EXHIBIT 10.3
TITLE OF AGREEMENT: PT 523 License Agreement
EFFECTIVE DATE:
PARTIES:
LICENSOR
▇▇▇▇-▇▇▇▇▇▇ Cancer Institute, Inc.
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
and
Ash ▇▇▇▇▇▇▇, Inc.
▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇
LICENSEE
▇▇▇▇▇▇ Health Sciences, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
DFCI AGREEMENT NO.:
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement, including all attachments, (hereinafter called
"Agreement"), effective as of December 19, 2002 ("Effective Date"), is between
the ▇▇▇▇-▇▇▇▇▇▇ Cancer Institute, Inc., a Massachusetts non-profit organization
having a principal place of business at ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇ ("DFCI") and ▇▇▇ ▇▇▇▇▇▇, Inc., a corporation having a place of business at
▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇ ("ASH, and together with
DFCI, the "Licensor") and ▇▇▇▇▇▇ Health Sciences, Inc., a Delaware corporation
having a principal place of business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇
("Licensee").
WHEREAS, DFCI and ASH are either sole or joint owners under certain
Patent Rights as defined below; and
WHEREAS, pursuant to a Patent Management Agreement effective February
1st 2002, Licensors agreed DFCI shall act as ASH'S sole and exclusive agent for
the licensing of such Patent Rights ; and
WHEREAS, Licensor desires to have the rights used to promote the public
interest by granting a royalty bearing, worldwide, exclusive license to the
Subject Technology to LICENSEE on the terms set forth herein; and
WHEREAS, Licensee, having represented to Licensor that it has the
financial capacity, strategic commitment, capabilities and/or experience to
develop, produce, market and sell resultant products, desires to obtain said
exclusive license under the Subject Technology.
NOW, THEREFORE, for and in consideration of the premises and other good
and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereto expressly agree as follows:
ARTICLE 1 -- DEFINITIONS
1.1 "Affiliate" means any company, corporation or other business entity
that is controlled by, controlling, or under common control with
Licensee. For this purpose "control" means direct or indirect
beneficial ownership of at least fifty percent (50%) interest in the
voting stock (or the equivalent) of the company, corporation or other
business or having the right to direct, appoint or remove a majority of
members of its board of directors (or their equivalents) or having the
power to control the general management of the company, corporation or
other business, by law or contract.
1.2 "Confidential Information" of Licensor shall mean all technical
reports, data or information disclosed by Licensee which is in writing
and marked "Confidential", "Proprietary" or the like, or, if disclosed
orally, is indicated as confidential at the time of disclosure and is
confirmed as confidential in writing within thirty (30) days after such
disclosure.
1.3 "Field of Use" means all commercial and non-commercial uses.
1.4 "First Commercial Sale" means the initial transfer of Licensed Product
by or on behalf of Licensee, an Affiliate or Sublicensee for cash or
non-cash consideration to which a fair market value can be assigned for
purposes of determining Net Sales.
1.5 "New Inventions" means any potential new invention disclosed for
example through an invention disclosure or a draft manuscript after the
Effective Date of this Agreement, which Inventors have an obligation to
assign to Licensor that arises from research by the Inventor(s) which
is specifically directed to the Subject Technology.
1.6 "Know-how" shall mean all technology, cell lines, biological materials,
compounds, know-how, methods, documents, materials, formulations,
materials, data, drawings and sketches, designs, testing and test
results, regulatory information of a like nature and all Confidential
Information related to PT523 which was developed as of the Effective
Date in the laboratories or under the direction of ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ and
▇▇▇▇▇ ▇. ▇▇▇▇▇, employees of DFCI and ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ and Ming-Teh Lin,
employees of ASH (hereinafter called "Inventors"), owned by any of the
Licensor, which the Licensors have the legal right to disclose and
license to the Licensee.
1.7 "Licensed Process" means any process covered in whole or in part by an
issued, unexpired claim or a pending claim covered by the Patent Rights
or which incorporates or uses the Know-how in whole or in part.
1.8 "Licensed Product(s)" shall mean:
(A) any product that is covered in whole or in part by a
valid and unexpired claim or pending claim contained
in the Patent Rights in the country in which the
product is made, used, leased or sold; or
(B) any product that is manufactured or used according to
a Licensed Process.
1.9 "Net Sales" means the gross income which is paid by unrelated third
parties to Licensee or Sublicensees for the sale of Licensed Products
under this Agreement in bona fide arms-length transactions less the
following deductions, which may not exceed reasonable and customary
amounts in the country in which the transaction occurs:
(A) Transportation charges or allowances actually paid or
granted;
(B) Trade, quantity, cash or other discounts and brokers'
or agents' commissions, if any, actually allowed and
taken;
(C) Credits or allowances made or given on account of
rejects, returns or retroactive price reductions for
any amount not collected that are specifically
identifiable to Licensed Products;
(D) Any tax or governmental charge directly on sale or
transportation, use or delivery of products paid by a
licensed entity and not recovered from the purchaser.
Net Sales shall include the fair market value of any non-cash
consideration from sale of Licensed Products received by Licensee, its
Affiliates or Sublicensees. Licensed Products are considered "sold"
when billed, invoiced or payment is received, whichever occurs first.
1.10 "Patent Rights" means (1) United States Patent No. 4,767,761 (DFCI
#111) entitled "Ornithine Derivatives and their Use as Methotrexate
Resistant Cell Inhibitors", solely owned by DFCI, which issued on
August 30, 1988 and any reissues, reexaminations or extensions of the
patent and (2) United States Provisional Patent Application, Serial No.
60/376,615, (DFCI #774) entitled "Pharmaceutically Active Ornithine
Derivatives, Ammonium Salts Thereof and Methods of Making Same" filed
on April 30, 2002 and applications derived therefrom, including
continuations, any claim(s) in any continuation-in-part to the extent
that the claims are directed to subject matter specifically described
in USSN 60/376,615 and entitled to the priority date of the application
under 35 U.S.C. ss.120, divisionals, substitutions, and any patents
issuing thereon; any reissues, reexaminations or extensions of the
patents; and any foreign counterparts of the patent application. Patent
application, Serial No. 60/376,615, is jointly owned between DFCI and
ASH and is the subject of a Patent Management Agreement signed February
1, 2002. Patent Rights existing on the Effective Date are listed on
Schedule 1.
1.11 "Parties" shall mean Licensee and Licensor, individually or
collectively.
1.12 "Sale" or "Sold" means any grant, sale, lease, assignment, transfer,
conveyance or other disposition of Licensed Products for value by or on
behalf of Licensee, any Affiliate(s) or Sublicensee(s).
1.13 "Sublicensee" means any natural person or legal entity, which is not an
Affiliate, to which Licensee grants a sublicense of some or all of the
rights granted to Licensee under this Agreement.
1.14 "Subject Technology" shall mean Patent Rights and Know-how individually
or collectively.
