CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
Exhibit 10.04
Execution Copy
AMENDED AND RESTATED
LICENSE AGREEMENT
The License Agreement made and entered into as of May 7, 1997 ("the date of
the original Agreement"), by and between Point Therapeutics, Inc. (formerly
known as Immune Therapeutics, Inc.), a Massachusetts corporation having its
principal place of business at 00 Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000
("Licensee") and Tufts University, a/k/a Trustees of Tufts College, a
corporation duly organized and existing under the laws of the Commonwealth of
Massachusetts and having a principal office at Xxxxxxx, Xxxxxxxxxxxxx 00000
("Tufts"), and New England Medical Center Hospitals, Inc., a corporation duly
organized and existing under the laws of the Commonwealth of Massachusetts and
having a principal office at Xxxxxx, Xxxxxxxxxxxxx 00000 ("NEMCH"; Tufts and
NEMCH referred to jointly as "Licensor"), as amended on November 5, 1997, is
hereby further amended and restated in its entirety as of January 12, 1999 ("the
date hereof") as follows:
ARTICLE I - DEFINITIONS.
-----------------------
1.1. "Patents" shall mean solely the United States and foreign patents and
patent applications set forth in Exhibit A attached hereto and any United States
and foreign patents issuing from any such patent applications, and any
continuations, continuations-in-part, divisions, reissues, extensions, and
renewals of any of the foregoing. "Patents" shall not include any other patents
or patent applications (whether or not owned or controlled, in whole or in any
part, by Tufts or NEMCH); provided, however, that Exhibit A may be amended from
time to time as prosecution of the Patents progresses and as new patent
applications are filed pursuant to the Sponsored Research Agreement dated as of
May 7, 1997 (the "Research Agreement").
1.2. "Technology" shall mean solely the trade secret, know-how, data and
other information (whether or not patentable or qualifying as a trade secret)
relating to the "Field of Use" that, after the date hereof, may from time to
time be set forth in Exhibit B by amendment to reflect the addition of
Technology pursuant to the Research Agreement. "Technology" shall not include
any other trade secret, know-how, data or other information (whether or not
owned or controlled, in whole or in any part, by Tufts or NEMCH).
1.3. "Confidential Technology" shall mean all Technology, and all
information in or concerning patent applications included in the Patents,
provided, however, that Licensee need not keep confidential any information
that:
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
(a) at the date of its disclosure by Licensor to Licensee was lawfully
known to Licensee as documented in Licensee's files and is revealed to Licensor
within thirty (30) days after Licensor's disclosure to Licensee; or
(b) at the date of disclosure by Licensor to Licensee was, or
thereafter becomes, through no fault of Licensee, publicly known by means of a
single publication or so widely known and used that it can be said to be
generally available to the public; or
(c) after its disclosure by Licensor to Licensee is also received by
the Licensee in good faith from a third party not under any direct or indirect
duty to Licensor not to disclose it.
1.4. "Field of Use" shall mean use of any and all Licensed Products for
diagnostics, vaccines and therapeutics.
1.5. "License Period" shall mean collectively the respective periods
commencing on the date of the original Agreement and expiring (unless sooner
terminated): as to the Patents, on a country-by-country basis on the expiration
of the last to expire of the Patents (treating pending applications as issued
patents for so long as they are pending) in the country in question; and as to
the Technology, on a country-by-country and product-by-product basis, on the
date that is [*] years from the date of the initial commercial sale of the
Licensed Product in question in the country in question.
1.6. "Licensed Products" shall mean all products (i) the making, using or
selling of which infringes (were it not for the License) at least one claim in a
pending application or unexpired and non-lapsed patent included in the Patents
(treating pending applications as issued patents for these purposes); and/or
(ii) which embody or are made in accordance with or using any aspect of the
Technology.
1.7. "Net Sales" shall mean the gross sales of Licensed Products billed to
customers by Licensee, its Subsidiaries, and its sublicensees, less the
following:
(a) allowances, credits, chargebacks, refunds and adjustments actually
credited to customers for spoiled, damaged, outdated and returned Licensed
Products, or otherwise actually credited to customers on account of rejection,
return or price reduction of Licensed Products;
(b) trade, quantity, cash, and prompt payment discounts actually
allowed and taken;
(c) rebates and price reductions or adjustments required by law,
regulations or contract, to the extent actually credited or paid to customers or
any other third party; and
(d) third-party charges of the following kinds collected by the seller
from the buyer and separately identified on the invoice: transportation charges,
sales taxes, excise taxes and customs duties, and governmental charges levied on
or measured by the sale.
-2-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
Net Sales shall also include and be deemed to have been made with respect
to any Licensed Product (i) sold or otherwise transferred by Licensee, its
Subsidiaries or its sublicensees to any third parry, intending that the Licensed
Product be ultimately used by an end-user, in return in whole or in part for
value or consideration, stated or otherwise, other than a monetary amount billed
to such third party or (ii) not sold or otherwise transferred to any third party
but rather used by itself by Licensee, its Subsidiary or sublicensee to provide
a commercial diagnostic or therapeutic service to an end-user. The amount of any
Net Sales as defined in the preceding sentence shall be imputed using the price
or prices at which such Licensed Product is then being sold to customers of
Licensee, its Subsidiaries or its sublicensees, as the case may be, in an
arm's-length sales transaction.
1.8. "Subsidiary" shall mean any corporation, partnership or other business
organization that directly or indirectly controls, is controlled by or is under
common control with Licensee. For the purpose of this Agreement, "control" shall
mean the holding directly or indirectly of fifty percent (50%) or more of the
voting stock or other ownership interest of the corporation or other business
organization invoiced.
1.9. "Territory" shall mean the world.
1.10. "Reserved Field of Use" shall mean the Reserved Field of Use as
defined in the Master License, Collaboration and Development Agreement.
1.11. "Multivalent Patents" shall mean those patents set forth on Exhibit
A-1 attached hereto and made a part hereof.
1.12. "Master License, Collaboration and Development Agreement" shall mean
the Master License, Collaboration and Development Agreement by and between
Licensee and Xxxxxxx-Xxxxx Squibb Company dated January 12, 1999.
1.13. "BMS Sublicense Agreement" shall mean the Sublicense Agreement by and
between Licensee and Xxxxxxx-Xxxxx Squibb Company dated January 12, 1999.
ARTICLE II - GRANT; SUBLICENSES.
------------------
2.1. Grant. Subject to the terms and conditions hereinafter set forth,
-----
Licensor hereby grants to Licensee, to the extent that it lawfully may, a
royalty-bearing, exclusive license to practice the Patents and use the
Technology in the Territory, only for the purpose of making, using, selling,
importing and offering for sale Licensed Products (the "License"). The License
shall exist as an exclusive, royalty-bearing license during and will terminate
as such at the end of the applicable License Period, unless sooner terminated as
hereinafter provided. If the License as to the Technology does not terminate
before the end of the applicable License Period for the Technology, then the
License to use the Technology shall continue in effect thereafter without
limitation of time as a non-exclusive, fully paid-up license without rights of
sublicensing; provided, however, that under such fully paid-up license,
notwithstanding the absence of sublicensing rights thereunder, Licensee's
Subsidiaries and sublicensees existing at the time of termination of the
applicable License Period shall have the right to continue to
-3-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
develop and commercialize each Licensed Product already in pre-clinical or
clinical development or in the market prior to the expiration of the applicable
License Period.
2.2. Reserved Rights. During the License Period, Licensor shall have no
---------------
right to use the Patents or Technology to make, use or sell Licensed Products
for commercial purposes, but Licensor reserves to itself (a) the right at all
times to practice the Patents, use the Technology, and make and use Licensed
Products for non-commercial research, teaching and educational purposes within
Licensor and to permit such activities at other not-for-profit institutions, (b)
the right at all times to permit E. I. du Pont de Nemours and Company to use
U.S. Patent [*] for its own internal research purposes only and (c) all
other rights not granted to Licensee, including the rights to use and permit the
use of Patents and Technology for any purpose not in conflict with the
provisions of the License. To the extent that any Patents and Technology have
been wholly or partially funded by the federal government, Licensee's rights are
also subject to the Federal Patent Policy under 37 CFR 401.
