SETTLEMENT AND LICENSE AGREEMENT
Exhibit 10.1
This is an agreement (hereinafter referred to as “Agreement”) dated as of this 21st
day of March, 2007 (the “Effective Date”), by and between Xxxxx Respiratory Therapeutics,
Inc., Xxxxx Respiratory Operations, Inc. and Xxxxx Respiratory Products, Inc., each such
corporation organized and existing under the laws of Delaware (together “Xxxxx”), and
Pharmaceutical Holdings Corp., a corporation organized and existing under the laws of Delaware, and
Mutual Pharmaceutical Co., Inc. and United Research Laboratories, Inc., each such corporation
organized and existing under the laws of Pennsylvania (together “Mutual”). Xxxxx and
Mutual are sometimes individually referred to herein as a “Party” and collectively referred
to herein as the “Parties”.
WHEREAS, Xxxxx and Mutual are parties to the patent litigations captioned, Xxxxx Respiratory
Operations, Inc. v. Pharmaceutical Holdings Corp., Mutual Pharmaceutical Co, Inc. and United
Research Laboratories, Inc., Civil Action No. 2:06-CV-04418-PD, and Xxxxx Respiratory Therapeutics,
Inc. v. Pharmaceutical Holdings Corp., Mutual Pharmaceutical Co, Inc. and United Research
Laboratories, Inc., Civil Action No. 2:06-CV-05485-PD, both of which are pending before the
Xxxxxxxxx Xxxx X. Xxxxxxx in the United States District Court for the Eastern District of
Pennsylvania (“District Court”) and to the related antitrust litigation captioned,
Pharmaceutical Holdings Corp., Mutual Pharmaceutical Co., Inc. and United Research Laboratories,
Inc. x. Xxxxx Respiratory Operations, Inc., Civil Action No. 2:07-CV-00217-PD, also pending before
the Xxxxxxxxx Xxxx X. Xxxxxxx in the District Court (the “Lawsuits”);
WHEREAS, Xxxxx manufactures, markets and sells the pharmaceutical formulations containing 600
and 1200 mg of guaifenesin alone and in combination with other active ingredients under the brand
names Mucinex® (guaifenesin 600 mg ER tablets), Mucinex® DM (guaifenesin 600
mg/pseudoephedrine 60 mg ER tablets), Mucinex® D (guaifenesin 600 mg/dextromethorphan 30
mg ER tablets) and Humibid® (guaifenesin 1200 mg ER tablets) and plans to manufacture,
market and sell future extended-release products containing guaifenesin (collectively “Xxxxx
Guaifenesin Products”);
WHEREAS, Mutual filed Abbreviated New Drug Application No. 78-333 (the “Mutual ANDA”)
seeking permission to market a 600 mg version of Mucinex® and a 1200 mg version of
Humibid®;
WHEREAS,
Mutual is in the process of developing versions of Mucinex® D and
Mucinex® DM;
WHEREAS, the Mutual ANDA contains Paragraph IV Certifications with respect to versions of the
Mucinex® (guaifenesin 600mg ER tablets) and Humibid® (guaifenesin 1200 mg ER
tablets) Xxxxx Guaifenesin Products where guaifenesin is the sole active ingredient;
WHEREAS, Xxxxx asserts that Mutual’s versions of Mucinex® and Humibid®
infringe Xxxxx’ U.S. Patent No. 6,372,252 (the “Xxxxx Patent”);
WHEREAS, with respect to the Xxxxx Patent, Mutual has asserted affirmative defenses and
counterclaims alleging invalidity, unenforceability and/or non-infringement;
WHEREAS, Mutual admits that the Mutual ANDA and the versions of Mucinex® and
Humibid® set forth therein infringe claims 24-28, 31-34 and 40 of the Xxxxx Patent and
claims 62-63 from Reexamination 90/007,514 filed April 22, 2005, and that the making, using,
selling, offering for sale or importing of the formulation set forth in the Mutual ANDA in versions
of Mucinex® D and Mucinex® DM (such as the Mutual Combination Guaifenesin
Products defined below) and other guaifenesin products would infringe the Xxxxx Patent;
WHEREAS, Mutual admits that the Xxxxx Patent is valid and enforceable;
WHEREAS, Mutual alleged as claims, counterclaims or affirmative defenses in the Lawsuits that
Xxxxx has committed exclusionary, anticompetitive and unlawful acts in violation of the Xxxxxxx
Act, the Xxxxxxx Act and state common law in connection with the Xxxxx Patent and NDA No. 21-282;
WHEREAS, Mutual hereby admits that Xxxxx has not committed any exclusionary, anticompetitive
or unlawful act in violation of the Xxxxxxx Act, the Xxxxxxx Act and/or any state common law in
connection with the Xxxxx Patent or NDA No. 21-282 or the Lawsuits;
WHEREAS, Mutual asserted that Xxxxx committed tortious interference and common law unfair
competition;
WHEREAS, Mutual admits that Xxxxx has not committed tortious interference or common law unfair
competition;
WHEREAS, Mutual agrees to withdraw each of its claims and counterclaims;
WHEREAS, the Parties wish to fully settle the Lawsuits, upon the terms and subject to the
conditions set forth in this Agreement;
WHEREAS, this Agreement and the Consent Judgment and Dismissal Without Prejudice (attached
hereto as Appendix B) are the only consideration exchanged by or on behalf of Mutual on the one
side, and Xxxxx on the other side, in reaching the agreement to dismiss the Lawsuits; and Mutual
and Xxxxx have each received no consideration from the other Party for their entry into this
Agreement other than that which is described in this Agreement and the Consent Dismissal Without
Prejudice; and this Agreement constitutes Mutual’s best independent
judgment as to how to most expeditiously and competitively sell guaifenesin products in the
United States;
WHEREAS, as a result of this Agreement, almost eight (8) years prior to expiration of the
Xxxxx Patent, Mutual will have the opportunity to sell a guaifenesin product resulting in
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increased competition for Xxxxx Guaifenesin Products, which competition otherwise might not have existed
until the expiration of the Xxxxx Patent;
WHEREAS, settlement of the Lawsuits will help both Xxxxx and Mutual avoid the substantial
uncertainty and risk involved in prolonged litigation;
WHEREAS, to the extent Mutual seeks approval of formulations subject to this Agreement as
Licensed Products, settlement of the Lawsuits will enable Mutual to file future ANDAs seeking final
FDA approval of such Licensed Products prior to the expiration of the Xxxxx Patent without being
subject to the applicability of an automatic thirty (30)-month stay of FDA approval, which would
arise by reason of potential patent actions filed by Xxxxx;
WHEREAS, settlement of the Lawsuits will permit both Xxxxx and Mutual to save litigation
costs, as well as to adhere to the judicially recognized mandate that encourages the settlement of
litigation;
WHEREAS, as a result of this Agreement, Mutual’s ability to enter into competition with the
Xxxxx Guaifenesin Products is not subject to its ability to obtain approval of the Mutual products;
WHEREAS, settlement of the Lawsuits will permit the management of both Xxxxx and Mutual to
focus their efforts on the conduct of their respective businesses rather than devoting substantial
time and resources to litigation;
WHEREAS, the public will benefit significantly from this final settlement as it will save
judicial resources and create certainty for Xxxxx and Mutual that will encourage the development,
investment and marketing of Mucinex®, Humibid® and other pharmaceutical
products;
WHEREAS, money saved by settling the Lawsuits can now be invested by Xxxxx and Mutual into
research and development, thereby benefiting consumers by identifying new uses for current drugs,
as well as furthering the creation of new medications.