1.15 "Territory" means worldwide
ARTICLE 2 -- GRANT OF LICENSES, RESERVED RIGHTS, SUBLICENSING,
GRANT BACKS, AND OPTIONS
2.1 LICENSE GRANTS. Subject to all of the terms and conditions of this
Agreement and the non-exclusive license granted to the United States
government, Licensor grants to Licensee an exclusive worldwide license
in the Field of Use to utilize the Subject Technology, and to make,
have made, use, lease and/or sell the Licensed Products and to practice
the Licensed Processes, during the term of this Agreement, unless
sooner terminated as hereinafter provided.
2.2 To Licensor's knowledge and belief, as of the Effective Date, DFCI has
exclusive right, title, and interest in and to US Patent No. 4,767,761.
To Licensor's knowledge and belief, said patent is free and clear of
all liens, charges, encumbrances and rights of third parties. Licensor
has received the assignment of each of the Inventors of any of their
right, title, and interest in and to Patent Application No. 60/376,615
to Licensors. To the Office of Research and Technology Ventures'
knowledge and belief and to Ash ▇▇▇▇▇▇▇, Inc.'s knowledge and belief
there are no licenses, options, restrictions, liens, disputes, or legal
proceedings relating to the rights granted to the Licensee under this
Agreement.
2.3 Licensor has the authority to issue licenses under Patent Rights.
2.4 To Licensor's knowledge and belief, as of the Effective Date, without
independent investigation, there is no claim, pending or threatened, of
infringement, interference or invalidity regarding, any part or all of
the Patent Rights.
2.5 AFFILIATES. Licensee is entitled to extend its exclusive, worldwide
licenses under this Article 2 to its Affiliates, subject to Article 2.6
and consistent with all of the terms and conditions of this Agreement.
If Licensee does extend its license and an Affiliate assumes
obligations under the Agreement, Licensee guarantees performance, under
this Agreement, by the Affiliate. If Licensor has a claim arising under
this Agreement against an Affiliate, Licensor may seek a remedy
directly against Licensee and may, but is not is not required to, seek
a remedy against the Affiliate. Any termination of the Agreement under
Article 8 as to Licensee also constitutes termination as to any
Affiliates.
2.6 NO IMPLIED LICENSES. Except for the patents contained in the Patent
Rights and Improvements, this Agreement confers no license or rights by
implication, estoppel or otherwise under any other patent applications
or patents owned in whole or in part by Licensor.
2.7 DFCI'S RESERVED RIGHTS. The licenses granted by Licensor are subject to
the following reserved rights.
2.7.1 The rights of the United States of America, as set forth in
Public laws 96-517 and 98-620, the regulations promulgated
thereunder, and the policy of any funding agencies. Any rights
granted hereunder, which are greater than permitted by Public
Laws 96-517 and 98-620, are subject to modification as
required to conform to the provisions of those statutes;
2.7.2 DFCI's right to make and use the Subject Technology in the
Field of Use solely for its own non-commercial research
purposes; and
2.7.3 DFCI's right to conduct pre-clinical and clinical trials of
the Subject Technology, provided that DFCI first obtain the
prior written consent of the Licensee.
2.7.4 DFCI's right to supply Know-how and grant non-exclusive,
non-transferable licenses under Subject Technology to other
organizations academic, governmental or not-for-profit
organizations to make and use Subject Technology for
non-commercial research purposes in the Field of Use and not
for use in human subjects, clinical trials or for diagnostic
purposes involving human subjects. DFCI agrees that during the
two year period following the Effective Date, that it will use
its reasonable best efforts to provide notice to Licensee of
any transfer described in this paragraph 2.7.4 to the extent
that DFCI's Office of Research and Technology Ventures has
knowledge of such transfer.
2.8 SUBLICENSES. Licensee has the right to grant sublicenses under this
Agreement consistent with the terms and conditions of this Agreement.
Licensee shall be responsible for its Sublicensees and shall not grant
any rights which are inconsistent with the rights granted to and
obligations of Licensee hereunder.
2.8.1 NOTICE. Licensee shall promptly notify Licensor in writing of
the identity and address of any Sublicensee with whom it
concludes a sublicense agreement, under this Agreement, and
shall supply Licensor with a copy of each sublicense agreement
at the specified address in Article 11. Such copy shall be
postmarked within thirty days of the execution of the
sublicense. Licensee shall also forward to Licensor annually a
copy of the reports received by Licensee from its Sublicensee
during the preceding twelve (12) month period under the
sublicenses as shall be pertinent to (1) its operations under
the sublicense and (2) a royalty accounting under the
sublicense agreement.
2.8.2 FORM AND CONTENT OF SUBLICENSES. Licensee shall issue any
sublicense(s) granted by it under this Agreement in writing
and shall attach a copy of this Agreement to all sublicenses.
Licensee shall include the equivalent of at least the
following provisions in all sublicenses.
(A) Sublicensee shall use its commercially reasonable
efforts to bring the subject matter of the sublicense
into commercial use as quickly as possible and shall
report annually to Licensee on its operations under
the sublicense.
(B) Sublicensee shall make payments due to Licensee in
relation to Net Sales of Licensed Products in a
timely manner, so that Licensee may comply with its
obligations to make payments to Licensor as set forth
in Articles 3 and 4 of this Agreement.
(C) The terms and conditions of Section 2.7, paragraphs
4.2.1 and 4.2.2, Sections 5.2 - 5.5, Sections 6.1 and
6.2, Article 7, Sections 8.4.4 and Articles 9, 10 and
12 of this Agreement are binding on the Sublicensee.
(D) Sublicensees do not have the right to grant further
sublicenses.
(E) No sublicense agreement concluded by Licensee under
this Agreement shall contain any provision which
would cause it to extend beyond the term of this
Agreement.
2.8.3 LICENSEE'S CONTINUING OBLIGATIONS. Nothing in this Section 2.8
may be construed to relieve Licensee of its obligations to
Licensor under this Agreement, including but not limited to
Licensee's obligations under Article 9.
2.9 LICENSE GRANT BACK. If Licensor receives a bona fide request from a
third party for a license under the Patent Rights to develop a product
in a field other than oncology, (the "New Product Opportunity")
Licensor shall so notify Licensee and request that Licensee enter into
good faith negotiations with the third party to grant a sublicense to
the Patent Rights to such third party. If the New Product Opportunity
is directly competitive with any Licensed Product then sold or under
development by Licensee or a Sublicensee, or included in Licensee's
annual strategic Development Plan then in force, Licensee may decline
the Licensor's request to grant such sublicense. If the New Product
Opportunity is not competitive with any Licensed Product
("Non-competing New Product Opportunity"), Licensee shall either (a)
provide Licensor, within six months of Licensee receipt of Licensor's
request, a plan for developing the Non-competing New Product
Opportunity, such plan to be implemented within six (6) months of its
submission to Licensor or (b) enter into good faith negotiations with
the third party to grant a sublicense on commercially reasonable terms
to allow such third party the ability to commercialize the
Non-competing New Product Opportunity. If Licensee does not provide
such plan to develop the Non-competing New Product Opportunity to
Licensor or a sublicense has not been granted to the third party within
twelve (12) months of the third party's request, Licensee shall grant
back rights to Patent Rights to Licensor to sufficiently enable
Licensor to grant a license to the third party to allow such third
party to commercialize the Non-competing New Product Opportunity.
