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EXHIBIT 10.19
CONFIDENTIAL TREATMENT REQUESTED
Confidential Portions Of This Agreement Which Have Been Redacted Are
Marked With Brackets ("[****]"). The Omitted Material Has Been Filed Separately
With The Securities And Exchange Commission.
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COGNEX(R)
ASSET PURCHASE AGREEMENT
between
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY
and
FIRST HORIZON PHARMACEUTICAL CORPORATION
Dated as of April 14, 2000
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This ASSET PURCHASE AGREEMENT (the "Agreement") is entered into as of
April 14, 2000, by and among ▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY, a Delaware corporation with
offices at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ ("▇▇▇▇▇▇-▇▇▇▇▇▇▇")
and FIRST HORIZON PHARMACEUTICAL CORPORATION, a Delaware corporation with
offices at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Horizon").
RECITALS
WHEREAS, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its Affiliates (as hereinafter defined)
are engaged in the business of manufacturing and selling pharmaceutical products
and own certain rights related to products containing tacrine hydrochloride
(1,2,3,4-tetrahydro-9-acridinamine monohydrochloride monohydrate) as its sole
active ingredient in the Territory and listed on Exhibit A hereto (the "Product"
or "Cognex");
WHEREAS, in addition to the Product, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its Affiliates
also own certain rights related to a once a day control release version of the
Product ("Cognex CR"); and
WHEREAS, the parties hereto intend that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and each of the
Affiliates of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ that will be caused by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to transfer
Assets (as hereinafter defined) pursuant to this Agreement (collectively the
"Selling Affiliates") shall sell to Horizon, and Horizon shall purchase from
▇▇▇▇▇▇-▇▇▇▇▇▇▇ and the Selling Affiliates, certain assets related to the Product
and Cognex CR upon the terms and subject to the conditions set forth in this
Agreement.
NOW, THEREFORE, in consideration of the foregoing recitals and the
mutual promises, representations, warranties, covenants and agreements
hereinafter set forth, and intending to be legally bound, the parties do hereby
agree as follows:
ARTICLE 1
PURCHASE AND SALE OF ASSETS
1.1 SALE OF ASSETS. Pursuant to the terms and conditions set forth in
this Agreement, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ agrees to sell and to cause the Selling
Affiliates to sell, convey, assign, grant, transfer and deliver to Horizon, and
Horizon agrees to purchase, acquire and receive from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and the
Selling Affiliates on the date that is three (3) Business Days after the date of
receipt of clearance from the Federal Trade Commission for the transactions
contemplated by this Agreement or such other date as the parties agree upon in
writing (the "Closing Date"), ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ entire interest in all of the
following assets related to the Product and Cognex CR (collectively, the
"Assets"):
1.1.1 Inventory. The inventories of finished Product owned by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ on the Closing Date and held for use in the Territory as
specified on Exhibit 1.1.1 hereto (the "Inventory"); provided, that the
expiration date for such Inventory of finished Product is at least fifteen (15)
months after the Closing Date. Inventory purchased by Horizon hereunder shall be
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delivered to Horizon as soon as practicable after Closing but in any event no
later than fifteen (15) days thereafter;
1.1.2 Intellectual Property. The Intellectual Property (as
hereinafter defined) and all valid and binding rights under contract to use such
Intellectual Property, including without limitation the Intellectual Property
listed on Exhibit 1.1.2. As used herein, "Intellectual Property" means, with
respect to the Product and Cognex CR, all of the following without limitation
and whether registered, issued, pending or in a draft form: all patents,
trademarks and trademark rights (the "Trademarks"), service marks and service
▇▇▇▇ rights, service names and service name rights, brand names, logos, slogans,
trade secrets, trade dress, processes, designs, methodologies, technical
information and know-how, in each case relating to the manufacture, packaging,
development, testing, distribution, marketing, use or sale of such Product;
1.1.3 Registrations. All regulatory approvals and applications
for regulatory approval for the Product and Cognex CR (including the Marketing
Authorizations for the Product) held by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Affiliates
(defined below) (collectively, the "Registrations") set forth on Exhibit 1.1.3.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall deliver such Registrations to Horizon as soon as
practicable after Closing but in any event no later than forty-five (45) days
thereafter. As used herein: the term "Affiliate" means (i) any company or
entity, more than fifty percent (50%) of whose voting stock or participating
profit interest is owned or controlled, directly or indirectly, by a party; (ii)
any Person which owns or controls, directly or indirectly, more than fifty
percent (50%) of the voting stock or participating profit interest of a party
and (iii) any Person which is under common control with a party hereto and the
term "common control" means a third party has direct or indirect ownership of
fifty percent (50%) or more of the voting stock or participating profit interest
of both the other company or entity and the party to this Agreement; "Marketing
Authorization" means the authorization to sell the Product as granted by the
relevant Governmental or Regulatory Authority (as hereinafter defined); and
"Person" means any natural person, corporation, general partnership, limited
partnership, proprietorship, other business organization, trust, union,
association or Governmental or Regulatory Authority. Notwithstanding the
foregoing, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall be permitted to retain one archive copy of the
Registrations;
1.1.4 Information and Know-How. All technical information
(including the master batch record, analytical methods including validation
protocol, and the drug master file), know-how, market research results, and the
like specifically relating to the manufacture, packaging, testing, development,
distribution, marketing, use or sale of the Product and Cognex CR (including the
raw materials used in the manufacture thereof) owned or possessed by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ or the Selling Affiliates on the Closing Date (collectively, the
"Information"). The Information, to the extent such Information has not
previously been provided to Horizon, shall be transferred as soon as practicable
after the Closing Date, but in any event no later than (a) thirty (30) days
thereafter with respect to Germany, Greece, France, Spain and Austria (the
"Primary Countries"); (b) sixty (60) days thereafter with respect to Australia,
Belgium, French Export Countries (Guadaloupe, Martinique, La Reunion, New
Caledonia and Tunisia), Hong Kong, Korea, Luxembourg, Portugal, Switzerland, the
United States and Puerto Rico (and, together with the Primary Countries, the
"Territory"); and (c) ninety (90) days thereafter with respect to countries
outside of the Territory. Notwithstanding the foregoing, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall
retain one archive copy of the Information pursuant to Section 5.14;
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1.1.5 Managed Care Agreements. To the extent their assignment
in part is permitted under the terms thereof or by the other party thereto, all
Managed Care Agreements (as hereinafter defined), to which ▇▇▇▇▇▇-▇▇▇▇▇▇▇ is a
party and which are utilized in connection with the sale of the Product by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ in the United States;
1.1.6 Goodwill. All goodwill associated with the Product other
than goodwill associated with any trademark, trade name, service ▇▇▇▇, service
name, slogan or logo used by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or any of its Affiliates prior to
the date hereof and not transferred to Horizon pursuant to this Agreement or any
of the other operative agreements which are necessary to completely sell,
convey, assign, grant, transfer and deliver the Assets to Horizon (the
"Operative Agreements");
1.1.7 Prepaid Royalties. All prepaid royalties relating to
the Assets and listed in Exhibit 1.1.7; and
1.1.8 Promotional Materials. The advertising and promotional
materials and sales training materials owned by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ related to the
Product (collectively, the "Promotional Materials").
1.2 EXCLUDED ASSETS. Notwithstanding anything in this Agreement to
the contrary, the following assets of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and the Selling Affiliates
(the "Excluded Assets") shall be excluded from and shall not constitute Assets:
1.2.1 Accounts Receivable. All trade accounts receivable and
all notes, bonds and other evidences of indebtedness and rights to receive
payments arising out of sales of the Product prior to the Closing Date,
including any rights of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Affiliates with respect to any
third party collection procedures or any contract or any other actions which
have accrued prior to the Closing Date in connection with the manufacture, sale
or use of any Product;
1.2.2 Litigation Claims. Any rights (including
indemnification), claims and recoveries under litigation of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or
its Affiliates against third parties arising out of or relating to events
occurring prior to the Closing Date;
1.2.3 Excluded Contract Rights. The rights of ▇▇▇▇▇▇-▇▇▇▇▇▇▇
or any of its Affiliates in, to and under all contracts of any nature, the
obligations of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or any of its Affiliates under which are not
expressly assumed by Horizon herein; and
1.2.4 Excluded Intellectual Property. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall
retain the right and title to any Intellectual Property and Information
utilized in connection with the manufacture, packaging, testing, development,
distribution, marketing, use or sale of any of ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ or its
Affiliates' products, other than the Product and Cognex CR, including, but not
limited to, those that are also used by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its Affiliates on
the Product, such as the ▇▇▇▇▇-▇▇▇▇▇ trademark, logo and designs.
1.3 ASSUMED LIABILITIES. Horizon shall assume and agrees to pay,
perform and discharge when due the following liabilities and obligations of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Affiliates arising in connection with the Product (the
"Assumed Liabilities"):
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1.3.1 Returns. All liabilities and obligations with respect
to (i) the returned units of the Product, from and after the date that is
twelve (12) months after the Closing Date and (ii) the returned units of the
Product during the first twelve (12) months following the Closing Date to the
extent such returns exceed $1.8 million;
1.3.2 Rebates and Chargebacks. All liabilities and
obligations arising from (i) all rebates to state Medicaid and other state and
local governmental programs and to pharmacy benefit management companies,
health plans, insurance companies, mail service pharmacies and other health
care providers based upon the utilization of the Product (collectively,
"Rebates") and (ii) all credits, chargebacks, reimbursements, administrative
fees and other payments to wholesalers and other distributors, group purchasing
organizations, insurers and other institutions (collectively, "Chargebacks"),
occurring in the third calendar quarter of 2000 and thereafter, subject to the
Rebate and Chargeback Reimbursement (defined below) to be paid to Horizon by
▇▇▇▇▇▇-▇▇▇▇▇▇▇, provided, however, that Horizon shall not be liable for any
Chargebacks or Rebates occurring in the first and second calendar quarters of
2000. For purposes of this Section 1.3.2, Rebates shall be deemed to have
occurred in the calendar quarter in which the pharmacy or other applicable
entity is reimbursed by Medicaid or other applicable entity and Chargebacks
shall be deemed to have occurred in the calendar quarter in which the
wholesaler or other applicable entity ships the Product that results in the
chargeback. As used herein, "Rebate and Chargeback Reimbursement" shall mean an
amount equal to the product of (i) the Rebates and Chargebacks occurring in the
third calendar quarter of 2000 and (ii) a fraction, the denominator of which is
92 and the numerator of which is the number of days elapsed in the second
quarter through the Closing Date. To the extent that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ is unable
to assign any agreement of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ for the payment of Rebates and
Chargebacks ("Managed Care Agreements") to Horizon with respect to the Product,
Horizon agrees to reimburse ▇▇▇▇▇▇-▇▇▇▇▇▇▇ for the amount of such Rebates and
Chargebacks under the Managed Care Agreements paid by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ within
thirty (30) days after receipt by Horizon of a written invoice from
▇▇▇▇▇▇-▇▇▇▇▇▇▇ for same;
1.3.3 Registrations. All liabilities and obligations with
respect to the Registrations arising or incurred from and after the Closing
Date, provided, however, with respect to the NDA establishment fee, Horizon
shall only be responsible for such fees which are incurred in connection with
the period beginning with the first full calendar year following the expiration
or earlier termination of the Supply Agreement (as defined herein);
1.3.4 Recalls. From and after the Closing Date, all
liabilities, obligations and responsibilities relating to voluntary and
involuntary recalls of Product sold by Horizon after the Closing Date, except to
the extent that such recall is for a failure of the Inventory to meet the
product specifications set forth in the Marketing Authorizations as such
specifications exist on the date hereof (the "Specifications"), where such
failure is due solely to the actions or omissions of ▇▇▇▇▇▇-▇▇▇▇▇▇▇;
1.3.5 Product Liability. From and after the Closing Date, all
liabilities, obligations and responsibilities relating to product liability
claims or threatened claims relating to Product sold by Horizon after the
Closing Date, other than product liability that results from a failure of the
Inventory to meet the Specifications, where such failure is due solely to the
actions or omissions of ▇▇▇▇▇▇-▇▇▇▇▇▇▇;
1.3.6 Research and Development. All liabilities, obligations
and responsibilities
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for any research and development conducted by Horizon and relating to the
Product after the Closing Date; and
1.3.7 Product Regulatory Obligations. All liabilities,
obligations and responsibilities undertaken by Horizon pursuant to Section 5.4.
1.4 RETAINED LIABILITIES. Except for the Assumed Liabilities,
Horizon shall not assume by virtue of this Agreement or any of the Operative
Agreements or the transactions contemplated hereby, and shall have no liability
for, any liabilities, debts or obligations of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ of any kind,
character or description whatsoever (the "Retained Liabilities").
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ARTICLE 2
CONSIDERATION FOR TRANSFER OF ASSETS
2.1 PURCHASE PRICE. (a) Subject to the terms and conditions of this
Agreement, in consideration for the sale and transfer of the Assets, Horizon
shall pay to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ (i) a non-refundable payment of Three Million Five
Hundred Thousand Dollars ($3,500,000) payable to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ on the Closing
Date, (ii) One Million Five Hundred Thousand Dollars ($1,500,000) payable to
▇▇▇▇▇▇-▇▇▇▇▇▇▇ upon the approval by the United States Food and Drug
Administration (the "FDA") of a new drug application ("NDA") for Cognex CR in
the United States which includes an approved package insert with the attributes
provided in Exhibit 2.1, as adjusted by the Price Adjustment described in
Section 2.1(b) below, if any; provided, however, that Horizon shall not be
required to seek approval of the NDA for Cognex CR from the FDA, and (iii) an
amount equal to the value of the Inventory transferred to Horizon pursuant to
the terms of this Agreement based on the Closing Inventory Value (as defined
below) payable to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ within thirty (30) days after the Closing Date.
The amounts set forth in Section 2.1 (a)(i), (ii) and (iii) are hereinafter
referred to collectively as the "Purchase Price". As used herein, "Business Day"
means a day during which banks are generally open for business in New York and
"Closing Inventory Value" means the value of the Inventory (including samples)
as of the Closing Date based on ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ calculation of the standard
cost of the Product.
(b) The amount payable pursuant to Section 2.1(a)(ii) above will be
reduced by an amount which is equal to the product of (i) total third-party
out-of-pocket expenses, reasonably incurred by Horizon relating to (A) the
performance by or on behalf of Horizon of additional studies in connection with
the approval of the NDA for Cognex CR to the extent required by the FDA
(including, but not limited to, manufacturing costs in connection with the
manufacture of trial batches of the Product and costs of literature searches and
analysis required for such studies) plus (B) returns incurred during the twelve
(12) month period following the Closing Date for Product sold prior to the
Closing Date by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ in an aggregate amount greater than $1.8 million
but less than $2.8 million ("Total Expense") and (ii) the applicable Factor (as
hereinafter defined) (the "Price Adjustment"). "Factor" shall be determined as
follows: if Total Expense is (i) less than or equal to $200,000 then the factor
will be 1.35, and (ii) greater than $200,000 and less than or equal to $500,000
then the factor will be 1.50. If Total Expenses is greater than $500,000 then
Horizon will not have any obligation to pay the amount set forth in Section
2.1(a)(ii). Under no circumstances shall ▇▇▇▇▇▇-▇▇▇▇▇▇▇ incur any obligation to
pay Horizon as a result of the calculation of the Price Adjustment.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ makes no representation or warranty that the NDA for Cognex CR
will be accepted for filing or approved by the FDA.
(c) Within thirty (30) days of the approval of the NDA for Cognex CR,
Horizon shall prepare and deliver to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ a written report showing the
components of Total Expenses (including returns) and the amount payable pursuant
to Section 2.1(a)(ii), if any (the "Report"). Concurrently with the submission
of such written report, Horizon shall pay ▇▇▇▇▇▇-▇▇▇▇▇▇▇ the amount shown to be
due thereon; provided, however, if the NDA for Cognex CR is approved by the FDA
during the twelve month period following the Closing Date, Horizon shall prepare
the Report within thirty (30) days following the end of such twelve (12) month
period.
(d) Horizon shall keep accurate records in sufficient detail to
determine the amount payable under Section 2.1(a)(ii). ▇▇▇▇▇▇-▇▇▇▇▇▇▇ may
designate an independent public accountant mutually acceptable to ▇▇▇▇▇▇-▇▇▇▇▇▇▇
and Horizon to review such records to verify
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the accuracy of information provided to ▇▇▇▇▇▇-▇▇▇▇▇▇▇. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall
pay the cost of any review of records conducted at the request of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ under this Section; provided, however, that if the independent
public accountant conducting the review concludes that the amount payable under
Section 2.1(a)(ii) was understated by 5% or more, Horizon shall pay the cost of
such review.
(e) All payments under this Section shall be made by wire transfer or
other immediately available funds to an account indicated by ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
2.2 ALLOCATION. The parties agree to allocate the Purchase Price among
the Assets in accordance with Exhibit 2.2.
2.3 CLOSING. The Closing shall take place at 11:00 a.m. EDT at ▇▇▇
▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ on the Closing Date or at such time and
place as the parties hereto may otherwise mutually agree.
ARTICLE 3
REPRESENTATIONS AND WARRANTIES
3.1 LEGAL AUTHORITY. Each party represents and warrants that it has
the legal power, authority and right to enter into this Agreement and to
perform its respective obligations set forth herein.
3.2 NO CONFLICTS. Each party represents and warrants that it is not a
party to any agreement or arrangement with any third party or under any
obligation or restriction, including pursuant to its Articles of Incorporation,
By-Laws or other organizational documents, which in any way limits or conflicts
with its ability to fulfill any of its obligations set forth herein.
3.3 TITLE TO ASSETS. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby represents and warrants
that: (i) it or the applicable Selling Affiliate has good and marketable title
to the Assets, free and clear of all liens; (ii) to its knowledge, except as
set forth in Exhibit 1.1.2, no sublicenses have been granted to any third party
with respect to the Assets; and (iii) to its knowledge, there are no adverse
claims of ownership to the Assets.
3.4 INTELLECTUAL PROPERTY RIGHTS. (a) Except as disclosed in Licenses
Out listed on Exhibit 1.1.2, (i) ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its Affiliates has the
exclusive right to use the Trademarks and (ii) all registrations with and
applications to Governmental or Regulatory Authorities in respect of such
Trademarks are valid and in full force and effect.
(b) ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby represents and warrants that, to its
knowledge without any inquiry of third parties, there are no patents,
trademarks, trade names or copyrights or any other proprietary rights of any
third person which would be infringed by the manufacture, use or sale of the
Product in the Territory.
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3.5 INVENTORY. The Inventory will be of salable quality, will meet the
Specifications, have been manufactured in accordance with current good
manufacturing practices and other applicable law.
3.6 LITIGATION. (a) ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby represents and warrants
that, to its knowledge, there is no litigation, action, suit, inquiry,
investigation, arbitration or other proceeding pending or threatened against
▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Affiliates specifically with respect to the Product, the
Assets or ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ right and ability to consummate the transaction
contemplated by this Agreement, nor does ▇▇▇▇▇▇-▇▇▇▇▇▇▇ know of any basis for
any such proceedings, investigations or inquiries.
(b) Horizon hereby represents and warrants that, to its knowledge,
there is no litigation, action, suit, inquiry, investigation, arbitration or
other proceeding pending or threatened against Horizon with respect to its
right and ability to consummate the transactions contemplated by this
Agreement.
3.7 CONSENTS AND APPROVALS. (a) Except as disclosed in Exhibit 3.7(a),
no consent, approval or action of, filing with or notice to any Governmental or
Regulatory Authority (as hereinafter defined) or any third party on the part of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ or any Selling Affiliate is required in connection with the
execution, delivery and performance of this Agreement or any of the Operative
Agreements to which it is a party or the consummation of the transactions
contemplated hereby or thereby, except (i) where the failure to obtain any such
consent, approval or action, to make any such filing or to give any such notice
will not adversely affect the ability of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to consummate the
transactions contemplated by this Agreement or the ability of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or
any Selling Affiliate to consummate the transactions contemplated by any
Operative Agreement or to perform its obligations hereunder or thereunder, or
have a material adverse effect on the condition of the Business or impair the
ability of Horizon to operate the Business in the ordinary course, and (ii)
those as would be required solely as a result of the identity or the legal or
regulatory status of Horizon or any of its Affiliates. As used herein,
"Governmental or Regulatory Authority" means any court, tribunal, arbitrator,
authority, agency, commission, official or other instrumentality of the United
States or any relevant country, state, province, county, city or other
political subdivision.
(b) Except as disclosed in Exhibit 3.7(b), no consent, approval or
action of, filing with or notice to any Governmental or Regulatory Authority
(as hereinafter defined) or any third party on the part of Horizon is required
in connection with the execution, delivery and performance of this Agreement or
any of the Operative Agreements to which it is a party or the consummation of
the transactions contemplated hereby or thereby, except where the failure to
obtain any such consent, approval or action, to make any such filing or to give
any such notice will not adversely affect the ability of Horizon to consummate
the transactions contemplated by this Agreement or the ability of Horizon to
consummate the transactions contemplated by any Operative Agreement or to
perform its obligations hereunder or thereunder.
(c) The parties acknowledge that transfer of the NDA for the Product
will not be completed until receipt and acceptance by the FDA of the
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Assignment Letters and the Horizon Assumption Letters.
3.8 HORIZON'S REPRESENTATION AND WARRANTY REGARDING THE PRODUCT.
Horizon represents and warrants that it and its Affiliates have not
manufactured, used or sold the
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Product anywhere worldwide or used the Trademarks anywhere worldwide prior to
the Closing Date. Horizon hereby acknowledges that it has been afforded the
opportunity to conduct due diligence with respect to the Product and to secure
such information from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ with respect to the Product as it deems
necessary to evaluate the merits of entering into the transactions contemplated
in this Agreement.
3.9 NO BROKERAGE FEE. Each party represents and warrants that no
broker, financial advisor or other Person is entitled to any brokerage fee or
commission in respect of the execution of this Agreement or the consummation of
the transactions contemplated hereby.
3.10 MANAGED CARE AGREEMENTS. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ represents and warrants
that the agreements of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ with the customers listed on Exhibit 3.10
hereto are all the Managed Care Agreements as of April 14, 2000. Also set forth
on Exhibit 3.10 are the rebate and/or discount terms with respect to each such
Managed Care Agreement as of April 14, 2000. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall deliver a
revised Exhibit 3.10 at the Closing listing all the Managed Care Agreements as
of the Closing Date. Each party will use its best efforts to notify the
customers set forth on Exhibit 3.10 that the Product has been transferred to
Horizon within three (3) Business Days after the Closing Date. Promptly after
the Closing Date, but in no event later than ten (10) Business Days following
the Closing Date, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall, subject to the required consent of the
applicable customer, assign all Managed Care Agreements existing on the Closing
Date and shall notify Horizon on a regular basis regarding each such consent
and assignment; provided, however, that with respect to those Managed Care
Agreements that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ is unable to assign, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall
fulfill all its obligations under each such Managed Care Agreement until its
expiration (it being understood and agreed that Horizon has an obligation to
reimburse ▇▇▇▇▇▇-▇▇▇▇▇▇▇ for Rebates and Chargebacks with respect to the
Managed Care Agreements pursuant to Section 1.3.2 hereof).
3.11 REGISTRATIONS. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby represents and warrants that
in the Territory, to its knowledge, (i) the Registrations are in good standing
and (ii) there is no pending or threatened action by the FDA or any relevant
Governmental or Regulatory Authority which will have a material adverse effect
on the Registrations. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ has paid the NDA maintenance fee for the
Product for the year 2000. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ makes no representation or warranty
that the NDA for Cognex CR will be accepted for filing or approved by the FDA.
3.12 CERTAIN FINANCIAL INFORMATION. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ represents and
warrants that the 1999 financial information provided to Horizon as of December
31, 1999, specifically, the gross sales, net sales, standard cost of goods and
gross profit of the Product as set forth in Section X of the Offering
Memorandum relating to the Product provided to Horizon, was based upon the
information contained in the books and records of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and, as such,
are accurate in all material respects. As used herein, "net sales" shall mean
the aggregate sales of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its Affiliates of Product to
unaffiliated third parties (but not including sales between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and
its Affiliates) less (i) bad debts related to the Product, and (ii) sales
returns and allowances, including, without limitation, trade, quantity and cash
discounts and any other adjustments, including, but not limited to, those
granted on account of price adjustments, billing errors, rejected goods,
damaged goods, recalls, returns, rebates, chargeback rebates, fees,
reimbursements or similar payments granted or given to wholesalers or other
distributors, buying groups, health care insurance carriers or other
institutions, freight and insurance charges billed to the customers, customs or
excise duties, sales tax and other taxes (except income taxes) or duties
relating to sales, and any payment in respect of sales to
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any Governmental or Regulatory Authority in respect of any Federal or state
Medicaid, Medicare or similar program, all as determined in a manner consistent
with the books and records of ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
3.13 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY PROVIDED HEREIN,
▇▇▇▇▇▇-▇▇▇▇▇▇▇ DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD
TO THE PRODUCTS, INCLUDING THE WARRANTY OF MERCHANTABILITY AND THE WARRANTY OF
FITNESS FOR A PARTICULAR PURPOSE. WITHOUT LIMITING THE FOREGOING, HORIZON
ACKNOWLEDGES THAT ▇▇▇▇▇▇-▇▇▇▇▇▇▇ HAS MADE NO REPRESENTATION OR WARRANTY AS TO
THE ABILITY TO MANUFACTURE OR SELL ANY OF THE PRODUCTS IN ACCORDANCE WITH
APPLICABLE LAW.
ARTICLE 4
INDEMNIFICATION
4.1 INDEMNIFICATION BY ▇▇▇▇▇▇-▇▇▇▇▇▇▇. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall indemnify,
defend and hold harmless Horizon against any loss, expense, liability or other
damages, including reasonable costs of investigation, interest, penalties and
attorneys' fees (collectively, "Losses") incurred by Horizon, its Affiliates or
any of their respective officers, directors, agents or employees (collectively,
the "Horizon Group") to the extent relating to or resulting from (a) any
inaccuracy of a representation or breach of a warranty made by ▇▇▇▇▇▇-▇▇▇▇▇▇▇
in this Agreement or (b) the Retained Liabilities; provided, however, that
▇▇▇▇▇▇-▇▇▇▇▇▇▇ will have no obligations under this Section for Losses to the
extent that they are caused by (i) any inaccuracy of a representation or breach
of a warranty made by Horizon in this Agreement or (ii) the gross negligence or
willful misconduct of any member of the Horizon Group. Horizon hereby agrees
that ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ liability under this Agreement from whatever cause,
whether pursuant to this Section or any other cause arising under this
Agreement, is limited to the amounts paid by Horizon to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ pursuant
to Section 2.1 as of the date of determination of such liability, provided,
however, that the limitation on liability contained in this sentence shall not
apply to a failure of the Inventory to meet the Specifications, where such
failure was due solely to the actions or omissions of ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
Furthermore, the parties agree that in no event will ▇▇▇▇▇▇-▇▇▇▇▇▇▇ be liable
to Horizon hereunder for special, consequential, indirect, punitive or similar
damages.
4.2 INDEMNIFICATION BY HORIZON. Horizon shall indemnify, defend and
hold harmless ▇▇▇▇▇▇-▇▇▇▇▇▇▇ against any Losses incurred by ▇▇▇▇▇▇-▇▇▇▇▇▇▇, its
Affiliates or any of their respective officers, directors, agents or employees
(collectively, the "Warner Group") relating to or resulting from (a) any
inaccuracy of a representation or breach of a warranty made by Horizon in this
Agreement; (b) any liabilities, obligations, commitments of, or claims against
any member of the Warner Group based on the manufacture, use or sale of the
Product in the Territory or use of the Trademarks or the Registrations in the
Territory, on and after the Closing Date; and (c) the Assumed Liabilities;
provided, however, that Horizon will have no obligations under this Section for
Losses to the extent that they are caused by (a) any inaccuracy of a
representation or breach of a warranty made by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ in this Agreement
or (b) the gross negligence or willful misconduct of any member of the Warner
Group. Furthermore, the
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parties agree that in no event will Horizon be liable to ▇▇▇▇▇▇-▇▇▇▇▇▇▇
hereunder for special, consequential, indirect, punitive or similar damages.
