within the
Patent
Rights.
1.5 "Know-how"
shall mean all tangible information
(other than those contained in the Patent Rights), existing prior to the
Effective Date of this Agreement, whether patentable or not (but which have
not
been patented) and physical objects related to the Licensed Product, including
but not limited to formulations, biological samples, tissues, animals,
organisms, compounds, intermediates, laboratory notebooks, in vitro, preclinical
or clinical design, information or results, other proprietary materials,
processes, including but not limited to manufacturing processes, data, drawings
and sketches, designs, testing and test results, regulatory information of
a
like nature, owned by any of Licensor, which Licensor has the right to disclose
and license to the Company.
1.6 “Licensed
Product(s)" shall mean:
1.6.1 Any
product which is covered in whole or in part by Patent Rights in the country
in
which the product is made, used, leased or sold;
1.6.2 Any
product which is manufactured using a process which is covered in whole or
in
part by Patent Rights in the country in which the process is used;
1.6.3 Any
product which is used according to a method or use which is covered in whole
or
in part by Patent Rights in the country in which the method is
used.
1.7 "Licensed
Process(es)" shall mean any process, use or method, which is covered, in
whole,
or in part, by Patent Rights in the country in which the process or method
is
used.
1.8 "Net
Sales" shall mean the total gross receipts for sales of Licensed Products
or
practice of Licensed Processes by or on behalf of the Company, any of its
Affiliates or sublicensees whether invoiced or not, less only the sum of
the
following:
1.8.1
Usual
trade discounts allowed and provided to customers;
1.8.2
Sales,
tariff duties and/or taxes directly imposed and with reference to particular
sales;
1.8.3
Amounts
allowed or credited on returns or rejections;
1.8.4
Bad debt
deductions actually written off during the accounting period; and
2
1.8.5
Outbound
transportation prepaid or allowed and transportation insurance;
1.8.6
No
deductions shall be made for commissions paid to individuals whether they
be
with independent sales agencies or regularly employed by Licensee and on
its
payroll, or for cost of collections. Notwithstanding anything to the contrary
in
this Article 1.8, Net Sales does not include sales of Licensed Products at
or
below the fully burdened cost of manufacturing solely for non-profit research
or
clinical testing or for indigent or similar public support or compassionate
use
programs. Net sales are calculated based on the final sale of the Licensed
Product to an independent third party end user. If (i) the end user is a
Sublicensee or Affiliate or (ii) if Licensed Product or Licensed Process
is sold
for consideration other than money, then Net Sales shall be calculated based
on
the final gross selling price of comparable Licensed Products sold in arm’s
length transactions by Licensee to an end user.
1.9 "Patent
Rights" shall mean all U.S. and foreign patents and patent applications set
forth in Exhibit A and:
1.9.1 Any
other
United States or foreign patent applications or patents that claim priority
to
any of the patents or applications listed in Exhibit A, together with any
and
all patents issuing thereon, including continuations, divisionals,
reexaminations, extensions, and reissue applications and any United States
or
foreign patents granted upon such applications, all of which shall be deemed
added to Exhibit A;
1.9.2 Any
other
intellectual property rights owned or controlled by the Licensor relating
to the
Technology that the Licensor has the right to license to the Company existing
prior to the Effective Date of this Agreement.
1.10
|
“Territory”
shall mean the world.
|
ARTICLE
2 - GRANT
2.1 Licensor
hereby grants to the Company and the Company accepts, subject to the terms
and
conditions of this Agreement, an exclusive license in the Field of Use to
practice under the Patent Rights and to utilize the Know-how in the Territory,
and (a) to make, have made, use, lease and/or sell the Licensed Products
and to
practice and have practiced the Licensed Processes, to the full end of the
term
for which the Patent Rights are granted, unless sooner terminated as hereinafter
provided and (b) to sublicense to third parties, in accordance with Section
2.2
below, the rights granted under subsection (a) of this Paragraph
2.1.
2.2 In
accordance with 2.1 above, Licensor hereby grants to the Company the right
to
grant sublicenses to third parties under the license granted hereunder in
its
sole discretion, provided, however, that the Company provides Licensor with
notice of its intent to enter into each such sublicense and the Company
reasonably considers Licensor’s objections to such sublicense, if any, before
the Company grants any such sublicense. Company agrees that any sublicenses
granted by it shall contain such provisions as are necessary for the Company
to
meet its obligations under this Agreement. The Company will remain obligated
to
Licensor under the terms of this Agreement, unless this Agreement terminates
in
accordance with its terms, without regard to whether the Company has entered
into a sublicense with a third party.
3
2.2.1 Within
thirty (30) days after execution or receipt thereof, as applicable, the Company
shall provide Licensor with a copy of each sublicense issued
hereunder.
2.2.2 Upon
termination of this Agreement other than by expiration in accordance with
paragraph 7.6, any and all sublicenses shall survive such termination, provided,
however, such sublicensee is not in default of such sublicense 90 days after
receiving notification from Licensor that (i) Licensor has terminated this
Agreement and (ii) Licensor believes that such sublicensee is in default
of the
sublicense agreement. Moreover, Licensor shall not be required to take on
any
additional obligations or restrictions in its agreement with sublicensee
not
already imposed on Licensor by this Agreement. Notwithstanding the foregoing,
if
Company believes that Licensor has terminated this Agreement for the primary
purpose of doing business directly with the sublicensee, the termination
may be
disputed under the provisions of Article 8.
2.3 Licensor
reserves to the University, Xxxxxxx Research & Cancer Center, and the
inventors the right to practice under the Patent Rights for noncommercial
research and education purposes, including research for any sponsors (provided
such research is for noncommercial purposes and funded by a not-for-profit
sponsor). Licensor, the University, Xxxxxxx Research & Cancer Center, and
the inventors shall not have the right to conduct human clinical trials with
any
Licensed Product or Licensed Process except if (i) other non-licensees would
have the right to conduct such clinical trials without the consent of the
Company or (ii) Licensor is granted the right to conduct human clinical trials
with a Licensed Product or Licensed Process by written agreement with the
Company.
2.4 Company
shall initially have a right of first refusal to obtain the exclusive rights
to
Licensor (a) continuations in part relating to the patents or patent
applications included in the Patent Rights and (b) United States and foreign
patent applications based on research funded by Company that would be
commercially important or necessary to practice the Patent Rights, including
any
continuations, continuations-in-part, divisionals, reissues, reexaminations,
or
extensions thereof (collectively (a) and (b) shall be the “Future Rights”).
