================================================================================
EXCLUSIVITY TRANSFER AGREEMENT
BY AND AMONG
ANDRX PHARMACEUTICALS, LLC,
ANDRX PHARMACEUTICALS, INC.,
IMPAX LABORATORIES, INC.
AND
TEVA PHARMACEUTICALS CURACAO N.V.
DATED JULY 31, 2003
================================================================================
Table of Contents
Page
----
ARTICLE I. INTERPRETATION AND DEFINITIONS.........................................................2
Section 1.1. Preamble..........................................................................2
Section 1.2. Headings..........................................................................2
Section 1.3. Definitions.......................................................................2
Section 1.4. Agreement with Respect to Each Product............................................8
ARTICLE II. PRINCIPAL TERMS........................................................................8
Section 2.1. Pre-Launch Manufacturing..........................................................8
Section 2.2. [XXXX]*; Exclusivity Transfer.....................................................9
Section 2.3. Option to Retain Production.......................................................9
Section 2.4. Marketing Efforts................................................................10
Section 2.5. Andrx Margin Payments and Additional Payments....................................11
Section 2.6. Impax Margin Payments............................................................14
Section 2.7. Shifting of Sales................................................................16
Section 2.8. Accounting Reconciliation/True-Up................................................16
Section 2.9. Dispute Resolution...............................................................16
ARTICLE III. REPRESENTATIONS AND WARRANTIES........................................................17
Section 3.1. Representations and Warranties of Andrx..........................................17
Section 3.2. Representations and Warranties of Impax..........................................17
Section 3.3. Representations and Warranties of Teva...........................................18
Section 3.4. No Other Representations.........................................................19
ARTICLE IV. COVENANTS.............................................................................19
Section 4.1. Regulatory Filings...............................................................19
Section 4.2. Cooperation......................................................................19
Section 4.3. Transferability of Andrx ANDA....................................................20
Section 4.4. Limited Remedies.................................................................20
ARTICLE V. INDEMNIFICATION AND CONTRIBUTION......................................................20
Section 5.1. Andrx Indemnification............................................................20
Section 5.2. Impax Indemnification............................................................21
Section 5.3. Teva Indemnification.............................................................21
Section 5.4. Other Indemnification............................................................21
Section 5.5. Claims; Notification.............................................................22
Section 5.6. No Consequential Damages.........................................................22
ARTICLE VI. CONFIDENTIALITY.......................................................................22
Section 6.1. General..........................................................................22
Section 6.2. Special Provisions Following Viability Date......................................22
Section 6.3. Disclosure Required by Law.......................................................23
Section 6.4. Return of Confidential Information...............................................23
Section 6.5. Publicity; Advertising...........................................................23
Section 6.6. Sole Property....................................................................23
Section 6.7. Effectiveness and Survival.......................................................23
Section 6.8. Intent...........................................................................23
ARTICLE VII. TERMINATION...........................................................................23
Section 7.1. Termination......................................................................23
Section 7.2. Effect of Termination............................................................24
ARTICLE VIII. MISCELLANEOUS.........................................................................25
Section 8.1. Force Majeure....................................................................25
Section 8.2. Amendments.......................................................................25
Section 8.3. Press Releases; Disclosures......................................................26
Section 8.4. Suits; Litigation................................................................26
Section 8.5. Payments in U.S. Dollars.........................................................26
Section 8.6. Governing Law....................................................................26
Section 8.7. Notices..........................................................................26
Section 8.8. Entire Agreement.................................................................28
Section 8.9. Independent Contractor...........................................................28
Section 8.10. Successors and Assigns...........................................................28
Section 8.11. Severability.....................................................................28
Section 8.12. Submission to Jurisdiction.......................................................28
Section 8.13. Waiver of Jury Trial.............................................................29
Section 8.14. Third Party Beneficiaries........................................................29
Section 8.15. Counterparts.....................................................................29
--------
* Filed under an application for confidential treatment.
i
EXCLUSIVITY TRANSFER AGREEMENT
This Exclusivity Transfer Agreement (this "Agreement") is entered into
as of July 31, 2003 by and among ANDRX PHARMACEUTICALS, LLC, a Delaware limited
liability company, and ANDRX PHARMACEUTICALS, INC., a Florida corporation, each
with offices located at 0000 Xxxxxx Xxxxx, Xxxxx, XX 00000 (such entities,
collectively, "Andrx"), IMPAX LABORATORIES, INC., a Delaware corporation with
offices located at 00000 Xxxxxxxx Xxxxxx, Xxxxxxx, XX 00000 ("Impax"), and TEVA
PHARMACEUTICALS CURACAO N.V., a Netherlands Antilles company with offices
located at Xxxxxxxxxxxx Xxxx 00 X, Xxxxxxx, Xxxxxxxxxxx Antilles ("Teva").
Andrx, Impax and Teva are sometimes collectively referred to herein as the
"Parties" and separately as a "Party." Certain capitalized terms used herein are
defined in Section 1.3 hereof.
WHEREAS, each of Andrx and Impax has filed ANDAs for each of the
Products and is seeking FDA Approval of such ANDAs;
WHEREAS, Andrx believes in good faith that, upon Final Approval by the
FDA of the applicable ANDA for each Product, Andrx is entitled to be awarded
First to File Exclusivity for each Product;
WHEREAS, as of the date hereof, Andrx does not have Final Approval by
the FDA of the Products due to regulatory, legal and/or technical issues;
WHEREAS, Impax and Teva have entered into a Strategic Alliance
Agreement dated June 27, 2001 (as may be amended from time to time, the
"Strategic Alliance Agreement"), whereby Teva and Impax have agreed, among other
things, to cooperate in completing the development of the Products and to
register, manufacture and Market the Products in the Territory;
WHEREAS, Impax has successfully scaled-up and validated its
manufacturing processes for the Products;
WHEREAS, Impax believes in good faith that its ANDAs for the Products
will soon receive Tentative Approval and that it can build commercial launch
quantities of its Products [XXXX]* of its Products for Marketing during the
Andrx Margin Period as further provided herein;
WHEREAS, the Parties desire to enter into this Agreement to make the
Products more quickly available in the Territory and, as further provided in
this Agreement, and are willing to share the Contract Margins from the sale of
the Products in the Territory; and
WHEREAS, in order to make the Products available in the Territory as
soon as possible, Impax and Teva desire that Andrx effect an Exclusivity
Transfer with respect to the Products to Impax and Teva, or if such [XXXX]* such
rights, all on the terms and subject to the conditions set forth in this
Agreement.
NOW THEREFORE, solely in consideration of the premises and the
representations, warranties, covenants and agreements herein contained and
intending to be legally bound hereby, the Parties hereby agree as follows:
-------
* Filed under an application for confidential treatment.
ARTICLE I.
INTERPRETATION AND DEFINITIONS
Section 1.1. Preamble. The preamble to this Agreement forms an integral
part hereof.
Section 1.2. Headings. Section headings in this Agreement are intended
solely for convenience of reference and shall be given no effect in the
interpretation of this Agreement.
Section 1.3. Definitions. For the purposes of this Agreement, the
following words and phrases shall bear the respective meanings assigned to them
below (and cognate expressions shall bear corresponding meanings):
(a) "Additional Payments" shall mean, (A) in the case of an Exclusivity
Transfer with respect to both Products, a total of up to [XXXX]* payable monthly
in arrears commencing at the beginning of the Andrx Margin Period and ending at
the end of the Exclusivity Period with respect to any Product, at the rate of
[XXXX]* per month, (B) in the case of an Exclusivity Transfer with respect to
[XXXX]* Product only, a total of up to [XXXX]*, payable monthly in arrears
commencing at the beginning of the Andrx Margin Period and ending at the end of
the Exclusivity Period with respect to such Product, at the rate of [XXXX]* per
month, (C) [XXXX]* payable monthly in arrears commencing at the beginning of the
Andrx Margin Period at the rate of [XXXX]* per month, (D) [XXXX]*, payable
monthly in arrears commencing at the beginning of the Andrx Margin Period at the
rate of [XXXX]* per month, and (E) in the case of an Exclusivity Transfer
[XXXX]* with respect to [XXXX]* only, nothing; provided, that, in the event of
[XXXX]*, the Additional Payments will be [XXXX]* (1) a total of up to[XXXX]* ,
at the rate of [XXXX]* per month, with respect to Exclusivity Transfers under
clause (A) above, (2) a total of up to[XXXX]* , at the rate of [XXXX]* per
month, with respect to the Exclusivity Transfer under clause (B) above, (3) a
total of [XXXX]*, at the rate of [XXXX]* per month, with respect [XXXX]* clause
(C) above, and (D) a total of [XXXX]*, at the rate of [XXXX]* per month, with
respect [XXXX]* clause (D) above.
--------
* Filed under an application for confidential treatment.
2
(b) "Affiliates" shall mean with respect to any Person, any Person that
is controlled by, controls, or is under common control with such Person. For
this purpose, "control" of a corporation or other business entity shall mean
direct or indirect beneficial ownership of more than fifty percent (50%) of the
voting interest in, or more than fifty percent (50%) in the equity of, or the
right to appoint more than fifty percent (50%) of the directors or management of
such corporation or other business entity.
(c) "ANDA" shall mean an Abbreviated New Drug Application filed with
the FDA pursuant to its rules and regulations.
