EXCLUSIVE LICENSE AGREEMENT BETWEEN THE JOHNS HOPKINS UNIVERSITY ROSETTA GENOMICS LTD JHU Ref: # - 4950
BETWEEN
THE
▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY
&
ROSETTA
GENOMICS LTD
JHU
Ref: # - 4950
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
LICENSE
AGREEMENT
THIS
LICENSE AGREEMENT (the “Agreement”) is entered into by and between THE ▇▇▇▇▇
▇▇▇▇▇▇▇ UNIVERSITY, a Maryland corporation having an address at ▇▇▇▇ ▇. ▇▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇-▇▇▇▇ (“JHU”) and Rosetta Genomics Ltd., an
Israeli corporation having an address at 10 ▇▇▇▇▇ St. Rehovot (“Company”), with
respect to the following:
RECITALS
WHEREAS,
as a center for research and education, JHU is interested in licensing PATENT
RIGHTS (hereinafter defined) in a manner that will benefit the public by
facilitating the distribution of useful products and the utilization of new
processes, but is without capacity to commercially develop, manufacture, and
distribute any such products or processes; and
WHEREAS,
a valuable invention(s) entitled "Discovery of Human miRNAs and Their Evaluation
with a Dicer KO" (JHU Ref. 4950) was developed during the course of research
conducted at JHU by Drs. Jordan ▇▇▇▇▇▇▇, ▇▇▇▇▇▇ Velculescu, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
and
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ (all hereinafter, "Inventors"). ▇▇. ▇▇▇▇▇▇▇▇▇▇ is an employee
of
▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical Institute (hereinafter “HHMI”); and
WHEREAS,
JHU has acquired through assignment all rights, title and interest, with the
exception of certain retained rights by the United States Government and HHMI,
in its interest in said valuable inventions; and
WHEREAS,
Company desires to obtain certain exclusive rights in such inventions as herein
provided to research, commercially develop, manufacture, produce, commercialize,
use, import, sell and distribute products and processes based upon or embodying
said valuable inventions throughout the world;
NOW
THEREFORE, in consideration of the premises and the mutual promises and
covenants contained in this Agreement, and for other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged,
the
parties hereto agree as follows:
ARTICLE
1
DEFINITIONS
All
references to particular Exhibits, Articles or Paragraphs shall mean the
Exhibits to, and Paragraphs and Articles of, this Agreement, unless otherwise
specified. For the purposes of this Agreement and the Exhibits hereto, the
following words and phrases shall have the following meanings:
1.1 "AFFILIATED
COMPANY" as
used
herein in either singular or plural shall
mean any corporation, company, partnership, joint venture or other entity,
which
controls, is controlled by or is under common control with Company. For purposes
of this Paragraph 1.1, control shall mean the ability to direct the activities
of the relevant entity, and shall include without limitation direct or indirect
(i) ownership of at least fifty percent (50%) of the outstanding voting stock
or
other ownership interest of the other organization or entity, or (ii) possession
of the power to elect or appoint at least fifty percent (50%) of the members
of
the governing body of the organization or other entity.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
1
1.2 “EFFECTIVE
DATE"
of this
License Agreement shall mean the date the last party hereto has executed this
Agreement.
1.3 "EXCLUSIVE
LICENSE"
shall
mean the exclusive grant by JHU to Company of its entire right and interest
in
the PATENT RIGHTS subject to rights retained by the United States Government,
if
any, in accordance with the ▇▇▇▇-▇▇▇▇ Act of 1980 (established by P.L. 96-517
and amended by P.L. 98-620, codified at 35 USC § 200 et. seq. and implemented
according to 37 CFR Part 401), and subject to the retained right of JHU and
HHMI
to make, have made, provide and use for their and The ▇▇▇▇▇ ▇▇▇▇▇▇▇ Health
Systems' purposes LICENSED PRODUCT(S), including the ability to distribute
any
biological material disclosed and/or claimed in PATENT RIGHTS for non-commercial
and nonprofit academic research use to non-commercial entities as is customary
in the scientific community.
1.4 "LICENSED
PRODUCT(S)"
as used
herein in either singular or plural shall mean any process or method, material,
compositions, drug, or other product or service, the manufacture, use, provision
or sale of which would constitute, but for the license granted to Company
pursuant to this Agreement, an infringement of a VALID CLAIM of PATENT RIGHTS
relating to a nucleic acid sequence (infringement shall include, but is not
limited to, direct, contributory, or inducement to infringe).
1.5 "NET
SALES"
shall
mean gross sales revenues and fees billed by Company and AFFILIATED COMPANY
from
the sale of LICENSED PRODUCT(S) less (i) customary trade, quantity, or cash
discounts to the extent actually allowed and taken; (ii) amounts repaid or
credited by reason of price adjustment, recall rejection or return; and (iii)
to
the extent separately stated on purchase 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 PRODUCTS, (iv) rebates and
chargebacks, including without limitation rebates to governmental or managed
care organizations; and (v) amounts received in respect of packing, freight,
shipping and insurance charges applicable to the LICENSED PRODUCTS sold.
If
a
LICENSED PRODUCT is sold or provided as part of a combination,
then:
(i) In
the
event that Company or an AFFILIATED COMPANY sells or provides for any
non-therapeutic purpose a LICENSED PRODUCT, which LICENSED PRODUCT (i) is a
nucleic acid sequence that is a LICENSED PRODUCT or (ii) is designed to detect
or modulate a nucleic acid sequence that is a LICENSED PRODUCT, in combination
with another nucleic acid sequence which is not a LICENSED PRODUCT or is
designed to detect or modulate another nucleic acid sequence which is not a
LICENSED PRODUCT (“Other Sequence”), the NET SALES for purposes of royalty
payments shall be calculated by [***]. However, in no event shall any such
credit be applied to reduce the amount payable hereunder in respect of any
such
LICENSED PRODUCT to less than [***] percent ([***]%) of that amount which would
otherwise have been paid or payable to JHU in respect thereof in accordance
with
the terms of the Agreement and prior to any credit for Other Sequences available
under this paragraph;
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
2
(ii) In
the
event that Company or an AFFILIATED COMPANY sells, in a particular country
during a particular year, a LICENSED PRODUCT for therapeutic purposes in
combination with a therapeutic product which is not a LICENSED PRODUCT and
when
combined with a LICENSED PRODUCT specifically enhances the activity and/or
efficacy of the LICENSED PRODUCT and/or acts synergistically with the LICENSED
PRODUCT (“Other Items”), the NET SALES for purposes of royalty payments shall be
calculated as follows:
(a)
If
all
LICENSED PRODUCTS and Other Items contained in the combination are available
separately in the particular country during such year, the NET SALES for
purposes of royalty payments will be calculated by [***] is the [***] in the
[***] in the [***] is the s[***] in the [***] in the [***].