NOW THEREFORE, in consideration of the promises, representations, warranties, covenants and
agreements contained herein, the receipt and sufficiency of which are hereby acknowledged, the
Parties hereto, intending to be legally bound hereby agree as follows:
1. The following terms, when used with initial capital letters, shall have the meaning set
forth below.
a. | “Xxxxx Patent” shall mean U.S. Patent No. 6,372,252. | ||
b. | “Affiliate” shall mean with respect to a Party, any person or entity that controls, is controlled by, or is under common control with, such Party. As used in this definition, “control” means (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or |
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shares having the right to vote for the election of directors, and (ii) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect at least fifty percent (50%) of the members of the governing body of such non-corporate entity. | |||
c. | “ANDA” shall mean an Abbreviated New Drug Application filed with the FDA in the Territory as defined in 21 USC § 355(j) and 21 US CFR Part 314. | ||
d. | “Bilayered Products” shall mean for purposes of this Agreement: any (i) guaifenesin-containing tablet comprising two portions compressed against one another so that the face of each portion is exposed as either the top or bottom of the tablet, wherein one portion comprises a sustained-release formulation of guaifenesin and the other portion comprises an immediate-release formulation of guaifenesin; (ii) guaifenesin-containing tablet comprising a core and a coating, wherein the core comprises a sustained-release formulation of guaifenesin in the center of the tablet and the coating comprises an immediate-release formulation of guaifenesin completely covering the core; or (iii) capsule product comprising beads of an immediate-release formulation of guaifenesin and beads of a sustained-release formulation of guaifenesin. For the sake of clarity, this definition shall not include (without limitation): (v) the formulation set forth in the Mutual ANDA; (w) a formulation only containing a sustained-release formulation as set forth in Col. 3, lines 25-43 of the Xxxxx Patent; (x) any formulation in which essentially all of the guaifenesin is mixed into a single batch or essentially identical batches of excipients; (y) any formulation in which essentially all of the guaifenesin is mixed into one or more batches of excipients comprising a sustained-release polymer; or (z) any formulation that does not contain two separate, discrete and internally contiguous regions of guaifenesin. | ||
e. | “Business Day” shall mean any day other than a Saturday, Sunday or day on which banks in New York, New York are authorized or obligated by applicable law to close. Any reference in this Agreement to “day” whether or not capitalized shall refer to a calendar day, not a Business Day. | ||
f. | “FDA” means the United States Food and Drug Administration and any successor agency having substantially the same functions. | ||
g. | “First Commercial Sale” shall mean the first commercial sale in the Territory of an Xxxxx Guaifenesin Product by Mutual, its Affiliate or single Sublicensee to the Retail Trade. First Commercial Sale shall not include a sale of an Xxxxx Guaifenesin Product among Mutual, a Mutual Affiliate or Mutual’s Sublicensee. | ||
h. | “Fully Allocated Cost Basis” shall mean, with respect to a particular Xxxxx Guaifenesin Product in any period, (i) to the extent that such Xxxxx |
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Guaifenesin Product is manufactured by Xxxxx, the direct costs to Xxxxx of manufacturing the units of finished Xxxxx Guaifenesin Product sold to Mutual during such period as calculated in accordance with generally accepted accounting principles in the United States consistently applied by Xxxxx, including (v) to the extent not already included in clause (w) below, the direct acquisition cost of all raw materials and components, including the active pharmaceutical ingredient used therein, (w) the direct costs, including direct labor and materials, of producing, packaging and labeling such Xxxxx Guaifenesin Product, (x) the direct costs for transportation, insurance and/or storage consistent with the delivery terms of such Xxxxx Guaifenesin Product and any applicable sales taxes, (y) a reasonable allocation of manufacturing overhead costs reasonably attributable to such Xxxxx Guaifenesin Product (but excluding corporate administrative overhead, depreciation and/or costs associated with excess capacity), and (z) any royalty payments made by Xxxxx to Third Parties as consideration for a license to manufacture such Xxxxx Guaifenesin Product); and (ii) to the extent that such Xxxxx Guaifenesin Product is manufactured by a Third Party contract manufacturer, the actual price paid by Xxxxx to such Third Party for the production, packaging and labeling of the units of such Xxxxx Guaifenesin Product sold in such period. | |||
i. | “Gross Profit” shall mean, with respect to an Xxxxx Guaifenesin Product in any period, the aggregate Net Sales of such Xxxxx Guaifenesin Product in such period, less the aggregate Fully Allocated Cost Basis of such Xxxxx Guaifenesin Product in such period. | ||
j. | “IRI Sales” shall mean, with respect to a product in any period, the sales of such product on a pro-rata daily basis in such period as reported by Information Resources, Inc. (“IRI”), or such other sales data source as the Parties may agree in writing. | ||
k. | “Launch Date” has the meaning given such term in Section 5(b)(i). | ||
l. | “License” has the meaning given such term in Section 4. | ||
m. | “Licensed Patents” shall mean the (i) the Xxxxx Patent and U.S. Patent Application No. 09/559,542 filed April 28, 2000, and any claims that issue from the Reexamination, and (ii) any U.S. reissue, reexamination, continuation, divisional or continuation-in-part thereof. | ||
n. | “Licensed Products” shall mean the collective reference to (i) the Mutual 600 mg Guaifenesin Product, (ii) the Mutual 1200 mg Guaifenesin Product, and (ii) the Mutual Combination Guaifenesin Products, defined herein, as well as (iv) any other product containing guaifenesin that is made with the formulation set forth in the Mutual ANDA; and a “Licensed Product” shall mean each of them. |
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o. | “Losses” shall mean all pending and potential claims, demands, all manner of actions, causes of action, suits, debts, liabilities, losses, damages, attorneys’ fees, costs, expenses, judgments, settlements, interest, punitive damages and other damages or costs of whatever nature, whether known or unknown, pending or future, certain or contingent. | ||
p. | “Marketing License Effective Date” has the meaning given such term in Section 5. | ||