(d) "Andrx Launch Date" shall mean, on a Product-by-Product basis, the
date on which Andrx or an Affiliate of Andrx makes its first commercial sale of
such Product to an unrelated third party in an arms-length transaction in the
Territory.
(e) "Andrx Margin" shall mean for each Product sold by Teva, Impax or
their respective Affiliates, respectively, (i) if Andrx effects an Exclusivity
Transfer with respect to such Product pursuant to Section 2.2(b) hereof, an
amount equal to [XXXX]*percent [XXXX]* of the Contract Margin of such Product
with respect to the Exclusivity Period for such Product, and (ii) if [XXXX]*
pursuant to Section 2.2(c) hereof, an amount equal to [XXXX]* percent [XXXX]* of
the Contract Margin of such Product.
(f) "Andrx Margin Period" shall have the meaning set forth in Section
2.4(a).
(g) "API" shall mean the bulk active pharmaceutical ingredient
bupropion used in the manufacture of the Products.
(h) "Applicable Law" shall mean the applicable laws, rules,
regulations, guidelines and requirements of any Governmental Entity related to
the development, registration, manufacture, importation, Marketing, sale and
distribution of the Products in the Territory.
(i) "Approval(s)" shall mean any and all approvals, licenses,
registrations or authorizations of the applicable Regulatory Authority necessary
for the Marketing of the Products and reimbursement, if applicable, in the
Territory.
(j) "Calendar Month" shall mean each of the twelve monthly periods of
the year, beginning in January and ending in December.
(k) "Calendar Quarter" shall mean the up to three (3) month period
ending on March 31, June 30, September 30 or December 31.
-------
* Filed under an application for confidential treatment.
3
(l) "cGMP" shall mean current good manufacturing practices as required
by the rules and regulations of the FDA as applicable to the manufacture,
packaging, handling, storage and control of the Products in the Territory.
(m) "Chargebacks" shall mean the amount paid by any Party or its
Affiliates to reconcile the amounts invoiced to persons in the chain of commerce
to the actual amount that such Party or its Affiliate has agreed to charge its
customer for the Product, without regard as to whether such customer acquires
the Product directly from the Party or its Affiliate or from a third party (such
as a wholesaler).
(n) "Competing Product" shall mean any finished pharmaceutical product
for sale in the prescription drug marketplace as a generic that contains the
same active ingredients in the same dosage form and strength as any Product,
with twice daily administration, other than Products sold under the trademark
Wellbutrin(R) SR or Zyban(R).
(o) "Confidential Information" shall mean the existence and terms of
this Agreement and the transactions contemplated hereby and all information,
data and/or know-how disclosed by any Party to another Party concerning the
Products or concerning the technology, marketing strategies or business of the
disclosing Party (whether disclosed prior to or subsequent to the date hereof).
Confidential Information shall not include information, data or know-how that
the receiving Party can show:
(i) was in the public domain at the time of the disclosure by
the disclosing Party, or thereafter becomes part of the public domain
without any fault of the receiving Party;
(ii) rightfully was in its possession prior to the disclosure
by the disclosing Party;
(iii) was lawfully obtained from a third party, who had the
right to make such disclosures as evidenced by written records; or
(iv) was developed by it independently of such disclosure as
evidenced by written records.
(p) "Contract Margin" shall mean, with respect to each Product
calculated separately, an amount equal to the Net Sales of such Product less
applicable Manufacturing Costs and less applicable Operating Expenses.
(q) "Cost of Materials" shall mean, on a Product-by-Product basis, the
actual direct cost for inactive and active materials required for the
manufacture of the particular Product [XXXX]*.
-------
* Filed under an application for confidential treatment.
4
(r) "Distribution Margin" shall mean the excess amount that Andrx
derives from the distribution of the Products through its Affiliates that act as
distributors (presently Anda, Inc., Anda Pharmaceutical, Inc. and VIP) to the
customers of such distributor Affiliates as of the date of this Agreement, as
opposed to (i) the sale of Products directly to warehousing retailers, [XXXX]*
or (ii) customers that are not customers of such distributor Affiliates as of
the date of this Agreement. As an example, if the average selling price of
Product by Andrx is $100 per unit to warehousing retailers, and such unit is
sold by Andrx's distributor Affiliate for $110 to an existing customer, the
Distribution Margin for such unit shall be $10.
(s) "Exclusivity Period" shall mean, with respect to any Product, the
period commencing on the date an Exclusivity Transfer is effected pursuant to
Section 2.2 hereof until the end of such First to File Exclusivity rights so
transferred.
(t) "Exclusivity Transfer" shall mean, with respect to any Product, the
transfer by Andrx of its First to File Exclusivity rights relating to such
Product to Impax and Teva in accordance with Section 2.2(b) hereof.
(u) "FDA" shall mean the United States Food and Drug Administration and
all agencies under its direct control or any successor organization.
(v) "Final Approval" shall mean, with respect to any Product, the final
FDA Approval of the ANDA of Impax or Andrx, as applicable, with respect to such
Product.
(w) "First to File Exclusivity" shall mean, to the extent applicable,
up to 180 days of marketing exclusivity in the United States from the FDA under
and pursuant to 21 U.S.C. Section 355(j)(5)(B)(iv) of the Federal Food, Drug and
Cosmetic Act, as amended.
(x) "Force Majeure Events" shall have the meaning set forth in Section
8.1.
(y) "Governmental Entity" shall mean any supernational, national,
foreign, federal, state or local judicial, legislative, executive,
administrative or regulatory body or authority.
(z) "HSR Act" shall mean the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements
Act of 1976, as amended, and the rules and regulations thereunder.
(aa) "Impax Launch Date" shall mean, on a Product-by-Product basis, the
date on which Impax, Teva or a designee of Impax or Teva makes its first
commercial sale of such Product to an unrelated third party in an arms-length
transaction in the Territory.
(bb) "Impax Margin" shall mean, for each Product sold by Andrx or its
Affiliates, respectively, an amount equal to: [XXXX]* percent [XXXX]* of the
Contract Margin of such Product; provided, that if Impax has not [XXXX]* * for
any reason other than substantial manufacturing delays resulting from the
non-timely supply of API, the foregoing [XXXX]*amount shall be reduced by
[XXXX]*percentage points for each full month delay in the provision of
such[XXXX]*. In the event the scheduled manufacture of Product is delayed by a
delay in the supply of API, as evidenced by documentation from the supplier, the
foregoing date of [XXXX]*shall be extended by the amount of time by which the
scheduled manufacture of Product was delayed by the non-supply of API. By way of
example, the foregoing percentage would be [XXXX]* and [XXXX]*, respectively, if
Impax [XXXX]*, respectively, except that, if the manufacturing delay resulted
from a month delay in the scheduled supply of API, the foregoing dates shall be
deemed to have been [XXXX]* and [XXXX]*, respectively, and the foregoing
percentages shall be deemed to have been [XXXX]* and [XXXX]*, respectively.
-------
* Filed under an application for confidential treatment.
5
(cc) "Impax Margin Period" shall have the meaning set forth in Section
2.4(b).
(dd) "Launch Quantities" shall mean, on a Product-by-Product basis, the
quantities to launch such Product for commercial sale in the Territory, as set
forth on Schedule 1.3(dd) hereto.
(ee) "Manufacturing Costs" shall mean, on a Product-by-Product basis,
the total of all actual direct manufacturing costs (including the Cost of
Materials and packaging material) allocable to the manufacture of the particular
Products sold in the Territory during the reporting period, as determined in
accordance with U.S. GAAP; provided, however, that Manufacturing Costs shall not
include any allocation or absorption of excess or idle capacity.
(ff) "Market" or "Marketing" shall mean promotion, distribution,
marketing, advertising and/or sale.
(gg) "Net Sales" shall mean, with respect to each of the Products sold,
the gross amount invoiced on an arms-length basis to third parties in the
Territory, when shipped to the customer, if terms of sale are F.O.B. shipping
point, and when received by the customer, if terms of sale are F.O.B.
destination, less the sum of: (a) [XXXX]*and (b) [XXXX]* respectively, in each
case determined in accordance with U.S. GAAP. Items in (b) above shall be
subject to adjustment pursuant to the reconciliation procedures set forth in
Section 2.8. [XXXX]*
For the purpose of calculating Net Sales, the Parties recognize and
agree that: (A) retroactive price adjustments will be recorded as a deduction to
derive Net Sales after the deduction is issued to the customers upon written
notification (including through electronic means) from the customer of the
amount of Product on their shelves, but only to the extent of an actual decrease
in the net market price of Product to that customer by Teva, Impax, Andrx or
their respective Affiliates, as the case may be (and, for purposes of
clarification, the retroactive price adjustment is not intended to be an
estimate of what is on the customers' shelves or an estimate in anticipation of
a potential decrease in the net market price of the Product); and (B) the
Distribution Margin shall not be included in Andrx's Net Sales, provided, that
the terms of the sale of the Products from Andrx to its distributor Affiliates
are on an arms-length basis.
-------
* Filed under an application for confidential treatment.
6
(hh) "Operating Expenses" shall mean, on a Product-by-Product basis,
[XXXX]*percent [XXXX]* of the Net Sales for each of the Products sold by Impax
and/or Teva or Andrx and/or its Affiliate, as applicable, on an arms-length
basis to third parties in the Territory as a contribution towards [XXXX]*.
(ii) "Person" shall mean any individual, partnership, association,
corporation, limited liability company, trust, or other legal person or entity.
(jj) [XXXX]*.
