EXHIBIT 10.37
EXECUTION COPY
LICENSE AGREEMENT
LICENSE AGREEMENT (this "Agreement") dated as of December 6, 2005 (the
"Effective Date") by and between MUTUAL PHARMACEUTICAL COMPANY, INC., a
Pennsylvania corporation, having its principal place of business at 0000
Xxxxxxxx Xxxxxx, Xxxxxxxxxxxx, XX 00000 (hereinafter referred to as "Mutual")
and KING PHARMACEUTICALS, INC., a Tennessee corporation, having its principal
place of business at 000 Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxx 00000 (hereinafter
referred to as "Licensee").
INTRODUCTION
WHEREAS, Mutual possesses certain intellectual property pertaining to the
pharmaceutical active ingredient known as metaxalone; and
WHEREAS, Licensee desires to license the use of such intellectual property
upon the terms and conditions set forth herein, including without limitation,
the royalties payable by Licensee to Mutual set forth herein, which reflect the
combined value of the know-how and patent rights licensed hereunder;
NOW, THEREFORE, in consideration of the mutual covenants and promises
contained herein and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, Mutual and Licensee agree as
follows:
DEFINITION.
1.1 "Affiliate" means any person, corporation, company, partnership, joint
venture, firm or other entity which controls, is controlled by or is under
common control with a Party. For purposes of this Section 1.1, "control" shall
mean (a) in the case of corporate entities, direct or indirect ownership of at
least fifty percent (50%) (or, if less, the maximum allowed by relevant law) of
the stock or shares entitled to vote for the election of directors and (b) in
the case of non-corporate entities, direct or indirect ownership of at least
fifty percent (50%) of the equity interest with the power to direct the
management and policies of such non-corporate entities.
1.2 "Confidential Information" means all proprietary materials and
information of a Party, whether or not patentable, which are communicated or
provided to the other Party pursuant to the terms of this Agreement and marked
in writing as confidential, including without limitation, the existence and
terms of this Agreement.
1.3 "Control" means, with respect to any (a) material, know-how or other
information or (b) intellectual property right, the possession of (whether by
ownership or license, other than pursuant to this Agreement), or the ability of
a Party or its Affiliates to grant access to, or a license or sublicense of,
such item or right as provided for herein without violating the terms of any
agreement or other arrangement with any Third Party
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
existing at the time such Party would be required hereunder to grant the other
Party such access or license or sublicense.
1.4 "Divestiture Transaction" has the meaning ascribed thereto in Section
3.3(c)(i).
1.5 "Existing Formulation" has the meaning ascribed thereto in Section
3.1(b)(iv).
1.6 "FDA" means the United States Food and Drug Administration, and any
successor agency.
1.7 "In Vivo Know-How" means any and all data and results in, from or
relating to any in vivo studies of the interaction of metaxalone with enzyme
systems or other drugs conducted by or on behalf of either Party or any
Affiliate thereof.
1.8 "In Vivo Patent Rights" means (a) any patent application with claims
covering In-Vivo Know-How, (b) all corresponding patent applications filed in
other jurisdictions, (c) all divisions, continuations and continuations-in-part
of such patent applications, (d) all patents issuing thereon and (e) all
reissues, reexaminations and extensions of any of the foregoing patents.
1.9 "Last 6 Months" has the meaning ascribed thereto in Section 3.3(b).
1.10 "Last 12 Months" has the meaning ascribed thereto in Section 3.3(a).
1.11 "Last 36 Months" has the meaning ascribed thereto in Section 3.3(b).
1.12 "Licensed Know-How" means (a) all data and results in, from or
relating to the in vitro enzyme studies described on Schedule A, including
without limitation the data and results in the study reports attached as
Schedule A1 and (b) all In Vivo Know-How owned or Controlled by Mutual.
1.13 "Licensed Patent Rights" means (a) the patent application attached as
Schedule B to this Agreement, (b) all corresponding patent applications filed in
other jurisdictions, (c) all divisions, continuations and continuations-in-part
of such patent applications, (d) all patents issuing thereon, (e) all reissues,
reexaminations and extensions of any of the foregoing patents and (f) In Vivo
Patent Rights owned or Controlled by Mutual.
1.14 "Licensed Products" means any product or kit containing or comprised
of the active pharmaceutical ingredient known as metaxalone and any method of
making or using the active pharmaceutical ingredient known as metaxalone.
1.15 "Net Sales" means the gross amount invoiced for the sale or other
disposition of Licensed Products by Licensee and its Related Parties to
non-sublicensee Third Parties, less (a) trade, quantity and early pay cash
discounts or rebates which are actually allowed, (b) amounts repaid or credited
by reason of returns and rebates, including
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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any statutory or contractual liability for rebates to be paid to or for the
benefit of any government entity including, but not limited to, rebates to be
paid pursuant to the Medicaid rebate legislation and state and local government
rebate programs, (c) any adjustments granted to customers for repayments,
allowances or credits for rejected or damaged product, retroactive price
adjustments (e.g., floorstock adjustments), reprocurement fees, promotional
allowances, chargebacks, or other customary discounts, deductions and
administrative fees directly related to such product, (d) special handling fees,
transportation and charges to the extent included in the invoice price and (e)
actual sales, use or excise taxes, tariff or custom duties, and other
governmental charges to the extent included in the invoice.
1.16 "Negotiation Period" has the meaning ascribed thereto in Section
3.3(c)(i).
1.17 "New Formulation Licensed Product" has the meaning ascribed thereto in
Section 3.1(b)(iv).
1.18 "Offer" has the meaning ascribed thereto in Section 3.3(c)(i).
1.19 "Party" means Mutual or Licensee; "Parties" means Mutual and Licensee.
1.20 "Reduced Royalty Period" has the meaning ascribed thereto in Section
3.3(c)(i).
1.21 "Related Parties" means, with respect to a Party, such Party's
Affiliates, and its and its Affiliates' distributors and permitted sublicensees
under this Agreement. Related Parties does not include wholesale distributors of
Licensee or its Affiliates who purchase Licensed Products from such Party or its
Affiliates in an arm's length transaction.