q. | “Mutual 600 mg Guaifenesin Product” shall mean (i) a formulation as defined in the Mutual ANDA containing a total of 600 mg of guaifenesin as its sole active ingredient, (ii) any similar formulation that does not require a new bioequivalence clinical study for FDA approval, or (iii) or any formulation for which Mutual provides Xxxxx with a certification letter pursuant to 21 U.S.C. § 355(j)(2)(B) representing that said formulation is subject to this Agreement as a Licensed Product, but excluding in each case any Bilayered Products. | ||
r. | “Mutual 1200 mg Guaifenesin Product” shall mean (i) a formulation as defined in the Mutual ANDA containing a total of 1200 mg of guaifenesin as its sole active ingredient, (ii) any similar formulation that does not require a new bioequivalence clinical study for FDA approval, or (iii) any formulation for which Mutual provides Xxxxx with a certification letter pursuant to 21 U.S.C. § 355(j)(2)(B) representing that said formulation is subject to this Agreement as a Licensed Product, but excluding in each case any Bilayered Products. | ||
s. | “Mutual ANDA” shall mean the Abbreviated New Drug Application No. 78-333. | ||
t. | “Mutual Combination Guaifenesin Products” shall mean the collective reference to: (i) Mutual’s combination formulation containing 60 mg or 120 mg of pseudoephedrine and a Mutual 600 mg Guaifenesin Product, (ii) Mutual’s combination formulation containing 30 mg of dextromethorphan and a Mutual 600 mg Guaifenesin Product, or (iii) any formulation for which Mutual provides Xxxxx with a certification letter pursuant to 21 U.S.C. § 355(j)(2)(B) representing that said formulation is subject to this Agreement as a Licensed Product, but excluding in each case Bilayered Products. | ||
u. | “Net Sales” shall mean, with respect to an Xxxxx Guaifenesin Product in any period, the gross sales revenue for such Xxxxx Guaifenesin Product actually invoiced by Xxxxx or its Affiliates or by Mutual, its Affiliates or its single Sublicensee, as the case may be, to the Retail Trade in the Territory, less (i) trade, quantity and early pay cash discounts or rebates which are actually deducted, (ii) amounts repaid or credited by reason of returns and rebates, including any statutory or contractual liability for rebates to be paid to or for |
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the benefit of any government entity including, but not limited to, rebates to be paid pursuant to federal, state and local government rebate legislation and/or programs, (iii) any adjustments granted to customers for repayments, allowances or credits for rejected Xxxxx Guaifenesin Product, retroactive price adjustements (e.g., floorstock adjustments), reprocurement fees, damaged Xxxxx Guaifenesin Product, promotional allowances, chargebacks, disputed amounts (that are actually not paid and written off by Xxxxx or Mutual, as the case may be), or other customary discounts, deductions and administrative fees, (iv) special handling fees, transportation and insurance charges to the extent included in the invoice price, or (v) actual sales, use or excise taxes, tariff or customs duties, and other governmental charges to the extent included in the invoice. | |||
v. | “Notice Date” has the meaning given such term in Section 5(b). | ||
w. | “Paragraph IV Certification” shall mean a certification as defined in 21 U.S.C. 355(j)(2)(A)(vii)(IV). | ||
x. | “Person” or “Persons” shall mean any individual, firm, corporation, partnership, limited liability company, trust, joint venture, governmental authority, or other entity or organization. | ||
y. | “Proceeding” shall mean any action, audit, litigation, investigation, suit or other proceeding. | ||
z. | “Reexamination” shall mean Reexamination 90/007,514 filed April 22, 2005, claims 62-63 of which are attached hereto as Appendix A. | ||
aa. | “Related Party” has the meaning given such term in Section 2. | ||
bb. | “Retail Trade” shall mean a Third Party that will sell a Licensed Product directly to the public (“Retailer”), and any distributors of such Licensed Product to the retail trade that do not package or repackage such Licensed Product and that do not sell such Licensed Product to any entity other than a Retailer. | ||
cc. | “Sublicensee” shall mean a person or entity to whom Mutual grants a single sublicense pursuant to Section 4. | ||
dd. | “Supply Agreement” has the meaning given such term in Section 6. | ||
ee. | “Territory” shall mean the United States of America and its territories, commonwealths and possessions, including without limitation the Commonwealth of Puerto Rico and the District of Columbia. |
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ff. | “Third Party” shall mean any person or entity other than Xxxxx and Mutual or their respective Affiliates. | ||
gg. | “Third Party Launch Notice” has the meaning given such term in Section 5(b). | ||
hh. | “Third Party Formulation” shall mean an extended-release pharmaceutical formulation, other than the Licensed Products, that is bioequivalent to an Xxxxx Guaifenesin Product or bioequivalent to any other Xxxxx’ product containing guaifenesin. |
2. Upon the terms and subject to the conditions of this Agreement, in consideration of the
mutual execution of this Agreement and the mutual agreement to be legally bound by the terms
hereof, each Party, on behalf of itself and its Affiliates, directors, officers, employees, agents,
representatives, heirs, assigns, predecessors or successors (“Related Parties”), hereby
releases, acquits and forever discharges the other Party and its Related Parties from any and all
Losses arising out of, derived from, predicated upon or relating to the infringement of the Xxxxx
Patent or the Reexamination by the Licensed Products, or the actions underlying the Lawsuits;
provided, however, that nothing in this Agreement shall prevent or impair the right
of either Party to bring a Proceeding in state or federal courts located in the Eastern District of
Pennsylvania for a breach of this Agreement (including, without limitation, any claim for
infringement of any intellectual property based upon activities that are not the subject of the
license grants hereunder) or any representation, warranty or covenant herein or therein. The
Parties agree to the entry of a Consent Dismissal Without Prejudice in the Lawsuits, which provides
that each Party shall bear its own costs of suit and attorneys’ fees. To effectuate this
provision, promptly following the execution of this Agreement, the Parties shall cause the Consent
Dismissal Without Prejudice attached hereto as Appendix B (each Party acknowledging that the
approval of the Court is required in order to make such Consent Dismissal Without Prejudice
effective) to be filed with the District Court, and shall take all other necessary actions to
obtain the settlement and dismissal of the Lawsuits.