Accordingly, promptly after such filing, invention or creation and prior
to
disclosing to any third party the existence of any Future Rights, the Licensor
shall disclose the applicable Future Rights to the Company. If the Company
so
determines, the Company and the Licensor shall negotiate, in good faith,
a
commercially reasonable exclusive license of the Future Rights to the Company.
If the Company and Licensor do not enter into a definitive exclusive license
with ninety (90) days from the date the Company received notice of such Future
Right from the Licensor, then the Licensor shall have the right to solicit
offers from third parties. If an offer relating
to a Future Right(s) is
extended to a third party under more
favorable
terms
than those offered to the Company
for such
Future Right(s),
such
terms presented to the third party shall be presented to Company and Company
shall have fifteen (15) days to accept such license on such offered terms
(the
Company’s “Right of First Refusal”). Both the Licensor and the Company shall be
obligated to negotiate such terms in good faith. If
an
offer is extended to a third party for less favorable terms then the last
offer
to the Company than Licensor has no obligation to present such offer to the
Company. The Right of First Refusal under this paragraph 2.4 shall extend
for
one year after the ninety (90) day negotiation period between the Company
and
the Licensor has expired under this paragraph 2.4 for the Future Rights being
negotiated after which Licensor shall have the right to solicit offers from
third parties relating to such Future Rights with no further obligation to
Company.
2.5 The
Company shall have the exclusive first option to negotiate in good faith
for a
license agreement to obtain the exclusive rights to any Improvement relating
to
the Technology created by or under the direction or control of the Inventor(s),
filed,
created or invented after the date of this Agreement (“Option Rights”).
Accordingly, promptly after such filing, invention or creation and prior
to
disclosing to any third party the existence of any Improvement, the Licensor
shall disclose the applicable Option Rights to the Company. If the Company
so
determines, the Company and the Licensor shall negotiate, in good faith,
a
commercially reasonable exclusive license of the Option Rights to the Company.
If the Company and Licensor do not enter into a definitive exclusive license
with ninety (90) days from the date the Company received notice of such Option
Rights from the Licensor, then the Licensor shall have the right to solicit
offers from third parties relating to such Option Rights with no further
obligation to Company.
4
2.6 The
license granted hereunder shall not be construed to confer any rights upon
Company by implication, estoppel or otherwise as to any technology except
as
specifically set forth herein.
ARTICLE
3 - COMMERCIALIZATION
3.1 The
Company shall use its commercially reasonable efforts to meet the Milestones
under Article 4.5 and to bring a Licensed Product to market through a thorough,
vigorous and diligent program for exploitation of the Licensed Products and
Licensed Processes as timely and efficiently as possible. Such program shall
include the preclinical and clinical development of Licensed Products and
Licensed Processes, including research and development, manufacturing,
laboratory and clinical testing and marketing. The Company shall continue
active, diligent marketing efforts for Licensed Product(s) throughout the
term
of this Agreement.
3.2 A
Development Committee (the “Committee”) shall be organized to monitor the
clinical progress of the Licensed Products at the Company’s expense. The
Committee will consist of independent scientific and technical thought leaders
that are highly regarded by the scientific community in the field of each
Licensed Product and at least one representative from each of Licensor and
the
Company. The Committee will be responsible for (i) making recommendations
to the
Company’s management relating to the pre-clinical and clinical development
strategy; (ii) analysis and assessment of ongoing pre-clinical and clinical
development of each Licensed Product; and (iii) assisting the Company to
prepare
pre-clinical and clinical development budgets. The actions and opinions of
the
Committee will be confidential, however, the Licensor representative may
report
clinical updates to a designated senior official at the Licensor who will
agree
to keep such information confidential. The Committee will meet at least two
(2)
times per year.
3.3 The
Company will conduct its first clinical study entitled "Targeted Inhibition
of
Akt Activation in patients with metastatic colorectal, pancreatic, breast
and
ovarian cancer: A phase I/II study and pharmacodynamic/pharmacokinetic
evaluation of the Akt activation inhibitor, Triciribine (TCN-P)." at the
facilities of the Licensor. The Company will reasonably consider using the
facilities of the Licensor to conduct future clinical studies.
ARTICLE
4 - ROYALTIES AND OTHER CONSIDERATION
4.1 The
Company agrees to pay to Licensor the royalties set forth below, and in
accordance with the provisions of Articles 4.5 and 4.6, to the end of the
term
of the Patent Rights or until this Agreement shall be terminated as hereinafter
provided:
4.1.1 During
the term of the License Agreement, the Company shall pay to the Licensor
“Running Royalties” equal to [***]
percent ([***]%) of
Net
Sales of Licensed Products, by the Company or its sublicensees, of up to
[***]
Dollars ($[***]) in
any
calendar year; [***]
percent ([***]%) of
Net
Sales of Licensed Products, by the Company or its sublicensees in excess
of
[***]
Dollars ($[***]) but
less
than [***]
Dollars ($[***]) in
any
calendar year; and [***]
percent ([***]%) of
Net
Sales of Licensed Products, by the Company or its sublicensees equal to or
in
excess of [***]
Dollars ($[***]) in
any
calendar year.
5
4.2 In
the
event that a Licensed Product is sold in the form of a combination product
containing one or more products or technologies which are themselves not
a
Licensed Product, the Net Sales for such combination product shall be calculated
by multiplying the sales price of such combination product by the fraction
A/(A+B) where A is the invoice price of the Licensed Product or the Fair
Market
Value of the Licensed Product if sold to an Affiliate and B is the total
invoice
price of the other products or technologies or the Fair Market Value of the
other products or technologies if purchased from an Affiliate. In the case
of a
combination product which includes one or more Licensed Products, the Net
Sales
for such combination product upon which the royalty due to Licensor is based
shall not be less than the normal aggregate Net Sales for such Licensed
Product.
4.3
Royalty
payments shall be paid in United States dollars in Tampa, Florida or at such
place as Licensor may reasonably designate consistent with the laws and
regulations controlling in the United States and if applicable in any foreign
country. Any taxes which the Company, its Affiliate or any sublicensee shall
be
required by law to withhold on remittance of the royalty payments shall be
deducted from such royalty payment to Licensor. The Company shall furnish
Licensor with the original copies of all official receipts for such taxes.
If
any currency conversion shall be required in connection with the payment
of
royalties hereunder, such conversion shall be made by using the exchange
rate
prevailing at Chase Manhattan Bank (N.A.) on the last business day of the
calendar quarterly reporting period to which such royalty payments
relate.
