[Portions of
this Exhibit have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A copy of this Exhibit with all
sections intact has been filed separately with the Securities and
Exchange Commission.]
TERMINATION, RELEASE AND
SETTLEMENT AGREEMENT
This termination, release and settlement
agreement (the “ Agreement ”) is made and
entered into as of this 6th day of August, 2008 (the “
Effective Date ”), between BioSante Pharmaceuticals,
Inc., a Delaware corporation with offices at 111 Barclay Boulevard,
Lincolnshire, Illinois 60069, on its own behalf and on behalf of
its predecessors, successors, assigns, parents, subsidiaries,
affiliates and/or affiliated companies (“ BioSante
”) and Nycomed US Inc., a New York corporation with offices
at 60 Baylis Road, P.O. Box 2006, Melville, NY 11747, on its own
behalf and on behalf of its predecessors, successors, assigns,
parents, subsidiaries, affiliates and/or affiliated companies
(“ Nycomed ”). BioSante and Nycomed
may hereinafter be individually referred to as “Party”
and collectively referred to as the
“Parties”.
RECITALS
WHEREAS, BioSante and Bradley Pharmaceuticals,
Inc. (“ Bradley ”) have entered into an
exclusive sublicense agreement, dated November 7, 2006 (the “
Sublicense Agreement ”), pursuant to which BioSante
has sublicensed certain rights for Elestrin (f/k/a Bio-E-Gel) to
Bradley, as more fully set forth in the Sublicense
Agreement;
WHEREAS, Nycomed acquired Bradley on or about
February 21, 2008 and succeeded to the rights and obligations of
Bradley under the Sublicense Agreement;
WHEREAS, Nycomed no longer wishes to sell
Elestrin and the Parties desire that all rights and licenses
concerning the product be returned and transferred by Nycomed to
BioSante on the terms and conditions set forth in this Agreement;
and
NOW, THEREFORE, in consideration of the mutual
covenants contained herein, and subject to and on the terms and
conditions herein set forth, the Parties hereto hereby agree as
follows:
ARTICLE 1
DEFINITIONS
1.1 Capitalized terms
used herein and not otherwise defined herein shall have the
meanings set forth for such terms in the Sublicense
Agreement.
ARTICLE 2
RETURN OF PRODUCT AND TERMINATION
OF SUBLICENSE
(a) Nycomed
hereby assigns all right, title and interest in and to the NDA for
the Product to BioSante, shall promptly transfer all documentation
related to such NDA in Nycomed’s possession to BioSante, and
agrees to take all further commercially reasonable action and
promptly execute such further documents as may be reasonably
necessary to give full effect to such assignment, including without
limitation, submitting a letter to the FDA requesting transfer of
the NDA to BioSante together with any related documents necessary
to effect such transfer. For the avoidance of doubt, the
foregoing activities by Nycomed shall be rendered without
additional charge to BioSante and are included in the payment being
made pursuant to Section 3.1.
(b) BioSante
shall cooperate with Nycomed, and take all further commercially
reasonable action, promptly comply with all reasonable requests by
Nycomed and promptly execute any documents as may be reasonably
necessary, to give full effect to the foregoing
assignment. In any event, from and after the Effective
Date, BioSante shall be responsible for the payment of all fees and
expenses in connection with the maintenance of the NDA, and in
connection with the foregoing transfer. Once the NDA for
the Product is transferred to BioSante, BioSante shall be
responsible for all obligations, responsibilities and liabilities
with respect to the NDA, and Nycomed’s obligations with
respect to the NDA shall cease, except as specifically provided in
this Agreement.
2.2 Transfer of
Other Information . Nycomed hereby assigns and shall
immediately provide to BioSante any and all material information,
documents, and know-how Nycomed has in its possession that relate
to the Product (including the manufacture, use or sale of the
Product), and any other information and documents in
Nycomed’s possession that BioSante may reasonably request,
and further including all reasonably accessible copies in whatever
form or media; provided, however, that Nycomed may retain one copy
of the foregoing for purposes of complying with its obligations
under this Agreement and the Sublicense
Agreement. Nycomed represents and warrants that Nycomed
(including through its predecessor, Bradley) has not made any
modifications or improvements to the patents and know-how provided
by BioSante relating to the Product. For the avoidance
of doubt, the foregoing activities by Nycomed shall be rendered
without additional charge to BioSante and are included in the
payment being made pursuant to Section 3.1.