3. Each Party acknowledges and agrees that:
(a) | It may have sustained Losses arising out of, derived from, predicated upon or relating to the infringement of the Xxxxx Patent or the Reexamination by the Licensed Products, or the actions underlying the Lawsuits, that are presently unknown and unsuspected, and that such actions might give rise to such Losses in the future. Nevertheless, each Party acknowledges and agrees that this Agreement has been negotiated and agreed upon, notwithstanding the existence of such possible Losses, all of which have been hereby released under Section 2 hereof. | ||
(b) | If any fact relating to this Agreement or the Lawsuits and now believed to be true is found hereafter to be other than, or different from, that which is now believed, each Party expressly assumes the risk of such difference in fact and agrees that this Agreement shall be, and will remain, effective |
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notwithstanding any such difference in fact, subject to each Party’s right to bring a Proceeding for a breach of any representation or warranty herein. | |||
(c) | This Agreement may be pleaded as a full and complete defense to, and used as a basis for injunction against, any Proceeding that may be instituted, prosecuted or attempted in breach hereof. |
4. (a) Xxxxx hereby grants to Mutual a non-exclusive, royalty-free, perpetual and irrevocable
license under the Licensed Patents (the “License”) to make, have made, sell or offer for
sale to the Retail Trade, use and import each Licensed Product commencing on or after the
applicable Marketing License Effective Date for such Licensed Product (as defined below in Section
5). For clarity, the License includes, without limitation, the right of Mutual or one of its
Affiliates to (i) make, use, import and have made reasonable launch quantities of each Licensed
Product up to six (6) months prior to the applicable Marketing License Effective Date, and (ii)
sell or offer for sale, but not ship, reasonable launch quantities of each Licensed Product up to
one (1) month prior to the applicable Marketing License Effective Date.
(b) The License includes the right to grant sublicenses under the License to (i) any Related
Party for any purpose, and (ii) a single Third Party solely for the purpose of selling or offering
for sale to the Retail Trade. If Mutual sublicenses any of its rights under the License with
respect to a Licensed Product to a Third Party, Mutual agrees that it and its Affiliates will not
sell or offer for sale such Licensed Product. For clarity, only one of Mutual and its Affiliates,
on the one hand, or a single Sublicensee, on the other hand, may sell to the Retail Trade pursuant
to this paragraph.
5. As to each Licensed Product, the “Marketing License Effective Date” shall be
defined as follows:
(a) | Mutual 600 mg Guaifenesin Product: Subject to Section 5(b) below, the Marketing License Effective Date for the Mutual 600 mg Guaifenesin Product shall be the later of (i) July 1, 2012 or (ii) the date Mutual obtains FDA approval to market such Licensed Product. | ||
(b) | All Licensed Products: Mutual shall provide Xxxxx notice within five (5) business days if it obtains final FDA approval for any Licensed Product. If Mutual has obtained FDA approval of a Licensed Product and has notified Xxxxx of that approval, then Xxxxx shall notify Mutual promptly in writing if it reasonably believes that a particular Third Party likely will commence the lawful sale of a Third Party Formulation corresponding to such Licensed Product in the Territory, and shall include in such notice (a “Third Party Launch Notice”) Xxxxx’ reasonable, good faith estimate of the first lawful commercial sale of such Third Party Formulation (“Notice Date”). Mutual shall notify Xxxxx in writing if Mutual reasonably believes that a particular Third Party will commence the lawful sale of a particular Third Party Formulation, and shall include in such notice Mutual’s reasonable, good faith estimate of such commencement date. |
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Mutual shall not have the right to set the Notice Date. If Xxxxx, after sending a Third Party Launch Notice, subsequently learns of new information, it may amend such Third Party Launch Notice; provided, however, that Xxxxx may not amend a Third Party Launch Notice to change the Notice Date in such Third Party Launch Notice at any time after the date which is ninety (90) days prior to such Notice Date. | |||
(i) | If Mutual obtains approval from FDA to market a Licensed Product and receives a corresponding Third Party Launch Notice, then the Marketing License Effective Date for such Licensed Product shall be the date that is sixty (60) days prior to the Notice Date in such Third Party Launch Notice; provided, however, that if a Third Party launches a corresponding Third Party Formulation and it and all other Third Parties selling a corresponding Third Party Formulation are subsequently enjoined by a court with appropriate jurisdiction in a final, non-appealable judgment from selling their respective corresponding Third Party Formulations in the Territory, then Mutual shall cease selling such Licensed Product until a Third Party commences or re-commences the lawful sale of a corresponding Third Party Formulation in the Territory. | ||
If the actual date of first lawful commercial sale of a formulation corresponding to the Licensed Product in such Third Party Launch Notice (“Launch Date”) by (x) a Third Party or (y) Xxxxx or its Affiliates under a private label, a store brand name or a genericized brand name used for such corresponding Third Party Formulation, then: |
(A) if such Launch Date occurs prior to the Notice Date but after the Marketing
License Effective Date, then Xxxxx shall pay Mutual an amount equal to ten
percent (10%) of the aggregate IRI Sales of Xxxxx, its Affiliates and licensees
(other than licensees under this Agreement) of the Xxxxx Guaifenesin Product
corresponding to such Licensed Product for each day in which the period between
the Marketing License Effective Date and the Launch Date is less than fifty (50)
days; provided, however, that if Xxxxx fails to notify Mutual of
a Notice Date or Launch Date that Xxxxx knows or in good faith should know is
likely to occur, then Xxxxx shall pay Mutual an amount equal to the Gross Profit
for such Xxxxx Guaifenesin Product in such period; or
(B) if such Launch Date occurs prior to the Notice Date but before the
Marketing License Effective Date or if such Launch Date occurs and Xxxxx has not
notified Mutual of a Notice Date (in which case such Launch Date
shall be deemed the Marketing License Effective Date), Xxxxx shall pay Mutual an
amount equal to ten percent (10%) of the aggregate IRI Sales of Xxxxx, its
Affiliates and licensees (other than licensees under this Agreement) of the
Xxxxx Guaifenesin Product corresponding to such Licensed Product for each day in
which Mutual’s launch of its corresponding
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Licensed Product is delayed beyond
the day that is fifty (50) days prior to such Launch Date, said period not to
exceed one hundred twenty (120) days in total; provided,
however, that if Xxxxx fails to notifies Mutual of a Notice Date or
Launch Date that Xxxxx knows or in good faith should know is likely to occur,
then Xxxxx shall pay Mutual an amount equal to Xxxxx’ Xxxxx Profit for such
Xxxxx Guaifenesin Product in such period; or
(C) if such Launch Date occurs after the Notice Date, then Mutual shall pay
Xxxxx an amount equal to ten percent (10%) of the aggregate IRI Sales of Mutual,
its Affiliates and its Sublicensee of such Licensed Product during the period
commencing seventy (70) days after the Marketing License Effective Date through
such Launch Date. Mutual’s IRI Sales shall be calculated starting from the date
of the first report by IRI of sales more than $25,000, for a period of the time
equaling the number of days between 70 days after the Marketing License
Effective Date and the Launch Date. Mutual agrees to provide all required
account information necessary to track Mutual’s IRI data.