4.4 Royalties
payable to Licensor shall be paid semi-annually on or before June 30 and
December 31 of each calendar year. Each such payment shall be for unpaid
royalties which accrued within or prior to the Company's two most recently
completed fiscal quarters.
4.5 As
further consideration for the license granted hereunder, the Company shall
pay
to Licensor the following one time “Milestone Payments” which shall not be
deducted from royalties otherwise owed or which may in the future be owing
payable to Licensor on account of sublicensing royalties and/or lump sum
payments received by the Company or its Affiliate from sublicensees pursuant
to
paragraph 4.1.2:
4.5.1 $40,000
upon execution of this Agreement.
4.5.2 Reimbursement
for costs incurred by Licensor with respect to Patent Rights upon execution
of
this Agreement, which in no case shall exceed $[***].
4.5.3 [***]
Dollars ($[***]) upon
the
acceptance by the Food and Drug Administration (the “FDA”) of a Company
sponsored Investigative New Drug Application (“an IND”) for a Licensed Product.
For the purposes of this section 4.5.3, the IND shall be deemed “accepted” by
the FDA sixty (60) days after submission of the IND to the FDA by the Company,
provided, however, that the FDA has not notified the Company that it will
not
allow human clinical trials to commence under such IND;
6
4.5.4 [***]
Dollars ($[***]) upon
the
first dosing of a patient, with a Licensed Product, in the first Phase II
clinical trial sponsored by the Company or its sublicensee in any country
under
a Company sponsored IND or equivalent;
4.5.5 [***]
Dollars ($[***]) upon
the
first dosing of a patient, with a Licensed Product, in the first Phase III
clinical trial sponsored by the Company or its sublicense in any country
under a
Company sponsored IND or equivalent;
4.5.6 [***]
Dollars ($[***]) upon
the
acceptance for review of the first Company sponsored (or sublicensee sponsored)
New Drug Application (and “NDA”) by the FDA;
4.5.7 [***]
Dollars ($[***]) upon
the
final approval by the FDA of the first Company sponsored (or sublicensee
sponsored) NDA for a Licensed Product filed by the Company or its
sublicensee;
4.6 No
payment obligations shall be due with respect to any sale or sublicense covering
any Licensed Product in a country if there are no issued Patent Rights
underlying such Licensed Product in such country.
4.7 Should
the Company or their sublicensees fail to file an IND for a Licensed Product
with the FDA by the first anniversary of this Agreement (the “Penalty Date”),
the Company shall remit a payment to the Licensor equal to [***]
Dollars ($[***]) The
Company shall remit an additional [***]
Dollars ($[***]) (each
a
“Penalty Payment”) for each thirty (30) day period following the Penalty Date
that it does not file an IND for a Licensed Product with the FDA. Upon
submission of an IND for a Licensed Product with the FDA, the Company shall
no
longer be required to make Penalty Payments.
4.8 To
the
extent that the Company or any Affiliate of the Company is required (i) after
appropriate legal analysis, or (ii) by order or judgment of any court in
any
jurisdiction, to obtain a license from a third party in order to practice
the
rights purported to be granted to the Company by Licensor hereunder under
Patent
Rights in such jurisdiction, then up to [***]
percent ([***]%) of
the
royalties payable under such license in such jurisdiction may be deducted
from
royalties otherwise payable to Licensor hereunder, provided that in no event
shall the aggregate royalties payable to Licensor in any semi-annual period
in
such jurisdiction be reduced by more than [***]
percent ([***]%) as
a
result of any such deduction.
4.9 Upon
each
anniversary of this Agreement, the Company shall commit at least twenty-five
thousand dollars ($25,000) specifically to be used in research and development
related to potential products, research or development of Licensed Process
or
Licensed Product (the “Sponsored Research Funds”).
4.9.1 To
the
extent consistent with University’s rules and policy, and Florida Law, the
“Sponsored Research Funds” will be placed in a designated University of South
Florida Research Foundation Research Fund(s) and disbursed to researchers
by
mutual agreement of Company and University’s Director of Sponsored Research, as
further described in a Sponsored Research Agreement.
4.10 Company
agrees to provide Licensor [***]
percent ([***]%) of
any
Fees received by Company prior to meeting the milestone contained hereunder
Article 4.5.3 and [***]
percent ([***]%) of
any
Fees received by the Company thereafter. As used herein, the term “Fees” means
any fees, payments, or monies received by Company directly related to the
sublicensing by the Company of rights to commercialize Licensed Products
or
Licensed Processes, excluding (a) payments received from the sale or issuance
of
debt or equity securities of the Company; (b) payments received by the Company
that are specifically designated in any agreement with a third party to be
dedicated to the research and development of the Technology or dedicated
to
establish a marketing and sales force for sales of the Technology; and (c)
payments resulting from the sale of one or more Licensed Products, including
royalties which shall be subject to Article 4.1.1.
7
ARTICLE
5 - REPORTS AND RECORDS
5.1 The
Company shall keep full, true and accurate books of account containing all
particulars that may be necessary for the purpose of showing the amounts
payable
to Licensor by way of royalty as aforesaid. Said books of account shall be
kept
at the Company's principal place of business and the supporting data shall
be
open upon reasonable notice to the Company, for three (3) years following
the
end of the calendar year to which they pertain, for inspection by Licensor’s
internal audit division and/or by another designated auditor selected by
Licensor, except one to whom the Company has reasonable objection, for the
purpose of verifying the Company's royalty statement or compliance in other
respects with this Agreement. Such obligation to maintain accurate books
of
account and the right to inspect them shall survive termination of this
Agreement. If an inspection shows an under reporting or underpayment in excess
of the greater of [***] Dollars ($[***]) or [***] percent ([***]%) of royalties
payable for any quarter then the Company shall reimburse Licensor for the
cost
of the inspection at the time the Company pays the unreported royalties,
including any late charges as required by paragraph 5.4 of this Agreement.
All
payments required under this Article 5 shall be due within thirty (30) days
of
the date Licensor provides the Company notice of the payment due.
