TERMINATION, RELEASE AND SETTLEMENT AGREEMENT
[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.]
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 ▇▇▇
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, 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 ▇▇ ▇▇▇▇▇▇ ▇▇▇▇, ▇.▇. ▇▇▇ ▇▇▇▇,
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, 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 ▇▇▇▇▇▇▇ Pharmaceuticals, Inc. (“▇▇▇▇▇▇▇”) 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 ▇▇▇▇▇▇▇, as more fully set forth in the Sublicense
Agreement;
WHEREAS,
Nycomed acquired ▇▇▇▇▇▇▇ on or about February 21, 2008 and succeeded to the
rights and obligations of ▇▇▇▇▇▇▇ 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
2.1 Transfer of
NDA.
(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, ▇▇▇▇▇▇▇) 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇ 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 code for the Product and enter into any managed
care contracts, commercial insurance contracts, contracts providing chargebacks
(if any), government contracts (including Medicare/Medicaid), and distribution
agreements concerning the marketing, sale and distribution of the Product under
BioSante’s NDC code, once such Product is manufactured with BioSante’s NDC code
pursuant to Section 4.2 and available for sale, as BioSante deems necessary or
appropriate, for the Product containing BioSante’s 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.]
2.12 Recalls. Nycomed
shall remain responsible for any involuntary or voluntary recalls of Product
sold by ▇▇▇▇▇▇▇ or Nycomed under the Sublicense Agreement or pursuant to Section
2.8 above; provided that Nycomed shall have full control, in its sole
discretion, over the handling of any such recalls. For the avoidance
of doubt, BioSante shall be solely responsible for the cost of conducting: (i)
any recalls made in the discretion of BioSante, or (ii) any recalls covered by
BioSante’s indemnification obligations under the Sublicense
Agreement.
2.13 Product
Returns.
(a) Nycomed
shall remain responsible for any returns of Product sold by ▇▇▇▇▇▇▇ or Nycomed
under the Sublicense Agreement or pursuant to Section 2.8 above; provided that
all such returns handled by BioSante are (i) in the ordinary course of business,
and (ii) in compliance with Nycomed’s return policy, a copy of which is attached
as Schedule
2.13. In the event of any such returns, BioSante shall refund
to Nycomed any royalty payment made by Nycomed to BioSante under the Sublicense
Agreement for such quantity of returned Product.
(b) BioSante
shall be responsible (including financially) for any returns of Product sold by
or on behalf of BioSante pursuant to Section 2.9, including Products containing
Nycomed’s NDC code; provided that the parties acknowledge that Nycomed will
handle returns processing of all such Products on behalf of BioSante pursuant to
Section 4.3 and for any returned Products containing Nycomed’s NDC
code. In the event that any Product sold by or on behalf of BioSante
pursuant to Section 2.9 containing Nycomed’s NDC code is returned, and the price
at which such Product was sold is higher than Nycomed’s WAC in effect
immediately prior to the Effective Date, then BioSante shall reimburse Nycomed
for the difference between (i) the amount of the credit to be provided for such
returned Product, and (ii) such Nycomed WAC less 10%.
2.14 Chargebacks and
Rebates.
(a) Nycomed
shall be responsible for all chargebacks under those contracts identified as
contracts providing chargebacks on Schedule 2.7 through
the end of the first full calendar quarter following the Effective
Date. Thereafter, BioSante shall be responsible for all such
chargebacks for all Products; provided, however, in the event that BioSante
enters into any contracts with third parties that provide for chargebacks in
connection with the Product containing BioSante’s NDC code, BioSante shall be
responsible for all such chargebacks on such Products, even during the foregoing
period.
(b) Nycomed
shall be responsible for all rebates, credits and adjustments under any managed
care or other commercial insurance contracts or government contracts (including
Medicare/Medicaid) through the end of the first full calendar quarter following
the Effective Date. Thereafter, BioSante shall be responsible for all
such rebates, credits and adjustments for all Products.
(c) Commencing
after the end of the first full calendar quarter following the Effective Date
(e.g., on
January 1, 2009), the parties acknowledge that Nycomed will continue to receive
invoices for chargebacks, rebates, credits and adjustments described in Sections
2.14(a) and (b) with respect to Products containing Nycomed’s NDC
code. Nycomed shall pay such invoices received on or after such date,
but BioSante shall reimburse Nycomed for any such amounts. Nycomed
shall send a copy of such invoices to BioSante and BioSante shall make such
payment to Nycomed within thirty (30) days after receipt of such
invoices.
2.15 Confidentiality. The
confidentiality provisions of Section 9 of the Sublicense Agreement shall
survive for a period of five (5) years from the Effective Date and are hereby
incorporated into this Agreement.
