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Exhibit 10.5
Confidential Materials omitted and filed
separately with the
Securities and Exchange Commission.
Asterisks denote omissions.
FIFTH AMENDMENT TO THE NOVEMBER 1, 2002
LICENSE
This Fifth Amendment, effective as of the date set forth above
the signatures of the parties below, pertains to the Amended and
Restated Exclusive Patent License Agreement, effective on November
1, 2002, as subsequently amended by a First Amendment on November
15, 2002, a Letter Agreement on September 12, 2003, a Letter
Agreement on October 22, 2003, a Second Amendment on November 19,
2003, a Third Amendment on April 2, 2004, and a Fourth Amendment on
July 17, 2004, by and between the Massachusetts Institute of
Technology ("M.I.T.") and Momenta Pharmaceuticals, Inc.
("COMPANY’)
WHEREAS, COMPANY possesses certain non-exclusive rights and
desires to obtain certain exclusive rights to M.I.T. Case No. 6582,
"A Method for the Mass Spectrometric Determination of the Molecular
Weight of Highly Acidic (and Basic) Organic and Biological
Molecules," by Klaus Biemann and Peter Juhasz; and
WHEREAS. M.I.T. is willing to grant such rights to COMPANY;
NOW, THEREFORE, M.I.T. and COMPANY hereby agree to modify the
Amended and Restated Exclusive Patent License Agreement as
follows:
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1.
The following definitions shall be added to Section
1:
" ANDA " shall mean a United States abbreviated new drug
application, or any successor form or foreign equivalent.
" ANTICOAGULANT PRODUCT " shall mean any product that
prevents, hinders or slows the clotting of blood, including, but
not limited to, unfractionated heparins, low molecular weight
heparins and ultra-low molecular weight heparins.
" BLA " shall mean a United States new biologics
application, or any successor form or foreign equivalent.
" ENOXAPARIN PRODUCT " shall mean a generic version of
Lovenox®.
" FIELD ANTICOAGULANT " shall mean (a) use in the
discovery, characterization and development of ANTICOAGULANT
PRODUCTS and (b) the pre-clinical and clinical testing, regulatory
filing and approval, use, manufacture, quality control, commercial
release specification, distribution and sale of ANTICOAGULANT
PRODUCTS.
"GENERIC ANTICOAGULANT PRODUCT" shall mean a generic
version of a particular branded ANTICOAGULANT PRODUCT.
"INNOVATIVE ANTICOAGULANT PRODUCT"
shall mean a new chemical entity marketed as a branded
ANTICOAGULANT PRODUCT.
" MARKETING APPROVAL FILING " shall mean an ANDA, BLA,
NDA or SNDA.
" SNDA " shall mean a United States supplementary new
drug application, or any successor form or foreign equivalent.
"TERRITORY" shall mean the world.
2.
The last sentence of Section 2.1, as amended, shall
be modified to read as follows:
Upon COMPANY’s exercise of such right, the Appendix of
this Agreement that describes the PATENT RIGHTS that dominate the
IMPROVEMENT shall be deemed to have been amended to add the
invention disclosure (and any related patent applications) covering
such IMPROVEMENT, and such IMPROVEMENT and any resulting patent
applications and patents shall thereafter be included in PATENT
RIGHTS for all purposes of this Agreement, without any additional
fee, other than the one Ten Thousand Dollar fee referred to in the
previous sentence, and M.I.T. shall provide COMPANY with an updated
Appendix C, D, E or H for its records.
3.
Section 2.2, as amended, shall be modified to read
as follows:
Exclusivity . In order to establish an exclusive
period for COMPANY and its AFFILIATES, M.I.T. agrees that it shall
not grant any other license for
(a) PATENT RIGHTS HEPARIN in FIELD ALL BUT MACHINES, (b)
PATENT RIGHTS HEPARINASE in FIELD MANUFACTURING, (c) PATENT
RIGHTS ENZYMES IN FIELD ENZYMES, but specifically excluding FIELD
RESEARCH REAGENTS, and (d) PATENT RIGHTS MASSPEC in FIELD
ANTICOAGULANT, in each case to develop, make, have made, use, sell,
offer to sell, lease and import LICENSED PRODUCTS or to develop and
perform LICENSED PROCESSES during the TERM.
4.
Section 2.5(a) shall be modified to read as
follows:
M.I.T. M.I.T. retains the right to practice under
the PATENT RIGHTS for research, teaching, and educational
purposes. In addition, in accordance with the NIH Guidelines
for Patenting of Research Tools, M.I.T. retains the right to grant
to not-for-profit institutions, nonexclusive, non-transferable
licenses under the PATENT RIGHTS HEPARIN and PATENT RIGHTS MASSPEC
for use as research tools and for research purposes only,
specifically not including manufacturing, quality assurance,
quality control, and clinical
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testing of commercial products or
characterization of a marketed product for commercial
purposes.
5.
Section 7.2(a), as amended, shall be modified to
read as follows:
COMPANY Right to Prosecute PATENT RIGHTS in Exclusive
Fields . So long as COMPANY remains the exclusive
licensee of PATENT RIGHTS HEPARIN in FIELD ALL BUT MACHINES,
COMPANY, to the extent permitted by law, shall have the right,
under its own control and at its own expense, to prosecute any
third party infringement of PATENT RIGHTS HEPARIN in FIELD ALL BUT
MACHINES, subject to Sections 7.4 and 7.5. So long as COMPANY
remains the exclusive licensee of PATENT RIGHTS HEPARINASE in FIELD
MANUFACTURING, COMPANY, to the extent permitted by law, shall have
the right, under its own control and at its own expense, to
prosecute any third party infringement of PATENT RIGHTS HEPARINASE
in FIELD MANUFACTURING, subject to Sections 7.4 and 7.5. So
long as COMPANY remains the exclusive licensee of PATENT RIGHTS
ENZYMES in FIELD ENZYMES excluding FIELD RESEARCH REAGENTS,
COMPANY, to the extent permitted by law, shall have the right,
under its own control and at its own expense, to prosecute any
third party infringement of PATENT RIGHTS ENZYMES in FIELD ENZYMES
excluding FIELD RESEARCH REAGENTS, subject to Sections 7.4 and
7.5. Lastly, so long as COMPANY remains the exclusive
licensee of PATENT RIGHTS MASSPEC in FIELD ANTICOAGULANT, COMPANY,
to the extent permitted by law, shall have the right, under its own
control and at its own expense, to prosecute any third party
infringement of PATENT RIGHTS MASSPEC in FIELD ANTICOAGULANT,
subject to Sections 7.4 and 7.5. If required by law, M.I.T.
shall permit any action under this Section to be brought in
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