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LICENSE AGREEMENT
This License Agreement ("Agreement") is by and between Mead Johnson &
Company ("Licensor"), having a place of business at 2404 Pennsylvania Street,
Evansville, IN 47721, Bristol-Myers Squibb Company ("BMS"), having a place of
business at 345 Park Avenue, New York, NY 10154, and Par Pharmaceutical, Inc.
("Licensee"), having a place of business at One Ram Ridge Road, Spring Valley,
New York 10977.
WHEREAS, Licensor is the owner of the registered trademark MEGACE in the
United States;
WHEREAS, Licensee acknowledges and agrees that Licensor has developed a
certain goodwill in the MEGACE trademark as indicating origin and a very high
degree of quality of goods manufactured, promoted and sold by Licensor in the
United States under and in relation to the MEGACE trademark;
WHEREAS, it is the desire and intention of the parties that Licensee be
permitted to use the MEGACE trademark in the United States and its possessions
and territories solely in connection with the packaging, promotion and sale of a
certain nanodispersion formulation of megestrol acetate currently being
developed by Licensee; and
WHEREAS, BMS is willing to engage in certain promotional activities with
respect to its MEGACE oral suspension product.
NOW THEREFORE, in consideration of the above and other valuable
consideration, the parties hereto agree as follows:
1. DEFINITIONS
1.1 "Affiliate" means any corporation or other entity which controls, is
controlled by, or is under common control with a party to this Agreement. A
corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or directly or indirectly controls fifty
percent (50%) or more of the voting stock or other ownership interest of the
other corporation or entity, or if it possesses, directly or indirectly, the
power to direct or cause the direction of the management and policies of the
corporation or other entity or the power to elect or appoint fifty percent (50%)
or more of the members of the governing body of the corporation or other entity.
1.2 "BMS Product" means the oral suspension formulation of megestrol
acetate being marketed and sold under the Licensed Trademark by BMS in the
Territory as of the Effective Date.
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1.3 "Confidential Information" means and includes, without limitation,
information and data of the disclosing party supplied to the receiving party,
whether communicated in writing or orally or by other means, in connection with
this Agreement, and which is designated confidential by the disclosing party at
the time of disclosure, and if disclosed or obtained orally or visually (or
otherwise in a non-written form), such information is described or summarized in
a writing or other tangible form and identified as confidential to the receiving
party within thirty (30) days of such disclosure. The terms, but not the
existence of this Agreement, shall be considered Confidential Information of
each party.
1.4 "Effective Date" means the date this Agreement is last signed by a
party to this Agreement.
1.5 "FDA" means the United States Food and Drug Administration.
1.6 "First Commercial Sale" means the first sale for use or consumption by
the public of Product (as defined below) in the Territory (as defined below)
after all required approvals to market and sell Product have been granted by the
FDA.
1.7 "Licensed Trademark" means MEGACE, U.S. Registration No. 834996.
1.8 "NDA" means a new drug application filed with the FDA.
1.9 "Net Sales" means the gross invoiced price at which Product is sold by
Licensee in an arms-length, unbundled transaction to an unaffiliated third
party, less (a) any sales tax, (b) any cash discount allowed and actually taken
by Licensee's customer and (c) any allowance to Licensee's customer for returned
or rejected Product, provided that such allowances relate to sales which were
previously included in royalty calculations under this Agreement, (d) payments
or rebates incurred pursuant to federal, state, and local government assistance
programs, such as Medicare or Medicaid programs, whether in existence now or
enacted at any time hereafter, (e) customer rebates paid, (f) chargebacks paid
on the sale or resale of Product, and (g) trade and quantity discounts given.
The aforementioned deductions shall be the only deductions from the invoice
price allowed for purposes of computing royalties under this Agreement. These
amounts are to be determined on an accrual basis in accordance with accounting
principles generally accepted in the United States.
1.10 "Product" means an oral suspension formulation of megestrol acetate
that is currently being developed by Licensee and that is manufactured using the
proprietary nanodispersion technology of Elan Corporation known as
NanoCrystal(R) Technology or similar technology.
1.11 "Territory" means the United States and its possessions and
territories.