2.3. Sublicenses. Licensee shall also have the right to grant to its
-----------
Subsidiaries or other sublicensees, exclusive or non-exclusive sublicenses under
the License during the License Period, provided, and Licensee agrees, that:
(a) the terms and conditions of each sublicense shall be consistent
with the terms and conditions of this Agreement and shall contain, among other
things (by way of example but not limitation), provisions substantially similar
to and consistent with: the "Net Sales" definition; the provisions of Article
III applicable to sub-licensees; Article V; Section 7.1 (so that no
representations or warranties inconsistent with that Article shall be extended
to or by any sublicensee); Article IX but the sublicense shall terminate
simultaneously with the expiration or termination of the License Period, except
as otherwise expressly agreed to by Licensor in writing or as provided in the
last sentence in Section 2.1; Article XI; and Article XII;
(b) each sublicense shall provide that the obligations to Licensor of
Sections 3.5, 3.6, 3.7, 7.1, 8.1, 8.5 and 9.3, and Articles V, XI and XII of
this Agreement shall be binding on the sublicensee and be enforceable both by
Licensor and Licensee;
(c) Licensee shall provide prior written notice to Licensor of each
sublicense. In the event a sublicensee: (i) possesses a net worth or market
capitalization of at least fifty million dollars ($50,000,000) and (ii) is
engaged in the development, manufacture or distribution of human therapeutic
products (the "Criteria"), then with respect to a sublicense entered into with
such sublicensee, Licensor's consent shall not be required. If the proposed
sublicensee lacks the Criteria, then Licensee shall obtain Licensor's prior
written consent to a sublicense agreement entered into with such sublicensee,
such consent not to be unreasonably withheld or delayed;
(d) Licensee shall furnish to Licensor a true and complete copy of
each sublicense agreement and each amendment thereto, promptly after the
sublicense or amendment has been agreed upon; and
-4-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
(e) No Subsidiary or other sublicensee shall have the right to further
license, sublicense, or assign its rights except as otherwise expressly agreed
to by Licensor in writing; and
(f) no sublicense shall relieve Licensee of any of its obligations
hereunder, and Licensee shall (A) take all steps necessary to enforce compliance
by its Subsidiaries and sublicensees with their obligations with respect to
Section 5.1 and Article XI hereof and (B) use its best efforts to enforce
compliance by its Subsidiaries and sublicensees with all other obligations
undertaken by or binding upon them in accordance with the provisions of
subsections (a) and (b) of this Section 2.3.
ARTICLE III - PAYMENTS; RECORDS.
-------------------------------
3.1. License Issue Fee. Licensee has heretofore paid to Licensor on the
-----------------
date of the original Agreement or thereabout the non-refundable sum of [*],
of which [*] has been credited toward patent reimbursement as indicated on
Exhibit C. On or about the one-year anniversary of the date of the original
Agreement, Licensee paid to Licensor the non-refundable sum of [*], of which
[*] has been credited toward patent reimbursement as indicated on Exhibit C.
Such payments shall not be creditable against any annual payments or royalties
due hereunder.
Equity. Licensor and its designees and Licensee have entered into a
------
Stock Issuance Agreement dated May 7, 1997 pursuant to which Licensee has issued
shares of its common stock to Licensor.
Sponsored Research. Licensee shall sponsor research at Tufts for two
------------------
years from the date of the original Agreement, as covered by the Sponsored
Research Agreement of even date with the original Agreement, to include payments
in the aggregate amount of [*].
3.2. Annual Payments. Commencing on the two-year anniversary of the date of
---------------
the original Agreement and continuing annually during the License Period,
Licensee agrees to pay to Licensor [*] per year. For the payments due on May
7, 1999 through May 7, 2010, up to [*] shall be credited toward patent
reimbursement as indicated on Exhibit C. After the past patent costs have been
fully reimbursed, each annual payment (commencing with the payment due on May 7,
2011) shall be creditable against the royalties that are due under Section 3.3
below, with respect to the 12-month period commencing on the due date of the
annual payment.
Milestone Payments. Licensee agrees to pay to Licensor the following
------------------
non-refundable milestone payments, which shall be made to Licensor within thirty
(30) days following the date of the milestone obtained by Licensee, its
Subsidiaries or sublicensees:
Milestone Payment Amount
--------- --------------
Commencement of First Phase III Clinical Trials
for Licensed Product $[*]
-5-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
First marketing application submitted for
Licensed Product [*]
First marketing approval for Licensed Product [*]
3.3. Running Royalties. Commencing with the initial sale of any Licensed
-----------------
Products by Licensee or its Subsidiaries in any country, Licensee agrees to pay
to Licensor royalties of either:
(a) [*] of the Net Sales of Licensed Products, the making, using or
selling of which infringes (were it not for the License) at least one claim in a
pending application or unexpired and non-lapsed patent included in the Patents
(treating pending applications as issued for these purposes); or
(b) [*] of the Net Sales, during the License Period of the Technology,
of Licensed Products that do not fall within the clause (a), above, but for use
any part or all of the Technology in the manufacture or the use thereof, or
both.
(c) Notwithstanding the foregoing provisions of this Section 3.3, if
Licensor has the right to obtain a patent in, at minimum, the following
countries: the United States, Canada, Japan and the European Convention member
countries of Belgium, France, Germany, Italy, The Netherlands, Spain,
Switzerland and United Kingdom, and if Licensee supports maintaining the patent
in the United States but Licensee and Licensor, under Section 4.4 below, decline
to support the corresponding patent or patent application in Australia, Canada,
Japan or any of the European Convention member countries (hereinafter a
"declined country"), then Licensee agrees to pay a [*] royalty on the Net Sales
of products in any such declined country for the lifetime of the United States
patent, the making, using or selling of which would have infringed the Patents
if Licensee had supported a corresponding patent or patent application in the
declined country. In determining such hypothetical infringement, reference shall
be made to the scope of the claims pending or obtained in the corresponding
United States patent or patent application.
Stacking Royalties. In the event that it is necessary, based on patent
------------------
rights held by one or more third parties in any country, for Licensee to pay
royalties to such third party or parties on any Licensed Product, then Licensee
may reduce the royalties on Net Sales owed to Licensor within a 12-month period
under this Section 3.3 with respect to sales of such Licensed Product in such
country, by the amount of such necessary royalties actually paid to the third
party or parties on Net Sales in sales in such country within the same 12-month
period, provided that no royalty payment to Licensor under this Agreement shall
be reduced by more than [*]. In the event that it is necessary,
based on patent rights held by Licensor other than the Patents, for Licensee to
obtain a license from Licensor (in addition to the License hereunder) in order
to make, use, sell, import or offer for sale Licensed Products, Licensor will
take into account any royalties due to Licensor under this Agreement when
establishing royalties for such additional license.
-6-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
3.4. Sublicense Fees and Royalties.
(a) Fees. As to each sublicense granted by Licensee under the License,
----
Licensee shall pay to Licensor [*] of all fees paid to Licensee by the
sublicensee: provided, however, that in the case of sublicenses which do not
provide for the Licensee's performance of research, development, manufacturing,
sales, distribution or marketing activities for the sublicensed Patents or
Technology, the portion of the fees payable to licensor hereunder shall be [*]
if the sublicense is executed during the first year of the License Period, [*]
if the sublicense is executed during the second year of the License Period, and
[*] thereafter. For purposes hereof, the term "fees" shall include, but is not
limited to, upfront payments, milestone payments and annual minimums, but it
does not include royalties based on Net Sales, the value of equity or debt
instruments issued to Licensee or funding for research and development programs
that are directly related to the development of Patents or Technology.
(b) Royalties. As to each sublicense granted by Licensee under the
---------
License, Licensee shall pay to Licensor the lesser of (1) [*] of the
sublicensee's Net Sales of Licensed Products, the making, using or selling of
which infringes (were it not for the License) at least one claim in a pending
application or unexpired and non-lapsed patent included in the Patents; and [*]
of the Net Sales of Licensed Products that do not fall within the preceding
clause, but do use Technology in the manufacture or the use thereof; or (2) [*]
of the royalties received by the Licensee from such sublicensee on account of
such Net Sales. Notwithstanding the foregoing, the royalties due to Licensor
shall not be less than [*] of the sublicensee's Net Sales.