2.16 Compliance with Governmental
Obligations. The compliance with governmental obligations
provisions of Section 12 of the Sublicense Agreement shall survive the
termination of the Sublicense Agreement and are hereby incorporated into this
Agreement.
2.17 Indemnity and
Insurance. The indemnity and insurance provisions of Section
13 of the Sublicense Agreement shall survive the termination of the Sublicense
Agreement for a period of five (5) years from the Effective Date.
2.18 Liability for
Debts. BioSante shall not be liable for any debts or
obligations to third parties incurred by ▇▇▇▇▇▇▇ or Nycomed concerning the
Product or otherwise in connection with activities under the Sublicense
Agreement. Nycomed shall not create or purport to create any
obligations in the name of or on behalf of BioSante.
ARTICLE
3
PAYMENT
3.1 Initial
Payment. BioSante shall pay Nycomed $100,000 within five (5)
business days after the Effective Date.
3.2 Additional
Payment. BioSante shall make an additional, one-time-only
payment to Nycomed if, prior to January 1, 2010, BioSante (i) grants to a third
party a sublicense or distribution rights for the Product in the Territory, or
(ii) transfers or assigns all or substantially all of the rights to the Product
in the Territory to a third party, or (iii) is acquired through merger,
acquisition or combination by a third party, or (iv) achieves cumulative net
sales of Product in the Territory, commencing as of the Effective Date,
exceeding $1,500,000. The amount of the payment shall be
$150,000. Upon the occurrence of any of the foregoing events,
BioSante shall promptly give notice of such event to Nycomed and shall make such
payment to Nycomed within fifteen (15) days after the occurrence of such
event. If none of the foregoing events occurs prior to January 1,
2010, then the obligation under this Section 3.2 shall be extinguished and no
such additional payment shall be required.
ARTICLE
4
INVENTORY AND WAREHOUSING OF
PRODUCT
4.1 Inventory.
(a) XXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX. [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.]
(b) XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX [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.]
(c) As
of the Effective Date, Nycomed shall transfer any rights, title or interest it
may have with respect to any empty bottles, caps, special machinery or upgrades
specifically for the Product located at the manufacturer, and any product
currently on stability; to BioSante, in each case on as “AS IS; WHERE IS”
basis.
4.2 BioSante NDC
Code. As of the Effective Date, BioSante shall be solely
responsible for manufacturing, or having manufactured, the Product, under
BioSante’s NDC code, for the fulfillment of all orders for Product pursuant to
Section 2.9. BioSante acknowledges that Nycomed will not fill orders
with Product containing Nycomed’s NDC code after XXXXXXXXXX. [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.]
4.3 Warehousing
Services.
(a) Nycomed
shall store the Product to be retained pursuant to Section 4.1(a) and any
Product that is released for commercial sale pursuant to Section 4.1(b) in its
warehouse facilities on behalf of BioSante for a reasonable transition period,
until BioSante has Product containing BioSante’s NDC code available for shipment
pursuant to Section 4.2, but in any event not later than June 30,
2009 or such sooner date pursuant to Section 4.5, so that
BioSante may exercise its rights under this Agreement and effect a smooth
transition of the distribution of the Product from Nycomed to
BioSante.
(b) During
the period described in Section 4.3(a), Nycomed shall handle the inventory,
returns processing, billing, receivable collections, and shipping of any orders
for Product as may be (i) received by ▇▇▇▇▇▇▇ or Nycomed, or (ii) requested by
BioSante, in both cases acting on behalf of BioSante. Nycomed shall
also provide customer service support on behalf of BioSante with respect to such
Product. In addition, Nycomed shall provide BioSante with monthly written
reports reporting all orders, shipments, returns, accounts receivable, and
collections or receipts. Except with respect to government contracts
for the supply of Product where pricing has already been established, the
selling price for Product during this period shall be determined by
BioSante. In the event that BioSante changes the selling price of the
Product during the period that Nycomed is providing warehousing services
pursuant to this Section 4.3, BioSante shall prepare the communication to
customers regarding such price change, and Nycomed shall be responsible for
sending such communication to such customers on behalf of
BioSante. All services provided pursuant to this Section 4.3 shall be
provided by Nycomed in a manner consistent with Nycomed’s normal practice and
course of business with which Nycomed provides such services for its other
products.