1.22 "Revised Labeling" has the meaning ascribed thereto in Section 2.5.
1.23 "Revised Labeling Patent Claim" has the meaning ascribed thereto in
Section 2.5.
1.24 "Third Party" means any person or entity other than Mutual or Licensee
or their Affiliates.
1.25 "Valid Claim" means a claim of an issued and unexpired patent within
the Licensed Patent Rights, which has not been withdrawn, canceled or terminally
disclaimed, or held unpatentable, invalid or unenforceable by a court or other
tribunal of competent jurisdiction in a final, non-appealable decision.
LICENSE
2.1 Grants. (a) Mutual hereby grants to Licensee and its Affiliates a
worldwide, co-exclusive (with Mutual) license under the Licensed Patent Rights
and under the Licensed Know-How, in each case to make, use, offer for sale, sell
and import Licensed Products. For the avoidance of doubt, the license granted to
Licensee herein shall include,
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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without limitation, the right to use Licensed Know-How and License Patent Rights
in connection with the regulatory approval, labeling and marketing of Licensed
Products.
(b) Licensee hereby grants to Mutual and its Affiliates a worldwide,
non-exclusive license under any and all In Vivo Know-How and In Vivo Patent
Rights owned or Controlled by Licensee, solely to make, use, offer for sale,
sell and import any products, kits or methods other than Licensed Products. For
the avoidance of doubt, the license granted to Mutual herein shall include,
without limitation, the right to use In Vivo Know-How and In Vivo Patent Rights
in connection with the regulatory approval, labeling and marketing of products
other than Licensed Products. In the event Mutual or its Affiliate enters into
any agreement with any Third Party granting such Third Party any license,
option, covenant not to xxx or other rights with respect to such In Vivo
Know-How or In Vivo Patent Rights, then Mutual shall pay to Licensee, at
Mutual's discretion, (i) [***] percent ([***]%) of [***] received from such
Third Party pursuant to such agreement or (ii) [***] percent ([***]%) of [***]
received from such Third Party pursuant to such agreement, [***] in connection
with generating such In Vivo Know-How and preparing, filing and prosecuting such
In-Vivo Patent Rights. In the event Licensee or its Affiliate enters into any
agreement with any Third Party granting such Third Party any license, option,
covenant not to xxx or other rights with respect to In Vivo Know-How or In Vivo
Patent Rights in connection with any products, kits or methods other than
Licensed Products, expressly excluding any other products currently owned,
Controlled or marketed by Licensee or its Affiliates, then Licensee shall pay to
Mutual [***] percent ([***]%) of [***] received from such Third Party pursuant
to such agreement.
2.2 Retained Rights. Mutual shall retain all other rights, title and
interests in and to the Licensed Patent Rights and Licensed Know-How, and agrees
that during the term of this Agreement it will not license these rights to any
Third Party for use in any Licensed Product.
2.3 Sublicenses. Each Party and its respective Affiliates shall have the
right to grant sublicenses under the licenses granted to it by the other Party
pursuant to Section 2.1. Such sublicenses shall be subject in all respects to
the terms and conditions of this Agreement.
2.4 Diligence. Licensee shall use commercially reasonable efforts and
diligence to make, use, offer for sale, sell and import Licensed Products,
consistent with reasonable scientific and business practices and judgments in
the pharmaceutical industry for products with similar commercial value, market
potential and profitability; provided that in no event will Licensee be
obligated to continue to market its currently-approved Licensed Product or to
bring to market a New Formulation Licensed Product.
2.5 Additional Licensee Obligations. Mutual and Licensee shall cooperate
(a) in obtaining or effecting revised labeling for Licensed Products
incorporating the Licensed Know-How ("Revised Labeling") and (b) to obtain an
issued patent within the Licensed Patent Rights with one or more Valid Claims
that cover Revised Labeling; provided, however, that if no Revised Labeling has
been obtained, then such Valid Claims shall be substantially the same in scope
as at least one of the pending claims in the Licensed Patent
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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Rights on the Effective Date, expressly excluding claims numbered [***]
("Revised Labeling Patent Claim"). Licensee shall use best efforts to obtain or
effect Revised Labeling in a reasonably prompt manner, and will discuss Revised
Labeling with FDA no later than March 31, 2006.
FEES AND ROYALTIES
3.1 Fees and Royalties.
(a) Licensee shall make a one-time, up-front payment to Mutual of US
$35,000,000 upon execution of this Agreement;
(b) Licensee shall pay to Mutual earned royalties on Net Sales as follows:
(i) a royalty of [***] percent ([***]%) of all Net Sales, as extended
payments in consideration for the rights granted under this Agreement to the
Licensed Know-How; and
(ii) a separate and additional royalty of [***] percent ([***]%) of
all Net Sales if the [***], beginning on the [***] of a Licensed Product with
[***]; and
(iii) a separate and additional royalty of [***] percent ([***]%) of
all Net Sales if the [***], beginning on the [***] and continuing for so long as
[***]; and
(iv) a separate and additional royalty of [***] percent ([***]%) of
all Net Sales if the [***] marketed or sold by Licensee, or by any Related
Parties to whom Licensee has granted rights or from whom Licensee has received
rights for such [***], if such [***] is different from the formulation(s) of
Licensed Product approved for marketing by FDA on the Effective Date ("Existing
Formulation"), expressly excluding different dosage strengths of the Existing
Formulation ("New Formulation Licensed Product"), beginning on the [***] final
approval; provided that once the total aggregate royalty payable pursuant to
this Section 3.1(b)(iv) equals US $[***], a separate and additional royalty
shall be payable under this Section 3.3(b)(iv) only in the event that the total
royalties payable pursuant to Section 3.1(b) for any calendar quarter are less
than [***] percent ([***]%) of Net Sales, in which case the royalty payable
pursuant to this Section 3.1(b)(iv) for such calendar quarter shall be at a rate
equal to the difference between [***] percent ([***]%) and the sum of the
royalty rates payable pursuant to Section 3.1(b) for such calendar quarter.
