SUPPLEMENTAL LICENSE AGREEMENT
EXHIBIT 10.18
This Supplemental License Agreement (“Supplemental License Agreement”), dated as of
March 30, 2007 (the “Commencement Date”), is by and among Purdue Pharma L.P., a Delaware limited
partnership, The P.F. Laboratories, Inc., a New Jersey corporation, Purdue Pharmaceuticals L.P., a
Delaware limited partnership (the foregoing are individually and collectively referred to as the
“Purdue Companies”), and IMPAX Laboratories, Inc., a Delaware corporation (“IMPAX”). The Purdue
Companies and IMPAX are sometimes referred to herein individually as a “Party” and collectively as
the “Parties.”
WITNESSETH:
WHEREAS, the Purdue Companies are the owners of United States patent numbers 5,549,912,
5,508,042 and 5,656,295 (the “Purdue Patents”), relating to and protecting controlled-release
oxycodone products, including the product OxyContin®, a controlled-release oxycodone product; and
WHEREAS, the Purdue Companies and IMPAX entered into a Settlement Agreement, dated as of March
30, 2007 (the “Settlement Agreement”), and a Patent License Agreement, dated as of March 30, 2007
(the “PLA”), pursuant to which IMPAX was granted (i) a license of limited duration under the Purdue
Patents to make, have made, use, offer to Sell, Sell and have Sold (as such terms are defined
below) a certain number of Bottles (as defined below) of the generic versions of OxyContin®
products specifically described in ANDA No. 76-318 and
ANDA No. 76-446, along with all amendments and supplements thereto (collectively referred to
herein as the “IMPAX ANDA”), and (ii) an option to request, among other things, that the Purdue
Companies enter into this Supplemental License Agreement; and
WHEREAS, this is the Supplemental License Agreement referred to in Section 1(e) of the PLA.
NOW THEREFORE, the Parties agree as follows:
1. License Grant; Supplemental License Amount.
(a) Grant of License. The Purdue Companies hereby grant to IMPAX, a non-exclusive,
royalty-free, non-transferable (except as provided in Sections 1(d) and 12 below) license of
limited duration under the Purdue Patents to make, have made, use, offer to Sell, Sell and have
Sold the number of bottles, each containing 100 tablets (“Bottles”), determined in accordance with
Section 1(e) below (the “Supplemental License Amount”), of the generic versions of OxyContin®
products specifically described in, and sold under, the IMPAX ANDA as approved as of the Signing
Date (the “IMPAX Product”) in and for the United States (the “Supplemental License”), during the
period (the “Supplemental License Period”) commencing at 12:01 a.m., New York City time, on the
Commencement Date and terminating at 11:59 p.m., New York City time, on the “Supplemental License
Termination Date” (as provided in Section 1(e) below).
(b) The Bottles sold by IMPAX, XXXX, or any party acting on their respective behalves,
pursuant to the Supplemental License shall be allocated according to dosage strength such that the
quantity of Bottles Sold of each dosage strength shall not vary by
more than twelve and one half percent (12.5%) from the number of Bottles set forth next to each dosage strength in Schedule 1
hereto; provided that, such variations, in the aggregate, may not
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increase the Supplemental License Amount or increase the aggregate number of labeled kilograms
of oxycodone hydrochloride in the Bottles Sold pursuant to this
Supplemental License above 349 kilograms per 100,000 Bottles Sold.
(c) Immediately upon the occurrence of the Supplemental License Termination Date all
solicitations for sale of IMPAX Product, offers to sell IMPAX Product, sales of IMPAX Product and
shipments of IMPAX Product into interstate commerce for commercial sale in the United States under
the Supplemental License shall cease as set forth in Section 2 hereof. Nothing herein shall
prohibit IMPAX from making, having made, using, selling, or offering for sale, any IMPAX Product
after the Terminal Date and subject to the provisions of the Settlement Documents.
(d) IMPAX shall have no right to sublicense the license rights granted herein except to grant
only the limited, non-transferable right to Sell, offer to Sell and distribute IMPAX Product
permitted to be Sold hereunder to XXXX under the terms and conditions of this Supplemental License
Agreement until the Supplemental License Termination Date. Except as expressly granted herein, no
other right, written or oral license or sublicense, covenant not to xxx, waiver or release of
future infringement or other written or oral authorization is granted or implied by this
Supplemental License Agreement. The Purdue Companies reserve all rights not expressly granted
herein, including the right to xxx for patent infringement for sales that are not permitted
pursuant to the Supplemental License, except to the extent such suit is prohibited by Section 8(b)
hereof. For the avoidance of any doubt, nothing herein shall preclude the Purdue Companies, for
themselves or through a third party acting on their behalf, from soliciting offers for sale,
offering for sale, selling, shipping or causing to be shipped a Generic NDA Equivalent (as defined
in the PLA).
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(e) Supplemental License Amount and Supplemental License Termination Date.
(i) The “Supplemental License Amount” shall mean the sum of the following amounts;
(1)
250,000 Bottles; plus
(2)
if at any time during the period which is fewer than 30 calendar days
immediately prior to the Commencement Date Mallinckrodt Inc., a
Delaware corporation or any of its Affiliates
(“Mallinckrodt”), sells and ships any Mallinckrodt Generic
Product (as defined below) into interstate
commerce for commercial sale to the Trade (as defined below) (that is not an
Affiliate of Mallinckrodt) in the United States and intended for subsequent immediate
distribution for patient use, then an additional 100,000 Bottles; plus
(3)
if at any time during the period which is 30 or more calendar days
but fewer than 60 calendar days immediately prior to the Commencement
Date Mallinckrodt sells and ships any Mallinckrodt Generic Product into
interstate commerce for commercial sale to the Trade (that is not an Affiliate of
Mallinckrodt) in the United States and intended for subsequent immediate distribution for
patient use, then an additional 50,000 Bottles; plus
(4)
if at any time during the period which is 60 or more calendar days
but fewer than 90 calendar days immediately prior to the Commencement
Date Mallinckrodt sells and ships any Mallinckrodt Generic Product into
interstate commerce for commercial sale to the Trade (that is not an Affiliate of
Mallinckrodt) in the United States and intended for subsequent immediate distribution for
patient use, then an additional 50,000 Bottles; plus
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(5) provided that IMPAX used its commercially reasonable efforts to sell the
License Amount during the License period under the PLA, in the event IMPAX sells
fewer than 523,000 Bottles from March 1, 2007 through the License Termination Date,
the number of Bottles equal to the difference between (A) 523,000 Bottles and (B) the
number of Bottles Sold by IMPAX, XXXX or any parties acting on their respective
behalves from March 1, 2007 through the License Termination Date, but in no event
will such amount exceed 150,000 Bottles; plus
(6)
in the event (A) the Purdue Companies engage in the promotion, marketing or shipment of the Product, either by themselves or through a third party
distributor or licensee, during the period beginning on the Signing Date and ending on the Commencement Date, or (B) Mallinckrodt sells and ships during the period commencing on the
Signing Date and ending on the License Termination Date any Mallinckrodt Generic Product into interstate
commerce for commercial sale to the Trade (that is not an Affiliate
of Mallinckrodt) in the
United States and intended for subsequent immediate distribution for patient use
pursuant to a license granted by any of the Purdue Companies, in the case of either
(A) or (B) but not both, then an additional 100,000 Bottles.