(c) Payments
for Product received by ▇▇▇▇▇▇▇ or Nycomed pursuant to Nycomed’s activities
under this section shall be held in trust for BioSante and paid over to BioSante
monthly, less: (i) any portion of such payments for other charges for third
party costs such as shipping, insurance, taxes, customs, duties and similar
charges that Nycomed actually incurs, whether or not reflected on the invoice to
customers, and (ii) any cost of Product to be reimbursed to Nycomed pursuant to
Section 4.1(b) for Product shipped in the prior month. For providing
the services specified in this section, BioSante shall pay Nycomed an
administrative handling fee of XXXXXXXXXX (X%) of the net selling price shown on
the invoices for sales of Product during the preceding month that Nycomed ships
on behalf of BioSante pursuant to this section, which Nycomed may deduct from
its payments to BioSante under this section. [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.]
(d) For
the avoidance of doubt: (i) Nycomed shall not be responsible for any services
whatsoever with respect to Product samples; and (ii) Nycomed shall not provide
any warehousing services under this Section 4.3 for any Product that BioSante
has manufactured pursuant to Section 4.2.
4.4 Insurance. Nycomed
shall maintain, for a period of one (1) year after the Effective Date,
comprehensive products liability insurance with reputable and financially secure
insurance carriers (but in no event less than rated A by AM Best) to cover its
activities related to the Product under this Agreement, for minimum limits of
$XXXXXXXXX combined single limit for bodily injury and property damage per
occurrence and in the aggregate. Such insurance shall include
BioSante as an additional named insured. Such insurance shall be
written to cover claims incurred, discovered, manifested, or made during or
within three (3) years after the Effective Date. [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.]
4.5 Early Termination of
Services. In the event that BioSante (i) grants to a third
party a sublicense or distribution rights for the Product in the Territory, or
(ii) transfers or assigns all or substantially all of the rights to the Product
in the Territory to a third party, or (iii) is acquired through merger,
acquisition or combination by a third party; BioSante shall notify Nycomed
within two business days of the execution of any agreement with respect to the
foregoing, and Nycomed’s obligations under Sections 2.3 and 4.3 shall terminate
sixty (60) days after the effective date or closing date of such agreement, as
applicable, (unless such obligations sooner terminate as provided in such
agreement or pursuant to Section 4.3).
4.6 BioSante Ongoing
Obligations. From and after the Effective Date, BioSante shall
be responsible for all obligations, responsibilities and liabilities in
connection with all matters pertaining to the Product, except as explicitly set
forth in this Agreement, including without limitation all obligations for any
on-going development and manufacturing activities.
ARTICLE
5
RELEASE OF
CLAIMS
5.1 Except as
specifically provided for in this Agreement, the Parties hereby unconditionally,
absolutely and irrevocably waive, release and forever discharge the other from
any and all, past, present or future causes of action, suits, dues, sums of
money, accounts, covenants, controversies, guarantees, promises, damages,
judgments, executions, rights, obligations, liabilities, defenses, rights of
set-off, claims for damages or specific performance, or claims or counterclaims
or demands of any nature whatsoever, at law or in equity, known or unknown,
fixed or contingent, which they may have or hereafter may acquire against the
other by reason of, arising out of, or related to any act or omission under the
Sublicense Agreement. For clarification, the Parties do not release
any obligations they may have to each other under provisions that survive the
termination of the Sublicense Agreement, including but not limited to the
confidentiality and indemnification provisions of the Sublicense
Agreement.
ARTICLE
6
MISCELLANEOUS
6.1 Reports and
Payments. Any payments due to BioSante under this Agreement
shall be made in accordance with Section 4 of the Sublicense Agreement and the
provisions of Section 4 of the Sublicense Agreement, including, but not limited
to the inspection and audit provisions.
6.2 Notices. Any
notice required or permitted to be given under this Agreement shall be
sufficient if sent by certified mail (return receipt requested) or express
courier, postage pre-paid, to the attention of the Chief Executive Officer of
the respective company at the address set forth above or to such other address
as a Party may specify by notice hereunder.
6.3 Assignment. This
Agreement and any of its respective rights and obligations shall be freely
assignable by BioSante, but shall only be assignable by Nycomed in connection
with a merger or acquisition of Nycomed US Inc.. This Agreement shall
be enforceable against and inure to the benefit of the permissible successors
and assigns of BioSante, and shall be enforceable against and inure to the
benefit of the permissible successors and assigns of Nycomed.
6.4 Non-Waiver and
Entirety. Any failure of either Party to enforce any
obligations under this Agreement shall not be deemed a waiver of such
obligations. This Agreement constitutes the entire agreement and
understanding of the Parties and supersedes all previous communication between
the Parties.
6.5 Governing
Law. This Agreement is governed by and construed in all
respects in accordance with the laws of the State of Illinois, USA and the
United States of America (without regard to conflicts of laws principles),
excluding the United Nations Convention on Contracts for the International Sale
of Goods.
6.6 Dispute
Resolution.