2.10 OPTION TO NEW INVENTIONS.
2.10.1 During the 18 months following the Effective Date of this
Agreement, Licensor shall promptly report, in writing, any New
Invention to Licensee. All information given to Licensee by
Licensor in accordance with this Section 2.10 will be deemed
Confidential Information.
2.10.2 Licensee shall have 45 days after receipt of report of New
Invention to evaluate New Invention and notify Licensor in
writing that it desires to license New Invention.
2.10.3 Upon notification by Licensee of its desire to acquire rights
to the New Invention, the Parties shall negotiate in good
faith a reasonable license fee and upon receipt of such
license fee by Licensor, Licensor will incorporate such New
Invention under the Patent Rights through an amendment to this
Agreement.
2.10.4 If the Licensee fails to notify Licensor pursuant to Section
2.10.2 or if the Licensee decides not to acquire rights to the
New Invention, Licensor shall have no further obligations to
Licensee with respect to the New Invention.
ARTICLE 3 -- CONSIDERATION - AMOUNTS AND TIME FOR PAYMENT
In partial consideration of the rights granted by Licensor to Licensee under
this Agreement, Licensee shall make the following payments to Licensor according
to this Article 3 and Article 4, on behalf of itself, any Affiliate(s) or
Sublicensee(s).
3.1 REIMBURSEMENTS AND OTHER FINANCIAL CONSIDERATION.
3.1.1 PATENT EXPENSES. Within thirty (30) days after the Effective
Date, Licensee shall reimburse Licensor for all out-of-pocket
expenses incurred and paid by Licensor as of the Effective
Date for filing, prosecuting, maintaining and enforcing Patent
Rights. Licensee acknowledges that, as of the Effective Date,
the total amount of these patent expenses is Eleven Thousand
Fifty Four dollars ($11,054).
3.1.2 INITIAL LICENSE FEE. Licensee shall pay to Licensor a
non-creditable, non-refundable license issue fee in the sum of
One Hundred Thousand Dollars ($100,000.00), which is due and
payable to Licensor within thirty (30) days of the Effective
Date of the Agreement.
3.1.3 MILESTONE PAYMENTS. With respect to each Licensed Product,
Licensee shall make the following milestone payments to
Licensor within 60 days of the occurrence of the following
events, whether Licensee, an Affiliate or Sublicensee achieves
the events.
------------------------------ ----------------------------------------------------------
PAYMENT EVENT
AMOUNT
------------------------------ ----------------------------------------------------------
$100,000 upon the dosing of the first patient in a Phase I
clinical trial of a Licensed Product pursuant to a
Licensee sponsored Investigational New Drug application
------------------------------ ----------------------------------------------------------
$100,000 upon completion of 50% of the enrollment of a Phase I
clinical trial of a Licensed Product
------------------------------ ----------------------------------------------------------
$800,000 upon initiation of a Phase III clinical trial (including
a Phase II/III)
------------------------------ ----------------------------------------------------------
$5,000,000 upon approval by FDA of a New Drug Application
------------------------------ ----------------------------------------------------------
3.1.4 RUNNING ROYALTIES. During the term of this Agreement as set
forth in Section 8.1, Licensee shall pay Licensor a
non-refundable semi-annual royalty in an amount equal to three
and one half percent (3.5%) of Net Sales by the Licensee, or
any Affiliate of the Licensee, of the Licensed Products.
3.1.5 SUBLICENSING RUNNING ROYALTIES. Licensee shall pay Licensor an
amount equivalent to the sum Licensor would otherwise have
received in running royalties if Licensed Products were sold
directly by Licensee, under Article 3.1.4. Recording and
payment of these royalties by Licensee must be made according
to the provisions of Article 4.
3.1.6 SUBLICENSING OR PARTNERING INCOME. The Licensee shall pay to
Licensor an amount equal to twenty percent (20%) of fees or
other non-royalty consideration received by Licensee from a
Sublicensee as a result of the granting of a sublicense by the
Licensee after the Effective Date of this Agreement but before
the initiation of a Phase II clinical trial including payments
of equity (other than in connection with a merger,
acquisition, consolidation, reorganization or other transfer
of all or substantially all of the Licensee's assets or
business), received by Licensee from a Sublicensee in
connection with a sublicense agreement. The Licensee shall pay
to Licensor an amount equal to fifteen percent (15%) of such
sublicense fees or other non-royalty consideration if the
granting of such sublicense to the Subject Technology by the
Licensee occurs after the initiation of a Phase II clinical
trial. Such fees shall include, but not be limited to:
(A) up front fees received by licensee for the granting
of a sublicense;
(B) milestone payments (to the extent that Licensee
receives payments for achieving milestones);
provided, however, that the Licensor shall not be
entitled to any milestone payments made to the
Licensee to the extent that the Licensors would be
otherwise entitled to a Milestone Payment pursuant to
paragraph 3.1.3 above;
(C) sublicense maintenance fees;
(D) any similar payments made by Sublicensees to either
Licensee or its Affiliate on account of sublicenses
granted under this Agreement.
Excluded from these royalty obligations are
(1) payments received by Licensee from Sublicensees in
connection with a research and development program;
(2) the sale by the Licensee of debt or equity securities
of the Licensee; and
(3) royalties covered by Section 3.1.4 or 3.1.5 above.
Licensee shall pay these royalties to Licensor within 45 days
of each calendar quarter in which the royalties are received
by Licensee or its Affiliate from Sublicensees.
3.2 WAIVER OR DEFERRAL. Waiver or deferral by Licensor of any payment owed
under any paragraph under Section 3.1 may not be construed as a waiver
or deferral of any subsequent payment owed by Licensee to Licensor.
3.3 COMBINATION PACKAGES. If a Licensed Product is sold in a combination
package or kit containing other active products or processes, then Net
Sales for purposes of determining royalty payments on the combination
package will be calculated using one of the following methods, but the
royalties payable to Licensor may not be reduced to less than fifty
percent (50%) of that provided for in paragraph 3.1.6 of this
Agreement:
(A) By multiplying the net selling price of the
combination by the fraction A/A+B, where A is the
gross selling price, during the royalty-paying period
in question, of the Licensed Product sold separately,
and B is the gross selling price during the royalty
period in question, of the other active products sold
separately; or
(B) If no separate sales are made of the Licensed Product
or any of the active products in such combination
package during the royalty-paying period in question,
Net Sales for the purposes of determining royalty
payments, must be calculated by dividing the net
selling price of the combination by the number of
functions performed by the combination sold where
such combination contains active agents other than
those licensed under this Agreement.