For the avoidance of doubt, the Supplemental License Amount (a) is the maximum number of Bottles
permitted to be sold hereunder and all sales of the IMPAX Product must immediately cease no later
than the Supplemental License Termination Date regardless of whether the amount of Bottles actually
sold during the Supplemental License Period is less than the Supplemental License Amount and (b)
will not exceed 700,000 Bottles.
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(ii) The “Supplemental License Termination Date” shall be:
(1) if the Supplemental License Amount is 250,000 Bottles, or if the Supplemental
License Amount is equal to 250,000 Bottles plus only one or both of the additional
amounts specified in clauses (i)(5) or (i)(6)(B) of the definition thereof, then
11:59 p.m., New York City time on January 29, 2008; provided,
however, that if this clause (1) applies and the Supplemental License Amount
also includes the additional amount specified in clause (i)(6)(A), then 11:59 p.m.,
New York City time on February 12, 2008; or
(2) if the Supplemental License Amount includes one of the additional amounts
specified in clauses (i)(2) through (i)(4) of the definition thereof, then 11:59
p.m., New York City time on February 29, 2008; provided, however,
that if this clause (2) applies and the Supplemental License amount includes one of
the additional amounts specified in clauses (i)(5) or (i)(6)(A), then 11:59 p.m.,
New York City time on March 14, 2008;
provided, however, that if this Supplemental License Agreement is terminated
pursuant to Section 10 hereof prior to the dates set forth in (1) or (2) above, then the
Supplemental License Termination Date shall be the effective date of such termination.
(iii) For purposes of this Supplemental License Agreement, the following terms have the
following meanings:
“Branded Product” means OxyContin® (oxycodone hydrochloride controlled-release) tablets, under NDA
number 20-553, together with all amendments and supplements thereto.
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“Mallinckrodt
Generic Product means any 10 mg, 20 mg, 40 mg or
80 mg (i) AB rated generic version of the Branded Product
or (ii) any Product, that is sold or distributed
in the United States by Mallinckrodt.
“Product” means, except when used in “Branded Product” and “IMPAX Product”, any of the authorized
generic versions of 10 mg, 20 mg, 40 mg and 80 mg OxyContin® (oxycodone hydrochloride
controlled-release) tablets, under NDA number 20-553, together with all amendments and supplements
thereto and as marketed by the Purdue Companies as of the Signing Date.
“Trade” means wholesalers, chains, distributors, retailers, pharmacies, mail order pharmacies or
any other classes of trade that participate in the distribution or sale of pharmaceutical products.
(iv) For purposes of this Section 1, the terms “Sell”, “Selling” or “Sold” mean selling
and shipping by IMPAX, XXXX, or any other party acting on their respective behalves to a
third party bona fide purchaser for commercial sale. For the avoidance of any doubt, sales
and shipments of Bottles by IMPAX to XXXX for subsequent selling and shipping to a third
party bona fide purchaser for commercial sale under a sublicense validly granted by IMPAX to
XXXX under Section 1(d) shall be permitted and shall be excluded for purposes of determining
the Bottles Sold hereunder.
(v) Each Party will inform the other Party in writing within five (5) business days of
becoming aware of the fact that Mallinckrodt has sold and shipped any
Mallinckrodt Generic Product into interstate
commerce for commercial sale to the Trade (that is not an Affiliate of Mallinckrodt) in the United
States and intended for subsequent immediate distribution for patient use. The Purdue
Companies will inform IMPAX in writing within five (5) business days of entering into an
agreement with any third party, the effect of
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which may result in additional Bottles being included within the Supplemental License
Amount.
2. Effective Date and Supplemental License Termination Date. (a) The provisions of
this Supplemental License Agreement shall become effective on the Commencement Date. This
Supplemental License Agreement and all rights granted to IMPAX under this Supplemental License
Agreement (including any permitted sublicense thereof) will terminate on the Supplemental License
Termination Date. Without limiting the foregoing, from and after the Supplemental License
Termination Date until the Terminal Date, IMPAX will not, directly or indirectly, make, have made,
use, sell or offer to sell, import or distribute, or authorize, permit or solicit others to make,
use, have made, use, sell or offer to sell, import or distribute, or indemnify others regarding or
participate in the profits of others arising from the sale of, any controlled-release oxycodone
product that (i) is covered by the IMPAX ANDA or (ii) otherwise infringes any of the claims of any
of the Purdue Patents, including without limitation any sales or shipments from IMPAX to XXXX;
provided, however, that this sentence shall not be deemed to be breached in connection with any
IMPAX Product that is shipped to a bona fide purchaser for commercial sale by IMPAX or XXXX, as
permitted under this Supplemental License Agreement, prior to the Supplemental License Termination
Date. From and after the Supplemental License Termination Date until the Terminal Date, IMPAX shall
prohibit XXXX or any licensee, distributor, or any other party acting in a similar capacity to
XXXX, from soliciting offers for, offering to sell, selling, distributing, shipping, or causing to
be shipped, IMPAX Product into interstate commerce for commercial sale in the United States;
provided, however, that this sentence shall not be deemed to be breached in connection with any
IMPAX Product that is shipped by XXXX to a bona fide third party purchaser for commercial sale, as
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permitted under this Supplemental License Agreement, prior to the Supplemental License
Termination Date. Promptly after the Supplemental License Termination Date, IMPAX shall destroy any
inventories of the IMPAX Product remaining in its possession or control, or in the possession or
control of any licensee, distributor or any other party acting in a similar capacity on the
Supplemental License Termination Date; provided, however, that IMPAX shall not be so obligated to
destroy such inventories in the event the Terminal Date occurs prior to the Supplemental License
Termination Date. Following the Supplemental License Termination Date, IMPAX shall deliver to the
Purdue Companies certificates from the Chief Financial Officer of IMPAX or any other executive
officer of IMPAX certifying (I) that IMPAX ceased, directly or indirectly, shipping, making, having
made, using, selling, offering to sell, importing, distributing, or indemnifying others regarding
or participating in the profits of others arising from the sale of any controlled-release oxycodone
product specified in clause (i) and (ii) herein (and has instructed XXXX to cease soliciting offers
for, offering to sell, selling, distributing, shipping or causing to be shipped) IMPAX Product into
interstate commerce for commercial sale in the United States on or before the Supplemental License
Termination Date, (II) the number of Bottles of IMPAX Product in each dosage strength sold by IMPAX
from the Commencement Date to the Supplemental License Termination Date, (III) that all inventories
of IMPAX Product remaining on the Supplemental License Termination Date have been destroyed (unless
IMPAX is not so obligated because the Terminal Date has occurred prior to the Supplemental License
Termination Date), (IV) that no sales resulting in sales above the Supplemental License Amount were
made by IMPAX between the Commencement Date and the Supplemental License Termination Date and (V)
that it has requested a certificate from XXXX and any party acting on IMPAX’s or DAVA’s behalf
making the certifications referred to in clauses (II) through (V)
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above with respect to XXXX or such party. The certifications referred to in clause (I) above
shall be delivered two (2) business days following the Supplemental License Termination Date and
the certifications referred to in clauses (II)-(V) above shall be delivered within ten (10)
calendar days following the Supplemental License Termination Date. The certifications of XXXX and
any other party acting on IMPAX’s or DAVA’s behalf shall be delivered as soon as possible following
the Supplemental License Termination Date.