2.3 Regulatory
Transition Services by Nycomed .
(a) Nycomed
shall cooperate with BioSante for a reasonable transition period,
not to exceed six (6) months after the Effective Date but no longer
than as provided in Section 4.5, so that BioSante may exercise its
rights under this Agreement and effect a smooth transition of the
Product from Nycomed to BioSante. Such cooperation shall
include the following activities: (i) post FDA Approval regulatory
obligations for the Product, including without limitation, the
preparation of annual reports and reports of adverse events for
submission to the FDA by BioSante, and cooperating with
governmental regulatory agencies regarding the current FDA
Approval; and (ii) investigating all complaints and adverse drug
experiences related to the Product. For the avoidance of
doubt, the services to be provided by Nycomed pursuant to this
Section 2.3(a) shall not include the review of promotional
materials.
(b) BioSante
may request services described in Section 2.3(a) from time to time
during the transition period set forth therein. At the
time of such request, BioSante may also request that Nycomed
provide a non-binding good faith estimate of the time required to
complete the requested services. In the event that
BioSante is not satisfied with the estimate, BioSante may elect to
withdraw its request for such services from Nycomed.
(c) BioSante
shall reimburse Nycomed for all of its out-of-pockets costs and
expenses (including costs paid to third parties for certain of the
foregoing activities) incurred in connection with Nycomed’s
performance of the foregoing activities in this Section
2.3. In addition, BioSante shall pay Nycomed at the rate
of $220 per hour for Nycomed’s time spent on the foregoing
activities. Following the end of each calendar month,
Nycomed shall issue an invoice to BioSante setting forth the time
spent by Nycomed personnel on such matters, and the expenses
incurred in connection with such activities. BioSante
shall pay such invoices within thirty (30) days after receipt of
such invoices.
2.4 Termination of
Sublicense Agreement . As of the Effective Date, and
subject to the terms of this Agreement, the Sublicense Agreement is
hereby terminated by the mutual agreement of BioSante and Nycomed
and is of no further force and effect, and BioSante and Nycomed
shall have no further rights and/or obligations under the
Sublicense Agreement, including without limitation the effect of
termination provisions set forth in Sections 16(f) through (j) of
the Sublicense Agreement, except as specifically provided for
herein. The Parties agree that the effect of the
termination of the Sublicense Agreement shall be as provided in
this Agreement. The performance of all obligations of
Nycomed under this Agreement shall be for and on behalf of
BioSante, unless otherwise specifically
provided. Notwithstanding the foregoing, solely to the
extent necessary for Nycomed to perform its obligations under this
Agreement, BioSante grants Nycomed a limited, non-exclusive,
non-sublicensable, non-transferable license to the patents and
know-how relating to the Product previously licensed to Nycomed
pursuant to the Sublicense Agreement.
2.5 Communications
with FDA . After the Effective Date, Nycomed shall
provide BioSante with copies of all correspondence and documents to
and from the FDA with respect to the Product in its possession, and
all notices received from the FDA related thereto, within three (3)
business days following transmission or receipt from the
FDA. However, after the Effective Date, Nycomed shall
not communicate with the FDA with respect to the
Product. BioSante shall be responsible for all
communications with the FDA with respect to the Product after the
Effective Date.
2.6 Marketing
Materials .
(a) Nycomed
shall, within fifteen (15) days of the Effective Date, provide
BioSante with copies of all materials concerning the marketing,
sale and distribution of the Product in its possession, including
but not limited to, market research performed by or for Nycomed or
Bradley and all customer lists, sales data, and marketing plans for
the Product in order to assist BioSante with a smooth transition of
the Product from Nycomed. BioSante may use, including
transfer, such materials and information, provided however that
BioSante must remove Nycomed’s name from any such materials
and information prior to such use. Nycomed shall have no
further obligations with respect to such materials.
(b) All
of the materials being provided pursuant to Section 2.6(a) are
being provided “AS IS, WHERE IS” and Nycomed expressly
disclaims any representations or warranties of any kind, express or
implied, as to such materials. BioSante shall be solely
responsible for the accuracy of the information contained in the
materials and compliance with all laws, rules and
regulations.
2.7 Third Party
Agreements .