3.4 REDUCED RATE. To the extent Licensee or any Affiliate of Licensee is
required, by order or judgment of any court to obtain in any
jurisdiction any license from a third party in order to practice the
rights purported to be granted to Licensee by Licensor hereunder under
issued patents in such jurisdiction, then up to fifty percent (50%) 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 semiannual period in such jurisdiction be reduced by
more than fifty percent (50%) as a result of any such deduction,
provided further that any excess deduction remaining as a result of
such limitation may be carried forward to subsequent periods.
ARTICLE 4 -- ROYALTY REPORTS, PAYMENTS AND FINANCIAL RECORDS
4.1 ROYALTY REPORTS. Following the First Commercial Sale of a Licensed
Product, within 45 days after March 31, June 30, September 30 and
December 31 of each year in which this Agreement is in effect, Licensee
shall deliver to Licensor full, true and accurate reports of its
activities and those of its Affiliates or Sublicensee(s), if any,
relating to this Agreement during the preceding three month period.
These reports must include at least the following:
(A) Number of Licensed Products manufactured and sold by
Licensee, and any Affiliates or Sublicensees, in each
country of the Territory;
(B) Total ▇▇▇▇▇▇▇▇ for the Licensed Products sold;
(C) Deductions applicable to determining Net Sales;
(D) The nature and amount of Sublicensing or Partnering
Income received under Article 3.1.6 and 3.1.6 by
Licensee; and
(E) Total royalties due to Licensor.
With each report, Licensee shall pay to Licensor the royalties due and
payable. If no royalties are due, Licensee shall so report. If multiple
Licensed Products are covered by the license granted under this
Agreement, Licensee shall separately identify each Licensed Product in
the royalty report and specify which patents/application within the
Patent Rights are used for each Licensed Product.
4.2 RECORD KEEPING.
4.2.1 BOOKS AND RECORDS. Licensee shall keep, and shall require its
Affiliates and Sublicensees to keep, true books of account
containing an accurate record (together with supporting
documentation) of all data necessary for determining the
amounts payable to Licensor. Licensee shall keep such records
at its principal place of business or the principal place of
business of the appropriate division of Licensee to which this
Agreement relates and shall require its Affiliates and
Sublicenses to keep their books and records in the same
manner.
4.2.2 INSPECTIONS. In order for Licensor to determine the
correctness of any report or payment made under this
Agreement, upon reasonable notice to the Licensee, Licensee
shall make its records available to Licensor for inspection
upon reasonable notice to the Licensee, for a period of three
(3) years following the end of the calendar year to which they
pertain. Licensee shall also require any Affiliates or
Sublicensees to make their records available for inspection by
Licensor, in the same manner as provided in this paragraph
4.2.2.
Licensor may inspect the records during regular business hours
by a certified public accountant selected by Licensor and
reasonably acceptable to the licensed entity whose records are
being inspected. In conducting inspections under this
paragraph 4.2.2, Licensee agrees that Licensor's accountant
may have access to all records which Licensor reasonably
believes to be relevant to calculating royalties owed to
Licensor under Article 3.
Licensor is responsible for the cost of any inspection, unless
the examination shows an underreporting or underpayment by any
entity in excess of five percent (5%) for any twelve month
period, in which case Licensee shall pay the cost of the
inspection as well as any additional sum that would have been
payable to Licensor had the Licensee reported correctly, plus
interest as set forth in Section 4.5.
4.3 FORM OF PAYMENTS AND TAXES. Licensee must make all payments to be made
to Licensor in Boston, Massachusetts, or at such other place or in such
other way as Licensor may reasonably designate. Payments must be paid
by check or wire transfer.
Licensee shall pay all amounts payable to Licensor under this Agreement
in United States funds without deduction for taxes, exchange,
collection or other charges that may be imposed by any country or
political subdivision with respect to any amounts payable to Licensor
under this Agreement. Licensee is responsible for paying, or ensuring
payment of, such taxes, exchange, collection or other charges.
4.4 CURRENCY CONVERSION. If any currency conversion is required in
connection with any payment owed to Licensor, the conversion will be
made at the buying rate for the transfer of such other currency as
quoted by the Wall Street Journal on the last business day of the
applicable accounting period in the case of any payment payable with
respect to a specified accounting period or, in the case of any other
payment, the last business day before the date the payment is due.
4.5 INTEREST. Any payment owed to Licensor under this Agreement that is not
made when due will accrue interest beginning on the first day following
the due date specified in Article 3. The interest will be calculated at
the annual rate of the sum of (a) three percent (3%) plus (b), the
prime interest rate quoted by Fleet Bank on the date the payment is
due, the interest being compounded on the last day of each calendar
quarter. However, the annual rate may not exceed the maximum legal
interest rate in Massachusetts. The payment of interest as required by
this Section does not foreclose Licensor from exercising any other
rights or remedies it has as a consequence of the lateness of any
payment.
ARTICLE 5 -- ARTICLE 5 - OPERATIONS UNDER THE LICENSE
5.1 DUE DILIGENCE
5.1.1 GENERAL OBLIGATIONS. Licensee shall use commercially
reasonable efforts to bring one or more Licensed Products to
the marketplace as soon as reasonably practicable, through a
diligent and aggressive program of development, production and
distribution. Such efforts must not be less than the efforts
expended by Licensee in connection with its other high
priority projects. After commercialization, Licensee shall
continue active and diligent efforts to keep Licensed Products
available to the public.
5.1.2 DEVELOPMENT PLAN. Within ninety (90) days after the Effective
Date, Licensee shall provide Licensor with a written
development plan that describes Licensee's plan for bringing
the Subject Technology to practical application ("Development
Plan"). The Development Plan must set forth the particular
Licensed Products and practical applications of Licensed
Products that Licensee initially intends to develop, cite
Licensee's specific goals and objectives for the ensuing year
for developing or commercializing the Licensed Intellectual
Property. The outline must include actual or projected
financial resources or strategic alliances that will be
required to meet such objectives together with a timeline for
meeting such specific goals and objectives.
5.1.3 SPECIFIC DILIGENCE BENCHMARKS. Licensee, its Affiliates or its
Sublicensees shall diligently pursue the following specific
effort and achievement benchmarks ("Specific Diligence
Benchmarks") by the dates specified in the following table:
-------------------------------- --------------------------------------------------------------
SPECIFIC DILIGENCE
BENCHMARKS DATE
-------------------------------- --------------------------------------------------------------
IND Filing Within six (6) Months of License Execution
-------------------------------- --------------------------------------------------------------
Initiation of Phase I Within three (3) Months of IND Approval
Clinical Trial
-------------------------------- --------------------------------------------------------------
Filing of NDA Within six (6) Months of Completion of Data Analysis of
Pivotal Trial
-------------------------------- --------------------------------------------------------------
For purposes of this paragraph 5.1.3, Licensor will consider
efforts of an Affiliate or Sublicensee as efforts of Licensee.