(b) IMPAX acknowledges and agrees that IMPAX’s violation or breach of this Supplemental
License Agreement would cause the Purdue Companies to suffer substantial damages and irreparable
harm that could not adequately be remedied by an action at law. Accordingly, IMPAX agrees that the
Purdue Companies will be entitled, without limitation, to specific performance or preliminary or
permanent injunctive relief without the requirement of posting a bond in any action, hearing,
litigation or suit for violation or breach of this Supplemental License Agreement, such rights and
remedies being in addition to all other rights and remedies available to the Purdue Companies at
law, in equity or otherwise, and IMPAX will not assert in opposition to the Purdue Companies’
request for any equitable relief that the Purdue Companies have an adequate remedy at law. IMPAX
hereby waives and agrees not to raise or assert as a defense or counterclaim in any action brought
by the Purdue Companies to enforce IMPAX’s obligations hereunder, any contention of
non-infringement, invalidity or unenforceability of the Purdue Patents, or invalidity or
unenforceability of the ‘331 Patent, or any contention under Federal or state antitrust or unfair
competition laws; provided, however, that Impax shall not be prohibited from providing evidence
that the Circuit Court of any U.S. district court has entered a judgment with respect to the validity
and/or enforceability of the Purdue Patents for purposes of determining whether or not the Terminal
Date shall have occurred. In addition to the foregoing rights and reservations, should IMPAX or XXXX (or any
other party acting on their respective behalves) ship any IMPAX Product into interstate commerce
for commercial sale in
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the United States in excess of the Supplemental License Amount or after the Supplemental
License Termination Date but prior to the Terminal Date (in either case, “Excess Sales”), the
Purdue Companies shall have the right to receive, and IMPAX agrees promptly to pay the Purdue
Companies (without any waiver or offset by the Purdue Companies of any right to further damages) an
amount equal to $0.12 for each milligram of oxycodone of Excess Sales sold; provided, however, that the rate per milligram payable shall be
increased by a percentage equal to the amount of any announced percentage increase in the price of the wholesale acquisition cost of the Branded Product by the Purdue Companies subsequent to the
Signing Date. If, and only if, IMPAX has not complied with Section 11 (which shall not, for the
avoidance of doubt, affect the liability of IMPAX to make payments to the Purdue Companies in
respect of Excess Sales under this Section 2(b)), any breach of the provisions of this Section 2 by
XXXX or any licensee, distributor, or any other party acting in a similar capacity to XXXX shall be
deemed to be a breach by IMPAX of this Supplemental License Agreement.
(c) If any of the certificates of the Chief Financial Officer of IMPAX (or any other executive
officer of IMPAX, if applicable) referred to in Section 2(a) hereof is not delivered to the Purdue
Companies in a timely manner, the Purdue Companies shall have, as their sole remedy for such
failure to deliver in a timely manner (as opposed to any noncompliance with any of the other
requirements of this Supplemental License Agreement), the right to engage a CPA Firm to conduct an
audit of IMPAX for the purposes of confirming that no sales of IMPAX Product resulted in Excess
Sales. Upon request by the Purdue Companies, IMPAX shall use its best efforts to exercise its audit
rights to conduct an audit of XXXX for the purposes of confirming that no sales of IMPAX Product
resulted in Excess Sales and that no sales of IMPAX Product occurred between the License
Termination Date and the Commencement Date. The CPA Firm shall be given access to and shall be permitted to examine and
copy such books and records of IMPAX, and to the extent permitted by XXXX, of XXXX, as it shall
request upon seven (7) business days’ notice having been given by the Purdue Companies and at all
reasonable times on business days for the purpose of reporting to the Parties that no sales of
IMPAX Product resulted in Excess Sales and that no sales of IMPAX Product occurred between the
License Termination Date and the
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Commencement Date. Prior to any such examination taking place, the
CPA Firm shall commit to IMPAX and, to the extent the CPA Firm is afforded access to DAVA’s books
and records, XXXX, to keeping all information and data contained in such books and records,
strictly confidential and shall not disclose such information or copies of such books and records
to any third person, including the Purdue Companies, but shall use the same only for the purpose of
the reviews and/or calculations which the CPA Firm needs to perform in order to confirm that no
sales of IMPAX Product resulted in Excess Sales and that no sales of IMPAX Product occurred between
the License Termination Date and the Commencement Date. Notwithstanding the foregoing, if the CPA
Firm determines that sales of IMPAX Product resulted in Excess Sales or that sales of IMPAX Product
occurred between the License Termination Date and the Commencement Date, then the Purdue Companies
shall be entitled to receive a full written report of the CPA Firm with respect to its findings.
The determination by the CPA Firm following such audit shall be final and binding on the Parties;
provided, however, that IMPAX shall have the right, prior to such determination becoming binding on
the Parties, to make a presentation to the CPA Firm (which presentation shall be completed in one
(1) business day) to ensure such CPA Firm has adequate information to make its determination;
provided further that, the Purdue Companies may be present at such presentation and may make a
presentation to the CPA Firm following the IMPAX presentation.