3.2 Calculation of Royalties. The obligation to pay royalties to Mutual
shall be imposed only once with respect to the same unit of Licensed Product,
and subject to adjustment pursuant to Section 3.3 below, the total royalties
payable on Net Sales for any calendar quarter shall equal the sum of the
applicable royalties set forth in Section 3.1 hereof, applied separately and
pro-rated as necessary for Net Sales in such calendar quarter.
3.3 Adjustment of Royalty Obligations; Right of First Offer.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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(a) 12-Month Sales Adjustment. Net Sales shall be calculated at the end of
each calendar quarter for the immediately preceding consecutive twelve
(12)-month period ("Last 12 Months"). If, based on any such quarterly
calculation, aggregate Net Sales are less than $[***] for the Last 12 Months,
then, notwithstanding anything to the contrary in this Agreement, the royalties
payable for such calendar quarter shall be at a rate of [***] percent ([***]%)
of all Net Sales. For the avoidance of doubt, if any quarterly calculation of
Net Sales for the Last 12 Months made after the application of the foregoing
royalty adjustment is greater than or equal to $[***], then all applicable
royalties pursuant to Section 3.1 shall be payable for such calendar quarter.
(b) Further Sales Adjustment. Net Sales shall also be calculated at the end
of each calendar quarter for the immediately preceding consecutive thirty-six
(36)-month period ("Last 36 Months") and the immediately preceding consecutive
six (6)-month period ("Last 6 Months"). If, based on any quarterly calculation
performed pursuant to Section 3.3(a) or this Section 3.3(b), aggregate Net Sales
are less than $[***] for the Last 36 Months or less than $[***] for the Last 6
Months then, notwithstanding anything to the contrary in this Agreement, the
royalties payable for such calendar quarter shall be at a rate of [***] percent
([***]%) of all Net Sales. For the avoidance of doubt, if any quarterly
calculation of Net Sales for the Last 12 Months made after the application of
the foregoing royalty adjustment is greater than or equal to $[***], then all
applicable royalties pursuant to Section 3.1 shall be payable for such calendar
quarter.
(c) Right of First Offer.
(i) During any period in which royalty payments are reduced pursuant
to Section 3.3(a) or (b) hereof ("Reduced Royalty Period"), neither Licensee nor
its Affiliates may enter into a transaction with a Third Party for the license,
sublicense, assignment, transfer or sale of all or substantially all of
Licensee's and/or its Affiliates' intellectual property rights or any other
assets relating to Licensed Products, by merger, sale of assets or otherwise (a
"Divestiture Transaction") to such Third Party without first providing Mutual
with a written offer ("Offer") to enter into a Divestiture Transaction at the
then-current fair market value for such intellectual property or assets. Mutual
shall have [***] ([***]) days after receipt of the Offer to notify Licensee in
writing of its interest in such Divestiture Transaction. If Mutual notifies
Licensee in writing within such [***] ([***]) day period that it is interested
in such Divestiture Transaction, then the Parties shall promptly commence good
faith negotiations for a period of up to [***] ([***]) months after Mutual's
receipt of the Offer and any mutually agreed extension of such period
("Negotiation Period") in an effort to reach a mutually acceptable definitive
agreement for such Divestiture Transaction. Licensee shall not, during the
Negotiation Period, solicit, offer, negotiate or enter into with any Third Party
any agreement, contract or understanding with respect to a Divestiture
Transaction or that would otherwise be inconsistent with Mutual's rights
hereunder.
(ii) If (x) Mutual notifies Licensee in writing that it is not
interested in such Divestiture Transaction or does not notify Licensee in
writing within such [***] ([***]) day period that it is interested in such
Divestiture Transaction, or (y) despite each Party's good faith efforts, Mutual
and Licensee are not able to reach agreement on and
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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execute a definitive agreement within the Negotiation Period, then, upon
expiration of the [***] ([***]) day period or the Negotiation Period, as
applicable, (A) no royalties shall be payable to Mutual under this Agreement for
any calendar quarter(s) that is part of the Reduced Royalty Period and (B)
Licensee may negotiate and enter into a Divestiture Transaction with any Third
Party; provided, however, that if this Agreement is sublicensed or assigned to
such Third Party in the Divestiture Transaction, such Third Party shall be
required to assume the obligations of Licensee under this Agreement, to the
extent not retained by Licensee (except that the provisions of this Section 3.3
shall no longer apply), and further provided that Licensee shall be required to
include a sublicense or assignment of this Agreement in the Divestiture
Transaction if, prior to the effective date of the definitive agreement for the
Divestiture Transaction, Revised Labeling has been obtained, a Revised Labeling
Patent Claim has issued and continues to be a Valid Claim, or a New Formulation
Licensed Product has been granted final marketing approval by the FDA; and
provided further, that, during the Reduced Royalty Period, Licensee and its
Affiliates may not enter into a Divestiture Transaction with a Third Party on
terms and conditions that, on the whole, are materially more favorable to such
Third Party than those previously offered to Mutual pursuant to this Section
3.3(c) without first offering a Divestiture Transaction to Mutual on the same or
substantially similar terms and conditions pursuant to the procedures set forth
in Section 3.3(c)(i) above.
3.4 Third Party Royalty Reduction. If Licensee or any Related Party thereof
is reasonably required to enter into an agreement(s) with any Third Party(ies)
in order to obtain rights to enable the use of the Licensed Know-How or the
Licensed Patent Rights in the labeling of Licensed Products to avoid infringing
or misappropriating the intellectual property rights of such Third Party(ies),
then, notwithstanding anything to the contrary in this Agreement, Licensee and
its Related Parties shall be entitled to a credit against any future royalties
payable to Mutual hereunder in an amount equal to [***] percent ([***]%) of the
amount of such royalties paid by Licensee and its Related Parties to such Third
Parties to obtain such rights, provided that the credit for any given calendar
quarter will not exceed the total royalties payable to Mutual for such calendar
quarter, and provided further that any royalties not so credited by reason of
the foregoing proviso may be carried forward for credit against royalties
payable to Mutual in any future calendar quarter.