Payments from Xxxxx to Mutual under this Section 5(b)(i) shall be due within
sixty (60) days after the end of the applicable payment calculation period
described in clause (A) or (B) above, as applicable, together with a written
report containing information in sufficient detail to permit confirmation of the
accuracy of the payment made. Payments from Mutual to Xxxxx described in
clause (C) above shall be made quarterly as set forth in Section 6(c).
Neither Party shall be entitled to any other money damages resulting from a
Launch Date failing to occur on the Notice Date or failure to provide a Notice
Date, however, this liquidated damages provision shall not affect the
availability of any equitable relief to which either Party might otherwise be
entitled.
(ii) If Mutual does not obtain approval from FDA to market a Licensed Product
prior to the Launch Date of a corresponding Third Party Formulation or Xxxxx
Guaifenesin Product, then the Marketing License Effective Date shall be the date
on which Mutual obtains FDA approval to market such Licensed Product
corresponding to such FDA-approved Third Party Formulation. Mutual, in its sole
discretion, may purchase from Xxxxx and Xxxxx shall supply, pursuant to the
terms of Section 6 of this Agreement, tablets of the Xxxxx Guaifenesin Product
corresponding to such Third Party Formulation, for sale by Mutual, its
Affiliates or a single independent Sublicensee to the Retail Trade under a
private label or a brand name other than Xxxxx’ brand names for the Xxxxx
Guaifenesin Product, in the Territory
commencing no earlier than ninety (90) days after the corresponding Launch Date.
To the extent that Mutual purchases tablets of Xxxxx Guaifenesin Product
pursuant to the Supply Agreement, Xxxxx grants Mutual a non-exclusive, perpetual
and irrevocable right to sell and offer for sale to the Retail Trade such
tablets supplied by Xxxxx under the Licensed Patents in the
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Territory and agrees, in a timely manner, to take all steps with respect to the New Drug
Applications and/or other marketing authorizations for such Xxxxx Guaifenesin
Product that are necessary in order to manufacture and supply such Xxxxx
Guaifeneisin Product tablets to Mutual hereunder and under the Supply Agreement
and to ensure that Mutual and its Affiliates or its single Sublicensee, as the
case may be, is authorized to sell such Xxxxx Guaifenesin Product. Only Mutual
and its Affiliates, on the one hand, or a single Sublicensee, on the other hand,
may sell to the Retail Trade pursuant to this paragraph.
6. (a) Mutual shall notify Xxxxx in writing of its election to purchase tablets of Xxxxx
Guaifenesin Product pursuant to Section 5(b)(ii), and the Parties shall promptly execute a supply
agreement in the form attached hereto as Appendix C (“Supply Agreement”). The tablets
supplied by Xxxxx shall be white and/or in such other reasonable mono-colored configuration
mutually agreeable to the Parties, and shall be manufactured using Xxxxx’ and its Affiliates’
bilayered technology.
(b) In consideration for such supply, Mutual shall pay Xxxxx a supply price equal to the sum
of the Fully Allocated Cost Basis for such tablets, and a royalty of ten percent (10%) of the Net
Sales of Mutual, its Affiliates or its Sublicensee of such Xxxxx Guaifenesin Product in the
Territory. Only one royalty shall be due with respect to the same unit of Xxxxx Guaifenesin
Product. No royalties shall be due upon the sale or other transfer among Mutual, its Affiliates
and a single Sublicensee, but in such cases the royalty shall be due and calculated upon such Net
Sales to the first independent Third Party in the Retail Trade.
(c) Within sixty (60) days after the end of each calendar quarter after the First Commercial
Sale of an Xxxxx Guaifenesin Product by Mutual, Mutual shall deliver to Xxxxx a written report
containing the following information for the prior calendar quarter, in sufficient detail to permit
confirmation of the accuracy of the royalty payment made: (i) the gross sales invoiced for such
Xxxxx Guaifenesin Product by Mutual and its Affiliates or its single Sublicensee, (ii) a
calculation of Net Sales of such Xxxxx Guaifenesin Product that is sold by Mutual, its Affiliates
and its single Sublicensee; (iii) the amount of taxes, if any, withheld to comply with applicable
law; and (iv) a calculation of payments due to Xxxxx with respect to the foregoing. Concurrent
with these reports, Mutual shall remit to Xxxxx any payment due for the applicable calendar
quarter. All such reports shall be considered Confidential Information of Mutual and shall be
maintained in confidence by Xxxxx pursuant to Section 20.
(d) If Mutual concludes that tax withholdings under the applicable law are required with
respect to payments to Xxxxx, Mutual shall withhold the required amount and pay it to the
appropriate governmental authority.
(e) All dollar ($) amounts specified in this Agreement are United States dollar amounts and
all payments to be made under this Agreement shall be made in United States dollars and shall be
paid by bank wire transfer in immediately available funds to such bank account in the United States
as may be designated in writing by the receiving Party from time to time.
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(f) Mutual and its single Sublicensee (as applicable) shall keep correct and complete books of
accounts and other records containing all information and data which may be necessary to ascertain
and verify the royalties and other amounts payable by Mutual to Xxxxx under Sections 5(b)(i) and
6(b) of this Agreement. Xxxxx shall keep correct and complete books of accounts and other records
containing all information and data which may be necessary to ascertain and verify the amounts
payable by Xxxxx to Mutual under Section 5(b)(i) of this Agreement. During the term of this
Agreement and for a period of two (2) years following its termination or expiration, each Party
(the “Payee”) shall have the right from time to time (at its expense) to have an
independent certified public accountant inspect such books and records of the other Party (the
“Payor”), its Affiliates, and its single Sublicensee (if applicable). Such inspection shall
be conducted after reasonable prior notice by the Payee to the Payor during the Payor’s ordinary
business hours and shall not be more frequent than once during each calendar year. Any such
independent certified accountant shall be reasonably acceptable to the Payor, shall execute the
Payor’s standard form of confidentiality agreement, and shall be permitted to share with the Payee
solely its findings with respect to the accuracy of the royalties or other amounts reported as
payable under this Agreement. If such accounting determines that the Payor paid the Payee less
than the amount properly due in respect of any period, then the Payor shall promptly reimburse the
Payee such amount and if the amount underpaid exceeds five percent (5%) of the amount actually due
then the Payor shall also reimburse the Payee for the costs of such audit.