4.3 INDEMNIFICATION PROCEDURES. In any case under this Agreement where
one party has indemnified the other against any claim or legal action,
indemnification will be conditioned on compliance with the procedure outlined
below. Provided that prompt notice is given of any claim or suit for which
indemnification might be claimed, the indemnifying party promptly will defend,
contest or otherwise protect against any such claim or suit (including by way
of settlement and release) at its own cost and expense. The indemnified party
may, but will not be obligated to, participate at its own expense in a defense
thereof by counsel of its own choosing, but the indemnifying party will be
entitled to control the defense unless the indemnified party has relieved the
indemnifying party from liability with respect to the particular matter. If the
indemnifying party fails timely to defend, contest or otherwise protect against
any such claim or suit, the indemnified party may, but will not be obligated
to, defend, contest or otherwise protect against the same, and make any
compromise or settlement thereof and recover the entire costs thereof from the
indemnifying party, including reasonable attorneys fees, disbursements and all
amounts paid as a result of such claim or suit or the compromise or settlement
thereof; provided, however, that if the indemnifying party undertakes the
timely defense of such matter, the indemnified party will not be entitled to
recover from the indemnifying party its costs incurred in the defense thereof.
The indemnified party will cooperate and provide such assistance as the
indemnifying party may reasonably request in connection with the defense of the
matter subject to indemnification.
ARTICLE 5
ADDITIONAL AGREEMENTS
5.1 MONTHLY REPORTS; RETURNS. (a) During the twelve month period
following the Closing Date, Horizon shall prepare and deliver to ▇▇▇▇▇▇-▇▇▇▇▇▇▇
a written monthly report showing all returns received by Horizon of Product sold
prior to the Closing Date by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ (the "Returns"). Within thirty (30)
days of the receipt of such monthly report, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall reimburse
Horizon for payments made by Horizon with respect to such Returns up to $1.8
million in the aggregate.
(b) Horizon shall keep accurate records in sufficient detail to
determine the amount of the reimbursement payable by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ under this
Section 5.1. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ may designate an independent public accountant
mutually acceptable to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon to review such records to
verify the accuracy of information provided to ▇▇▇▇▇▇-▇▇▇▇▇▇▇. ▇▇▇▇▇▇-▇▇▇▇▇▇▇
shall pay the cost of any review of records conducted at the request of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ under this Section; provided, however, that if the independent
public accountant conducting the review concludes that the amount payable under
this Section 5.1 were overstated by 5% or more, Horizon shall pay the cost of
such review.
5.2 USE OF ▇▇▇▇▇▇-▇▇▇▇▇▇▇ NAME. (a) Horizon shall not use the name of
▇▇▇▇▇▇-▇▇▇▇▇▇▇, ▇▇▇▇▇-▇▇▇▇▇ or any of ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ Affiliates (collectively,
the "▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name") in any manner whatsoever in connection with the
manufacture, use, sale, promotion, advertising or distribution of the Product
after the Closing Date, provided, however, Horizon may use the inventory and
Promotional Materials purchased from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ by Horizon
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hereunder bearing the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name (including inventory purchased under
the Supply Agreement) until such inventory expires or is depleted, whichever
occurs first ("Final Inventory Sell Off Date"). Except as otherwise set forth
in this Section 5.2 or in Section 5.3 hereof, Horizon shall have no right to
use the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name without the prior written consent of
▇▇▇▇▇▇-▇▇▇▇▇▇▇.
(b) Horizon hereby agrees that any Inventory purchased from
▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereunder and bearing the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name will be held,
maintained and distributed in accordance with applicable pharmaceutical current
good manufacturing practices, the Registrations, and all applicable laws.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have no responsibility for costs and expenses associated
with any recall of the Inventory on or after the Closing Date attributable to a
determination by a Governmental or Regulatory Authority that the use of the
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name on such Inventory would constitute misbranding within the
meaning of the Federal Food, Drug, and Cosmetic Act or similar laws in the
Territory.
5.3 USE OF PROMOTIONAL MATERIALS. Horizon hereby agrees that any
Promotional Materials purchased from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereunder and bearing the
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name (i) will not be used after the Final Inventory Sell Off
Date; and (ii) will be held, maintained and distributed in accordance with the
Registrations and all applicable laws. From the Closing Date until the Final
Inventory Sell Off Date, Horizon shall have the right, subject to
▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ prior written consent, to apply the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name on any
new promotional materials (including, but not limited to, journal ads,
convention materials, sales aids, and medical education materials) for the
Product. Horizon shall submit such promotional materials in final form, together
will all data and documentation required to support any claims made therein, to
▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ regulatory group which shall determine, within ten (10)
Business Days after receipt, whether to grant written consent to use such
promotional materials. Horizon shall have no other right to use the
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name other than as set forth herein and in Section 5.2 above.
Horizon agrees that after the Final Inventory Sell Off Date all promotional
materials and Promotional Materials containing the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name shall be
destroyed at Horizon's sole cost and expense. Use of the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name on
promotional materials and the use of the Promotional Materials by Horizon shall
be at Horizon's risk.
5.4 PRODUCT REGULATORY OBLIGATIONS.
5.4.1. FDA Contacts. On and after the Closing Date, Horizon
shall be responsible for all contacts with the FDA and other regulatory
authorities with respect to the Product, and all other responsibilities under
the Registrations; provided that either party shall notify the other party
immediately, and in no event later than (A) forty-eight (48) hours after receipt
of any contact or communication from the FDA or any other Governmental or
Regulatory Authority in the Territory and (B) five (5) Business Days after
receipt of any contact or communication with any other third party, that in
either case, in any way requests or suggests the need for a recall or withdrawal
of a lot of Product manufactured by or on behalf of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or otherwise
calls into question the quality or safety of such a Product lot. Horizon shall
be responsible for investigating any such request or suggestion and for any
communications with any Governmental or Regulatory Authority relating thereto;
provided that Horizon shall comply with all reasonable requests by
▇▇▇▇▇▇-▇▇▇▇▇▇▇.
5.4.2. Customer Complaints. Horizon shall be solely
responsible for responding to any Product complaint received on or after the
Closing Date. Each party shall notify the other
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in the event that such a party receives a report of a Product complaint
relating to a Product lot manufactured by or on behalf of ▇▇▇▇▇▇-▇▇▇▇▇▇▇. The
complaint recipient shall use all reasonable efforts to provide such notice to
the other party within forty eight (48) hours if the complaint involves
allegations of suspected or actual product tampering, contamination or
mislabeling, and shall provide such notice to the other party within five (5)
Business Days in the case of all other complaints. Horizon shall be responsible
for investigating all such Product complaints and responding to the
complainant, provided each party shall comply with all reasonable requests from
the other in connection therewith.
5.4.3. Adverse Event Reporting. (a) On and after the Closing
Date until such date that each of the Registrations are transferred to Horizon
(the "Transfer Date"), each party shall have a continuing obligation to notify
the other party of any adverse drug experience reported to such party arising
from or in connection with the use of the Product. This notification shall occur
within seventy-two (72) hours for an unexpected fatal or life-threatening
serious adverse drug experience (as defined in 21 CFR 312.32) associated with
the Product and arising during clinical trials. For post-marketing adverse drug
experience reports, the parties agree as follows:
(i) ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall report to Horizon all adverse drug
experiences within five (5) Business Days after the time such
report becomes known to any employee, agent or Affiliate of
▇▇▇▇▇▇-▇▇▇▇▇▇▇. All other post-marketing adverse drug
experience reports for the Product shall be reported to
Horizon by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ on a rolling fifteen (15)-day
basis.
(ii) Horizon shall report to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ all serious adverse
drug experience reports for the Product within five (5)
Business Days after the time such report becomes known to any
employee, agent or Affiliate of Horizon and all other adverse
drug experience reports for the Product on a rolling fifteen
(15)-day basis.
All notifications pursuant to this paragraph shall be by fax or e-mail at such
numbers (or e-mail addresses) agreed upon by the parties' respective drug safety
organizations. Horizon shall have sole responsibility to investigate such
adverse experience reports and for reporting such reports to Governmental and
Regulatory Authorities. Except as otherwise stated above, the terms "adverse
drug experience" and "serious adverse drug experience" used in this paragraph
shall have the meanings set forth in 21 CFR 314.80.
(b) On and after the Transfer Date, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have
a continuing obligation to notify Horizon of any postmarketing adverse drug
experience reported to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ arising from or in connection with the use
of a Product in post-marketed use. This notification shall occur within five (5)
days for all post-marketing adverse drug experience reports. This notification
shall be by fax. Horizon shall have sole responsibility to investigate such
adverse experience reports and for reporting such reports to applicable
Governmental or Regulatory Authorities. Following the Closing Date, Horizon
shall provide ▇▇▇▇▇▇-▇▇▇▇▇▇▇ with reasonable access to the post-marketing and
clinical safety database for the Product as necessary in connection with any
ongoing legal and/or regulatory requirements of ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
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(c) The parties shall use reasonable efforts to enter into a
separate drug safety sharing agreement describing the procedures and other
logistics to implement the provisions in this Section 5.4 within ninety (90)
days after execution of this Agreement.
5.4.4 Assistance with Regulatory Obligations Transfer. For a
period of up to sixty (60) days following the Closing Date, ▇▇▇▇▇▇-▇▇▇▇▇▇▇
agrees to provide assistance and cooperation reasonably requested by Horizon in
connection with the transfer of the Registrations to Horizon in the United
States and all other countries except the European countries in the Territory.
During the term of the Transition Services Agreement and for a period of up to
sixty (60) days following the termination of the Transition Services Agreement,
▇▇▇▇▇▇-▇▇▇▇▇▇▇ agrees to provide assistance and cooperation reasonably requested
by Horizon in connection with the transfer of the Registrations to Horizon in
the European countries in the Territory.
5.4.5 Transfer of Registration. The parties shall use all
reasonable efforts to transfer the Registrations from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and the
Selling Affiliates to Horizon or its designee six (6) months after the Closing
Date.
5.5 PAYMENT OF TRANSACTION EXPENSES. All sales taxes, use taxes, value
added taxes, transfer taxes, filing fees (including trademark assignment fees)
and similar taxes, fees, charges and expenses (excluding any taxes arising from
income or gains earned by ▇▇▇▇▇▇-▇▇▇▇▇▇▇) required to be paid in connection with
the sale of the Assets to Horizon will be borne and paid by Horizon. All legal
fees and other expenses incurred on behalf of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ in connection with
the negotiation of this Agreement will be borne by ▇▇▇▇▇▇-▇▇▇▇▇▇▇; and all legal
fees and other expenses incurred on behalf of Horizon in connection with the
negotiation of this Agreement will be borne by Horizon.
5.6 ACCESS TO ▇▇▇▇▇▇-▇▇▇▇▇▇▇ RECORDS. To the extent required by the
Securities and Exchange Commission in connection with an initial public offering
of or other financing for Horizon and upon five Business Days' prior written
notice from Horizon, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ agrees to provide Horizon and up to two (2)
employees of an independent accounting firm designated by Horizon with
reasonable access to financial records pertaining to the Product covering a
period ending not more than three (3) years prior to the date of such request.
Prior to granting any access to such records, the designated accounting firm
shall first agree not to disclose any confidential information contained in such
financial records. Horizon shall pay all costs and expenses in connection with
the review of such financial records.
5.7 LIMITATION ON TRANSFER. Horizon hereby agrees that until such time
as Horizon has discharged all its payment obligations hereunder (other than the
payment obligation set forth in Section 2.1(a)(ii)), it shall not convey, sell,
assign, transfer, license or otherwise dispose of any of the Assets (other than
Inventory in the ordinary course of business) without the prior written consent
of ▇▇▇▇▇▇-▇▇▇▇▇▇▇, which consent shall not be unreasonably withheld, provided,
that Horizon shall have the right to assign its rights and obligations under
this Agreement to any third party successor to all or substantially all of its
entire business. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will respond to such written request for
transfer of the Assets within forty-five (45) days after receipt of such written
request from Horizon.
5.8 CONFIDENTIALITY. For a period of five (5) years from the Closing
Date, each party shall hold in confidence and use its best efforts to have all
of their respective Affiliates and representatives hold in confidence all
confidential information of the other party, and, except as
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contemplated by this Agreement, shall not disclose, publish, use or permit
others to use the same; provided, however, that the foregoing restriction shall
not apply to any portion of the foregoing which was or becomes available on a
non-confidential basis to the other party or when such disclosure is required
by a Governmental or Regulatory Authority or is otherwise required by law or is
necessary in order to establish rights under this Agreement or any other
agreements referred to herein. In the event the transaction contemplated hereby
is not consummated, upon the request of the other party, each party hereto
will, and will cause its Affiliates, any Person who has provided, or who is
providing, financing to such party and their respective Representatives to,
promptly (and in no event later than five (5) Business Days after such request)
redeliver or cause to be redelivered all copies of confidential documents and
information furnished by the other party in connection with this Agreement or
the transactions contemplated hereby and destroy or cause to be destroyed all
notes, memoranda, summaries, analyses, compilations and other writings related
thereto or based thereon prepared by the party furnished such documents and
information or its representatives, provided, however, that each party shall be
entitled to keep one archival copy of such confidential documents and
information and related materials solely as evidence of what was redelivered
and destroyed hereunder, and for no other purpose.
5.9 TRANSITION SERVICES. Subsequent to the Closing Date, ▇▇▇▇▇▇-▇▇▇▇▇▇▇
agrees to provide certain transition services to Horizon pursuant to the
Transition Services Agreement (as hereinafter defined).
5.10 FURTHER ASSURANCES. ▇▇▇▇▇▇-▇▇▇▇▇▇▇, at any time after the Closing
Date, at the request of Horizon and at Horizon's sole expense, shall execute,
acknowledge and deliver any further assignments, and other assurances, documents
and instruments of transfer that may be reasonably necessary for the purpose of
assigning and granting to Horizon all Assets to be conveyed pursuant to this
Agreement.
5.11 THIRD PARTY CONSENTS. To the extent that any Managed Care Contract
is not assignable without the consent of another party, this Agreement shall not
constitute an assignment or an attempted assignment thereof if such assignment
or attempted assignment would constitute a breach thereof. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and
Horizon shall use their commercially reasonable efforts to obtain the consent of
such other party to the assignment of any such Managed Care Contract to Horizon
in all cases in which such consent is or may be required for such assignment. If
any such consent shall not be obtained, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall cooperate with
Horizon in any reasonable arrangement designed to provide for Horizon the
benefits intended to be assigned to Horizon under the relevant Managed Care
Contract, including enforcement at the cost and for the account of Horizon of
any and all right of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or any of its Affiliates against the other
party thereto arising out of the breach or cancellation thereof by such other
party or otherwise. If and to the extent that such arrangement cannot be made,
Horizon shall have no obligation pursuant to Section 1.3 or otherwise with
respect to any such Managed Care Contract. The provisions of this Section 5.11
shall not affect the right of Horizon not to consummate the transactions
contemplated by this Agreement if the condition to its obligations hereunder
contained in Section 3.7 has not been fulfilled.
5.12 NOTIFICATION TO THE TRADE. The parties shall each use their best
efforts to notify ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ customers in the United States of the sale of
the Product to Horizon within three (3) Business Days after the Closing Date.
The parties will agree to notify Warner-
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▇▇▇▇▇▇▇'▇ customers outside the United States upon the transfer of the
Registration of the Product.
5.13 POST CLOSING OPERATION OF BUSINESS. For twelve (12) months
following the Closing Date, Horizon will operate the Business only in the
ordinary course.
5.14 DOCUMENT RETENTION. Each party agrees for a period which is the
longer of three (3) years after the Closing Date and the applicable period
required by law or any Governmental or Regulatory Authority not to destroy or
otherwise dispose of any Registrations or Information unless such party shall
first offer in writing to surrender such documentation to the other party and
such other party shall not agree in writing to take possession thereof during
the ten (10) day period after such offer is made.
5.15 CERTAIN FTC UNDERTAKINGS. (a) Horizon shall, within ten (10) days
after the Closing Date, submit to the United States Federal Trade Commission
(the "Commission") a certification attesting to its good faith intention to
obtain expeditiously all of the necessary FDA approvals to sell and manufacture
or have manufactured Cognex, together with a business plan setting forth the
forecasted dates for completion of necessary preparations and final FDA
approvals.
(b) Horizon shall, submit to the Commission and Interim Trustee
periodic reports setting forth, in detail, the efforts of Horizon to market the
Product and to obtain FDA approvals to sell and manufacture or have manufactured
the Product. Horizon shall submit the first such report sixty (60) days after
the date of the Consent Order relating to the merger of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and
Pfizer Inc., and every sixty days thereafter, until all necessary FDA approvals
are obtained by or on behalf of Horizon.
(c) In the event that Horizon (i) ceases to sell the Product in the
United States for a period exceeding sixty (60) days, or (ii) abandons its
efforts to obtain all necessary FDA approvals to sell and manufacture or have
manufactured Cognex, Horizon shall notify the Commission and the Interim Trustee
within ten (10) days thereafter. Horizon shall provide the Commission and the
Interim Trustee with access to all records and facilities that relate to its
efforts to manufacture and sell the Product.
(d) In the event that Horizon, other than for reasons that are outside
of its control, (i) voluntarily ceases for sixty (60) days or more the sale of,
or otherwise fails to pursue good efforts to sell the Product in the United
States prior to obtaining all necessary FDA approvals; (ii) fails to pursue sale
and manufacture (or third party manufacture) of the Product within one (1) year
from the date the Commission approves this Agreement, provided, however, that
the one (1) year period may be extended by the Commission in three (3) month
increments for a period not to exceed one (1) year if it appears that such FDA
approvals are likely to obtain with such extended period, the Commission may
order that the Product revert to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and the Product will be divested
by the divestiture trustee appointed by the Commission to a new purchaser.
Horizon shall be entitled to receive the proceeds from the sale of the Product
by the divestiture trustee, up to a maximum of $3.5 million, within thirty (30)
days after ▇▇▇▇▇▇-▇▇▇▇▇▇▇ receives such proceeds. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have no
further obligation or liability to Horizon in connection with the reversion of
Product to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereunder.
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ARTICLE 6
COVENANTS OF THE PARTIES
6.1 COVENANTS OF ▇▇▇▇▇▇-▇▇▇▇▇▇▇. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ covenants and agrees
with Horizon that, at all times from and after the date hereof until the
Closing, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will comply with all covenants and provisions of this
Section 6.1, except to the extent Horizon may otherwise consent in writing.
6.1.1 Investigation by Horizon. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will provide
Horizon and its Representatives with full access, upon reasonable prior notice
and during normal business hours, to the officers, employees and agents of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ who have any responsibility for the conduct of the Business, to
▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ accountants and to the Assets.
6.1.2 Conduct of Business. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will operate the
Business only in the ordinary course, consistent with past practice.
6.1.3 Fulfillment of Conditions. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will execute
and deliver at the Closing each Operative Agreement that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ is
required hereby to execute and deliver as a condition to the Closing, will take
all commercially reasonable steps necessary or desirable and proceed diligently
and in good faith to satisfy each other condition to the obligations of Horizon
contained in this Agreement and will not take or fail to take any action that
could reasonably be expected to result in the nonfulfillment of any such
condition.
6.1.4 Regulatory and Other Approvals. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will take
all commercially reasonable steps necessary or desirable to make all filings
with and to give all notices to Governmental or Regulatory Authorities or any
other Person required of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to consummate the transactions
contemplated hereby and by the Operative Agreements, including without
limitation those described in Exhibits 3.7(a) and 3.7(b).
6.2 COVENANTS OF HORIZON. Horizon covenants and agrees with
▇▇▇▇▇▇-▇▇▇▇▇▇▇ that, at all times from and after the date hereof until the
Closing, Horizon will comply with all covenants and provisions of this Section
6.2, except to the extent ▇▇▇▇▇▇-▇▇▇▇▇▇▇ may otherwise consent in writing.
6.2.1 Fulfillment of Conditions. Horizon will execute and
deliver at the Closing each Operative Agreement that Horizon is hereby required
to execute and deliver as a condition to the Closing, will take all commercially
reasonable steps necessary or desirable and proceed diligently and in good faith
to satisfy each other condition to the obligations of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ contained
in this Agreement and will not take or fail to take any action that could
reasonably be expected to result in the nonfulfillment of any such condition.
6.2.2 Regulatory and Other Approvals. Horizon will take all
commercially reasonable steps necessary or desirable, and proceed diligently and
in good faith and use all commercially reasonable efforts, as promptly as
practicable to obtain all consents, approvals or actions of, to make all filings
with and to give all notices to Governmental or Regulatory Authorities or any
other Person required of Horizon to consummate the transactions
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contemplated hereby and by the Operative Agreements, including without
limitation those described in Exhibits 3.7(a) and 3.7(b).
ARTICLE 7
CONDITIONS TO OBLIGATIONS OF THE PARTIES
7.1 CONDITIONS TO OBLIGATIONS OF HORIZON. The obligations of Horizon
hereunder to purchase the Assets and to assume and pay, perform and discharge
the Assumed Liabilities are subject to the fulfillment, at or before the
Closing, of each of the following conditions (all or any of which may be waived
in whole or in part by Horizon in its sole discretion):
7.1.1 Representations and Warranties. The representations and
warranties made by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ in this Agreement, taken as a whole, shall be
true and correct, in all material respects, on and as of the Closing Date as
though made on and as of the Closing Date or, in the case of representations and
warranties made as of a specified date earlier than the Closing Date, on and as
of such earlier date.
7.1.2 Performance. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have performed and
complied with, in all material respects, the agreements, covenants and
obligations required by this Agreement to be so performed or complied with by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ at or before the Closing.
7.1.3 Orders and Laws. There shall not be in effect on the
Closing Date any order or law restraining, enjoining or otherwise prohibiting or
making illegal the consummation of any of the transactions contemplated by this
Agreement or any of the Operative Agreements.
7.1.4 Deliveries. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have delivered to
Horizon an Assignment, Assumption and ▇▇▇▇ of Sale in the form of Exhibit
7.1.4(a) (the "Assignment, Assumption and ▇▇▇▇ of Sale"), a Trademark assignment
in the form of Exhibit 7.1.4(b) and except as otherwise provided herein, such
other documents and instruments as may be necessary to completely sell, convey,
assign, grant, transfer and deliver the Assets to Horizon.
7.1.5 Supply Agreement. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have delivered to
Horizon a manufacturing and supply agreement between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its
Affiliate and Horizon in the form of Exhibit 7.1.5 (the "Supply Agreement").
7.1.6 ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Assignment Letters. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall
have delivered to Horizon letters from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to the FDA, transferring
all rights and responsibilities under the Registrations to Horizon, in form
reasonably satisfactory to counsel for Horizon (the "▇▇▇▇▇▇-▇▇▇▇▇▇▇ Assignment
Letters").
7.1.7 Third Party Consents. The consents (or in lieu thereof
waivers) listed on Exhibit 3.7(a) shall have been obtained and shall be in full
force and effect.
7.1.8 Sublicense. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have delivered to
Horizon a sublicense of the License Agreement between ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, M.D.
and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ dated September 27, 1990 substantially in the form of Exhibit
7.1.8 (the "Sublicense").
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20
7.1.9 Regulatory Consents and Approvals. All consents,
approvals and actions of, filings with and notices to the relevant Governmental
or Regulatory Authority set forth in Exhibits 3.7(a) and 3.7(b), necessary to
permit Horizon and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to perform their obligations under this
Agreement, to permit Horizon, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and the Selling Affiliates to
perform their respective obligations under the Operative Agreements and to
consummate the transactions contemplated hereby and thereby shall have been duly
obtained, made or given and shall be in full force and effect, and all
terminations or expirations of waiting periods imposed by any such Governmental
or Regulatory Authority necessary for the consummation of the transactions
contemplated by this Agreement and the Operative Agreements shall have occurred.
7.1.10 Transition Services Agreement. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall
have delivered to Horizon a transition services agreement between ▇▇▇▇▇▇-▇▇▇▇▇▇▇
or its Affiliate and Horizon substantially in the form of Exhibit 7.1.10 (the
"Transition Services Agreement").
7.1.11 Assignment of Licenses. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have
delivered to Horizon an assignment and assumption agreement in the form of
Exhibit 7.1.11 (the "License Agreement").
7.2 CONDITIONS TO OBLIGATIONS OF ▇▇▇▇▇▇-▇▇▇▇▇▇▇. The obligations of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereunder to sell or cause the Selling Affiliates to sell the
Assets are subject to the fulfillment, at or before the Closing, of each of the
following conditions (all or any of which may be waived in whole or in part by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ in its sole discretion):
7.2.1 Representations and Warranties. The representations and
warranties made by Horizon in this Agreement, taken as a whole, shall be true
and correct in all material respects on and as of the Closing Date as though
made on and as of the Closing Date.
7.2.2 Performance. Horizon shall have performed and complied
with, in all material respects, the agreements, covenants and obligations
required by this Agreement to be so performed or complied with by Horizon at or
before the Closing.
7.2.3 Orders and Laws. There shall not be in effect on the
Closing Date any order or law restraining, enjoining or otherwise prohibiting or
making illegal the consummation of any of the transactions contemplated by this
Agreement or any of the Operative Agreements.
7.2.4 Deliveries. Horizon shall have delivered to
▇▇▇▇▇▇-▇▇▇▇▇▇▇ the Assignment, Assumption and ▇▇▇▇ of Sale and except as
otherwise provided herein, such other documents and instruments as may be
necessary to completely sell, convey, assign, grant, transfer and deliver the
Assets to Horizon.
7.2.5 Supply Agreement. Horizon shall have delivered to
▇▇▇▇▇▇-▇▇▇▇▇▇▇ the Supply Agreement.
7.2.6. Horizon Assumption Letters. Horizon shall have
delivered to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ letters from Horizon to the FDA assuming all rights
and responsibilities under the Registrations, in form reasonably satisfactory to
counsel for ▇▇▇▇▇▇-▇▇▇▇▇▇▇ (the "Horizon Assumption Letters").
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21
7.2.7 Third Party Consents. The consents (or in lieu thereof
waivers) listed on Exhibit 3.7(b) shall have been obtained and shall be in full
force and effect.
7.2.8 Sublicense. Horizon shall have delivered to
▇▇▇▇▇▇-▇▇▇▇▇▇▇ the Sublicense.
7.2.9 Regulatory Consents and Approvals. All consents,
approvals and actions of, filings with and notices to the relevant Governmental
or Regulatory Authority set forth in Exhibits 3.7(a) and 3.7(b), necessary to
permit Horizon and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to perform their obligations under this
Agreement, to permit Horizon, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and the Selling Affiliates to
perform their respective obligations under the Operative Agreements and to
consummate the transactions contemplated hereby and thereby shall have been duly
obtained, made or given and shall be in full force and effect, and all
terminations or expirations of waiting periods imposed by any such Governmental
or Regulatory Authority necessary for the consummation of the transactions
contemplated by this Agreement and the Operative Agreements shall have occurred.
7.2.10 Transition Services Agreement. Horizon shall have
delivered to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ the Transition Services Agreement.
7.2.11 Assignment of Licenses. Horizon shall have delivered
to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ the License Agreement.