3.5. Statements; Payments. Licensee shall, within sixty (60) days after the
--------------------
last days of March, June, September and December in each year or portion thereof
during the License Period, and within sixty (60) days after the end of the
License Period, provide Licensor with a statement accounting for the Net Sales
of Licensed Products by Licensee, its Subsidiaries and its sublicensees (and
with copies of the corresponding statements to Licensee from its Subsidiaries
and sublicensees), and all amounts described in Section 3.4, for the immediately
preceding three (3) month period or portion thereof, accompanied by payment for
the full amount of royalties and other payments due under this Article III for
that period or portion thereof. Each such statement shall be certified by the
Chief Financial Officer of Licensee as being true, correct and complete. All
such payments shall be made payable to "Trustees of Tufts College" and shall be
sent to Xxxxxxxx X. Xxxxxx, Associate Xxxxxxx for Research, Tufts University,
000 Xxxxxxxx Xxx., Xxxxxx, XX 00000.
3.6. Currencies. All payments to be paid to Licensor shall be computed and
----------
made in United States Dollars, and Licensee shall use best efforts to convert
royalty payments payable on Net Sales in any country to United States Dollars;
provided, however, that if conversion to and transfer of such Dollars cannot be
made by Licensee, its Subsidiaries or its sublicensees in any country for any
reason, Licensee may pay such sums in the currency of the country in which such
Net Sales are made, deposited in
-7-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
Licensor's name in a bank designated by Licensor in any such country. The rate
of exchange of local currencies to U.S. Dollars shall be at the rate of exchange
prevailing at the Bank of Boston (or such other bank in Boston, Massachusetts or
New York, New York as Licensor may designate from time to time), for currencies
of the amounts involved, as such rate is stated for the first business day after
the end of the period with respect to which the royalties are due. To the extent
that any sublicense from Licensee to any Sublicensee hereunder which is approved
in writing by Licensor contains currency provisions different from the
foregoing, such currency provisions shall apply for the purpose of determining
royalty payments to Licensor on Net Sales by such sublicensee.
3.7. Records; Audits. Licensee shall keep (and cause to be kept) and
---------------
maintain complete and accurate records of Net Sales of the Licensed Products by
Licensee, its Subsidiaries and its sublicensees, and all other payments made by
or received by Licensee, its Subsidiaries and its sublicensees as described in
Sections 3.3 and 3.4, in accordance with generally accepted accounting
procedures. Such records shall be accessible to independent certified public
accountants selected by Licensor and reasonably acceptable to Licensee, by
audits conducted not more than once a year during the License Period and for one
year after the termination thereof, at any reasonable times during business
hours, for the purpose of verifying Net Sales and any royalties due thereon.
Such accountants shall disclose to Licensor only information relating to the
accuracy of the records kept and the payments made, and shall be under a duty to
keep confidential any other information obtained from such records. Licensee,
its Subsidiaries and its sublicensees shall not be required to retain such
records for more than three (3) years after the close of any calendar
quarter-year. No period shall be subject to audit under this Section more than
once as to any entity being audited. Results of any such audit shall be made
available to both parties. The determination by an independent, certified public
accountant pursuant to this Section 3.7 as to the amount due and payable by
Licensee hereunder shall be conclusive and binding upon both parties.
3.8. Substantial Underpayment. If any such audit reveals that the aggregate
------------------------
of royalties paid during any four consecutive calendar quarters was more than
[*] less than the amount that should have been paid, then the reasonable
expenses of the audit shall be borne by Licensee, which shall pay those expenses
within thirty (30) days after demand therefor by Licensor accompanied by the
accountants' statement therefor.
3.9. Taxes. All taxes and charges which may be imposed by any government
-----
taxing authority on the amounts paid by Licensee to Licensor under this
Agreement shall be assumed by Licensee. In the event Licensee is required to
withhold such taxes or charges from the Licensor, Licensee shall deliver to
Licensor true copies of the receipts or returns covering each such payment. In
the event a waiver is available for the payment of any such tax imposed by a
foreign government as a result of Licensor's status as a non-profit
organization, Licensor agrees to consider, in its sole discretion, any
reasonable request by Licensee to cooperate in any efforts initiated by Licensee
to obtain such a waiver. Licensee agrees to reimburse Licensor for Licensor's
reasonable out of pocket costs and expenses incurred in considering such
requests and cooperating with such waiver process, including outside counsel
fees, if any.
-8-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
ARTICLE IV - TECHNOLOGY DISCLOSURE; PATENT PROSECUTION.
------------------------------------------------------
4.1. [Intentionally left blank].
4.2. [Intentionally left blank].
4.3. [Intentionally left blank].
4.4. Patent Prosecution. Licensor shall apply for, seek prompt issuance of,
------------------
and maintain while the License is in effect, the Patents in the United States
and in the foreign countries listed on Exhibit A attached hereto. Licensee may
request, in writing, Licensor to file and prosecute patent applications for the
Patents in any one or more other countries, and Licensor may of its own accord
elect to file and prosecute any such other patent applications. If Licensee
makes any request for such an additional foreign patent applications, and if
Licensor decides not to file such an application or prosecute same or maintain a
patent so obtained, Licensor shall thereafter promptly notify Licensee and
Licensee shall then be entitled to take over the application, prosecution or
maintenance, as the case may be, of such patent application or such patent for
the benefit of Licensor. In such case, Licensor shall cooperate fully with
Licensee and provide all such information and data and execute any documents
reasonably required in order to allow Licensee to do so. Licensee shall
cooperate with Licensor in any prosecution, filing, and maintenance that
Licensor is required to or elects to undertake hereunder.
Abandonment. Licensee may request, in writing, Licensor to abandon a patent
-----------
or patent application within the Patents (including a request not to obtain
patent protection) in one or more "Core Countries": United States, Australia,
Canada, Japan, and the European Convention member countries of Belgium, France,
Germany, Italy, The Netherlands, Spain, Switzerland and United Kingdom, or in
one or more countries other than Core Countries, in which event the following
provisions shall apply:
(i) Core Countries. If Licensee requests Licensor to abandon such a
--------------
patent or patent application in one or more Core Countries, Licensor shall, no
later than three (3) months after such request, give notice to Licensee to
inform it whether or not Licensor has elected to maintain the subject patent or
patent application in at least one Core Country covered by Licensee's request.
If Licensor notifies Licensee that it has elected to so maintain the subject
patent or patent application, such patent or patent application shall no longer
be considered Patents under this Agreement, and Licensee shall have no further
rights or interest in or to the subject patent or patent application, or the
information included therein, worldwide. If Licensor notifies Licensee that it
has elected to abandon the subject patent or patent application as requested by
Licensee, Licensor and Licensee may, by mutual agreement, cause the information
included in such patent or patent application to become Technology for all
purposes of this Agreement in the requested countries; otherwise Licensee shall
thereafter have no further rights or interest in or to the subject patent or
patent application, or the information included therein, in the requested
countries.
-9-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
(ii) Other Countries. If Licensee requests Licensor to abandon such a
---------------
patent or patent application in any one or more countries other than a Core
Country, Licensor shall, no later than three (3) months after such request, give
notice to Licensee to inform it whether or not Licensor has elected to maintain
the subject patent or patent application in any or all of the countries covered
by Licensee's request. If Licensor notifies Licensee that it has elected to
maintain the subject patent or patent application in any of such countries, such
patent or patent application shall continue as Patents under this Agreement in
such countries, but Licensor shall pay all costs associated with such patent or
patent application. If Licensor notifies Licensee that it has elected to abandon
the subject patent or patent application in any or all of the countries covered
by Licensee's request, Licensor and Licensee may, by mutual agreement, cause the
information included in such patent or patent application to become Technology
for all purposes of this Agreement in such countries; otherwise Licensee shall
thereafter have no further rights or interest in or to the subject patent or
patent application, or the information included therein, in those countries.
4.5. Patents Expenses. Licensee shall pay all reasonable costs associated
----------------
with the preparation, filing, prosecution and maintenance of the Patents.