(kk) "Product(s)" shall mean each of the following finished
pharmaceutical products for the prescription drug marketplace: (1) bupropion ER,
100 mg strength and (2) bupropion ER, 150 mg strength, but only with respect to
products that are bioequivalent to Wellbutrin(R) SR and/or Zyban(R).
(ll) "Product Waiver" shall mean [XXXX]*
(mm) [XXXX]*
(nn) [XXXX]*
(oo) "Regulatory Authority" shall mean any and all governmental bodies,
organizations and agencies whose approval is necessary to develop, manufacture,
import, use, and/or Market the Product in the Territory.
(pp) "Regulatory Documentation" shall mean all submissions to
Regulatory Authorities, including clinical studies, tests, and biostudies
relating to the Product, including, without limitation, all ANDAs, 505(b)(2)
applications, and DMFs as well as all correspondence with Regulatory Authorities
(registration and licenses, regulatory drug lists, advertising and promotion
documents), adverse event files, complaint files, manufacturing records and
inspection reports.
(qq) [XXXX]*
(rr) "Retain Production" shall have the meaning set forth in Section
2.3(a).
-------
* Filed under an application for confidential treatment.
7
(ss) "Specifications" shall mean, for a particular Product, the agreed
specifications, methods and processes of the Product as contained in the
applicable Approval for that Product.
(tt) "Tentative Approval" shall mean, with respect to any Product, the
tentative FDA Approval of the ANDA of Impax with respect to such Product.
(uu) "Territory" shall mean the United States of America and its
territories, districts and possessions.
(vv) "U.S. GAAP" shall mean generally accepted accounting principles in
the United States, as consistently applied by the reporting entity.
Section 1.4. Agreement with Respect to Each Product. Except as
otherwise provided herein, the Parties acknowledge and agree that this Agreement
shall apply to each Product individually and that the Parties shall be entitled
to exercise their rights under this Agreement with respect to each Product
separately.
ARTICLE II.
Principal Terms
Section 2.1. Pre-Launch Manufacturing.
(a) [XXXX]* Impax shall commence to manufacture the Products in order
to supply to Teva and its Affiliates Launch Quantities of the Products. Andrx
shall pay to Impax [XXXX]* % of the Cost of Materials of such Launch Quantities
(including API purchased pursuant to Section 2.1(b)) within [XXXX]* days of
written request by Impax and the provision of reasonable documentation of
Impax's payment of such Cost of Materials. Subject to the provisions of Section
2.3 hereof, within [XXXX]* days following the initial Impax Launch Date[XXXX]*.
(b) During the term of this Agreement, Andrx shall use commercially
reasonable efforts to cause [XXXX]* (collectively, the "Supplier") to supply the
API necessary for the manufacture of the Products (and shall assign or otherwise
allow Impax to enforce Andrx's rights and remedies with respect to any supply of
API sent to Impax that Andrx facilitated pursuant to this section, pursuant to
an assignment substantially in the form attached hereto as Exhibit A), as may be
requested from time to time in writing by Impax. After sufficient API has been
acquired for the manufacture of Launch Quantities of the Products, Impax and
Teva each agrees to pay to Andrx [XXXX]*% of the actual price for each such
order before the date Andrx is required to pay Supplier for such API, as
reflected by appropriate documentation supplied by Andrx. In connection with all
such orders and deliveries, Teva and Impax hereby acknowledge and agree that
Andrx has provided no representation or warranty to Impax or Teva with respect
to the quality or timely delivery of such API by the Supplier. The foregoing
obligation shall cease at the end of the Andrx Margin Period, and shall not
prevent Andrx from using API provided by Supplier that is not invoiced to Impax
and Teva for its own use.
-------
* Filed under an application for confidential treatment.
8
Section 2.2. [XXXX]*; Exclusivity Transfer.
(a) [XXXX]*Impax shall notify Andrx in writing that it has satisfied
the criteria for the [XXXX]*
(b) Following receipt of the [XXXX]* and except if Andrx Retains
Production pursuant to Section 2.3 hereof, Andrx shall, subject to Section
2.2(c) hereof, take all steps necessary to promptly effect the Exclusivity
Transfer with respect to the Product(s) that are the subject[XXXX]*, including,
without limitation, by (1) [XXXX]*(3) delivering the letter substantially in the
form attached hereto as Exhibit B (the "Exclusivity Transfer Letter") or such
other version of that letter that FDA advises it would prefer, to the FDA, with
copies to Impax and Teva.
(c) Within [XXXX]*following Andrx's receipt[XXXX]*, Andrx will notify
Impax and Teva in writing[XXXX]*. Andrx further agrees to promptly notify Impax
and Teva in writing of any material changes from the information provided in
such initial notice. [XXXX]*After the Exclusivity Transfer(s) are effected
[XXXX]*, Impax shall take all steps necessary to receive Final Approval of the
Product(s) and launch the Product(s) as soon as reasonably practicable
thereafter.
(d) During the period commencing on the Impax Launch Date with respect
to any Product and ending on the earlier of (i) the [XXXX]*anniversary thereof
and (ii) the date Andrx is able to Market such Product of its own, Teva hereby
agrees to sell a portion of its supply of such Product to [XXXX]*an Affiliate of
Andrx, with comparable quantities, incentives, pricing and terms that are
equivalent to the most favorable terms given by Teva to any wholesaler.
Section 2.3. Option to Retain Production.
(a) Notwithstanding anything set forth in Section 2.2 hereof, prior to
Andrx's receipt [XXXX]* or on or prior to the [XXXX]* following Andrx's receipt
[XXXX]*, Andrx may elect to manufacture and Market its own Products ("Retain
Production"), in lieu of effecting the Exclusivity Transfer(s) [XXXX]* pursuant
to such Section 2.2, by (1) notifying Impax and Teva of its bona fide intent to
manufacture and Market its own Product(s), (2) using commercially reasonable
efforts to commence commercial sales of such Product(s) to an unrelated third
party within the Territory within a reasonable time, not to exceed a period of
[XXXX]* from the date of such notice, and (3) actually commencing such
commercial sales of such Product(s) by the end of such [XXXX]* period; provided,
that Andrx may Retain Production only with respect to [XXXX]*or with respect to
the [XXXX]* only, but not with respect to the [XXXX]* only. In the event Andrx
is unable to commercially sell its Product(s) to an unrelated third party within
the Territory in the foregoing [XXXX]* period, Andrx shall immediately effect an
Exclusivity Transfer with respect to the Product(s) or, [XXXX]* and Andrx shall
no longer have the ability to Retain Production. Notwithstanding anything to the
contrary in Section 8.1 hereof, Force Majeure shall not apply to such six-month
deadline to commence commercial sales of the Products pursuant to this Section
2.3(a).
-------
* Filed under an application for confidential treatment.
9
(b) If Andrx elects to Retain Production pursuant to this Section 2.3,
Andrx shall, within ten (10) days of notice from Impax (which notice shall not
be sent more often than monthly), reimburse Impax and Teva for their share of
the Manufacturing Costs incurred relating to the Products that will not
otherwise be able to be sold by Teva (provided Teva uses commercially reasonable
efforts to sell such Product in the ordinary course), including the cost of
destruction (as evidenced by proof of destruction), but only to the extent such
Manufacturing Costs (i) were not previously paid by Andrx pursuant to Section
2.1(a), (ii) do not include Impax's scale-up and validation costs or costs
related to Product that did not or would not meet all of the applicable
specifications or otherwise would not be suitable for commercial sale, and (iii)
may include depreciation but not any other Manufacturing Costs that are non-cash
in nature. Prior to sending Product for destruction, Impax/Teva shall notify
Andrx of the Product to be destroyed, including the reason for destruction and
expiration date of the Product. Andrx shall have the right to raise reasonable
objections to such destruction if such Product is commercially saleable.
(c) If Andrx Retains Production pursuant to this Section 2.3, the
provisions of this Agreement, other than this Section 2.3, Sections 2.4(b), 2.6,
2.7, 2.8, 2.9, 3.1, 4.2, 4.4, 5.1, 5.4, 5.5 and 5.6 and Articles VI and VIII
(and the related defined terms contained in Article I), shall terminate and be
of no further force and effect with respect to the Product(s) for which Andrx
Retained Production. In such event, Impax shall not be required to reimburse
Andrx for its share of the API or the Cost of Materials pursuant to Section
2.1(a), until such time as the amount that Andrx is required to pay Impax and
Teva pursuant to Section 2.3(b) is determined, and at such time the amounts owed
shall be reconciled and promptly paid.
Section 2.4. Marketing Efforts.
(a) During the period commencing on the Impax Launch Date of a Product,
and until the six month anniversary of such date (such period, the "Andrx Margin
Period"), unless Andrx has effected an Exclusivity Transfer [XXXX]*with respect
to the 100 mg strength Product only, Teva, pursuant to the Strategic Alliance
Agreement, shall use its commercially reasonable efforts (utilizing its
marketing, distribution and management systems) to develop a market for and
maximize the sale of such Product in the Territory, such effort to be no less
than those efforts used by Teva in relation to its other products. Impax and
Teva shall have the full right at all times to authorize any other Person to
manufacture the Products.
-------
* Filed under an application for confidential treatment.