ARTICLE 8
GENERAL
8.1 ASSIGNMENT. Until such time as Horizon has discharged all its
payment obligations hereunder (other than the payment obligation set forth in
Section 2.1(a)(ii)), this Agreement may not be assigned by Horizon without the
prior written consent of ▇▇▇▇▇▇-▇▇▇▇▇▇▇; provided, that Horizon shall have the
right to assign its rights and obligations under this Agreement to any third
party successor to all or substantially all of its entire business.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ will respond to Horizon's written request for assignment within
forty-five (45) days after receipt of such written request from Horizon. This
Agreement will be binding upon and will inure to the benefit of permitted
assigns and successors. Notwithstanding anything to the contrary in this herein,
Horizon may sublicense the Assets to a third party manufacturer to the extent
and only to the extent necessary to manufacture the Product for Horizon.
8.2 NOTICES. All notices, requests, demands and other
communications required or permitted under this Agreement shall be in writing
and shall be deemed to have been duly given, made and received on the date when
delivered by hand delivery with receipt acknowledged, or upon the next business
day following receipt of telex or telecopy transmission, or upon the third day
after deposit in the United States mail, registered or certified with postage
prepaid, return receipt requested, addressed as set forth below:
(a) If to ▇▇▇▇▇▇-▇▇▇▇▇▇▇:
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▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn: President, Pharmaceutical Sector
Fax: ▇▇▇-▇▇▇-▇▇▇▇
with a copy to:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Senior Vice President and General Counsel
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
(b) If to Horizon:
First Horizon Pharmaceutical Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Vice President, Corporate Development
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
First Horizon Pharmaceutical Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Legal Counsel
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Any party may alter the addresses to which communications or copies are to be
sent by giving, notice of such change of address in conformity with the
provisions of this Section for giving notice.
8.3 TERMINATION. (a) Notwithstanding anything contained in this
Agreement to the contrary, this Agreement may be terminated at any time prior to
the Closing Date: (i) by the mutual consent of the parties; (ii) by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ if the Closing shall not have occurred on or before June 30,
2000, other than due to a delay in receiving clearance from the Federal Trade
Commission to proceed with the transactions contemplated herein; (iii) by either
party in the event of a material breach by the other party of any of its
agreements, representations or warranties contained herein, as the case may be,
and the failure of such breaching party to cure such breach within fourteen (14)
days after receipt of notice from the non-breaching party requesting such breach
to be cured, or (iv) by either party if consummation of the transactions
contemplated hereby shall violate a decree, injunction or similar order of any
Governmental or Regulatory Authority.
(b) Any party desiring to terminate this Agreement pursuant to Section
8.3(a) shall provide five (5) days' prior written notice of such termination to
the other party to this Agreement.
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23
(c) If this Agreement is validly terminated pursuant to Section
8.3(a), this Agreement will forthwith become null and void, and there will be
no liability or obligation on the part of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or Horizon (or any of
their representatives or Affiliates), except that the provisions with respect
to expenses in Section 5.5 and confidentiality in Section 5.8 will continue to
apply following any such termination.
8.4 SURVIVAL OF REPRESENTATIONS AND WARRANTIES. All representations
and warranties made by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ in this Agreement shall survive from the
Closing Date for a period of two (2) years and terminate thereafter. All
indemnification provisions made by the parties hereto under this Agreement
shall survive indefinitely.
8.5 SEVERABILITY. If any provision of this Agreement is held to be
invalid or unenforceable for any reason, the remaining provisions will continue
in full force without being impaired or invalidated in any way, and the parties
agree to replace any invalid provision with a valid provision which most
closely approximates the intent and economic effect of the invalid provision.
8.6 HEADINGS. Headings used in this Agreement are for reference
purposes only and in no way define, limit, construe or describe the scope or
extent of such paragraph, or in any way affect this Agreement.
8.7 NO WAIVER. No term or provisions hereof shall be deemed waived,
and no breach excused, unless such waiver or consent is in writing and signed
by the party claimed to have waived or consented. The waiver by any party of a
breach of any provision of this Agreement will not operate or be interpreted as
a waiver of any other or subsequent breach.
8.8 RELATIONSHIP OF THE PARTIES. Nothing in this Agreement should be
construed to create a partnership, agency, joint venture or employer-employee
relationship. None of the parties has the authority to assume or create any
obligation, express or implied, on behalf of any other party.
8.9 GOVERNING LAW. This Agreement shall be governed and construed in
accordance with the laws of the State of New York. Each party hereby consents
to the personal jurisdiction of the state and federal courts located in New
York.
8.10 ENTIRE AGREEMENT; AMENDMENT. This Agreement, including all
Exhibits and Schedules hereto (which Exhibits and Schedules are hereby
incorporated into and made a part of this Agreement), and the additional
documents required to be delivered on the Closing Date, constitute the final,
complete and exclusive agreement among the parties with respect to the subject
matter hereof and supersede any previous proposals, negotiations, agreements,
arrangements or warranties, whether verbal or written, made among the parties
with respect to such subject matter. This Agreement may be amended or modified
only by mutual agreement in writing of the authorized representatives of the
parties.
8.11 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and all of which shall
together constitute one and the same instrument. This Agreement shall become
binding when one or more counterparts hereof shall bear the signatures of all
parties indicated as signatories hereto.
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8.12 NO THIRD PARTY BENEFICIARY. The terms and provisions of this
Agreement are intended solely for the benefit of each party hereto and their
respective successors or permitted assigns, and it is not the intention of the
parties to confer third-party beneficiary rights upon any other Person.
8.13 PUBLIC ANNOUNCEMENTS. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon will not issue or
make any reports, statements or releases to the public or generally to the
employees, customers, suppliers or other Persons with respect to this Agreement
or the transactions contemplated hereby without the consent of the other
parties, which consent shall not be unreasonably withheld. If any party is
unable to obtain the approval of its public report, statement or release from
the other party and such report, statement or release is, in the opinion of
legal counsel to such parties, required by law in order to discharge such
party's disclosure obligations, then such party may make or issue the legally
required report, statement or release and promptly furnish the other parties
with a copy thereof. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon will also obtain the other
parties' prior approval of any press release to be issued immediately following
the Closing Date announcing the consummation of the transactions contemplated by
this Agreement.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first above written.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY
By:
--------------------------------------
Name:
Title:
FIRST HORIZON PHARMACEUTICAL CORPORATION
By:
--------------------------------------
Name:
Title:
24
26
EXHIBIT A
PRODUCT
Cognex
27
EXHIBIT 1.1.1
[****]-CONFIDENTIAL TREATMENT REQUESTED
FINISHED PRODUCT INVENTORY
---------------------------------------------------------------------------------------------------------------------
FINISHED PRODUCT INVENTORY (PACKAGED)
---------------------------------------------------------------------------------------------------------------------
COUNTRY DOSAGE STRENGTH QUANTITY EXPIRATION DATE COST (US$)
------- --------------- -------- --------------- ----------
US
10 mg 2,100* 07/31/2001 $[*****]
20 mg 31,900* 03/30/2002 $[*****]
40 mg 7,200* 05/30/2001 $[*****]
* - 120 ct bottles
FRANCE
40 mg 103*** 10/01/2001 $[*****]
*** - 112 ct packages
GREECE
10 mg 1,000* 08/01/2001 $[*****]
30 mg 520* 10/01/2001 $[*****]
40 mg 1,223* 10/01/2001 $[*****]
* - 56 ct packages
---------------------------------------------------------------------------------------------------------------------
FINISHED PRODUCT IN GERMANY (PACKAGED BUT NOT SHIPPED)
---------------------------------------------------------------------------------------------------------------------
COUNTRY DOSAGE STRENGTH QUANTITY EXPIRATION DATE COST
------- --------------- -------- --------------- ----
GREECE 40 mg 1,520 (56 ct) 10/01/2001 $[*****]
GRAND TOTAL $[*****]
---------------------------------------------------------------------------------------------------------------------
28
EXHIBIT 1.1.2
INTELLECTUAL PROPERTY
TRADEMARKS
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- ------- ----- ------ ----------- ---------- -----------
USA COGNEX 73/762382 07NO1988 1543222
13JE1989 13JE2009 WLP G
ANDO COGNEX 12903 04DE1998 12467
04DE1998 04DE2008 WLP G
AOIP COGNEX 82989 16NO1993 33312
15SE1994 16NO2003 WLP G
ARGE COGNEX 1668032 19OC1988 1419731
26FE1993 26FE2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ 01MY1995 A497479
01MY1995 17OC2009 WLP G
ATRA COGNEX AM4962/89 11OC1989 129313
09MR1990 31JA2000 WLP G
ATRA COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
BENE COGNEX 65023 14SE1998 457086
02FE1999 26OC2008 WLP G
BENE COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 29DE1999 814501605
28AU1990 28AU2000 WLP G
BRAZ COGNEX CR 819637173 04NO1996 819637173
13JL1999 13JL2009 WLP G
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- ------- ----- ------ ----------- ---------- -----------
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 08SE1992 21730
30SE1993 08SE2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
CAMB COGNEX 1803 08OC1992 1801
21AP1993 08OC2002 WLP G
CHIL COGNEX 443093 12MR1999 539520
01JL1999 27AP2009 WLP G
29
CHIL COGNEX CR 357493 10OC1996 489543
14JL1997 14JL2007 WLP G
CHIN COGNEX 93125913 02DE1993 765722
14SE1995 13SE2005 WLP G
COLO COGNEX 309872 11SE1989 147849
10NO1993 10NO2003 WLP G
COLO COGNEX CR 96056701 25OC1996 197101
15MY1997 15MY2007 WLP G
COST COGNEX NONE 07DE1994 95326
27MR1996 27MR2006 WLP G
CTM COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
CUBA COGNEX 1033/96 11JE1996 125203
28FE1997 11JE2006 WLP G
CZEC COGNEX 71543-92 04SE1992 179288
31AU1994 04SE2002 WLP G
DENM COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
DENM COGNEX 6580/1989 07SE1989 7273/1992
07AU1992 07AU2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 70025
15JA1994 15JA2014 WLP G
ECUA COGNEX 42184/93 08OC1993 3834-94
14NO1994 14NO2004 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 11OC1993 88550
22JE1998 11OC2003 WLP G
ESTO COGNEX 9303722 14AP1993 16105
30JE1995 30JE2005 WLP G
FINL AXONYL 4039/91 27AU1991 122292
21SE1992 21SE2002 WLP G
FINL COGNATEX 4040/91 27AU1991 122293
21SE1992 21SE2002 WLP G
FINL COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
30
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- ------- ----- ------ ----------- ---------- -----------
FINL COGNEX 5965/89 21NO1989 119949
06JL1992 06JL2002 WLP G
▇▇▇▇ AXONYL 102120 30NO1998 1513315
08JA1999 10JA2009 WLP G
▇▇▇▇ COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
▇▇▇▇ COGNEX 963139 01JE1998 1495729
10JL1998 25OC2008 WLP G
GBRI COGNEX 1361554 21SE1995 1361554
21SE1995 25OC2005 WLP G
GBRI COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
GBRI COGNEX CR 2111743 03OC1996 2111743
04AP1997 03OC2006 WLP G
GEOR COGNEX TM1998013151 24FE1998 11272
11DE1998 11DE2008 WLP G
GERM COGNEX W38616/5WZ 16FE1999 1158143
16FE1999 31OC2008 WLP G
GERM COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
GERM COGNEX IN CYRILLIC 39629332.8 04JL1996 39629332
21NO1996 31JL2006 PDGB G
GREC COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
GREC COGNEX 95564 30MR1999 95564
30MR1999 12SE2009 WLP G
GUAT COGNEX 7368-93 05NO1993 80261
24JE1996 23JE2006 WLP G
▇▇▇▇ COGNEX 539/0 25OC1993 73/100
12JL1994 12JL2004 WLP G
HOND COGNEX 10427/93 20OC1993 59959
25MY1994 25MY2004 WLP G
HONG COGNEX 6695/88 21AU1995 686/1990
06OC1995 21OC2009 WLP G
HONG COGNEX IN CHINESE CHARACTERS 95/04659 21AP1995 4917/1997
01MY1997 21AP2004 WLP G
HONG COGNEX IN CHINESE CHARACTERS 9703229 11MR1997 B6434/1998
25JE1998 11MR2004 PDA G
HONG COGNEX IN CHINESE CHARACTERS 9703228 11MR1997 B7477/1998
27JL1998 11MR2004 PDA G
HUNG COGNEX M9204478 15SE1992 137076
17AU1993 15SE2002 WLP G
ICEL COGNEX NONE 09AU1999 1038/1989
14OC1999 08DE2009 WLP G
31
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- ------- ----- ------ ----------- ---------- -----------
INDI COGNEX WLP F 609118 11OC1993
INDO COGNEX NONE 11SE1989 271725
13FE1992 13AU2001 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
IREL COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
IREL COGNEX 6377/89 27NO1996 135633
27NO1996 26NO2006 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 14OC1993 89254
13SE1995 13OC2000 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇ COGNEX RM98C005339 28OC1998 557807
13JA1992 03NO1998 WLP G
ITAL COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
JAMA COGNEX 5/4953 19OC1993 27282
14NO1996 19OC2000 WLP G
JAPA COGNEX 119497/1988 20OC1988 2313556
28JE1991 28JE2001 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 33170
23OC1993 23OC2000 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
KENY COGNEX 40928 23NO1993 40928
30MR1995 23NO2000 WLP G
KORS COGNEX 93-35581 07OC1993 307643
08FE1995 08FE2005 WLP G
KORS COGNEX IN KOREAN CHARACTERS 94-49286 09DE1994 331529
16JA1996 16JA2006 PDA ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
LAOS COGNEX 1342 11SE1992 1437
20JL1993 11SE2002 WLP G
LATV COGNEX M-93-2209 08MR1993 M33894
20OC1996 08MR2003 WLP G
LEBA COGNEX WLP F 61860 18AU1994
LITH COGNEX 12922 05OC1993 23927
16DE1996 05OC2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
32
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- ------ ----------- ---------- -----------
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ MA/5572/89
22JL1996 12SE2010 WLP G
MEXI COGNEX 160501 11FE1993 452998
24FE1994 11FE2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 ▇ ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 188209
14DE1994 19OC2009 WLP G
NICA COGNEX 93-02730 29NO1993 26207
12JL1994 11JL2004 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇
NORW AXONYL 91/4361 28AU1991 175093
14MR1996 14MR2006 WLP G
NORW COGNATEX 91/4360 28AU1991 154564
14JA1993 14JA2003 WLP G
NORW COGNEX 89/4387 11SE1989 144521
21MR1991 21MR2001 WLP G
PAKI COGNEX WLP F 104073 27SE1989
PANA COGNEX 77106 04SE1995 77106
28OC1996 28OC2006 WLP G
PARA COGNEX 18125 18DE1991 154686
24JE1992 24JE2002 WLP G
PERU COGNEX 240536 20AP1994 79857
19AU1994 10MY2004 WLP G
PHIL COGNEX 76718 08JL1991 55601
02JL1993 02JL2013 WLP G
POLA COGNEX Z-113342 09SE1992 79098
28OC1994 09SE2002 WLP G
PORT COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
PORT COGNEX 259054 12OC1989 259054
06MY1993 06MY2003 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 33734
04NO1994 04NO2004 WLP G
ROMA COGNEX 27765 16SE1992 19848
26MR1996 16SE2002 WLP G
▇▇▇▇ COGNEX 165803 09NO1992 120087
09NO1992 09NO2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
33
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- ------ ----------- ---------- -----------
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 89/9005
29MR1999 26SE2009 WLP G
SALV COGNEX 3743 14OC1993 156
08MY1995 08MY2005 WLP G
SAUD COGNEX 22612 16OC1993 314/37
25JL1994 26JE2003 WLP G
SING COGNEX 5960/89 02JL1996 S/5960/89
19FE1997 08SE2006 WLP G
SLOV COGNEX Z-9870111 27JA1998 9870111
05OC1998 26JA2008 WLP G
SLVK COGNEX ▇-▇▇▇▇▇-▇▇ 04SE1992 174926
14JE1995 04SE2002 WLP G
SPAI COGNEX 1521725 05MY1999 1521725
01JA2000 28SE2009 WLP G
SPAI COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
SPAI COGNEX CR 2050172 02OC1996 2050172
05MR1997 02OC2006 WLP G
SWED COGNEX 89-08491 23AU1989 244648
30DE1992 30DE2002 WLP G
SWED COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
SWED COGNEX CR 96-09133 08OC1996 326021
16JA1998 16JA2008 WLP G
SWIT COGNEX 7341 02OC1989 376663
12JL1990 02OC2009 WLP G
SYRI COGNEX WLP D
TADJ COGNEX IN CYRILLIC NONE 21NO1996 IR666352
21NO1996 21NO2006 PDGB G
TAIW COGNEX (78)01408 28JA1989 477796
16MR1990 15MR2000 WLP G
TAIW COGNEX IN CHINESE CHARACTERS 82059910 06DE1993 654939
16SE1994 15SE2004 WLP G
THAI COGNEX 371708 09NO1998 KOR83130
08DE1998 09NO2008 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇ COGNEX 11383/93 20OC1993 147828
20OC1993 19OC2003 WLP G
UKRA COGNEX 93084114 03AU1993 8843
31OC1997 03AU2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
URUG COGNEX 265939 15OC1993 265939
11AU1994 11AU2004 WLP G
34
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- ------ ----------- ---------- -----------
URUG COGNEX CR 290345 09OC1996 290345
01SE1997 01SE2007 WLP G
UZBE COGNEX IN CYRILLIC NONE 21NO1996 IR666352
21NO1996 21NO2006 PDGB G
VENE COGNEX WLP F 19772-88 24OC1988
VENE COGNEX CR WLP F 86384 05NO1996
VIET COGNEX 8630 06AU1992 7554
22FE1993 06AU2002 WLP G
YUGO COGNEX Z-1124/92 16SE1992 40303
19SE1997 16SE2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
ZIMB COGNEX 874/93 12OC1993 974/93
14FE1994 12OC2003 WLP G
PATENTS
MASTER FILE REPORT PCMASTER REPORTER
13MR2000 9 05 PAGE: 1
TACRINE PATENT PORTFOLIO
Docket Number Ctry CsTp RlTp FlTp FlNo St
------ ------ ---- ---- ---- ---- ---- --
3626 USA P 01 G
APP#: 391808
DATE:09AU1989
▇▇▇#: 5019395
DATE:28MY1991
EXP.DT:28MY2008
ABSTRACT:
PD-3626 US *** THE PENETRATION OF VARIOUS
DRUGS THROUGH LIVING MEMBRANES IS IMPROVED BY
THEIR USE IN TRANSDERMAL COMPOSITIONS
CONTAINING CERTAIN PENETRATION-ENHANCING
SYSTEMS. THIS APPLICATION IS A C-I-P OF USSN
165,322 FILED 3/8/88.
3626 ASTL G
APP#: 30258/89
DATE:23FE1989
▇▇▇#: 611771
DATE:03DE1991
EXP.DT:23FE2009
3626 ASTL 02 G
APP#: 70061/91
DATE:29JA1991
▇▇▇#: 634015
DATE:18JE1993
EXP.DT:29JA2011
3626 ATRA E G
APP#: E90571
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
35
3626 ATRA E 02 G
APP#: E114481
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
▇▇▇▇ ▇▇▇▇ ▇ ▇▇ ▇
▇▇▇#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 DENM F
APP#: 1096/89
DATE:07MR1989
▇▇▇#:
DATE:
EXP.DT:
3626 DENM E 02 G
APP#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 EPC E G
APP#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
3626 EPC E 02 G
APP#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 ▇▇▇▇ E G
APP#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
3626 ▇▇▇▇ E 02 G
APP#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 GBRI E G
APP#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
36
▇▇▇▇ ▇▇▇▇ E 02 G
APP#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 GERM E 02 G
APP#: EP0499662
DATE:19FE1991
▇▇▇#: P69105480.0
DATE:30NO1994
EXP.DT:19FE2011
3626 GERW E G
APP#: EP0332147
DATE:07MR1989
▇▇▇#: ▇▇▇▇▇▇▇▇▇.0
DATE:16JE1993
EXP.DT:07MR2009
3626 GREC E G
APP#: EP0332147
DATE:07MR1989
▇▇▇#: 3008708
DATE:16JE1993
EXP.DT:07MR2009
3626 GREC E 02 G
APP#: EP0499662
DATE:19FE1991
▇▇▇#: 3014988
DATE:30NO1994
EXP.DT:19FE2011
3626 IREL G
APP#: 390/89
DATE:07FE1989
▇▇▇#: 62871
DATE:15FE1995
EXP.DT:07FE2009
3626 IREL 02 G
APP#: 305/91
DATE:29JA1991
▇▇▇#: 64308
DATE:10JL1995
EXP.DT:29JA2011
3626 ITAL E G
APP#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
3626 ITAL E 02 G
APP#: 20674BE/95
DATE:19FE1991
37
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
▇▇▇▇ ▇▇▇▇ G
APP#: 53069/89
DATE:07MR1989
▇▇▇#: 2939264
DATE:11JE1999
EXP.DT:07MR2009
3626 KORS 02 G
APP#: 1750/91
DATE:01FE1991
▇▇▇#: 191456
DATE:25JA1999
EXP.DT:01FE2011
3626 LUXE E G
APP#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
3626 LUXE E 02 G
APP#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 NETH E G
APP#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
3626 NETH E 02 G
APP#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 NEWZ G
APP#: 228094
DATE:22FE1989
▇▇▇#: 228094
DATE:20FE1992
EXP.DT:22FE2009
3626 NEWZ 02 G
APP#: 236921
DATE:28JA1991
▇▇▇#: 236921
DATE:09FE1994
EXP.DT:28JA2011
38
3626 PHIL G
APP#: 38267
DATE:01MR1989
▇▇▇#: 26548
DATE:19AU1992
EXP.DT:19AU2009
3626 PHIL 02 G
APP#: 41919
DATE:31JA1991
▇▇▇#: 31671
DATE:18JA1999
EXP.DT:18JA2016
3626 PORT 02 G
APP#: 96779
DATE:15FE1991
▇▇▇#: 96779
DATE:26JE1998
EXP.DT:26JE2013
3626 SAFR G
APP#: 89/1031
DATE:09FE1989
▇▇▇#: 89/1031
DATE:31OC1990
EXP.DT:09FE2009
3626 SAFR 02 G
APP#: 91/0624
DATE:28JA1991
▇▇▇#: 91/0624
DATE:28OC1992
EXP.DT:28JA2011
3626 SPAI E G
APP#: EP0332147
DATE:07MR1989
▇▇▇#: 2056981
DATE:16JE1993
EXP.DT:07MR2009
39
3626 SPAI E 02 G
APP#: EP0499662
DATE:19FE1991
▇▇▇#: 2064780
DATE:30NO1994
EXP.DT:19FE2011
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
▇▇▇▇ ▇▇▇▇ ▇ ▇▇ ▇
▇▇▇#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3626 SWIT E G
APP#: 89104017.2
DATE:07MR1989
▇▇▇#: EP0332147
DATE:16JE1993
EXP.DT:07MR2009
3626 SWIT E 02 G
APP#: 91102354.7
DATE:19FE1991
▇▇▇#: EP0499662
DATE:30NO1994
EXP.DT:19FE2011
3884 USA G
APP#: 387722
DATE:31JL1989
▇▇▇#: 4999430
DATE:12MR1991
EXP.DT:31JL2009
ABSTRACT:
NOVEL PRODRUGS OR DEPOT DERIVATIVES OF
1,2,3,4-TETRAHYDRO-9-ACRIDINAMINE ARE
DESCRIBED, AS WELL AS, METHODS FOR THE
PREPARATION AND PHARMACEUTICAL COMPOSITIONS
OF SAME, WHICH ARE USEFUL AS ANALGESIC AGENTS
FOR THE TREATMENT OF PAIN, AS SLEEP AIDS AND
AS AGENTS FOR TREATING THE SYMPTOMS OF SENILE
DEMENTIA, ALZHEIMER'S DISEASE, HUNTINGTON'S
CHOREA, TARDIVE DYSKINESIA, HYPERKINESIA,
MANIA, OR SIMILAR CONDITIONS OF CEREBRAL
INSUFFICIENCY CHARACTERIZED BY DECREASED
CEREBRAL A CETYLCHOLINE PRODUCTION OR
RELEASE.