Licensor shall send Licensee invoices on a monthly basis for any such patent
expense incurred by Licensor, and Licensee shall pay such invoices within thirty
(30) days of receipt thereof. In connection with sending Licensee invoices,
Licensor shall provide copies of all backup documentation supporting the
invoices and such other reasonable information and detail as Licensee shall
request in order to ascertain the correctness of the invoice. For all past costs
associated with the preparation, filing, prosecution and maintenance of the
Patents and incurred by Licensor prior to the date of this Agreement, Licensee
shall reimburse Licensor according to the schedule on Exhibit C.
4.6. Prosecution Cooperation. Licensor agrees to keep Licensee fully
-----------------------
informed of patent prosecution and maintenance, including submitting promptly to
Licensee copies of all Official Actions and other papers received from Patent
Offices anywhere in the world. In addition, Licensor agrees to provide to
Licensee drafts of patent applications and responses to office actions to be
submitted to the various patent offices around the world, reasonably in advance
of submitting any such paper, so that Licensee may provide its comments, which
shall be reasonably taken into account. Patent counsel for prosecuting the
Patents shall be mutually acceptable to Licensor and Licensee. Licensor shall
not abandon any of the Patents without first consulting Licensee.
4.7. Assignment of Rights. Tufts faculty and staff are obligated to assign
--------------------
to Tufts their rights in the Patents and Technology.
ARTICLE V - CONFIDENTIALITY.
---------------------------
5.1. Limitations on Use, Disclosure. Licensee agrees to treat
------------------------------
confidential all Confidential Technology disclosed to it by Licensor. Licensee
shall not use any Confidential Technology including, but not limited to, the
information disclosed to Licensee under the Non-Disclosure Agreement regarding
"Potentiation of the Immune Response" dated October 4, 1996, for any purpose
except by exercise of the License.
-10-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
Licensee may disclose Confidential Technology for reasonable business purposes
only under the terms of a confidentiality agreement. Licensee agrees that it
will exercise every reasonable precaution to prevent the disclosure of
Confidential Technology by any of its directors, officers, employees or agents
to other parties, other than to its Subsidiaries and its sublicensees. Any
Confidential Technology disclosed to Subsidiaries or sublicensees shall be
disclosed on the basis of and subject to the confidentiality provisions of this
Agreement. Licensee agrees to limit the disclosure of the Confidential
Technology to those agents or employees of Licensee, its Subsidiaries, and its
sublicensees who have a need to know for the purpose of making, using or selling
Licensed Products, and who are obligated to Licensee to comply, on behalf of
Licensee, with the terms of this Agreement. Licensee agrees to be responsible
for all such compliance and failure thereof.
Licensor agrees to treat as confidential all information disclosed to it by
Licensee that is identified in writing as being confidential ("Licensee
Confidential Information"). Licensor shall use the Licensee Confidential
Information for purposes of this Agreement only.
5.2. Cessation. Any information which is Confidential Technology at the
---------
date of disclosure thereof to Licensee, its Subsidiaries or its sublicensees or
is Licensee Confidential Information at the date of disclosure thereof to
Licensor shall cease to be Confidential Technology or Licensee Confidential
Information, respectively, and the party receiving information ("Recipient")
from the disclosing party ("Discloser") shall be released from the provisions of
Section 5.1 as to such information on the date when, through no act or omission
on the part of Recipient such information becomes (a) publicly known by way of a
single publication in which such confidential information is disclosed in
reasonable detail or (b) so widely known and used that it can be said to be
generally available to the public or (c) known to Recipient by receipt in good
faith from a third party not under any duty to Discloser not to disclose it.
Notwithstanding the foregoing, however, Recipient agrees that before Recipient
may claim that any information is not or was not Confidential Technology or
Licensee Confidential Information, or claim the right to make any use of
disclosure in reliance on the immediately preceding sentence, Recipient will
give to Discloser at least sixty (60) days' prior written notice specifying in
reasonably complete detail the information in question, the planned use or
disclosure, the claimed exception permitting such use or disclosure, and the
factual basis supporting Recipient's claim that the exception would permit the
planned use or disclosure. The royalties due to Licensor hereunder with respect
to Net Sales shall not in any way be reduced or otherwise adversely affected by
reason of any Confidential Technology ceasing to be or failing to have the
characteristics of Confidential Technology as defined herein.
5.3. Time Limit. The provisions of this Article V shall continue to apply
----------
to any information which is Confidential Technology or Licensee Confidential
Information for so long as it shall remain such, notwithstanding any termination
of this Agreement or the License or expiration of the License Period, provided,
however, that the obligations of confidentiality under this Article shall in any
event expire and cease to exist fifteen (15) years from the date of the original
Agreement.
-11-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
ARTICLE VI - DILIGENCE.
----------------------
6.1. Initial Diligence. Licensee agrees to use its best efforts to effect
-----------------
introduction of a therapeutic or vaccine Licensed Product into the United States
commercial market as soon as practical, consistent with sound and reasonable
business practices and judgments. Licensee shall provide annual reports of such
efforts to Licensor within thirty (30) days of each anniversary of the date of
the original Agreement.
Evidence that Licensee, or its sublicensee, has achieved milestones (i)
through (iii), as scheduled below, shall be deemed, in and of itself to be a
sufficient showing by Licensee of such best efforts. The milestones are as
follows:
(i) raised or received for research or other purposes a total of [*],
including the initial financing, through venture capital investors, strategic
partners or other sources within three (3) years of the date of the original
Agreement (Licensee hereby certifies that Licensee has raised such funds);
(ii) filed (or had a sublicensee file) an IND for a Licensed Product
in the United States within six (6) years of the date of the original Agreement;
and
(iii) beginning not later than six (6) years after the date of the
original Agreement and for a period of at least six (6) years, spent (or had a
sublicensee spend) at least [*] in direct costs (including salaries) annually in
performing work necessary for the development of the Patents and Technology.
6.2. Product Sale. Licensor shall have the right at any time after twelve
------------
(12) years from the date of the original Agreement to terminate the License and
Licensor's obligations under this Agreement if Licensee, its Subsidiaries or its
sublicensees have not by the time of such termination sold a therapeutic or
vaccine Licensed Product into the United States market.
6.3. Continued Diligence re Additional Licensed Products. After market
---------------------------------------------------
introduction of an initial Licensed Product, Licensee agrees to continue to show
diligence, consistent with sound and reasonable business practices and
judgments, in developing and commercializing additional Licensed Products.
6.4. Termination of License for Discontinuation of Development.
---------------------------------------------------------
(a) So long as the BMS Sublicense Agreement is in effect, if at any
time Licensee decides to discontinue all development and commercialization
programs relating to Licensed Products within the Reserved Field of Use,
Licensee shall give notice of such intent to Licensor and Licensor shall have
the option to terminate the License granted hereunder solely with respect to the
Reserved Field of Use on thirty (30) days' notice to Licensee. Upon any such
termination Point shall have no further financial responsibility for prosecution
and maintenance of the Multivalent Patents.
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CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
(b) So long as the BMS Sublicense Agreement is in effect, if at any
time BMS decides to discontinue all development and commercialization programs
relating to Licensed Products not within the Reserved Field of Use, Licensee
shall give notice of such intent to Licensor and Licensor shall have the option
to terminate the license granted hereunder solely with respect to the Field of
Use other than the Reserved Field of Use on thirty (30) days' notice to
Licensee. Upon any such termination, Point shall have no further financial
responsibility for the prosecution and maintenance of any such Patents other
than the Multivalent Patents.
(c) If at any time the BMS Sublicense Agreement is not in effect and
Licensee decides to discontinue all development and commercialization programs
relating to the Field of Use, Licensee shall give notice of such intent to
Licensor, and Licensor shall have the option to terminate the License granted
hereunder solely with respect to such discontinued programs upon thirty (30)
day's notice to Licensee. Upon any such termination, Point shall have no further
financial responsibility for the prosecution and maintenance of any Patents on
the discontinued programs.
6.5. Consent to Change Milestones. Notwithstanding the foregoing, Licensor
----------------------------
shall not unreasonably withhold its consent and approval to any revision of such
milestones whenever requested in writing by Licensee and supported by evidence
of technical difficulties or delays that the parties could not have reasonably
foreseen.