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2. LICENSE GRANT
2.1 Licensor hereby grants to Licensee, and Licensee accepts, an
exclusive, non-assignable (except as provided in Article 16), non-sublicensable
right and license to use the Licensed Trademark in the Territory solely in
connection with the packaging, promotion, and sale of the Product during the
term of this Agreement, subject to the right of Licensor and its Affiliates,
including but not limited to BMS, to manufacture, market, promote and sell any
and all of Licensor's own current or future products and any and all of its
Affiliates' current or future products containing megestrol acetate under the
Licensed Trademark, including but not limited to the BMS Product, which right
shall not be transferable or assignable to any third party except as provided in
Article 16. For purposes of clarity Par shall have the right to sell the Product
under the Licensed Trademark through its normal distribution methods by selling
the Product to wholesalers, distributors, retail chains and the like, who will
then resell the Product bearing the Licensed Trademark.
2.2 It is expressly understood and agreed by Licensee that no right
whatsoever to grant any sublicense to use the Licensed Trademark is granted
hereunder, and that no further right to the Licensed Trademark is granted
hereunder except as specifically set forth herein.
3. OBLIGATIONS OF LICENSEE
3.1 Licensee shall use the Licensed Trademark in connection with the sale
of the Product. Such use shall comply with the standards, specifications,
instructions and directions approved by Licensor in writing.
3.2 In the event that Licensee wants to change the standards,
specifications, instructions and directions approved by Licensor, Licensee shall
not implement any such change before the expiration of forty-five (45) days from
the date Licensee gives written notice to Licensor of the desired change. In the
absence of formal written refusal notified by Licensor to Licensee within such
forty-five (45) day period, Licensor will be considered as having authorized
such changes. In the event of formal written refusal, and if Licensee still
wishes to implement such change in the Product, this Agreement may be terminated
by Licensor subject to a notice period of three months, during which period such
change shall be withheld.
3.3 Licensee undertakes to comply with all laws pertaining to trademarks
in force at any time in the Territory including, but not limited to, compliance
with marking requirements and shall indicate on all labeling, packaging or
printed material that the Licensed Trademark is registered, is owned by Licensor
and is licensed from Licensor.
3.4 Licensee will permit Licensor or one or more duly authorized
representatives or agents of Licensor to inspect, examine and test the Product,
on the premises of Licensee at all reasonable times, and to inspect the offices,
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plants, equipment, facilities, and materials of Licensee which relate to the
Licensee's use of the Licensed Trademark. Licensee shall, upon request of
Licensor, submit without cost to Licensor or its duly authorized representative
or agent samples of the Product which it sells or intends to sell under the
Licensed Trademark for the purpose of ascertaining compliance with the
provisions of this Agreement.
3.5 Licensee agrees that the Product shall be of a very high standard and
quality so as to protect and enhance the prestige of the Licensed Trademark and
the goodwill pertaining thereto. Licensor shall advise Licensee of each and
every discrepancy in such very high degree of quality or in the adherence to the
standards, specifications, instructions and directions approved by Licensor,
whereupon Licensee shall promptly arrange to the satisfaction of Licensor for
correction of each and every such discrepancy.
3.6 Consistent with the terms hereof, Licensee agrees to use commercially
reasonable efforts to promote a very high level of good reputation of the
Licensed Trademark in connection with the manufacture, promotion and sale of the
Product.
3.7 Licensee shall also use commercially reasonable efforts to obtain FDA
approval for the Product and to commercialize the Product in the Territory.
Licensee shall provide BMS with quarterly written updates on the progress
Licensee is making with respect to obtaining FDA approval for the Product *****.
3.8 Failure to abide by the quality control provisions in this Agreement
constitutes a material breach of this Agreement.