40
3884 ATRA E G
APP#: E119885
DATE:03JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:03JL2010
3884 ATRA D E 01 G
APP#: E186908
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
▇▇▇▇ ▇▇▇▇ ▇ ▇ ▇▇ ▇
▇▇▇#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
3884 CANA F
APP#: 2022297
DATE:30JL1990
▇▇▇#:
DATE:
EXP.DT:
3884 DENM E G
APP#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 DENM D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
3884 EPC E G
APP#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 EPC D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
41
DATE:24NO1999
EXP.DT:31JL2009
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 ▇▇▇▇ D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
3884 GBRI E G
APP#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 GBRI D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
3884 GERM D E 01 G
APP#: EP0628548
DATE:30JL1990
▇▇▇#: 69033369.2
DATE:24NO1999
EXP.DT:31JL2009
3884 GERW E G
APP#: EP0411534
DATE:30JL1990
▇▇▇#: P69017789.5
DATE:15MR1995
EXP.DT:30JL2010
3884 GREC E G
APP#: EP0411534
DATE:30JL1990
▇▇▇#: 3016106
DATE:15MR1995
EXP.DT:30JL2010
3884 GREC D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
42
3884 IREL G
APP#: 2751/90
DATE:30JL1990
▇▇▇#: 66823
DATE:16JA1996
EXP.DT:30JL2010
3884 IREL D 01 F
APP#: 950609
DATE:11AU1995
▇▇▇#:
DATE:
EXP.DT:
3884 ITAL E G
APP#: 24477BE/95
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 ITAL D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
▇▇▇▇ ▇▇▇▇ G
APP#: 199361/90
DATE:30JL1990
▇▇▇#: 2930245
DATE:21MY1999
EXP.DT:30JL2010
3884 LUXE E G
APP#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 LUXE D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
3884 NETH E G
APP#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 NETH D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
43
EXP.DT:31JL2009
3884 SPAI E G
APP#: EP0411534
DATE:30JL1990
▇▇▇#: 2068955
DATE:15MR1995
EXP.DT:30JL2010
3884 SPAI D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 SWED D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
3884 SWIT E G
APP#: 90114586.2
DATE:30JL1990
▇▇▇#: EP0411534
DATE:15MR1995
EXP.DT:30JL2010
3884 SWIT D E 01 G
APP#: 94112223.6
DATE:30JL1990
▇▇▇#: EP0628548
DATE:24NO1999
EXP.DT:31JL2009
4370 USA P 01 G
APP#: 098871
DATE:24SE1987
▇▇▇#: 4816456
DATE:28MR1989
EXP.DT:09SE2007
ALL PATENTS WITH THE DOCKET NUMBER
4370 ARE SUBJECT TO THE LICENSE WITH
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ (SEE OTHER LEGAL
MATTERS SECTION)
ABSTRACT:
A METHOD FOR TREATING CENTRAL NERVOUS SYSTEM
OR PERIPHERAL NERVOUS SYSTEM CHOLOINERGIC
DEFICIT STATES SUCH AS ALZHEIMER'S DISEASE
IN A MAMMAL, SAID METHOD COMPRISING
ADMINISTERING TO SAID MAMMAL AN AMOUNT OF A
MONOAMINE ACRIDINE DERIVATIVE EFFECTIVE IN
THE TREATMENT OF A CHOLINERGIC DEFICIT STATE
AN
44
D FOR A TIME SUFFICIENT TO ACHIEVE A SUITABLE BLOOD LEVEL TO
TREAT SAID CHOLINERGIC DEFICIT STATE. THE PREFERRED MONOAMINE
ACRIDINE DERIVATIVE IS 1,2,3,4-TETRAHYDRO-5-AMINO
ACRIDINE A UNIT DOSAGE PHARMACEUTICAL COMPOSITION OF MATTER
COMPRISING AN EFFECTIVE AMOUNT OF SAID MONOAMINE ACRIDINE
DERIVATIVE SUFFICIENT TO TREAT SAID CHOLINERGIC DEFICIT
STATE AND A PHARMACEUTICALLY ACCEPTABLE INERT CARRIER
THEREFOR IS ALSO DISCLOSED. CIP OF U.S. SERIAL NO. 914,076
FILED 01OC1986. NO PRIORITY
4370 ASTL G
APP#: 80707/87
DATE:28SE1987
▇▇▇#: 621035
DATE:03MR1993
EXP.DT:28SE2007
4370 ASTL D 02 F
APP#: 78886/94
DATE:17NO1994
▇▇▇#:
DATE:
EXP.DT:
4370 ATRA E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:26OC2014
4370 ATRA X G
APP#: E106245
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 ATRA J X G
APP#: SZ9/96
DATE:23MY1996
▇▇▇#: SZ9/96
DATE:23FE1998
EXP.DT:05MY2009
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
▇▇▇▇ ▇▇▇▇ X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 BELG J X F
APP#: 96C0021
DATE:05JE1996
▇▇▇#:
45
DATE:
EXP.DT:
4370 DENM P F
APP#: 2958/88
DATE:28SE1987
▇▇▇#:
DATE:
EXP.DT:
4370 EPC E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 EPC X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 ▇▇▇▇ X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 GBRI X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 GERM E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 GERM X G
APP#: EP0328535
DATE:28SE1987
▇▇▇#: P3789967.2
DATE:01JE1995
EXP.DT:28SE2007
46
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 ITAL X G
APP#: 4919/BE94
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 LUXE E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 LUXE X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 MEXI F
APP#: 923762
DATE:29JE1992
▇▇▇#:
DATE:
EXP.DT:
4370 ▇▇▇▇ ▇ ▇
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
▇▇▇▇ ▇▇▇▇ X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
47
4370 SWIT X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 ▇▇▇▇ ▇ ▇
APP#: 52934
DATE:16JE1995
▇▇▇#: C0328535/01
DATE:30AP1996
EXP.DT:16JE2010
48
4627 USA C 01 G
APP#: 08/422019
DATE:12AP1995
▇▇▇#: 5576022
DATE:19NO1996
EXP.DT:19NO2013
ABSTRACT:
RELEASE COMPOSITION COMPRISING;(A) A
WATER-INSOLUBLE POLYMER IN AN AMOUNT FROM
ABOUT 40% TO ABOUT 90%; (B) A WATER-SOLUBLE
POLYMER IN AN AMOUNT UP TO ABOUT 10%; AND (C)A
SECOND PLASTICIZING AGENT IN AN AMOUNT UP TO
ABOUT 10%; WHEREIN THE SUSTAINING LAYER AND
THE IMMEDIATE RELEASE COMPOSITION ARE PRESENT
IN THE SUSTAINED RELEASE COMPOSITION IN A
RATIO BY WEIGHT FROM ABOUT 1:9 TO ABOUT 4:6,
RESPECTIVELY, AND THE IMMEDIATE RELEASE
COMPOSITION AND THE SUSTAINED RELEASE
COMPOSITION ARE PRESENT IN THE DRUG DELIVERY
SYSTEM IN A RATIO BY WEIGHT FROM ABOUT 0.0 1:1
TO ABOUT 1:1, RESPECTIVELY. CONTINUATION OF
USSN 08/096140 FILED 7/22/93.
5180 USA G
APP#: 07/999999
DATE:22DE1986
▇▇▇#: 4631286
DATE:23DE1986
EXP.DT:22DE2006
ABSTRACT: PATENTS WITH THE DOCKET NUMBER
5180 ARE SUBJECT TO THE LICENSE
AGREEMENT WITH ▇▇▇▇▇▇▇-▇▇▇▇▇▇▇
(SEE OTHER LEGAL MATTERS SECTION)
5180 USA C 01 G
APP#: 07/999999
DATE:27JE1988
▇▇▇#: 4754050
DATE:28JE1988
EXP.DT:22DE2006
5180 USA C 02 G
APP#: 07/999999
DATE:29MY1989
▇▇▇#: 4835275
DATE:30JE1989
EXP.DT:22DE2006
5180 USA C 03 G
APP#: 07/999999
DATE:12JE1989
▇▇▇#: 4839364
DATE:13JE1989
EXP.DT:22DE2006
5180 USA P 01 G
APP#: 07/999999
DATE:22DE1986
▇▇▇#: 4695573
DATE:23DE1986
EXP.DT:22DE2006
5180 ASTL G
APP#: 99999
DATE:23OC1981
49
▇▇▇#: 589141
DATE:24OC1981
EXP.DT:23OC2001
5180 ASTL 01 G
APP#: 99999
DATE:18JL1985
▇▇▇#: 615768
DATE:19JL1985
EXP.DT:18JL2005
5180 ATRA E G
APP#: E63903
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
▇▇▇▇ ▇▇▇▇ ▇
▇▇▇#: 99999
DATE:02DE1988
▇▇▇#: 1292744
DATE:03DE1988
EXP.DT:03DE2005
5180 CZEC D
APP#:
DATE:
▇▇▇#:
DATE:
EXP.DT:
5180 DENM G
APP#: 99999
DATE:23OC1985
▇▇▇#: 167250
DATE:24OC1985
EXP.DT:23OC2005
5180 DENM 01 G
APP#: 99999
DATE:25NO1992
▇▇▇#: 168704
DATE:26NO1992
EXP.DT:25NO2012
50
5180 EPC E G
APP#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
5180 FINL G
APP#: 99999
DATE:22OC1985
▇▇▇#: 86421
DATE:23OC1985
EXP.DT:22OC2005
5180 ▇▇▇▇ E G
APP#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
5180 GBRI E G
APP#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
5180 GERM E G
APP#: EP0179383
DATE:14OC1985
▇▇▇#: P3582995.0
DATE:15OC1985
EXP.DT:14OC2005
5180 HUNG G
APP#: 99999
DATE:17OC1985
▇▇▇#: 196183
DATE:18OC1985
EXP.DT:17OC2005
▇▇▇▇ ▇▇▇▇ D
APP#:
DATE:
▇▇▇#:
DATE:
EXP.DT:
5180 ISRA 01 D
APP#:
DATE:
▇▇▇#:
DATE:
EXP.DT:
5180 ITAL E G
APP#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
51
▇▇▇▇ ▇▇▇▇ D
APP#:
DATE:
▇▇▇#:
DATE:
EXP.DT:
▇▇▇▇ ▇▇▇▇ 01 D
APP#:
DATE:
▇▇▇#:
DATE:
EXP.DT:
5180 KORS D
APP#:
DATE:
▇▇▇#:
DATE:
EXP.DT:
5180 LUXE E G
APP#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
5180 NETH E G
APP#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
5180 NEWZ G
APP#: 213932
DATE:22OC1981
▇▇▇#: 213932
DATE:23OC1981
EXP.DT:22OC2001
5180 NEWZ 01 G
APP#: 229248
DATE:22OC1981
▇▇▇#: 229248
DATE:23OC1981
EXP.DT:22OC2001
5180 NORW G
APP#: 99999
DATE:23OC1985
▇▇▇#: 169121
DATE:24OC1985
EXP.DT:23OC2005
52
5180 NORW 01 G
APP#: 99999
DATE:29OC1990
▇▇▇#: 172847
DATE:30OC1990
EXP.DT:29OC2010
5180 PHIL G
APP#: 99999
DATE:16OC1985
▇▇▇#: 22614
DATE:17OC1985
EXP.DT:17OC2002
5180 PORT G
APP#: 81362
DATE:29NO1982
▇▇▇#: 81362
DATE:30NO1982
EXP.DT:29NO2002
5180 SAFR G
APP#: 85/08136
DATE:23OC1985
▇▇▇#: 85/08136
DATE:24OC1985
EXP.DT:23OC2005
5180 SPAI G
APP#: 99999
DATE:22OC1985
▇▇▇#: 548137
DATE:23OC1985
EXP.DT:23OC2005
5180 SPAI 01 G
APP#: 99999
DATE:29AP1986
▇▇▇#: 554568
DATE:30AP1986
EXP.DT:30AP2006
5180 SPAI 02 G
APP#: 99999
DATE:29AP1986
▇▇▇#: 554569
DATE:30AP1986
EXP.DT:30AP2006
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
5180 SWIT E G
APP#: 99999
DATE:14OC1985
▇▇▇#: EP0179383
DATE:15OC1985
EXP.DT:14OC2005
53
LICENSES
Licenses In:
1. Royalty Agreement between Mount Sinai School of Medicine and
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company dated as of September 8, 1987.
2. Agreement between Shire Holdings Limited and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
dated as of April 20, 1990.
3. License Agreement between ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, M.D. and ▇▇▇▇▇▇-▇▇▇▇▇▇▇
Company dated as of September 27, 1990.
4. Settlement and License Agreement between ▇▇▇▇▇▇▇-▇▇▇▇▇▇▇
Pharmaceuticals Inc. and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company dated as of September
28, 1994.
Licenses Out:
1. Technology License Agreement between Je Il Pharmaceutical Co., Ltd. and
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company dated as of November 1, 1995. (Korea)
2. Trademark License Agreement between Je Il Pharmaceutical Co., Ltd. and
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company dated as of November 1, 1995. (Korea)
3. Amendment Agreement among ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company, ▇▇▇▇▇-▇▇▇▇▇ & Company
and G&M S.A. dated as of August 1, 1994 to the Pharmaceutical License
Agreement dated March 17, 1989 between the parties. (Argentina)
54
EXHIBIT 1.1.3
REGULATORY APPROVALS
The following Marketing Authorizations relating to the Product:
-------------------------------------------------------------------------------------------------------------------
REGISTRATION REGISTRATION REGISTRATION
COUNTRY FILED APPROVED NUMBER
-------------------------------------------------------------------------------------------------------------------
EUROPEAN
UNION
-------------------------------------------------------------------------------------------------------------------
Austria 17-Jan-94 18-Dec-95
-------------------------------------------------------------------------------------------------------------------
Belgium 2-May-94 11-Dec-95
-------------------------------------------------------------------------------------------------------------------
France Jun-90 5-May-94
-------------------------------------------------------------------------------------------------------------------
French Export
Countries
-------------------------------------------------------------------------------------------------------------------
Germany 3-May-94 22-Jun-95
-------------------------------------------------------------------------------------------------------------------
Greece 3-May-94 31-July-95
-------------------------------------------------------------------------------------------------------------------
Luxembourg 3-May-94 29-Nov-95
-------------------------------------------------------------------------------------------------------------------
Norway
-------------------------------------------------------------------------------------------------------------------
Portugal 5-May-94 1-July-97
Nacional
-------------------------------------------------------------------------------------------------------------------
Spain 27-Apr-94 15-Dec-95
-------------------------------------------------------------------------------------------------------------------
Switzerland 7-Feb-94 16-Jun-95
-------------------------------------------------------------------------------------------------------------------
U.K. 29-Apr-94 22-May-97
-------------------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇▇▇▇ ▇-▇▇▇-▇▇ ▇▇-▇▇▇-▇▇
-------------------------------------------------------------------------------------------------------------------
U.S. 1-Jun-90 9-Sep-93
-------------------------------------------------------------------------------------------------------------------
LATIN AMERICA
-------------------------------------------------------------------------------------------------------------------
Argentina 15-Jun-94
-------------------------------------------------------------------------------------------------------------------
Brazil 15-Sep-94
-------------------------------------------------------------------------------------------------------------------
Chile 17-Dec-94
-------------------------------------------------------------------------------------------------------------------
Colombia 29-Jun-95
-------------------------------------------------------------------------------------------------------------------
Ecuador 30-Oct-95 (10+40 mg)
13-Nov-95 (30 mg)
-------------------------------------------------------------------------------------------------------------------
El Salvador 30-Aug-95
-------------------------------------------------------------------------------------------------------------------
Guatemala 17-May-94
-------------------------------------------------------------------------------------------------------------------
Peru 21-Aug-95
-------------------------------------------------------------------------------------------------------------------
Puerto Rico
-------------------------------------------------------------------------------------------------------------------
Uruguay 15-Oct-94
-------------------------------------------------------------------------------------------------------------------
VENEZUELA 9-Dec-94
-------------------------------------------------------------------------------------------------------------------
ASIA
-------------------------------------------------------------------------------------------------------------------
Hong Kong 1-Aug-95
-------------------------------------------------------------------------------------------------------------------
Israel Oct-96
-------------------------------------------------------------------------------------------------------------------
55
-------------------------------------------------------------------------------------------------------------------
REGISTRATION REGISTRATION REGISTRATION
COUNTRY FILED APPROVED NUMBER
-------------------------------------------------------------------------------------------------------------------
Korea 9-Feb-96
-------------------------------------------------------------------------------------------------------------------
Philippines 14-May-96
-------------------------------------------------------------------------------------------------------------------
Singapore 24-Aug-95
-------------------------------------------------------------------------------------------------------------------
56
EXHIBIT 1.1.7
[****]-CONFIDENTIAL TREATMENT REQUESTED
PREPAID ROYALTIES
An amount equal to $[****] less the actual royalty payable by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to
Licensor under the License Agreement dated as of September 27, 1990 between
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, M.D. and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company for the period beginning
April 1, 2000 and ending on May 31, 2000.
57
EXHIBIT 2.1
PACKAGE INSERT PROVISIONS FOR COGNEX CR
INDICATIONS
COGNEX CR is indicated for the treatment of mild to moderate dementia of the
Alzheimer type.
CLINICAL ADVERSE EXPERIENCES, WARNINGS, PRECAUTIONS
COGNEX CR labeling will include liver monitoring recommendations that are no
worse than that of COGNEX IR.
DOSAGE AND ADMINISTRATION
The dosage range of COGNEX CR is 100 to 200 mg once a day.
58
EXHIBIT 2.2
ALLOCATION
The Purchase Price is allocated as follows:
$500,000 of the Purchase Price should be allocated to Intellectual Property and
any licenses. Any remaining portion of the Purchase Price should be allocated
to goodwill.
59
EXHIBIT 3.7(A)
GOVERNMENTAL AND THIRD PARTY CONSENTS
Issuance of a Decision and Order by the Federal Trade Commission in the matter
of Pfizer Inc., a corporation; and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company, a corporation,
approving Horizon as the purchaser of the Cognex Divestiture Assets, as defined
therein.
Consent of Mount Sinai School of Medicine ("Mt. Sinai") to the assignment of the
Agreement dated September 8, 1987 between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Mt. Sinai.
60
EXHIBIT 3.7(B)
GOVERNMENTAL AND THIRD PARTY CONSENTS
Issuance of a Decision and Order by the Federal Trade Commission in the matter
of Pfizer Inc., a corporation; and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company, a corporation,
approving Horizon as the purchaser of the Cognex Divestiture Assets, as defined
therein.
61
EXHIBIT 3.10
MANAGED CARE CUSTOMERS
62
[*****]-CONFIDENTIAL TREATMENT REQUESTED
COGNEX CONTRACTS
ALPHA LISTING
Renewal/ Current Rights to
Term. Rights Rebate/ Contract Change Assign. Primary Admin.
Name Type Contact Phone Term Both Parties Discount Price Price/ Rights Whole- Fee Amend.
Person Number Rebate saler
[*****]
-----------------------------------------------------------------------------------------------------------------------------------
PENDING
-----------------------------------------------------------------------------------------------------------------
[*****]
-----------------------------------------------------------------------------------------------------------------------------------
*[*****]
63
EXHIBIT 7.1.4(A)
ASSIGNMENT, ASSUMPTION AND ▇▇▇▇ OF SALE
THIS GENERAL ASSIGNMENT, ASSUMPTION AND ▇▇▇▇ OF SALE is
entered into this __ day of May, 2000, by and among FIRST HORIZON
PHARMACEUTICAL CORPORATION, a Delaware corporation ("Horizon"), and
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY, a Delaware corporation ("▇▇▇▇▇▇-▇▇▇▇▇▇▇").
WHEREAS, Horizon and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ have entered into a
Asset Purchase Agreement, dated as of April 14, 2000 (the "Asset Purchase
Agreement"; capitalized terms not defined herein shall have the meanings
ascribed to them in the Asset Purchase Agreement), pursuant to which
▇▇▇▇▇▇-▇▇▇▇▇▇▇ has agreed to sell to Horizon and Horizon has agreed to purchase
from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ certain of the assets of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ relating to the
Product and Horizon has agreed, in consideration therefor, to assume certain
obligations in connection therewith;
NOW, THEREFORE, the parties hereto agree as follows:
1. Conveyance and Acceptance. (a) ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby irrevocably sell,
assign, and transfer to Horizon, free and clear of all liens, all of
▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ right, title and interest in the Assets and Assumed
Liabilities, other than the Retained Liabilities, as the same shall exist on the
date hereof (collectively, the "Assigned Assets").
(b) Horizon hereby accepts the sale, assignment and transfer of
the Assigned Assets.
2. Further Assurances. (a) At any time or from time to time after the date
hereof, at Horizon's request and without further consideration, ▇▇▇▇▇▇-▇▇▇▇▇▇▇
shall execute and deliver to Horizon such other instruments of sale, transfer,
conveyance, assignment and confirmation, provide such materials and information
and take such other actions as Horizon may reasonably deem necessary or
desirable in order more effectively to sell, assign and transfer to Horizon and
to confirm Horizon's title to, all of the Assigned Assets, and, to the fullest
extent permitted by law, to put Horizon in actual possession and operating
control of the Assigned Assets and to assist Horizon in exercising all rights
with respect thereto.
(b) ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby constitutes and appoints Horizon the
true and lawful attorney of ▇▇▇▇▇▇-▇▇▇▇▇▇▇, with full power of substitution, in
the name of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or Horizon, but on behalf of and for the benefit of
Horizon: (i) to demand and receive from time to time any and all of the
Assigned Assets and to make endorsements and give receipts and releases for and
in respect to the same and any part thereof; (ii) to institute, prosecute,
compromise and settle any and all Actions that Horizon may deem proper in order
to collect, assert or enforce any claim, right or title of any kind in or to
the Assigned Assets; (iii) to defend or compromise any and all Actions in
respect of any of the Assigned Assets; and (iv) to do all such acts and things
in relation to the matters set forth in the preceding clauses (i) through (iii)
as Horizon shall deem desirable. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby acknowledges that the
appointment hereby made and the powers hereby granted are coupled with an
interest and are not and shall not be revocable by it in any manner or for any
reason. Horizon shall indemnify and hold harmless ▇▇▇▇▇▇-▇▇▇▇▇▇▇
64
and its officers, directors, employees, agents and Affiliates from any and all
Losses caused by or arising out of any breach of law by Horizon in its exercise
of the aforesaid powers.
3. Assumption of Liabilities. (a) Horizon hereby undertakes and agrees from
and after the date hereof, subject to the limitations contained herein, to
assume and to pay, perform and discharge when due the Assumed Liabilities.
(b) Nothing contained herein shall require Horizon to pay or discharge
any debts or obligations expressly assumed hereby so long as Horizon shall in
good faith contest or cause to be contested the amount or validity thereof.
(c) Other than as specifically stated above or in the Asset Purchase
Agreement, Horizon assumes no debt, liability or obligation of ▇▇▇▇▇▇-▇▇▇▇▇▇▇,
including without limitation the Retained Liabilities, by this General
Assignment, Assumption and ▇▇▇▇ of Sale, and it is expressly understood and
agreed that all debts, liabilities and obligations not assumed hereby by
Horizon shall remain the sole obligation of ▇▇▇▇▇▇-▇▇▇▇▇▇▇, its successors and
assigns.
(d) No person other than the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its respective
successors and assigns shall have any rights under the provisions of this
Section 3.
4. Miscellaneous. (a) This General Assignment, Assumption and ▇▇▇▇ of
Sale may be executed in any number of counterparts, each of which will be deemed
an original, but all of which together will constitute one and the same
instrument.
(b) This General Assignment, Assumption and ▇▇▇▇ of Sale shall be
governed by, and construed and interpreted in accordance with, the laws of the
State of New York applicable to a contract executed in that State.
(c) This General Assignment, Assumption and ▇▇▇▇ of Sale shall be
binding upon and shall inure to the benefit of permitted assigns and
successors.
IN WITNESS WHEREOF, this General Assignment, Assumption and
▇▇▇▇ of Sale has been duly executed and delivered by a duly authorized officer
of each party on the day and year first above written.
FIRST HORIZON PHARMACEUTICALS CORPORATION
By:
--------------------------------------
Name:
Title:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY
By:
--------------------------------------
Name:
Title:
65
EXHIBIT 7.1.4(B)
TRADEMARK ASSIGNMENT
WHEREAS, [▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY] [NAME OF AFFILIATE], a corporation organized
and existing under the laws of the state of [Delaware][State of Incorporation],
with an office and place of business at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇, is the owner of the trademarks listed on the attached schedule
(the "Trademarks"), and
WHEREAS, FIRST HORIZON PHARMACEUTICAL CORPORATION, a corporation organized and
existing under the laws of Delaware, with an office and place of business at
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇, pursuant to an Asset
Purchase Agreement dated April 14, 2000 among said parties, is desirous of
acquiring all rights, title and interest in and to the Trademark, including the
goodwill associated therewith;
NOW, THEREFORE, for good and valuable consideration, the receipt of which is
hereby acknowledged, said ▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY hereby assigns to said FIRST
HORIZON PHARMACEUTICAL CORPORATION all rights, title and interest in the
Trademark and the goodwill associated therewith.
[▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY]
[NAME OF AFFILIATE]
---------------------------
Name:
Title:
Date:
66
TRADEMARK ASSIGNMENT
SCHEDULE OF TRADEMARKS
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- ------ ----------- ---------- -----------
USA COGNEX 73/762382 07NO1988 1543222
13JE1989 13JE2009 WLP G
ANDO COGNEX 12903 04DE1998 12467
04DE1998 04DE2008 WLP G
AOIP COGNEX 82989 16NO1993 33312
15SE1994 16NO2003 WLP G
ARGE COGNEX 1668032 19OC1988 419731
26FE1993 26FE2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ 01MY1995 A497479
01MY1995 17OC2009 WLP G
ATRA COGNEX AM4962/89 11OC1989 129313
09MR1990 31JA2000 WLP G
ATRA COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
BENE COGNEX 65023 14SE1998 457086
02FE1999 26OC2008 WLP G
BENE COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 29DE1999 814501605
28AU1990 28AU2000 WLP G
BRAZ COGNEX CR 819637173 04NO1996 819637173
13JL1999 13JL2009 WLP G
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- ------ ------------ ----------- ----------
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 08SE1992 21730
30SE1993 08SE2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
CAMB COGNEX 1803 08OC1992 1801
21AP1993 08OC2002 WLP G
CHIL COGNEX 443093 12MR1999 539520
01JL1999 27AP2009 WLP G
CHIL COGNEX CR 357493 10OC1996 489543
14JL1997 14JL2007 WLP G
67
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- ------- ----- ------ ----------- ---------- -----------
INDI COGNEX WLP F 609118 11OC1993
INDO COGNEX NONE 11SE1989 271725
13FE1992 13AU2001 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
IREL COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
IREL COGNEX 6377/89 27NO1996 135633
27NO1996 26NO2006 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 14OC1993 89254
13SE1995 13OC2000 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇ COGNEX RM98C005339 28OC1998 557807
13JA1992 03NO1998 WLP G
ITAL COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
JAMA COGNEX 5/4953 19OC1993 27282
14NO1996 19OC2000 WLP G
JAPA COGNEX 119497/1988 20OC1988 2313556
28JE1991 28JE2001 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 33170
23OC1993 23OC2000 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
KENY COGNEX 40928 23NO1993 40928
30MR1995 23NO2000 WLP G
KORS COGNEX 93-35581 07OC1993 307643
08FE1995 08FE2005 WLP G
KORS COGNEX IN KOREAN CHARACTERS 94-49286 09DE1994 331529
16JA1996 16JA2006 PDA ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
LAOS COGNEX 1342 11SE1992 1437
20JL1993 11SE2002 WLP G
LATV COGNEX M-93-2209 08MR1993 M33894
20OC1996 08MR2003 WLP G
LEBA COGNEX WLP F 61860 18AU1994
LITH COGNEX 12922 05OC1993 23927
16DE1996 05OC2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
68
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- --------- ----------- ---------- -----------
CHIN COGNEX 93125913 02DE1993 765722
14SE1995 13SE2005 WLP G
COLO COGNEX 309872 11SE1989 147849
10NO1993 10NO2003 WLP G
COLO COGNEX CR 96056701 25OC1996 197101
15MY1997 15MY2007 WLP G
COST COGNEX NONE 07DE1994 95326
27MR1996 27MR2006 WLP G
CTM COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
CUBA COGNEX 1033/96 11JE1996 125203
28FE1997 11JE2006 WLP G
CZEC COGNEX 71543-92 04SE1992 179288
31AU1994 04SE2002 WLP G
DENM COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
DENM COGNEX 6580/1989 07SE1989 7273/1992
07AU1992 07AU2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 70025
15JA1994 15JA2014 WLP G
ECUA COGNEX 42184/93 08OC1993 3834-94
14NO1994 14NO2004 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ 11OC1993 88550
22JE1998 11OC2003 WLP G
ESTO COGNEX 9303722 14AP1993 16105
30JE1995 30JE2005 WLP G
FINL AXONYL 4039/91 27AU1991 122292
21SE1992 21SE2002 WLP G
FINL COGNATEX 4040/91 27AU1991 122293
21SE1992 21SE2002 WLP G
FINL COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
69
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- ------------------- ----- ------ ----------- ---------- -----------
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ MA/5572/89
22JL1996 12SE2010 WLP G
MEXI COGNEX 160501 11FE1993 452998
24FE1994 11FE2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 188209
14DE1994 19OC2009 WLP G
NICA COGNEX 93-02730 29NO1993 26207
12JL1994 11JL2004 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇
NORW AXONYL 91/4361 28AU1991 175093
14MR1996 14MR2006 WLP G
NORW COGNATEX 91/4360 28AU1991 154564
14JA1993 14JA2003 WLP G
NORW COGNEX 89/4387 11SE1989 144521
21MR1991 21MR2001 WLP G
PAKI COGNEX WLP F 104073 27SE1989
PANA COGNEX 77106 04SE1995 77106
28OC1996 28OC2006 WLP G
PARA COGNEX 18125 18DE1991 154686
24JE1992 24JE2002 WLP G
PERU COGNEX 240536 20AP1994 79857
19AU1994 10MY2004 WLP G
PHIL COGNEX 76718 08JL1991 55601
02JL1993 02JL2013 WLP G
POLA COGNEX Z-113342 09SE1992 79098
28OC1994 09SE2002 WLP G
PORT COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
PORT COGNEX 259054 12OC1989 259054
06MY1993 06MY2003 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 33734
04NO1994 04NO2004 WLP G
ROMA COGNEX 27765 16SE1992 19848
26MR1996 16SE2002 WLP G
▇▇▇▇ COGNEX 165803 09NO1992 120087
09NO1992 09NO2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
70
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- ------ ----------- ---------- -----------
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ 89/9005
29MR1999 26SE2009 WLP G
SALV COGNEX 3743 14OC1993 156
08MY1995 08MY2005 WLP G
SAUD COGNEX 22612 16OC1993 314/37
25JL1994 26JE2003 WLP G
SING COGNEX 5960/89 02JL1996 S/5960/89
19FE1997 08SE2006 WLP G
SLOV COGNEX Z-9870111 27JA1998 9870111
05OC1998 26JA2008 WLP G
SLVK COGNEX ▇-▇▇▇▇▇-▇▇ 04SE1992 174926
14JE1995 04SE2002 WLP G
SPAI COGNEX 1521725 05MY1999 1521725
01JA2000 28SE2009 WLP G
SPAI COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
SPAI COGNEX CR 2050172 02OC1996 2050172
05MR1997 02OC2006 WLP G
SWED COGNEX 89-08491 23AU1989 244648
30DE1992 30DE2002 WLP G
SWED COGNEX 80846 01AP1996 80846
03AU1998 01AP2006 WLP G
SWED COGNEX CR 96-09133 08OC1996 326021
16JA1998 16JA2008 WLP G
SWIT COGNEX 7341 02OC1989 376663
12JL1990 02OC2009 WLP G
SYRI COGNEX WLP D
TADJ COGNEX IN CYRILLIC NONE 21NO1996 IR666352
21NO1996 21NO2006 PDGB G
TAIW COGNEX (78)01408 28JA1989 477796
16MR1990 15MR2000 WLP G
TAIW COGNEX IN CHINESE CHARACTERS 82059910 06DE1993 654939
16SE1994 15SE2004 WLP G
THAI COGNEX 371708 09NO1998 KOR83130
08DE1998 09NO2008 WLP G
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ ▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇ COGNEX 11383/93 20OC1993 147828
20OC1993 19OC2003 WLP G
UKRA COGNEX 93084114 03AU1993 8843
31OC1997 03AU2003 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
URUG COGNEX 265939 15OC1993 265939
11AU1994 11AU2004 WLP G
71
Ctry Trademark
Curr Reg D Renewal Owner Status Curr App No Cur App Dt Curr Reg No
---------- --------- ----- ------ ----------- ---------- -----------
URUG COGNEX CR 290345 09OC1996 290345
01SE1997 01SE2007 WLP G
UZBE COGNEX IN CYRILLIC NONE 21NO1996 IR666352
21NO1996 21NO2006 PDGB G
VENE COGNEX WLP F 19772-88 24OC1988
VENE COGNEX CR WLP F 86384 05NO1996
VIET COGNEX 8630 06AU1992 7554
22FE1993 06AU2002 WLP G
YUGO COGNEX Z-1124/92 16SE1992 40303
19SE1997 16SE2002 WLP ▇
▇▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇ IR666352
21NO1996 21NO2006 PDGB G
ZIMB COGNEX 874/93 12OC1993 974/93
14FE1994 12OC2003 WLP G
72
EXHIBIT 7.1.5
SUPPLY AGREEMENT
This SUPPLY AGREEMENT (the "Agreement") is made and entered
into as of [____], 2000 (the "Effective Date"), by and between ▇▇▇▇▇-▇▇▇▇▇
PHARMACEUTICALS LIMITED, a company organized and existing under the laws of the
Cayman Islands ("SUPPLIER"), and FIRST HORIZON PHARMACEUTICAL CORPORATION, a
corporation organized and existing under the laws of Delaware ("PURCHASER").