ARTICLE VII - REPRESENTATIONS, WARRANTIES, AND LIMITATIONS.
----------------------------------------------------------
7.1. Licensor Disclaimer. LICENSOR MAKES NO REPRESENTATIONS, EXTENDS NO
-------------------
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED (INCLUDING, WITHOUT
LIMITATION, ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PURPOSE), AND
ASSUMES NO RESPONSIBILITIES WHATSOEVER, WITH RESPECT TO THE PATENTS OR
TECHNOLOGY OR THE USE THEREOF, OR THE MANUFACTURE, POSSESSION, USE, MARKETING,
SALE, OR OTHER DISPOSITION BY LICENSOR, LICENSEE OR ANYONE ELSE, OF LICENSED
PRODUCT(S) OR ANY OTHER PRODUCTS OR SERVICES (INCLUDING, WITHOUT LIMITATION,
PRODUCTS MADE BY LICENSOR, AND LICENSOR SERVICES, THAT ARE OR WERE FURNISHED TO
LICENSEE AT ANY TIME BEFORE, ON OR AFTER THE DATE OF THE ORIGINAL AGREEMENT),
EXCEPT ONLY AS EXPRESSLY STATED BELOW IN THIS ARTICLE VII. Without limitation of
the foregoing generality, nothing contained herein or in any disclosure of the
Patents or Technology made by or on behalf of Licensor shall be construed as
extending any representation or warranty with respect to the Patents or
Technology or Licensed Products or the results to be obtained by the use of the
Patents or Technology or any Licensed Products; or that anything made, used or
sold by use of the Patents or Technology or any part thereof, alone or in
combination, will be free from infringement of patents of third parties.
LICENSOR SHALL NOT BE LIABLE TO LICENSEE, ITS SUBSIDIARIES, ITS SUBLICENSEES OR
ANY OTHER PARTY, REGARDLESS OF THE FORM OR THEORY OF ACTION (WHETHER CONTRACT,
TORT, INCLUDING NEGLIGENCE, STRICT LIABILITY OR OTHERWISE), FOR ANY SPECIAL,
-13-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER EXTRAORDINARY DAMAGES ARISING OUT
OF OR RELATED TO THIS AGREEMENT, PATENTS, THE TECHNOLOGY, THE LICENSED PRODUCTS
OR ANY PRODUCTS OR SERVICES FURNISHED OR NOT FURNISHED BY LICENSOR, EVEN IF
LICENSOR HAS BEEN ADVISED OF THE POSSIBILITY THEREOF.
Licensee agrees that all warranties, if any, in connection with the sale or
other disposition of any Licensed Products (or any products made by Licensor and
furnished at any time to Licensee) by Licensee, its Subsidiaries or its
sublicensees will be made by them and will not directly or impliedly obligate
Licensor.
7.2. Licensor Representations. Notwithstanding the first sentence of
------------------------
Section 7.1, Licensor:
(a) Represents that Licensor are corporations organized and existing
under the laws of the Commonwealth of Massachusetts and has the power and
authority to enter into this Agreement.
(b) Represents that Licensor has taken all necessary action to
authorize its execution and delivery of this Agreement by the representatives of
Licensor who carried out such execution and delivery, and to authorize the
performance by Licensor of its obligations hereunder.
(c) Represents that execution and delivery of this Agreement and its
performance by Licensor will not result in any breach or violation of, or
constitute a default under, any agreement, instrument, judgment or order to
which Licensor is a party or by which it is bound.
(d) Represents that, to the best of its knowledge, Licensor has the
lawful right to grant to Licensee, in accordance with the provisions of this
Agreement, a license to practice the United States patents and patent
applications set forth in Exhibit A attached hereto.
7.3. Licensee Representations. Licensee represents and warrants to Licensor
------------------------
that:
(a) Licensee is a corporation organized and existing under the laws of
the Commonwealth of Massachusetts and has the power and authority to enter into
this Agreement.
(b) Licensee has taken all necessary action to authorize its execution
and delivery of this Agreement by the representatives of Licensee who carried
out such execution and delivery, and to authorize the performance by Licensee of
its obligations hereunder.
(c) Execution and delivery of this Agreement and its performance by
Licensee will not result in any breach or violation of, or constitute a default
under, any
-14-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
agreement, instrument, judgment or order to which Licensor is a party or by
which it is bound.
ARTICLE VIII - INDEMNITY; INSURANCE; INFRINGERS.
-----------------------------------------------
8.1. Indemnity. Licensee agrees to exonerate, indemnify, and hold harmless
---------
Licensor, its trustees, officers, employees, and agents, from all costs,
expenses (including attorneys' fees), interest, losses, obligations,
liabilities, and damages paid or liability for which is incurred by any of said
parties ("Losses"), and which arise out of or are in connection with or are for
the purpose of avoiding any and all claims, demands, actions, causes of action,
suits, appeals, and proceedings ("Claims"), all whether groundless or not, or
the settlement thereof, based on any actual or alleged injuries, damages or
liability of any kind whatsoever (including, without limitation, personal
injury, death, property damage, breach of warranty or breach of contract)
arising, directly or indirectly, out of any one or more of: any breach by
Licensee of its representations, warranties or agreements hereunder; or out of
any manufacture, marketing, possession, use, sale or other disposition of
Licensed Products or products furnished by Licensor to Licensee in connection
herewith or in connection with the Research Agreement (whether same occurs
during or after the License or during or after the License Period) by Licensee,
its Subsidiaries, its sublicensees, or anyone claiming by, through or under any
of them; or any acquisition, possession, disclosure or use of the Patents or
Technology or any thereof, by Licensee, its Subsidiaries, its sublicensees or
anyone claiming by, through or under any of them; or the presence of Licensee's
or its Subsidiaries' or its sublicensees' officers, agents, employees, invitees,
or property or any thereof on Licensor's premises.
8.2. Defense; Settlement. Licensee shall defend and control negotiation of
-------------------
settlement of any Claim, with counsel of Licensee's choosing approved in advance
by Licensor, which approval shall not be unreasonably withheld. Licensor agrees
to cooperate fully in the defense of any Claim and may participate in the
defense with counsel of Licensor's choosing, such separate counsel to be at
Licensor's expense unless a conflict of interest exists between Licensee and
Licensor with respect to the defense, in which case Licensor's separate counsel
shall be at Licensee's expense. Any settlement by which Licensor would incur any
obligation or liability (other than for the payment of money as to which
Licensee has an indemnity obligation hereunder and as to which Licensee has
provided to Licensor reasonable assurances for Licensee's full and prompt
satisfaction of the same), whether for the taking of any action, the refraining
from any action or otherwise, shall require the advance written consent of
Licensor, which consent shall not be unreasonably withheld.
8.3. Insurance. Not later than thirty (30) days before the time when (i)
---------
any Licensed Product shall be clinically tested with human subjects, or (ii)
Licensee, any Subsidiary or any sublicensee shall make, use or sell any Licensed
Products or any products furnished to Licensee by Licensor at any time (before,
on or after the date of the original Agreement) in connection herewith or in
connection with the Research Agreement, and at all times thereafter until the
expiration of all applicable statutes of limitation pertaining to any testing,
manufacture, marketing, possession, use, sale or other disposition of any
Licensed Products or the aforesaid products furnished by Licensor
-15-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
(whether same occurs or exists during or after the existence of the License or
during or after the License Period), Licensee will at Licensee's expense, obtain
and maintain in full force and effect, comprehensive general liability
insurance, including product liability insurance, protecting Licensor against
all claims, suits, obligations, liabilities, and damages, based upon or arising
out of actual or alleged bodily injury, personal injury, death or any other
damage to or loss of persons or property, caused by any such testing,
manufacture, marketing, possession, use, sale or other disposition. Such
insurance policy or policies shall be issued by companies rated by A. M. Best as
A VIII or better (or other companies acceptable to Licensor), shall name
Licensor as an additional named insured, shall have limits of at least one
million dollars ($1,000,000) per occurrence with an aggregate of three million
dollars ($3,000,000), shall be non-cancelable except upon thirty (30) days prior
written notice to Licensor, and shall provide that as to any loss covered
thereby and also by any policies obtained by Licensor itself, Licensee's
policies shall provide primary coverage for Licensor and Licensor's policies
shall be considered excess coverage for Licensor.