5.2 Within
sixty (60) days from the end of each quarter of each calendar year, specifically
sixty days from March 31, June 30, September 30, and December 31, the Company
shall deliver to Licensor complete and accurate reports, giving such particulars
of the business conducted by the Company during the preceding quarter under
this
Agreement as shall be pertinent to a royalty accounting hereunder, in a format
similar to Exhibit D and shall include at least the following along with
the
information requested in Exhibit D:
5.2.1 All
Licensed Products and Licensed Processes used, leased or sold, by or for
the
Company or its Affiliates;
5.2.2 Total
amounts invoiced for Licensed Products and Licensed Processes used, leased
or
sold, by or for the Company or its Affiliates;
5.2.3 Deductions
applicable in computed Net Sales, if any;
5.2.4 Total
royalties due based on Net Sales by or for the Company or its Affiliates
or any
sublicensee;
5.2.5 Names
and
addresses of all sublicensees and Affiliates of the Company;
5.2.6 On
an
annual basis, the Company's year-end financial statements.
8
5.3 With
each
such quarterly report submitted, the Company shall pay to Licensor the royalties
due and payable under this Agreement. If no royalties shall be due, the Company
shall indicate such in the report.
5.4 Amounts
which are not paid when due and which are not the subject of a bona fide
dispute
shall accrue interest from the due date until paid, at a rate equal to the
then
prevailing prime rate of Citibank, N.A., plus [***] percent ([***]%), compounded
annually.
5.5 The
Company agrees to forward to Licensor annually a copy of any report, which
is in
substance similar to the report required by this Article 5, received from
any
sublicensee and other documents received from any sublicensee as may be
pertinent to an accounting of royalties.
5.6 Licensor
agrees to hold in confidence each report delivered by the Company pursuant
to
this Article 5 until the termination of this Agreement. Notwithstanding the
foregoing, Licensor may disclose any such information required to be disclosed
pursuant to any judicial, administrative or governmental request, subpoena,
requirement or order, provided that Licensor take reasonable steps to provide
the Company with the opportunity to contest such request, subpoena, requirement
or order. However, it is understood and agreed that according to Florida
Statute
1004.22, Licensor shall make available upon request the title and description
of
a research project, the name of the researcher, and the amount and source
of
funding provided for such project.
5.7 Company
may submit a new statement correcting for an unintentional and newly discovered
overpayment for a period of one (1) year after the receipt of any such report
and payment. Company’s sole remedy for such overpayment shall be credit against
the following years payments due Licensor.
5.8 Company
shall provide Development Reports, of which a sample is attached hereto as
Exhibit C, semiannually, the first report being due six (6) months after
the
Effective Date of this Agreement.
ARTICLE
6 - PATENT PROSECUTION AND MAINTENANCE
6.1 The
Company shall diligently prosecute and maintain the Patent Rights as set
forth
in Exhibit A hereto (as the same may be amended or supplemented from time
to
time after the date hereof), including, but not limited to, the filing of
patent
applications which may be required. The Company agrees to keep Licensor
reasonably well informed with respect to the status and progress of any such
applications, prosecutions and maintenance activities and to consult in good
faith with Licensor and take into account Licensor’s comments and requests with
respect thereto. The Company will provide Licensor, under confidentiality,
with
copies of all filings covering products
incorporating the Technology.
Company
shall ensure that Licensor is simultaneously copied with Company on all
communication from patent counsel, including attachments related to Patent
Rights between Company and patent counsel. The Licensor shall be given the
opportunity to review and comment upon the breadth and coverage of said patent
applications, and patent counsel chosen by the Company and approved by Licensor,
such approval not to be unreasonably withheld, shall use all due care to
address
and incorporate any comments offered by the Licensor. In addition, Licensor
shall have the right to designate its own separate counsel, at Licensor’s
expense, to review and comment upon the prosecution and drafting of any
applications, prosecution or maintenance documents and said comments shall
also
be given due consideration. Both parties agree to provide reasonable cooperation
to each other to facilitate the application and prosecution of patents pursuant
to this Agreement.
9
6.2 The
Company may, in its discretion, elect to abandon any patent applications
or
issued patent in the Patent Rights, in which case the Company shall have
no
further royalty obligation to Licensor in respect of any Licensed Products
and
Licensed Processes, the manufacture, use or sale of which is covered by an
issued claim of such abandoned Patent Rights. Prior to any such abandonment,
the
Company shall give Licensor at least sixty (60) days notice and a reasonable
opportunity to take over prosecution of such Patent Rights. In such event,
Licensor shall have the right, but not the obligation, to commence or continue
such prosecution and to maintain any such Patent Rights under its own control
and at its expense and the Company shall then have no royalty or other
obligation to Licensor in respect of any Licensed Products and Licensed
Processes, the manufacture, use or sale of which is covered by an issued
claim
of such Patent Rights. The Company agrees to cooperate in such activities
including execution of any assignments or other documents necessary to enable
Licensor to obtain and retain sole ownership and control of such Patent
Rights.
ARTICLE
7 - TERMINATION
7.1 If
the
Company shall become bankrupt, or shall file a petition in bankruptcy, or
if the
business of the Company shall be placed in the hands of a receiver, assignee
or
trustee for the benefit of creditors, whether by the voluntary act of the
Company or otherwise, this Agreement shall automatically terminate.
7.2 Should
the Company fail to make payment to Licensor of royalties due in accordance
with
the terms of this Agreement which are not the subject of a bona fide dispute
between Licensor and the Company, Licensor shall have the right to terminate
this License Agreement within seventy five (75) days after giving written
notice
of termination unless the Company shall pay to Licensor, within the seventy
five
(75) day period, all such royalties due and payable. In the event of a bona
fide
dispute over royalties, the parties shall resolve such dispute in accordance
with Article 8. Subject to Article 8 and the immediately preceding sentence,
upon the expiration of the seventy five (75) day period, if the Company shall
not have paid all such royalties due and payable, the rights, privileges
and
license granted hereunder shall, at the option of Licensor,
terminate.
7.3 Upon
any
material breach or default of this Agreement by the Company, other than as
set
forth in Paragraph 7.1 and 7.2 above, which shall always take precedence
in that
order over any material breach or default referred to in this Section 7.3,
Licensor shall have the right to terminate this Agreement and the rights,
privileges and license granted hereunder by giving seventy five (75) days
prior
written notice to the Company. Such termination shall become effective
immediately unless the Company shall have cured any such breach or default
prior
to the expiration of the seventy five (75) day period referred to above.
If a
dispute regarding termination is addressed according to Article 7, this license
shall remain in full force and effect until such dispute is settled in a
manner
that is not further appealable or not appealed.
7.4 The
Company shall have the right at any time to terminate this Agreement in whole
or
as to any portion of the Patent Rights, for any reason or no reason, by giving
six (6) months notice thereof in writing to Licensor, and upon payment of
all
amounts due Licensor through the effective date of the termination.