Capitalized terms not otherwise defined herein shall have the meanings set forth
in Article 1.
WITNESSETH:
WHEREAS, PURCHASER has purchased the Product from SUPPLIER pursuant to
an asset purchase agreement between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company and PURCHASER dated
as of April 14, 2000 (the "Asset Purchase Agreement");
WHEREAS, PURCHASER does not have immediate capacity for manufacturing
or causing to be manufactured the Products or the Active Ingredient;
WHEREAS, pursuant to the terms of the Asset Purchase Agreement,
SUPPLIER has undertaken to supply Product and the Active Ingredient to
PURCHASER;
WHEREAS, SUPPLIER is a manufacturer with adequate capacity for
manufacturing PURCHASER's Product and Active Ingredient;
WHEREAS, the parties desire to enter into a Supply Agreement pursuant
to which SUPPLIER shall supply the Products and the Active Ingredient to
PURCHASER; and
NOW, THEREFORE, in consideration of the foregoing and of the mutual
promises contained herein, the parties agree as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms will have the meanings
set forth below:
"Active Ingredient" means tacrine hydrochloride.
"Affiliate" means (i) any company or entity, more than fifty percent
(50%) of whose voting stock or participating profit interest is owned or
controlled, directly or indirectly, by a party; (ii) any company, entity or
person which owns or controls, directly or indirectly, more than fifty percent
(50%) of the voting stock or participating profit interest of a party and (iii)
any company, entity or person which is under common control with a party hereto.
The term "common control" means a third party has direct or indirect ownership
of fifty percent (50%) or more of the voting stock or participating profit
interest of both the other company or entity and the party to this Agreement.
"Asset Purchase Agreement" has the meaning set forth in the Recitals.
73
"Business Day" means a day during which banks are generally open for
business in New York.
"GMPs" means the regulatory standards and the principles and
guidelines of good manufacturing practice, as in effect from time to time,
relating to the manufacture of medicinal products including, but not limited to,
standards for equipment, facilities, production and quality control established
by the applicable Governmental or Regulatory Authority.
"Governmental or Regulatory Authority" means any court, tribunal,
arbitrator, agency, commission, official or other instrumentality of the
European Community or any relevant country, state, province, county, city or
other political subdivision.
"Marketing Authorization" means the authorization to sell the Product,
as granted by the relevant Governmental or Regulatory Authorities.
"Manufacturing Authorization" means any authorization necessary to
manufacture the Product, as granted by the relevant Governmental or Regulatory
Authorities.
"Product" means the filled capsule shells and the fully-finished and
packaged pharmaceutical product, in each case containing the Active Ingredient
supplied pursuant to this Agreement and set forth in Schedule A or otherwise
pursuant to Article 2 of this Agreement.
"Production Fee" means the appropriate fees set forth on Exhibit I to
this Agreement.
"Proprietary Information" has the meaning set forth in Section 6.1.
"Raw Materials" means all raw materials and packaging materials
(including labeling), other than the Active Ingredient, needed to produce the
Product.
"Reimbursement Amount" has the meaning set forth in Section 5.4.
"Specifications" means the specifications and procedures currently
utilized by SUPPLIER in testing Raw Materials and the Active Ingredient and in
manufacturing and testing the Product which are according to the Marketing
Authorizations for the Product in effect on the date hereof or such other
manufacturing specifications as are mutually agreed upon in writing by the
parties hereto, including all stability requirements set forth therein.
2. PRODUCTION ARRANGEMENT.
2.1 Appointment. PURCHASER hereby appoints SUPPLIER and SUPPLIER
hereby agrees to be a supplier of the Product and the Active Ingredient to
PURCHASER pursuant to and for the term of this Agreement.
2.2 Agreement to Supply and Purchase the Product. (a) Schedule A
hereto sets forth the total number of filled capsule shells of Product that
SUPPLIER will supply to PURCHASER during the year 2000. Schedule A shall
indicate the allocation of such filled capsule shells as between the U.S. and
the "rest of world."
74
(b) On or prior to April 21, 2000, PURCHASER shall provide to
SUPPLIER a schedule (the "Production Schedule") indicating the manner in which
such filled capsule shells shall be packaged and labeled. The Production
Schedule shall include the information set forth on Schedule B to this
Agreement. SUPPLIER shall promptly confirm its ability to manufacture and
package the product in accordance with the Production Schedule. Thereafter,
SUPPLIER shall use its commercially reasonable efforts to supply to PURCHASER
the Product in such quantities and on such dates as set forth in the agreed-upon
Production Schedule, subject to SUPPLIER's ability to complete any required
packaging and labeling changes. In the event SUPPLIER is unable to supply the
Product to PURCHASER on a delivery date set forth on the Production Schedule,
for a reason other than SUPPLIER's inability to complete packaging and labeling
changes in time, SUPPLIER shall use its commercially reasonable efforts to
deliver such Product as soon as practicable thereafter, but in any event, no
later than thirty (30) days after the applicable delivery date.
(c) PURCHASER shall purchase from SUPPLIER Product in the
quantities and on the delivery dates set forth in the Production Schedule. In
the event PURCHASER fails at any time to purchase all Product manufactured and
made available for delivery by SUPPLIER as specified in this Section 2.2(b),
PURCHASER shall pay to SUPPLIER an amount equal to the total Production Fee
which would have otherwise been paid to SUPPLIER had PURCHASER purchased the
quantity specified on the Production Schedule on the applicable date.
2.3 Active Ingredient and Raw Materials. (a) SUPPLIER will at all
times acquire, at its own cost and expense, the Active Ingredient and Raw
Materials, in such quantities as are necessary to enable SUPPLIER to manufacture
and supply the desired quantities of the Product during the term of this
Agreement. SUPPLIER will perform all quality control procedures with respect to
the Active Ingredient and Raw Materials in accordance with the Specifications.
(b) SUPPLIER will, or will cause its Affiliates to, use its
commercially reasonable efforts to provide PURCHASER with the Active Ingredient
in the quantity, on the delivery date and at the price set forth on Schedule C
hereto. In the event SUPPLIER or its Affiliate is unable to supply the Active
Ingredient to PURCHASER on the delivery date set forth on Schedule C, SUPPLIER
shall, or shall cause its Affiliate to, use its commercially reasonable efforts
to deliver such Active Ingredient as soon as practicable thereafter, but in any
event, no later than thirty (30) days after the original delivery date.
(c) PURCHASER shall purchase from SUPPLIER the Active Ingredient
in the quantities and on the delivery dates set forth in Schedule C. Subject to
Section 10.3 hereof, in the event PURCHASER fails at any time to purchase all of
the Active Ingredient manufactured and made available for delivery by SUPPLIER
as specified in this Section 2.3(c), PURCHASER shall pay to SUPPLIER an amount
equal to the total Production Fee which would otherwise have been paid to
SUPPLIER had PURCHASER purchased the quantity specified on Schedule C on the
applicable date.
2.4 Changes to Production Schedule. Purchaser may request changes
to the Production Schedule relating to the allocation of Product among
countries, quantity and dosage strength and SUPPLIER shall use commercially
reasonable efforts to effectuate such changes; provided, however, that such
changes shall not in any way decrease the obligation of
75
PURCHASER to purchase the aggregate equivalent amount of Product as set forth on
the Production Schedule as originally agreed upon by the parties.
2.5 Controlling Provisions. In ordering and delivering, PURCHASER
and SUPPLIER may employ their standard forms, but nothing in those forms shall
be construed to modify or amend the terms of this Agreement and in case of
conflict herewith, this Agreement shall control.
3. DELIVERY AND ACCEPTANCE.
3.1 Delivery. The Products and Active Ingredient shall be
delivered to a carrier designated by PURCHASER at SUPPLIER's or its Affiliates
plants in Holland, Michigan, ▇▇▇▇ Baja, Puerto Rico or Frieburg, Germany, as
PURCHASER shall direct. Title to and risk of loss for the Product or Active
Ingredient shall transfer to PURCHASER upon delivery to PURCHASER or its
designee at the designated location(s) set forth above.
3.2 Acceptance of Shipments. After receipt of a shipment of
Products or Active Ingredient, PURCHASER shall within ten (10) Business Days
after delivery thereof, visually inspect the Product or Active Ingredient
shipment and communicate acceptance or rejection to SUPPLIER in writing. The
parties agree that PURCHASER's visual inspection consists of (i) comparing the
applicable order against the documentation accompanying the shipment to verify
that the delivery date, identity, quantity and exterior shipment labeling comply
with the order and (ii) visually inspecting the exterior of the shipment to
verify that the shipment appears to be in good condition.
3.3 Failure to meet Specifications. In addition, after the date of
acceptance by PURCHASER pursuant to Section 3.2, PURCHASER shall be entitled to
return any shipment of Product or Active Ingredient, in whole or in part, to the
extent that such Product or Active Ingredient fails to meet Specifications (as
such Specifications existed on the date of delivery), where such failure is due
solely to the actions or omissions of SUPPLIER.
4. PRODUCTION FEE AND PAYMENT.
4.1 Production Fees. Subject to Sections 2.2(c) and 2.3(c),
PURCHASER will pay SUPPLIER the applicable Production Fees for Product
(including costs of Active Ingredient, Raw Materials, manufacturing, filling,
inspecting, quality control, stability testing and packaging) or Active
Ingredient delivered to PURCHASER hereunder.
4.2 Invoices. SUPPLIER will issue an invoice to PURCHASER for the
full Production Fee with each shipment of the Product and Active Ingredient
delivered in accordance with Section 3.1. SUPPLIER will invoice PURCHASER in
U.S. dollars for all other amounts due hereunder on or after performance or
occurrence of the event that entitles SUPPLIER to be paid such amount by
PURCHASER. All invoices hereunder will be due and payable by PURCHASER in U.S.
dollars within thirty (30) days after receipt of the invoice by PURCHASER.
4.3 Taxes. In addition to payment of the Production Fee, PURCHASER
will be responsible for the payment of any sales and use taxes on the Product or
Active Ingredient delivered by SUPPLIER to PURCHASER.
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5. QUALITY CONTROL.
5.1 Manufacturing Process and Quality Assurance. The Product will
be manufactured by SUPPLIER in compliance with applicable laws and the
Specifications and in accordance with the manufacturing, quality assurance and
validation procedures currently employed by SUPPLIER in manufacturing the
Product or such other procedures as may be mutually agreed upon, or as may be
required under the applicable Marketing Authorizations.
5.2 Modifications. Any request for modification of the
Specifications (including a change of the Raw Materials or Active Ingredient)
will be made by the requesting party to the other party in writing. SUPPLIER
will inform PURCHASER of the amount of any additional costs (including capital
expenditures) that any such modification would reasonably entail, if any, and,
if PURCHASER elects to adopt the modification, the Production Fee will be
increased by the amount of such additional costs, and the relevant documents and
related schedules will be revised accordingly. If SUPPLIER is technically unable
to comply with a modification proposed by PURCHASER or if PURCHASER is unwilling
to pay the additional costs associated with any modification, the requesting
party will have the option to withdraw the proposed modification or, if the
requesting party can demonstrate that it reasonably requires such modification
for business or regulatory reasons, to terminate this Agreement. Each party will
notify the other party as soon as reasonably possible of any proposed changes to
the Specifications, procedures or other areas that have an impact on the other
party's performance of this Agreement. In no event will SUPPLIER be required to
make (or not to make) a modification that it deems prohibited (or required) by
applicable regulations or regulatory authorities. Notwithstanding the foregoing,
SUPPLIER shall not have the right to terminate this Agreement pursuant to this
Section 5.2 if PURCHASER is unwilling to pay the additional costs associated
with any modification proposed by SUPPLIER, other than modifications that are
required for regulatory reasons.
5.3 Testing. SUPPLIER will perform such quality assurance testing
as required under the applicable Specifications, and will provide evidence of
such testing to PURCHASER or its designee in a certificate of analysis for each
Product lot which confirms that the Product lot has been manufactured and
analyzed by SUPPLIER according with the applicable Specifications. SUPPLIER
shall provide a copy of the applicable certificate of analysis to PURCHASER with
each Product lot that is delivered to PURCHASER or by facsimile on the date of
delivery.
5.4 Reimbursement for Non-Conforming Product. If the Product fails
to meet the Specifications, where such failure is due solely to the actions or
omissions of SUPPLIER, SUPPLIER will credit PURCHASER with the Reimbursement
Amount. The "Reimbursement Amount" will be deemed equal to the sum of any costs
reasonably expended by PURCHASER in order to identify the defect (i.e.,
testing), plus all Production Fees paid on account of the subject Product. The
Reimbursement Amount will be payable sixty (60) days after rejection of the
subject Product in accordance with this Section. At PURCHASER's option, (i)
SUPPLIER will be relieved of any obligation to deliver any Product with respect
to the non-conforming batch, or (ii) SUPPLIER will replace the non-conforming
batch with substitute Product that conforms with the Specifications and any
other requirements of this Agreement, within sixty (60) calendar days from the
date PURCHASER notifies SUPPLIER of its election of option (ii) of this Section
5.4, in which case PURCHASER will pay to SUPPLIER amounts in accordance with
Article 4 based on the substitute Product. SUPPLIER will dispose of the
non-conforming Product at its own expense This Section 5.4 sets forth
PURCHASER's sole remedy for non-conforming
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Product that is identified before sale thereof by PURCHASER to PURCHASER's
customer, and under no circumstances will SUPPLIER be liable to PURCHASER for
any damages, including, without limitation, direct, special, incidental or
consequential damages (including, without limitation, loss of business, profits,
or goodwill), arising therefrom (whether in contract, tort, negligence or
otherwise) or in connection with its performance under this Agreement.
5.5 Access for Quality Control. Subject to SUPPLIER's reasonable
ability to assure the confidentiality of its other projects, SUPPLIER will
permit PURCHASER's representatives and representatives of applicable
Governmental or Regulatory Authorities to enter SUPPLIER's plants located in
Holland, Michigan, ▇▇▇▇ Baja, Puerto Rico or Freiburg, Germany upon reasonable
advance written notice and at reasonable intervals during regular business hours
solely for the purpose of making quality control inspections of the facilities
used in production of the Product or Active Ingredient for PURCHASER, including
manufacturing, receiving, sampling, analyzing, storing, handling, packaging,
shipping and disposing of the Active Ingredient and the Product. In addition,
the parties agree that a member of SUPPLIER's pharmaceutical quality assurance
team shall be present at all such inspections.
6. CONFIDENTIAL INFORMATION.
6.1 Confidentiality. PURCHASER and SUPPLIER will at all times
maintain as confidential any information, technology, formulation, process,
packaging, analytical methods, stability data, registration data or know-how of
a proprietary or confidential nature relating to the Product or Active
Ingredient disclosed by the other party pursuant to or in connection with this
Agreement (the "Proprietary Information"); provided, however, that the term
"Proprietary Information" does not include information which becomes available
to the receiving party following the date of this Agreement on a
non-confidential basis from a source other than the disclosing party, its
representatives or Affiliates, if such source is not under an obligation,
(whether contractual, legal or fiduciary) to the disclosing party, its
representatives or its Affiliates to keep such information confidential.
6.2 Survival of Confidentiality. PURCHASER and SUPPLIER hereby
agree that the provisions of this Article 6 and the obligations of
confidentiality herein will endure for a period of five (5) years after the
expiration or termination of this Agreement; provided, however, that with
respect to Proprietary Information regarding, arising out of, relating to,
reflecting, incorporating or based upon scientific, technological (including,
without limitation, analytical, manufacturing or formulation technology),
regulatory or compliance matters, the obligations of confidentiality herein will
not terminate.
7. INDEMNIFICATION.
7.1 Indemnification of SUPPLIER. PURCHASER will defend, indemnify,
and hold harmless SUPPLIER, its officers, agents, employees and Affiliates from
any loss, claim, action, damage, penalty, fine, expense or liability (including
reasonable defense costs and attorneys fees) ("Claim") to the extent the same
arises out of or is related to (a) the breach of any representation, warranty or
guarantee made by PURCHASER herein, (b) the handling, possession or use of the
Product following delivery to PURCHASER in accordance with Section 3.1
including, without limitation, express and implied warranties of
merchantability, fitness for a particular purpose and strict liability, unless
the claim results from the applicable Product failing
78
to conform to the Specifications, where such non-compliance is due solely to the
actions or omissions of SUPPLIER or (c) any other negligent act or omission of
PURCHASER.
7.2 Indemnification of PURCHASER. SUPPLIER will defend, indemnify,
and hold harmless PURCHASER, its officers, agents, employees and Affiliates from
any Claim to the extent the same arises out of or is related to (a) the breach
of any representation, warranty or guarantee made by SUPPLIER herein or (b) any
other negligent act or omission of SUPPLIER.
7.3 Indemnification Procedures. In any case under this Agreement
where one party has indemnified the other against any claim or legal action,
indemnification will be conditioned on compliance with the procedure outlined
below. Provided that prompt notice is given of any claim or suit for which
indemnification might be claimed, the indemnifying party promptly will defend,
contest or otherwise protect against any such claim or suit (including by way of
settlement and release) at its own cost and expense. The indemnified party may,
but will not be obligated to, participate at its own expense in a defense
thereof by counsel of its own choosing, but the indemnifying party will be
entitled to control the defense unless the indemnified party has relieved the
indemnifying party from liability with respect to the particular matter. If the
indemnifying party fails timely to defend, contest or otherwise protect against
any such claim or suit, the indemnified party may, but will not be obligated to,
defend, contest or otherwise protect against the same, and make any compromise
or settlement thereof and recover the entire costs thereof from the indemnifying
party, including reasonable attorneys fees, disbursements and all amounts paid
as a result of such claim or suit or the compromise or settlement thereof;
provided, however, that if the indemnifying party undertakes the timely defense
of such matter, the indemnified party will not be entitled to recover from the
indemnifying party its costs incurred in the defense thereof. The indemnified
party will cooperate and provide such assistance as the indemnifying party may
reasonably request in connection with the defense of the matter subject to
indemnification.
8. RECALLS.
8.1 Recalls. If any Product must be recalled by reason of failure
to meet the Specifications, any requirements of any applicable Governmental or
Regulatory Authority or any other requirements of law, PURCHASER will pay all
costs and expenses in order to effect the recall unless such recall is caused by
a failure of the Product to meet the Specifications, where such failure is due
solely to the actions or omissions of SUPPLIER. However, SUPPLIER will, in any
event, comply with any regulatory obligations arising from its status as
manufacturer of the recalled Product, and otherwise cooperate as reasonably
required in PURCHASER's efforts.
8.2 Reimbursement by PURCHASER. PURCHASER will reimburse SUPPLIER
for any costs reasonably expended by SUPPLIER to effect the recall, including
any cost associated with the Product that cannot be shipped due to the condition
requiring the recall, unless the recall is required due to the failure of the
Product to meet the Specifications, where such failure is due solely to the
actions or omissions of SUPPLIER.
8.3 Reimbursement by SUPPLIER. If PURCHASER can demonstrate that
the failure to meet applicable legal requirements is caused by failure of the
Product to meet the Specifications, where such failure is due solely to the
actions or omissions of SUPPLIER, SUPPLIER will reimburse PURCHASER for (a) any
cost reasonably expended by PURCHASER to effect the recall and (b) the
Reimbursement Amount in accordance with Section 5.4.
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9. RECORDS AND AUDITS.
9.1 Hold Period. For one (1) year after the expiration date of any
particular Product batch(es), or longer if required by applicable law or
Governmental or Regulatory Authority (the "Hold Period"), each party will
maintain, as applicable, records and samples relating to such batch(es)
sufficient to substantiate and verify its duties and obligations hereunder,
including but not limited to, records of orders sent and received, Product
manufactured, work in progress, Product analyses and quality control tests,
distribution of the Product and the like. During the Hold Period, neither party
will destroy any records relating to regulatory compliance or quality assurance
without giving the other party advance written notice and an opportunity to take
possession of or copy such records.
9.2 Notice of Governmental or Regulatory Authority Actions. Each
party agrees to advise the other party in a timely manner of any actions by any
Governmental or Regulatory Authority with respect to the Product. Such notice
remains subject, in all respects, to the provisions of Article 6.
10. TERM AND TERMINATION.
10.1 Term. Subject to the termination provisions of Section 10.2,
this Agreement will expire on the date (the "Termination Date") which is two
years from the Effective Date. PURCHASER shall have the option, by providing
SUPPLIER with at least 90 days' prior written notice of the Termination Date, to
extend the term of this Agreement for an additional one year period, provided
PURCHASER has used good faith efforts to arrange for an alternative source of
supply of the Product and Active Ingredient. In the event PURCHASER elects to
extend this Agreement for an additional one year period, the parties shall
commence good faith negotiations regarding terms and conditions for the
continued supply of Active Ingredient or Product by SUPPLIER.
10.2 Termination. PURCHASER shall have the right to terminate this
Agreement upon 60 days' prior written notice to SUPPLIER. In addition, each
party will have the right to terminate this Agreement (i) by giving the other
party written notice thereof if the other party fails to perform or violates any
material provision of this Agreement in any material respect, and such failure
continues unremedied for a period of thirty (30) days after the date the
notifying party gives written notice to the defaulting party with respect
thereto; or (ii) immediately if the other party is declared insolvent or
bankrupt by a court of competent jurisdiction, or a voluntary petition of
bankruptcy is filed in any court of competent jurisdiction by the other party,
or the other party makes or executes any assignment for the benefit of
creditors.
10.3 Effect of Termination. Unless otherwise agreed to between the
parties, all Raw Materials, Active Ingredient, work in progress or Product on
hand as of the effective date of expiration or termination of this Agreement
will be treated as follows as soon as practicable following such expiration or
termination:
(a) Raw Materials presently owned by SUPPLIER, as set forth on
Schedule D hereto, or otherwise purchased by SUPPLIER
reasonably based on any purchase orders for Product or Active
Ingredient submitted by PURCHASER, and not utilized by
SUPPLIER for the manufacture of the Product up to and
including
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the date of such expiration or termination, shall be delivered
by SUPPLIER to PURCHASER, whereupon PURCHASER will pay
SUPPLIER therefor in accordance with the costs set forth on
Schedule D or in an amount equalling SUPPLIER's actual cost
for such materials as documented by SUPPLIER to PURCHASER;
(b) Work in progress commenced by SUPPLIER in accordance with this
Agreement will, at the option of PURCHASER (but at the option
of either party in the case of termination hereof by it under
Section 10.2), (i) cease, and such work in progress will
remain with SUPPLIER (in which case PURCHASER will pay
SUPPLIER an amount equal to SUPPLIER's actual costs incurred
in connection with the performance and cessation of such work
less the cost to SUPPLIER of materials that can be returned by
SUPPLIER or used by SUPPLIER in later batches of other
products manufactured by SUPPLIER as reasonably determined by
SUPPLIER) or (ii) be completed by SUPPLIER and delivered to
PURCHASER, whereupon PURCHASER will pay SUPPLIER therefor in
accordance with the terms hereof; provided, however, that in
the case of expiration under Section 10.1, PURCHASER will not
have such option and will proceed under clause (ii) of this
provision; and
(c) Active Ingredient and Product manufactured pursuant to
Schedule C and the Production Schedule, respectively, will be delivered by
SUPPLIER to PURCHASER, whereupon PURCHASER will pay SUPPLIER therefor in
accordance with the terms hereof.
10.4 No Release. The expiration or termination of this Agreement
will not operate to release any party from any liability incurred prior to or
upon termination hereof or which subsequently arises under the operation of
Article 22.
11. REGULATORY MATTERS.
11.1 Compliance. Each party will provide reasonable assistance to
the other if necessary to respond to any Governmental or Regulatory Authority
audits, inspections, inquiries or requests concerning the Product or otherwise
necessary to comply with GMPs. PURCHASER's employees present at the facility
will at all times adhere to safety regulations, GMPs and work schedules
generally applicable to SUPPLIER's own employees.
11.2 Compliance Audits. Each party will notify the other party
within forty-eight (48) hours after it receives notice of a Governmental or
Regulatory Authority audit involving the Product or any component thereof and
will provide to such party copies of any resulting document of action (FDA Form
483 inspectional observation report (or other equivalent report), regulatory
letters, etc.) or of relevant sections thereof, resulting from these audits
within five (5) Business Days after receipt (solely to the extent such documents
directly relate to the Product).
12. TRADEMARKS AND LABELING.
12.1 Trademarks and Labeling for U.S. Product. (a) PURCHASER shall
provide SUPPLIER with labeling instructions for Product to be sold in the U.S.
prior to or on the Effective Date. SUPPLIER will affix labeling to the Product
to be sold in the U.S. as instructed by PURCHASER. PURCHASER shall pay all costs
incurred by SUPPLIER in connection with the
81
implementation of such labels bearing PURCHASER's name and trademark. Nothing
contained herein will give PURCHASER any right to use any SUPPLIER trademark and
PURCHASER will not obtain any right, title or interest in any SUPPLIER trademark
by virtue of this Agreement or the performance by SUPPLIER of services
hereunder; provided, however, that SUPPLIER will permit PURCHASER to use
SUPPLIER's trademark in connection with the Product to the extent permitted
under the Asset Purchase Agreement or required by applicable law or regulation.