4. OBLIGATIONS OF BMS AND CO-PROMOTION OPTION
4.1 For the purpose of building the brand equity and goodwill of the
Licensed Trademark, BMS shall provide those promotional activities set forth in
Attachment A for the BMS Product during 2003 and 2004. Such promotional
activities shall be completed prior to January 1, 2005. Licensee shall reimburse
BMS for BMS' external costs and expenses incurred in carrying out these
promotional activities and its internal costs and expenses incurred in carrying
out the ***** described in Attachment A, up to a total of $2,000,000.00. BMS
shall send Licensee quarterly invoices for any such costs and expenses
(including any sales/use taxes imposed on BMS for promotional materials)
incurred in carrying out the promotional activities set forth in Attachment A,
and Licensee shall pay each invoice within thirty (30) days of receipt of each
invoice. At the end of each calendar quarter, BMS shall provide Licensee with a
written quarterly update on the promotional activities carried out by BMS in
that calendar quarter and the promotional activities BMS contemplates carrying
out in the upcoming calendar quarter. The amount of each promotional activity
set forth in Attachment A that is carried out by BMS shall be within the sole
discretion of BMS, and BMS may even eliminate a particular type of promotional
activity if BMS determines that that particular promotional activity is not
effective in building the brand equity and goodwill of the Licensed Trademark or
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is less effective than other promotional activities; provided, however, BMS
agrees that it will act in good faith in making such decisions and will promote
the BMS Product in a fashion consistent with the terms and spirit of this
Agreement. For the avoidance of doubt, BMS shall not be required to incur more
than a total of $2,000,000.00 in internal and external costs and expenses in
carrying out the promotional activities to be provided under this Section 4.1,
with such costs and expenses being comprised of the external costs and expenses
incurred in carrying out the promotional activities and the internal costs and
expenses incurred in carrying out the ***** described in Attachment A. For the
further avoidance of doubt, Licensee will not participate in the promotional
activities to be provided under this Section 4.1. It is contemplated that
Licensor will assist BMS in carrying out the ***** described in Attachment A. In
that case, the internal and external costs and expenses incurred by Licensor in
carrying out all or part of the ***** will be included in the quarterly invoices
sent by BMS under this Section 4.1 and will be paid by Licensee.
4.2 *****. For the avoidance of doubt, BMS shall be free to determine, in
its sole discretion, whether or not to pursue any patent infringement lawsuit
against any third party that files an abbreviated new drug application (ANDA) in
the Territory against BMS' NDA for the BMS Product or markets in the Territory a
product containing a suspension of megestrol acetate.
4.3 BMS shall have the option of co-promoting the Product in the
Territory, but excluding the territories and possessions of the United States.
BMS shall have ninety (90) days from the date Licensee notifies BMS in writing
of the filing date of the NDA for the Product to exercise its option. BMS shall
notify Licensee in writing that BMS wants to exercise its option to co-promote
the Product, whereupon BMS and Licensee shall negotiate the terms and conditions
of the co-promotion in good faith and enter into an agreement to co-promote the
Product.
5. RESTRICTIONS ON USE
5.1 Licensee acknowledges and agrees that:
(a) Licensee will make no use of and will not seek to register the
Licensed Trademark except as permitted by this Agreement, and Licensee will make
no use of or seek to register any other mark which, in whole or in part, either
substantially resembles or is confusingly similar to the Licensed Trademark or
any element thereof;
(b) Licensee recognizes the distinctiveness (whether inherent or
acquired), validity, originality and value of the Licensed Trademark and the
goodwill relating to the Licensed Trademark;
(c) The Licensed Trademark is and shall remain the sole and exclusive
property of Licensor, and all uses by Licensee of the Licensed Trademark shall
inure solely to the benefit of Licensor; and
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(d) The goodwill in the Licensed Trademark might be significantly impaired
if Licensee were not to maintain a very high degree of quality of goods.
5.2 Licensee agrees that the form and manner in which the Licensed
Trademark is used on and in relation to the Product, and including on any
advertisements, labeling and in any other manner whatsoever, shall first be
approved in writing by Licensor, which approval shall not be unreasonably
withheld.
6. REPRESENTATIONS AND WARRANTIES
6.1 Licensor represents and warrants that it owns the Licensed Trademark
and has the right to grant the license under Article 2.
6.2 Each party hereby represents and warrants to the other parties as
follows:
(a) Such party is a corporation duly organized, validly existing and in
good standing under the laws of the jurisdiction in which it is incorporated.
(b) Such party (i) has the requisite power and authority to enter into
this Agreement and to perform its obligations hereunder, and (ii) has taken all
corporate action necessary on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of such party, and
constitutes a legal, valid, binding obligation, enforceable against such party
in accordance with its terms.
(c) All necessary consents, approvals and authorizations of all
governmental authorities and other third parties required to be obtained by such
party in connection with its execution of this Agreement have been obtained.
(d) The execution and delivery of this Agreement and the performance of
such party's obligations hereunder (a) do not conflict with or violate any
requirement of applicable laws or regulations, and (b) do not conflict with, or
constitute a default under, any contractual obligation of such party.
7. PAYMENTS, ROYALTIES AND RECORDS
7.1 Upon signing this Agreement, Licensee shall pay Licensor
$5,000,000.00.
7.2 Upon the First Commercial Sale of Product under the Licensed Trademark
in the Territory, Licensee shall pay Licensor $5,000,000.00.
7.3 For the avoidance of doubt, the payments in Sections 7.1 and 7.2 are
not refundable or creditable towards future royalties.