6.6.1 Conciliation. The
parties wish first to seek an amicable settlement of all disputes, controversies
or claims arising out of or relating to this Agreement by conciliation in
accordance with the UNCITRAL Conciliation Rules now in force. If
assistance is needed in connection with the appointment of a conciliator or
other administrative matters, JAMS Endispute, Inc., shall be the institution to
render such assistance. The language to be used in the conciliation
proceedings shall be English.
6.6.2 Arbitration. Subject
to possible court proceedings under section 6.6.4 of this Agreement, if any
conciliation proceedings under section 6.6.1 of this Agreement are
terminated in accordance with Article 15 of the UNCITRAL Conciliation Rules or
rejected in accordance with Article 2 of those Rules, without resolution of the
disputes, controversies or claims, then all said disputes, controversies or
claims shall be determined by arbitration in accordance with the UNCITRAL
Arbitration Rules now in force, as supplemented by the IBA Rules on the Taking
of Evidence in International Commercial Arbitration, as adopted June 1, 1999,
insofar as said IBA Rules are not inconsistent with the express provisions of
this Agreement. The language to be used in the arbitral proceedings
shall be English. There shall be three (3) arbitrators, and the
appointing authority shall be JAMS Endispute, Inc. In rendering the
award, the arbitrator shall follow and apply the substantive laws of the State
of Illinois (without regard to conflict or choice of laws
principles). The arbitrator shall have the authority to award
compensatory damages only, subject to the limitations described in this
Agreement. Each Party shall pay the fees of its own attorneys,
expenses of witnesses and all other expenses and costs in connection with the
presentation of such party’s case (collectively, “Attorneys’
Fees”). The remaining cost of the arbitration, including
without limitation, fees of the arbitrator, costs of records or transcripts and
administrative fees (collectively, “Arbitration Costs”) shall be
borne equally by the Parties. Notwithstanding the foregoing, the
arbitrator in the award may apportion said Attorneys’ Fees and Arbitration Costs
pursuant to Articles 38 through 40 of the UNCITRAL Arbitration
Rules. The award rendered by the arbitrator shall be final, and
judgment may be entered in accordance with the applicable law by any court
having jurisdiction thereof.
6.6.3 Confidentiality. The
existence and resolution of any conciliation and/or arbitration shall be kept
confidential, and the Parties, the conciliator and the arbitrator shall not
disclose to any person any information about such arbitration.
6.6.4 Court
Proceedings. Section 6.6.2 of this Agreement shall not be
construed to prevent either Party from seeking injunctive relief against the
other Party from any judicial or administrative authority of competent
jurisdiction to enjoin that party from breaching this Agreement or interim
relief pending the resolution of a dispute by arbitration, pursuant to said
section 6.6.2. Any action to confirm an arbitration award or any
other legal action related to this Agreement between the Parties may be
instituted in any court of competent jurisdiction. BioSante and
Nycomed each waive their right to a trial by jury in any such court
proceedings.
6.6.5 Location. The
conciliation and arbitration shall be conducted in New York, New York, unless
the dispute also involves a dispute with respect to the Product between BioSante
and Antares pursuant to an agreement between BioSante and Antares, in which case
they shall be conducted in Chicago, Illinois.
6.7 Severability. Each
Party hereby acknowledges that it does not intend to violate any public policy,
statutory or common laws, rules, regulations, treaty or decision of any
government agency or executive body thereof of any country or community or
association of countries. Should one or more provisions of this
Agreement be or become invalid, the Parties agree that it is their intent that
the remainder of the Agreement shall continue in effect, and shall substitute,
by mutual consent, valid provisions for such invalid provisions which valid
provisions in their economic effect are sufficiently similar to the invalid
provisions that it can be reasonably assumed that the Parties would have entered
into this Agreement with such valid provisions.
6.8 Headings. Section headings
contained in this Agreement are for convenience of reference only and shall not
in any way affect the interpretation of this Agreement.
6.9 Further
Assurances. Each Party agrees to take or cause to be taken
such further actions, and to execute, deliver and file or cause to be executed,
delivered and filed such further documents and instruments, and to obtain such
consents, as may be reasonably required or requested in order to effectuate
fully the purposes, terms and conditions of this Agreement.
6.10 Execution. This
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original, but all of which together shall constitute one and the same
instrument.
* * * * *
IN
WITNESS THEREOF, BioSante and Nycomed have caused this Agreement to be executed
by their duly authorized representatives as of the Effective Date.
BIOSANTE
PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇.
▇▇▇▇▇
▇▇▇▇▇▇▇
▇. ▇▇▇▇▇
Chief
Executive Officer and President
NYCOMED
US INC.
By: ▇▇▇▇ ▇.
▇▇▇▇▇▇▇
▇▇▇▇ ▇.
▇▇▇▇▇▇▇
Chief
Executive Officer