(b) SUPPLIER and PURCHASER shall use their best efforts to
complete the conversion of labels to PURCHASER's name and trademark for Product
to be sold in the U.S.
(c) As between PURCHASER and SUPPLIER and with respect to Product
to be sold in the U.S., PURCHASER shall be solely responsible for ensuring that
approved Product labels, Product inserts and other printed materials, if any,
comply with all applicable laws, provided, however, that SUPPLIER warrants that
Product supplied hereunder prior to the conversion of labels to PURCHASER's name
and trademark in accordance herewith shall comply with the applicable Marketing
Authorization as it exists on the date hereof.
(d) No change to Product labels or Product inserts for Product to
be sold in the U.S. may be made without the prior written approval of PURCHASER.
12.2 Trademarks and Labeling for Non-U.S. Product. (a) PURCHASER
will, for a period of approximately one year, or such other period as is
appropriate or required under applicable local law or as directed by any
Governmental or Regulatory Authority (the "Transition Period"), sell Product
outside of the U.S. that bears the labeling and tradedress of an Affiliate of
SUPPLIER. PURCHASER and SUPPLIER shall use good faith efforts to mutually agree
on a schedule for the transition to PURCHASER's labeling and tradedress which
shall allow such transition to occur prior to the end of the Transition Period.
SUPPLIER will, or will cause its Affiliates to, affix labeling to the Product to
be sold outside of the U.S. as instructed by PURCHASER. PURCHASER shall pay all
costs incurred by SUPPLIER in connection with the implementation of such labels
bearing PURCHASER's name and trademark for Product to be sold outside of the
U.S. From and after the change of such labels and tradedress, nothing contained
herein will give PURCHASER any right to use any SUPPLIER trademark and PURCHASER
will not obtain any right, title or interest in any SUPPLIER trademark by virtue
of this Agreement or the performance by SUPPLIER of services hereunder;
provided, however, that SUPPLIER will permit PURCHASER to use SUPPLIER's
trademark in connection with the Product to the extent permitted under the Asset
Purchase Agreement or required by applicable law or regulation.
(b) As between PURCHASER and SUPPLIER and with respect to Product
to be sold outside of the U.S., PURCHASER shall be solely responsible for
ensuring that approved Product labels, Product inserts and other printed
materials, if any, comply with all applicable laws, provided, however, that
SUPPLIER warrants that Product supplied hereunder prior to the conversion of
labels to PURCHASER's name and trademark in accordance herewith shall comply
with the applicable Marketing Authorizations as they exist on the date hereof.
(c) Subject to this Section 12.2, No change to Product labels or
Product inserts may be made without the prior written approval of PURCHASER for
Product to be sold outside of the U.S.
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13. RELATIONSHIP OF PARTIES.
13.1 Independent Contractors. It is not the intent of the parties
hereto to form any partnership or joint venture. Each party will, in relation to
its obligations hereunder, act as an independent contractor, and nothing in this
Agreement will be construed to give either party the power or authority to act
for, bind or commit the other party in any way whatsoever.
13.2 Public Statements. SUPPLIER and PURCHASER each agree not to
disclose the terms or status of this Agreement in any public statements, whether
oral or written, including but not limited to shareholder reports,
communications with stock market analysts, statements to other customers or
prospective customers, press releases or other communications with the media, or
prospectuses, without the other party's prior written consent, which will not be
unreasonably withheld, or as required by applicable law. If possible, each party
will give the other at least five (5) Business Days advance written notice of a
disclosure required by applicable law and will cooperate with the other party to
minimize the scope and content of such disclosure.
14. WARRANTIES.
14.1 SUPPLIER's Warranty. SUPPLIER hereby represents and warrants
as follows:
(a) The Product will conform with the Specifications.
(b) Subject to Section 5.2(b) of the Asset Purchase Agreement,
SUPPLIER will comply in all material respects with any law, regulation,
ordinance, order, injunction, decree or requirement applicable to the
manufacture of the Product or Active Ingredient (including GMPs); provided that
PURCHASER will reimburse SUPPLIER for any increased costs that SUPPLIER
reasonably incurs (and cannot reasonably defer) in manufacturing the Product or
Active Ingredient, or operating the respective facilities in which the Product
or Active Ingredient is manufactured, as a result of any change in such laws or
regulations.
(c) SUPPLIER will maintain in effect all material governmental
permits, licenses, orders, applications and approvals required of it and make
all filings and notifications required of it regarding the manufacturing of the
Product and Active Ingredient; and SUPPLIER will manufacture the Product and
Active Ingredient in material compliance with all such permits, licenses,
orders, applications and approvals.
(d) SUPPLIER and SUPPLIER's employees and Affiliates have never
been (i) debarred or (ii) convicted of a crime for which a person can be
debarred, under Section 306(a) or 306(b) of the Generic Drug Enforcement Act of
1992. SUPPLIER agrees that it will promptly notify PURCHASER in the event of any
such debarment or conviction. The terms of the preceding sentence shall survive
the termination or expiration of this Agreement.
(e) The Product shall, at the time it is delivered under Section
3.1, not be adulterated or misbranded within the meaning of the FFDCA or any
equivalent local legislation. SUPPLIER shall have no responsibility for costs
and expenses associated with any recall of Product on or after the date hereof
attributable to a determination by a governmental or regulatory authority that
the use of the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name on such Product would constitute misbranding
within the meaning of the FFDCA.
83
(f) SUPPLIER has full authority to enter into this Agreement.
14.2 PURCHASER's Warranty. PURCHASER hereby represents and warrants
as follows:
(a) PURCHASER owns all rights to the Product trademarks and trade
names, if any, and the Product labeling bearing PURCHASER's name and trademarks
meets regulatory requirements.
(b) The use and sale of the Product (in the country where sold and
for its indicated purpose) bearing PURCHASER's name and trademarks by or on
behalf of PURCHASER or its customers will not infringe any trademark or trade
name of any third person.
(c) PURCHASER will comply in all material respects with any law,
regulation, ordinance, order, injunction, decree or requirement applicable to
the marketing of the Product.
(d) PURCHASER will maintain in effect all material required
governmental permits, licenses, orders, applications and approvals regarding the
marketing of the Product, including the respective Marketing Authorizations, and
PURCHASER will market the Product in accordance with all such permits, licenses,
orders, applications and approvals. PURCHASER shall not make any changes to the
respective Marketing Authorizations affecting the Specifications without the
prior written consent of SUPPLIER, which will not be unreasonably withheld.
SUPPLIER shall respond to PURCHASER'S written request for any such change within
thirty (30) days after receipt of such written request from PURCHASER.
(e) PURCHASER warrants and represents that it has full authority
to enter into this Agreement, that it has been granted full rights and license
to sell the Product and that nothing contained in any other agreement prohibits
or restricts PURCHASER from entering into any part of this Agreement.
14.3 NO IMPLIED WARRANTIES. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
THIS AGREEMENT, SUPPLIER AND PURCHASER MAKE NO REPRESENTATIONS AND EXTEND NO
WARRANTIES OF ANY KIND REGARDING THE SUPPLY OF THE PRODUCT, EITHER EXPRESS OR
IMPLIED, INCLUDING, IN THE CASE OF SUPPLIER, ANY EXPRESS OR IMPLIED WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
15. ASSIGNMENT.
15.1 Until such time as PURCHASER has discharged all its payment
obligations under the Asset Purchase Agreement (other than the payment
obligation set forth in Section 2.1(a)(ii) thereof), this Agreement may not be
assigned by PURCHASER without the prior written consent of SUPPLIER; provided,
that PURCHASER shall have the right to assign its rights and obligations under
this Agreement to any third party successor to all or substantially all of its
entire business. SUPPLIER will respond to PURCHASER's written request for
assignment within forty-five (45) days after receipt of such written request
from PURCHASER. This Agreement will be binding upon and will inure to the
benefit of permitted assigns and successors.
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16. GOVERNING LAW.
16.1 This Agreement will be governed by the laws of the State of
New York. Each party hereby consents to the personal jurisdiction of the state
and federal courts located in New York.
17. FORCE MAJEURE.
17.1 Except in the case of monetary obligations of one party to the
other hereunder, neither party hereto will be liable to the other in damages
for, nor will this Agreement be terminable by reason of, any delay or default in
such party's performance hereunder if such delay or default is caused by
conditions beyond such party's control including, but not limited to, acts of
nature, regulation or law or other action of any government or any agency
thereof, war, insurrection, civil commotion, destruction of production
facilities or materials by earthquake, fire, flood or storm, strikes, epidemic,
or unforeseen failure of suppliers, public utilities or common carriers. Each
party hereto agrees promptly to notify the other party of any event of force
majeure above and to employ all reasonable efforts towards prompt resumption of
its performance hereunder when possible if such performance is delayed or
interrupted by reason of such event.
18. NOTICES.
18.1 All notices, requests, demands and other communications
required or permitted under this Agreement shall be in writing and shall be
deemed to have been duly given, made and received on the date when delivered by
hand delivery with receipt acknowledged, or upon the next Business Day following
receipt of telex or telecopy transmission, or upon the third day after deposit
in the United States mail, registered or certified with postage prepaid, return
receipt requested, addressed as set forth below:
If to PURCHASER:
First Horizon Pharmaceutical Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Vice President, Corporate Development
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
First Horizon Pharmaceutical Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Legal Counsel
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
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If to SUPPLIER:
▇▇▇▇▇-▇▇▇▇▇ Pharmaceuticals Limited
▇▇. ▇.▇ ▇▇▇▇ ▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attn: General Manager
with a copy to:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Vice President, Pharmaceutical
Manufacturing
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Senior Vice President and General Counsel
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Any party may alter the addresses to which communications or copies are to be
sent by giving, notice of such change of address in conformity with the
provisions of this section for giving notice.
19. HEADINGS.
19.1 Headings used in this Agreement are for reference purposes only
and in no way define, limit, construe or describe the scope or extent of such
paragraph, or in any way affect this Agreement.
20. SEVERABILITY.
20.1 If any provision of this Agreement is held to be invalid or
unenforceable for any reason, the remaining provisions will continue in full
force without being impaired or invalidated in any way, and the parties agree to
replace any invalid provision with a valid provision which most closely
approximates the intent and economic effect of the invalid provision.
21. WAIVER.
21.1 No term or provisions hereof shall be deemed waived, and no breach
excused, unless such waiver or consent is in writing and signed by the party
claimed to have waived or consented. The waiver by any party of a breach of any
provision of this Agreement will not operate or be interpreted as a waiver of
any other or subsequent breach.
22. SURVIVAL.
22.1 The provisions of Sections 2.3(b), 5.4, 5.5, 10.3, 10.4 and
13.2 and Articles 6-9 and 11 will survive the termination or expiration of this
Agreement.
86
22.2 The provisions of this Agreement which do not survive termination
or expiration hereof (as the case may be) will, nonetheless, be controlling on,
and will be used in construing and interpreting, the rights and obligations of
the parties hereto with regard to any dispute, controversy or claim that may
arise under, out of, in connection with, or relating to this Agreement.
23. ENTIRE AGREEMENT.
23.1 This Agreement, together with the Schedules hereto and the Asset
Purchase Agreement, constitutes the entire agreement and understanding between
the parties hereto and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company with respect to the subject matter
hereof and supersedes any prior agreements, negotiations, understandings,
representations, statements and writings relating thereto. To the extent there
is any conflict between this Agreement, any purchase order and any of the
Schedules attached hereto, this Agreement will take precedence. This Agreement
may not be amended or modified unless such amendment or modification is made in
writing and executed by a duly authorized officer or agent of each party hereto.
24. COUNTERPARTS.
24.1 This Agreement may be executed in two or more counterparts, each
of which shall be deemed an original and all of which shall together constitute
one and the same instrument. This Agreement shall become binding when one or
more counterparts hereof shall bear the signatures of all parties indicated as
signatories hereto.
25. NO THIRD PARTY BENEFICIARY.
25.1 The terms and provisions of this Agreement are intended solely for
the benefit of each party hereto and their respective successors or permitted
assigns, and it is not the intention of the parties to confer third-party
beneficiary rights upon any other person or entity.
IN WITNESS WHEREOF, the parties have caused this Agreement to be entered into by
their duly authorized representatives, to be effective as of the date first
above written.
▇▇▇▇▇-▇▇▇▇▇ FIRST HORIZON PHARMACEUTICAL
PHARMACEUTICALS LIMITED CORPORATION
By: By:
--------------------------- -------------------------
Name: Name:
Title: Title:
87
[****]-CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT I - PRODUCTION FEES*
PRODUCT: TACRINE
AFFILIATE PRESENTATION WITH UNIT OF MEASURE CONSOLIDATED COST
--------- --------------------------------- -----------------
Austria 10 mg x 56 [*****]
20 mg x 56 [*****]
30 mg x 112 [*****]
40 mg x 112 [*****]
France 10 mg x 56 HOSP [*****]
10 mg x 56 [*****]
10 mg x 28 [*****]
10 mg x 28 MS [*****]
20 mg x 56 [*****]
20 mg x 28 [*****]
30 mg x 112 [*****]
30 mg x 28 [*****]
40 mg x 112 HOSP [*****]
40 mg x 112 [*****]
40 mg x 28 [*****]
Germany 10 mg x 56 [*****]
10 mg x 112 [*****]
10 mg x 112 TAP5 [*****]
20 mg x 56 [*****]
20 mg x 112 [*****]
20 mg x 112 TAP5 [*****]
30 mg x 56 [*****]
30 mg x 112 [*****]
30 mg x 112 TAP5 [*****]
40 mg x 56 [*****]
40 mg x 112 [*****]
40 mg x 112 TAP5 [*****]
10 mg x 56 - samples [*****]
Greece 10 mg x 56 [*****]
20 mg x 56 [*****]
30 mg x 56 [*****]
40 mg x 56 [*****]
Puerto Rico 10 mg x 120 [*****]
20 mg x 120 [*****]
30 mg x 120 [*****]
40 mg x 120 [*****]
Spain 10 mg x 56 (Zaimer) [*****]
20 mg x 56 (Zaimer) [*****]
30 mg x 112 (Zaimer) [*****]
40 mg x ▇▇▇ (▇▇▇▇▇▇) [*****]
▇▇▇▇▇▇ ▇▇▇▇▇▇ 10 mg x 120 [*****]
88
20 mg x 120
30 mg x 120 [*****]
40 mg x 120 [*****]
Active Ingredient $[*****] per kilo
Filled Capsule Shells $
* Fifteen Days prior to each scheduled delivery date, SUPPLIER shall set the
Production Fee based on Suppliers calculation of the standard cost which shall
include the costs of Active Ingredient, Raw Materials, manufacturing, filling,
inspecting, quality control, stability testing and packaging. The Production Fee
for the Product to be delivered in the year 2000 is set forth herein. The
Production Fee is subject to adjustment as provided in the Agreement.
89
SCHEDULE A
DOSAGE STRENGTH NUMBER OF CAPSULES FOR U.S. NUMBER OF CAPSULES FOR "REST OF WORLD"
--------------- --------------------------- --------------------------------------
10 mg 3,828,000* none
20 mg None 3,828,000
30 mg 3,828,000 none
40 mg 3,828,000 3,828,000
* 600,000 of these capsules will be provided to PURCHASER in containers for use
by PURCHASER in packaging samples.
90
SCHEDULE B
FORM OF PRODUCTION SCHEDULE*
Country Dosage Strength Quantity Delivery Date
------- --------------- -------- -------------
* The Production Schedule submitted by PURCHASER to SUPPLIER pursuant to Section
2.2(b) of this Agreement will provide the above information for the Product
manufactured by SUPPLIER in 2000 plus an allocation of the following filled
capsule shells currently located in SUPPLIER's Affiliate in Freiburg, Germany
(for non-U.S.
Product):
BULK CAPSULES IN GERMANY (UNPACKAGED)
COUNTRY DOSAGE STRENGTH QUANTITY EXPIRATION DATE
(CAPSULES)
GERMANY
10 mg 3,600,000 09/01/2001
30 mg 2,290,000 11/01/2001
40 mg 1,720,000 11/01/2001
91
SCHEDULE C
[****]-CONFIDENTIAL TREATMENT REQUESTED
TACRINE HYDROCHLORIDE SUPPLY SCHEDULE
ITEM DELIVERY DATE
QUANTITY PRICE/UNIT
Tacrine Hydrochloride [*****]* [*****] [*****]
Tacrine Hydrochloride [*****]** [*****] [*****]
* PURCHASER shall provide SUPPLIER with at least 90 days' notice prior to the
date on which it desires to receive the Active Ingredient. PURCHASER's desired
date of delivery shall fall within the range set forth above. SUPPLIER shall use
commercially reasonable efforts to deliver the Active Ingredient on such date.
In the event PURCHASER desires to receive from SUPPLIER Product manufactured
using this batch of Active Ingredient, PURCHASER shall provide to SUPPLIER a
purchase order which shall specify the quantities, dosage strengths, country of
destination and any other information necessary for SUPPLIER to fill such order;
provided that any Product shall be manufactured in full batch sizes for any
particular dosage strength. Such purchase order shall be delivered to SUPPLIER
no earlier than the date on which such Active Ingredient would otherwise be
delivered as provided above and, in any event, at least 90 days prior to the
date on which such Product is to be delivered by SUPPLIER to PURCHASER. SUPPLIER
shall use commercially reasonable efforts to supply to PURCHASER the Product in
such quantities and on such dates as provided in such purchase order.
** PURCHASER shall provide SUPPLIER, prior to the date which is 180 days prior
to the Termination Date, written notice of its desire to receive this batch of
Active Ingredient. SUPPLIER shall use commercially reasonable efforts to deliver
the Active Ingredient on or prior to the Termination Date. In the event
PURCHASER desires to receive from SUPPLIER Product manufactured using this batch
of Active Ingredient PURCHASER shall provide to SUPPLIER with notice of its
desire at least 9 months prior to the Termination Date. Thereafter, PURCHASER
shall provide to SUPPLIER a purchase order which shall specify the quantities,
dosage strengths, country of destination and any other information necessary for
SUPPLIER to fill such order; provided that any Product shall be manufactured in
full batch sizes for any particular dosage strength. Such purchase order shall
be delivered to SUPPLIER on the date which is 90 days prior to the Termination
Date. SUPPLIER shall use commercially reasonable efforts to supply to PURCHASER
the Product on or prior to the Termination Date.
92
SCHEDULE D
[****]-CONFIDENTIAL TREATMENT REQUESTED
RAW MATERIALS SCHEDULE
PRIMARY TACRINE HYDROCHLORIDE RAW MATERIALS
CURRENT AFTER 1 LOT AFTER 2 LOTS AFTER 3 LOTS
KG/LOT COST/KG INV. VALUE INV. VALUE INV. VALUE INV. VALUE
------ ------- ---- ----- ---- ----- ---- ----- ---- -----
2-Aminobenzonitrile 273 [*****] 1,114 [*****] 841 [*****] 568 [*****] 295 [*****]
Sodium Carbonate 500 [*****] 545 [*****] 45 [*****] 0 [*****] 0 [*****]
Zinc Chloride 390 [*****] 800 [*****] 410 [*****] 20 [*****] 0 [*****]
TOTAL [*****] [*****] [*****] [*****]
93
EXHIBIT 7.1.8
SUBLICENSE
THIS AGREEMENT is made as of the ___ day of May 2000 by and between
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY, corporation organized and existing under the laws of
the state of Delaware and having its principal place of business at ▇▇▇ ▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter referred to as "LICENSOR")
and FIRST HORIZON PHARMACEUTICAL CORPORATION, a corporation organized and
existing under the laws of the state of Delaware and having its principal place
of business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ (hereinafter
referred to as "LICENSEE"). This Sublicense is a sublicense pursuant to Section
2.01 of the License Agreement dated the 27th day of September, 1990 by and
between ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, M.D., an individual having his principal place of
business at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
(hereinafter referred to as "▇▇▇▇▇▇▇") and LICENSOR (the "License Agreement").
Unless otherwise defined herein, all capitalized terms shall have the meanings
set forth in Article I.
W I T N E S S E T H:
WHEREAS, ▇▇▇▇▇▇▇ is the owner of the Licensed Patents (as hereinafter
defined) and has developed and is the owner of the Agreement Compound Studies
(as hereinafter defined);
WHEREAS, pursuant to the License Agreement, ▇▇▇▇▇▇▇ granted LICENSOR
an exclusive license under the Licensed Patents throughout the world (except
Canada where ▇▇▇▇▇▇▇ may wish to grant a license to LICENSOR and to
PharmaScience Inc., a Canadian corporation ("PharmaScience"));
WHEREAS, on the date hereof, LICENSEE has purchased from LICENSOR,
pursuant to the Asset Purchase Agreement dated April 14, 2000, certain assets
relating to the Cognex(R) business and LICENSOR has agreed to sublicense the
Licensed Patents to LICENSEE pursuant to Section 2.1 thereof;
NOW, THEREFORE, in consideration of the mutual covenants herein
contained, LICENSOR and LICENSEE agree as follows:
I. DEFINITIONS
The following terms as used in this Agreement shall have the meanings set forth
in this Article:
1.01 "Affiliate", with respect to any Person, means any other Person
controlling, controlled by or under direct or indirect common control with such
Person in question. A Person shall be deemed to control a corporation (or other
entity) if such Person possesses, directly or indirectly, the power to direct
or cause the direction of the management and policies of such corporation (or
other entity), whether through the ownership of voting securities, by contract,
or otherwise.
1.02 "Agreement Compound" means the pharmaceutical compound
1,2,3,4-tetrahydro-9-aminoacridine (known by the generic names "Tacrine" and
"THA"), including all salts and hydrates.
1
94
1.03 "Agreement Compound Studies" means all Data together with all of
SUMMER's protocols, write-ups, analyses, compilations and other writings
relating to the Data in whatever stage of completion and whether in preparation
for submission to regulatory authorities or otherwise.
1.04 "Data" means, whether generated by ▇▇▇▇▇▇▇ or any of SUMMER's
researchers or investigators, all preclinical (including, but not limited to,
chemistry, formulation stability and analytical development methodology),
clinical, toxicology and other data (including, but not limited to, raw and
underlying data such as patient records, computer software, adverse events
data, etc.) resulting from, referring, or relating to, all studies performed or
to be performed or completed by or on behalf of ▇▇▇▇▇▇▇ in connection with
Agreement Compound.
1.05 "Exclusivity Period" means, with respect to a given country, the
period of time during which no third party can obtain governmental approval to
sell Agreement Compound based, in whole or in part, on data submitted by
LICENSOR to obtain its approval to sell Agreement Compound in said country.
1.06 "Licensed Compound" means Agreement Compound which (or the use or
sale of which) is covered by a Valid Claim.
1.07 "Licensed Patents" means all, patents and patent applications
covering the manufacture, use or sale of Product, Agreement Compound or
compounds used in the production thereof, owned or controlled by ▇▇▇▇▇▇▇ at any
time during the term of this Agreement, or under which ▇▇▇▇▇▇▇ is or shall
become empowered to grant licenses, including, but not limited to, the United
States Patent and all patents issuing from corresponding applications in
countries outside the United States, and any and all reissues, reexaminations,
extensions, substitutions, confirmations, registrations, revalidations,
additions, continuations, continuations-in-part or divisions of or to any of
the aforesaid patents. If a particular patent or patent application is directed
toward an invention of general applicability to all pharmaceuticals or
pharmaceuticals across a broad range of therapeutic areas, it would not be
deemed to be covered within the definition of "Licensed Patents" because such
patent or patent application may have incidental applicability to Agreement
Compound.
1.08 "Losses" means any and all damages, fines, fees, penalties,
deficiencies, losses and expenses (including without limitation interest, court
costs, reasonable fees of attorneys, accountants and other experts or other
expenses of litigation or other proceedings or of any claim, default or
assessment).
1.09 "NDA" means the United States New Drug Application filed by the
LICENSOR on June 1, 1990 (NDA #20-070) in connection with the use of Agreement
Compound for the treatment of Alzheimer's disease.
1.10 "Net Sales" means the actual gross sales of Licensed Compound and
Products by LICENSEE and its Affiliates to nonaffiliated customers less trade,
cash and quantity discounts and broker's or agent's commissions, if any,
actually allowed or paid; returns, allowances and adjustments actually granted
customers; prime vendor and institutional rebates; freight insurance and other
transportation costs and all taxes (except income taxes), tariffs, duties and
other similar governmental charges paid by LICENSEE, its Affiliates or
sublicensees. In the event of sale of Products containing Licensed Compound in
combination with other active ingredients, the Net Sales for such products
shall be determined by multiplying what would otherwise be the Net Sales of
such products by a fraction, the numerator of which shall be the production
cost of Licensed Compound contained therein
2
95
and the denominator of which shall be the total production cost of all active
ingredients contained therein, the production cost of each to be determined
using the standard production cost formula of LICENSEE, provided, however, that
in no event shall the Net Sales for combination products be reduced by more
than sixty-five percent (65%).
1.11 "Payable Royalties" means the amount of royalties calculated to
be paid by LICENSEE, its Affiliates or sublicensees pursuant to this Agreement
reduced by (a) any amounts paid to third parties pursuant to Section 3.08 and
(b) the provisions of Section 3.09.
1.12 "Person" means any corporation, company, partnership, joint
development, other entity or natural person.
1.13 "Product" means any finished pharmaceutical product which
contains Agreement compound as an active ingredient, whether alone or in
combination form which (or the use or sale of which) is covered by a Valid
Claim.
1.14 "United States Patent" means United States Patent No. 4,816,456
and any reexaminations or reissues thereof.
1.15 "Valid Claim" means a claim which but for the license granted
hereunder, would be infringed by LICENSOR's, its Affiliate's or sublicensee's
manufacture, use or sale of Product and/or Licensed Compound, and which is in
an unexpired issued patent owned by ▇▇▇▇▇▇▇ included within the Licensed
Patents which has not been held invalid or unenforceable by a decision of a
court of competent jurisdiction, unappealable or unappealed within the time
allowed for appeal, and which has not been held by an applicable governmental
agency, or expressly admitted in writing by the owner, to be invalid through
reissue, reexamination, disclaimer or otherwise, and, in the case of a holding,
is unappealable or unappealed within the time allowed for appeal.
II. GRANT
2.01 Grant of License. LICENSOR hereby grants to LICENSEE an exclusive
sublicense (and the right to sublicense) under the Licensed Patents to make,
use, and sell Licensed Compound and Products in all countries of the world;
provided, however, that ▇▇▇▇▇▇▇ may, in addition to the license granted to
LICENSOR in Canada, grant a nonexclusive license (without the right to
sublicense) under the Canadian Licensed Patents to PharmaScience for the sole
purpose of making, using, and selling Licensed Compound and Product in Canada
without the right to send Agreement Compound and/or Product outside of Canada.
To the extent Net Sales are made by any sublicensee of LICENSEE, they will be
treated for royalty purposes as if made by LICENSEE.
2.02 Sublicense Subject To License. LICENSEE acknowledges that, as a
licensee under the License Agreement, LICENSOR can not sublicense to LICENSEE
rights other than those it has been granted under the License Agreement.
III. PAYMENTS
3.01 Payments to LICENSOR. In consideration of the aforesaid grant of
license to LICENSEE and the further covenants contained in this Agreement,
including the covenant contained in Section [****]-CONFIDENTIAL TREATMENT
REQUESTED
3
96
6.03(a), LICENSEE shall pay to LICENSOR's Designee the amounts set forth below
pursuant to the terms set forth herein.