10
(b) During the period commencing on the Andrx Launch Date of a Product
pursuant to Section 2.3 and until the six month anniversary of such date (such
period, the "Impax Margin Period"), Andrx shall use its commercially reasonable
efforts (utilizing its marketing, distribution and management systems) to
develop a market for and maximize the sale of such Product in the Territory,
such effort to be no less than those efforts used by Andrx in relation to its
other products. Andrx shall have the full right at all times to authorize any
other Person to manufacture the Products.
Section 2.5. Andrx Margin Payments and Additional Payments.
(a) Within thirty (30) days following each Calendar Quarter during the
Andrx Margin Period, Teva shall (i) compute and report to Andrx and Impax in a
mutually acceptable format and detail in US $ and units the Net Sales,
Manufacturing Costs, Operating Expenses, Contract Margin and Andrx Margin for
each Product sold in the Territory by Impax, Teva and/or their Affiliates during
that Calendar Quarter within the Andrx Margin Period, and (ii) pay Andrx the
amount of the Andrx Margin with respect to the Andrx Margin Period, as reflected
in such report, and any Additional Payment, on or before the date such report is
required to be provided. Within ten (10) days following each of the three
reporting months (comprised of a four or five week period in a Calendar Quarter,
in accordance with Teva's financial reporting), Teva shall provide Andrx with a
report with reasonable detail in US $ and units setting forth the Net Sales,
Manufacturing Costs, Operating Expenses, Contract Margin and Andrx Margin for
each Product sold in the Territory by Impax, Teva and/or their Affiliates during
such month. In addition to such report, the chief financial officer of Teva or
its Affiliate, Teva Pharmaceuticals U.S.A., Inc., shall provide Andrx with a
certification (in a form substantially similar to that attached in Exhibit D),
that all information included in such report is complete and accurate, to the
best of his knowledge and belief. Teva shall be entitled to rely on information
provided to it by Impax with respect to Manufacturing Costs.
(b) Impax and Teva shall have the sole and exclusive right to determine
all terms and conditions of sale of the Products to their customers.
(c) Impax and Teva shall each keep complete and accurate records and
books of account containing all information required for the computation and
verification of the Net Sales, Manufacturing Costs and Contract Margin. Each of
Impax and Teva further agrees that, at the request of Andrx, it will permit one
or more firms of independent accountants selected by Andrx, except any as to
whom Impax or Teva reasonably objects, to have access upon reasonable notice and
during ordinary working hours to such records as may be necessary to audit, with
respect to any payment report period ending prior to such request, the
correctness of any report or payment made under this Agreement, or to obtain
information as to the payments due for any such period in the case of failure of
Impax or Teva to report or make payment pursuant to the terms of this Agreement.
Such accountant shall not disclose to Andrx any information relating to the
business of Impax or Teva except that which is necessary to inform Andrx of:
11
(i) the accuracy or inaccuracy of Impax's or Teva's reports
and payments;
(ii) compliance or non-compliance by Impax or Teva with the
terms and conditions of this Agreement; and
(iii) the extent of any such inaccuracy or non-compliance.
In the event that any such inspection reveals a deficiency in excess of
[XXXX]* of a payment with respect to a period covered by the inspection
(provided that the deficiency is at least $[XXXX]*), Impax or Teva, as
applicable, shall promptly pay Andrx, the deficiency, plus interest thereon at
the prime rate (as reported in the Wall Street Journal) per annum, and shall
reimburse Andrx for the reasonable and documented fees and expenses paid to such
accountants, and any accountants retained pursuant to Section 2.9 below, in
connection with their inspection of such period. If necessary to substantiate
the deficiency claimed to be revealed, the Parties shall utilize the procedure
set forth in Section 2.9 below.
(d) The obligation of Impax and Teva to provide the reports and to make
the payments contemplated in this Section 2.5 and the right of Andrx to conduct
its audits pursuant to this Section 2.5 shall survive the termination or
expiration of this Agreement until the period ending one year after such
termination or expiration.
(e) If either Andrx, on the one hand, or Impax or Teva, on the other
hand, becomes Lawfully Able (as defined below) to Market a Product during the
period in which it is entitled to receive a percentage of the Contract Margin
from the sale of the other Party's Product, on a Product-by-Product basis (the
"Second Entrant"), the Parties shall at that time negotiate, in good faith, an
alternative payment arrangement (the "Alternative Payment") with respect to the
Viability Period (as defined below), in lieu of the Andrx Margin or the Impax
Margin, as applicable, that gives the Party the same economic value as would
have existed under this Agreement but for this Section 2.5(e) and assuming the
Second Entrant was not Lawfully Able to Market that Product, and that is not
directly based on the actual sales or actual net sales of such Product by Teva,
Impax or Andrx. "Lawfully Able" shall be the date (such date, or such later date
when the Product becomes commercially viable, if Andrx decides to and can
demonstrate to Impax and Teva's satisfaction that such Product is not yet
commercially viable, the "Viability Date") on which both of the following shall
exist: (1) the Party obtains Final Approval of the Product, and (2) the Party is
and otherwise remains able to lawfully Market the Product. The Party who becomes
Lawfully Able shall give prompt Notice of that fact to the other Parties (the
"Viability Notice Date"). For the period (the "Viability Period") commencing on
the Viability Date through and including the end of the Andrx Margin Period or
the Impax Margin Period, as the case may be, the Parties shall continue to pay
each other, on a quarterly basis, at a monthly rate equal to 100% of the amounts
paid in the full Calendar Month immediately preceding the Viability Date,
subject to retroactive adjustment and reconciliation upon agreement or final
determination of the Alternative Payment.
-------
* Filed under an application for confidential treatment.
12
(f) If the Parties are unable to reach agreement as to the Alternative
Payment within fifteen days of the Viability Notice Date, any Party shall have
the right, exercisable by written notice to the other Parties, to invoke the
arbitration procedures set forth in this Section 2.5(f), as follows:
(1) Within 10 days after the Viability Notice Date, Andrx, on
the one hand, and Teva and Impax jointly, on the other hand, shall
exchange proposed good-faith Alternative Payment amounts ("initial
exchange"), provided that the number, once exchanged, may only be
changed thereafter in a manner that moves that Party's number closer to
the other Party's number. At the time of said initial exchange, each
Party shall provide the other Party with all reasonable data and
information relevant to its proposed Alternative Payment.
(2) Any dispute shall thereafter be submitted for expedited
determination to a panel comprised of three (3) arbitrators having
expertise in the determination of amounts similar to the Alternative
Payment. Andrx, on the one hand, and Teva and Impax, jointly on the
other hand, shall each select one arbitrator. The arbitrators shall
then select the third arbitrator. The arbitrators selected by the
Parties shall be selected within twenty (20) days of the Viability
Notice Date. The arbitrators shall then select the third arbitrator
within ten (10) days thereafter. The parties shall use commercially
reasonable efforts to expedite resolution of the arbitration.
(3) Andrx, on the one hand, and Teva and Impax, jointly on the
other hand, shall each submit to the arbitrators its proposed
Alternative Payment amount. Each Party shall inform the other Parties
of its proposed Alternative Payment amount at the same time, subject to
the proviso in subsection (f)(1) above. At the time of submission of
any proposed Alternative Payment to the arbitrators, such Party shall
provide the other Party with any data and information not previously
provided to the other Party relevant to the issue of resolving the
proposed Alternative Payment, and, unless otherwise agreed by the
Parties, there shall be no additional changes in each Party's proposed
Alternative Payment after the 10th day following the date set by the
arbitrators for the completion of any information exchange. The
arbitrators shall make their own joint valuation of the Alternative
Payment amount in accordance with the preceding Section 2.5(e) and
shall determine the final Alternative Payment as between the two
proposed Alternative Payments the one that is closest to amount they
determined. The authority of the arbitrators shall be limited solely to
a choice between the two proposed Alternative Payments that are
submitted to them by a date they determine.
(4) The arbitration shall be held in New York, New York at
such place as may be agreed upon by the Parties. The arbitrators shall
have sole discretion with regard to the admissibility of any evidence
and all other matters relating to the conduct of the arbitration. The
arbitrators shall, in rendering their decision, apply the substantive
laws of the New York (regardless of its or any other jurisdiction's
choice of law principles). The decision of the arbitrators shall be
final and not appealable, except in the case of fraud or bad faith, or
misapplication of the substantive laws of New York on the part of the
arbitrators or any Party to the arbitration proceeding in connection
with the conduct of such proceedings.
13
(5) The arbitrators shall determine the proportion in which
the Parties shall pay the costs and arbitrator fees of the arbitration,
and each Party shall pay its own costs (including, without limitation,
reasonable attorney's fees) and expenses in connection with such
arbitration.
(6) The arbitration proceeding shall be confidential and,
except as required by applicable law, neither Party shall make (or
instruct the arbitrators to make) any public announcement with respect
to the proceedings or decision of the arbitrator without prior written
consent of the other Party. The existence of any dispute submitted for
arbitration, and the award of the arbitrator, shall be kept in
confidence by the Parties and the arbitrators, except as required in
connection with the enforcement of such award or as otherwise required
by applicable law.
(7) Promptly following the final determination by the
arbitrators of the Alternative Payment pursuant to this Section 2.5(f),
such amount shall be reconciled with any amounts previously paid
pursuant to Section 2.5(e). Any amounts owing as a result of such
reconciliation shall be promptly paid, but in no event later than five
(5) business days after such final determination.
Section 2.6. Impax Margin Payments.