(g) The Payor shall pay interest to the Payee on the aggregate amount of any payments that are
not paid on or before the date such payments are due under this Agreement at a rate per annum equal
to the lesser of one percent (1%) per month or the highest rate permitted by applicable law,
calculated on the number of days such payments are paid after the date such payments are due and
compounded monthly.
7. Mutual hereby admits that the products described in the Mutual ANDA would infringe claims
24-28, 31-34 and 40 of the Xxxxx Patent and claims 62-63 (Appendix A) from the Reexamination in the
Territory, and that if Mutual were to make, use, offer for sale, or sell a Licensed Product in the
Territory, such product would infringe said claims of the Xxxxx Patent and the Reexamination,
respectively. Notwithstanding the above, nothing in this Agreement shall be construed or cited as
an admission of infringement (a) by any product other than a Licensed Product or (b) of any foreign
patent or currently pending patent applications.
8. Mutual hereby admits that the Xxxxx Patent and claims issuing from the Reexamination are
valid and enforceable in the Territory and agrees not to challenge the validity or enforceability
of the Xxxxx Patent in the Territory on any grounds in the future. Notwithstanding the above,
nothing in this Agreement shall (a) be construed or cited as an admission of validity or
enforceability of any foreign patent or currently pending patent
applications or (b) prohibit Mutual from asserting that a non-Licensed Product does not
infringe the Xxxxx Patent or claims issuing from the Reexamination on the grounds that such
non-Licensed Product is identical to prior art not currently known to Mutual and/or its counsel.
Prior art currently known to Mutual and/or its counsel includes, but is not limited to, all prior
art cited: (i) in the Lawsuit, (ii) in the Xxxxx patent, (iii) in the Reexamination, (iv) in U.S.
Patent
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No. 6,955,821 and (v) in any divisional, continuation, or continuation in part of U.S.
Application No. 09/559,542 that is currently publicly available, or any other prior art that is
currently in the possession of Mutual or its counsel.
9. In the event Mutual breaches this Agreement by launching a Licensed Product prior to its
Marketing License Effective Date, Mutual hereby consents to the entry of a preliminary injunction
prohibiting such sales.
10. If Mutual files a new ANDA and provides a certification letter pursuant to 21 U.S.C. §
355(j)(2)(B) representing that the new formulation is a Licensed Product, then all references in
this Agreement to the Mutual ANDA shall automatically include such new ANDA. Nevertheless, nothing
in this Agreement shall prohibit Xxxxx from commencing a patent infringement suit against Mutual
based upon a new ANDA seeking FDA approval of Bilayered Products.
11. In accordance with 35 U.S.C. § 287, Mutual agrees to affix or provide the proper patent
markings to all Licensed Products offered for sale or sold under this Agreement.
12. Mutual acknowledges and agrees that, except as otherwise expressly stated in this
Agreement, nothing in this Agreement gives Mutual any rights: (a) with respect to any Licensed
Product outside the Territory; (b) with respect to any product other than a Licensed Product; or
(c) to make, use, import, offer for sale, market or sell any generic version of any Xxxxx
guaifenesin product at any time prior to the applicable Marketing License Effective Date.
13. Xxxxx hereby agrees not to interfere with or attempt to influence in any way FDA’s review
of Mutual’s, Mutual’s Affiliates or its single Sublicensee’s ANDAs for Licensed Products or to
comment on such ANDAs to FDA. To the extent Mutual continues to seek FDA approval of the Mutual
ANDA, Mutual hereby confirms its prior statement to FDA that it intends to submit to FDA’s Office
of Generic Drugs all bioequivalence data that Mutual submitted in NDA 21-950 and all correspondence
between FDA and Mutual regarding NDA 21-950. If Mutual decides to withdraw its ANDA, Mutual will
do so within five (5) days of making that decision. If Mutual decides to pursue approval of the
Mutual ANDA or refile the Mutual ANDA, Mutual affirms that it will submit the foregoing biostudies
and correspondence to FDA’s Office of Generic Drugs in sufficient time to allow review of this
information prior to approval of the Mutual ANDA.
14. Xxxxx hereby covenants not to xxx Mutual for patent infringement for making, using,
selling or offering for sale Licensed Products, including without limitation a suit under 35 U.S.C.
§ 271(e)(2) in response to the filing of an ANDA by Mutual, except if making, using, selling or
offering for sale Licensed Products is a violation or breach of the Agreement, Xxxxx may initiate
suit against Mutual.
15. Each Party hereto represents and warrants to the other Party that, as of the date hereof:
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(a) | this Agreement is a legal, valid and binding obligation of the warranting Party, enforceable against such Party in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by general principles of equity; | ||
(b) | the warranting Party is not subject to any judgment, order, injunction, decree or award of any court, administrative agency or governmental body that would or might interfere with its performance of any of its material obligations hereunder; and | ||
(c) | the warranting Party has full power and authority to enter into and perform its obligations under this Agreement in accordance with its terms. |
16. Xxxxx represents and warrants that, as of the date hereof, it (i) presently owns, licenses
or has the legal rights to the Xxxxx Patent and NDA No. 21-282, (ii) has the legal right to grant
the License and other rights granted to Mutual hereunder, (iii) has the right to settle the
Lawsuits, and (iv) is required to pay a royalty in respect of the manufacture of Xxxxx Guaifenesin
Products of not more than $500,000 dollars annually. Mutual represents and warrants that it has
the right to settle the Lawsuits. Mutual further represents and warrants that, as of the date
hereof, Mutual Pharmaceutical Company, Inc. presently owns and has the legal rights to the Mutual
ANDA.
17. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS
OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
WARRANTIES OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE.
18. Neither Party hereto may assign any of its rights or obligations under this Agreement
without the prior written consent of the other Party, except to an Affiliate, or in
connection with a merger, reorganization, change of control or sale of all or substantially all of
the business of such Party to which this Agreement relates. Any purported assignment in violation
of the foregoing shall be null and void ab initio and of no force or effect. No assignment of this
Agreement will relieve the assigning Party from any of its obligations hereunder. In the event of
a permitted assignment, this Agreement shall be binding upon and inure solely to the benefit of the
Parties and their respective successors and permitted assigns.