8.4. Certificates; Policies. Licensee will forthwith after the obtaining of
----------------------
such insurance required by Section 8.3, obtain and delivery to Licensor
certificates of and copies of, and at all times thereafter deliver without
further demand replacement certificates and copies of, all such insurance
policies that are in force and effect. As often as is reasonably requested by
Licensor, Licensee will furnish to Licensor a complete list, statement, and
description of all insurance called for in this Article, together with
certificates and copies of policies for each insurance company issuing any
thereof, that such insurance is in full force and effect, that all premiums have
been paid, and that such insurance will not be canceled except upon thirty (30)
days prior written notice to Licensor.
8.5. Infringers. Each party shall inform the other promptly in writing of
----------
any alleged infringement of the Patents in the Field of Use by a third party,
including all details then available.
In general, with respect to any infringement of any Patent (other than U.S.
Patent [*] (the "[*] Patent") and the Multivalent Patents) in the Field of Use,
Licensee (or a sublicensee designated by Licensee and approved by Licensor for
this purpose) shall have the first right, but shall not be obligated, to take
any legal action at its own expense against the infringer. In any infringement
action commenced by Licensee (or its sublicensee), all expenses of Licensee (and
its sublicensee) shall first be reimbursed by any recovery and all remaining
recovery for infringement shall be shared 75% to Licensee (and its sublicensee)
and 25% to Licensor.
With respect to any infringement of any Patent (other than the [*] Patent
and the Multivalent Patents), if neither Licensee nor its sublicensee has taken
legal action or been successful in obtaining cessation of the infringement,
within one-hundred twenty (120) days of written notification from Licensor of
such infringement, or if Licensee and its sublicensee elect not to continue
prosecuting any legal action against an infringer, Licensee shall give notice
thereof to Licensor and Licensor shall have the right, but shall not be
obligated, to take any legal action at its own expense against the infringer. In
any
-16-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
such action by Licensor, all expenses of Licensor shall first be reimbursed by
any recovery and all remaining recovery for infringement shall be shared 75% to
Licensor and 25% to Licensee.
Multivalent Patents. With respect to any infringement of the Multivalent
--------------------
Patents, in the Field of Use, Licensor shall have the first right, but shall not
be obligated, to prosecute at its own expense any such infringements, and
Licensee agrees that Licensor may join Licensee as a plaintiff at the expense of
Licensor. In any infringement action commenced solely by Licensor, all expenses
of Licensor shall first be reimbursed by any recovery and all remaining recovery
for infringement shall be shared 75% to Licensor and 25% to Licensee.
If Licensor has not taken legal action or been successful in obtaining
cessation of the infringement, within one-hundred twenty (120) days of written
notification from Licensee of infringement of the Multivalent Patents, or if
Lessor elects not to continue prosecuting any legal action against an infringer,
Licensee shall have the right (while the License is exclusive with respect to
the Multivalent Patents), but shall not be obligated, to prosecute at its own
expense any such infringement. Licensee may join Licensor as a plaintiff in any
such infringement suit at Licensee's expense. In any such action by Licensee,
all expenses of Licensee shall first be reimbursed by any recovery and all
remaining recovery for infringement shall be shared 25% to Licensor and 75% to
Licensee. Licensee shall indemnify Licensor against any order for costs or other
payments that may be made against Licensor in such proceedings.
By mutual agreement, Licensee and Licensor may agree to institute a suit
with respect to the Multivalent Patents jointly, the suit being brought in both
their names. Such agreement shall cover such matters as the sharing of recovery,
reimbursement of costs and expenses, exercise of control, and other relevant
matters.
If any action or suit alleging invalidity or non infringement of the
Multivalent Patents shall be brought against Licensee, Licensee shall defend
such action or suit at its sole expense, but Licensor shall have the right, at
its election made within sixty (60) days after commencement of that action or
suit, to intervene and take over the sole defense of the action or suit at
Licensor's sole expense unless the claim of the infringement has been asserted
by the claimant against Licensee as a counterclaim or other defensive pleadings
in an action theretofore commenced by Licensee against such claimant.
du Pont Patent. The parties acknowledge that the [*] Patent is co-owned by
--------------
Licensor and E. I. du Pont de Nemours and Company ("du Pont"); du Pont's rights
and interests therein were (a) exclusively licensed to Licensor pursuant to a
License Agreement made as of March 17, 1990 (the "du Pont License Agreement")
between them and (b) exclusively sublicensed to Licensee pursuant to this
Agreement. The parties acknowledge that, as provided in Section 4.3 of the du
Pont License Agreement:
"If within ninety (90) days after having been notified by [du Pont] of
any alleged infringement ... [of the [*] Patent, Licensor] has been
unsuccessful in persuading the alleged infringer to desist and has not
-17-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
brought, and is not diligently prosecuting an infringement action, or if
[Licensor] notifies [du Pont] at any time prior thereto of its intention
not to bring suit against any alleged infringer, then, in that event, [du
Pont] may, but shall not be obligated to, prosecute, at its own expense,
any infringement of the [[*] Patent]...."
Accordingly, Licensor agrees to exercise, upon request of Licensee, its right
(as provided in Section 4.1 of the du Pont License Agreement), and designate
Licensee or a sublicensee of Licensee in Licensor's name, to take appropriate
legal actions with respect to any infringement of the [*] Patent at the expense
of Licensee (or its sublicensee).
With respect to any infringement of the [*] Patent, if Licensee (or its
sublicensee) has not brought and continued to diligently prosecute an action to
obtain cessation of the infringement, within sixty (60) days of written
notification to Licensee from Licensor or du Pont of such infringement, the
right to take legal action against the infringer shall revert to du Pont and
Licensor in accordance with Section 4.3 of the du Pont License Agreement.
Further, the parties acknowledge that, as, provided in Section 4.4 of the
du Pont License Agreement:
"... [Licensor] may withhold up to [*] of the payments otherwise ...
due [du Pont under the du Pont License Agreement] and apply the same toward
reimbursement of [Licensor's] expenses ... in connection [with the
enforcement and/or defense of the [*] Patent]. Any recovery of damages by
[Licensor] for any such suit shall be applied first in satisfaction or any
unreimbursed expenses and legal fees of [Licensor] relating to the suit or
settlement thereof, and next toward reimbursement of [du Pont] for any
payments withheld and applied pursuant to [Section 4.4 of the du Pont
License Agreement]. Any remaining recoveries shall be used to reimburse
[Licensor] for lost profits and [du Pont] shall be entitled to lost
payments on account of such lost profits. The balance thereafter remaining
from such recovery shall be divided among [du Pont] and [Licensor] [*] to
[du Pont] and [*] to [Licensor]."
Accordingly, the parties agree that (i) any and all amounts so withheld from
payments otherwise due du Pont under the du Pont License Agreement shall be
applied toward the reimbursement of expenses incurred by Licensee, its
sublicensee and/or Licensor in connection with the pursuit of such suit or
settlement thereof, and (ii) if Licensee has taken the lead in the infringement
action Licensee shall be entitled to receive the entire [*] of the finally
remaining amount of recoveries due Licensor as so provided in the du Pont
License Agreement.
The parties acknowledge that, as provided in Section 4.5 of the du Pont
License Agreement:
-18-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
"In the event that a declaratory Judgment action alleging invalidity
or noninfringement of any of [the [*] Patent] is brought against [du
Pont], [Licensor], at its option, shall have the right, within thirty (30)
days after commencement of such action, to intervene and take over the sole
defense of the action at its own expense.
Accordingly, Licensor agrees to exercise, upon request of Licensee, its right
(as so provided in the du Pont License Agreement), and designate Licensee or a
sublicensee of Licensee in Licensor's name, to take over the defense of such an
action at the expense of Licensee (or its sublicensee).
All Patents. With respect to infringement of any Patent, no settlement,
-----------
consent judgment or other voluntary final disposition of a suit may be entered
into without the joint consent of Licensor and Licensee, which consent shall not
be withheld unreasonably.