(b) If
the
combination includes Other Items which are not sold separately in the particular
country during such year (but all LICENSED PRODUCTS contained in the combination
are available separately in the particular country during such year), the NET
SALES for purposes of royalty payments will be calculated by [***].
(c) If
the
LICENSED PRODUCTS contained in the combination are not sold separately, the
parties agree to negotiate a reduction in the royalty rate to reflect the fair
value that the LICENSED PRODUCT attributed to the overall product sold, but
in
no event shall the royalty rates be reduced by greater than [***] percent
([***]%).
The
term
"Other Items" does not include solvents, diluents, carriers, excipients, buffers
or the like used in formulating a product; however,
(iii) In
no
event shall Company apply the credit in both paragraphs (i) and (ii) above
to
the same sale of a LICENSED PRODUCT.
1.6 "PATENT
RIGHTS"
shall
mean the (i) U.S. patent application Serial No. 60/ , filed on ______________,
and assigned to JHU entitled “Discovery of Human miRNAs and Their Evaluation
with a Dicer KO” and the invention disclosed and claimed therein, (ii) all
continuations, divisions, and reissues based thereon, (iii) claims of
continuation-in-part applications directed to subject matter specifically
described in (i), (iv) any corresponding foreign patent applications, and (v)
any U.S. patents, or foreign patents issuing, granted or registered on any
of
(i) through (iv).
1.7 “ROYALTY
TERM”
shall
mean, with respect to each LICENSED PRODUCT in each country, the period during
which there is a VALID CLAIM.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
3
1.8 “SUBLICENSEE(S)”
as
used
herein in either singular or plural shall mean any person or entity other than
an AFFILIATED COMPANY to which Company has granted a sublicense to some or
all
of the rights granted to COMPANY under this Agreement.
1.9 “VALID
CLAIM” shall
mean either: (a) a claim of an issued and unexpired patent included within
the
PATENT RIGHTS which has not been revoked or held unenforceable, unpatentable
or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal,
and
which has not been disclaimed, denied or admitted to be invalid or unenforceable
through reexamination, reissue, disclaimer or otherwise; or (b) a claim of
a
pending patent application included within the PATENT RIGHTS, which claim has
not been abandoned or finally disallowed without the possibility of appeal
or
refiling of such application, and has been pending for less than six (6) years
from the date such claim was filed in a first national filing non-provisional
patent application in the country of interest and has not been (i) canceled,
(ii) withdrawn from consideration, (iii) finally determined to be unallowable
by
the applicable governmental authority (and from which no appeal is or can be
taken), or (iv) abandoned.
ARTICLE
2
LICENSE
GRANT
2.1 Grant.
Subject
to the terms and conditions of this Agreement, JHU hereby grants to Company
an
EXCLUSIVE LICENSE to make, have made, manufacture, provide, use, import,
commercialize, distribute, offer for sale and sell the LICENSED PRODUCT(S)
in
the United States and worldwide under the PATENT RIGHTS. This
Grant shall apply to the Company and any AFFILIATED COMPANY, except that any
AFFILIATED COMPANY shall not have the right to grant a sublicense to others
as
set forth in Paragraph 2.2 below. If any AFFILIATED COMPANY exercises rights
under this Agreement, such AFFILIATED COMPANY shall be bound by all terms and
conditions of this Agreement, including but not limited to indemnity and
insurance provisions and royalty payments, which shall apply to the exercise
of
the rights, to the same extent as would apply had this Agreement been directly
between JHU and the AFFILIATED COMPANY. In addition, Company shall remain fully
liable to JHU for all acts and obligations of AFFILIATED COMPANY such that
acts
of the AFFILIATED COMPANY shall be considered acts of the Company.
2.2 Sublicense.
Company
may sublicense to others under this Agreement subject to the terms and
conditions of this Paragraph 2.2. As a condition to its validity and
enforceability, each sublicense agreement shall: (a) incorporate by reference
the terms and conditions of this Agreement, (b) be consistent with the terms,
conditions and limitations of this Agreement, (c) name JHU and HHMI as an
intended third party beneficiaries of the obligations of SUBLICENSEE without
imposition of obligation or liability on the part of JHU, HHMI or their
Inventors to the SUBLICENSEE, and (d) specifically incorporate Paragraphs 6.2
“Representations by JHU”, 7.1 “Indemnification”, 10.1 “Use of Name”, 10.4
“Product Liability” into the body of the sublicense agreement, and cause the
terms used in therein to have the same meaning as in this Agreement. Company
shall promptly provide to JHU each sublicense agreement, executed by both
Company and SUBLICENSEE. To the extent that any terms, conditions or limitations
of any sublicense agreement are inconsistent with this Agreement, those terms,
conditions and limitations are null and void against JHU and HHMI.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
4
2.3
Government
Rights. The
United States Government may have acquired a nonexclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced for or on behalf
of
the United States the inventions described in PATENT RIGHTS throughout the
world. The rights granted herein are additionally subject to: (i) the
requirement that any LICENSED PRODUCT(S) produced for use or sale within the
United States shall be substantially manufactured in the United States (unless
a
waiver under 35 USC § 204 or equivalent is granted by the appropriate United
States government agency), (ii) the right of the United States government to
require JHU, or its licensees, including Company, to grant sublicenses to
responsible applicants on reasonable terms when necessary to fulfill health
or
safety needs, and, (iii) other rights acquired by the United States government
under the laws and regulations applicable to the grant/contract award under
which the inventions were made.
ARTICLE
3
FEES,
ROYALTIES, & PAYMENTS
3.1 License
Fee. Company
shall pay to JHU within [***] of the EFFECTIVE DATE of this Agreement a license
fee as set forth in Exhibit
A.
JHU
will not submit an invoice for the license fee, which is nonrefundable and
shall
not be credited against royalties or other fees.
3.2
Minimum
Annual Royalties. Company
shall pay to JHU minimum annual royalties as set forth in Exhibit
A.
Such
minimum annual royalties shall be due, without invoice from JHU, within [***]
of
each anniversary of the EFFECTIVE DATE beginning with the first anniversary
until the expiration of the ROYALTY TERM. Running royalties accrued under
Paragraph 3.3 and paid to JHU during the one year period preceding an
anniversary of the EFFECTIVE DATE shall be credited against the minimum annual
royalties due on that anniversary date.
3.3 Running
Royalties. Company
shall pay to JHU a running royalty as set forth in Exhibit
A,
for
each LICENSED PRODUCT(S) sold or provided by Company and AFFILIATED COMPANIES,
based on NET SALES during the ROYALTY TERM. Such payments shall be made
quarterly.