5.1.4 ADJUSTMENTS TO SPECIFIC DILIGENCE BENCHMARKS. In the event
that, despite the diligent efforts of Licensee, Licensee fails
to meet or expects to fail to meet any of the Specific
Diligence Benchmarks set forth above in section 5.1.3, and can
provide to Licensor reasonable evidence of its diligent
efforts as well as a reasonable alternative plan for the
meeting of these development benchmarks, upon written request
of Licensee, the Parties shall negotiate, in good faith,
revised Specific Diligence Benchmarks which shall be
incorporated in this Agreement by amendment.
5.1.5 DEVELOPMENT AND COMMERCIALIZATION REPORTS. On or before each
anniversary of the Effective Date, Licensee shall provide to
Licensor a written report describing the efforts by Licensee,
or any Affiliates or Sublicensees, to bring one or more
Licensed Products to the marketplace. The report must be in
sufficient detail to permit Licensor to monitor Licensee's
compliance with the due diligence provisions of this
Agreement.
Licensee shall include at least the following in these
reports: (a) a summary of Licensee's progress toward meeting
the goals and objectives that had been established for the
previous year; (b) a summary of Licensee's goals and
objectives for the ensuing year for developing and
commercializing a Licensed Product including an identification
of any additional Licensed Products that Licensee intends to
develop; and (c) if applicable, (i) a summary of those unmet
goals and objectives from the previous year, and an
explanation for the failure to meet such goals and objectives
and (ii) a summary describing the corrective steps the
Licensee intends to take with respect to the aforementioned
unmet goals and objectives.
5.1.6 FAILURE TO PERFORM. Licensee's failure to perform with any due
diligence requirement provided in Sections 5.1.1, 5.1.2 and
5.1.5 or in the event that the parties cannot, in good faith,
agree on revised Specific Diligence Benchmarks as provided for
in Section 5.1.4, shall be grounds for Licensor to terminate
this Agreement according to Section 8.2.3
5.2 U.S. MANUFACTURE. Licensee shall manufacture Licensed Products leased,
used or sold in the United States substantially in the United States as
required by 35 U.S.C. 204 and 37 C.F.R. 401 et. seq., as amended.
Licensee shall also require any Affiliate(s) or Sublicensee(s) to
comply with this U.S. manufacture requirement.
If Licensee provides reasonable evidence to Licensor that domestic
manufacture of a Licensed Product is not commercially feasible, at
Licensee's request, Licensor will cooperate with Licensee to seek a
waiver from the United States government with respect to the United
States manufacture requirement. If a waiver is to be sought, Licensee
shall provide Licensor with the required information, prepare the
initial paperwork necessary for applying for or obtaining the waiver
and bear all costs associated with the waiver process. Licensee
acknowledges that Licensor can not guarantee that a waiver can or will
be obtained.
5.3 OTHER GOVERNMENT LAWS. Licensee shall comply with, and ensure that its
Affiliates and Sublicensees comply with, all government statutes and
regulations that relate to Licensed Products. These include but are not
limited to FDA statutes and regulations, the Export Administration Act
of 1979, as amended, codified in 50 App. U.S.C. 2041 et seq. and the
regulations promulgated thereunder or other applicable export statutes
or regulations.
5.4 PATENT MARKING. Licensee shall ▇▇▇▇, and shall require its Sublicensees
and Affiliates to ▇▇▇▇, all Licensed Products sold in the United States
with the word "Patent" and the number or numbers of the issued
patent(s) applicable to the Licensed Product.
5.5 PUBLICITY; USE OF NAME. Nothing contained in this Agreement shall be
construed as granting any right to the Licensee or its Affiliates or
Sublicensees, if any, to use in advertising, publicity, or other
promotional activities any name, trade name, trademark, or other
designation of Licensor or any of its units (including contraction,
abbreviation or simulation of any of the foregoing) without the prior,
written consent of Licensor, provided, however, that Licensor
acknowledge and agree that the Licensee may use the names of Licensor
and the names of the Inventors in various documents used by the
Licensee for capital raising and financing without such prior written
consent or where the use of such names shall be otherwise required by
law.
ARTICLE 6 -- PATENT PREPARATION, FILING, PROSECUTION AND MAINTENANCE
6.1 RESPONSIBILITY. The Licensee, is responsible for preparing, filing,
prosecuting and maintaining the patent applications and patents
included within the Patent Rights and for paying all associated costs.
For purposes of this Agreement, patent prosecution includes ex parte
prosecution, interference proceedings, reissues, reexaminations and
oppositions. The Licensee shall provide, or cause its agent to provide,
copies of relevant correspondence between the Licensee and the United
States Patent Office or the various foreign patent offices and give
Licensor reasonable opportunity to advise the Licensee or it's counsel
on such matters. Licensor designates the following individual or
department for receiving the patent-related correspondence.
Patent Counsel
Office of Patent Counsel
▇▇▇▇-▇▇▇▇▇▇ Cancer Institute
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Upon Licensor's request, the Licensee shall be available to consult
with Licensor on matters relating to preparing, filing, prosecuting or
maintaining any of the applications or patents within Patent Rights.
The Licensee, acting reasonably, shall consider the legitimate
interests of Licensor in performing its responsibility under this
Section 6.1. Licensee designates the following individual or department
to receive such requests from Licensor.
[INSERT INDIVIDUAL OR DEPARTMENT HERE]
6.2 COOPERATION. Licensor shall cooperate with the Licensee in preparing,
filing, prosecuting and maintaining the patent applications and patents
within Patent Rights. The Parties shall provide prompt notice to each
other of any matter that comes to their attention that may affect the
patentability, validity or enforceability of any patent application or
patent within Patent Rights.
6.3 RELINQUISHING RIGHTS. . If Licensee elects not to prepare, prosecute,
and/or maintain any patents or patent applications in any country in
the world Licensee shall give Licensor ninety (90) days advance written
notice; relinquish responsibility for prosecution of said application
or patent; and surrender its license under such patent application or
patent. However, if Licensee is surrendering any patent or application
within Patent Rights on which an interference proceeding or opposition
has been declared or filed, the notice period is one hundred and eighty
(180) days. Thereafter, Licensee will have no further obligation to pay
any royalties or other payments under this Agreement with respect to
any such country including without limitation patent expenses for the
patents or patent applications that it surrendered, but excluding any
accrued but unpaid royalties and/or expenses owed to the Licensor as of
the date of the relinquishment of such rights.
6.4 PROSECUTION BY LICENSOR. Licensor shall thereafter have the right, but
not any obligation, to prosecute, obtain issuance of, and/or maintain
such patent or patent application relinquished by Licensee in such
country at its own cost, and any such applications and resultant
patents shall not be subject to this Agreement.