In any infringement suit that either party brings to enforce the Patents,
the other party shall at the request and expense of the party bringing the suit,
cooperate in all reasonable respects, including, to the extent possible,
obtaining the testimony of its employees and making available physical evidence
in the possession of that party.
Licensee shall have the exclusive right in accordance with the provisions
of Section 2.3 to sublicense any alleged infringer in the Territory for the
Field of Use, for future use of the Patents.
ARTICLE IX - LICENSE TERMINATION.
--------------------------------
9.1 Events. The License granted hereunder may be terminated by Licensor
------
pursuant to Article VI or one of the following subsections:
(a) Material Default. If Licensee shall fail after thirty (30) days
----------------
written notice from Licensor to pay to Licensor any royalties or other payments
payable hereunder, or shall fail in any material way to perform any other
agreement required to be performed by Licensee under this Agreement, or if any
representation or warranty of Licensee contained in this Agreement shall prove
to have been inaccurate or misleading in any material way when made (referred to
collectively and individually as a "material default"), then, without limitation
of and in addition to any and all other rights and remedies available to
Licensor with respect to such material default, Licensor may terminate the
License (whether in its exclusive or non-exclusive period) and Licensor's
obligations hereunder by written notice to Licensee at any time after the
expiration of such thirty (30) day notice period if Licensee has not cured the
material default and the effects thereof before Licensor gives such notice of
termination to Licensee, unless Licensee commences mediation or arbitration
proceedings hereunder to contest such material default, in which event Tufts'
right to terminate the License shall be stayed until such proceedings shall have
been completed.
(b) Cessation of Business. If Licensee shall have commenced to carry
---------------------
on the business of selling any Licensed Products (either directly or through any
-19-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
Subsidiary or sublicensee) and shall at any time thereafter cease for a
consecutive period of one hundred eighty (180) days to carry on such business
actively (either directly or through any Subsidiary or sublicensee), Licensor
may at any time thereafter while that state of affairs continues, terminate the
License by written notice to Licensee.
(c) Insolvency. Should the Licensee become insolvent, this Agreement
----------
will immediately terminate without any requirement for providing notice to
Licensee.
9.2. Termination by Licensee. Licensee shall have the right to terminate
-----------------------
this Agreement and the License granted it hereunder for any reason within ninety
(90) days' notice to Licensor at any time.
9.3. Effects. Upon termination of the License for any reason, nothing
-------
herein shall be construed to release a Licensee from any obligations hereunder
except those of Article VI, but all rights of Licensee and its Subsidiaries and
its sublicensees to make, use or sell Licensed Products, or to practice the
Patents and use the Technology, shall cease immediately, except that (i)
Licensee, its Subsidiaries, and its sublicensees may after the effective date of
such termination and for one year thereafter sell all Licensed Products that
they may have on hand at the date of termination, and may complete manufacture
of Licensed Products then in the process of manufacture, and sell them, provided
that they pay all royalties due thereon with respect to Net Sales, as provided
in this Agreement; and (ii) if the License has been terminated by Licensor
pursuant to Section 9.1, each sublicensee (other than a Subsidiary) may elect
(by giving written notice thereof to Licensor within 60 days after termination
of the License) to continue its sublicense for the term thereof and perform all
of its obligations thereunder for the direct benefit of Licensor; provided, that
such election may be made solely by sublicensees under sublicenses which (x) are
then in good standing, (y) satisfy the conditions of Sections 2.3(a) and (b)
hereof and (z) grant exclusive rights to such sublicensees. Upon termination,
Licensee will disclose to Licensor all data and information developed by
Licensee during the term of the Agreement in the Field of Use.
ARTICLE X - NOTICE.
------------------
Any notice or communication required to be given hereunder in writing shall
be given by registered or certified mail, return receipt requested, or delivered
by courier, return receipt requested, charges and postage prepaid, addressed to
the parties, respectively, at the following address:
In the case of Tufts to:
Xxxxxxxx X. Xxxxxx
Associate Xxxxxxx for Research
Tufts University
000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
with a copy to:
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CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
Massachusetts Biomedical Initiatives, Inc.
Attn: Vice President, Commercial Development
00 Xxxxxxx Xxxxxx
Xxxxxxx, XX 00000
with a second copy to:
Xxxx Xxx Xxxxxx, Esq.
General Counsel
Tufts University
Xxxxxx Xxxx
Medford, MA 02155
or in the case of NEMCH to:
Xxxxx Xxxxx
Vice President of Research Administration
New England Medical Center Hospitals, Inc.
00 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
with a copy to:
Xxxxx XxXxxxx, Esq.
Director, Technology Transfer
New England Medical Center Hospitals, Inc.
000 Xxxxxxxxxx Xxxxxx, Xxx 000
Xxxxxx, XX 00000
or in the case of Licensee to:
Xxxxxx X. Xxxxxxx, Xx.
Point Therapeutics, Inc.
00 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
with a copy to:
Xxxxx X. Xxxx, Esq.
Xxxxx and Xxxxxx LLP
00 Xxxxx Xxxxx
Xxxxxx, XX 00000
or at such other respective substitute addresses as the addressee may designate
in writing to the other party.
-21-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
ARTICLE XI - NON-USE OF NAMES.
-----------------------------
Licensee agrees that it, its Subsidiaries and its sublicensees will not use
the name "Tufts University" or "New England Medical Center Hospitals, Inc." or
any variant thereof, or identify Tufts or NEMCH or any portion of Tufts or
NEMCH, or any inventor or any of the Patents or Technology, as a party to this
Agreement, or as a participant in inventing the inventions of the Patents or
creating the Technology, including, without limitation, in any advertising or
promotional sales literature, without prior express written consent of Licensor,
which consent may be withheld or withdrawn by Licensor in its complete and
uncontrolled discretion for any reason whatsoever and at any time or times.
However, notwithstanding the foregoing, Licensor will make no objection to any
proper reference by Licensee to published technical publications by such
inventors or creators; and, subject to the confidentiality requirements hereof,
Licensor will make no objection to Licensee's making such disclosures as in the
reasonable opinion of legal counsel as required as a matter of law, and such
general disclosures of this Agreement as may be desired by Licensee for purposes
of grant solicitations from governmental authorities, or as reasonably
determined by Licensee for the purposes of obtaining financing for Licensee, or
as reasonably determined by Licensee for the conduct of its business, other than
advertising or sales promotion. Licensee shall impose and enforce the
requirements of this Article on its Subsidiaries and sublicensees.
For Tufts, such approval shall be obtained from the Associate Xxxxxxx for
Research. For NEMCH, such approval shall be obtained from the Vice President for
Research Administration. Licensor agrees to respond within ten (10) business
days of Licensor's receipt of any request for approval under this Article,
provided that such request is delivered to the addresses indicated above in
Article X and is prominently marked "Urgent -- Please respond within ten days."
ARTICLE XII - COMPLIANCE WITH LAWS.
----------------------------------
12.1. Export Controls. The Export Control Regulations of the U.S.
---------------
Department of Commerce prohibit, except under special validated license, the
exportation from the United States of technical data relating to certain
commodities (listed in the Regulations), unless the exporter has received
certain written assurance from the foreign importer. In order to facilitate the
exchange of technical information under this Agreement, Licensee therefore
hereby agrees and gives its assurance to Licensor that Licensee will not, unless
any required prior authorization is obtained from the U.S. Office of Export
Control, re-export directly or indirectly any technical data received from
Licensor under this Agreement and will not export directly the Licensed Products
or such technical data to any country listed on either the Commodity Control
List or Militarily-Critical Technologies List. Licensor makes no representation
as to whether any such license is required or, if one is required, as to whether
it will be issued by the U.S. Department of Commerce.
12.2. Other Laws. In addition to the foregoing export control requirements,
----------
Licensee agrees that it, its Subsidiaries, and its sublicensees will comply with
all applicable mandatory or permissive patent marking laws, rules, and
regulations and
-22-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
comply with all other laws, rules, and regulations of all governmental
authorities applicable to any of their activities contemplated by this
Agreement, and will comply with all necessary and desirable practices in
connection and compliance with safety recommendations of trade associations or
governmental authorities.
ARTICLE XIII - MISCELLANEOUS PROVISIONS.