The
royalties, and other amounts payable by Company to JHU pursuant to this
Agreement (“Payments”) shall be reduced [***] applicable to such Payments, and
are to be remitted [***], such that the actual maximum payment by the Company
hereunder shall not exceed the amounts or the rates provided herein. JHU shall
be responsible for paying [***]. If applicable laws require that [***], the
Company shall (a) [***] amount, (b) [***], and (c) [***] therefor, and such
other information as may be necessary [***].
In
the
event any LICENSED PRODUCT shall be sold by Company to an AFFILIATED COMPANY,
by
an AFFILIATED COMPANY to Company, or among AFFILIATED COMPANIES for subsequent
resale to an unaffiliated third party, then the royalty due hereunder shall
be
based upon [***] unaffiliated third party purchaser of such LICENSED
PRODUCT.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
5
In
the
event that non-monetary consideration is received by Company or AFFILIATED
COMPANIES from the sale of LICENSED PRODUCT in an arms-length transaction,
[***]
for such sale.
In
the
event that (i) Company
or
an AFFILIATED COMPANY is required to make payment of royalties to non-AFFILIATES
in order to obtain a license or similar rights from such non-AFFILIATES, in
the
absence of which license or rights Company could not make, use or sell a
LICENSED PRODUCT and which rights are (in
the
reasonable opinion of Company’s counsel)
necessary in order for Company to make, use or sell
LICENSED
PRODUCTS, and (ii) the total royalty burden on Company required to make, use
or
sell a LICENSED PRODUCT exceeds [***] percent ([***]%), then the royalty rate
to
be applied hereunder shall be calculated by the following:
Adjusted
JHU Royalty = [***]% x [***]
[***].
However, in no event shall any such adjustment reduce the royalty rate hereunder
in respect of any such Licensed Product to less than [***] percent
([***]%).
3.4 Royalty
Floor. In
no
event shall any credits or royalty adjustments be applied to reduce the amount
payable to JHU in respect of any LICENSED PRODUCT to less than [***] percent
([***]%) of NET SALES, where the definition of NET SALES for the purposes of
this Paragraph 3.4 is limited to the first paragraph of Paragraph
1.5.
3.5 Sublicense
Consideration.
Company
shall pay to JHU a percentage of consideration received for sublicenses under
this Agreement as set forth in Exhibit
A.
This
sublicense consideration shall be due, without the need for invoice from JHU,
within [***] of the effective date of each sublicense agreement (running
royalties shall be paid quarterly). Such consideration shall mean consideration
of any kind received by the Company or AFFILIATED COMPANIES from a
SUBLICENSEE(S) for the grant of a sublicense under this Agreement, such as
upfront fees, milestone fees, running royalties on LICENSED PRODUCTS and
including any premium paid by the SUBLICENSEE(S) over Fair Market Value for
stock of the Company or an AFFILIATED COMPANY in consideration for such
sublicense. However, not included in such sublicense consideration are amounts
paid to the Company or an AFFILIATED COMPANY by the SUBLICENSEE(S) for [***],
each pursuant to a [***], or amounts paid by a SUBLICENSEE to [***]. The term
"Fair Market Value" shall mean the average price that the stock in question
is
publicly trading at for twenty (20) trading days prior to the announcement
of
its purchase by the SUBLICENSEE(S) or if the stock is not publicly traded,
the
value of such stock as determined by the higher of (i) the most recent private
financing through a financial investor (an entity whose sole interest in the
Company or AFFILIATED COMPANY is financial) of the Company or AFFILIATED COMPANY
that issued the shares, and at Company’s option and expense (ii) the independent
valuation by an accounting or other financial services firm mutually acceptable
to JHU and Company.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
6
3.6 Patent
Reimbursement. In
accordance with Paragraph 4.1 below, Company will reimburse JHU, within thirty
(30) days of the receipt of an invoice from JHU, for all costs associated with
the preparation, filing, maintenance, and prosecution of PATENT RIGHTS incurred
by JHU subsequent to the EFFECTIVE DATE of this Agreement.
3.7 Form
of Payment. All
payments under this Agreement shall be made in U.S. Dollars. Checks are to
be
made payable to “The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University". Wire transfers may be made
through:
Bank
of
America
NY,
NY
▇▇▇▇▇
▇▇▇▇▇▇▇ University Central Lockbox
Transit/Routing/ABA
number: ▇▇▇▇▇▇▇▇▇
SWIFT
code: ▇▇▇▇▇▇▇▇
CHIPS
ABA
number: None
Account
Number: 003936830516
Type
of
account: Depository
Reference:
JHU Tech Transfer
(JHU
REF.
4950)
Attn:
Financial Manager
Company
shall be responsible for any and all costs associated with wire transfers.
3.8 Late
Payments.
In the
event that any payment due hereunder is not made when due, the payment shall
accrue interest beginning on the [***] following the due date thereof,
calculated at the annual rate of the sum of (a) [***] percent ([***]%) plus
(b)
the prime interest rate quoted by The Wall Street Journal on the date said
payment is due, the interest being compounded on the last day of each calendar
quarter, provided however, that in no event shall said annual interest rate
exceed the maximum legal interest rate for corporations. Each such payment
when
made shall be accompanied by all interest so accrued. Said interest and the
payment and acceptance thereof shall not negate or waive the right of JHU to
seek any other remedy, legal or equitable, to which it may be entitled because
of the delinquency of any payment including, but not limited to termination
of
this Agreement as set forth in Paragraph 9.2.
3.9 Invoicing
and Receipts.
Company
may at their option and expense provide along with any payment to JHU a receipt
for such payment along with a self-addressed, postage paid envelope. If such
payment is correct and processed by JHU, JHU shall promptly sign and return
such
receipt to Company.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
7
ARTICLE
4
PATENT
PROSECUTION, MAINTENANCE, & INFRINGEMENT
4.1 Prosecution
& Maintenance.
JHU, at
Company's expense (except as provided below), and following reasonable
consultation with Company (as provided below), shall file, prosecute and
maintain all patents and patent applications specified under PATENT RIGHTS
and,
subject to the terms and conditions of this Agreement, Company shall be licensed
thereunder. Title to all such patents and patent applications shall reside
in
JHU. JHU shall have full and complete control over all patent matters in
connection therewith under the PATENT RIGHTS, provided however, that JHU shall
(a) cause its patent counsel to timely copy Company on all official actions
and
written correspondence with any patent office, and (b) allow Company an
opportunity to comment and advise JHU. JHU shall consider and reasonably
incorporate all comments and advice provided by Company. By concurrent written
notification to JHU and its patent counsel at least thirty (30) days in advance
(or later at JHU’s discretion) of any filing or response deadline, or fee due
date, Company may elect not to have a patent application filed in any particular
country or not to pay expenses associated with prosecuting or maintaining any
patent application or patent, provided that Company pays for all costs incurred
up to the date of JHU’s receipt of such notification. Failure to provide such
notification can be considered by JHU to be Company’s authorization to proceed
with the relevant filing at Company’s expense. Upon such notification, JHU may
file, prosecute, and/or maintain such patent applications or patent at its
own
expense and for its own benefit, and any rights or license granted hereunder
held by Company, AFFILIATED COMPANIES or SUBLICENSEE(S) relating to the PATENT
RIGHTS which comprise the subject of such patent applications or patent and/or
apply to the particular country, shall terminate.