3.5 Reports and Payments. Within [***] ([***]) days after the end of each
calendar quarter, Licensee shall deliver to Mutual (a) a written report showing
its computation of royalties due for such quarter on a country-by-country and
product-by-product basis and (b) payment of the royalties due for such calendar
quarter. With respect to sales of Licensed Products sold for United States
Dollars, the sales and royalties payable shall be expressed in United States
Dollars. With respect to sales of Licensed Products sold for a currency other
than United States Dollars, the sales and royalties payable shall be expressed
in their United States Dollar equivalent calculated using the applicable
conversion rates for buying United States Dollars published by The Wall Street
Journal on the last business day of the calendar quarter to which the royalty
report relates. All royalty payments shall be made in United States Dollars and
shall be paid by bank wire transfer in immediately available funds to the
following bank account:
Beneficiary Bank: [***]
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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ABA# [***]
Account # to credit: [***]
3.6 Tax Withholding. If Licensee determines in good faith that tax
withholdings under the laws of any country are required with respect to payments
to Mutual, Licensee shall withhold the required amount and pay it to the
appropriate governmental authority. In any such case, Licensee shall promptly
provide Mutual with original receipts or other evidence reasonably desirable and
sufficient to allow Mutual to document such tax withholdings for purposes of
claiming foreign tax credits and similar benefits, and the Parties will
cooperate to reduce or remove the application of such withholding requirements
to the extent reasonably possible and at no cost to Licensee.
3.7 Records. Licensee shall keep, and shall require all Related Parties to
keep, true and accurate books of accounts and other records containing all
information and data which may be necessary to ascertain and verify the
royalties payable under this Agreement. During the term of this Agreement and
for a period of [***] ([***]) years following its termination, Mutual shall have
the right from time to time (not to exceed once during each calendar year) to
have an independent certified public accountant inspect such books and records
of Licensee and its Affiliates for the immediately preceding [***] ([***]) year
period. Any such independent certified accountant must be reasonably acceptable
to Licensee, and shall execute a standard form of confidentiality agreement with
Licensee, and shall be permitted to share with Mutual solely its findings with
respect to the accuracy of the royalties reported as payable under this
Agreement.
INTELLECTUAL PROPERTY
4.1 Patent Prosecution. Mutual shall have the right, [***], to prepare,
file, prosecute and maintain the Licensed Patent Rights. Mutual shall keep
Licensee promptly informed with respect to same, and shall from time to time, or
at Licensee's reasonable request, consult with Licensee regarding the status of
such activities and shall provide Licensee, at Mutual's request, with copies of
all documents filed in connection with, and all written communications relating
to, same. In the event that Mutual determines not to prepare, file, prosecute or
maintain any patent application or patent within the Licensed Patent Rights,
Mutual shall promptly notify Licensee, and thereupon, Licensee shall have the
right, [***], to prepare, file, prosecute and maintain any such patent
application or patent.
4.2 Infringement.
(a) Each Party shall promptly report in writing to the other Party during
the term of this Agreement any suspected infringement of the Licensed Patent
Rights or In Vivo Patent Rights licensed to Mutual and its Affiliates pursuant
to Section 2.1(b) and any suspected unauthorized use or misappropriation of any
Licensed Know-How, In Vivo
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SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
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Know-How licensed to Mutual and its Affiliates pursuant to Section 2.1(b) or
Confidential Information of which it becomes aware, and shall provide the other
Party with all available evidence supporting such suspected infringement or
unauthorized use or misappropriation.
(b) Except as provided in Section 4.2(d) of this Agreement, Licensee shall
have the right to initiate an appropriate suit anywhere in the world against any
Third Party who at any time is suspected of infringing all or any portion of the
Licensed Patent Rights or using without proper authorization all or any portion
of the Licensed Know-How by virtue of the making, using, offering for sale,
selling or importing of any Licensed Product. Licensee shall give Mutual
reasonable advance notice of its intent to file such suit and the reasons
therefor. Further, Licensee shall keep Mutual promptly informed, and shall from
time to time consult with Mutual regarding the status of any such suit and shall
provide Mutual with copies of all documents filed in, and all written
communications relating to, such suit.
(c) Licensee shall have the [***] right to select counsel for any suit
referred to in Section 4.2(b) of this Agreement and shall pay [***] of the suit,
including without limitation [***]. If necessary, Mutual shall join as a party
to the suit but shall be under no obligation to participate except to the extent
that such participation is required as the result of being a named party to the
suit. Mutual shall offer reasonable assistance to Licensee in connection
therewith [***] to Licensee except for [***]. [***], Licensee shall provide
counsel for Mutual and pay for [***], unless Mutual elects to be represented in
any such suit by its own counsel, which shall be [***]. Licensee shall not
settle any such suit involving rights of Mutual without obtaining the prior
written consent of Mutual, which consent shall not be unreasonably withheld.
(d) In the event that Licensee elects not to initiate an infringement or
other appropriate suit pursuant to Section 4.2(b) of this Agreement, Licensee
shall promptly advise Mutual of its intent not to initiate such suit, and Mutual
shall have the right, [***], to initiate an appropriate suit anywhere in the
world against any Third Party who at any time is suspected of infringing all or
any portion of the Licensed Patent Rights or using without proper authorization
all or any portion of the Licensed Know-How. Mutual shall give Licensee
reasonable advance notice of its intent to file such suit and the reasons
therefor, and shall provide Licensee with an opportunity to make suggestions and
comments regarding such suit. Further, Mutual shall keep Licensee promptly
informed, and shall from time to time consult with Licensee regarding the status
of any such suit and shall provide Licensee with copies of all documents filed
in, and all written communications relating to, such suit.
(e) In exercising its rights pursuant to Section 4.2(d) of this Agreement,
Mutual shall have [***] right to select counsel and shall pay [***] including
without limitation [***]. If necessary, Licensee shall join as a party to the
suit but shall be under no obligation to participate except to the extent that
such participation is required as a result of being a named party to the suit.