10
7.5 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any obligation that matured prior to the effective
date of such termination or obligations under Articles 4, 5, 8, 10, 13, and
15,
or as specifically specified in such Article. The Company and/or any sublicensee
thereof may, however, after the effective date of such termination and
continuing for a period not to exceed twelve (12) months thereafter, sell
all
completed Licensed Products, and any Licensed Products in the process of
manufacture at the time of such termination, and sell the same, provided
that
the Company shall pay or cause to be paid to Licensor the royalties thereon
as
required by Article 4 of this Agreement and shall submit the reports required
by
Article 5 hereof on the sales of Licensed Products.
7.6 In
the
event of termination under this Article 7, Licensor shall have the right
to
cross-reference and rely upon any such approvals and use all data submitted
by
Company to
any
regulatory agency in
connection with Licensed Products, Licensed Processes or any products covered
under the Patent Rights that Licensor or its other Licensee’s may seek approval
on
and,
following termination of this Agreement, Licensor shall have the unrestricted
right to provide such data to third parties.
7.7 If
not
terminated sooner, this Agreement shall terminate, on a country by country
basis, on the date of the last to expire claim contained in the Patent Rights,
at which time the Company will have an irrevocable, paid up, royalty-free
license under the Patent Rights to make, have made, use, have used, sell
and
have sold Licensed Products and Licensed Processes.
ARTICLE
8 - DISPUTE RESOLUTION
8.1 Any
dispute arising from or relating to this Agreement, excluding any dispute
relating to patent validity or infringement, which have not been resolved
by
good faith negotiations between the parties, shall be resolved by final and
binding arbitration in Tampa, Florida, in accordance with the rules of the
American Arbitration Association. One arbitrator shall be selected by Licensor,
one arbitrator shall be selected by the Company and the third arbitrator
shall
be selected by mutual agreement of the first two arbitrators. The arbitrators
shall have no power to add to, subtract from or modify any of the terms or
conditions of this Agreement. Any award rendered in such arbitration may
be
enforced by either party in either the courts of the State of Florida or
in the
United States District Court for the Middle District of Florida, to whose
jurisdiction for such purposes Licensor and Company each hereby irrevocably
consents and submits.
8.2 Any
claim, dispute, or controversy concerning the validity, enforceability, or
infringement of any patent contained in the Patent Rights licensed hereunder
shall be resolved in any court having jurisdiction thereof.
8.3 In
the
event that, in any arbitration proceeding, any issue shall arise concerning
the
validity, enforceability, or infringement of any patent contained in the
Patent
Rights licensed hereunder, the arbitrators shall, to the extent possible,
resolve all issues other than validity, enforceability, and infringement;
in any
event, the arbitrators shall not delay the arbitration proceeding for the
purpose of obtaining or permitting either party to obtain judicial resolution
of
such issues, unless an order staying the arbitration proceeding shall be
entered
by a court of competent jurisdiction. Neither party shall raise any issue
concerning the validity, enforceability, or infringement of any patent contained
in the Patent Rights licensed hereunder, in any proceeding to enforce any
arbitration award hereunder, or in any proceeding otherwise arising out of
any
such arbitration award.
11
8.4
The
costs of such arbitration shall be borne proportionate to the finding of
fault
as determined by the Arbitrator. Judgment on the arbitration award may be
entered by any court of competent jurisdiction.
8.5 Notwithstanding
the foregoing, nothing in this Article shall be construed to waive any rights
or
timely performance of any obligations existing under this
Agreement.
ARTICLE
9 - INFRINGEMENT AND OTHER ACTIONS
9.1 The
Company and Licensor shall promptly provide written notice, to the other
party,
of any alleged infringement by a third party of the Patent Rights and provide
such other party with any available evidence of such infringement. Licensor
and
Company shall consult one another in a timely manner concerning any appropriate
response to the infringement.
9.2 During
the term of this Agreement, the Company shall have the right, but not the
obligation, to prosecute and/or defend, at its own expense and utilizing
counsel
of its choice, any infringement of, and/or challenge to, the Patent Rights.
In
furtherance of such right, Licensor hereby agrees that the Company may join
Licensor as a party in any such suit (and will join at the Company’s request),
provided that the Company pay all of Licensor’s reasonable out-of-pocket
expenses. The Company shall indemnify and hold Licensor harmless against
any
costs, expenses, liability, claims or damages made against or sustained by
Licensor in connection with such involvement, other than resulting from
Licensor's negligence or willful misconduct. Company may not settle or
compromise any such suit in a manner that imposes additional obligations
or
restrictions on Licensor not already imposed by this Agreement without
Licensor’s written permission. Any recovery of damages pursuant to this
Paragraph 9.2 shall be retained entirely by the Company and allocated pursuant
to 9.4 below.
9.3 In
the
event that a claim or suit is asserted or brought against the Company alleging
that the manufacture or sale of any Licensed Product by the Company, an
Affiliate of the Company, or any sublicensee, or the use of such Licensed
Product by any customer of any of the foregoing, infringes proprietary rights
of
a third party, the Company shall give written notice thereof to Licensor.
The
Company may, in its sole discretion, modify such Licensed Product to avoid
such
infringement and/or may settle on terms that it deems advisable in its sole
discretion, subject to paragraph 9.2. Otherwise,
the Company shall have the right, but not the obligation, to defend any such
claim or suit. In the event the Company elects not to defend such suit, Licensor
shall have the right, but not the obligation to do so at its sole
expense.
9.4 Any
recovery of damages by the Company, in any such suit, shall be applied first
in
satisfaction of any unreimbursed expenses and legal fees of the Company relating
to the suit. The balance remaining from any such recovery shall be treated
as
royalties received by the Company from sublicensees and shared by Licensor
and
the Company in accordance with Paragraphs 4.1 and 4.2 hereof as applicable.
9.5 The
Company may credit the cost of any litigation costs incurred by the Company
in
any country pursuant to this Article 9 including all amounts paid in judgment
or
settlement of litigation within the scope of this Article 9 against royalties
or
other fees thereafter payable to the Licensors hereunder for such country.
If
the costs of such litigation in such country exceeds the royalties payable
to
the Licensors in any year in which such costs are incurred then the amount
of
such costs, expenses and amounts paid in judgment or settlement, in excess
of
the royalties payable shall be carried over and credited against royalty
payments in future years for such country.