4.2 Notification. Each
party will notify the other promptly in writing when any infringement by a
third
party is uncovered or suspected.
4.3 Infringement.
Company
shall have the first right, but not the obligation, to enforce any patent within
PATENT RIGHTS against any infringement or alleged infringement thereof, and
shall at all times keep JHU informed as to the status thereof. Before Company
commences an action with respect to any infringement of such patents, Company
shall give careful consideration to the views of JHU and to potential effects
on
the public interest in making its decision whether or not to ▇▇▇. Thereafter,
Company may, at its own expense, institute suit against any such infringer
or
alleged infringer and control and defend such suit in a manner consistent with
the terms and provisions hereof and recover any damages, awards or settlements
resulting therefrom, subject to Paragraph 4.5. However, no settlement, consent
judgment or other voluntary final disposition of the suit may be entered into
without the prior written consent of JHU, which consent shall not be
unreasonably withheld. This right to ▇▇▇ for infringement shall not be used
in
an arbitrary or capricious manner. JHU shall reasonably cooperate in any such
litigation at Company's expense, including the joining of JHU and its AFFILIATED
COMPANIES as a party to such action, as may be required by the law of the
particular forum where enforcement is being sought.
If
Company elects not to enforce any patent within the PATENT RIGHTS, then it
shall
so notify JHU in writing within ninety (90) days of receiving notice that an
infringement exists, and JHU may, in its sole judgment and at its own expense,
take steps to enforce any patent and control, settle, and defend such suit
in a
manner consistent with the terms and provisions hereof, and recover, for its
own
account, any damages, awards or settlements resulting therefrom.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
8
4.4 Patent
Invalidity Suit.
If a
declaratory judgment action is brought naming Company as a defendant and
alleging invalidity of any of the PATENT RIGHTS, JHU may elect to take over
the
sole defense of the action at its own expense. Company shall cooperate fully
with JHU in connection with any such action.
4.5 Recovery.
Any
recovery by Company under Paragraph 4.3 shall be deemed to reflect loss of
commercial sales, and Company shall pay to JHU [***] percent ([***]%) of the
recovery net of all reasonable costs and expenses associated with each suit
or
settlement. If the cost and expenses exceed the recovery, then [***] of the
excess shall be credited against royalties payable by Company to JHU hereunder
in connection with sales of LICENSED PRODUCT covered in the PATENT RIGHTS which
are the subject of the infringement suit, in the country of such legal
proceedings, provided, however, that any such credit under this Paragraph shall
not exceed [***] percent ([***]%) of the royalties otherwise payable to JHU
with
regard to sales in the country of such action in any one calendar year, with
any
excess credit being carried forward to future calendar years.
ARTICLE
5
OBLIGATIONS
OF THE PARTIES
5.1 Reports.
Company
shall provide to JHU the following written reports according to the following
schedules, all of which shall be treated as Confidential Information of the
Company.
(a)
Company shall provide quarterly Royalty Reports, substantially in the format
of
Exhibit
B
and due
within [***] of the end of each calendar quarter following the first commercial
sale of a LICENSED PRODUCT. Royalty Reports shall disclose the amount of
LICENSED PRODUCT(S) sold, the total NET SALES of such LICENSED PRODUCT(S),
and
the running royalties due to JHU as a result of NET SALES by Company, AFFILIATED
COMPANIES and SUBLICENSEE(S) thereof. Payment of any such royalties due shall
accompany such Royalty Reports.
(b)
Until
Company, an AFFILIATED COMPANY or a SUBLICENSEE(S) has achieved a first
commercial sale of a LICENSED PRODUCT or LICENSED SERVICE, or
received FDA market approval, Company shall provide semiannual Diligence
Reports, due within [***] of the end of every June and December following the
EFFECTIVE DATE of this Agreement. These Diligence Reports shall describe
Company's, AFFILIATED COMPANIES or any SUBLICENSEE(S)'s technical efforts
towards meeting its obligations under the terms of this Agreement.
(c)
Company shall provide Annual Reports within [***] of the end of every December
following the EFFECTIVE DATE of this Agreement. Annual Reports shall
include:
(i)
evidence of insurance as required under Paragraph 10.4, or, a statement of
why
such insurance is not currently required, and
(ii)
identification of all AFFILIATED COMPANIES which have exercised rights pursuant
to Paragraph 2.1, or, a statement that no AFFILIATED COMPANY has exercised
such
rights, and
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
9
(iii)
notice of all FDA approvals of any LICENSED PRODUCT(S) obtained by COMPANY,
AFFILIATED COMPANY or SUBLICENSEE, the patent(s) or patent application(s)
licensed under this Agreement upon which such product or service is based,
and
the commercial name of such product or service, or, in the alternative, a
statement that no FDA approvals have been obtained.
5.2 Records.
Company
shall make and retain, for a period of three (3) years following the period
of
each report required by Paragraph 5.1, true and accurate records, files and
books of account containing all the data reasonably required for the full
computation and verification of sales and other information required in
Paragraph 5.1. Such books and records shall be in accordance with generally
accepted accounting principles consistently applied. Company shall permit the
inspection and copying of such records, files and books of account by JHU or
its
agents during regular business hours upon ten (10) business days' written notice
to Company. Such inspection shall not be made more than once each calendar
year.
All costs of such inspection and copying shall be borne by JHU, provided that
if
any such inspection shall reveal that an underpayment has been made to JHU
in
the amount equal to [***] percent ([***]%) or more of such payment in any
calendar year, such costs shall be borne by Company. As a condition to entering
into any such agreement, Company shall include in any agreement with its
AFFILIATED COMPANIES or its SUBLICENSEE(S) which permits such party to make,
use, sell, provide or import the LICENSED PRODUCT(S), a provision requiring
such
party to retain records of sales of LICENSED PRODUCT(S) and other information
as
required in Paragraph 5.1 and permit JHU to inspect such records as required
by
this Paragraph.