(a) All
managed care contracts, commercial insurance contracts, government
contracts, contracts providing chargebacks, distribution agreements
and manufacturing arrangements concerning the manufacture,
marketing, sale and distribution of the Product to which Nycomed is
a party are identified on Schedule 2.7 .
(b) With
respect to all manufacturing arrangements described on Schedule
2.7 , promptly following the Effective Date, Nycomed shall
notify the other party to such agreements that Nycomed no longer
has rights to the Product and advising that the Product is to be
removed from the list of products covered by such
arrangements. Nycomed shall notify all manufacturers
that BioSante will, from and after the Effective Date, be
responsible for the Product. Nycomed will transfer all
manufacturing agreements, protocols, documentation and samples
relating to the manufacture of the Product in its possession to
BioSante, and will notify all manufacturers that they may share
with BioSante all manufacturing history for the Product, including
but not limited to Product (and samples) manufacturing records and
files, out of spec reports, and stability studies. As of
the Effective Date, BioSante shall be responsible for entering into
any manufacturing agreements, as BioSante deems necessary or
appropriate, for the Product. All on-going work (
e.g. , stability studies) will be continued by BioSante at
its sole option and expense from the Effective Date; Nycomed will
not cause any stability studies or any other ongoing activities
essential to the manufacture or ongoing stability studies of the
Product to be cancelled or delayed. BioSante
acknowledges that activities relating to several development
activities, including but not limited to samples, bottles and
containers for the Product have been suspended by
Nycomed. In the event that BioSante elects to
re-commence any of the foregoing activities, BioSante shall be
responsible for such activities, including without limitation all
costs associated with such activities, following the Effective
Date. Nycomed shall be responsible for the costs
associates with ongoing stability studies for Product and Product
samples through the Effective Date, and BioSante shall be
responsible for such costs following the Effective Date.
(c) With
respect to all managed care contracts, commercial insurance
contracts, contracts providing chargebacks, government contracts
and distribution agreements described on Schedule 2.7 , at
the appropriate time following the Effective Date, which shall be
promptly after BioSante obtains its own NDC code for the Product
pursuant to Section 2.11 and has Product manufactured with
BioSante’s NDC code pursuant to Section 4.2 available for
sale, XXXXXXXXXXXXXXXXXXXXXXXXXXX, Nycomed shall notify the other
party to such contracts, agreements and arrangements that Nycomed
no longer has rights to the Product and advising that the Product
is to be removed from the list of products covered by such
contracts, agreements and arrangements and that from that date
BioSante will supply Product. Following BioSante
obtaining its own NDC code for the Product pursuant to Section
2.11, BioSante shall be responsible for entering into any managed
care contracts, commercial insurance contracts, contracts providing
chargebacks, government contracts, and distribution agreements, as
BioSante deems necessary or appropriate, for the Product containing
its NDC code. [Portions of this Section have been omitted
pursuant to a request for confidentiality under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended. A copy of
this Exhibit with all sections intact has been filed separately
with the Securities and Exchange Commission.]
2.8 Fulfilling
Nycomed Orders . Nycomed shall fulfill all orders
for Product received by it or by Bradley prior to the Effective
Date, and shall pay all royalties and milestones due on Net Sales
thereof in accordance with Section 3 of the Sublicense
Agreement.
2.9 Fulfilling
BioSante Orders . For orders for the Product
received by Bradley or Nycomed after the Effective Date, Nycomed
shall (i) during the period and on the terms and conditions set
forth in Section 4.3, fill such orders on behalf of BioSante, and
(ii) after such period, refer any orders for the Product to
BioSante. For the avoidance of doubt, all sales made pursuant to
this Section 2.9 are on behalf of BioSante, and no royalties shall
be due on Net Sales thereof pursuant to the Sublicense
Agreement.
2.10 Non-compete
. With the exception of filling orders pursuant to
Section 2.8 or filling orders pursuant to Sections 2.9(i) and 4.3
on behalf of BioSante, Nycomed and its Affiliates shall not market
or sell any low-dose topical estrogen gel product(s) for the
treatment of menopausal hot flashes for a period of twelve (12)
months from the Effective Date.
2.11 BioSante
Obligations . Promptly following the Effective Date,
BioSante shall take all actions reasonably necessary to obtain, as
soon as practicable XXXXXXXXXXXXXXXXX, its own NDC