At Mutual's request, Licensee shall offer reasonable assistance to Mutual in
connection therewith [***] to Mutual except for [***]. At Mutual's expense,
Mutual shall provide counsel for Licensee and pay for [***], unless Licensee
elects to be represented in any such suit by its own counsel, which shall be
[***].
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
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Mutual shall not settle any such suit involving rights of Licensee without
obtaining the prior written consent of Licensee, which consent shall not be
unreasonably withheld, it being understood and agreed that Licensee shall have
the sole right to settle any such suit to the extent such settlement includes a
license or sublicense of any rights under the Licensed Patent Rights or the
Licensed Know-How.
(f) Any damages, royalties, license fees or other compensation (including
any amount received in settlement of such litigation) received in connection
with a suit under this Section 4.2 shall be allocated first to [***]including
[***]; and (i) if Licensee has initiated the suit, then any of the remaining
amount [***] and the balance being retained by Licensee or (ii) if Mutual has
initiated the suit, [***] with the balance being retained by Mutual.
(g) As between Mutual and Licensee, Mutual shall have [***] to initiate an
appropriate suit anywhere in the world against any Third Party who at any time
is suspected of infringing all or any portion of the Licensed Patent Rights or
using without proper authorization all or any portion of the Licensed Know-How
by virtue of the making, using, offering for sale, selling or importing of any
product that is not a Licensed Product. If Mutual or any Third Party permitted
to do so by Mutual initiates such a suit under this Section 4.2(g) with respect
to products other than Licensed Products, Mutual shall keep Licensee promptly
informed, and shall from time to time consult with Licensee regarding the status
of such suit and shall provide Licensee with copies of all documents filed in,
and all written communications relating to, such suit to the extent any of the
foregoing are reasonably related to the ownership, inventorship, validity,
enforceability or interpretation of any claims of any of the Licensed Patent
Rights that also cover Licensed Products or any portion of the Licensed Know-How
that also relate to Licensed Products, so as to enable Licensee and its Related
Parties to preserve the commercial value of the Licensed Patent Rights and the
Licensed Know-How to the extent reasonably possible with respect to Licensed
Products.
(h) As between Mutual and Licensee, Mutual shall have [***] to initiate an
appropriate suit anywhere in the world against any Third Party who at any time
is suspected of infringing all or any portion of the In Vivo Patent Rights
licensed by Licensee to Mutual and its Affiliates pursuant to Section 2.1(b) or
using without proper authorization all or any portion of the In Vivo Know-How
licensed by Licensee to Mutual and its Affiliates pursuant to Section 2.1(b) by
virtue of the making, using, offering for sale, selling or importing of any
product that is neither a Licensed Product nor any other product currently
owned, Controlled or marketed by Licensee or its Affiliates. Mutual shall give
Licensee reasonable advance notice of its intent to file such suit and the
reasons therefor. Further, Mutual shall keep Licensee promptly informed, and
shall from time to time consult with Licensee regarding the status of any such
suit and shall provide Licensee with copies of all documents filed in, and all
written communications relating to, such suit. Licensee shall have the [***] to
select counsel for any such suit and shall [***], including without limitation
[***]. If necessary, Licensee shall join as a party to such suit, but shall be
under no obligation to participate except to the extent that such participation
is required as the result of being a named party to such suit. Licensee shall
offer reasonable assistance to Mutual in connection therewith [***] to Mutual
[***]. [***], Mutual shall provide
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
10
counsel for Licensee and pay for [***] unless Licensee elects to be represented
in any such suit by its own counsel, [***]. Mutual shall not settle any such
suit involving rights of Licensee without obtaining the prior written consent of
Licensee, which consent shall not be unreasonably withheld.
CONFIDENTIAL INFORMATION
5.1 Treatment of Confidential Information. Each Party shall maintain in
confidence the Confidential Information of the other Party and shall not
disclose, divulge or otherwise communicate such Confidential Information to
others, or use it for any purpose, except pursuant to, and in order to carry
out, the terms and objectives of this Agreement. Each Party may disclose
Confidential Information of the other Party to its Affiliates, and to its and
their directors, employees, consultants, subcontractors, sublicensees, agents
and investors, in each case who have a specific need to know such Confidential
Information and who are bound by a like obligation of confidentiality and
restriction on use.
5.2 Release from Restrictions. The provisions of Section 5.1 of this
Agreement shall not apply to any Confidential Information disclosed hereunder
which:
(a) was known or used by the receiving Party or any of its Affiliates prior
to its date of disclosure to the receiving Party, as demonstrated by competent
evidence of the receiving Party or any of its Affiliates;
(b) either before or after the date of the disclosure to the receiving
Party is lawfully disclosed to the receiving Party or any of its Affiliates by
an independent, unaffiliated Third Party rightfully in possession of the
Confidential Information;
(c) either before or after the date of the disclosure to the receiving
Party becomes published or generally known to the public through no fault or
omission on the part of the receiving Party or its Affiliates;
(d) is required to be disclosed by the receiving Party to comply with
applicable laws or regulations, to defend or prosecute litigation, to file for
patent protection, or to file for regulatory approval to test or market Licensed
Products; provided, however, that, where available, the receiving Party takes
reasonable and lawful actions to avoid and/or minimize the degree of such
disclosure; or
(e) is independently developed by the receiving Party or any of its
Affiliates without reference to the Confidential Information of the disclosing
Party.
TERMINATION
6.1 Term. This Agreement shall commence on the Effective Date and unless
terminated earlier in accordance with Section 6.2 of this Agreement, shall
continue until the later of (a) the expiration of the last to expire of the
Licensed Patent Rights and (b) twenty (20) years after the filing date of the
patent application set forth on Schedule 1.12.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
11
6.2 Termination For Breach. Without limiting any other legal or equitable
remedies that a Party may have, each Party shall be entitled to terminate this
Agreement by written notice to the other Party in the event that the other Party
shall be in default of any of its material obligations hereunder and shall fail
to remedy any such default within [***] ([***]) days after written notice
thereof by the non-breaching Party ("Cure Period"). Notwithstanding the
foregoing, in the event Licensee's termination under this Section 6.2 for an
uncured material breach by Mutual would be effective after an FDA grant of
approval for Revised Labeling, then Licensee may elect, in its sole discretion
and in lieu of its termination right and without limiting any other legal or
equitable remedies that it may have, to reduce the royalties payable to Mutual
under this Agreement by [***] percent ([***]%) commencing on the expiration of
the applicable Cure Period.