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If the report of the CPA Firm shows that sales of IMPAX Product resulted in Excess Sales or
that sales of IMPAX Product occurred between the License Termination Date and the Commencement
Date, IMPAX shall pay to the Purdue Companies (i) the amount specified in Section 2(b) and (ii) the
fees and expenses of the CPA Firm. If the CPA Firm reports that no such sales resulted in Excess
Sales and that no sales of IMPAX Product occurred between the License Termination Date and the
Commencement Date, the Purdue Companies shall pay the fees and expenses of the CPA Firm. IMPAX
shall cooperate with and shall use its best efforts to cause XXXX and its Affiliates to cooperate
with the CPA Firm in conducting such audit, including, without limitation, by providing sales
records relating to their sale of IMPAX Product.
(d) During the Supplemental License Period, the Purdue Companies will use their commercially
reasonable efforts to assist IMPAX with respect to its submission of applications to the Drug
Enforcement Administration for quota allocations of oxycodone hydrochloride for use in
manufacturing the IMPAX Product under the Supplemental License, including providing information
about the Settlement Agreement and this Supplemental License Agreement relevant to such
applications by IMPAX.
(e) The Supplemental License and all rights granted to IMPAX under the Supplemental License
may be terminated immediately by the Purdue Companies by notice to IMPAX if IMPAX (i) fails to
comply with any of the terms or provisions of this Supplemental License Agreement, the Settlement
Agreement or the PLA, (ii) has solicited offers for, offered to sell, sold, shipped or caused to be
shipped, IMPAX Product into interstate commerce for commercial sale in the United States, including
without limitation any sales or shipments among IMPAX and its Affiliates between the License
Termination Date and the Commencement Date or (iii) directly or
indirectly encourages Mallinckrodt to commence Selling (as defined in
Section 1(e)(iv) hereof) any Mallinckrodt Generic Product at any time.
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3. Food and Drug Administration. (a) Pursuant to 21 C.F.R. § 314.94(a)(12)(v), and
within 10 business days after the Commencement Date, IMPAX shall submit to the FDA, with a copy to
the Purdue Companies, a statement that IMPAX has been granted a license with respect to the Purdue
Patents with respect to the IMPAX Product, pursuant to the terms of this Supplemental License
Agreement.
(b) Pursuant to 21 C.F.R. § 314.94(a)(12)(viii)(A), and within 10 business days of the
Supplemental License Termination Date, IMPAX shall submit to the FDA, with a copy to the Purdue
Companies, an amendment to IMPAX’s certifications in the IMPAX ANDA with respect to the Purdue
Patents, changing those certifications to certifications under 21 C.F.R. § 314.94(a)(12)(i)(A)(3)
and requesting that the FDA promptly change the IMPAX ANDA approval from an effective approval to a
tentative approval. In the event the Terminal Date (as defined in the Settlement Agreement) has
occurred prior to the date upon which IMPAX would otherwise be required to amend, pursuant to the
terms of this Section 3(b), IMPAX’s certifications in the IMPAX ANDA, then IMPAX shall not be
required to amend such certifications with respect to the IMPAX Product. From and after the
Terminal Date, nothing herein will prohibit IMPAX from filing or maintaining with respect to the
IMPAX Product a certification, including but not limited to a certification based on invalidity or
unenforceability pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) and 21 C.F.R. §
314.94(a)(12)(i)(A)(4); provided, however, if there is a vacatur,
reversal or settlement of the type referred to in paragraph 19(x) or
(y) of the Settlement Agreement then within ten (10) days of the
issuance of such reversal or vacatur or within ten (10) days after
being notified in writing by the Purdue Companies of such settlement,
IMPAX shall submit to the FDA, with a copy to the Purdue Companies,
an amendment to IMPAX’s certifications and requests to the FDA
specified in this Section 3(b).
4. Registration. IMPAX will be responsible for, and will bear all costs involved in
respect of, the registration of the IMPAX Product with any governmental regulatory agencies.
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5. WARRANTY DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS SUPPLEMENTAL LICENSE
AGREEMENT, THE PLA OR IN THE SETTLEMENT AGREEMENT, NEITHER PARTY NOR THEIR AFFILIATES MAKES ANY
REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
NON-INFRINGEMENT, INCLUDING WITHOUT LIMITATION (1) FOR THE PURDUE COMPANIES, WITH RESPECT TO THE
PURDUE PATENTS OR ANY LICENSE GRANTED BY ANY OF THE PURDUE COMPANIES HEREUNDER, OR (2) ANY
MATERIALS OR INFORMATION PROVIDED BY SUCH PARTY OR ANY OF ITS AFFILIATES UNDER THIS SUPPLEMENTAL
LICENSE AGREEMENT, THE PLA OR THE SETTLEMENT AGREEMENT, OR (3) WITH RESPECT TO ANY PRODUCTS OR
SERVICES OF EITHER PARTY HERETO OR THEIR AFFILIATES. FURTHERMORE, UNLESS EXPRESSLY STATED IN THIS
SUPPLEMENTAL LICENSE AGREEMENT, THE PLA OR IN THE SETTLEMENT AGREEMENT, NOTHING IN THIS
SUPPLEMENTAL LICENSE AGREEMENT, THE PLA OR THE SETTLEMENT AGREEMENT SHALL BE CONSTRUED AS A
WARRANTY THAT ANY PATENT, THE PRACTICE OF ANY INVENTION CLAIMED IN ANY PATENT OR OTHER PROPRIETARY
RIGHTS INCLUDED IN THE PURDUE PATENTS OR ANY LICENSE GRANTED BY ANY OF THE PURDUE COMPANIES DO NOT,
OR THE MAKING, HAVING MADE, USING, SELLING, OFFERING FOR SALE OR IMPORTING OF IMPAX PRODUCTS BY
IMPAX DOES NOT INFRINGE ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY
WHO IS NOT AN AFFILIATE OF THE PURDUE COMPANIES. IT IS
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HEREBY AGREED AND ACKNOWLEDGED BY IMPAX THAT THE PURDUE COMPANIES ARE GIVING NO GUARANTEE OR
WARRANTY, EXPRESS OR IMPLIED, TO IMPAX IN RELATION TO THE SAFETY OR THERAPEUTIC EFFECTIVENESS OF
THE IMPAX PRODUCT. FURTHER, IMPAX WILL NOT OWE ANY SUCH GUARANTEE OR WARRANTY TO ANY THIRD PARTIES
ON BEHALF OF THE PURDUE COMPANIES.
6. Bankruptcy. The Supplemental License is, and shall otherwise be deemed to be, for
purposes of Section 365(n) of Title XI of the Bankruptcy Code, a license of rights to “intellectual
property” as defined in Section 101(56) of the Bankruptcy Code.