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7.4 Licensee shall pay to Licensor as a royalty for the use of the
Licensed Trademark an amount equal to ***** (**) percent of the Net Sales of
Product sold by Licensee under the Licensed Trademark in the Territory during
the term of this Agreement. The right to the royalty shall arise at the time of
shipment by Licensee of the Product marked with the Licensed Trademark.
7.5 Within thirty (30) days following the end of each calendar quarter
(i.e., 30 days after March 31, June 30, September 30 and December 31), Licensee
shall furnish to Licensor a complete and accurate written statement showing the
Net Sales of Product sold by Licensee during the preceding calendar quarter as
well as the royalties due thereon in accordance with the provisions of this
Article 7. Licensee shall begin providing such statements once the First
Commercial Sale of Product occurs. Thereafter, such statements shall be
furnished to Licensor whether or not any Product has been sold during the
preceding calendar quarter.
7.6 Payment for the royalties due in a calendar quarter shall be due
thirty (30) days from the end of that calendar quarter. The receipt or
acceptance by Licensor of any of the statements furnished pursuant to this
Agreement or of any royalties paid hereunder (or the cashing of any royalty
check paid hereunder) shall not preclude Licensor from questioning the
correctness thereof at any time.
7.7 All payments which shall become due under any provision of this
License Agreement shall be made by Licensee to Licensor without discount or
offset. Payment shall be made electronically to the account indicated below or
to such other account or at such bank or other location that Licensor shall
designate:
Bank: *****
ABA No.: *****
Account Name: *****
Account No.: *****
7.8 Licensee shall pay all taxes and charges imposed on Licensee by any
government or taxing authority with respect to payments by Licensee to Licensor;
to the extent Licensee is required to withhold such taxes or charges, the
amounts due from Licensee to Licensor shall be recalculated so as to yield to
Licensor, after deduction for such taxes or charges, the amounts otherwise due.
7.9 Licensee shall keep, during the term of this Agreement, and for three
(3) years thereafter, accounting books relating to the Product and records
containing all information necessary for an accurate determination of royalties
hereunder. Such accounting books relating to the Product and records shall be
open for inspection and verification at Licensor's expense at reasonable
intervals by an independent certified public accountant reasonably acceptable to
Licensee who shall disclose to Licensor only what is necessary for such
verification. In the event that any such inspection discloses that Licensee has
failed to make payment of royalties in an amount in excess of ***** percent
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(**%) of the total quarterly royalty due for any quarterly period, Licensee
shall be responsible for the cost of such inspection and shall reimburse
Licensor, within thirty (30) days of notification by Licensor to Licensee, its
costs and expenses incurred by Licensor in conducting such inspection. The right
of inspection to verify royalties due for a particular calendar year shall
terminate three (3) years after the end of any such calendar year. The foregoing
limitation of thirty-six (36) months shall not apply if Licensor's accountant
discovers evidence of material misrepresentations by Licensee.
7.10 Should Licensee fail to make any payment under this Agreement by the
date on which the same shall become due and payable, Licensee shall pay interest
thereon at ***** on the due date (or the next to occur business day if such date
is not a business day) plus ***** percent (**%) during such overdue period from
such date until the date on which Licensor receives such payment.
7.11 Beginning with the calendar year in which the third anniversary of
the First Commercial Sale of Product in the Territory falls, Licensee shall pay
minimum royalties of $***** in each calendar year to keep this Agreement in
effect. In the event that the royalties paid under Section 7.4 are less than
$***** in any such calendar year, then Licensee may pay the Licensor within
thirty (30) days of the end of such calendar year the difference between the
royalties actually paid under Section 7.4 during that calendar year and $*****.
8. WAIVER
Licensee expressly waives, relinquishes and releases any and all claims which
Licensee may have against Licensor, BMS or any Affiliate of Licensor or BMS for
any indirect, incidental or consequential losses, including but not limited to
lost profits.
9. LIMITATIONS ON ACTIONS
Licensee agrees not to take any action which implies that Licensee is affiliated
with Licensor or BMS or any of Licensor's or BMS' Affiliates.
10. NO ASSIGNMENT
This Agreement is not intended to be and shall not be construed as an
assignment, in part or in whole, of the Licensed Trademark or of any business
name, trademark, tradename or service mark rights of Licensor or BMS.