19. For avoidance of doubt, all rights and licenses granted under or pursuant to any section
of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the
U.S. Bankruptcy Code (the “Bankruptcy Code”), licenses of “intellectual property” as
defined under the Bankruptcy Code. The Parties shall retain and may fully exercise all of their
respective rights and elections under the Bankruptcy Code; provided, however, that
should Xxxxx become a party to a bankruptcy proceeding and such proceeding is not dismissed within
thirty (30) days then, to the extent permitted by law, this Agreement and the licenses granted by
Xxxxx hereunder shall be adopted by any bankruptcy trustee or relevant Third Party charged with the
disposition of same, and shall not be rejected by same, it being the Parties’ intent that, in
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such event, Mutual and its Affiliates and single Sublicensee shall be entitled to retain the rights
granted to them hereunder by Xxxxx.
20.
(a) | With respect to the Confidential Information pertaining to the subject matter of this Agreement that was exchanged between the Parties prior to the Effective Date of the Agreement, the Protective Order entered in the Lawsuit shall govern; provided, however, that each Party agrees that within five (5) years after the Effective Date, unless subject to litigation, it shall return to the other Party all documentation or other tangible evidence or embodiment of Confidential Information belonging to the other Party that it or its outside counsel has retained pursuant to the Protective Order and not to use same, unless otherwise agreed in writing. With respect to Confidential Information exchanged after the Effective Date of the Agreement, each Party shall keep confidential and not disclose to others or use for any purpose, other than as authorized by this Agreement or the Supply Agreement, all such Confidential Information that was provided to it by the other Party or its Affiliates or Sublicensee or their respective employees or representatives. For purposes of this Agreement, “Confidential Information” means proprietary or confidential know-how, trade secrets, formulae, data, inventions, technology and other information of such Party. To the extent a Party considers information “Confidential” under this Agreement, it shall be so identified and marked, or if provided orally shall be memorialized in writing and identified as “Confidential” within thirty (30) days after disclosure. This Section shall not apply to any Confidential Information that: (i) was already known to the recipient at the time of disclosure, as reasonably documented by written records; (ii) is or later becomes public knowledge through no fault of the recipient; (iii) is received from a Third Party having the lawful right to disclose the information; or (iv) is independently developed by employees of the recipient without access to the disclosing Party’s Confidential Information. A Party may disclose Confidential Information of the other Party to (x) its Affiliates and Sublicensee, and to its and their directors, employees, consultants and agents, 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, and (y) to the extent such disclosure is required to comply with applicable law or to defend or prosecute litigation; provided, however, that the receiving Party provides prior written notice of such disclosure pursuant to clause (y) to the disclosing Party and takes reasonable an lawful actions to avoid or minimize the degree of such disclosure, including upon the disclosing Party’s request, seeking confidential treatment of such Confidential Information. Upon the expiration or termination of this Agreement for any reason, each Party agrees, except as otherwise provided in this Agreement, to return within thirty (30) days to the other Party all documentation or |
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other tangible evidence or embodiment of Confidential Information belonging to the other Party and not to use same, unless otherwise agreed in writing. | |||
(b) | Prior to the execution of this Agreement by both Parties the Parties shall agree in writing upon one or more press releases to be issued separately by the Parties publicizing the execution of this Agreement, and any Party holding a press conference regarding this Agreement shall provide a copy of the transcript sufficiently in advance to provide an opportunity for the other Party to provide comments. Each Party agrees that it will not make disparaging public comments about the other Party in connection with this Agreement, the Lawsuits or the Mutual ANDA. Mutual affirms that it does not currently intend to send out a press release publicizing the execution of this Agreement. Except as consistent with press releases mutually agreed by the Parties, and information disclosed in this Agreement as provided to the pertinent regulatory authorities such as the Securities and Exchange Commission, no public announcement or other disclosure to Third Parties concerning the existence of or terms of this Agreement shall be made, either directly or indirectly, by either Party, without first obtaining the written approval of the other Party and agreement upon the nature, text and timing of such announcement or disclosure; provided, however, either Party shall have the right to make any such public announcement or other disclosure required by law after such Party has provided to the other Party a copy of such announcement or disclosure and a reasonable opportunity to comment thereon. Each Party agrees that it shall cooperate fully with the other with respect to all disclosures regarding this Agreement to the Securities Exchange Commission and any other governmental or regulatory agencies, including requests for confidential treatment of proprietary information of either Party included in any such disclosure. |
21. The Parties each covenant that, at their own expense:
(a) | they shall use their respective reasonable efforts to resolve any and all objections that may be asserted with respect to this Agreement under any applicable law; | ||
(b) | they shall use their respective reasonable efforts to obtain approval of this Agreement under all applicable laws and shall make all required filings with all governmental authorities, including without limitation the reporting of this Agreement to the Federal Trade Commission and the Department of Justice pursuant to Section 1112 of Title XI of the Medicare Prescription Drug Improvement and Modernization Act of 2003; | ||
(c) | they shall use their respective reasonable efforts to comply with and terminate any investigation or inquiry regarding the Agreement by any |
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government authority, including in exchanging information, permitting reasonable access to Xxxxx’ and Mutual’s documents, officials and data in connection with receiving approvals of this Agreement by all governmental authorities; | |||
(d) | if any administrative, judicial or legislative action or proceeding is instituted (or threatened to be instituted) challenging the transaction contemplated by this Agreement as violative of any applicable law, Xxxxx and Mutual will render reasonable assistance to contest and resist any such action or proceeding, and to have vacated, lifted, reversed or overturned any decree, judgment, injunction or other order (whether temporary, preliminary or permanent) that is in effect and that challenges this Agreement, including, without limitation, by pursuing all reasonable avenues of administrative and judicial appeal; and | ||
(e) | they shall promptly inform each other of any material communication made to, or received by such Party from any governmental authority regarding this Agreement. |
22. The relationship between the Parties created by this Agreement is one of independent
contractors. Neither Xxxxx nor Mutual shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall be binding on the
other, without the prior consent of the other Party. All persons employed by a Party shall be
employees of such Party and not of the other Party and all costs and obligations incurred by reason
of any such employment shall be for the account and expense of such Party.
23. Should this Agreement be rendered null and void for any reason, Xxxxx agrees not to use
any of the stipulations contained herein or attached hereto in any subsequent litigation.
24. Any representation, warranty, covenant, term or condition of this Agreement which may
legally be waived, may be waived, or the time of performance thereof extended, at any time by the
Party hereto entitled to the benefit thereof, and any term, condition or covenant (including,
without limitation, the period during which any condition is to be satisfied or any obligation
performed) may be amended by the Parties hereto at any time. Any such waiver, extension or
amendment by a Party shall be evidenced by an instrument in writing executed by an officer of such
Party authorized to execute waivers, extensions or amendments. No waiver by any Party, whether
express or implied, of its rights under any provision of this Agreement or otherwise shall
constitute a waiver of such Party’s rights under such provisions at any other time or a waiver of
such Party’s rights under any other provision of this Agreement. No failure by any Party to take
any action against any breach of this Agreement or default by the other Party shall constitute a
waiver of the non-breaching Party’s right to enforce any provision of this Agreement
or to take action against such breach or default or any subsequent breach or default by such
other Party.