3.02 In the event that ▇▇▇▇▇▇▇, without LICENSOR's prior written
consent and unless compelled by applicable court or agency order, takes an
affirmative action that permits a third party (other than PharmaScience in
Canada) to make, use or sell Product or Agreement Compound in any country such
that LICENSEE does not have an exclusive market in such country for Product or
Agreement Compound (i.e. ▇▇▇▇▇▇▇ disclaims a Licensed Patent, or grants a
license to, covenants not to ▇▇▇, or otherwise agrees not to enforce a Licensed
Patent or indemnifies a third party), LICENSOR shall pay to LICENSEE an amount
equal to all amounts recovered by LICENSOR pursuant to Section 3.02 of the
License Agreement, less reasonable costs and expenses of LICENSOR in effecting
such recovery. LICENSOR shall use its commercially reasonably efforts to
recover what it is entitled to under Section 3.02 of the License Agreement.
LICENSOR agrees that any request by ▇▇▇▇▇▇▇ pursuant to Section 3.02 of the
License Agreement will be communicated to LICENSEE in writing promptly and that
LICENSOR shall not consent or object without direction to so do from LICENSEE.
3.03 Royalty. (a) In further consideration of the rights granted
hereunder, LICENSEE shall pay to LICENSOR's Designee from June 1, 2000, and for
the remaining term of this Agreement, except as hereinafter provided, the
following royalties:
(1) [INTENTIONALLY OMITTED]
(2) [*****] of Net Sales in the United States, until the date
of expiration of the United States Patent;
(3) In each country outside the United States where there is
a Licensed Patent, [*****] of Net Sales in said country; such
royalties shall continue thereafter until the end of the Exclusivity
Period in said country; and
(4) Beginning with the end of the Exclusivity Period in each
country outside the United States where there is a Licensed Patent,
[*****] of Net Sales in said country; such royalties shall continue
thereafter until the date of expiration of the applicable Licensed
Patent.
(b) Notwithstanding the foregoing, the amount of Payable Royalties in
any quarter shall be reduced by any and all Prepaid Royalties until such time
that all Prepaid Royalties have been credited against Payable Royalties. As
used herein, "Prepaid Royalties" means royalties in the amount of $[*****] that
were prepaid by LICENSOR to ▇▇▇▇▇▇▇, less an amount equal to the amount of
royalties payable by LICENSOR to ▇▇▇▇▇▇▇ under the License Agreement for the
period beginning April 1, 2000 and ending May 31, 2000.
(c) For purposes of this Agreement, and in response to the advice of
the United States Federal Trade Commission in connection with the approval of
the merger of LICENSOR and Pfizer Inc., LICENSOR irrevocably appoints ▇▇.
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ as its Designee (where indicated) for purposes of Articles
III and IV of this Agreement.
[****]-CONFIDENTIAL TREATMENT REQUESTED
4
97
3.04 Payment. (a) All payments to be made by LICENSEE to LICENSOR's
Designee hereunder shall be made as follows:
(i) Seventy-five percent (75%) to ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, M.D. or a bank
account designated in writing by ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇.
(ii) Twenty-five percent (25%) to Burns, Doane, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇.
Current wiring instructions are:
Crestar Bank
[*****]
Burns, Doane, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ LLP
[*****]
The payment pursuant to clause (a)(ii) is mandated by a Stipulation and Order
Re Enforcement of Judgment and, by order of the Superior Court of the State of
California for the County of Los Angeles, may not be revoked by ▇▇▇▇▇▇▇ for any
reason.
(b) All payments to be made by LICENSEE as provided in Section 3.04(a)
above shall be made in United States dollars in the United States. For
converting into United States dollars a royalty accrued in another currency,
the conversion rate shall be the closing commercial buying rate of exchange for
United States dollars and such other currency quoted by Citibank, N.A. (or its
successors in interest) in New York for the last business date of the quarterly
period for which payment is being made.
3.05 Taxes Withheld. Any income or other tax that LICENSEE or its
Affiliates is required to withhold and pay on behalf of LICENSOR's Designee
with respect to the royalties payable to LICENSOR's Designee under this
Agreement shall (without regard to the provisions of Section 3.03(b)) be
deducted from such royalties prior to remittance to LICENSOR's Designee.
LICENSEE shall provide LICENSOR's Designee with documentary evidence of said
payments.
3.06 Computation of Royalties. All sales of Product and Licensed
Compound between LICENSEE and any of its Affiliates and/or sublicensees shall
be disregarded for purposes of computing royalties under this Article III.
Nothing herein contained shall obligate LICENSEE to pay LICENSOR's Designee
more than one royalty on any unit of a Product.
3.07 Licenses to Affiliates. (a) LICENSOR shall, at the request of
LICENSEE, sign sublicense agreements directly with LICENSEE's Affiliates in
those countries where the sale of Licensed Compound or Product by LICENSEE or
its Affiliates would infringe a Valid Claim. Such license agreements shall
contain substantially the same language as contained herein with appropriate
changes in parties and territory. It shall be LICENSEE's responsibility to
register such agreements with the appropriate authorities.
(b) Royalties received by LICENSOR's Designee directly from LICENSEE's
Affiliates pursuant to such agreements shall be credited towards LICENSEE's
royalty obligation under Section 3.03 hereof.
5
98
(c) Notwithstanding any other term or provision of this Agreement, the
failure of LICENSOR to comply with the provisions of Section 3.07(a) within
sixty (60) days of a request by LICENSEE or such Affiliate to comply with such
provision, shall immediately release LICENSEE of any and all obligations of
LICENSEE to make payments of any kind, including, but not limited to, payments
pursuant to Sections 3.03 and 6.04, until LICENSOR has complied with such
provisions.
3.08 Offset of Royalties. LICENSEE shall be entitled to offset against
the royalties otherwise due hereunder any amounts payable to third parties in
respect of other patent rights covering the manufacture, use or sale of
Agreement Compound that would preclude LICENSEE from practicing a Licensed
Patent without obtaining a license thereunder, except royalties due under the
Settlement and License Agreement dated as of September 28, 1994 between
▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ Pharmaceuticals Inc. and LICENSOR.
3.09 Reduction of Royalties. (a) In the event that any third party
begins the sale of Product in any country where there is a Licensed Patent and
the sale of Product by all such third parties in the aggregate in such country
reaches or exceeds the percentages set forth below of the sales of Product in
such country made by LICENSEE, its Affiliates and any sublicensees in any
fiscal quarter, then payment of royalties (and the obligation to pay royalties)
shall be reduced with respect to Net Sales in such country pursuant to the
schedule set forth below for so long as such third party sales shall continue.
The amount of aggregate third party sales for a fiscal quarter shall be
determined by LICENSEE (a) in the United States, by data obtained from
Information Management Systems ("IMS") and (b) in any other country in which
there is a Licensed Patent, by data obtained from IMS drugstore audits
supplemented by LICENSEE's sampling of hospital and other institutional
purchasers.
6
99
Aggregate Third Party
Sales as Percentage Percentage of
of LICENSEE's Sales Royalties Suspended
in Any Fiscal Quarter for Such Fiscal Quarter
10% and greater but 25%
less than 15%
15% and greater but 50%
less than 20%
20% and greater but 75%
less than 25%
25% and greater but 90%
less than 35%
35% and greater 100%
(b) Upon the resumption of full royalty payment following any
reduction of payment under any Section of this Agreement, no payment shall be
made with respect to any royalties not received during the period of reduction.
(c) Notwithstanding any other term or provision of this Agreement, the
payment of royalties (and the obligation to pay royalties) shall terminate in
its entirety in a particular country in the event that ▇▇▇▇▇▇▇, without
LICENSOR's prior written consent and unless compelled by applicable court or
agency order, takes an affirmative action that permits a third party (other
than PharmaScience in Canada) to make, use or sell Product or Agreement
compound in such country such that LICENSEE does not have an exclusive market
in such country for Product or Agreement Compound (e.g. ▇▇▇▇▇▇▇ grants a
license to, covenants not to ▇▇▇, or otherwise agrees not to enforce a Licensed
Patent or indemnifies such third party). LICENSOR agrees that any request by
▇▇▇▇▇▇▇ pursuant to Section 3.09(c) of the License Agreement will be
communicated to LICENSEE in writing promptly and that LICENSOR shall not
consent or object without direction to so do from LICENSEE.
IV. RECORDS AND PAYMENTS
4.01 Quarterly Reports and Payments. Beginning one hundred and twenty
(120) days after the second fiscal quarter of 2000 and one hundred and twenty
(120) days after the end of any subsequent fiscal quarter during the term of
this Agreement, LICENSEE shall deliver or cause to be delivered to LICENSOR's
Designee and to Burns, Doane, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ LLP, a written report showing
all sales of Product by LICENSEE and its Affiliates during the preceding
quarterly period and showing the calculation of Net Sales and the amount
payable as royalties as calculated in accordance with Article III hereof,
provided, however, that the first such report shall cover only the month of
June 2000. Concurrently with the submission of each such written report,
LICENSEE shall pay LICENSOR's Designee or cause to be paid the amount of
royalties shown to be due thereon, subject to the other provisions of this
Agreement.
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100
4.02 Records. LICENSEE shall keep or cause to be kept accurate records
in sufficient detail to enable the royalties payable hereunder to be
determined. Upon the request of LICENSOR's Designee (but not more frequently
than once in each fiscal year), LICENSOR's Designee may designate an
independent public accountant mutually acceptable to LICENSOR's Designee and
LICENSEE to review such records to verify the accuracy of the royalty payments
made or payable hereunder during the preceding fiscal year, but only as to any
period ending not more than two (2) years prior to the date of such request.
Said accountant shall not disclose to LICENSOR or any other party any
information except that which should properly be contained in a royalty report
required under this Agreement. LICENSOR's Designee shall pay the cost for any
review of records conducted at the request of LICENSOR's Designee under this
Section 4.02; provided, however, that in the event that such review shall
reveal a discrepancy of greater than twenty percent (20%) in the royalty
payment due to LICENSOR's Designee hereunder, LICENSEE shall pay the cost of
such review. In addition, in the event that LICENSEE seeks indemnification
under Section 9.03 of this Agreement or if LICENSOR reasonably needs access to
such records in connection with any action or proceeding against LICENSOR by
▇▇▇▇▇▇▇, LICENSOR shall have the right to review LICENSEE's records to verify
the accuracy of the royalty payments made or payable hereunder, upon reasonable
notice and during regular business hours.
V. PATENT PROSECUTION AND INFRINGEMENT
5.01 Prosecution. LICENSOR shall use all reasonable measures to cause
▇▇▇▇▇▇▇ to prosecute all applications for Licensed Patents and maintain all
such applications and issued Licensed Patents at his own expense and LICENSOR
shall keep LICENSEE currently advised of all steps taken or to be taken in the
prosecution of such applications (including reissues and reexaminations) and
improvements therein and shall furnish LICENSEE with copies of all such patent
applications and papers received from and filed with each patent office
promptly after filing or receipt. SUMMER's has undertaken in the License
Agreement to take all reasonable and necessary actions to obtain and maintain
Licensed Patents. In the event that ▇▇▇▇▇▇▇ elects or has elected not to file
applications in any country or countries or not to continue to prosecute any
application, including an application involved in an appeal or opposition
proceeding, or not to maintain any Licensed Patent or application for Licensed
Patent by failure to pay any required annuity, renewal or working fee, LICENSOR
shall so advise LICENSEE in time to enable LICENSEE to take appropriate action
and LICENSEE shall be entitled to file such applications or take such other
action at its expense and to own such resultant patents without the obligation
to pay any royalties under such patents pursuant to this Agreement or
otherwise. In such event, LICENSOR shall and shall use all reasonable measures
to cause ▇▇▇▇▇▇▇, at LICENSEE's request, but at no additional cost to LICENSEE,
execute whatever documents are necessary to transfer to LICENSEE full ownership
of such application or Licensed Patent. Notwithstanding any other term or
provision of this Agreement, the payment of royalties (and the obligation to
pay royalties) shall terminate in its entirety in a particular country in the
event that ▇▇▇▇▇▇▇ fails to comply with the provisions of Section 5.1 of the
License Agreement with respect to such country.
5.02 Infringement Actions. LICENSOR and LICENSEE shall promptly notify
each other of any infringement of the Licensed Patents which may come to their
attention. ▇▇▇▇▇▇▇, at his sole discretion, may undertake to obtain a
discontinuance of the aforesaid infringement and/or ▇▇▇▇▇▇▇ may bring suit
against such infringer.
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101
It is understood and agreed that ▇▇▇▇▇▇▇ shall bear solely all costs and
expenses associated with any suit or action pursuant to Section 5.02 of the
License Agreement and shall be entitled to retain and keep any and all sums
received, obtained, collected or recovered whether by judgment, settlement or
otherwise, as a result of such suit. ▇▇▇▇▇▇▇ shall have the right to prosecute
by counsel of his choice, and in connection therewith shall have the full right
to conduct the prosecution thereof.
VI. CONFIDENTIALITY AND OTHER OBLIGATIONS
6.01 Confidentiality. (a) Each party agrees that, without the prior
written consent of the other party or unless required by law, it shall not
disclose to any third party the terms of this Agreement or any confidential
information regarding the other party or the business of such party which has
been made available to it pursuant to Article III or Article IV hereof. It is
understood that LICENSEE and LICENSOR, without the consent of the other party,
may disclose in press releases or to third parties the existence and general
nature of this Agreement without disclosing the specific terms hereof.
(b) It is further understood that LICENSOR shall not be entitled to
disclose to any third party or to publish for any purpose (scholarly,
educational or otherwise) any Agreement Compound Study or any portion, extract
or analysis (partial or full) thereof without the prior written consent of
LICENSEE. It is understood that such restriction is a worldwide restriction.
If any third party has an obligation to present a document relating to
Agreement Compound to LICENSOR prior to its publication for LICENSOR's comment
and approval, LICENSOR shall give LICENSEE access to such document and assist,
in all respects requested, LICENSEE in communicating to such third party its
comments or concerns relating to the publication of any such document. LICENSEE
may instruct LICENSOR to withhold its approval in the event that, in LICENSEE's
reasonable opinion, its commercial position regarding Product may be prejudiced
by such publication.
(c) LICENSOR shall take all reasonable measures to restrain ▇▇▇▇▇▇▇,
his employees, agents and advisors and former employees, agents and advisors
from publishing or disclosing to any third party the Agreement Compound Studies
or any portion, extract or analysis (partial or full) thereof.
(d) LICENSOR shall refrain from making untrue statements regarding
Agreement Compound or Licensed Patents.
(e) Notwithstanding any other provision of this Section 6.01, LICENSEE
or LICENSOR shall be permitted to respond to any lawful court or other tribunal
demand (including subpoenas, interrogatories, or document requests) seeking
information or documents relating to the validity of the Licensed Patents.
6.02 Agreement Compound Studies. In addition to the provisions of
Section 6.01(b), LICENSOR shall take all reasonable measures to prevent ▇▇▇▇▇▇▇
from selling or conveying the Agreement Compound Studies to any third party or
allowing the Agreement Compound Studies to be used by any third party for
purposes of gaining approval for any Person other than LICENSEE from any
governmental body to market Agreement Compound or Product. LICENSEE shall not
sell or convey its equivalent of the Agreement Compound Studies (the "Licensee
Studies") to any third party nor allow the Licensee Studies to be used by any
third party for purposes of gaining approval for any
9
102
such third party from any governmental body to market Licensed Compound or
Product unless the sales by such third party are included in the calculation of
Net Sales.
6.03 Non-Competition. (a) During the term of this Agreement, LICENSOR
shall not assist and shall use all reasonable measure to prevent ▇▇▇▇▇▇▇ from
assisting (other than PharmaScience with respect to Canada only) any third
party to develop, register, promote or market Agreement Compound or Product.
(b) During the term of this Agreement, LICENSEE shall not assist any
third party to develop, register, promote or market Licensed Compound or
Product where the sale or use of Product or Licensed Compound is covered by a
Licensed Patent; provided, however, that LICENSEE is permitted to assist a
third party if the sales of such third party, if any, are included in the
calculation of Net Sales.
(c) Notwithstanding any other term or provision of this Agreement, the
payment of royalties shall terminate in its entirety in the event that LICENSOR
breaches the obligations of Section 6.03(a) or ▇▇▇▇▇▇▇ breaches the obligations
of Section 6.03(a) of the License Agreement.
6.04 Activities of LICENSEE. It is understood that LICENSEE regularly
has discussions with other Persons with respect to licensing and related
activities with respect to pharmaceutical products, including those in the
field of cognition, as a result of which LICENSEE may, during the term of this
Agreement, market products (not containing Licensed Compound) that will compete
with Product. In the event that during the term of this Agreement LICENSEE
commences the sale or promotion in the United States of a product (other than
Product) for the treatment of Alzheimer's Disease and at the time of such
commencement the payment of royalties due under this Agreement for Net Sales in
the United States has not been reduced by more than twenty-five percent (25%)
or terminated pursuant to Section 3.09 hereof or otherwise, LICENSEE will pay
to LICENSOR's Designee a one-time payment of one million dollars
($1,000,000.00). This payment is in full and complete compensation for any loss
of royalties to LICENSOR's Designee that might be caused by LICENSEE's sale of
competing product(s) inside or outside the United States. Payment of the amount
due under this Section 6.04 shall not relieve LICENSEE of the obligations to
pay royalties on this sale of Product pursuant to the terms of this Agreement.
Notwithstanding the foregoing, if LICENSOR incurs the obligation under the
terms of Section 6.04 of the License Agreement to make payment to ▇▇▇▇▇▇▇,
LICENSEE shall not be obligated to make any payment pursuant to this Section
6.04, as it is a one-time payment.
VII. REPRESENTATIONS AND WARRANTIES
7.01 Representations and Warranties of LICENSOR. LICENSOR hereby
represents and warrants the following:
(a) LICENSOR is the valid licensee of the Licensed Patents pursuant to
the terms of the License Agreement.
(b) LICENSOR has the right to enter into this Agreement and grant the
sublicense under the Licensed Patents pursuant to this Agreement. LICENSOR is
not a party to any other agreement or under any obligation to any third party
that would prevent LICENSOR from entering into this Agreement.
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103
(c) To LICENSOR's knowledge, as of the date hereof, the Licensed
Patents are composed of the patents listed on Exhibit A.
(d) To LICENSOR's knowledge, except as set forth in Exhibit B hereof,
there are no patents owned by others and there are no trade secret or
proprietary rights of others which would be infringed or violated by the
making, using or selling of Agreement Compound or Products by LICENSEE anywhere
in the world.
(e) As of the date of this Agreement, there are no adverse
actions, suits or claims pending against LICENSOR, or to LICENSOR's knowledge,
against ▇▇▇▇▇▇▇ in any court or by or before any governmental body or agency
with respect to Licensed Patents or Agreement Compound and to the best of
LICENSOR's knowledge, no such actions, suits or claims have been threatened
against LICENSOR.
(f) No other Person or organization presently has any effective option
or license with respect to the manufacture, use or sale of Agreement Compound
or Products anywhere in the world, or is presently authorized to use the
Agreement Compound Studies anywhere in the world.
(g) LICENSOR makes no warranties other than as expressly stated
herein.
VIII. TERM OF AGREEMENT
8.01 Term. Unless sooner terminated as provided herein, this Agreement
shall commence as of the date first above written and shall continue until the
expiration of the last-to-expire Licensed Patent.
8.02 Termination. This Agreement may be terminated by either party
upon breach of this Agreement by the other party on sixty (60) days' prior
written notice to the breaching party, the notice to become effective at the
end of the-sixty (60) day period unless the breach is sooner cured by the
breaching party. The parties hereto agree that neither the reduction in
royalties pursuant to Section 3.09 nor the sales by a third party in a country
where there is a Licensed Patent shall constitute a breach of this Agreement by
which either party may terminate this Agreement.
8.03 Continuing Rights. Termination of this Agreement for any reason
shall be without prejudice to:
(a) LICENSOR's right to receive all royalties accrued and unpaid and
then due to be paid to LICENSOR's Designee by LICENSEE pursuant to the terms of
this Agreement on the effective date of such termination;
(b) the rights and obligations provided in Section 4.02 and Section
8.02 hereof; and
(c) any other remedies which either party may then or thereafter have
hereunder or otherwise.
[****]-CONFIDENTIAL TREATMENT REQUESTED
11
104
8.04 Waiver. Failure to terminate this Agreement following breach or
failure to comply with this Agreement shall not be deemed a waiver of the
non-breaching party's defenses, rights or causes of action arising from such or
any future breach or noncompliance.
IX. MISCELLANEOUS
9.01 Force Majeure. If for reasons of Force Majeure, as hereinafter
defined, either party fails to comply with its obligations hereunder, such
failure shall not constitute breach of contract. For the purpose of this
Article, Force Majeure shall mean acts of God; acts, regulations or laws of any
government; wars; civil commotion; destruction of production facilities or
materials; fire; earthquake or storm; labor disturbances; failure of public
utilities or common carriers and any other causes (not resulting from an action
of or failure to act by either party) beyond the reasonable control of either
party.
9.02 Assignment. LICENSEE may assign this Agreement in whole or in
part to any Affiliate or Affiliates who shall be substituted directly in whole
or in part for it hereunder, provided, however, that LICENSEE shall guarantee
the performance of its Affiliate assignee hereunder. This Agreement shall not
otherwise be assignable by either party without the prior written consent of
the other party, except to the successor or assignee of all or substantially
all of its business related to Licensed Products and provided that LICENSOR's
Designee shall be permitted to assign his right to receive monies under this
Agreement.
9.03 Indemnification.
(a) Indemnification by LICENSOR. LICENSOR shall indemnify and hold
LICENSEE and its agents, directors, officers and employees and representatives
harmless from and against any and all Losses which they may at any time incur
by reason of any action or proceeding brought by any third party against
LICENSEE arising out of or resulting from any misrepresentation, breach of
warranty or non-fulfillment of or failure to perform any agreement or covenant
made by LICENSOR in this Agreement, where the Loss is not one for which LICENSOR
is indemnified by LICENSEE pursuant to Section 9.03(b).
(b) Indemnification by LICENSOR. LICENSEE shall indemnify and hold
LICENSOR and its agents, directors, officers and employees and representatives
harmless from and against any and all Losses which they may at any time incur
by reason of any action or proceeding brought by any third party including, but
not limited to, LICENSOR's Designee, against LICENSOR arising out of or
resulting from any misrepresentation, breach of warranty or non-fulfillment of
or failure to perform any agreement or covenant made by LICENSEE in this
Agreement.
(c) Survival. The obligation of the parties in this Section 9.03 shall
survive the expiration or earlier termination of this Agreement to the extent
permitted by applicable Law.
9.04 Expenses. Whether or not the transactions contemplated hereby are
consummated, all costs, expenses and disbursements incurred in connection with
this Agreement and the transactions contemplated hereby shall be paid by the
party hereto incurring such costs and expenses.
9.05 Notices. Any notice or report required or permitted to be given
or made under this Agreement by one of the parties hereto to the other shall be
in writing and sent to the other party at its
12
105
address indicated below or to such other address as the addressee shall have
theretofore furnished in writing to the addressor:
If to LICENSEE:
First Horizon Pharmaceutical Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Chief Financial Officer
With a copy to: Legal Counsel
If to LICENSOR:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President, Pharmaceutical Sector
with a copy to: Vice President and General Counsel
If to Designee:
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇, M.D.
▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
If to Burns, Doane, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ LLP:
Burns, Doane, ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇ LLP
▇▇▇▇▇ ▇▇▇
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
9.07 Governing Law. This Agreement shall be construed and the
respective rights of the parties hereto determined according to the substantive
law of New Jersey, United States of America other than those provisions
governing conflict of laws. Each party hereto hereby irrevocably submits to the
jurisdiction of any court in the State of New Jersey.
9.08 Entire Agreement. The terms and provisions contained in this
Agreement constitute the entire Agreement between the parties and shall
supersede all previous communications, representations, agreements or
understandings, either oral or written, between the parties hereto with respect
to the subject matter hereof, and no agreement or understanding varying or
extending this Agreement shall be binding upon either party hereto, unless in
writing which specifically refers to this Agreement, signed by duly authorized
officers or representatives of the respective parties and the provisions of
this Agreement not specifically amended thereby shall remain in full force and
effect.
13
106
9.09 Non-Waiver. Any waiver must be explicitly in writing. The waiver
by either of the parties to this Agreement of any breach of any provision
hereof by the other party shall not be construed to be a waiver of any
succeeding breach of such provision or a waiver of the provision itself.
9.10 Severability. If and to the extent that any court or tribunal of
competent Jurisdiction holds any of the terms, provisions or conditions or
parts thereof of this Agreement, or the application hereof to any
circumstances, to be invalid or to be unenforceable in a final nonappealable
order, the remainder of this Agreement and the application of such term,
provision or condition or party thereof to circumstances other than those as to
which it is held invalid or unenforceable shall not be affected thereby, and
each of the other terms, provisions and conditions of this Agreement shall be
valid and enforceable to the fullest extent of the law.
9.11 Agency. The relationship of the parties under this Agreement is
that of independent contractors. Neither party shall be deemed to be the agent
of the other, and neither is authorized to take any action binding upon the
other.
9.12 Counterparts and Headings. This Agreement may be executed in
counterparts, each of which shall be deemed to be an original and both together
shall be deemed to be one and the same Agreement. All headings in this
Agreement are inserted for convenience of reference only and shall not affect
its meaning or interpretation.
IN WITNESS WHEREOF, LICENSOR and LICENSEE have executed this Agreement in
duplicate as of the day and year first above written.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY
----------------------------
Name:
Title:
FIRST HORIZON PHARMACEUTICAL CORPORATION
-----------------------------
Name:
Title:
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107
EXHIBIT A
4370 USA P 01 G
APP#: 098871
DATE:24SE1987
▇▇▇#: 4816456
DATE:28MR1989
EXP.DT:09SE2007
ABSTRACT:
A METHOD FOR TREATING CENTRAL NERVOUS SYSTEM OR PERIPHERAL
NERVOUS SYSTEM CHOLOINERGIC DEFICIT STATES SUCH AS ALZHEIMER'S
DISEASE IN A MAMMAL, SAID METHOD COMPRISING ADMINISTERING
TO SAID MAMMAL AN AMOUNT OF A MONOAMINE ACRIDINE DERIVATIVE
EFFECTIVE IN THE TREATMENT OF A CHOLINERGIC DEFICIT STATE AND
FOR A TIME SUFFICIENT TO ACHIEVE A SUITABLE BLOOD LEVEL TO TREAT
SAID CHOLINERGIC DEFICIT STATE. THE PREFERRED MONOAMINE ACRIDINE
DERIVATIVE IS 1,2,3,4-TETRAHYDRO-5-AMINO ACRIDINE A UNIT DOSAGE
PHARMACEUTICAL COMPOSITION OF MATTER COMPRISING AN EFFECTIVE
AMOUNT OF SAID MONOAMINE ACRIDINE DERIVATIVE SUFFICIENT TO TREAT
SAID CHOLINERGIC DEFICIT STATE AND A PHARMACEUTICALLY ACCEPTABLE
INERT CARRIER THEREFOR IS ALSO DISCLOSED. CIP OF U.S. SERIAL NO.