11. PROTECTION OF LICENSED TRADEMARKS
11.1 Licensee shall promptly notify Licensor in writing of any
infringements or imitations by others of the Licensed Trademark on goods similar
to those covered by this Agreement which may come to Licensee's attention, and
Licensor shall have the sole right to determine whether or not any action shall
be taken on account of any such infringements or imitations. Licensee agrees to
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assist Licensor at Licensor's expense to the extent necessary in the procurement
of any protection or to protect any of Licensor's rights to the Licensed
Trademark, and Licensor, if it so desires, may commence or prosecute any claims
or suits in its own name or join Licensee as a party thereto to so protect its
rights. Licensor shall bear all costs, including attorneys' fees of all suits
brought by it.
11.2 Licensee shall not institute any suit or take any action against
third parties on account of any such infringements or imitations without first
obtaining the written consent of Licensor to do so. If such consent is granted,
Licensee may bring action in its own name. All costs and expenses, including
legal fees, incurred in connection with any such suits which are so instituted
by Licensee with the consent of Licensor shall be borne solely by Licensee, and
any damages collected shall be solely for Licensee's account.
11.3 Licensee hereby indemnifies and shall defend and hold harmless
Licensor, BMS and their Affiliates, and the officers, directors and employees of
each of them ("Indemnified Parties") from and against any and all damages,
losses, liabilities, claims, judgments, costs and expenses arising out of, or in
any way relating to the use of the Licensed Trademark or to the manufacture,
marketing, promotion, distribution and sale of the Product by Licensee, its
Affiliates, officers, employees, or agents, including, but not limited to, use
of other trademarks or intellectual property not belonging to Licensor on
packaging or in marketing, advertising or promotional materials related to the
sale of the Product. With respect to the foregoing indemnity, Licensee shall
defend and hold harmless the Indemnified Parties at no cost or expense to the
Indemnified Parties, including but not limited to, reasonable attorney's fees
and court costs. Licensee shall have the right to defend any such action or
proceeding with attorneys of its own selection, and any Indemnified Party shall
have the right to be represented by attorneys of its selection.
11.4 Licensee shall promptly notify Licensor of any claims arising out of
the use of the Licensed Trademark, and Licensor shall assist Licensee in the
defense of any such claim. In such case, Licensee's obligation to pay royalties
shall continue under the terms of this Agreement, and Licensee shall continue to
pay such royalties.
12. TERM AND TERMINATION
12.1 Unless terminated earlier, this Agreement shall remain in force from
the Effective Date for a period of ten (10) years, and be automatically
renewable for additional ten (10) year increments, assuming all provisions of
this Agreement are complied with, specifically the quality control provisions
set forth herein.
12.2 *****.
12.3 Licensor or BMS may terminate this Agreement immediately under any
circumstance where Licensee has failed to perform or meet any material term,
obligation or condition of this Agreement and has failed to correct the same
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within thirty (30) days after written notice to Licensee by Licensor or BMS.
Licensee may terminate this Agreement immediately under any circumstance where
Licensor or BMS has failed to perform or meet any material term, obligation or
condition of this Agreement and has failed to correct the same within thirty
(30) days after written notice to Licensor or BMS by Licensee. The failure of a
party to insist in any one or more instances upon the performance by another
party of any term or obligation or condition of this Agreement or to reserve any
right or privilege conferred upon a party by this Agreement shall not be
construed as thereafter waiving any right or privilege of that party under this
Agreement.
12.4 Notwithstanding anything in this Agreement to the contrary, this
Agreement shall be deemed to have terminated automatically without further
notice or legal action by Licensor or BMS in the event:
(a) The First Commercial Sale of Product under the Licensed Trademark in
the Territory does not occur within six (6) months of the date the FDA approves
the NDA for the Product,
(b) Licensee shall fail to remit to Licensor periodic royalty statements
and/or royalties due thereunder for two consecutive calendar quarters,
(c) Licensee shall become insolvent or shall commit any act or bankruptcy
or insolvency,
(d) the majority control of the shares of the Licensee shall have been
transferred to a non-affiliated company,
(e) Licensee shall attempt to transfer or assign this Agreement to any
third party without the written consent of Licensor,
(f) Licensee shall fail to obtain FDA approval to market the Product in
the Territory within three (3) years of the Effective Date, or
(g) Licensee elects not to sell or ceases to sell the Product under the
Licensed Trademark in the Territory.