6.3 Consequences of Termination. Upon any termination of this Agreement,
neither Party shall be relieved of any obligations incurred prior to such
termination, it being understood and agreed that Licensee shall have no royalty
obligations hereunder with respect to the Net Sales made after the effective
date of any termination of this Agreement. Except as provided herein, upon the
termination of this Agreement (a) by Mutual for the material breach of Licensee,
unless the termination arises out of the action or inaction of the relevant
sublicensee, or (b) by mutual agreement of Mutual and Licensee, all sublicenses
granted by Licensee and its Affiliates under this Agreement shall continue in
full force and effect as licenses directly with Mutual; provided, that
Licensee's and its Affiliates' sublicensees agree in writing to assume the
obligations of Licensee and its Affiliates' hereunder and Mutual shall have no
obligation under any such sublicense except to maintain the continued
effectiveness of the sublicense.
6.4 Disposition of Licensed Products. Upon any termination of this
Agreement, Licensee shall, within [***] ([***]) days of the effective date of
such termination, notify Mutual in writing of the amount of Licensed Products
which Licensee and its Related Parties then have completed on hand, the sale of
which would, but for the termination, be subject to royalty payments, and
Licensee and its Related Parties shall thereupon be permitted during the [***]
([***]) months following such termination to sell that amount of Licensed
Products; provided, however, that Licensee shall pay the aggregate royalty due
thereon at the conclusion of the earlier of [***] ([***]) days after the last
such sale or [***] ([***]) days after the end of such [***] ([***])-month
period.
6.5 Survival of Obligations; Return of Confidential Information.
Notwithstanding the expiration or any termination of this Agreement, the
obligations of the Parties under Sections 3.6, 4.2 (a) through (e) (in the event
of expiration of this Agreement or in the event of termination of this Agreement
but only with respect to litigation initiated prior to the effective date of
such termination), 4.2(f), 6.3, 6.4, 6.5, 7.3, 7.4, 7.5, 7.6(a), 7.7, 7.8, 7.9,
7.10, 7.11, 7.12, 7.13, 7.15 and Article V shall survive and continue to be
enforceable. Furthermore, Section 2.1(b) shall survive any termination of this
Agreement by Mutual for a material breach by Licensee. Upon any termination of
this Agreement, each Party shall promptly return to the other Party all tangible
Confidential Information of the other Party.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
12
MISCELLANEOUS
7.1 Representations and Warranties.
(a) Representations and Warranties of the Parties. Each Party hereby
represents and warrants to the other Party that (i) it is duly organized and
validly existing under the laws of its jurisdiction of incorporation or
formation, and has full corporate or other power and authority to enter into
this Agreement and to carry out the provisions hereof; (ii) it is duly
authorized to execute and deliver this Agreement and to perform its obligations
hereunder, and the person or persons executing this Agreement on its behalf has
been duly authorized to do so by all requisite corporate action; and (iii) this
Agreement is legally binding upon it and enforceable in accordance with its
terms.
(b) Representations and Warranties of Mutual. Mutual hereby represents and
warrants to Licensee that as of the Effective Date (i) it has full power and
authority to grant the licenses set forth in this Agreement; (ii) Mutual owns
all right, title and interest in and to the Licensed Patent Rights and the
Licensed Know-How, free and clear of any encumbrances, liens, charges, adverse
claims, pledges, assignments, licenses, and covenants by Mutual not to xxx any
Third Party; (iii) all patent applications within the Licensed Patent Rights
have been duly prepared, filed, prosecuted and maintained in accordance with all
applicable laws, rules and regulations; (iv) no government funding has been
obtained or used in connection with the research and development of any Licensed
Know-How or the subject matter disclosed in any of the Licensed Patent Rights,
including without limitation pursuant to any grants from the National Institutes
of Health; (v) the Licensed Know-How and Licensed Patent Rights include all of
the intellectual property owned or Controlled by Mutual specifically relating to
the labeling of Licensed Products in accordance with the Licensed Know-How and
Licensed Patent Rights; and (vi) to the knowledge of Mutual, without having made
any special inquiry in connection with the execution of this Agreement, the use
of Licensed Know-How or the Licensed Patent Rights in the labeling of Licensed
Products would not infringe or misappropriate the intellectual property rights
of any Third Party in the United States.
7.2 Disclaimer. EXCEPT AS MAY BE EXPRESSLY SET FORTH HEREIN, MUTUAL MAKES
NO REPRESENTATIONS OR WARRANTIES OF ANY KIND CONCERNING THE LICENSED PATENT
RIGHTS, LICENSED PRODUCTS AND THE RIGHTS GRANTED HEREUNDER, INCLUDING, WITHOUT
LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,
NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS, OR THE ABSENCE OF LATENT OR OTHER
DEFECTS, WHETHER OR NOT DISCOVERABLE, AND HEREBY DISCLAIMS THE SAME.
SPECIFICALLY, AND NOT TO LIMIT THE FOREGOING, EXCEPT AS EXPRESSLY SET FORTH
HEREIN, MUTUAL MAKES NO WARRANTY OR REPRESENTATION (A) REGARDING THE VALIDITY OR
SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF THE LICENSED
PATENT RIGHTS, AND (B) THAT THE EXPLOITATION OF THE LICENSED PATENT RIGHTS OR
ANY LICENSED PRODUCT WILL NOT INFRINGE ANY PATENTS OR OTHER INTELLECTUAL
PROPERTY RIGHTS OF ANY THIRD PARTY.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
13
7.3 Indemnification and Liability Limitation. (a) Licensee agrees to defend
Mutual, its agents, directors, officers and employees, at Licensee's sole
expense, and will indemnify and hold harmless Mutual, its agents, directors,
officers and employees, from and against any and all losses, costs, damages,
fees or expenses arising out of or in connection with (i) Licensee's or any of
its Related Parties' manufacture, use or sale of any Licensed Product,
including, but not limited to, any actual or alleged injury, damage, death or
other consequence occurring to any person as a result, directly or indirectly,
of the possession, use or consumption of any Licensed Product, whether claimed
by reason of breach of warranty, negligence, product defect or otherwise, and
regardless of the form in which any such claim is made or (ii) any breach of the
representations, warranties or covenants made by Licensee hereunder, except, in
each case, to the extent attributable to negligence or willful misconduct by or
on behalf of Mutual. In the event of any such claim against Mutual or any agent,
director, officer or employee, Mutual shall promptly notify Licensee in writing
of the claim and Licensee shall manage and control, at its sole expense, the
defense of the claim and its settlement. Mutual shall cooperate with Licensee
and may, at its option and expense, be represented in any such action or
proceeding.