ARTICLE 7 -- ARTICLE 7 - PATENT INFRINGEMENT AND ENFORCEMENT
7.1 The Licensee 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.
7.2 During the term of this Agreement, the Licensee 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. Before Licensee commences any legal
proceeding with respect to the infringement, Licensee shall consider in
good faith the views of Licensor. In furtherance of such right,
Licensor hereby agrees that the Licensee may join Licensor as a party
in any such suit if required by law, at Licensee's expense. No
settlement, consent judgment or other voluntary final disposition of
any such suit which would adversely affect the rights of Licensor may
be entered into without the consent of Licensor, which consent shall
not be unreasonably withheld.
7.3 In the event that a claim or suit is asserted or brought against the
Licensee alleging that the manufacture or sale of any Licensed Product
by the Licensee, an Affiliate of the Licensee, 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 Licensee
shall give written notice thereof to the Licensors. The Licensee 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. Otherwise, the Licensee shall have the right, but not
the obligation to defend any such claim or suit. Licensee shall NOT
enter into any settlement, consent judgment or other voluntary final
disposition of any action under this Section 7.3 that adversely affects
DFCI without the consent of DFCI, which consent shall not be
unreasonably withheld, unless, the settlement includes any express or
implied admission of liability or wrongdoing on DFCI's part, in which
case DFCI's right to grant or deny consent is absolute and at its sole
discretion. In the event the Licensee elects not to defend such suit,
the Licensor shall have the right, but not the obligation to do so at
its sole expense.
7.4 Any recovery of damages pursuant to paragraph 7.3 above in any such
suit, shall be applied first in satisfaction of any unreimbursed
expenses and legal fees of either party relating to the suit and then
to Licensor for any royalties credited in accordance with paragraph
7.5. The balance remaining from any such recovery shall be shared by
Licensor and the Licensee in accordance with Paragraph 3.1.6 hereof.
7.5 The Licensee may credit up to fifty percent (50%) of any litigation
costs incurred by the Licensee in any country pursuant to this Article
7 and up to 50% of all amounts paid in judgment or settlement of
litigation within this Article 7 scope of against royalties thereafter
payable to the Licensors hereunder for such country and apply the same
toward one-half of its actual, reasonable out-of-pocket litigation
costs. If one-half of such litigation costs in such country exceeds 50%
of royalties payable to the Licensors in any year in which such costs
are incurred than the amount of such costs, expenses and amounts paid
in judgment or settlement, in excess of such 50% of the royalties
payable shall be carried over and credited against royalty payments in
future years for such country.
7.6 Action at Request of Licensor. Licensor may request that Licensee to
take steps to protect the Patent Rights from an apparent infringement.
Licensee shall notify Licensor, within 90 days of receiving a written
request from Licensor, of action it intends to take, if any, to compel
termination of the alleged infringing action or to initiate legal
proceedings against the alleged infringer.
7.7 Licensor independently has the right to join any legal proceeding
brought by Licensee under this Section 7and fund up to 50% of the cost
of the legal proceeding from the date of joining. If Licensor elects to
join as a party plaintiff pursuant to this paragraph 7.3, Licensor may
jointly participate in the action with Licensee, but Licensee's counsel
will be lead counsel.
7.8 If within six (6) months after receiving notice of any alleged
infringement, the Licensee 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
Licensee 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 Licensor may,
for such purposes, join the Licensee as a party plaintiff. The total
cost of any such infringement action commenced solely by Licensor shall
be borne by Licensor and any amounts paid by third parties shall be
distributed as described in paragraph 7.4 above.
7.9 SETTLEMENT. Regardless of whether Licensee is joined in any legal
proceeding initiated by Licensor, no settlement, consent judgment or
other voluntary final disposition of the legal proceeding may be
entered into without the consent of Licensor.
7.10 In any suit to enforce and/or defend the Patent Rights pursuant to this
License 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 8 -- TERM AND TERMINATION
8.1 TERM. Unless terminated earlier under the provisions of this Agreement,
this Agreement will terminate on the expiration date of the last to
expire of patents within Patent Rights.
8.2 TERMINATION BY LICENSOR. Licensor has the right to immediately
terminate this Agreement and all licenses granted hereunder by
providing Licensee with written notice of termination, upon the
occurrence of any of the following events:
8.2.1 Licensee ceases to carry on its business with respect to
Licensed Products.
8.2.2 Licensee fails to pay on schedule any royalty or other payment
that has become due and is payable under Articles 3 or 4 of
this Agreement and has not cured the default by making the
required payment, together with interest due, within 30 days
of receiving a written notice of default from Licensor
requesting such payment.
8.2.3 Licensee fails to meet any of the due diligence requirements
set forth in Article 5 unless Licensee has cured the default
by meeting the obligation within thirty (30) days of receiving
written notice of default from Licensor.
8.2.4 Licensee is convicted of a felony relating to the manufacture,
use, sale or importation of Licensed Products.
8.2.5 Licensee materially breaches any other provision of this
Agreement, unless Licensee has cured the breach within 90 days
of receiving written notice from Licensor specifying the
nature of the breach.
8.2.6 Licensor shall have the right, at its option, to cancel and
terminate this Agreement in the event that Licensee shall (i)
become involved in insolvency, dissolution, bankruptcy or
receivership proceedings affecting the operation of its
business or (ii) make an assignment of all or substantially
all of its assets for the benefit of creditors, or in the
event that (iii) a receiver or trustee is appointed for
Licensee and Licensee shall, after the expiration of thirty
(30) days following any of the events enumerated above, have
been unable to secure a dismissal, stay or other suspension of
such proceedings. In the event of termination of this
Agreement, all rights to the Subject Technology shall revert
to Licensor.
8.3 TERMINATION BY LICENSEE. Licensee has the right to terminate this
Agreement without cause by giving Licensor ninety (90) days prior
written notice.
8.4 EFFECT OF TERMINATION.
8.4.1 NO RELEASE. Upon termination of this Agreement for any reason,
nothing in this Agreement may be construed to release either
Party from any obligation that matured prior to the effective
date of the termination.
8.4.2 SURVIVAL. The provisions of Section 3.1.1 (patent expenses)
Article 4 (Royalty Reports, Payments and Financial Records),
Section 5.5 (Use of Names; Publicity), paragraph 8.4.3
(Inventory), Sections 9 (Indemnification, Defense and
Insurance), Article 10 (Warranty Disclaimers) and Article 12
(Dispute Resolution) survive termination of this Agreement.
8.4.3 INVENTORY. Licensee, any Affiliate(s) and any Sublicensees
whose sublicenses are not converted as provided in paragraph
8.4.4, may, after the effective date of termination, sell all
Licensed Products that are in inventory as of the date of
written notice of termination, and complete and sell Licensed
Products which the licensed entity(ies) can clearly
demonstrate were in the process of manufacture as of the date
of written notice of termination, provided that Licensee shall
pay to Licensor the royalties thereon as required by Article 3
and shall submit the reports required by Article 4 on the
sales of Licensed Products.