7. Indemnification. (a) IMPAX shall defend, indemnify and hold harmless the Purdue
Companies, their Affiliates and the respective owners, directors, officers, agents and employees of
each of them (collectively, the “Purdue Parties”), from and against any and all expenses, demands,
liabilities, damages or money judgments (“Losses”) incurred by or rendered against the Purdue
Parties resulting from (i) any claim, action or proceeding by any third party arising out of the
making, use, offer for sale or sale of the IMPAX Product or any products previously made, used or
sold under the IMPAX ANDA, (ii) any claim, action or proceeding by any third party arising out of
any material breach by IMPAX of any of its representations, warranties, covenants or agreements
made under this Supplemental License Agreement, and (iii) any breach by IMPAX of the third and
fourth sentences of Section 2(a) of this Supplemental License Agreement; provided, however, that
IMPAX will not be liable to indemnify the Purdue Parties for any Losses of the Purdue Parties to
the extent such Losses were caused by (x) the negligence or willful misconduct or wrongdoing of the
Purdue Parties or (y) any material breach by the Purdue Parties of their representations,
warranties, covenants or agreements under this
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Supplemental License Agreement and provided, further, that IMPAX’s maximum liability for
claims made (other than claims based on willful misconduct) by the Purdue Companies under Section
7(a)(ii) with respect to claims made by Teva or Endo and for claims made (other than claims based on willful
misconduct) by the Purdue Companies under Section 7(a)(iii), shall be limited to the greater of (A)
IMPAX’s aggregate gross margin from the sale of IMPAX Product
after the Signing Date and (B) $0.06 per milligram of labeled
oxycodone hydrochloride sold by IMPAX after the Signing Date and such
per milligram rate shall be increased by a percentage equal to the amount of any
announced percentage increase in the price of the wholesale
acquisition cost of the Branded Product by the Purdue Companies subsequent to the Signing Date (the greater of such amounts, the “Aggregate
Gross Margin”), determined in accordance with United States generally accepted accounting
principles, consistently applied (and derived from IMPAX’s audited financial statements to the
extent possible), without duplication for any amounts paid to the Purdue Companies by IMPAX
pursuant to the limitation on liability provided for in the proviso to Section 7(a) of the PLA. In
the event that the Purdue Companies object to a determination made by IMPAX as to the Aggregate
Gross Margin in connection with a claim for indemnification made by the Purdue Companies hereunder,
the Purdue Companies will have the right to engage a CPA Firm to conduct an audit of IMPAX for the
purposes of confirming the Aggregate Gross Margin on substantially the same basis as in Section
2(c) hereof. The determination by the CPA Firm following such audit of Aggregate Gross Margin shall
be final and binding on the Parties; provided, however, that IMPAX shall have the right, prior to
such determination becoming binding upon the Parties, to make a presentation to the CPA Firm (which
presentation shall be completed in one (1) business day) to ensure such CPA Firm has adequate
information to make its determination; provided further that, the Purdue Companies may be present
at such presentation and may make a presentation to the CPA Firm following the IMPAX presentation.
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(b) The Purdue Companies shall defend, indemnify and hold harmless IMPAX, its Affiliates, and
the respective directors, officers, agents and employees of each of them (together, the “IMPAX
Parties”), from and against any and all Losses incurred by or rendered against the IMPAX Parties
resulting from (i) any claim, action or proceeding by any third party arising out of the sale by
the Purdue Companies of their controlled-release oxycodone product, including the product
OxyContin® and (ii) any claim, action or proceeding by any third party arising out of the Purdue
Companies’ material breach of any of their representations, warranties, covenants or agreements
made under this Supplemental License Agreement; provided, however, that the Purdue Companies will
not be liable to indemnify IMPAX for any Losses of IMPAX to the extent such Losses were caused by:
(x) the negligence or willful misconduct or wrongdoing of IMPAX or (y) any material breach by IMPAX
of its representations, warranties, covenants or agreements under this Supplemental License
Agreement. The provisions of this Section 7 shall not apply to any claims made by either Party or
by third parties under Federal or state antitrust or unfair competition laws.
8. Purdue Companies’ Representations and Warranties; Covenant Not to Xxx.
(a) The Purdue Companies hereby represent and warrant as of the date hereof that: (i) each of
them has all necessary partnership or corporate, as applicable, power and authority to execute and
deliver this Supplemental License Agreement and to perform its obligations hereunder, and that the
execution, delivery and performance of this Supplemental License Agreement have been duly and
validly authorized by each of them; (ii) upon execution and delivery of this Supplemental License
Agreement by each of the Purdue Companies, this Supplemental License Agreement shall constitute the
legal, valid and binding agreement of each of them, enforceable against each of them in accordance
with its terms, subject to bankruptcy,
18
insolvency, reorganization, moratorium or other similar laws affecting the enforceability of
creditors’ rights generally and other general equitable principles which may limit the right to
obtain certain remedies; (iii) neither the execution, delivery and performance of this Supplemental
License Agreement nor the consummation or performance of this Supplemental License Agreement by the
Purdue Companies shall contravene, conflict with or result in any material violation or material
breach, as the case may be, of any law applicable to the Purdue Patents or any material contract to
which the Purdue Companies are a party; (iv) the Purdue Companies, their Affiliates and any
purchaser acquiring the Purdue Patents in compliance with the Settlement Documents, collectively
own all right, title and interest in and to each and every patent and/or patent application within
the Purdue U.S. Patent Family, and have not granted or otherwise transferred to any third party any
right to enforce any patent or patent applications included in the Purdue U.S. Patent Family, or
any right to practice any patent or patent application included in the Purdue U.S. Patent Family
that would conflict with the Supplemental License granted to IMPAX hereunder; (v) as of the Signing
Date, the licenses granted to Teva Pharmaceuticals USA, Inc.
(“Teva”) and its Affiliates and Endo Pharmaceuticals
Holdings Inc. (“Endo”) and its Affiliates, respectively, are the only licenses or
options to license to the Purdue Patents granted by the Purdue Companies for the sale in the United
States of any 10 mg, 20 mg, 40 mg or 80 mg controlled-release oxycodone product that is (A) an AB
rated generic version of OxyContin® as described in NDA No. 20-553, together with all amendments
and supplements thereto or (B) an authorized generic approved pursuant to NDA No. 20-553, together
with all amendments and supplements thereto, and (vi) as of the Signing Date, to its knowledge,
Purdue had not received any notice of certification pursuant to 21 C.F.R § 314.94(a)(12)(i)(A)(4)
for any AB rated generic version of Oxycontin® as described in NDA No. 20-553, together with all
19
amendments
and supplements thereto from any third party other than Teva, Endo,
Mallinckrodt, KV Pharmaceutical Company and Actavis Totowa LLC or any
of their Affiliates. The Purdue Companies
also represent and warrant to IMPAX that any violation or breach of this Supplemental License
Agreement by IMPAX may cause the Purdue Companies to suffer substantial damages and irreparable
harm, including causing the Purdue Companies to be in violation or breach of, or severely
disadvantaged under, certain material agreements the Purdue Companies have entered into with third
parties, provided however, that the Purdue Companies acknowledge and agree that IMPAX has not been
provided a copy of such agreements nor an opportunity to review such agreements.