12
9.6 If
within
six (6) months after receiving notice of any alleged infringement, the Company
shall have been unsuccessful in persuading the alleged infringer to desist,
or
shall not have brought and shall not be diligently prosecuting an infringement
action, or if the Company shall notify Licensor, at any time prior thereto,
of
its intention not to bring suit against the alleged infringer, then, and
in
those events only, Licensor shall have the right, but not the obligation,
to
prosecute, at its own expense and utilizing counsel of its choice, any
infringement of the Patent Rights, and the Company may, for such purposes,
join
the Licensor as a party plaintiff. The total cost of any such infringement
action commenced solely by Licensor shall be borne by Licensor and Licensor
shall keep any recovery or damages for infringement or otherwise derived
therefrom and such shall not be applicable to any royalty obligation of the
Company.
9.7 In
any
suit to enforce and/or defend the Patent Rights pursuant to this Agreement,
the
party not in control of such suit shall, at the request and expense of the
controlling party, cooperate in all respects and, to the extent possible,
have
its employees testify when requested and make available relevant records,
papers, information, samples, specimens, and the like.
ARTICLE
10 - LIMITATION OF LIABILITY, INDEMNITY
10.1 EXCEPT
AS
OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSOR MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTY OF MERCHANTABILITY, FITNESS
FOR
A PARTICULAR PURPOSE, AND VALIDITY OF PATENTED RIGHTS CLAIMS, ISSUED OR PENDING.
10.2 The
Company agrees to defend, indemnify and hold Licensor, the University and
their
trustees, inventors, officers, employees and affiliates, harmless from and
against all liability, demands, damages, including without limitation, expenses
or losses including death, personal injury, illness or property damage arising
directly or indirectly: (a) out of use by the Company, Company’s Affiliates,
sublicensees, or its transferees of inventions licensed or information furnished
under this Agreement or (b) out of any use, sale or other disposition by
the
Company, Company’s Affiliates, sublicensees, or its transferees of Patent
Rights, Licensed Products or Licensed Processes, in each case which are not
the
result of Licensor's negligence or willful misconduct. The Company agrees
that
any sublicense agreement it enters relative to the Licensed Products and/or
Licensed Processes shall contain a covenant by such sub-licensee providing
for
the indemnification of Licensor as provided in this Article.
10.3 Licensor
shall not be liable to Company or Company’s customers or sublicensees for any
damages, including but not limited to, direct, special, incidental, indirect,
economic, or consequential damages resulting from design defects, testing,
labeling, manufacture, or other application of Licensed Products manufactured,
tested, designed, sublicensed or sold pursuant to this Agreement.
10.4 Company
shall procure and maintain commercial general liability insurance, including
without limitation, product liability insurance, in amounts customary in
the
relevant industry in which Company commercially exploits Licensed Products
or
Licensed Process. Such insurance coverage shall extend to indemnities of
Company
and Licensor shall be named as an insured. Insurance coverage shall be obtained
through insurance carriers reasonably acceptable to Licensor. Product liability
insurance shall be maintained prior to the first commercial sale of a Licensed
Product and shall be continued for a commercially reasonable amount of time
after the expiration of this Agreement.
13
10.5 LICENSEE
shall promptly notify RESEARCH FOUNDATION of all claims involving the
Indemnities.
10.6 Nothing
in this Agreement shall be construed as a warranty or representation by RESEARCH
FOUNDATION or University that it will not grant licenses to others to make,
use
or sell products or processes not covered by the claims of the Patent Rights
which may be similar to or compete with products made or sold by LICENSEE
or its
sublicensee.
ARTICLE
11 - ASSIGNMENT
This
Agreement and the rights and duties appertaining hereto may not be assigned
by
either party without first obtaining the written consent of the other which
consent shall not be unreasonably withheld. Any such purported assignment,
without the written consent of the other party, shall be null and of no effect.
Notwithstanding the foregoing, the Company may assign this Agreement without
the
consent of Licensor (i) to a purchaser, merging or consolidating corporation,
or
acquiror of substantially all of the Company's assets or business and/or
pursuant to any reorganization qualifying under section 368 of the Internal
Revenue Code of 1986 as amended, as may be in effect at such time, or (ii)
to an
Affiliate of the Company. In either such case, Company shall notify Licensor
in
writing within thirty (30) days of such assignment. Notwithstanding the
foregoing, Licensor may assign this Agreement or any individual sections
or
paragraphs under this Agreement, without the consent of Company, to Xxxxxxx
Research & Cancer Center.
ARTICLE
12 - PAYMENT OF FEES AND EXPENSES
Each
of
the Company and Licensor shall be responsible for their own expenses relating
to
the preparation and consummation of this Agreement and the agreements and
transactions contemplated hereby.
ARTICLE
13 - USE OF NAMES AND PUBLICATION
13.1 Nothing
contained in this Agreement shall be construed as granting any right to the
Company or its Affiliates to use in advertising, publicity, or other promotional
activities any name, trade name, trademark, or other designation of Licensor,
the inventors, the University nor any of its employees, any of its units
(including contraction, abbreviation or simulation of any of the foregoing),
nor
any adaptation thereof, without the prior, written consent of Licensor;
provided, however,
Company
may state that such has been licensed by Licensor under one or more of the
patents and/or applications comprising the Patent Rights.
13.2 Nothing
herein shall be deemed to establish a relationship of principal and agent
between Licensor and the Company, nor any of their agents or employees for
any
purpose whatsoever.
13.3 In
the
event that Licensor desires to publish or disclose, by written, oral or other
presentation, Patent Rights, Know-how, or any material information related
thereto then Licensor shall notify the Company and in writing by facsimile
where
confirmed by the receiving party, and/or by certified or registered mail
(return
receipt requested) of their intention at least sixty (60) days prior to any
speech, lecture or other oral presentation and at least ninety (90) days
before
any written or other publication or disclosure. The Licensor shall include
with
such notice a description of any proposed oral presentation or, in any proposed
written or other disclosure, a current draft of such proposed disclosure
or
abstract. The Company may request that the Licensor, no later than thirty
(30)
days following the receipt of such notice, delay such presentation, publication
or disclosure for up to an additional sixty (60) days in order to enable
the
Company to file, or have filed on their behalf, a patent application, copyright
or other appropriate form of intellectual property protection related to
the
information to be disclosed or request that Licensor do so. Upon receipt
of such
request to delay such presentation, publication or disclosure, Licensor shall
arrange for a delay of such presentation, publication or disclosure until
such
time as the Company or Licensor have filed, or had filed on its behalf, such
patent application, copyright or other appropriate form of intellectual property
protection in form and in substance reasonably satisfactory to the Company
and
Licensor. If the Licensor does not receive any request from the Company to
delay
such presentation, publication or disclosure, Licensor may submit such material
for presentation, publication or other form of disclosure.