914,076 FILED 01OC1986. NO PRIORITY
4370 ASTL G
APP#: 80707/87
DATE:28SE1987
▇▇▇#: 621035
DATE:03MR1993
EXP.DT:28SE2007
4370 ASTL D 02 F
APP#: 78886/94
DATE:17NO1994
▇▇▇#:
DATE:
EXP.DT:
4370 ATRA E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:26OC2014
4370 ATRA X G
APP#: E106245
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
15
108
4370 ATRA J X G
APP#: SZ9/96
DATE:23MY1996
▇▇▇#: SZ9/96
DATE:23FE1998
EXP.DT:05MY2009
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
▇▇▇▇ ▇▇▇▇ X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 BELG J X F
APP#: 96C0021
DATE:05JE1996
▇▇▇#:
DATE:
EXP.DT:
4370 DENM P F
APP#: 2958/88
DATE:28SE1987
▇▇▇#:
DATE:
EXP.DT:
4370 EPC E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 EPC X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 ▇▇▇▇ X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
16
109
4370 GBRI X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 GERM E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 GERM X G
APP#: EP0328535
DATE:28SE1987
▇▇▇#: P3789967.2
DATE:01JE1995
EXP.DT:28SE2007
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 ITAL X G
APP#: 4919/BE94
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 LUXE E F
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 LUXE X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 MEXI F
APP#: 923762
DATE:29JE1992
▇▇▇#:
DATE:
EXP.DT:
17
110
4370 ▇▇▇▇ ▇ ▇
APP#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
▇▇▇▇ ▇▇▇▇ X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
▇▇▇▇ ▇▇▇▇ ▇ ▇
▇▇▇#: 931177982.4
DATE:26OC1994
▇▇▇#:
DATE:
EXP.DT:
4370 SWIT X G
APP#: 87906711.4
DATE:28SE1987
▇▇▇#: EP0328535
DATE:01JE1995
EXP.DT:28SE2007
4370 ▇▇▇▇ ▇ ▇
APP#: 52934
DATE:16JE1995
▇▇▇#: C0328535/01
DATE:30AP1996
EXP.DT:16JE2010
In addition, there are corresponding patents in Canada, Japan and Brazil which
are in the process of being abandoned. It may be possible to revive these
patents if Horizon so desires.
18
111
EXHIBIT B
Settlement and License Agreement dated as of September 28, 1994 between
▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ Pharmaceuticals Inc. and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company (Shutske patent)
Agreement dated September 8, 1987 between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company and Mount Sinai
School of Medicine
19
112
EXHIBIT 7.1.10
TRANSITION SERVICES AGREEMENT
TRANSITION SERVICES AGREEMENT, dated May ___, 2000, between FIRST
HORIZON PHARMACEUTICAL CORPORATION, a corporation organized and existing under
the laws of Delaware, whose principal office is located at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Horizon"), and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY, a
corporation organized and existing under the laws of Delaware, whose principal
office is located at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
("▇▇▇▇▇▇-▇▇▇▇▇▇▇"). All capitalized terms not otherwise defined herein shall
have the meanings ascribed to them in the Asset Purchase Agreement, dated as of
April 14, 2000 (the "Purchase Agreement"), by and between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and
Horizon.
WITNESSETH:
WHEREAS, pursuant to the Purchase Agreement, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ has agreed
to sell and Horizon has agreed to purchase the Assets;
WHEREAS, it is a condition to the consummation of the transactions
contemplated by the Purchase Agreement that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon enter
into this Agreement;
WHEREAS, the parties wish to facilitate an orderly transfer of the
Cognex business to Horizon; and
WHEREAS, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and certain of its Affiliates (the "Service
Providers") are willing to provide certain transitional administrative services
to Horizon upon the terms and conditions set forth below;
NOW THEREFORE, in consideration of the mutual covenants and agreements
set forth in this Agreement, the parties hereto agree as follows:
Article 1. Definitions. As used in this Agreement, the following terms will
have the meanings set forth below:
"Business" means the Cognex business in the European countries in the
Territory.
"Business Data" means all files, documents, books and records relating
to the Business in the possession or under the control of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or
certain of its Affiliates in connection with the Services.
"Incremental Services" will have the meaning set forth in Section 5.2.
"Invoice" will have the meaning set forth in Section 5.3.
"Service Providers" will have the meaning set forth in the forepart of
this Agreement.
"Services" will have the meaning set forth in Section 2.1.
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Article 2. Services.
2.1 Services to be Made Available. In accordance with the terms
and provisions of this Agreement, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ agrees to provide or cause to
be provided to Horizon the transitional services relating to the Business that
are described on Schedule A hereto (collectively, the "Services") for the term
of this Agreement. Except as may be agreed by ▇▇▇▇▇▇-▇▇▇▇▇▇▇, provision of each
such Service will be limited to substantially the same number and quality of
employees as are currently involved in the conduct of the Business.
2.2 Controlling Provisions. In ordering and delivering Services
and Incremental Services hereunder, ▇▇▇▇▇▇-▇▇▇▇▇▇▇, the Service Providers and
Horizon may employ their standard forms, but nothing in those forms will be
construed to modify or amend the terms of this Agreement and in case of conflict
herewith, this Agreement will control.
2.3 Cash Management. In the event that provision of any of the
Services requires ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or any Service Provider to receive cash or
other moneys on behalf of Horizon, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will utilize or cause to be
utilized commercially reasonable efforts to assure that such cash or other
moneys are promptly credited to one or more accounts designated by Horizon.
Horizon agrees that payments to Horizon may be made in local currency and that
if Horizon elects to receive payment in any currency other than the currency of
payment, Horizon bears all currency exchange costs and risk related thereto.
Article 3. Title to Equipment and Media.
3.1 Property of ▇▇▇▇▇▇-▇▇▇▇▇▇▇. Unless furnished to ▇▇▇▇▇▇-▇▇▇▇▇▇▇
or any Service Provider by Horizon, all equipment used in connection with
providing the Services and all media upon which information of Horizon is stored
in connection with the Services is and will remain the property of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ or the relevant Service Provider.
Article 4. Intentionally Omitted.
Article 5. Billing.
5.1 Fees. Services relating to the maintenance of the Business in
the ordinary course will be provided to Horizon for the term of this Agreement,
free of charge.
5.2 Incremental Services and Out-of-Pocket Expenses. (a) Horizon
will be charged, per hour, the amount shown in Schedule A for the Incremental
Services referred to therein, plus applicable value added taxes; provided,
however, Horizon will not be charged for Incremental Services to the extent such
Incremental Services are required solely as a result of a breach of this
Agreement by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or the Service Providers. As used herein,
"Incremental Services" means Services that would not, in the ordinary course of
business, be required to operate the Business, including, but not limited to
responding to investigations by Governmental or Regulatory Authorities regarding
the Product. Horizon will have the option of terminating an Incremental Service
and its corresponding fees, as set forth in Schedule A hereto, upon seven (7)
days' written notice to ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
(b) Horizon will be charged for all of ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇
and the Service Providers' unrelated third-party out-of-pocket expenses,
reasonably incurred in connection with providing the Services and Incremental
Services; provided, however, Horizon will not be charged for any such unrelated
third-party out-of-pocket
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expenses to the extent such unrelated third-party out-of-pocket expenses
resulted solely from a breach of this Agreement by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or the Service
Providers. Before incurring any single such expense in excess of the local
equivalent of U.S.$5,000, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will notify Horizon or cause Horizon to
be notified. Horizon promptly will approve or reject such expense. If Horizon
rejects such expense, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will be released from all obligations to
provide any Services or Incremental Services reasonably dependent upon the
activities related to such expense.
5.3 Payment. Unless otherwise agreed, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will
issue or cause to be issued a monthly invoice (the "Invoice(s)") for the fees
relating to Incremental Services rendered pursuant to this Agreement and for
reimbursement of any third party, out-of-pocket expense incurred in connection
with providing the Services or Incremental Services (which invoice will include
copies of all third party invoices that exceed the local equivalent of
U.S.$5,000) and Horizon will pay or cause to be paid such Invoice to an account
designated by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ in immediately available funds within thirty (30)
days from the date of invoice. Unless Horizon specifically objects in writing,
▇▇▇▇▇▇-▇▇▇▇▇▇▇ will be entitled to cause any Invoice that is unpaid within such
thirty (30) day period to be paid from funds of any Horizon account that
▇▇▇▇▇▇-▇▇▇▇▇▇▇ may manage on Horizon's behalf hereunder. Horizon acknowledges
that the out-of-pocket expenses will be incurred in local currency, and the
terms of reimbursement thereof in any alternative currency shall be subject to
the agreement of ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
Article 6. Indemnification.
6.1 Indemnification by Horizon. Horizon will indemnify and hold
▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its respective Affiliates, agents, directors, officers,
employees and representatives harmless from and against any and all Losses which
they may at any time incur by reason of any Action brought by any Governmental
Authority or other third party arising out of or resulting from (a) any
misrepresentation, breach of warranty or non-fulfillment of or failure to
perform any agreement or covenant made by Horizon in this Agreement, (b) any
negligent act or omission of Horizon or any of its Affiliates and (c) provision
of the Services or Incremental Services, provided that in providing the Services
or Incremental Services ▇▇▇▇▇▇-▇▇▇▇▇▇▇ employs at least the same level of care
as it currently employs in providing similar services for its own businesses.
6.2 Indemnification by ▇▇▇▇▇▇-▇▇▇▇▇▇▇. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will
indemnify and hold Horizon and its respective Affiliates, agents, directors,
officers, employees and representatives harmless from and against any and all
Losses which they may at any time incur by reason of any Action brought by any
Governmental Authority or other third party arising out of or resulting from any
misrepresentation, breach of warranty or non-fulfillment of or failure to
perform any agreement or covenant made by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ in this Agreement;
provided, however, that with respect to the provision of Services or Incremental
Services, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will be liable only to the extent of its failure to
employ at least the same level of care as it employs in providing similar
services for its own businesses or the gross negligence or willful misconduct of
▇▇▇▇▇▇-▇▇▇▇▇▇▇.
6.3 Indemnification Procedures. Indemnification under Section 6.1
or Section 6.2 will be conditioned on compliance with the procedure outlined
below. Provided that prompt notice is given of any claim or suit for which
indemnification might be claimed, the indemnifying party promptly will defend,
contest or otherwise protect against any such claim or suit (including by way of
settlement and release) at its own cost and expense. The indemnified party may,
but will not be obligated to, participate at its own expense in a defense
thereof by counsel of its own choosing, but the indemnifying party will be
entitled to control the defense unless the indemnified party has relieved the
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indemnifying party from liability with respect to the particular matter. If the
indemnifying party fails timely to defend, contest or otherwise protect against
any such claim or suit, the indemnified party may, but will not be obligated to,
defend, contest or otherwise protect against the same, and make any compromise
or settlement thereof and recover the entire costs thereof from the indemnifying
party, including reasonable attorneys fees, disbursements and all amounts paid
as a result of such claim or suit or the compromise or settlement thereof;
provided, however, that if the indemnifying party undertakes the timely defense
of such matter, the indemnified party will not be entitled to recover from the
indemnifying party its costs incurred in the defense thereof. The indemnified
party will cooperate and provide such assistance as the indemnifying party may
reasonably request in connection with the defense of the matter subject to
indemnification.
6.4 Disclaimer. Except as expressly provided herein, the Services
and Incremental Services are provided "as is" and without any express or implied
warranties, including the warranties of merchantability and fitness for a
particular purpose.
6.5 Certain Losses. Under no conditions will ▇▇▇▇▇▇-▇▇▇▇▇▇▇ be
liable for any special, incidental or consequential damages (including, without
limitation, loss of business, profits or good will) in connection with its
performance under this Agreement.
6.6 Survival. The provisions of this Article 6 will survive the
expiration or earlier termination of this Agreement for so long as an
indemnified party hereunder may have liability under applicable Law.
Article 7. Term; Termination.
7.1 Term. This Agreement will expire on November 30, 2000, or
earlier upon termination of all Services and Incremental Services pursuant to
Section 7.2.
7.2 Termination. (a) In the event that either party materially
fails to perform any of its duties or obligations pursuant to this Agreement and
such failure is not cured within thirty (30) days after notice to such party
specifying the nature of such material failure, the other party may terminate
this Agreement upon further notice to the defaulting party.
(b) Horizon may terminate this Agreement upon thirty (30)
days' prior written notice to ▇▇▇▇▇▇-▇▇▇▇▇▇▇. Horizon will be relieved of any
obligation to pay for terminated Services and Incremental Services from and
after the effective date of such termination; provided, however, that Horizon
will continue to pay for any noncancellable commitments reasonably made by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ in anticipation of providing the Services as required herein.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ agrees to use its commercially reasonable efforts to provide
Horizon with a list of any such noncancellable commitments at least seven (7)
days prior to the termination of the Agreement by Horizon.
(c) Either party may, in its discretion and without
prejudice to its other rights and remedies at law, terminate this Agreement
immediately in the event that the other party becomes insolvent, has a receiver,
examiner or liquidator appointed over the whole or any part of its assets, has
an order made or resolution passed for it to be wound up or enters into any
arrangement or composition with its creditors.
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(d) ▇▇▇▇▇▇-▇▇▇▇▇▇▇ may terminate this Agreement if any
entity or person (other than Horizon or any of its Affiliates) acquires
ownership or control of 50% or more of Horizon's voting capital stock or
substantially all of its assets.
7.3 Effect of Termination. (a) Expiration or termination of this
Agreement for any reason, will not release either party from any liability which
at said time it has already incurred to the other party, nor affect in any way
the survival of any rights, duties or obligations of either party that are
expressly stated elsewhere in this Agreement to survive said expiration or prior
termination. Nothing in the immediately preceding sentence will affect the right
of the party aggrieved by any breach of this Agreement to be compensated for any
injury or damage resulting therefrom that is incurred before or after such
expiration or termination.
(b) Upon expiration or termination of this Agreement, all
fees owed by Horizon to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ for Services and Incremental Services
provided through the date of such expiration or termination will be paid within
thirty (30) days of the date of such expiration or termination.
(c) Promptly after the expiration or earlier termination
of this Agreement, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ will deliver or make available to Horizon all
of the Business Data, and if at any time after the termination of this Agreement
▇▇▇▇▇▇-▇▇▇▇▇▇▇ discovers in its possession or under its control any other
Business Data, it will forthwith deliver such Business Data to Horizon.
Notwithstanding the foregoing, to the extent any of the Business Data are items
susceptible to duplication and are either (x) used in connection with any of
▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ businesses other than the Business or (y) are required by Law
to be retained by ▇▇▇▇▇▇-▇▇▇▇▇▇▇, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ may deliver photostatic copies
or other reproductions from which, in the case of Business Data referred to in
clause (x).
Article 8. Miscellaneous.
8.1 Further Assurances. Subject to the provisions hereof, each of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon will execute and deliver such other agreements,
documents or instruments and take or cause to be taken such other actions as may
be reasonably required in order to effect the purposes of this Agreement and to
consummate the transactions contemplated hereby. Subject to the provisions
hereof, each of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon will, in connection with entering
into this Agreement, performing its obligations hereunder and taking any and all
actions relating hereto, comply with all applicable Laws, obtain all required
consents and approvals and make all required filings with any Governmental
Authority and promptly provide the other with all such information as the other
party may reasonably request in order to be able to comply with the provisions
of this sentence.
8.2 Notices. All demands, notices, requests and other
communications hereunder must be in writing and will be deemed to have been duly
given only if delivered personally or by facsimile transmission or by mail
(first class, postage prepaid) to the parties at the following addresses or
facsimile numbers:
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if to ▇▇▇▇▇▇-▇▇▇▇▇▇▇, addressed to:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attention: President, Pharmaceutical Sector
Fax No: (▇▇▇) ▇▇▇-▇▇▇▇
if to HORIZON, addressed to:
First Horizon Pharmaceutical Corporation
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Chief Financial Officer
Fax No: (▇▇▇) ▇▇▇-▇▇▇▇
a copy of all notices and communications hereunder having the effect of
amending, supplementing, modifying or assigning this Agreement shall be
provided to:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Senior Vice President and General Counsel
Facsimile No. (▇▇▇) ▇▇▇-▇▇▇▇
or to such other address as a party hereto shall specify to the other party
hereto in writing.
8.3 Confidentiality. All confidential information of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ disclosed to Horizon or any of its Affiliates in connection
herewith and all confidential information of Horizon and its Affiliates
disclosed to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Service Providers in connection herewith will
be held in confidence and will not be disclosed by the other party to any third
party or used outside the scope of this Agreement, except that Horizon or
▇▇▇▇▇▇-▇▇▇▇▇▇▇, as the case may be, may disclose such information to its
Affiliates or its employees who are under a similar obligation of secrecy in
furtherance of the purposes of this Agreement; provided, however, that the
aforesaid obligation of confidentiality assumed by Horizon and its Affiliates
and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its Service Providers hereunder will not apply to any
confidential information (collectively referred to as "Information" for purposes
of this Section 8.3) which (i) was or becomes available to Horizon or
▇▇▇▇▇▇-▇▇▇▇▇▇▇, as the case may be, on a non-confidential basis from a source
that is not under an obligation (whether contractual, legal or fiduciary) to the
other party to keep such information or data confidential, (ii) was previously
known to the Receiving Party (defined below), as established by competent
evidence or (iii) was or becomes a part of the public domain through no fault of
the Disclosing Party (defined below). If the party receiving Information of the
other party (the "Receiving Party") is requested in any judicial or
administrative proceeding or by any Governmental Authority to disclose any
Information of the other party (the "Disclosing Party"), the Receiving Party
will give the Disclosing Party prompt notice of such request so that the
Disclosing Party may seek an appropriate protective order. The Receiving Party
will cooperate fully with the Disclosing Party in obtaining such an order. If in
the absence of a protective order the Receiving Party is nonetheless compelled
to disclose Information of the Disclosing Party, the Receiving Party may make
such disclosure without liability hereunder, provided that the Receiving Party
gives the Disclosing Party written notice of the Information to be disclosed as
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far in advance of its disclosure as is practical and, upon the Disclosing
Party's request and at its expense, the Receiving Party will use reasonable
efforts to obtain reasonable assurances that confidential treatment will be
accorded to such Information. The obligations of confidentiality in this Section
8.3 will survive the expiration or earlier termination of this Agreement until
the confidential information disclosed hereunder is no longer "Information" as
defined herein.
8.4 Third Party Beneficiaries. Each party intends that this
Agreement will not benefit or create any right or cause of action in or on
behalf of any Person other than ▇▇▇▇▇▇-▇▇▇▇▇▇▇, the Service Providers and
Horizon.
8.5 Entire Agreement. This Agreement, including all Schedules
hereto (which Schedules are hereby incorporated into and made a part of this
Agreement), constitutes the entire agreement between the parties and supersedes
all previous communications, representations, agreements or understandings,
either oral or written, between the parties with respect to the subject matter
hereof and this Agreement may be amended, supplemented or modified only by a
written instrument duly executed by or on behalf of each party hereto.
8.6 Authority. Horizon hereby authorizes ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and its
Affiliates and subcontractors to do all such things in the name or for the
account of Horizon as may be necessary or desirable for, or incidental to, the
performance of any of the Services in the ordinary course of business, including
the execution and delivery of any document.
8.7 Contractual Relationship. Nothing contained in this Agreement
will be deemed to create any joint venture, partnership or principal-agent
relationship between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon or any of their respective
Affiliates and neither of the parties will hold itself out in any manner which
would indicate any such relationship with the other.
8.8 Assignment. This Agreement may not be assigned by either party
without the prior written consent of the other party. This Agreement will be
binding upon and, subject to the terms of the foregoing sentence, inure to the
benefit of the parties hereto, their respective successors, legal
representatives and assigns.
8.9 Waiver. Any term or condition of this Agreement may be waived
at any time by the party that is entitled to the benefit thereof, but no such
waiver will be effective unless set forth in a written instrument duly executed
by or on behalf of the party waiving such term or condition. No waiver by any
party of any term or condition of this Agreement, in any one or more instances,
will be deemed to be or construed as a waiver of the same or any other term or
condition of this Agreement on any future occasion. All remedies, either under
this Agreement or by law or otherwise afforded, will be cumulative and not
alternative.
8.10 Headings. The headings used in this Agreement have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.
8.11 Invalid Provisions. If any provision of this Agreement is held
to be illegal, invalid or unenforceable under any applicable present or future
law, and if the rights or obligations of any party hereto under this Agreement
will not be affected materially and adversely thereby, (a) such provision will
be fully severable, (b) this Agreement will be construed and enforced as if such
illegal, invalid or
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unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement will remain in full force and effect and will not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom and (d) in lieu of such illegal, invalid or unenforceable
provision, there will be added as a part of this Agreement by mutual agreement
of the parties, a legal, valid and enforceable provision as similar in terms to
such illegal, invalid or unenforceable provision as may be possible.
8.12 Force Majeure. Except in the case of monetary obligations
hereunder, the occurrence of an event which materially interferes with the
ability of a party to perform its obligations or duties hereunder that is not
within the reasonable control of the party affected, not due to malfeasance and
that could not with the exercise of due diligence have been avoided ("Force
Majeure"), including, but not limited to, fire, accident, labor difficulty,
strike, riot, civil commotion, act of nature, delay or errors by shipping
companies or change in Law will not excuse such party from the performance of
its obligations or duties under this Agreement, but will merely suspend such
performance during the continuation of Force Majeure. The party prevented from
performing its obligations or duties because of Force Majeure will promptly
notify the other party hereto (the "Other Party") of the occurrence and
particulars of such Force Majeure and will provide the Other Party, from time to
time, with its best estimate of the duration of such Force Majeure and with
notice of the termination thereof. The party so affected will use its best
efforts to avoid or remove such causes of nonperformance. Upon termination of
Force Majeure, the performance of any suspended obligation or duty will promptly
recommence. Except as otherwise specifically provided herein, neither party will
be liable to the other party for any direct, indirect, consequential,
incidental, special, punitive or exemplary damages arising out of or relating to
the suspension or termination of any of its obligations or duties under this
Agreement by reason of the occurrence of Force Majeure. In the event that Force
Majeure has occurred and is continuing for a period of at least 2 months, the
Other Party will have the right to terminate this Agreement upon 30 days notice.
8.13 Governing Law. This Agreement and the rights and obligations
of the parties hereunder will be governed by, and construed and interpreted in
accordance with, the laws of New York applicable to a contract executed and
performed in such state.
8.14 Counterparts. This Agreement may be executed in counterparts,
each of which will be deemed an original, but both of which together will
constitute one and the same instrument.
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IN WITNESS WHEREOF, this Agreement has been duly executed and delivered
by the duly authorized officer of each party, as of the date first above
written.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY
By:
---------------------------------------
Name:
-------------------------------
Title:
-------------------------------
FIRST HORIZON PHARMACEUTICAL CORPORATION
By:
---------------------------------------
Name:
-------------------------------
Title:
-------------------------------
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Schedule A
[****]-CONFIDENTIAL TREATMENT REQUESTED
SERVICES
1. Services :
Services
Regulatory Services :
Maintenance of Registrations, including processing of payments for renewal and
annual fees
Contact with Governmental and Regulatory Authorities with respect to the
Product, including reporting of adverse events
Responding to customer complaints or physician inquiries
Providing a Qualified Person for the release of the Product in the European
countries in the Territory
Preparation and filing of Product Periodic Safety Update Report
Sales administration: Sales orders, shipping management, billing, processing of
returns (including providing Horizon with monthly reports of returns in the
Primary Countries) and collection services
Storage of Product (to the extent ordinarily stored in facilities of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Affiliates)
Assistance with transferring the foregoing functions to Horizon or its designee
2. Incremental Services
Services Hourly Fee*
------------------------------------------------------------------------------------------------------------
Regulatory Services: $ [*****]
Investigation of
- any request or suggestions that the Product needs to be recalled or
withdrawn**
- any request or suggestion that calls into question the quality** or safety of
the Product
122
-adverse events
Quality investigations of customer complaints including but not limited to
complaints alleging suspected or actual product tampering, contamination** or
mislabeling***
Any communications with physicians in relation to the Product.
Any periodic testing of Product as requested by Governmental or Regulatory
Authorities
Responding to an investigation or inquiry of any Governmental or Regulatory
Authority concerning the Product, including but not limited to further
investigation or inquiry regarding the mouse carcinogenicity study.
Management of Product recalls**
*Plus applicable value added taxes
** Horizon shall not bear the cost of such service where the recall is for a
failure of Products manufactured by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to meet Specifications, where
such failure is due solely to the actions or omissions of ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
***Horizon shall not bear the cost of such service where the investigation is
for a failure of Products manufactured by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to meet Specifications,
where such failure is due solely to the actions or omissions of ▇▇▇▇▇▇-▇▇▇▇▇▇▇
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EXHIBIT 7.1.10
LICENSE AGREEMENT (ASSIGNMENT AND ASSUMPTION)
ASSIGNMENT AND ASSUMPTION AGREEMENT, dated May __, 2000, by and between
First Horizon Pharmaceutical Corporation, a company incorporated under the laws
of Delaware and having its principal place of business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇,
▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Horizon") and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company, a
company incorporated under the laws of Delaware and having its principal place
of business at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇.▇.▇.
("Warner"). Capitalized terms not otherwise defined herein shall have the
meanings set forth in Article 1.
WHEREAS, Warner entered into the contracts listed in Appendix A hereof (the
"Contracts"), in connection with the development, manufacturing, marketing,
promotion and sale of the Cognex products; and
WHEREAS, on the date hereof, Warner has sold its Cognex business to Horizon
pursuant to the terms of an Asset Purchase Agreement dated April 14, 2000 (the
"Asset Purchase Agreement");
WHEREAS, Warner wishes, pursuant to the terms of the Asset Purchase Agreement,
to assign the Contracts to Horizon and Horizon is willing to accept the rights
and assume the obligations relating thereto;
NOW, THEREFORE, in consideration of the promises and mutual covenants herein
contained, the Parties hereto agree as follows:
ARTICLE 1
ASSIGNMENT AND ASSUMPTION
1.1 Assignment. Warner hereby transfers and assigns to Horizon, its
successors and permitted assigns, all right, title and interest of Warner in, to
and under the Contracts.
1.2 Assumption. Horizon hereby assumes as its own liability until
discharged in full, and agrees to perform, each and every obligation on the part
of Warner arising and to be performed under the Contracts on and after the date
hereof, with the same force and effect as if Horizon had been originally a party
to the Contracts.
ARTICLE 2
MISCELLANEOUS
2.1 Governing Law. This Agreement shall be governed by and construed in
accordance with the law of the State of New York.
1
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2.2 Severability. If any provision of this Agreement is held to be
illegal, invalid or unenforceable under any applicable present or future law,
and if the rights or obligations of any party hereto under this Agreement will
not be materially and adversely affected thereby, (i) such provision will be
fully severable, (ii) this Agreement will be construed and enforced as if such
illegal, invalid or unenforceable provision had never comprised a part hereof,
(iii) the remaining provisions of this Agreement will remain in full force and
effect and will not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom and (iv) in lieu of such illegal, invalid
or unenforceable provision, there will be added automatically as a part of this
Agreement, a legal, valid and enforceable provision as similar in terms to such
illegal, invalid or unenforceable provision as may be possible.
2.3 Assignment. This Agreement and any rights and obligations hereunder
shall not be assignable by a party hereto, without the prior written consent of
the other party; provided that Horizon may assign this Agreement to one or more
of its affiliates.
2.4 Further Assurances. Each party hereto shall execute such other
documents and instruments and take such other actions as may be necessary to
effect the transactions contemplated hereby and further to comply with all
applicable Laws in connection with this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized representatives, on the day and year set forth above.
FIRST HORIZON PHARMACEUTICAL CORPORATION
----------------------------------------
Name:
Title:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY
----------------------------------------
Name:
Title:
2
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APPENDIX A
CONTRACTS
1. Settlement and License Agreement dated as of September 28, 1994 between
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company and ▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ Pharmaceuticals Inc.
2. Agreement dated September 8, 1987 between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company and
Mount Sinai School of Medicine.
3. Agreement dated April 20, 1990 between ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company and Shire
Holdings Limited.
3