(a) If Andrx Retains Production of any Product, then within thirty (30)
days following each Calendar Quarter ending during the Impax Margin Period,
Andrx shall compute and report to Impax and Teva in a mutually acceptable format
and detail in US $ and units the Net Sales, Manufacturing Costs, Operating
Expenses, Contract Margin and Impax Margin for each Product sold in the
Territory by Andrx and/or its Affiliates during the Calendar Quarter within the
Impax Margin Period, and (ii) pay Impax the amount of the Impax Margin reflected
in such report, on or before the date such report is required to be provided.
Within ten (10) days following each calendar month, Andrx shall provide Impax
and Teva with a report with reasonable detail in US $ and units setting forth
the Net Sales, Manufacturing Costs, Operating Expenses, Contract Margin and
Impax Margin for each Product sold in the Territory by Andrx and/or its
Affiliates during such month. In addition to such report, Andrx's Chief
Financial Officer shall provide Impax and Teva with a certification (in a form
substantially similar to that attached in Exhibit D), that all information
included in such report is complete and accurate, to the best of his knowledge
and belief.
(b) Andrx shall have the sole and exclusive right to determine all
terms and conditions of sale of the Products to its customers.
14
(c) Andrx shall keep complete and accurate records and books of account
containing all information required for the computation and verification of the
Net Sales, Manufacturing Costs and Contract Margin. Andrx further agrees that,
at the request of Impax or Teva, it will permit one or more firms of independent
accountants selected by Impax or Teva, except any to whom Andrx reasonably
objects, to have access upon reasonable notice and during ordinary working hours
to such records as may be necessary to audit, with respect to any payment report
period ending prior to such request, the correctness of any report or payment
made under this Agreement, or to obtain information as to the payments due for
any such period in the case of failure of Andrx to report or make payment
pursuant to the terms of this Agreement. Such accountant shall not disclose to
Impax or Teva any information relating to the business of Andrx except that
which is necessary to inform Impax of:
(i) the accuracy or inaccuracy of Andrx's reports and payments;
(ii) compliance or non-compliance by Andrx with the terms and
conditions of this Agreement; and
(iii) the extent of any such inaccuracy or non-compliance.
In the event that any such inspection reveals a deficiency in excess of
[XXXX]*of a payment with respect to a period covered by the inspection (provided
that the deficiency is at least $[XXXX]*), Andrx shall promptly pay Impax or
Teva, as applicable, the deficiency, plus interest thereon at the prime rate (as
reported in the Wall Street Journal) per annum, and shall reimburse Impax or
Teva, as applicable, for the reasonable and documented fees and expenses paid to
such accountants, and any accountants retained pursuant to Section 2.9 below, in
connection with their inspection of such period. If necessary to substantiate
the deficiency claimed to be revealed, the Parties shall utilize the procedure
set forth in Section 2.9 below.
(d) If, after Retaining Production pursuant to Section 2.3, Andrx
transfers its First to File Exclusivity Rights to a Person other than Teva and
Impax in accordance with this Agreement, then Andrx shall pay Impax the Impax
Margin in accordance with this Section 2.6, which Impax Margin shall be
calculated based on the Contract Margin and related definitions of such other
Person rather than Andrx. As a condition to any such transfer, Andrx will ensure
that Andrx provides, or such other Person agrees to provide, Teva and Impax with
the rights set forth in Section 2.6(a), (c) and (e) and Sections 2.7, 2.8 and
2.9 hereof.
(e) The obligation of Andrx to provide the reports and to make the
payments contemplated in this Section 2.6 and the right of Impax and Teva to
conduct its audits pursuant to this Section 2.6 shall survive the termination or
expiration of this Agreement until the period ending one year after such
termination or expiration.
-------
* Filed under an application for confidential treatment.
15
Section 2.7. Shifting of Sales. From and after the initial commercial
sale of the Product in the Territory by either Impax or Andrx, that Party will
not knowingly engage in any material manufacturing or Marketing practice outside
the normal course of its business for the primary purpose of shifting sales from
one period, with respect to which either the Andrx Margin or the Impax Margin is
payable, into another period with respect to which there is no margin sharing
arrangement. The sole remedy of either Impax or Andrx in the event of a breach
of this Section 2.7 is to have reclassified any Net Sales that have been so
shifted; provided, however, that neither Andrx nor Impax shall have any right to
assert its rights or remedies under this Section 2.7 with respect to any
manufacturing or Marketing practice of the other that does not result in a
payment discrepancy of at least [XXXX]* Dollars ($[XXXX]*).
Section 2.8. Accounting Reconciliation/True-Up. Within ninety (90) days
of the end of the Andrx Margin Period or the Impax Margin Period, as applicable,
Teva (in the case of the Andrx Margin Period) and Andrx (in the case of the
Impax Margin Period) shall provide the other Party with a revised calculation of
the Andrx Margin and the Impax Margin, respectively, based on the actual (rather
than accrued) amounts described in clauses (a) and (b) of the definition of Net
Sales. Any amounts owing by one Party to another as a result of such
recalculation shall be paid by the applicable Party within ten (10) days of such
report. All such calculations shall be made using the "first in, first out"
(FIFO) accounting concept, and not, among other things, any other accounting
utilized by the customers. These recalculations shall be subject to review and
dispute by the other Party pursuant to Sections 2.5, 2.6 and 2.9 hereof. Such
revised calculation shall be accompanied by a certification (in a form
substantially similar to that attached in Exhibit D) of the chief financial
officer of Teva or its Affiliate, Teva Pharmaceuticals U.S.A., Inc. (in the case
of the Andrx Margin Period) or of the chief financial officer of Andrx (in the
case of the Impax Margin Period) that all information included in such report is
complete and accurate, to the best of his knowledge and belief.
Section 2.9. Dispute Resolution.
(a) Except as provided in Section 2.5(f), if the Parties are unable to
agree upon any amount payable under this Agreement, then they agree to retain a
mutually acceptable, nationally recognized independent certified public
accounting firm, which may not be any of the Parties' primary outside
accountants, to review the relevant books and records and to submit to the
Parties its written determination as to the amount in dispute and the basis for
its determination. The determination by the independent accounting firm will be
binding on the Parties absent manifest error.
(b) Any accountants retained by any Party to review amounts pursuant to
this Agreement (including, without limitation, pursuant to Section 2.5, 2.6 or
2.9 hereof) shall be paid by such Party on a hourly or fixed (rather than on a
contingency) basis.
-------
* Filed under an application for confidential treatment.
16
ARTICLE III.
Representations and Warranties
Section 3.1. Representations and Warranties of Andrx. Andrx hereby
represents and/or warrants and/or undertakes to Impax and Teva that:
(a) it has the corporate power and authority to enter into this
Agreement and to perform its obligations hereunder;
(b) neither the execution and delivery of this Agreement by Andrx nor
its performance hereunder conflicts with or results in any violation or breach
of, or constitute (with or without due notice or lapse of time or both) a
default under any of the terms or conditions of any note, bond, mortgage,
indenture, license, agreement or other instrument or obligation to which it or
any of its Affiliates is a party or by which it or any of its Affiliates or any
of their respective properties or assets may be bound, or to its best knowledge,
violate any statute, law, rule, regulation, writ, injunction, judgment, order or
decree of any court, administrative agency or governmental authority binding on
it or any of its Affiliates or any of their respective properties or assets,
excluding any such breaches or defaults that, individually and in the aggregate,
would not have a material adverse effect on its business or financial condition;
(c) this Agreement is a legal, valid and binding agreement of Andrx
enforceable in accordance with its terms;
(d) neither it nor any of its Affiliates have or will, directly or
indirectly, enter into any contract or any other transaction with any third
party or Affiliate that conflicts or derogates from its undertakings hereunder;
(e) Andrx believes in good faith that, upon Final Approval by the FDA
of the applicable ANDA for each Product, Andrx is entitled to be awarded First
to File Exclusivity for each of the Products; and
(f) neither it nor any of its Affiliates have been debarred or is
subject to debarment and will not use in any capacity, in connection with the
services to be performed under this Agreement, any Person who has been debarred
pursuant to Xxxxxxx 000 xx xxx Xxxxxx Xxxxxx Food, Drug and Cosmetic Act.
Section 3.2. Representations and Warranties of Impax. Impax hereby
represents and/or warrants and/or undertakes to Andrx and Teva that:
(a) it has the corporate power and authority to enter into this
Agreement and to perform its obligations hereunder;
(b) neither the execution and delivery of this Agreement by Impax nor
its performance hereunder conflicts with or results in any violation or breach
of, or constitute (with or without due notice or lapse of time or both) a
default under any of the terms or conditions of any note, bond, mortgage,
indenture, license, agreement or other instrument or obligation to which it is a
party or by which it or any of its properties or assets may be bound, or to its
best knowledge, violate any statute, law, rule, regulation, writ, injunction,
judgment, order or decree of any court, administrative agency or governmental
authority binding on it or any of its properties or assets, excluding any such
breaches or defaults that, individually and in the aggregate, would not have a
material adverse effect on its business or financial condition;
17
(c) this Agreement is a legal, valid and binding agreement of Impax,
enforceable in accordance with its terms;
(d) it has not and will not, directly or indirectly, enter into any
contract or any other transaction with any third party or Affiliate that
conflicts or derogates from its undertakings hereunder;
(e) in the event and to the extent that Impax and/or its Affiliates
shall manufacture the Products, all such Products shall: (a) meet the applicable
Specifications at the time of shipment; (b) meet regulatory requirements of any
relevant Regulatory Authority in the Territory; (c) be manufactured, packaged,
tested, stored and shipped in accordance with applicable cGMPs, the Approvals
and Applicable Law; (d) not be adulterated or misbranded under the United States
Food, Drug and Cosmetic Act, as amended from time to time; and (e) be produced,
packaged, tested and stored in facilities that have been approved by the
applicable Regulatory Authority, to the extent required by Applicable Law;
(f) in the event and to the extent that Impax and/or its Affiliates
shall manufacture the Products, Impax's and/or its Affiliates' manufacturing
facilities for such Products shall conform in all respects to Applicable Law
governing such facilities; and
(g) neither it nor any of its Affiliates have been debarred or is
subject to debarment and will not use in any capacity, in connection with the
services to be performed under this Agreement, any Person who has been debarred
pursuant to Xxxxxxx 000 xx xxx Xxxxxx Xxxxxx Food, Drug and Cosmetic Act, or who
is the subject of a conviction described in such section.