13. POST-TERMINATION
13.1 Upon the expiration or termination of this Agreement for any reason,
Licensee acknowledges and agrees that:
(a) Except as provided by Section 13.1(e), Licensee shall immediately
discontinue and forever thereafter desist from any and all use of the Licensed
Trademark and any name or mark confusingly similar to the Licensed Trademark or
any element thereof,
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(b) Except as may be necessary to retain historical records for legal, tax
and regulatory purposes Licensee shall destroy all printed matter bearing the
Licensed Trademark, remove or alter all signs bearing the Licensed Trademark,
and take whatever additional action is necessary to effect discontinuance of use
of the Licensed Trademark;
(c) Licensee shall not seek to register the Licensed Trademark or any mark
confusingly similar thereto or any element thereof in any country,
(d) Licensee shall not make any use, or seek any type of registration of
any trade name, business or corporate name which in whole or in part either
substantially resembles or is confusingly similar to the Licensed Trademark or
any element thereof, and
(e) Upon termination by Licensor in accordance with Article 12, Licensee
may dispose of Product covered by this Agreement which is on hand until
exhaustion of the stock or for three (3) months after such termination,
whichever occurs first, provided royalties with respect to that period are paid
and statements are furnished for that period. Upon the termination of this
Agreement under the provisions of Article 12 above, notwithstanding anything to
the contrary herein, all royalties on sales of Product previously made shall
become immediately due and payable.
13.2 Upon termination of this Agreement for any reason, all licenses
granted by Licensor hereunder shall revert to Licensor.
13.3 Upon termination of this Agreement under Section 12.2 or 12.3, any
external expense incurred by BMS under Section 4.1 on or before the termination
date or that BMS is obligated as of the termination date to pay shall be
reimbursed by Licensee.
14. CONFIDENTIALITY
14.1 During the term of this Agreement and for five (5) years after
termination or expiration of this Agreement, each party hereby agrees to not
disclose and to use reasonable efforts to maintain the secrecy of any and all
Confidential Information disclosed by another party under the terms of this
Agreement, with the exception of the following:
a. information which, at the time of disclosure, is available to the
public;
b. information which, after disclosure, becomes available to the
public by publication or otherwise, other than by breach of this
Agreement by the receiving party;
c. information that the receiving party can establish by prior
records was already known to it or was in its possession at the
time of disclosure and not subject to any obligation of
confidentiality or restriction on use;
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d. information that the receiving party obtains from a third party;
provided, however, that such information was not acquired,
directly or indirectly, by the third party from the disclosing
party and was obtained by the receiving party without any
obligation of confidentiality or restriction on use and where
such third party was not under an obligation of confidentiality;
e. information that the receiving party can establish was
independently developed by persons in its employ or otherwise who
had no contact with and were not aware of the content of the
Confidential Information;
f. information that the disclosing party gives written consent to
the receiving party to disclose; and
g. information relating to the tax treatment and tax structure of
the transactions (but not including information relating to the
identity of Licensor, Licensee, BMS or their respective
Affiliates, which identity shall remain confidential)
contemplated by this Agreement and all materials of any kind that
are provided to it relating to such tax treatment and tax
structure. Notwithstanding this subparagraph (g), disclosure of
any such information shall not be permitted to the extent that
nondisclosure is necessary in order to comply with applicable
securities laws.
14.2 Except as otherwise provided in this Agreement, the receiving party
will not disclose any such Confidential Information to any person other than to
its directors, officers or employees, and only then if they have a clear need to
know such Confidential Information in connection with the performance of their
professional responsibilities.
14.3 The receiving party shall take reasonable steps, including those
steps taken to protect its own information, data or other tangible or intangible
property that it regards as proprietary or confidential, to insure that the
Confidential Information is not disclosed or duplicated for the use of any third
party, and shall take reasonable steps to prevent its officers and employees, or
any others having access to the Confidential Information, from disclosing or
making unauthorized use of any Confidential Information, or from committing any
acts or omissions that may result in a violation of this Agreement.
14.4 Title to, and all rights emanating from the ownership of, all
Confidential Information disclosed under this Agreement shall remain vested in
the disclosing party. Nothing herein shall be construed as granting any license
or other right to use the Confidential Information other than as specifically
agreed upon by the parties.
14.5 The confidentiality obligations contained in this Article 14 shall
not apply to the extent that the receiving party is required to disclose
information by law, order or regulation of a governmental agency or a court of
competent jurisdiction, including as may be required in connection with any
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filings made with, or by the disclosure policies of a major stock exchange. In
the event that the receiving party must disclose Confidential Information of the
disclosing party pursuant to any such law, order or regulation, it will disclose
only that portion of the Confidential Information that, in the opinion of its
legal counsel, is legally required to be disclosed and will exercise reasonable
efforts to ensure that any such information so disclosed will be accorded
confidential treatment.