(b) Mutual agrees to defend Licensee, its agents, directors, officers and
employees, at Mutual's sole expense, and will indemnify and hold harmless
Licensee, its agents, directors, officers and employees, from and against any
and all losses, costs, damages, fees or expenses arising out of or in connection
with (i) Mutual or any of its Related Parties' manufacture, use or sale of any
Licensed Product, including, but not limited to, any actual or alleged injury,
damage, death or other consequence occurring to any person as a result, directly
or indirectly, of the possession, use or consumption of any Licensed Product,
whether claimed by reason of breach of warranty, negligence, product defect or
otherwise, and regardless of the form in which any such claim is made or (ii)
any breach of the representations, warranties or covenants made by Mutual
hereunder, except, in each case, to the extent attributable to negligence or
willful misconduct by or on behalf of Licensee. In the event of any such claim
against Licensee, or any agent, director, officer or employee, Licensee shall
promptly notify Mutual in writing of the claim and Mutual shall manage and
control, at its sole expense, the defense of the claim and its settlement.
Licensee shall cooperate with Mutual and may, at its option and expense, be
represented in any such action or proceeding.
(c) NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT
SHALL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY
OF LIABILITY. THIS LIMITATION SHALL APPLY EVEN IF THE PARTIES HAVE BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THAT THIS LIMITATION SHALL
NOT APPLY TO DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF
CONFIDENTIALITY AND NON-USE IMPOSED UNDER ARTICLE V OR TO THE PARTIES' INDEMNITY
OBLIGATIONS UNDER THIS AGREEMENT.
7.4 Treatment Upon Bankruptcy.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
14
(a) Assumption and Assignment of Agreement.
(i) Notwithstanding any other provision of this Agreement, each Party
hereby consents to the assumption of this Agreement by the other Party (the
"Debtor Party") in any case commenced by or against the Debtor Party under Title
11 of the United States Code, as amended (the "Bankruptcy Code") to the extent
that such consent is required under Section 365(c)(1) of the Bankruptcy Code,
but only if the Debtor Party is otherwise entitled to assume this Agreement
under the applicable requirements of the Bankruptcy Code. The sole purpose of
the foregoing consent is to overcome any restriction potentially imposed by
Section 365(c)(1) of the Bankruptcy Code on the Debtor Party's assumption of
this Agreement in a bankruptcy case concerning the Debtor Party. It is not
intended to limit any other rights of the Party that is not the Debtor Party
(the "Non-Debtor Party") under this Agreement or any provision of the Bankruptcy
Code, including Section 365(c)(1). The foregoing consent applies only to the
assumption of this Agreement by the Debtor Party and does not apply to the
Debtor Party's assignment of this Agreement or any rights hereunder to a Third
Party.
(ii) Notwithstanding any other provision of this Agreement, the
Non-Debtor Party hereby consents to the assignment of this Agreement by the
Debtor Party to a Third Party solely in connection with a sale of all or
substantially all of the Debtor Party's business or assets relating to this
Agreement to such Third Party, pursuant to an orderly sale process under Section
363 of the Bankruptcy Code or a confirmed plan under Section 1129 of the
Bankruptcy Code, that contemplates the continued operation of the purchased
business or assets; provided that such Third Party promptly agrees in writing to
be bound by the terms and conditions of this Agreement and the Debtor Party is
otherwise entitled to assign this Agreement under the applicable requirements of
the Bankruptcy Code. The sole purpose of the foregoing consent is to overcome
any restriction potentially imposed by Section 365(c)(1) of the Bankruptcy Code
on the Debtor Party's assignment of this Agreement under the specific
circumstances described in this Section 7.4(a)(ii). It is not intended to limit
any other rights of the Non-Debtor Party under this Agreement or any provision
of the Bankruptcy Code, including Section 365(c)(1), or to apply to the
assignment of this Agreement in any other context.
(iii) Notwithstanding any other provision of this Agreement, but
subject to subsection (ii) above, the Debtor Party may only assign this
Agreement to a Third Party in any case commenced by or against it under the
Bankruptcy Code with the prior written consent of the Non-Debtor Party.
(b) Intellectual Property Rights. This Agreement and all rights related to
and licenses of intellectual property granted under this Agreement by one Party
to the other Party are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101(35A) of the Bankruptcy Code. In addition
to any other rights, elections and remedies under this Agreement, any related
agreements, the Bankruptcy Code, or any other applicable law, upon a written
request under Section 365(n) of the Bankruptcy Code, the Non-Debtor Party shall
be entitled to complete access to any intellectual property of the Debtor Party
pertaining to the rights granted in the licenses under this Agreement, all
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
15
embodiments of such intellectual property and all documents, material, data,
records, analyses, and information related thereto (including all clinical data,
INDs, NDAs, regulatory approvals, regulatory filings, and all other
documentation reasonably useful in respect of Licensed Products).