Section 3.3. Representations and Warranties of Teva. Teva hereby
represents and/or warrants and/or undertakes to Andrx and Impax that:
(a) it has the corporate power and authority to enter into this
Agreement and to perform its obligations hereunder;
(b) neither the execution and delivery of this Agreement by Teva nor
its performance hereunder conflicts with or results in any violation or breach
of, or constitute (with or without due notice or lapse of time or both) a
default under any of the terms or conditions of any note, bond, mortgage,
indenture, license, agreement or other instrument or obligation to which it is a
party or by which it or any of its properties or assets may be bound, or to its
best knowledge, violate any statute, law, rule, regulation, writ, injunction,
judgment, order or decree of any court, administrative agency or governmental
authority binding on it or any of its properties or assets, excluding any such
breaches or defaults that, individually and in the aggregate, would not have a
material adverse effect on its business or financial condition;
18
(c) this Agreement is a legal, valid and binding agreement of Teva,
enforceable in accordance with its terms;
(d) it has not and will not, directly or indirectly, enter into any
contract or any other transaction with any third party or Affiliate that
conflicts or derogates from its undertakings hereunder; and
(e) neither it nor any of its Affiliates have been debarred or is
subject to debarment and will not use in any capacity, in connection with the
services to be performed under this Agreement, any Person who has been debarred
pursuant to Xxxxxxx 000 xx xxx Xxxxxx Xxxxxx Food, Drug and Cosmetic Act, or who
is the subject of a conviction described in such section.
Section 3.4. No Other Representations. Except for the representations
and warranties of the Parties expressly set forth in this Agreement, no Party
makes any express or implied representation or warranty with respect to the
Products or otherwise, including, without limitation, regarding patent
infringement.
ARTICLE IV.
Covenants
Section 4.1. Regulatory Filings. Within 10 business days following the
date hereof, each Party hereto shall file or cause to be filed with the Federal
Trade Commission and the Department of Justice any notifications required to be
filed under the HSR Act, and the rules and regulations promulgated thereunder
with respect to the Exclusivity Transfer contemplated hereby. Such Parties will
use all commercially reasonable efforts to coordinate such filings and any
responses thereto, to make such filings promptly and to respond promptly to any
requests for additional information made by either of such agencies. The
Exclusivity Transfers contemplated under this Agreement shall not be effected
unless and until all applicable waiting periods under the HSR Act shall have
expired or been terminated or the Parties agree in writing that it is not
necessary ("HSR Clearance"). If the HSR Clearance is not obtained prior to the
date of the [XXXX]*, the period of time reflected in Section 2.3(a)(3) shall be
extended to nine months. The filing fees of such filings, if any, shall be
equally shared by Teva, Andrx and Impax. At the time the Parties make the above
filings pursuant to the HSR Act, they shall submit a copy of such filing,
including this Agreement, to the Health Care Division of the Bureau of
Competition of the Federal Trade Commission.
Section 4.2. Cooperation. Each of the Parties shall use its
commercially reasonable efforts to take, or cause to be taken, all such further
actions and to do, or cause to be done, all things necessary, proper or
advisable to consummate and make effective as promptly as practicable the
transactions contemplated by this Agreement, including but not limited to, (i)
seeking Final Approval of their respective ANDAs for the Products as soon as
reasonably practicable; (ii) obtaining all consents from any Governmental Entity
and other third parties required for the consummation of transactions
contemplated by this Agreement, (iii) timely making all necessary filings under
the HSR Act and (iv) following delivery of a Product Waiver by Andrx to the FDA,
cooperate with the FDA so that it issues Final Approval of the Impax ANDA as
soon as reasonably practicable.
-------
* Filed under an application for confidential treatment.
19
Section 4.3. Transferability of Andrx ANDA. Andrx shall be free to
assign or transfer any Andrx ANDA for the Products provided that such assignment
or transfer of any such Andrx ANDA does not delay, in any significant respect,
the obtaining of a Final Approval of such Andrx ANDA. Upon an assignment of any
Andrx ANDA to a transferee ("Transferee"), as herein contemplated, such
Transferee shall, as a condition to such assignment or transfer, enter into a
certification with Teva and Impax pursuant to which it will agree to be bound by
and shall assume, observe, perform and satisfy all covenants, agreements,
restrictions, prohibitions, warranties and guarantees contained herein on the
part of Andrx as principal obligor and shall be entitled to all of the rights
and benefits of Andrx hereunder (and the Agreement shall be construed
accordingly); provided that no such assignment shall relieve Andrx of such
covenants, agreements, restrictions, prohibitions, warranties and guarantees
contained herein and Andrx shall thereupon become jointly and severally liable
with such Transferee for the observance, performance and satisfaction of same.
As a condition to any assignment or transfer, Andrx or the Transferee shall pay
Impax the Impax Margin in accordance with Section 2.6, which Impax Margin shall
be calculated based on the Contract Margin and related definitions of the
Transferee. Andrx will also ensure that Andrx provides, or such other Transferee
agrees to provide, Teva and Impax with the rights set forth in Section 2.6(a)
and (e) and Sections 2.7, 2.8 and 2.9 hereof.
Section 4.4. Limited Remedies.
(a) Except as otherwise set forth in the Strategic Alliance Agreement
as between Teva and Impax, the Parties hereto hereby covenant and agree that the
remedies provided for herein shall be the only remedies available under the law
with respect to any claim among the Parties arising under this Agreement or the
transactions contemplated hereby.
(b) Except with respect to a willful breach of this Agreement by a
Party, such Party shall not be liable to any other Party for special, indirect,
incidental, consequential damages or lost profits, whether in contract,
warranty, negligence, tort, strict liability or otherwise, arising out of this
Agreement or the transactions contemplated hereby.
ARTICLE V.
Indemnification and Contribution
Section 5.1. Andrx Indemnification. Andrx covenants and agrees to
indemnify, defend and save Impax and its directors, officers, shareholders,
employees, servants and agents (collectively the "Impax Indemnitees") and Teva
and its directors, officers, shareholders, employees, servants and agents
(collectively, the "Teva Indemnitees") harmless from and against any and all
losses, liabilities, damages, costs and expenses, including reasonable
attorney's fees and disbursements (collectively, "Damages") in connection with
any and all suits, investigations, claims or demands by third parties resulting
from or arising out of Andrx's material breach of this Agreement.
20
Section 5.2. Impax Indemnification. Impax covenants and agrees to
indemnify, defend and save Andrx and its directors, officers, shareholders,
employees, servants and agents (collectively the "Andrx Indemnitees") and the
Teva Indemnitees harmless from and against any Damages in connection with any
and all suits, investigations, claims or demands by third parties resulting from
or arising out of Impax's material breach of this Agreement.
Section 5.3. Teva Indemnification. Teva covenants and agrees to
indemnify, defend and save Andrx Indemnitees and the Impax Indemnitees harmless
from and against any Damages in connection with any and all suits,
investigations, claims or demands by third parties resulting from or arising out
of Teva's material breach of this Agreement.
Section 5.4. Other Indemnification. With respect to any third Person
claim, including, without limitation, any claim for patent infringement,
inducing infringement or product liability, in each case when Sections 5.1, 5.2
and 5.3 are not applicable, the Parties agree that they shall respectively be
responsible for Damages associated with the sale of Product(s) during either the
Andrx Margin Period or the Impax Margin Period, as applicable, whether through
contribution or indemnification, in proportion to their respective share of the
Contract Margins (including any division of profits between Impax and Teva
pursuant to the Strategic Alliance Agreement); provided that (i) any Damages
that are associated with the sale of Product(s) after the Andrx Margin Period or
the Impax Margin Period, as applicable, shall be exclusively borne by the Party
making such Product sale that gave rise to the liability for such Damages
(except that, in the case of Product sales by Impax or Teva, such Damages shall
be allocated pursuant to the Strategic Alliance Agreement), (ii) neither Impax
nor Teva shall be liable for any Damages that exceeds the cumulative Impax
Margin payments made to such Party under this Agreement, with respect to Damages
arising from liability that results from the sale of Product(s) by Andrx and/or
its Affiliates, (iii) if Impax or Teva incurs Damages arising from liability
that results from the sale of Product(s) by Andrx and/or its Affiliates in an
amount which exceeds the cumulative Impax Margin payments made to Impax and/or
Teva under this Agreement, Andrx shall indemnify, defend and hold harmless Impax
and Teva for any such excess Damages, (iv) Andrx shall not be liable for any
Damages that exceeds the cumulative Andrx Margin payments and Additional
Payments made to Andrx under this Agreement, with respect to Damages arising
from liability that results from the sale of Product(s) by Teva, Impax and/or
their Affiliates, and (v) if Andrx incurs Damages arising from liability that
results from the sale of Product(s) by Teva, Impax and/or their Affiliates in an
amount which exceeds the cumulative Andrx Margin payments and Additional
Payments made to Andrx under this Agreement, Impax and Teva shall jointly and
severally indemnify, defend and hold harmless Andrx for any such excess Damages
(but for which, as between Teva and Impax, shall be in accordance with the
Strategic Alliance Agreement). If any Damages result from a claim for product
liability for which Impax, Teva or Andrx has product liability insurance
covering such product, then this section shall only apply after any and all
recoveries actually received by such Party from such applicable product
liability insurance has been applied.