8.4.4 SUBLICENSES. Any sublicenses will terminate contemporaneously
with this Agreement. However, any Sublicensee not in default
under its sublicense may request conversion of the sublicense
to a license directly between DFCI and Sublicensee. DFCI shall
not unreasonably withhold its acceptance of such conversion,
however, as a condition of DFCI's acceptance, the Sublicensee
must first agree to be bound by all of the provisions of this
Agreement.
8.4.5 INFORMATION. Upon termination of the Agreement under the
provisions of Section 8.2, Licensee agrees to provide Licensor
with a copy of all data, including such data generated during
a clinical trial, produced during the term of this Agreement,
and to grant to Licensor the exclusive license to use such
data in exchange for a continuing royalty equal to one percent
(1%) of Net Sales or other royalty and non-royalty
compensation received by Licensor of any Licensed Product that
is subsequently sold by Licensor if such termination occurs
after the completion of a Phase I clinical trial or two
percent (2%) of Net Sales or other royalty and non-royalty
compensation received by Licensor of any Licensed Product that
is subsequently sold by Licensor if such termination occurs
after the initiation of a Phase II clinical trial. Uses may
include, but are not limited to, regulatory filings, patent
filings and publications.
ARTICLE 9 -- INDEMNIFICATION, DEFENSE AND INSURANCE
INDEMNIFICATION AND DEFENSE.
9.1 Licensee shall indemnify, defend and hold harmless Licensor and its
trustees officers, medical and professional staff, employees, and
agents and their respective successors, heirs and assigns (the
"Indemnitees"), against any liability, damage, loss or expense
(including reasonable attorneys' fees and expenses of litigation)
incurred by or imposed upon the Indemnitees, or any one of them, in
connection with any claims, suits, actions, demands or judgments (a)
arising out of the design, production, manufacture, sale, use in
commerce, lease, or promotion by Licensee or by a Sublicensee,
Affiliate or agent of Licensee, or any product, process or service
relating to, or developed pursuant to, this Agreement or (b) arising
out of any other activities to be carried out pursuant to this
Agreement.
9.2 Licensee's indemnification under Section 9.1(a) applies to any
liability, damage, loss or expense whether or not it is attributable to
the negligent activities of the Indemnitees. Licensee's indemnification
under 9.1(b) does not apply to any liability, damage, loss or expense
to the extent that it is attributable to (a) the negligent activities
of the Indemnitees, or (b) the intentional wrongdoing or intentional
misconduct of the Indemnitees.
9.3 If any such action is commenced or claim made or threatened against
Licensor or other Indemnitees as to which Licensee is obligated to
indemnify it (them) or hold it (them) harmless, Licensor or the other
Indemnitees shall promptly notify Licensee of such event. Licensee
shall assume the defense of, and may settle, that part of any such
claim or action commenced or made against Licensor (or other
Indemnitees) which relates to Licensee's indemnification and Licensee
may take such other steps as may be necessary to protect it. Should it
become necessary as a result of a conflict of interests for the
Licensor to obtain separate counsel to represent Licensor in any such
action, then Licensee, at its sole cost, shall provide counsel
reasonably acceptable to the Licensor. In all cases, choice of counsel
shall be reasonably acceptable to Licensor. Licensee will not be liable
to Licensor or other Indemnitees on account of any settlement of any
such claim or litigation affected without Licensee's consent. The right
of Licensee to assume the defense of any action is limited to that part
of the action commenced against Licensor and/or Indemnitees that
relates to Licensee's obligation of indemnification and holding
harmless.
9.4 Licensee shall require any Affiliates or Sublicensee(s) to indemnify,
hold harmless and defend Licensor under the same terms set forth in
Sections 9.1 - 9.3.
INSURANCE.
9.5 At such time as any product, process or service relating to, or
developed pursuant to, this Agreement is being commercially distributed
or sold (other than for the purpose of obtaining regulatory approvals)
by Licensee or by a Sublicensee, Affiliate or agent of Licensee,
Licensee shall, at its sole cost and expense, procure and maintain
policies of commercial general liability insurance in amounts not less
than $2,000,000 per incident and $2,000,000 annual aggregate and naming
the Indemnitees as additional insureds. Such commercial general
liability insurance must provide (a) product liability coverage and (b)
contractual liability coverage for Licensee's indemnification under
Sections 9.1 through 9.3 of this Agreement. If Licensee elects to
self-insure all or part of the limits described above (including
deductibles or retentions which are in excess of $250,000 annual
aggregate), such self-insurance program must be acceptable to the
Licensor and the Licensor's associated Risk Management Foundation. The
minimum amounts of insurance coverage required under these provisions
may not be construed to create a limit of Licensee's liability with
respect to its indemnification obligation under Sections 9.1 through
9.3 of this Agreement.
9.6 Licensee shall provide Licensor with written evidence of such insurance
upon request of Licensor. Licensee shall provide Licensor with written
notice at least fifteen (15) days prior to the cancellation,
non-renewal or material change in such insurance; if Licensee does not
obtain replacement insurance providing comparable coverage within such
fifteen (15) day period, Licensor has the right to terminate this
Agreement effective at the end of such fifteen (15) day period without
any notice or additional waiting periods.
9.7 Licensee shall maintain such comprehensive general liability insurance
beyond the expiration or termination of this Agreement during (a) the
period that any product, process, or service, relating to, or developed
pursuant to, this Agreement is being commercially distributed or sold
(other than for the purpose of obtaining regulatory approvals) by
Licensee or by a Sublicensee, Affiliate or agent of Licensee and (b) a
reasonable period after the period referred to in 9.7(a) above which in
no event shall be less than fifteen (15) years.
9.8 Licensee shall require any Affiliates or Sublicensee(s) to maintain
insurance in favor of Licensor and the Indemnitees under the same terms
set forth in Sections 9.5 - 9.7.
ARTICLE 10 -- DISCLAIMER OF WARRANTIES
10.1 LICENSOR MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR
A PARTICULAR PURPOSE WITH RESPECT TO ANY PATENT, TRADEMARK, SOFTWARE,
NON-PUBLIC OR OTHER INFORMATION, OR TANGIBLE RESEARCH PROPERTY,
LICENSED OR OTHERWISE PROVIDED TO LICENSEE HEREUNDER AND HEREBY
DISCLAIMS THE SAME.
10.2 LICENSOR DOES NOT WARRANT THE VALIDITY OF THE PATENT RIGHTS LICENSED
HEREUNDER AND MAKES NO REPRESENTATION WHATSOEVER WITH REGARD TO THE
SCOPE OF THE LICENSED PATENT RIGHTS OR THAT SUCH PATENT RIGHTS MAY BE
EXPLOITED BY LICENSEE, AFFILIATE OR SUBLICENSEE WITHOUT INFRINGING
OTHER PATENTS.