---------------------------------------
13.1. Assignment. Licensee shall not assign the License or this Agreement
----------
without the prior written consent of Licensor, which consent shall not be
unreasonably withheld; provided, however, that Licensee, without such consent,
may assign all of its rights hereunder to the acquiring party in connection with
the transfer of all or substantially all of its business and assets to an
acquiring party or in the event of its merger or consolidation with that
acquiring party, if and only if the assignee shall assume all obligations of
Licensee under this Agreement. However, no assignment or other transfer by
Licensee shall relieve Licensee of any obligations hereunder and Licensee shall
continue to be primarily and jointly and severally liable (along with such
assignee or other transferee) for the performance of all obligations of Licensee
and such assignee or other transferee hereunder.
13.2. Independent Contractors. The parties hereto shall be independent
-----------------------
contractors with respect to each other, and nothing contained herein shall be
construed as constituting either of them as the agent, principal, employee,
servant, joint venturer or partner of the other for any purpose whatsoever.
13.3. Governing Law. This Agreement shall be governed by and construed in
-------------
accordance with Massachusetts law.
13.4. Sole Agreement. This Agreement and any Exhibits annexed hereto (each
--------------
of which is hereby made part hereof by this reference), and any other documents
which may be expressly incorporated by reference herein, constitute the entire
and only agreement between the parties concerning the subject matter hereof; and
all prior negotiations, representations, warranties, agreements, and
understandings related thereto are superseded hereby.
13.5. Severability. If any provision of this Agreement shall to any extent
------------
be found to be invalid or unenforceable, the remainder of this Agreement shall
not be affected thereby, and any such invalid or unenforceable provision shall
be reformed so as to be valid and enforceable to the fullest extent permitted by
law.
13.6. Headings. Headings of Articles, Sections, and subsections included
--------
herein are for convenience of reference only and shall not be used to construe
this Agreement.
13.7. Financial Confidentiality. Both parties agree to keep the financial
-------------------------
terms of this Agreement confidential. Notwithstanding the foregoing, Licensee
may make non-public disclosures to prospective investors and lenders as are
reasonably necessary for the purposes of obtaining financing.
-23-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
ARTICLE XIV - DISPUTE RESOLUTION.
--------------------------------
14.1. Alternative Dispute Resolution. Subject to Section 14.2 below, for
------------------------------
all disputes, controversies, or differences which may arise between the parties
out of or in relation to or in connection with this Agreement, or for the breach
thereof, which cannot be resolved by mutual agreement, the parties agree to
attempt in good faith to settle such disputes by mediation to be held in
accordance with the Commercial Mediation Rules (the "Mediation Rules") of the
American Arbitration Association ("the Association") as the Mediation Rules then
exist, in Boston, Massachusetts, with the following deviations from the
Mediation Rules. By mutual agreement, the parties shall select at least one
qualified neutral mediator to serve. The party requesting mediation shall
designate its nominee or nominees in the request, which shall be addressed to
the Association with a simultaneous copy to the other party. The other party may
accept a nominee of the requesting party or may designate its own nominee or
nominees. The requesting party may accept a nominee of the other party or reject
the nominee. If within thirty (30) days of the initial request for mediation,
the parties are unable to select a mutually satisfactory, qualified neutral
mediator, a mediator shall be appointed by the Association according to the
Mediation Rules.
If the parties are unable to resolve any dispute through mediation, the
parties may resort to arbitration, litigation, or some other dispute-resolution
procedure. If the parties agree to submit to arbitration following an
unsuccessful mediation, the arbitration shall be held in accordance with the
Commercial Arbitration Rules (the "Arbitration Rules") of the Association as the
Arbitration Rules then exist, in Boston, Massachusetts, with the following
deviations for the Arbitration Rules. The arbitrators shall consist of one
Licensor nominee, one Licensee nominee, and a third person jointly selected by
those two nominees. The party requesting arbitration shall designate its nominee
in the request, which shall be addressed to the Association with a simultaneous
copy to the other party. If the other party shall fail within thirty (30) days
of the request for arbitration to nominate the second arbitrator or if the two
arbitrators are unable to agree upon the third arbitrator within thirty (30)
days after selection of the second arbitrator, then in either case the
arbitration panel will be completed according to the Rules. Both legal and
equitable remedies shall be available to the arbitrators. The award of a
majority of the arbitration panel shall be final and binding on the parties
hereto and shall be enforceable in any court having jurisdiction. Licensor and
Licensee each irrevocably consent and submit to the jurisdiction of the courts
of the Commonwealth of Massachusetts and the United States District Court for
the District of Massachusetts.
Each party shall pay fifty percent (50%) of the mediation or arbitration
filing fees, mediators' or arbitrators' fees and the like, but shall bear its
own attorneys' fees and other costs in such mediation or arbitration.
14.2. Judicial Relief. Claims, disputes, or controversies concerning the
---------------
validity, infringement, construction or effect of any patent including, without
limitation, any patent licensed hereunder, shall be resolved in any court having
jurisdiction thereof, and the parties submit to the jurisdiction of the United
States District Court for the District of Massachusetts. In the event that, in
any mediation or arbitration proceeding, any issue
-24-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
shall arise concerning the validity, infringement, construction, or effect of
any patent licensed hereunder, the mediators or arbitrators shall assume the
validity of all claims as set forth in such patent. In any case, the mediators
or arbitrators shall not delay the mediation or arbitration proceeding for the
purpose of obtaining or permitting either party to obtain judicial resolution of
such an issue, unless an order staying such mediation or arbitration proceeding
shall be entered by a court of competent jurisdiction. Neither party shall raise
any issue concerning the validity, infringement, construction, or effect of any
patent licensed hereunder in any proceeding to enforce any mediation or
arbitration award hereunder in any proceeding otherwise arising out of any such
mediation or arbitration award. Nothing in Section 14.1 shall be construed to
waive any rights or timely performance of any obligations existing under this
Agreement. Moreover, each party acknowledges that appropriate cases (as
determined by the courts of competent jurisdiction) of a violation by either
party of any of the provisions of this Agreement may entitle the other party to
equitable judicial relief, and this relief shall be available in addition to,
and shall not be unavailable by reason of, the mediation or arbitration
provisions of Section 14.1 above. Such equitable judicial relief may be by
temporary restraining orders, preliminary and permanent injunctions, and such
other equitable relief as any court of competent jurisdiction may deem just and
proper.
IN WITNESS WHEREOF, the parties hereto have duly executed and delivered
this Amended and Restated License Agreement under seal to be effective as of the
date hereof.
TUFTS UNIVERSITY POINT THERAPEUTICS, INC.
By: /s/ Xxxxxxxx X. Xxxxxx By: /s/ Xxxxxx X. Xxxxxxx, Xx.
----------------------------------------- ---------------------------
Xxxxxxxx X. Xxxxxx Xxxxxx X. Xxxxxxx, Xx.
Associate Xxxxxxx for Research President and CEO
Date: 1/12/99 Date: 1/12/99
--------------------------------------- -------------------------
NEW ENGLAND MEDICAL CENTER HOSPITALS, INC.
By: /s/ Xxxxx X. Xxxxx
-----------------------------------------
Xxxxx X. Xxxxx
Vice President of Research Administration
Date: 1/12/99
---------------------------------------
-25-
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
EXHIBIT A
TO
AMENDED AND RESTATED LICENSE AGREEMENT
BETWEEN TUFTS AND NEMCH AND POINT THERAPEUTICS, INC.
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
SCHEDULE A-1
MULTIVALENT PATENTS
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
[*]
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
EXHIBIT B
TO
AMENDED AND RESTATED LICENSE AGREEMENT
BETWEEN
TUFTS AND NEMCH AND POINT THERAPEUTICS, INC.
Technology: None.
----------
CONFIDENTIAL TREATMENT REQUESTED
Where the text of this document has been redacted, it has been marked
"[*]". Such redacted portion has been filed separately with the Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Exchange Act of
1934, as amended.
EXHIBIT C
TO
AMENDED AND RESTATED LICENSE AGREEMENT
BETWEEN
TUFTS AND NEMCH AND POINT THERAPEUTICS, INC.
Schedule for Reimbursement for Past Patent Expenses:
----------------------------------------------------
[*]