21
Section 5.5. Claims; Notification.
(a) As soon as a Party becomes aware of the possibility of a claim
involving indemnification under this Article V, the indemnified Party shall give
the indemnifying Party prompt written notice in writing and shall permit the
indemnifying Party to have control over the defense of such claim or suit. The
indemnified Party agrees to provide all reasonable information and assistance to
the indemnifying Party in such defense. No such claims shall be settled other
than by the Party defending the same, and then only with the consent of the
other Party, which shall not be unreasonably withheld or delayed; provided,
however, that the indemnified Party shall have no obligation to consent to any
settlement of any such claim which imposes on the indemnified Party any
liability or obligation which cannot be assumed and performed in full by the
indemnifying Party.
(b) As soon as any Party becomes aware of the possibility of a claim
involving contribution under Section 5.4, such Party shall notify the other
Parties and the Parties shall cooperate in the defense of such claim. Each of
the Parties shall provide all reasonable information and assistance to such
defense.
Section 5.6. No Consequential Damages. Except in the event of and to
the extent of Damages awarded to a third party in connection with the
indemnification provisions set forth in Sections 5.1, 5.2, 5.3 or 5.4, above and
except with respect to a willful breach of this Agreement by a Party, such Party
shall not be liable to any other Party for special, indirect, incidental,
consequential damages or lost profits, whether in contract, warranty,
negligence, tort, strict liability or otherwise, arising out of the manufacture,
Marketing, distribution, sale or use of the Products.
ARTICLE VI.
Confidentiality
Section 6.1. General. Each of the Parties agrees that: (a) it will not
disclose any Confidential Information of the other to any third party at any
time during the Term without the prior written consent of the disclosing Party;
(b) it will not make use of any Confidential Information of the other Parties
for any purpose other than for the purposes set forth in, or in furtherance of
the transactions contemplated by this Agreement; and/or (c) it will use all
commercially reasonable efforts to prevent unauthorized publication or
disclosure by any person of such Confidential Information including requiring
its employees, consultants or agents to enter into similar confidentiality
agreements in relation to such Confidential Information.
Section 6.2. Special Provisions Following Viability Date. In addition,
any information exchanged by the Parties following delivery of a Viability Date
Notice given pursuant to Section 2.5(e) and (f) shall be provided only to (1)(a)
the outside advisors (e.g. financial advisors, lawyers or accountants) of the
receiving Party and (b) officers of the receiving Party specifically approved by
the disclosing Party (not including sales and marketing personnel), if any,
which approval shall not be unreasonably withheld, and in each case of clauses
(a) and (b), who need to review such information in connection with the
determination of the Alternative Payment, and (2) the arbitrators designated
pursuant to Section 2.5(e). Such information shall be used by such persons
solely in connection with the determination of the Alternative Payment.
22
Section 6.3. Disclosure Required by Law. Notwithstanding the foregoing,
each Party shall be permitted upon reasonable prior written notice to the other
Parties to disclose (1) Confidential Information to the FDA or if otherwise
required by Applicable Law, other applicable law or court order and (2) to any
Governmental Entity the tax treatment and tax structure of any transactions
entered into under this Agreement and all materials of any kind (including any
opinions or other tax analyses) that are provided to that Party relating to such
tax treatment and tax structure.
Section 6.4. Return of Confidential Information. At the request of the
disclosing Party, all Confidential Information in any form will be returned to
the Party who disclosed the Confidential Information within thirty (30) days of
the termination or expiration of this Agreement, save for the retention of one
(1) copy of the Confidential Information by each receiving Party as a record of
the receiving Party's ongoing confidentiality obligations under this Agreement.
Section 6.5. Publicity; Advertising. No Party shall use the name of any
other Party in any publicity or advertising nor, except as required by law or
court order, publicly disclose information related to this Agreement or the
terms and conditions hereof without the prior written consent of such other
Party.
Section 6.6. Sole Property. Each of the Parties agrees that all
Confidential Information that it receives from the other Parties and/or its
Affiliates in connection with the Products is the sole property of the
disclosing Party and shall be used by it only in accordance with the terms and
provisions of this Agreement.
Section 6.7. Effectiveness and Survival. This Article VI shall be in
effect (A) (i) if there is a Product Waiver, during the Andrx Margin Period and
(ii) if Andrx Retains Production, during the Impax Margin Period, and in each
case, for a period of five (5) years following the termination or expiration
thereof, and (B) otherwise, for a period of five (5) years following the date
hereof.
Section 6.8. Intent. The Parties acknowledge that it is their intention
to limit the disclosure of Confidential Information hereunder to the Products
and matters directly related thereto.
23
ARTICLE VII.
Termination
Section 7.1. Termination. This Agreement may be terminated at any time:
(a) by mutual written agreement of Andrx, Impax and Teva;
(b) by Andrx if it has not received a [XXXX]* or by Impax or Teva, if
Andrx has not [XXXX]* Exclusivity Transfer or Retained Production pursuant to
Section 2.2 or 2.3, as applicable,[XXXX]*;
(c) by Andrx, if Impax or Teva shall have materially breached any of
its representations, warranties, covenants or other agreements contained in this
Agreement, which are not cured or cannot be reasonably expected to be cured
within 30 days of notice of such breach by Andrx;
(d) by Impax or Teva, if Andrx shall have materially breached any of
its representations, warranties, covenants or other agreements contained in this
Agreement, which are not cured or cannot be reasonably expected to be cured
within 30 days of notice of such breach by Impax or Teva;
(e) by any Party if a court of competent jurisdiction or governmental,
regulatory or administrative agency or commission shall have issued a final and
nonappealable order, judgment or decree or taken any other action having the
effect of permanently restraining, enjoining or otherwise prohibiting the
transactions contemplated by this Agreement.
Section 7.2. Effect of Termination.
(a) In the event of the termination of this Agreement by Impax or Teva
pursuant to Section 7.1(d), Andrx shall, within ten (10) days of notice from
Impax or Teva, reimburse Impax and Teva for their Manufacturing Costs incurred
relating to the Products to the same extent as set forth in Section 2.3(b)
herein.
(b) In the event of the termination of this Agreement by any Party
pursuant to Section 7.1(b), Andrx shall, within ten (10) days of notice from
Impax or Teva, reimburse Impax and Teva for their Manufacturing Costs incurred
relating to the Products to the same extent as set forth in Section 2.3(b)
herein.
(c) In the event of the termination of this Agreement by Impax or Teva
pursuant to Section 7.1(b), notwithstanding Section 7.2(d) below, the obligation
of Andrx to pay the Impax Margin pursuant to Section 2.6 hereof and Andrx's
other obligations pursuant to Section 2.4(b) and 2.6 shall survive the
termination of this Agreement as if this Agreement had not been terminated.
(d) Upon the termination of this Agreement by any Party pursuant to
Section 7.1, this Agreement shall forthwith become void as to such terminating
Party and there shall be no liability on the part of any Party hereto (or any
stockholder, director, officer, partner, employee, agent, consultant or
representative of such Party) to the Party that has terminated this Agreement,
except as set forth in this Section 7.2, provided, that nothing contained in
this Agreement shall relieve any Party from liability for any breach of this
Agreement, including, without limitation, the obligations of the breaching Party
or Parties hereto to pay the Impax Margin or Andrx Margin and Additional
Payments, as applicable; and provided, further, that this Section 7.2 and
Articles V and VI and Sections 4.4, 8.5, 8.6, 8.7, 8.8, 8.9, 8.10, 8.11, 8.12,
8.13, 8.14 and 8.15 shall survive termination of this Agreement by any Party.
-------
* Filed under an application for confidential treatment.
24
ARTICLE VIII.
MISCELLANEOUS
Section 8.1. Force Majeure.
(a) No Party shall be liable for non-performance or delay in the
fulfillment of its obligations (other than payment obligations) when any such
non-performance or delay shall be occasioned by any unforeseeable cause beyond
the reasonable control of the Parties, as the case may be, including without
limitation, acts of God, fire, flood, earthquakes, explosions, sabotage,
strikes, or labor disturbances (regardless of the reasonableness of the demands
of the labor force), civil commotion, riots, military invasions, wars, failure
of utilities, failure of carriers, or any acts, restraints, requisitions,
regulations, or directives issued by a competent government authority ("Force
Majeure Events").
(b) In the event that any Party is prevented from discharging its
obligations under this Agreement on account of a Force Majeure Event, such Party
shall notify the other Parties forthwith, and shall nevertheless make every
endeavor, in the utmost good faith, to discharge its said obligations, even if
in a partial or compromised manner.