14
ARTICLE
14 - PAYMENTS, NOTICES AND OTHER COMMUNICATIONS
Any
payment, notice or other communication required or permitted to be given
pursuant to this Agreement shall be in writing and sent by certified first
class
mail, postage prepaid, by hand delivery or by facsimile if confirmed in writing,
in each case effective upon receipt, at the addresses below or as otherwise
designated by written notice given to the other party:
In
the
case of Licensor:
USF
Research Foundation, Inc.
USF
Xxx
00000
Xxxxx,
Xxxxxxx 00000-0000
Attention:
Assistant Director
Tel:
000-000-0000
Fax:
000-000-0000
In
the
case of the Company:
Greenwich
Therapeutics, Inc.
000
Xxxxxxx Xxxxxx, 00xx Xxxxx
Xxx
Xxxx,
XX 00000
Attn:
President
Tel:
000-000-0000
Fax:
000-000-0000
15.
CONFIDENTIALITY
15.1 Any
proprietary or confidential information relating to the Patent Rights (including
but not limited to Know-how and patent prosecution documents relating to
Patent
Rights) collectively constitute the “Confidential Information." The Company and
Licensor agree that they will not use the Confidential Information for any
purpose unrelated to this Agreement, and will hold it in confidence during
the
term of this Agreement and for a period of five (5) years after the termination
or expiration date of this Agreement. The Company shall exercise with respect
to
such the Confidential Information the same degree of care as the Company
exercises with respect to its own confidential or proprietary information
of a
similar nature, and shall not disclose it or permit its disclosure to any
third
party (except to those of its employees, consultants, or agents who are bound
by
the same obligation of confidentiality as the Company is bound by pursuant
to
this Agreement). However, such undertaking of confidentiality by the Company
shall not apply to any information or data which:
15
15.1.1 The
Company receives at any time from a third-party lawfully in possession of
same
and having the right to disclose same.
15.1.2 Is,
as of
the date of this Agreement, in the public domain, or subsequently enters
the
public domain through no fault of the Company.
15.1.3 Is
independently developed by the Company as demonstrated by written evidence
without reference to information disclosed to the Company by
Licensor.
15.1.4 Is
disclosed pursuant to the prior written approval of Licensor.
15.1.5 Is
required to be disclosed pursuant to law or legal process (including, without
limitation, to a governmental authority) provided, in the case of disclosure
pursuant to legal process, reasonable notice of the impending disclosure
is
provided to Licensor and Licensor has agreed to such disclosure in writing
or
has exhausted its right to contest such disclosure.
ARTICLE
16 - MISCELLANEOUS PROVISIONS
16.1 This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of the State of Florida, without regard to principles of conflicts
of laws.
16.2 If
this
Agreement or any associated transaction is required by the law of any nation
to
be either approved or registered with any governmental agency, the Company
shall
assume all legal obligations to do so and the costs in connection therewith.
16.3 The
parties hereto acknowledge that this Agreement, including the Appendices
and
documents incorporated by reference, sets forth the entire agreement and
understanding of the parties hereto as to the subject matter hereof, and
shall
not be subject to any change of modification except by the execution of a
written instrument subscribed to by the parties hereto.
16.4 The
provisions of this Agreement are severable, and in the event that any provision
of this Agreement shall be determined to be invalid or unenforceable under
any
controlling body of law, such invalidity or unenforceability shall not in
any
way affect the validity or enforceability of the remaining provisions
hereof.
16.5 The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this Agreement shall not constitute a waiver
of
that right or excuse a similar subsequent failure to perform any such term
or
condition by the other party.
16.6 The
headings of the several articles are inserted for convenience of reference
only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
16.7 This
Agreement will not be binding upon the parties until it has been signed below
on
behalf of each party, in which event, it shall be effective as of the date
recited on page one. The provision of this Agreement shall be binding upon
and
shall inure to the benefit of the parties hereto, their heirs, administrators,
successors and assigns.
16
16.8 This
Agreement embodies the entire understanding of the parties and shall supersede
all previous communications, representations or understandings, either oral
or
written, between the parties relating to the subject matter hereof.
16.9 Each
party hereto shall be excused from any breach of this Agreement which is
proximately caused by governmental regulation, act of war, strike, act of
God or
other similar circumstance normally deemed outside the control of the
parties.
16.10 Company
agrees to xxxx the Licensed Products sold in the United States with all
applicable United States patent numbers. All Licensed Products shipped to
or
sold in other countries shall be marked in such a manner as to conform with
the
patent laws and practice of the country of manufacture or sale.
16.11 It
is
understood that Licensor is subject to United States laws and regulations
controlling the export or transfer of defense articles, technical data, computer
software, laboratory prototypes, and other commodities (collectively “technical
information”). Said laws include but are not limited to: the Export Control Act,
International Traffic in Arms Regulations and the Export Administration Act
of
1979. Licensor’s obligations hereunder are contingent on compliance with said
laws and regulations. It is understood that compliance with said laws and
regulations may require of both Licensor and Company: (1) export license(s);
(2)
written compliance plan(s) with said laws and regulations; or (3)
modification(s) to existing facilities. Licensor does not represent that
a
license(s), compliance plan(s) or modification(s) will or will not be required.
In the event that an export license(s) is required, Licensor does not represent
that it shall be issued by the cognizant governmental agencies. In the event
that a compliance plan(s) or modification(s) is required, Licensor does not
represent that said plan(s) or modification(s) will be approved by the cognizant
governmental agencies. In all cases the cost of any (1) export licenses for
Company or Company’s employees; (2) compliance plans required of Company; and
(3) modifications to Company’s facilities shall be the sole responsibility of
Company. Company hereby agrees to comply with any export controls or federal
regulations which may apply to the Licensed Products or Licensed
Processes.
ARTICLE
17-REPRESENTATIONS AND WARRANTIES
17.1 Licensor,
to the best of its knowledge, represents and warrants that:
17.1.1 Licensor
has all right, title, and interest in and to the Patent Rights and Know-how,
including the exclusive, absolute, irrevocable right, title and interest
thereto, free and clear of all liens, charges, encumbrances or other
restrictions or limitations of any kind whatsoever.