14.6 Upon written request of the disclosing party, the receiving party
shall destroy or return promptly to the disclosing party all written materials
and documents, as well as any computer software or other media, made available
or supplied by the disclosing party to the receiving party that contains
Confidential Information, together with any copies thereof, except that the
receiving party may retain one copy of each such document or other media for
archival purposes, subject to protection and non-disclosure in accordance with
the terms of this Agreement.
14.7 The parties agree that the Confidential Information shall only be
used in connection with the parties' respective rights and obligations under
this Agreement.
14.8 The parties agree that the public announcement of the execution of
this Agreement shall be in the form of a reasonably and mutually acceptable
press release to be issued within forty-five (45) days of the Effective Date.
Thereafter and notwithstanding the foregoing, each party shall be entitled to
make or publish any public statement that is consistent with and of no greater
scope or containing no additional information regarding this Agreement than the
contents of such press release without the need for further approval by the
other parties.
15. USE BY AGENTS
Licensee shall be responsible for all uses of the Licensed Trademark by its
agents involved in the packaging, promotion and sale of the Product, and at the
request of Licensor shall require such agents to agree in writing to be bound by
the provisions of this Agreement in a form satisfactory to Licensor.
16. ASSIGNABILITY
Licensee may not, without the prior written consent of Licensor and BMS, assign
this Agreement and its rights and obligations hereunder. Each of Licensor and
BMS may not, without the written consent of Licensee, assign this Agreement and
its rights and obligations hereunder; provided, however, each of Licensor and
BMS may, without such consent, assign this Agreement and its rights and
obligations hereunder to any Affiliate or in connection with the transfer or
sale of all or substantially all of the assets to which this Agreement relates,
or in the event of its merger or consolidation or change in control or similar
transaction. Any purported assignment in violation of the preceding sentences
shall be void. Any permitted assignee shall assume all obligations of its
assignor under this Agreement. For the avoidance of doubt, Licensor may assign
this Agreement and its rights and obligations hereunder without the written
consent of Licensee in the event it sells or transfers the Licensed Trademark,
and BMS may assign this Agreement and its rights and obligations hereunder
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ASTERISKS DENOTE SUCH OMISSION
without the written consent of Licensee in the event it sells or transfers the
BMS Product.
17. ADVERSE EVENT AND PRODUCT QUALITY COMPLAINT REPORTING
17.1 BMS and Licensee each seek the cooperation of the other party in
exchanging information concerning adverse events and/or reactions associated
with the use in humans of the Product and the BMS Product. Within three (3)
months of the Effective Date, BMS and Licensee shall enter into a separate
written agreement consistent with this Article 17 and containing mutually
acceptable guidelines and procedures for the receipt, recordation, communication
(as between BMS and Licensee) and exchange of adverse event information for the
Product and the BMS Product (the "Safety Data Exchange Agreement").
17.2 Licensee shall record, investigate, obtain additional information,
summarize and review all adverse events reported to it which are associated with
the Product. BMS shall record, investigate, obtain additional information,
summarize and review all adverse events reported to it which are associated with
the BMS Product.
17.3 Licensee shall maintain, at its own expense, a safety database which
shall reference any adverse event/reaction associated with the Product occurring
anywhere in the world. BMS shall maintain, at its own expense, a safety database
which shall reference any adverse event/reaction associated with the BMS Product
occurring anywhere in the world.
17.4 The parties agree that English shall be the language used for safety
data exchange and the method of transmission shall be either facsimile,
electronic mail or, when available, electronic submission in International
Council for Harmonization (ICH) E2b, M2 format. Raw data or databases shall not
be shared between BMS and Licensee, unless otherwise agreed in the Safety Data
Exchange Agreement to be entered into pursuant to Section 17.1 above.
17.5 The definition for adverse events/reactions in the Safety Data
Exchange Agreement to be entered into pursuant to Section 17.1 above shall be
consistent with current ICH guidelines and FDA regulations. BMS and Licensee
shall exchange serious adverse events associated with the Product and the BMS
Product, including those from clinical trial cases and those reported to be
related to biomedical research. In addition, all reports of exposure to the
Product or the BMS Product during pregnancy and all reports of overdoses of the
Product or the BMS Product will be exchanged regardless of whether they result
in an adverse event/reaction.