(b)
The Purdue Companies hereby covenant that neither they, nor any of their Affiliates will xxx,
assert any claim or counterclaim against or otherwise participate in any action or proceeding in
the United States against IMPAX or its Affiliates claiming that the manufacture, use, sale, offer
for sale or importation of IMPAX Product pursuant to the Supplemental License, between the
Commencement Date and the Supplemental License Termination Date, infringes any patents
owned, licensed or controlled by the Purdue Companies or their Affiliates. Moreover, if and only if
(1) IMPAX does not breach Section 2(a) hereof, (2) the Purdue Companies or their Affiliates assert
one but not both claims of the U.S. Patent 5,508,042 in a case or proceeding leading to the
occurrence of the Terminal Date by virtue of paragraph 5(a)(B) of the Settlement Agreement, and (3)
IMPAX manufactures, uses, sells, offers for sale or imports 10, 20 or 40 mg dosage strength IMPAX
Product thereafter, then the Purdue Companies hereby covenant that neither they nor any of their
Affiliates will xxx, assert any counterclaim against or otherwise participate in any action or
proceeding against IMPAX or its Affiliates in the United States claiming that the manufacture, use,
sale, offer for sale or importation of 10, 20 or 40 mg dosage strength IMPAX Product infringes the
claim of U.S. Patent No. 5,508,042 not asserted in the case or proceeding leading to the occurrence
of the Terminal Date by virtue of paragraph 5(a)(B) of the Settlement Agreement; provided, however,
if the judgment referred to in paragraph 5(a)(B) of the Settlement Agreement is subsequently
reversed or vacated or the case or proceeding is settled by the parties, then such covenant shall
terminate 48 hours after the issuance of such reversal or vacatur or 48 hours after IMPAX receives
notice of the settlement of such case or proceeding. These covenants not to xxx shall be
non-transferable (except as provided in Section 12 of this Supplemental License Agreement). Nothing
in this Section shall be interpreted
20
to prohibit the Purdue Companies from (i) suing, asserting any claim or counterclaim against
or otherwise participating in any action or proceeding against IMPAX with respect to any
formulations of oxycodone (other than the activities permitted pursuant to the Supplemental License
or other than the covenants granted in the first and second sentences of this Section 8(b)), or
(ii) enforcing this Supplemental License Agreement, the Settlement Agreement, the PLA or the
Consent Judgment. Notwithstanding any provision herein to the contrary, this Section does not apply
to, negate, or in any way limit any legal rights which the Purdue Companies may have relating in
any manner to claims regarding any patents against owners, holders, licensees or beneficiaries of
an ANDA (other than the manufacture, use, sale, offer for sale or importation of IMPAX Product
under clause (i) of the immediately preceding sentence of this Section 8(b)) approved by, or
submitted before or after the date of this Supplemental License Agreement to, the FDA for a
controlled-release oxycodone product that is an AB rated generic version of OxyContin® (oxycodone
hydrochloride controlled-release) Tablets under NDA No. 20-553, together with all amendments and
supplements thereto, regardless of whether such ANDA owner, holder, licensee or beneficiary is or
would otherwise be a manufacturer, supplier, importer, distributor, purchaser or user of the IMPAX
Product. The Purdue Companies further acknowledge that (1) the appropriate remedy for breach of
this Section 8(b) by the Purdue Companies is immediate dismissal, with prejudice of any patent
infringement action brought in breach of this Section 8(b); (2) time is of the essence in
dismissing any action brought in breach of this Section 8(b); and (3) that any available form of
expedited relief to have the dismissal granted and/or considered on appeal, including but not
limited to, a motion for hearing on shortened time, shall be appropriate in the event any of the
Purdue Companies brings an action in violation of this Section 8(b). The Purdue Companies further
agree not to oppose, directly or
21
indirectly, any motion to dismiss an action brought in breach of this Section 8(b) and not to
oppose any request for expedited ruling on such motion to dismiss.
(c) The Purdue Companies hereby covenant that between the Commencement Date and the
Supplemental License Termination Date neither they, nor any of their Affiliates, will file, assist
(directly or indirectly) in the filing of, cause any other person (directly or indirectly) to file,
participate (directly or indirectly) in, or otherwise assist (directly or indirectly) a citizens' petition under 21 CFR 10.30, 10.33 or 10.35 requesting
agency action inconsistent with the Supplemental License;
provided that IMPAX has been in full compliance with the provisions of the fourth, fifth and sixth
sentences of Section 2(a) of the PLA. The Purdue Companies further acknowledge that Impax would
suffer substantial and irreparable harm from their breach of this covenant, that Impax would not
have an adequate remedy at law for such breach, and that a temporary restraining order, preliminary
injunction, and/or permanent injunction requiring withdrawal of such citizens' petition would be an appropriate remedy for such
breach.
9. IMPAX’s Representations and Warranties.
(a) IMPAX hereby represents and warrants as of the date hereof that: (i) it has all necessary
corporate power and authority to execute and deliver this Supplemental License Agreement and to
perform its obligations hereunder, and that the execution, delivery and performance of this
Supplemental License Agreement have been duly and validly authorized by it; (ii) upon execution and
delivery of this Supplemental License Agreement by IMPAX, this Supplemental License Agreement shall
constitute the legal, valid and binding agreement of IMPAX, enforceable against it in accordance
with its terms, subject to bankruptcy, insolvency, reorganization, moratorium or other similar laws
affecting the enforceability of creditors’ rights generally and other general equitable principles
which may limit the right to obtain certain remedies; (iii) neither the execution, delivery and
performance by IMPAX of this Supplemental
22
License Agreement nor the consummation or performance of this Supplemental License Agreement
by IMPAX shall contravene, conflict with or result in any material violation or material breach, as
the case may be, of any law applicable to IMPAX or any material contract to which IMPAX is a party;
(iv) no party other than IMPAX and XXXX is authorized to ship items from IMPAX’s warehouse; and (v)
IMPAX has not solicited offers for, offered to sell, sold, shipped or caused to be shipped IMPAX
Product into interstate commerce for commercial sale in the United States between the License
Termination Date and the Commencement Date.