5.3 Diligent
Efforts. Company
shall exercise commercially reasonable diligent efforts to develop and to
introduce the LICENSED PRODUCT(S) into the commercial market as soon as
practicable, consistent with sound and reasonable business practice and
judgment; thereafter, until the expiration or termination of this Agreement,
Company shall endeavor to keep LICENSED PRODUCT(S) reasonably available to
the
public. Company shall also exercise reasonable efforts to develop LICENSED
PRODUCT(S) suitable for different indications within the LICENSED FIELD, so
that
the PATENT RIGHTS can be commercialized as broadly and as speedily as sound
and
reasonable business practice and judgment would deem practicable.
5.3(a) No
Warranty.
Subject
to Company’s obligations set forth in Section 5.3, for the removal of doubt,
nothing contained in this Agreement shall be construed as a warranty by the
Company that any development to be carried out as aforesaid will actually
achieve its aims or any other results, and the Company makes no warranties
whatsoever as to any results to be achieved in consequence of the carrying
out
of any such development. FURTHERMORE,
THE COMPANY DOES NOT ASSUME ANY DUTY OR OBLIGATION TO SUCCEED IN ANY TRIAL,
REGISTRATION OR COMMERCIALIZATION OF THE LICENSED PRODUCT(S), NOR DOES THE
COMPANY MAKE ANY REPRESENTATION TO THE EFFECT THAT THE COMMERCIALIZATION OF
THE
LICENSED PRODUCT(S) WILL SUCCEED, OR THAT IT WILL BE ABLE TO SELL THE LICENSED
PRODUCT(S) IN ANY QUANTITY.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
10
5.4 Other
Products. After
(i)
clinical evidence of efficacy or evidence of efficacy in an accepted preclinical
animal model, and (ii) a commercially reasonable offer from a potential
SUBLICENSEE, is provided in writing by JHU or by another party, to Company
on or
after three (3) years from the EFFECTIVE DATE, demonstrating the practicality
of
a particular market or use within the LICENSED FIELD which is not being
developed or commercialized by Company, Company shall either provide JHU with
a
reasonable development plan and start development or attempt to reasonably
sublicense the particular market or use to a third party. If within six (6)
months of such notification by JHU, Company has not initiated such development
efforts or have sublicensed, or then be working diligently to sublicense, that
particular market or use, JHU may terminate Company’s license for such
particular market or use. This Paragraph 5.4 shall not be applicable if Company
reasonably demonstrates to JHU that commercializing such LICENSED PRODUCT(S)
or
LICENSED SERVICE(S) or granting such a sublicense in said market or use would
have a potentially adverse commercial effect upon marketing or sales of the
LICENSED PRODUCT(S) developed and being sold by Company.
5.5 Patent
Acknowledgement. Company
agrees that all packaging containing individual LICENSED PRODUCT(S) sold
by
Company, AFFILIATED COMPANIES and SUBLICENSEE(S) of Company will be marked
with
the number of the applicable patent(s) licensed hereunder in accordance with
each country's patent laws.
ARTICLE
6
REPRESENTATIONS
6.1 Duties
of the Parties. JHU
is
not a commercial organization. It is an institute of research and education.
Therefore, JHU has no ability to evaluate the commercial potential of any PATENT
RIGHTS or LICENSED PRODUCT or other license or rights granted in this Agreement.
It is therefore incumbent upon Company to evaluate the rights and products
in
question, to examine the materials and information provided by JHU, and to
determine for itself the validity of any PATENT RIGHTS, its freedom to operate,
and the value of any LICENSED PRODUCTS or other rights granted.
6.2 Representations
by JHU.
JHU
warrants that it has good and marketable title to its interest in the inventions
claimed under PATENT RIGHTS with the exception of certain retained rights of
the
United States Government, which may apply if any part of the JHU research was
funded in whole or in part by the United States Government, and HHMI. JHU
warrants and represents that it has no knowledge of any legal suit, proceeding
or claim of ownership by a third party contesting JHU’s ownership or the
validity of the PATENT RIGHTS. JHU does not warrant the validity of any patents
or that practice under such patents shall be free of infringement. EXCEPT AS
EXPRESSLY SET FORTH IN THIS PARAGRAPH 6.2, COMPANY, AFFILIATED COMPANIES AND
SUBLICENSEE(S) AGREE THAT THE PATENT RIGHTS ARE PROVIDED "AS IS", AND THAT
JHU
MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED
PRODUCT(S) INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY.
JHU
DISCLAIMS ALL WARRANTIES WITH REGARD TO PRODUCT(S) AND SERVICE(S) LICENSED
UNDER
THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESSED OR
IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE.
NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY
DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF JHU AND INVENTORS,
FOR
DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND
CONSEQUENTIAL DAMAGES, ATTORNEYS' AND EXPERTS' FEES, AND COURT COSTS (EVEN
IF
JHU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING
OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, OR SALE OF THE PRODUCT(S)
AND
SERVICE(S) LICENSED UNDER THIS AGREEMENT. COMPANY, AFFILIATED COMPANIES AND
SUBLICENSEE(S) ASSUME ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED
BY A PRODUCT AND/OR SERVICE MANUFACTURED, USED, OR SOLD BY COMPANY, ITS
SUBLICENSEE(S) AND AFFILIATED COMPANIES WHICH IS A LICENSED PRODUCT(S) OR AS
DEFINED IN THIS AGREEMENT.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
11
6.3 Corporate
Authority.
Notwithstanding the foregoing, JHU hereby represents that it has the full power
and authority to enter into this Agreement and to convey the rights herein
conveyed.
ARTICLE
7
INDEMNIFICATION
7.1 Indemnification.
JHU,
HHMI and the Inventors will have no legal liability exposure to third parties
if
JHU does not license the LICENSED PRODUCT(S), and any royalties JHU, HHMI and
the Inventors may receive is not adequate compensation for such legal liability
exposure. Therefore, JHU requires Company to protect JHU, HHMI and Inventors
from such exposure to the same manner and extent to which insurance, if
available, would protect JHU, HHMI and Inventors. Furthermore, JHU, HHMI and
the
Inventors will not, under the provisions of this Agreement or otherwise, have
control over the manner in which Company or its AFFILIATED COMPANIES or its
SUBLICENSEE(S) or those operating for its account or third parties who purchase
LICENSED PRODUCT(S) from any of the foregoing entities, develop, manufacture,
market or practice the inventions of LICENSED PRODUCT(S).
(a)
Company,
AFFILIATED COMPANY and SUBLICENSEE shall indemnify, defend with counsel
reasonably acceptable to JHU, and hold JHU, The ▇▇▇▇▇ ▇▇▇▇▇▇▇ Health Systems,
their present and former trustees, officers, Inventors of PATENT RIGHTS, agents,
faculty, employees and students harmless as against any judgments, fees,
expenses, or other costs arising from or incidental to any product liability
or
other lawsuit, claim, demand or other action brought as a consequence of the
practice of said inventions by any of the foregoing entities, whether or not
JHU
or said Inventors, either jointly or severally, is named as a party defendant
in
any such lawsuit and whether or not JHU or the Inventors are alleged to be
negligent or otherwise responsible for any injuries to persons or property.