17.1.2 There
are
no licenses, options, restrictions, liens, rights of third parties, disputes,
royalty obligations, proceedings or claims relating to, affecting, or limiting
Licensor’s rights or the rights of the Company under this Agreement, or which
may lead to a claim of infringement or invalidity regarding, any part or
all of
the Patent Rights or Know How or their use.
17.1.3 There
is
no claim, pending or threatened, of infringement, interference or invalidity
regarding any part or all of the Patent Rights or Know-how or their use.
17.1.4 The
US
and foreign patent applications and patents itemized on Exhibit A set forth
all
of the patents and patent applications for the Technology in the Field of
Use
owned by or licensed by Licensor on the Effective Date.
17
17.1.5 There
are
no inventors of Patent Rights other than those listed as inventors on the
patent
filings.
17.1.6 Licensor
has provided Company with copies of all documents reflecting support or funding
for all or part of the research leading to Patent Rights and Know How, and
has
listed all funding agencies on Exhibit B.
17.2 It
is
understood that the United States Government (through its agencies or otherwise)
or the Government of the State of Florida may have funded research during
the
course of or under which some of the inventions of the Patent Rights may
have
been conceived or made. The United States Government and the Government of
the
State of Florida are entitled, as a right, under the provisions of 35 U.S.C.
§202-212 and applicable regulations of Title 37 of the Code of Federal
Regulations and other federal and state regulations, to a nonexclusive,
nontransferable, irrevocable, paid-up license to practice or have practiced
the
inventions of such Patent Rights for governmental purposes. Any license granted
to LICENSEE in this Agreement shall be subject to such right, if
any.
17.3 Each
of
Company and Licensor warrants and represents that the persons signing this
Agreement on its behalf have authority to execute this Agreement and that
execution of this Agreement does not violate any law, rule, or regulation
applicable to it or any contract or other agreement by which it is
bound.
(signatures
on next page)
18
IN
WITNESS WHEREOF,
the
parties hereto have executed this Agreement, in triplicate by proper persons
thereunto duly authorized.
GREENWICH THERAPEUTICS, INC. | UNIVERSITY
OF SOUTH FLORIDA RESEARCH FOUNDATION, Inc. |
||
By: ________________________ | By: ________________________ | ||
Name:
________________________
|
Name: Xxx Xxxxx, Ph.D. | ||
Title:
_______________________
|
Title: Executive Director & Secretary | ||
Date:
________________________
|
Date: ________________________ |
UNIVERSITY
OF SOUTH FLORIDA
BOARD
OF TRUSTEES, a public body
corporate
|
|||
By: ________________________ | |||
Name:
________________________
|
|||
Title:
_______________________
|
|||
Date:
________________________
|
|||
By: ___________________________ | |||
Name: ___________________________ | |||
Title: ___________________________ | |||
Date: ________________________ | |||
(signature
page to the License Agreement by and among
the
parties above date April 19, 2005)
19
EXHIBIT
A
[***]
20
EXHIBIT
B
Support
& funding leading to Patent Rights and Know How:
National
Cancer Institute
CA89242
& CA77935
21
EXHIBIT
C
Form
of
Development Report
THIS
REPORT IS CONFIDENTIAL AND MAY CONTAIN MATERIAL NON PUBLIC
INFORMATION
When
appropriate, indicate estimated start date and finish date for
activities.
A. Date
Development Plan Initiated and Time Period Covered by this Report.
B. Development
Report
1. Activities
completed since last report including the object and parameters of the
development, when initiated, when
completed and the results.
2. Activities
currently under investigation, i.e., ongoing activities including object
and
parameters of such activities,
when initiated, and projected date of completion.
C. Future
Development Activities
1. Activities
to be undertaken before next report including, but not limited to, the type
and
object of any studies conducted
and their projected starting and completion dates.
2. Estimated
total development time remaining before a product will be
commercialized.
D. Changes
to Initial Development Plan
1. Reasons
for change.
2. Variables
that may cause additional changes.
E.
Items
to be Provided if Applicable:
1. Information
relating to Licensed Products that has become publicly available, e.g.,
published articles, competing products,
patents, etc.
2. Development
work being performed by third parties, other than Licensee, to include name
of
third party, reasons
for use of third party, planned future uses of third parties including
reasons
why and type of work.
3. Update
of
competitive information trends in industry, government compliance (if
applicable) and market plan.
4.
Information
and copies of relevant materials evidencing the status of any patent
applications or other protection relating to Licensed Products or the
Licensed
Patents.
PLEASE
SEND DEVELOPMENT REPORTS TO:
University
of South Florida Research Foundation, Inc. 0000 X. Xxxxxx Xxxxxx, XXX000 Xxxxx, XX 00000 ATTN: Assistant Director Phone No.: 000-000-0000 Fax No.: 000-000-0000 |
University of South Florida
Division of Patents & Licensing 0000 X. Xxxxxx Xxxxxx, XXX000 Xxxxx, XX 00000 ATTN:
Director
Phone No.: 000-000-0000
Fax No.: 000-000-0000 |
22
Exhibit
D
USF
Royalty Report
Licensee:__________________________ Agreement
No:_______________________
Inventor(s):_______________________
USF Ref: No:_______________________
Period
Covered: From:____/_____/_____ Through:_______/_______/_____________
Prepared
By:_______________________ Approved
by:________________________
If
License covers several major product lines, please prepare a separate report
for
each line. Then combine all product lines into a summary report.
Report
Type: ___Single Product Line Report
________________________________
___Multiproduct
Summary Report Page __ of ___ Pages
Report
Currency: ___US Dollars ___Other_________________________
Country
|
Gross
Sales
|
*Less
Allowances
|
Net
Sales
|
Royalty
Rate
|
Royalty
|
Due
|
This
Year
|
Last
Year
|
|||||
U.S.A.
|
||||||
Canada
|
||||||
Europe
|
||||||
Japan
|
||||||
Others:
|
||||||
TOTAL:
|
Total
Royalty:________Conversion Rate(s):___________Royalty in U.S.
Dollars:________________
Milestone
Payment 1:_________;Milestone Payment 2:_________Milestone Payment
3:__________
The
following Royalty forecast is non-binding and for USF’s internal planning
purposes only:
Royalty
Forecast Under this Agreement: Next
Quarter:________Q2:______Q3:______Q4:______
On
a
separate page, please indicate the reason for returns or other adjustments
if
significant. Also, note any unusual occurrences that affect royalty amounts
during this period. To assist USF’s forecasting, please comment on any
significant expected trends in sales volume.
23