(c) Rejection in Bankruptcy. Any rejection of this Agreement by the Debtor
Party pursuant to Section 365 of the Bankruptcy Code shall constitute a material
breach of this Agreement not subject to notice or cure and, at the election of
the Non-Debtor Party, shall cause an immediate and automatic termination of this
Agreement. Upon any such rejection, all rights, elections and remedies of the
Non-Debtor Party to this Agreement (including under Section 365 of the
Bankruptcy Code) are expressly reserved. Further, upon any such rejection, the
Parties intend and agree that the Non-Debtor Party may elect to retain its
rights under this Agreement pursuant to Section 365(n) of the Bankruptcy Code
and that such election shall, among other things, entitle the Non-Debtor Party
to invoke and exercise all of its rights to any intellectual property under this
Agreement and any other related agreements.
7.5 Publicity. To the extent required by applicable law, Licensee shall
include in its regulatory filings a description of the terms of this Agreement.
To the extent practicable, Licensee shall provide Mutual with a copy of any such
proposed description of the terms of this Agreement before including same in any
regulatory filing, and shall consider in good faith Mutual's comments with
respect thereto. If required to file this Agreement by applicable law, Licensee
shall consult with Mutual in advance of such filing and shall use reasonable
efforts to obtain confidential treatment of its terms, to the extent reasonably
possible. Except as set forth above, neither Party shall have the right to
originate any publicity, news release or other public announcement, written or
oral, relating to this Agreement or the existence of an arrangement between the
Parties, without the prior written approval of the other Party except as
otherwise required by law.
7.6 Assignment; Assumption. (a) Except as set forth in Section 7.4 hereof,
and subject to Mutual's right of first offer pursuant to Section 3.3(c), neither
this Agreement nor any of the rights or obligations hereunder may be assigned by
either Party without the prior written consent of the other Party, not to be
unreasonably withheld, except to an Affiliate or to a person or entity who
acquires all or substantially all of the business of the assigning Party to
which this Agreement relates, by merger, sale of assets or otherwise, or to one
or more financial institutions providing financing to such Party, pursuant to
the terms of the relevant security agreement.
(b) If this Agreement is sublicensed or assigned to any Third Party in
connection with a Divestiture Transaction, such Third Party shall be required to
assume the obligations of Licensee under this Agreement. Furthermore, Licensee
shall be required to include a sublicense or assignment of this Agreement in any
Divestiture Transaction if, prior to the effective date of the definitive
agreement for the Divestiture Transaction, Revised Labeling has been obtained, a
Revised Labeling Patent Claim has issued and continues to be a Valid Claim, or a
New Formulation Licensed Product has been granted final marketing approval by
the FDA.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
16
7.7 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the laws of the State of New York, without regard to any rule or
choice of law principle of New York that would dictate the application of the
law of another jurisdiction.
7.8 Waiver. The waiver by either Party of a breach or a default of any
provision of this Agreement by the other Party shall not be construed as a
waiver of any succeeding breach of the same or any other provision, nor shall
any delay or omission on the part of either Party to exercise or avail itself of
any right, power or privilege that it has or may have hereunder operate as a
waiver of any right, power or privilege by such Party.
7.9 Notices. All notices which are required or permitted hereunder shall be
in writing and sufficient if delivered personally, sent by facsimile (effective
on the date sent) (and promptly confirmed by personal delivery, registered or
certified mail or overnight courier), sent by nationally-recognized overnight
courier (effective two (2) business days after sent) or sent by registered or
certified mail, postage prepaid, return receipt requested (effective when
delivered, per return receipt), addressed as follows:
If to Licensee, at:
King Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx
Xxxxxxx, XX 000000
Attention: General Counsel
Telephone: _______________
Fax: _____________________
If to Mutual at:
Mutual Pharmaceutical Company, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: President
Telephone: (000) 000-0000
Fax: (000) 000-0000
With a copy to:
Mutual Pharmaceutical Company, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: Legal Department
Telephone: (000) 000-0000
Fax: (000) 000-0000
; or to such other address(es) and telecopier numbers as may from time to
time be notified by either Party to the other hereunder.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
17
7.10 No Agency. Nothing herein shall be deemed to constitute either Party
as the agent or representative of the other Party or both Parties as joint
venturers or partners for any purpose. Neither Party shall be responsible for
the acts or omissions of the other Party, and neither Party will have authority
to speak for, represent or obligate the other Party in any way without prior
written authority from the other Party.
7.11 Entire Agreement. This Agreement contains the full understanding of
the Parties with respect to the subject matter hereof and supersedes all prior
understandings and writings relating thereto. No waiver, alteration or
modification of any of the provisions hereof shall be binding unless made in
writing and signed by the Parties by their respective officers thereunto duly
authorized.
7.12 Severability. In the event that any provision of this Agreement is
held by a court of competent jurisdiction to be unenforceable because it is
invalid or in conflict with any law or any relevant jurisdiction, the validity
of the remaining provisions shall not be affected, and the rights and
obligations of the Parties shall be construed and enforced as if the Agreement
did not contain the particular provisions held to be unenforceable.
7.13 Successors and Assigns. This Agreement shall be binding upon and inure
to the benefit of the Parties hereto and their permitted successors and assigns
pursuant to Section 7.6.
7.14 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.
7.15 Reporting to U.S. Government Agencies. The Parties shall report this
Agreement to the United States Federal Trade Commission and the United States
Department of Justice, Antitrust Division, pursuant to Section 1112 of Title XI
of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and
shall cooperate in responding to any requests from such government agencies.
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
18
IN WITNESS WHEREOF, the Parties hereto have caused this License Agreement
to be executed as a sealed instrument in their names by their properly and duly
authorized officers or representatives as of the date first above written.
MUTUAL PHARMACEUTICAL COMPANY, INC.
By: /s/ Xxxxxxx X. Xxxxxxx
------------------------------------
Name: Xxxxxxx X. Xxxxxxx, M.D., Ph.D.
Title: Chief Executive Officer and
President
KING PHARMACEUTICALS, INC.
By: /s/ Xxxxx Xxxxxxxx
------------------------------------
Name: Xxxxx Xxxxxxxx
Title: President and Chief Executive
Officer
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
19
Schedule A
Licensed Know-How
In Vitro Enzyme Studies
1. [***]
2. [***]
1. [***]
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
Schedule A1
Study Reports
See Attached
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
Schedule B
Licensed Patent Rights
See Attached
PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934.
