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Exhibit 10.30(b)
AMENDMENT NO. 1
TO
LICENSE AND SUPPLY
AGREEMENT
This AMENDMENT NO. 1 TO
LICENSE AND SUPPLY AGREEMENT (this “ Amendment
”) is entered into as of November 19, 2004, by and between
PRONOVA BIOCARE A.S., a corporation incorporated under the laws of
Norway (“ Pronova ”), located at Postboks 420,
Vollsveien 6, NO-1327, Lysaker, Norway, and Reliant
Pharmaceuticals, Inc., a Delaware corporation (“
Reliant ”), located at 110 Allen Road, Liberty Corner,
New Jersey, 07938.
RECITALS
WHEREAS , Reliant and
Pronova are parties to that certain License and Supply Agreement,
dated as of August 9, 2004 (the “ Original Agreement
”); and
WHEREAS , the parties
desire to amend the Original Agreement in the manner set forth
herein.
NOW, THEREFORE , for
good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, Pronova and Reliant hereby agree to
be bound as follows:
1. Definitions .
Capitalized terms used but not defined herein shall have the
respective meanings given to such terms in the Original Agreement,
as amended hereby.
2. Section 1 - Amended
Definitions . The following definitions as contained in
Section 1 of the Original Agreement shall be deleted in
their entirety and replaced with the following:
“1.6 “ API
” means the K85EE active pharmaceutical ingredient with
Specifications set forth in Schedule 1.6 , as more
particularly described in NDA #21-654 and/or NDA #21-853 for
Omacor ® .”
“1.23 “
Product ” means the pharmaceutical product containing
the API and certain excipients described in NDA #21-654 and/or NDA
#21-853 for Omacor ® , including any and all
dosage forms, formulas, strengths and package sizes and types
thereof, whether or not currently marketed, and whether or not sold
on a prescription or over-the-counter (OTC) basis, which is covered
in whole or in part, or is made or used by a process or method
covered in whole or in part, by at least one unexpired issued claim
in the Patents in the Territory or by Product Know-How, in which
any such process, product or part thereof is made, used or
sold.”
“1.26 “
Registrations ” means all regulatory approvals,
filings, applications and similar materials applicable to the
Product or any Additional Product in the Territory, including,
without limitation, any Drug Identification Numbers (“
DINs ”), Investigational New Drug Applications
(“ INDs ”), NDAs, chemistry, manufacturing and
control (“ CMC ”) data, pharmaceutical
development reports, and any reference materials
for API, related substances,
degradation products and intermediates, in each case with all
supplements and amendments thereto, applicable to the Product or
any Additional Product in the Territory, and all documents,
correspondence and other materials related thereto issued or sent
by or to any Governmental Authority including, without limitation,
the Registration filing for the Product as more particularly
described in NDA # 21-654 and/or NDA # 21-853 for Omacor
® .”
3. Section 1 – New
Definition of “Full Regulatory Approval” . The
Original Agreement shall be amended by adding the following new
definition as Section 1.13A :
“1.13A “ Full
Regulatory Approval ” means, with respect to the Product,
the approval or authorization granted by a Regulatory Authority
(FDA) for NDA # 21-853 in the Territory for the initial and ongoing
commercialization of the Product for [***].”
4. Section 3.2 – FDA
Approval of Product Registration . The following sentence shall
be added to the end of Section 3.2 of the Original
Agreement:
“Reliant shall complete
and file the “new owner” requirements as outlined in 21
CFR 314.72, a copy of which is attached hereto as Exhibit
3.2 , within two (2) business days of notification that Abbott
has filed a transfer request for NDA 21-654 with the FDA (as
contemplated by Section 3.7(c) of Amendment No. 1 to the Abbott
Agreement, dated as of November 11, 2004); provided, however
, that nothing herein shall be deemed to create any liability or
other obligation of Reliant or any of its Affiliates to Abbott or
any of its Affiliates under the Abbott Agreement (as amended) or
otherwise.”
In addition, the Original
Agreement shall be amended by adding thereto new Exhibit 3.2
in the form attached hereto as Exhibit A .
5. Section 3.3 –
Additional Development Work for Product . Section 3.3 of
the Original Agreement shall be deleted in its entirety and
replaced with the following:
“3.3 “
Additional Development Work for Product . RELIANT will
contribute to and fund all further development of the Product
(other than development costs otherwise funded by Abbott) relating
to NDA #21-853 in order to [***]; provided , that, RELIANT
shall not be required to fund more than [***] in further
development work under this Section 3.3; provided, further ,
that PRONOVA shall be solely responsible for any expenses with
respect to supply chain or manufacturing issues raised by the FDA.
Upon Full Regulatory Approval, RELIANT will pay to PRONOVA the
final approval payment pursuant to Section 4.1 (as set out
in Schedule 4.1 ), which will be reduced by [***] of all
pre-marketing development out of pocket costs and amounts paid to
unrelated third-parties actually incurred prior to final FDA
approval by or on behalf of RELIANT in accordance with this
Section 3.3 , provided that in no event shall such reduction
reduce the final approval payment below USD 0.”
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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6. Section 4.1 –
Up-Front, Approvable and Final Approval Payments . Section
4.1 of the Original Agreement shall be deleted in its entirety
and replaced with the following:
“4.1 Up Front,
Approvable and Final Approval Payments . In consideration of
the License and other rights granted to RELIANT under this
Agreement, RELIANT shall pay to PRONOVA, in accordance with this
Agreement, payments according to the model set out in Schedule
4.1 attached hereto.”
In addition, Schedule
4.1 to the Original Agreement shall be deleted and replaced in
its entirety with the amended Schedule 4.1 in the form
attached hereto as Exhibit B .
7. Section 5.1 –
Manufacture and Supply . Section 5.1 of the Original
Agreement shall be deleted in its entirety and replaced with the
following:
“5.1 Manufacture and
Supply . Subject to Section 5.12 , PRONOVA shall, after
FDA approval of the Product for the indication HTG under NDA #
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