Practice of the inventions covered by LICENSED PRODUCT(S) by an AFFILIATED
COMPANY or an agent or a SUBLICENSEE(S) or a third party on behalf of or for
the
account of Company or by a third party who purchases LICENSED PRODUCT(S) from
Company, shall be considered Company's practice of said inventions for purposes
of this Paragraph. The obligation of Company to defend and indemnify as set
out
in this Paragraph 7.1(a) shall survive the termination of this Agreement, shall
continue even after assignment of rights and responsibilities to an AFFILIATED
COMPANY or SUBLICENSEE, and shall not be limited by any other limitation of
liability elsewhere in this Agreement.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
12
(b)
HHMI
and
its trustees, officers, employees, and agents (collectively, “HHMI
Indemnitees”), will be indemnified, defended by counsel acceptable to HHMI, and
held harmless by Company, AFFILIATED COMPANY and SUBLICENSEE from and against
any claim, liability, cost, expense, damage, deficiency, loss, or obligation,
of
any kind or nature (including, without limitation, reasonable attorneys’ fees
and other costs and expenses of defense) (collectively, “Claims”), based upon,
arising out of, or otherwise relating to this Agreement, including without
limitation any cause of action relating to product liability. The previous
sentence will not apply to any Claim that is determined with finality by a
court
of competent jurisdiction to result solely from the gross negligence or willful
misconduct of an HHMI Indemnitee.
The obligation of Company to defend and indemnify as set out in this Paragraph
7.1 (b) shall survive the termination of this Agreement, shall continue even
after assignment of rights and responsibilities to an AFFILIATED COMPANY and
SUBLICENSEE, and shall not be limited by any other limitation of liability
elsewhere in this Agreement.
ARTICLE
8
CONFIDENTIALITY
8.1 Confidentiality.
If
necessary, the parties will exchange information, which they consider to be
confidential. The recipient of such information agrees to accept the disclosure
of said information which is marked as confidential at the time it is sent
to
the recipient, and to employ all reasonable efforts to maintain the information
secret and confidential, such efforts to be no less than the degree of care
employed by the recipient to preserve and safeguard its own confidential
information, and in any event no less than a reasonable degree of care. The
information shall not be disclosed or revealed to anyone except employees of
the
recipient who have a need to know the information and who have entered into
a
secrecy agreement with the recipient under which such employees are required
to
maintain confidential the proprietary information of the recipient and such
employees shall be advised by the recipient of the confidential nature of the
information and that the information shall be treated accordingly.
The
obligations of this Paragraph shall also apply to AFFILIATED COMPANIES and/or
SUBLICENSEE(S) provided such information by Company. JHU's, Company's,
AFFILIATED COMPANIES, and SUBLICENSEES' obligations under this Paragraph shall
extend until five (5) years after the termination of this Agreement.
8.2 Exceptions.
The
recipient's obligations under Paragraph 8.1 shall not extend to any part of
the
information:
|
a.
|
that
can be demonstrated to have been in the public domain or publicly
known
and readily available to the trade or the public prior to the date
of the
disclosure; or
|
|
b.
|
that
can be demonstrated, from written records to have been in the recipient's
possession prior to the date of disclosure;
or
|
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
13
|
c.
|
that
becomes part of the public domain or publicly known by publication
or
otherwise, not due to any unauthorized act by the recipient;
or
|
|
d.
|
that
is demonstrated from written records to have been developed by or
for the
receiving party without reference to confidential information disclosed
by
the disclosing party.
|
|
that
is required to be disclosed by law, government regulation or court
order.
|
Without
limiting any of the foregoing, it is understood that either Party or its
AFFILIATED COMPANIES may make disclosure of this Agreement and the terms hereof
in any filings required by the SEC (or any other securities exchange authority),
may file this Agreement as an exhibit to any filing with the SEC (or any other
securities exchange authority) and may distribute any such filing in the
ordinary course of its business. However, to the maximum extent allowable by
SEC
(or any other securities authority) rules and regulations, the Parties shall
be
obligated to maintain the confidentiality obligations set forth herein and
shall
redact any confidential information set forth in such filings as may be
reasonably requested by the disclosing Party.
8.3 Right
to Publish. JHU
may
publish manuscripts, abstracts or the like describing the PATENT RIGHTS and
inventions contained therein provided confidential information of Company as
defined in Paragraph 8.1, is not included or without first obtaining approval
from Company to include such confidential information. Otherwise, JHU and the
Inventors shall be free to publish manuscripts and abstracts or the like
directed to the work done at JHU related to the licensed technology without
prior approval.
ARTICLE
9
TERM
& TERMINATION
9.1 Term. The
term
of this Agreement shall commence on the EFFECTIVE DATE and shall continue,
in
each country, until the date of expiration of the last to expire patent included
within PATENT RIGHTS in that country or if no patents issue then for the ROYALTY
TERM.
9.2 Termination By
Either Party. This
Agreement may be terminated by either party, in the event that the other party
(a) files or has filed against it a petition under the Bankruptcy Act, makes
an
assignment for the benefit of creditors, has a receiver appointed for it or
a
substantial part of its assets, or otherwise takes advantage of any statute
or
law designed for relief of debtors or (b) fails to perform or otherwise breaches
any of its material obligations hereunder, if, following the giving of notice
by
the terminating party of its intent to terminate and stating the grounds
therefor, the party receiving such notice shall not have cured the failure
or
breach within thirty (30) days. In no event, however, shall such notice or
intention to terminate be deemed to waive any rights to damages or any other
remedy which the party giving notice of breach may have as a consequence of
such
failure or breach.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
14
9.3 Termination
by Company.
Company
may terminate this Agreement and the license granted herein, for any reason,
upon giving JHU ninety (90) days written notice.
9.4 Obligations
and Duties upon Termination.
If this
Agreement is terminated, both parties shall be released from all obligations
and
duties imposed or assumed hereunder to the extent so terminated, except as
expressly provided to the contrary in this Agreement. Upon termination, both
parties shall cease any further use of the confidential information disclosed
to
the receiving party by the other party. Termination of this Agreement, for
whatever reason, shall not affect any obligation of either party, including
payment obligations, which shall have accrued prior to such termination.
Termination shall not affect JHU's right to recover unpaid royalties, fees,
reimbursement for patent expenses, or other forms of financial compensation
incurred prior to termination. Upon termination Company shall submit a final
royalty report to JHU and any royalty payments, fees, unreimbursed patent
expenses and other financial compensation due JHU shall become immediately
payable. Furthermore, upon termination of this Agreement, all rights in and
to
the licensed technology shall revert immediately to JHU at no cost to JHU.