25. The Parties agree and acknowledge that this Agreement is the product of both Parties and
shall not be construed against either of the Parties other than in accordance with its
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terms. The Parties acknowledge that each has been advised by counsel during the course of negotiation of this
Agreement and, therefore, that this Agreement shall be interpreted without regard to any
presumption or rule requiring construction against the Party causing this Agreement to be drafted.
26. The Parties agree that there is no adequate remedy at law for the damage which either
Party might sustain for breach of this Agreement and, accordingly, each Party shall be entitled, as
its option, to specific performance, in addition to any other remedy at law or in equity, to
enforce the terms hereof.
27. All notices, requests, consents and other communications required or permitted under this
Agreement shall be in writing and shall be (as elected by the Party giving such notice) hand
delivered by messenger or courier service, or mailed by registered or certified mail (postage
prepaid), return receipt requested, or delivered by overnight delivery service, addressed to:
In the case of Xxxxx:
Xxxxx Respiratory Therapeutics, Inc.
0 Xxxx Xxxxx Xxxx
Xxxx Xxxxx Xxxx
Xxxxxxx, XX 00000
Attention: CEO
0 Xxxx Xxxxx Xxxx
Xxxx Xxxxx Xxxx
Xxxxxxx, XX 00000
Attention: CEO
with a copy to
Xxxxx Respiratory Therapeutics, Inc.
0 Xxxx Xxxxx Xxxx
Xxxx Xxxxx Farm
Chester, NJ 07930
Attention: General Counsel
0 Xxxx Xxxxx Xxxx
Xxxx Xxxxx Farm
Chester, NJ 07930
Attention: General Counsel
and
In the case of Mutual:
Mutual Pharmaceutical Company, Inc.
0000 Xxxxxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: President
0000 Xxxxxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: President
with a copy to:
Mutual Pharmaceutical Company, Inc.
0000 Xxxxxxxx Xxxxxx
0000 Xxxxxxxx Xxxxxx
- 00 -
Xxxxxxxxxxxx, XX 00000
Attention: Legal Department
Attention: Legal Department
Each such notice shall be deemed delivered (a) on the date delivered if by personal or overnight
delivery, and (b) on the date upon which the return receipt is signed or delivery is refused or the
notice is designated by the postal authorities as not deliverable, as the case may be, if mailed.
A contemporaneous courtesy copy of any communications with FDA under this Agreement shall be
provided to a single designated outside law firm, which shall not communicate this information to
Xxxxx.
28. This Agreement and any dispute arising out of or related to this Agreement shall be
governed by and construed in accordance with the internal laws of the State of New York, without
giving effect to conflicts of law principles that would dictate the application of the law of
another jurisdiction. Any Proceeding against any Party with respect to this Agreement or any
judgment entered by any court in respect of this Agreement shall be brought in state or federal
courts located in the Eastern District of Pennsylvania, and the Parties hereto accept the exclusive
jurisdiction of such courts for the purpose of any such suit, action or proceeding. In addition,
the Parties irrevocably waive, to the fullest extent permitted by law, any objection that they may
now or hereafter have to the laying of venue of any suit, action or proceeding arising out of or
relating to this Agreement, or any judgment entered by any court in respect hereof brought in the
Eastern District of Pennsylvania and further irrevocably waive any claim that any suit, action or
proceeding brought in the Eastern District of Pennsylvania was brought in an inconvenient forum.
29. This Agreement may be executed in any number of counterparts, and execution by each of the
Parties of anyone of such counterparts will constitute due execution of this Agreement. Each such
counterpart hereof shall be deemed to be an original instrument, and all such counterparts together
shall constitute but one agreement.
30. This Agreement, including the Appendices attached hereto, together with the Supply
Agreement, contains every obligation and understanding between the Parties relating to the subject
hereof and merges all prior discussions, negotiations and agreements, if any, between them, and
none of the Parties shall be bound by any conditions, definitions, understandings, warranties or
representations other than as expressly provided or referred to herein.
31. If any provision of this Agreement is held invalid, illegal or unenforceable for any
reason, the Parties shall negotiate in good faith for a substitute provision to continue the intent
and purpose of such invalid provision taking into account the intent and purpose of the
overall Agreement, and the validity, legality and enforceability of the remaining provisions shall
not be in any way impaired thereby.
32. No person other than the Parties hereto and their respective Affiliates, successors and
permitted assigns shall be deemed an intended beneficiary hereunder or have any legal or equitable
rights or benefits to enforce any provision of this Agreement.
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This Agreement is signed as indicated below by duly authorized representatives of Xxxxx and Mutual,
respectively, effective as of the date first written above.
XXXXX RESPIRATORY THERAPEUTICS, INC. | ||||
By: | /s/ Xxxxxx X. Xxxxxx | |||
Name: | Xxxxxx X. Xxxxxx | |||
Title: | COO | |||
Date: | 3/21/2007 | |||
XXXXX RESPIRATORY OPERATIONS, INC. | ||||
By: | /s/ Xxxxxx X. Xxxxxx | |||
Name: | Xxxxxx X. Xxxxxx | |||
Title: | COO | |||
Date: | 3/21/2007 | |||
XXXXX RESPIRATORY PRODUCTS, INC. | ||||
By: | /s/ Xxxxxx X. Xxxxxx | |||
Name: | Xxxxxx X. Xxxxxx | |||
Title: | COO | |||
Date: | 3/21/2007 | |||
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PHARMACEUTICAL HOLDINGS CORP. | ||||
By: | /s/ Xxxxxxx X. Xxxxxxx, M.D., Ph.D. | |||
Name: | Xxxxxxx X. Xxxxxxx, M.D., Ph.D. | |||
Title: | President & CEO | |||
Date: | 3/21/07 | |||
MUTUAL PHARMACEUTICAL CO., INC. | ||||
By: | /s/ Xxxxxxx X. Xxxxxxx, M.D., Ph.D. | |||
Name: | Xxxxxxx X. Xxxxxxx, M.D., Ph.D. | |||
Title: | President & CEO | |||
Date: | 3/21/07 | |||
UNITED RESEARCH LABORATORIES, INC. | ||||
By: | /s/ Xxxxxxx X. Xxxxxxx, M.D., Ph.D. | |||
Name: | Xxxxxxx X. Xxxxxxx, M.D., Ph.D. | |||
Title: | President & CEO | |||
Date: | 3/21/07 | |||
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