(c) Notwithstanding Section 8.1(a) hereof, if, as a result of a Force
Majeure Event (which shall include Product recalls and Product safety issues
which occurs as a result of events beyond the reasonable control of the
Parties), a Party does not Market a Product, the Andrx Margin Period (with
respect to a suspension of Marketing by Teva) and the Impax Margin Period (with
respect to a suspension of Marketing by Andrx), as applicable, shall be
suspended (such period when Marketing is suspended, the "Suspension Period"),
and no Additional Payments or other payments shall be required to be made with
respect to such period. When and if such Force Majeure Event shall end and the
Party has recommenced Marketing such Product, the Suspension Period shall be
added to the end of the Andrx Margin Period and the Impax Margin Period, as
applicable, and any remaining payment obligations shall resume.
(d) This Section 8.1 shall not apply to such six-month deadline for
Andrx to commence commercial sales of the Products pursuant to this Section
2.3(a).
Section 8.2. Amendments. The terms and provisions of this Agreement may
be modified or amended, or any of the provisions hereof waived, temporarily or
permanently, in a writing executed and delivered by the Parties hereto. No
waiver of any of the provisions of this Agreement shall be deemed to or shall
constitute a waiver of any other provision hereof (whether or not similar). No
delay on the part of any Party in exercising any right, power or privilege
hereunder shall operate as a waiver thereof.
25
Section 8.3. Press Releases; Disclosures. Any and all press releases,
publicity or other form of public written disclosures relating to this Agreement
shall be mutually agreed to by the Parties (the consent of a Party not to be
unreasonable withheld or unduly delayed and in any event a Party shall respond
within two (2) business days of receiving a request, failing which it shall be
deemed to have consented) including, if applicable, the time of release of such
public written disclosures as well as the content of such public written
disclosures. For releases or announcements required by applicable law, the Party
making the release or announcement shall, before making any such release or
announcement, afford the other Parties a reasonable opportunity to review and
comment. Any copy of this Agreement to be filed with the Securities and Exchange
Commission or any other Governmental Entity shall be redacted to the fullest
extent permitted by applicable law and to the reasonable satisfaction of the
Parties; provided, however, in the event that the Securities and Exchange
Commission or other Governmental Entity, as applicable, objects to the redaction
of any portion of this Agreement after the initial submission, the filing Party
shall inform the other Parties of the objections and shall in good faith respond
to the objections in an effort to limit the disclosure required by the
Securities and Exchange Commission or Governmental Entity, as applicable.
Section 8.4. Suits; Litigation. In the event that there are any claims,
actions, demands or suits by a third party, attempting to invalidate this
Agreement in any manner whatsoever, Impax, Teva and Andrx hereto agree to
vigorously defend such claims, actions, demands or law suits and each of Impax,
Teva and Andrx shall bear its own legal cost in such defense and will cooperate
with each other in any such defense.
Section 8.5. Payments in U.S. Dollars. All payments required to be paid
under this Agreement shall be made in lawful currency of the United States.
Section 8.6. Governing Law. This Agreement shall be governed by and
interpreted in accordance with the laws of the State of New York without giving
effect to the principles of conflict of laws thereof.
Section 8.7. Notices. Each notice, demand or other communication to be
given or made hereunder shall be made in writing and may be made by facsimile
transmission. Any notice, demand or other communication or document to be given,
made or delivered by one Party to another pursuant to this Agreement shall
(unless that Party has by prior notice specified another address or fax number)
be given, made or delivered to the other Parties addressed as follows:
If to Andrx: ANDRX PHARMACEUTICALS, LLC
ANDRX PHARMACEUTICALS, INC.
0000 Xxxxxx Xxxxx
Xxxxx, XX 00000
Attention: Xxxxx Xxxxx, EVP &
General Counsel
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to: ANDRX CORPORATION
0000 Xxxxxx Xxxx
Xxxxxx, XX 00000
Attention: [XXXX]*, SVP & CFO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
-------
* Filed under an application for confidential treatment.
26
If to Impax: IMPAX LABORATORIES, INC.
0000 Xxxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000
Attention: Xxxxx X. Xxxxxxx, Co-CEO
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
With copies to: IMPAX LABORATORIES, INC.
00000 Xxxxxxxx Xxxxxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention: Xxxxx Xxx, Ph.D. President
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Blank Rome Comisky & XxXxxxxx, LLP
Xxx Xxxxx Xxxxxx
Xxxxxxxxxxxx, XX 00000
Attn: Xxxxx Xxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
and to Teva, as per below.
If to Teva: TEVA PHARMACEUTICALS CURACAO X.X.
Xxxxxxxxxxxx Xxxx 00 X
Xxxxxxx, Xxxxxxxxxxx Antilles
Attention: General Manager
Telephone: 000-0-000-0000
Facsimile: 599-9-736-7066
With copies to: TEVA NORTH AMERICA
0000 Xxxxxxx Xxxx
Xxxxx Xxxxx, Xxxxxxxxxxxx 00000
Attention: Vice President and
General Counsel
Teva North America
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Xxxxxxx Xxxx & Xxxxxxxxx
000 Xxxxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxx X. Xxxxx
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
and to Impax as per the above.
27
Any notice, demand or other communication so addressed to any Party to this
Agreement shall be deemed to have been delivered (i) in the case of any notice,
demand or other communication made be facsimile transmission, when dispatched
with confirmed answer back or (ii) in all other cases upon receipt.
Section 8.8. Entire Agreement. Except for the Strategic Alliance
Agreement between Teva and Impax, this Agreement embodies the entire agreement
between the Parties hereto with respect to the subject matter provided herein.
Section 8.9. Independent Contractor. Nothing herein shall constitute
the Parties hereto as principal and agent or as partners or joint venturers.
Each Party hereto is an independent contractor with respect to the other.
Section 8.10. Successors and Assigns. The terms and provisions hereof
shall inure to the benefit of, and be binding upon, Andrx, Impax, Teva and their
respective successors and permitted assigns. Neither Andrx, Impax or Teva shall
assign this Agreement or any part of it to any third party without the prior
written consent of the other Parties; provided, however, that Teva may, without
obtaining the consent of Impax or Andrx, assign this Agreement or delegate any
of its rights or obligations hereunder to any of its Affiliates, provided that
Teva agrees to remain primarily liable for the full and timely performance by
such Affiliate of all its obligations hereunder.
Section 8.11. Severability. Any provision of this Agreement that is
prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction,
be ineffective to the extent of such prohibition or unenforceability without
invalidating the remaining provisions hereof, and any such prohibition or
unenforceability in any jurisdiction shall not invalidate or render
unenforceable such provision in any other jurisdiction. To the extent permitted
by applicable law, the Parties hereby waive any provision of law, which renders
any provision of this Agreement prohibited or unenforceable in any respect.
Should any provision of this Agreement be so held to be unenforceable, such
provision, if permitted by law, shall be considered to have been superseded by a
legally permissible and enforceable clause which corresponds most closely to the
intent of the Parties as evidenced by the provision held to be unenforceable.
Section 8.12. Submission to Jurisdiction. Each of Andrx, Impax and Teva
hereby irrevocably and unconditionally consents to submit to the exclusive
jurisdiction of the Federal Courts of the Southern District of New York or the
state courts of the Supreme Court, New York County for any litigation arising
out of or relating to this Agreement and the transactions contemplated hereby
(and agrees not to commence any litigation relating hereto or thereto except in
such courts), and further agrees that service of any process, summons, notice or
document by U.S. registered mail to its respective address set forth in this
Agreement shall be effective service of process for any litigation brought
against it in any such court. Each of the Parties hereto hereby irrevocably and
unconditionally waives any objection to the laying of venue of any litigation
arising out of this Agreement or the transactions contemplated hereby in the
courts of the Southern District of the State of New York or the United States of
America, in each case located in the New York County, hereby further irrevocably
and unconditionally waives and agrees not to plead or claim in any such court
that any such litigation brought in any such court has been brought in an
inconvenient forum.
28
Section 8.13. Waiver of Jury Trial. ANDRX, IMPAX AND TEVA HEREBY WAIVE
ANY RIGHT THEY MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY ACTION, PROCEEDING
OR LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH
THIS AGREEMENT.
Section 8.14. Third Party Beneficiaries. No section of this Agreement
is intended to confer upon any Person other than the Parties any rights or
remedies hereunder.
Section 8.15. Counterparts. This Agreement may be executed in one or
more counterparts, each of which shall be deemed an original but all of which,
taken together, shall constitute one and the same instrument. This Agreement may
be delivered by facsimile transmission and receipt of facsimile copy of any
Party's signature shall be considered to be receipt of an original copy thereof;
provided that any Party executing this Agreement by facsimile shall, as soon as
practicable following execution of this Agreement, provide an originally
executed counterpart of this Agreement to the other Parties.
[This page is intentionally left blank]
29
IN WITNESS WHEREOF, each of the Parties has executed this Agreement as
of the date first written above.
ANDRX PHARMACEUTICALS, LLC
By: ________________________________________________
Name:
Title:
ANDRX PHARMACEUTICALS, INC.
By: ________________________________________________
Name:
Title:
IMPAX LABORATORIES, INC.
By: ________________________________________________
Name:
Title:
TEVA PHARMACEUTICALS CURACAO N.V.
By: ________________________________________________
Name:
Title:
By: ________________________________________________
Name:
Title:
30