Upon
termination of this Agreement, any SUBLICENSEE(S) may become a direct licensee
of JHU, provided that JHU’s obligations to SUBLICENSEE(S) are no greater than
JHU’s obligations to Company under this Agreement. Company shall provide written
notice of such to each SUBLICENSEE(S) with a copy of such notice provided to
JHU.
ARTICLE
10
MISCELLANEOUS
10.1 Use
of Name. Company,
AFFILIATED COMPANIES and SUBLICENSEE(S) shall not use the name of the ▇▇▇▇▇▇
▇▇▇▇▇▇ Medical institute, The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University or The ▇▇▇▇▇ ▇▇▇▇▇▇▇
Health System or any of their constituent parts, such as the ▇▇▇▇▇ ▇▇▇▇▇▇▇
Hospital or any contraction thereof or the name of Inventors in any advertising,
promotional, sales literature or fundraising documents without prior written
consent from an authorized representative of JHU. Company, AFFILIATED COMPANIES
and SUBLICENSEE(S) shall allow at least seven (7) business days notice of any
proposed public disclosure for JHU's and/or HHMI’s review and comment or to
provide written consent. For the purposes of this Paragraph, notice to HHMI
should be directed to:
▇▇▇▇▇▇
▇▇▇▇▇▇ Medical Institute
▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn:
Office of the General Counsel
Without
limiting any of the foregoing, it is understood that the Company may use the
name of the ▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical Institute, The ▇▇▇▇▇ ▇▇▇▇▇▇▇ University or
The
▇▇▇▇▇ ▇▇▇▇▇▇▇ Health System in any filings as required by the SEC (or any other
securities exchange authority), and may distribute any such filing in the
ordinary course of its business.
10.2 No
Partnership. Nothing
in this Agreement shall be construed to create any agency, employment,
partnership, joint venture or similar relationship between the parties other
than that of a licensor/licensee. Neither party shall have any right or
authority whatsoever to incur any liability or obligation (express or implied)
or otherwise act in any manner in the name or on the behalf of the other, or
to
make any promise, warranty or representation binding on the other.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
15
10.3 Notice
of Claim.
Each
party shall give the other or its representative immediate notice of any suit
or
action filed, or prompt notice of any claim made, against them arising out
of
the performance of this Agreement or arising out of the practice of the
inventions licensed hereunder.
10.4 Product
Liability.
Prior to
initial human testing or first commercial sale of any LICENSED PRODUCT(S) in
any
particular country, Company shall establish and maintain, in each country in
which Company, an AFFILIATED COMPANY or SUBLICENSEE(S) shall test or sell
LICENSED PRODUCT(S), product liability or other appropriate insurance coverage
in the minimum amount of [***] dollars ($[***]) per claim and will annually
present evidence to JHU that such coverage is being maintained. Upon JHU's
request, Company will furnish JHU with a Certificate of Insurance of each
product liability insurance policy obtained. JHU and HHMI shall be listed as
an
additional insureds in Company's said insurance policies. If such Product
Liability insurance is underwritten on a ‘claims made’ basis,
Company agrees that any change in underwriters during the term of this Agreement
will require the purchase of ‘prior acts’ coverage to ensure that coverage will
be continuous throughout the term of this Agreement.
10.5 Governing
Law.
This
Agreement shall be construed, and legal relations between the parties hereto
shall be determined, in accordance with the laws of the State of Maryland
applicable to contracts solely executed and wholly to be performed within the
State of Maryland without giving effect to the principles of conflicts of laws.
Any disputes between the parties to the Agreement shall be brought in the state
or federal courts of Maryland. Both parties agree to waive their right to a
jury
trial.
10.6 Notice.
All
notices or communication required or permitted to be given by either party
hereunder shall be deemed sufficiently given if transmitted by facsimile with
confirmed transmission, mailed by registered mail or certified mail, return
receipt requested, or sent by overnight courier, such as Federal Express, to
the
other party at its respective address set forth below or to such other address
as one party shall give notice of to the other from time to time hereunder.
Faxed notices shall be deemed to be received on the first business day following
the date of confirmed transmission. Mailed notices shall be deemed to be
received on the third business day following the date of mailing. Notices sent
by overnight courier shall be deemed received the following business day.
| If to Company: |
▇▇
▇▇▇▇▇
▇▇.
▇▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇▇
Attn:
President
Fax:
▇▇▇▇
▇ ▇▇▇ ▇▇▇▇
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
16
| If to JHU: |
Technology
Transfer
|
▇▇▇▇▇
▇▇▇▇▇▇▇ University
▇▇▇
▇.
▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇
▇▇▇▇▇
▇▇▇▇▇▇▇▇▇,
▇▇ ▇▇▇▇▇
Attn:
Director
Fax:
(▇▇▇) ▇▇▇-▇▇▇▇
10.7 Compliance
with All Laws.
In all
activities undertaken pursuant to this Agreement, both JHU and Company covenant
and agree that each will in all material respects comply with such Federal,
state and local laws and statutes, as may be in effect at the time of
performance and all valid rules, regulations and orders thereof regulating
such
activities.
10.8 Successors
and Assigns.
Neither
this Agreement nor any of the rights or obligations created herein, except
for
the right to receive any remuneration hereunder, may be assigned by either
party, in whole or in part, without the prior written consent of the other
party, except that either party shall be free to assign this Agreement to an
AFFILIATED COMPANY or in connection with any sale of substantially all of its
assets without the consent of the other. This Agreement shall bind and inure
to
the benefit of the successors and permitted assigns of the parties hereto.
10.9 No
Waivers; Severability.
No
waiver of any breach of this Agreement shall constitute a waiver of any other
breach of the same or other provision of this Agreement, and no waiver shall
be
effective unless made in writing. Any provision hereof prohibited by or
unenforceable under any applicable law of any jurisdiction shall as to such
jurisdiction be deemed ineffective and deleted herefrom without affecting any
other provision of this Agreement. It is the desire of the parties hereto that
this Agreement be enforced to the maximum extent permitted by law, and should
any provision contained herein be held by any governmental agency or court
of
competent jurisdiction to be void, illegal and unenforceable, the parties shall
negotiate in good faith for a substitute term or provision which carries out
the
original intent of the parties.
10.10 Entire
Agreement; Amendment.