10.3 THE LIABILITY OF LICENSOR THEIR AGENTS, OR THEIR EMPLOYEES, WITH
RESPECT TO ANY AND ALL SUITS, ACTIONS, LEGAL PROCEEDINGS, CLAIMS,
DEMANDS, DAMAGES, COSTS AND EXPENSE ARISING OUT OF THE PERFORMANCE OR
NON PERFORMANCE OF ANY OBLIGATION UNDER THIS AGREEMENT WHETHER BASED ON
CONTRACT, WARRANTY, TORT (INCLUDING WITHOUT LIMITATION NEGLIGENCE),
STRICT LIABILITY, STATUTORY OR OTHERWISE SHALL BE LIMITED TO DIRECT,
ACTUAL DAMAGES INCURRED AS A RESULT OF LICENSOR'S FAILURE TO PERFORM
ITS OBLIGATIONS AS REQUIRED BY THIS AGREEMENT AND SHALL NOT EXCEED IN
THE AGGREGATE A SUM EQUAL TO THE TOTAL AMOUNTS PAYABLE TO LICENSOR
UNDER THIS AGREEMENT.
ARTICLE 11 -- NOTICES
11.1 NOTICES TO LICENSOR. Unless otherwise specified in this Agreement,
reports, notices and other communications from Licensee to Licensor as
provided hereunder must be sent to:
Sr. Vice President for Research
▇▇▇▇-▇▇▇▇▇▇ Cancer Institute
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
A copy of the notice must also be sent to:
Vice President,
Office of Research & Venture Technology
▇▇▇▇-▇▇▇▇▇▇ Cancer Institute
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
or other individuals or addresses as Licensor subsequently furnish by written
notice to Licensee.
11.2 NOTICES TO LICENSEE. Unless otherwise specified in this Agreement,
reports, notices and other communications from Licensor to Licensee as
provided hereunder must be sent to:
or other individuals or addresses as Licensee may subsequently furnish by
written notice to Licensor.
ARTICLE 12 -- DISPUTE RESOLUTION
12.1 NEGOTIATION BETWEEN THE PARTIES. The parties shall first attempt to
resolve any controversy that arises from this Agreement, or claim for
breach of the Agreement, by good faith negotiations, first between
their respective business development representatives and then, if
necessary, between senior representatives for the parties, such as the
Sr. Vice President for Research or President of Licensor and the
President of Licensee.
12.2 Any dispute arising from or relating to this Agreement shall be
determined before a tribunal of three arbitrators in Boston,
Massachusetts in accordance with the rules of the American Arbitration
Association. One arbitrator shall be selected by the Licensors, one
arbitrator shall be selected by the Licensee and the third arbitrator
shall be selected by mutual agreement of the first two arbitrators.
12.3 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.
12.4 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.
12.5 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.
ARTICLE 13 -- CONFIDENTIALITY
13.1 Except as otherwise provided in Paragraph 13.2 below, during the Term
of this Agreement and for a period of five (5) years from the Effective
Date of this Agreement, Licensee agrees to use reasonable efforts not
to disclose to third parties any Confidential Information of Licensor.
Licensee shall restrict the dissemination of Licensor's Confidential
Information to employees, agents, or collaborators involved with the
research based on the need to know for the performance of research.
13.2 Information received from Licensor hereto shall not be deemed
Confidential Information, and Licensee will have no obligation with
respect to such information:
13.2.1 which, as of the effective date of this Agreement, is part of
the public domain;
13.2.2 which subsequently becomes part of the public domain through
no fault of the Licensee;
13.2.3 which the Licensee can show was in its possession, as
evidenced by written records kept in the ordinary course of
business or by the proof of actual use at the time of
executing this Agreement, and which information had not been
wrongfully acquired, directly or indirectly, from the
Licensor;
13.2.4 which is subsequently disclosed to the Licensee by a third
party not in violation of any right of, or obligation to, the
Licensor hereto; or
13.2.5 is required to be disclosed by operation of law, provided that
the Licensor has received advanced notice of the proposed
disclosure by the Licensee;
13.2.6 Except by the Licensor's express written approval that
Confidential Information can be released from obligations of
confidentiality
ARTICLE 14 -- INDEPENDENT CONTRACTOR
For the purpose of this Agreement and all services to be provided hereunder,
both parties are and will be deemed to be, independent contractors and not
agents or employees of the other. Neither party has authority to make any
statements, representations or commitments of any kind, or to take any action,
that will be binding on the other party.
ARTICLE 15 -- SEVERABILITY
If any one or more of the provisions of this Agreement is held to be invalid,
illegal or unenforceable, the validity, legality or enforceability of the
remaining provisions of this Agreement will not in any way be affected or
impaired thereby.
ARTICLE 16 -- 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 Licensee may assign this Agreement (i) to a
purchaser, merging or consolidating corporation, or acquirer of substantially
all of the Licensee'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 Licensee.
ARTICLE 17 -- ENTIRE AGREEMENT
This instrument contains the entire Agreement between the parties. No verbal
agreement, conversation or representation between any officers, agents, or
employees of the parties either before or after the execution of this Agreement
may affect or modify any of the terms or obligations herein contained.
ARTICLE 18 -- MODIFICATIONS IN WRITING
No change, modification, extension, or waiver of this Agreement, or any of the
provisions herein contained is valid unless made in writing and signed by a duly
authorized representative of each party.
ARTICLE 19 -- GOVERNING LAW
The validity and interpretation of this Agreement and the legal relations of the
parties to it are governed by the laws of the State of Massachusetts without
regard to any choice of law principal that would dictate the application of the
law of another jurisdiction.
ARTICLE 20 -- CAPTIONS
The captions are provided for convenience and are not to be used in construing
this Agreement.
ARTICLE 21 -- CONSTRUCTION
The parties agree that they have participated equally in the formation of this
Agreement and that the language herein should not be presumptively construed
against either of them.
IN WITNESS WHEREOF, the parties hereto have caused this agreement to be
executed in quadruplicate by their duly authorized representatives as of the
date first above written.
▇▇▇▇-▇▇▇▇▇▇ CANCER INSTITUTE, INC. ▇▇▇▇▇▇ HEALTH SCIENCES, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇. Del ▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
----------------------------- --------------------------
Title: Vice President Title: President
----------------------------- --------------------------
Date: December 19, 2002 Date: December 19, 2002
----------------------------- --------------------------
ASH ▇▇▇▇▇▇▇, INC.
By: /s/ [signature illegible]
----------------------------
Title: President and CEO
----------------------------
Date: December 16, 2002
----------------------------
SCHEDULE ▇
▇▇▇▇▇▇ ▇▇▇▇▇▇
▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇ Patent No. 4,767,761 (DFCI #111) entitled "Ornithine
Derivatives and their Use as Methotrexate Resistant Cell Inhibitors.
2. United States Provisional Patent Application, Serial No. 60/376,615,
(DFCI #774) entitled "Pharmaceutically Active Ornithine Derivatives,
Ammonium Salts Thereof and Methods of Making Same" filed April 30,
2002.