10. Termination. In the event of a material breach by IMPAX of this Supplemental
License Agreement or the Settlement Agreement, the Purdue Companies will have the right to
terminate this Supplemental License Agreement upon written notice to IMPAX, such termination to
take effect immediately upon the delivery of such notice to IMPAX.
11. XXXX Breach Event. Notwithstanding anything to the contrary contained in this
Supplemental License Agreement (except for liability in respect of Excess Sales in Section 2(b)
hereof), including without limitation the last sentence of Section 2(b) hereof, IMPAX shall not be
deemed to have breached this Supplemental License Agreement to the extent that such breach has
resulted solely from the actions (or inactions) of XXXX under the XXXX Supply Agreement that were
not directly or indirectly taken (or not taken) at the direction of IMPAX, or in any way suggested,
encouraged or expressly or tacitly approved of, authorized, waived or released by IMPAX (any such
event, a “XXXX Breach Event”), provided that IMPAX shall have complied with each of the following:
(i) Within two days of the Commencement Date, IMPAX shall have delivered a written
notice to XXXX and DDN/Obergfel Pharmaceutical Logistics (“DDN”), in a form reasonably
acceptable to the Purdue Companies, notifying such
23
persons of the Supplemental License Termination Date, that such persons will be
prohibited from selling, offering for sale, making customer solicitations or shipping IMPAX
Product from and after such date, that any rights granted to XXXX under Section 1(d) will
have expired, and, with respect to XXXX only, of IMPAX’s intention to pursue all available
legal and equitable remedies against XXXX to the extent that XXXX takes any such actions
from and after such date, including the sale, offer for sale, distribution or shipment of
IMPAX Product.
(ii) Upon the earlier of (A) any time during the period commencing on the 5th business
day preceding the Supplemental License Termination Date and ending on the 2nd business day
preceding the Supplemental License Termination Date and (B) if this Supplemental License
Agreement is terminated by the Purdue Companies under Section 10 hereof, within two business
days of receipt of a written request from the Purdue Companies after the Supplemental
License Termination Date, IMPAX shall have delivered a written notice to XXXX and DDN in the
same form as the notice provided under clause (i) above, notifying such persons of the
Supplemental License Termination Date, that such persons will be prohibited from selling,
offering for sale, making customer solicitations or shipping IMPAX Product from and after
such date, that any rights granted to XXXX under Section 1(d) will have expired, and, with
respect to XXXX only, of IMPAX’s intention to pursue all available legal and equitable
remedies against XXXX to the extent that XXXX takes any such actions from and after such
date, including the sale, offer for sale, distribution or shipment of IMPAX Product.
(iii) IMPAX shall have used its best efforts to cause XXXX to deliver the
certifications required by Section 2(a) hereof.
24
(iv) If the Supplemental License Termination Date shall have occurred, IMPAX shall have
delivered a written notice to XXXX within two business days thereafter requesting that any
IMPAX Product then in DAVA’s possession or control promptly be returned to IMPAX, at IMPAX’s
expense.
(v) IMPAX shall forward copies of the notices referred to in clauses (i), (ii) and (iv)
above to the Purdue Companies in the manner provided in Section 16 within two business days
of the sending of each such notice.
(vi) If a XXXX Breach Event shall have occurred, IMPAX shall pursue any and all legal
and equitable remedies it may have against XXXX in connection with the facts and
circumstances giving rise to such event, and shall allow the Purdue Companies to participate
in any action or claim that it makes and/or asserts against XXXX in relation thereto at
IMPAX’s expense (including any expense incurred by the Purdue Companies for the retention of
its own counsel in connection with such matter). Any recoveries made against XXXX in
accordance with this Section 11 shall be for the benefit of, and be promptly paid by IMPAX
to, the Purdue Companies.
(vii) IMPAX shall have monitored DAVA’s inventory levels of IMPAX Product prior to the
Supplemental License Termination Date as reported to IMPAX under and in a manner consistent
with the XXXX License Agreement and via any other lawful method reasonably available to
IMPAX, and shall have taken steps reasonably calculated to ensure, based on such
information, that IMPAX Product is not supplied to XXXX in an amount that is reasonably
anticipated to have resulted in Excess Sales, and to minimize the inventory of IMPAX Product
in DAVA’s possession or control as of the Supplemental License Termination Date.
25
12. No Assignment. This Supplemental License Agreement is binding upon and shall
inure to the benefit of each Party hereto and each of its successors and permitted assigns. IMPAX
may not assign (by way of merger, acquisition, statute, operation of law or otherwise) this
Supplemental License Agreement (an “Assignment”) without the prior written consent of the Purdue
Companies which may be withheld in the Purdue Companies’ sole discretion; provided, however, that
the Purdue Companies’ consent shall not be required if such Assignment is part of the transfer of
all or substantially all of IMPAX’s assets or all of the equity or capital stock of IMPAX; provided
that such assignee is bound by and subject to the Settlement Agreement. Any Assignment, attempted
Assignment or assignment of the rights granted hereunder, by IMPAX, in contravention of the
provisions of this Section 12 shall be void and shall have no force or effect In the event that any
of the Purdue Companies (or any of their respective successors and assigns) sells or assigns (other
than in connection with the grant of a security interest) any of the Purdue Patents to any other
person or entity, such person or entity shall agree to assume the obligations of such Purdue
Company under this Supplemental License Agreement in writing as a condition to such acquisition.
13. Entire Agreement. This Supplemental License Agreement, along with the PLA, the
Settlement Agreement and the documents referred to herein and therein, set forth the entire
agreement and understanding among the Parties hereto as to the subject matter hereof and supersede
all other documents, oral consents or understandings, if any, made between the Purdue Companies and
IMPAX (excluding any agreements or stipulations endorsed by court order) before the Commencement
Date with respect to the subject matter hereof. None of the terms of this Supplemental License
Agreement shall be amended or modified except in a writing signed by each of the Parties hereto. To
the extent there is an inconsistency between any provisions of
26
this Supplemental License Agreement and the Settlement Agreement, the provisions of the
Settlement Agreement shall govern. The Parties acknowledge that there have been a number of drafts
of this Supplemental License Agreement exchanged between them prior to the Parties’ agreement on
the final version of the Supplemental License Agreement which has been executed by them. The
Parties expressly agree that all such prior drafts have been superseded by this executed
Supplemental License Agreement and shall not be used in any dispute between the Parties as evidence
with respect to interpreting the meaning of any provision of this Supplemental License Agreement.