Company
and JHU acknowledge that they have read this entire Agreement and that this
Agreement, including the attached Exhibits constitutes the entire understanding
and contract between the parties hereto and supersedes any and all prior or
contemporaneous oral or written communications with respect to the subject
matter hereof, all of which communications are merged herein. It is expressly
understood and agreed that (i) there being no expectations to the contrary
between the parties hereto, no usage of trade, verbal agreement or another
regular practice or method dealing within any industry or between the parties
hereto shall be used to modify, interpret, supplement or alter in any manner
the
express terms of this Agreement; and (ii) this Agreement shall not be modified,
amended or in any way altered except by an instrument in writing signed by
both
of the parties hereto.
10.11 Delays
or Omissions.
Except
as expressly provided herein, no delay or omission to exercise any right, power
or remedy accruing to any party hereto, shall impair any such right, power
or
remedy to such party nor shall it be construed to be a waiver of any such breach
or default, or an acquiescence therein, or in any similar breach or default
be
deemed a waiver of any other breach or default theretofore or thereafter
occurring. Any waiver, permit, consent or approval of any kind or character
on
the part of any party of any breach or default under this Agreement, or any
waiver on the part of any party of any provisions or conditions of this
Agreement, must be in writing and shall be effective only to the extent
specifically set forth in such writing. All remedies either under this Agreement
or by law or otherwise afforded to any party, shall be cumulative and not
alternative.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
17
10.12 Force
Majeure.
If
either party fails to fulfill its obligations hereunder (other than an
obligation for the payment of money), when such failure is due to an act of
God,
or other circumstances beyond its reasonable control, including but not limited
to fire, flood, civil commotion, riot, war (declared and undeclared),
revolution, or embargoes, then said failure shall be excused for the duration
of
such event and for such a time thereafter as is reasonable to enable the parties
to resume performance under this Agreement, provided however, that in no event
shall such time extend for a period of more than one hundred eighty (180)
days.
10.13 Further
Assurances.
Each
party shall, at any time, and from time to time, prior to or after the EFFECTIVE
DATE of this Agreement, at reasonable request of the other party, execute and
deliver to the other such instruments and documents and shall take such actions
as may be required to effectively carry out the terms of this Agreement.
10.14 Survival.
All
representations, warranties, covenants and agreements made herein and which
by
their express terms or by implication are to be performed after the execution
and/or termination hereof, or are prospective in nature, shall survive such
execution and/or termination, as the case may be. This shall include Paragraphs
3.7 (Late Payments), 5.2 (Records), and Articles 6, 7, 8, 9, and
10.
10.15 Third
Party Beneficiary.
HHMI is
not a party to this Agreement and has no liability to any licensee,
SUBLICENSEE(S) or user of anything covered by this Agreement, but HHMI is an
intended third-party beneficiary of the Agreement and certain of its provisions
are for the benefit of HHMI and are enforceable by HHMI in its own
name.
10.16 Headings.
Article
headings are for convenient reference and not a part of this Agreement. All
Exhibits are incorporated herein by this reference.
10.17 Counterparts.
This
Agreement may be executed in counterparts, each of which shall be deemed an
original and all of which when taken together shall be deemed but one
instrument.
10.18 NEITHER
PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY PUNITIVE OR EXEMPLARY DAMAGES,
RELATED TO AND/OR CONNECTED WITH THE PERFORMANCE OF THIS AGREEMENT, EVEN IF
THE
FIRST PARTY IS ADVISED OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
THIS LIMITATION SHALL NOT APPLY TO A PARTY'S DUTY OF INDEMNIFICATION AGAINST
CLAIMS BROUGHT BY THIRD PARTIES.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
18
IN
WITNESS WHEREOF, this Agreement shall take effect as of the EFFECTIVE DATE
when
it has been executed below by the duly authorized representatives of the
parties.
|
THE
▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY
|
ROSETTA
GENOMICS LTD
|
|
/s/
▇▇▇▇ ▇. ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇
|
/s/
▇▇▇▇
▇▇▇▇▇▇
|
|
▇▇▇▇
▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
|
Name:
▇▇▇▇ ▇▇▇▇▇▇
|
|
Executive
Director
|
Title:
CEO
|
|
▇▇▇▇▇
▇▇▇▇▇▇▇ Technology Transfer
|
Rosetta
Genomics
|
|
August
2, 2006
|
August
2, 2006
|
|
(Date)
|
(Date)
|
EXHIBIT
A. LICENSE FEE & ROYALTIES.
EXHIBIT
B. SALES & ROYALTY REPORT FORM.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
19
EXHIBIT
A
LICENSE
FEE & ROYALTIES
1.
License
Fee: The
license fee due under Paragraph 3.1 is [***] dollars
($[***]).
2.
Minimum Annual Royalties: The
minimum annual royalties due on anniversaries of the Effective Date pursuant
to
Paragraph 3.2:
| 1st anniversary: |
[***]
dollars ($[***]).
|
| 2nd anniversary: | [***] dollars ($[***]). |
| 3rd anniversary: | [***] dollars ($[***]). |
| 4th anniversary: | [***] dollars ($[***]). |
| 5th anniversary: | [***] dollars ($[***]). |
| 6 th anniversary and thereafter: | [***] dollars ($[***]). |
3.
Royalties:
The
running royalty rate payable under Paragraph 3.3 is:
Licensed
Product - [***]%
4. Sublicense
consideration: The
percent sublicense consideration payable under Paragraph 3.5 is:
[***]
percent ([***]%) for any sublicense agreement to make, use or sell LICENSED
PRODUCTS, and entered into with a sublicensee within [***] after the EFFECTIVE
DATE of this Agreement,
[***]
percent ([***]%) for any sublicense agreement to make, use or sell LICENSED
PRODUCTS, and entered into with a sublicensee more than [***] after the
EFFECTIVE DATE but before the second anniversary of the EFFECTIVE DATE,
and
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
20
[***]
percent ([***]%) for any sublicense agreement to make, use or sell LICENSED
PRODUCTS, and entered into with a sublicensee more than [***] after the
EFFECTIVE DATE.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
21
EXHIBIT
B
QUARTERLY
SALES & ROYALTY REPORT
FOR
LICENSE AGREEMENT BETWEEN ROSETTA GENOMICS LTD AND
THE
▇▇▇▇▇ ▇▇▇▇▇▇▇ UNIVERSITY DATED
___________________________
FOR
PERIOD OF ______________ TO ______________
TOTAL
ROYALTIES DUE FOR THIS PERIOD $___________
|
PRODUCT
ID
|
PRODUCT
NAME
|
*JHU
REFERENCE
|
1st
COMMERCIAL SALE DATE
|
TOTAL
NET
SALES/SERVICES
|
ROYALTY
RATE
|
AMOUNT
DUE
|
*
Please
provide the JHU Reference Number or Patent Reference
This
report format is to be used to report quarterly royalty statements to JHU.
It
should be placed on Company letterhead and accompany any royalty payments due
for the reporting period. This report shall be submitted even if no sales are
reported.
Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
Page
22