17.6 To comply with FDA regulations, BMS collects and evaluates
information it receives that questions the purity, identity, potency or quality
of any licensed product. Licensee shall inform BMS' Office of the Vice
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President, Global Pharmacovigilance and Labeling, P.O. Box 5400, Pennington,
N.J. 08534, of any product quality complaint it receives.
18. MISCELLANEOUS
18.1 This Agreement is the entire agreement between the parties as to its
subject matter and supersedes all previous agreements between the parties,
whether oral or written, and may be modified only by a written instrument signed
by duly authorized representatives of the parties.
18.2 The failure of a party to enforce any provision herein is not a
waiver of that provision nor does it affect the validity of this Agreement or
any part of it, or the right of that party thereafter to enforce that provision
or any other provision.
18.3 This Agreement is acknowledged to have been made and shall be
construed and interpreted in accordance with the substantive laws of the State
of New York, without reference to choice of law principles. Competent
jurisdiction is exclusively given to the state and federal courts in the State
of New York.
18.4 All notices to be given under this Agreement shall be in writing and
properly given if sent by acknowledged telex or facsimile or certified or
registered mail to the party receiving such notice at the address below or in
accordance with the last written instructions received from such party
concerning the mailing address to be used for such notices. The date of the
notice shall be the date the notice is received by the recipient.
If to Licensor or BMS: Bristol-Myers Squibb Company
777 Scudders Mill Road
Plainsboro, NJ 08536
Fax: 609-897-6399
Attention: Mr. Frank Pasqualone,
Senior Vice President, Oncology
with a copy to: Bristol-Myers Squibb Company
P. O. Box 4000
Princeton, NJ 08543-4000
Fax: 609-252-4232
Attention: Vice President & Senior Counsel,
Corporate and Business Development
If to Licensee: Par Pharmaceutical, Inc.
One Ram Ridge Road
Spring Valley, NY 10977
Fax: 201-391-5364
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ASTERISKS DENOTE SUCH OMISSION
Attn: Mr. Dennis O'Connor, Chief Financial Officer
18.5 It is expressly agreed that the parties shall be independent
contractors with respect to this Agreement and that the relationship between the
parties created by this Agreement shall not constitute a partnership, joint
venture or agency. No party shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on another party, without the prior consent of the other party to do
so.
18.6 In the event that any provision of this Agreement is or becomes
legally ineffective, this shall not affect the validity of the remaining
provisions hereof. In lieu of the valid provision, the parties to this Agreement
shall agree upon a valid provision which approaches best the commercial purpose
of the intended provision.
18.7 This Agreement may be executed in one or more counterparts, by manual
or facsimile signature, but all of which together shall constitute one and the
same instrument. This Agreement shall become effective upon the Effective Date.
18.8 The headings and titles of the Article and Sections of this License
Agreement are inserted for convenience only and shall not be deemed to be part
hereof or affect the construction or interpretation of any provision hereof.
18.9 Termination or expiration of this Agreement shall not relieve any
party hereto from any obligation to make any payment, including but not limited
to any payment under Section 7.1, 7.2 or 7.4, or any liability accruing prior to
such termination or expiration or pursuant to any provisions of this Agreement
that expressly survive termination or expiration thereof, nor preclude any Party
from pursuing any rights and remedies it may have hereunder in law or equity
which accrued or are based upon any event occurring prior to such termination or
expiration. Without limiting the foregoing, Articles 8, 13 and 14 and Sections
7.9, 7.10, 11.3, 18.1, 18.2 and 18.3 shall survive termination or expiration of
this Agreement.
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ASTERISKS DENOTE SUCH OMISSION
IN WITNESS WHEREOF the Parties hereto have duly executed this Agreement.
MEAD JOHNSON & COMPANY PAR PHARMACEUTICAL, INC.
By: /S/ SANDRA LEUNG By: /S/ SCOTT TARRIFF
---------------------------- -----------------------------
Name: Sandra Leung Name: Scott Tarriff
---------------------------- -----------------------------
Date: August 6, 2003 Date: August 6, 2003
---------------------------- -----------------------------
BRISTOL-MYERS SQUIBB COMPANY
By: /S/ BRIAN A. MARKISON
----------------------------
Name: Brian A. Markinson
----------------------------
Date: August 6, 2003
----------------------------
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ATTACHMENT A
***** PROMOTIONAL ***** ACTIVITIES
*****.
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