14. Enforceability. Any term or provision of this Supplemental License Agreement
which is invalid or unenforceable in any jurisdiction shall, as to that jurisdiction, be
ineffective to the extent of such invalidity or unenforceability, without rendering invalid or
unenforceable the remaining terms and provisions of this Supplemental License Agreement in such
jurisdiction or in any other jurisdiction.
15. Governing Law. This Supplemental License Agreement, and the rights and
obligations created hereunder, shall be governed by and interpreted according to the substantive
laws of the State of New York without regard to its choice of law or conflicts of law principles.
16. Notices. Any notice required under this Supplemental License Agreement shall be
in writing and shall be given (and shall be deemed to be duly given upon receipt) by delivery in
person, by facsimile or by registered or certified mail (postage prepaid, return receipt requested)
to the respective Parties at the following addresses (or at such other address for a Party as shall
be specified by like notice):
If to any of the Purdue Companies:
Purdue Pharma L.P.
One Stamford Forum
000 Xxxxxxx Xxxxxxxxx
One Stamford Forum
000 Xxxxxxx Xxxxxxxxx
00
Xxxxxxxx, XX 00000-0000
Attn: Xxxxxx X. Xxxxx
Executive Vice President
Chief Legal Officer
Fax No.: (000) 000-0000
Attn: Xxxxxx X. Xxxxx
Executive Vice President
Chief Legal Officer
Fax No.: (000) 000-0000
with a copy to:
Xxxxxxxxxx & Xxxxx LLP
00 Xxxxxxxxxxx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxx X. Xxxxx
Fax No.: (000) 000-0000
00 Xxxxxxxxxxx Xxxxx
Xxx Xxxx, XX 00000
Attn: Xxxxxx X. Xxxxx
Fax No.: (000) 000-0000
If to IMPAX:
IMPAX Laboratories, Inc.
00000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Chief Executive Officer
Fax No.: (000) 000-0000
00000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Chief Executive Officer
Fax No.: (000) 000-0000
with a copy to:
IMPAX Laboratories, Inc.
00000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Legal Department
Fax No.: (000) 000-0000
00000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Legal Department
Fax No.: (000) 000-0000
17. Effect of Waiver. A waiver by any Party of any term or condition of this
Supplemental License Agreement in any one instance shall not be deemed or construed to be a waiver
of such term or condition for any other instance in the future (whether similar or dissimilar) or
of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements
contained in this Supplemental License Agreement shall be cumulative and none of them shall be a
limitation of any other remedy, right, undertaking, obligation or agreement of any of the Parties.
18. Legal Advice; Investigation. Each of the Parties agrees that it has received
independent legal advice from its attorneys with respect to the rights and asserted rights arising
28
out of this Supplemental License Agreement, the PLA and the Settlement Agreement. Each of the
Parties further agrees that it and its counsel have had adequate opportunity to make whatever
investigation or inquiry they may deem necessary or desirable in connection with the subject matter
of this Supplemental License Agreement, prior to the execution hereof.
19. Counterparts. This Supplemental License Agreement may be executed in counterparts
(including by facsimile or other electronic transmission), and each fully executed counterpart
shall be deemed an original of this Supplemental License Agreement.
20. Definitions. All capitalized terms used herein and not defined shall have the
meanings specified in the PLA or in the Settlement Agreement. The definitions of the terms herein
apply equally to the singular and plural of the terms defined. Whenever the context may require,
any pronoun will include the corresponding masculine, feminine and neuter forms. The words
“include”, “includes” and “including” will be deemed to be followed by the phrase “without
limitation.” Unless the context requires otherwise, (A) any definition of or reference to any
agreement, instrument or other document herein will be construed as referring to such agreement,
instrument or other document as from time to time amended, supplemented or otherwise modified
(subject to any restrictions on such amendments, supplements or modifications set forth herein or
therein) and (B) the words “herein,” “hereof” and “hereunder,” and words of similar import, will be
construed to refer to this Supplemental License Agreement in its entirety and not to any particular
provision hereof.
[remainder of this page intentionally left blank]
29
Supplemental License Agreement Signature Page
IN WITNESS WHEREOF, each of the Parties has caused this Supplemental License Agreement to be
executed as of the date first written above by its duly authorized officer or agent.
PURDUE PHARMA L.P. |
||||
By: | Purdue Pharma Inc., its general partner | |||
By: | /s/ Xxxxxx Xxxxxxx | |||
Name: | Xx Xxxxxxx | |||
Title: | EVP & CFO | |||
THE P.F. LABORATORIES, INC. |
||||
By: | /s/ Xxxxxx Xxxxxxx | |||
Name: | Xx Xxxxxxx | |||
Title: | EVP & CFO | |||
PURDUE PHARMACEUTICALS L.P. |
||||
By: | Purdue Pharma Inc., its general partner | |||
By: | /s/ Xxxxxx Xxxxxxx | |||
Name: | Xx Xxxxxxx | |||
Title: | EVP & CFO | |||
IMPAX LABORATORIES, INC. |
||||
By: | /s/ Xxxxx X. Xxxx | |||
Name: | Xxxxx X. Xxxx | |||
Title: |
Schedule 1
SUPPLEMENT LICENSE AMOUNT
(a)
250,000 Bottles
Description | Number of Bottles | |||
10 mg 100 ct |
47,500 | |||
20 mg 100 ct |
82,500 | |||
40 mg 100 ct |
75,000 | |||
80 mg 100 ct |
45,000 |
(b)
300,000 Bottles
Description | Number of Bottles | |||
10 mg 100 ct |
57,000 | |||
20 mg 100 ct |
99,000 | |||
40 mg 100 ct |
90,000 | |||
80 mg 100 ct |
54,000 |
(c)
350,000 Bottles
Description | Number of Bottles | |||
10 mg 100 ct |
66,500 | |||
20 mg 100 ct |
115,500 | |||
40 mg 100 ct |
105,000 | |||
80 mg 100 ct |
63,000 |
(d)
400,000 Bottles
Description | Number of Bottles | |||
10 mg 100 ct |
76,000 | |||
20 mg 100 ct |
132,000 | |||
40 mg 100 ct |
120,000 | |||
80 mg 100 ct |
72,000 |
(e)
450,000 Bottles
Description | Number of Bottles | |||
10 mg 100 ct |
85,500 | |||
20 mg 100 ct |
148,500 | |||
40 mg 100 ct |
135,000 | |||
80 mg 100 ct |
81,000 |
(f) Additional Bottles
Percentage of Supplemental | ||||
Description | License Amount | |||
10 mg 100 ct |
19 | % | ||
20 mg 100 ct |
33 | % | ||
40 mg 100 ct |
30 | % | ||
80 mg 100 ct |
18 | % |
32