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EXHIBIT 10.17
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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PONSTEL(R)
ASSET PURCHASE AGREEMENT
between
▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY
and
FIRST HORIZON PHARMACEUTICAL CORPORATION
Dated as of April 10, 2000
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This ASSET PURCHASE AGREEMENT (the "Agreement") is entered into as of
April 10, 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, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ is engaged in the business of manufacturing
and selling pharmaceutical products and owns certain rights related to the
product listed on Exhibit A hereto (the "Product"); and
WHEREAS, the parties hereto intend that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall sell to
Horizon, and Horizon shall purchase from ▇▇▇▇▇▇-▇▇▇▇▇▇▇, certain assets related
to the Product 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, convey, assign, grant,
transfer and deliver to Horizon, and Horizon agrees to purchase, acquire and
receive from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ on April 14, 2000 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 (collectively, the "Assets")
in the United States and Puerto Rico (the "Territory"):
1.1.1 Inventory. The inventories of finished Product
(including samples) 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 twelve (12) months after the Closing Date. Inventory purchased by Horizon
hereunder shall be delivered to Horizon as soon as practicable after Closing but
in any event no later than fifteen (15) days thereafter;
1.1.2 Trademarks. All the rights in the Territory to the
trademarks listed on Exhibit 1.1.2 hereto (the "Trademarks");
1.1.3 Registrations. All regulatory approvals and
applications for regulatory approval for the Product in the Territory (including
the NDA for the Product) held by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ or its Affiliates (defined
below) (collectively, the "Registrations") set forth on Exhibit 1.1.3; provided,
however, that ▇▇▇▇▇▇-▇▇▇▇▇▇▇ retains such rights under the Registrations, if
any, as may be required for ▇▇▇▇▇▇-▇▇▇▇▇▇▇ to manufacture, have manufactured,
sell, market, distribute or use the Product outside the Territory.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall deliver such Registrations to Horizon as soon as
practicable after Closing but in any event no later than forty-
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five (45) days thereafter. As used herein: the term "Affiliate" shall mean (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 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; and "NDA" means the new drug application
for the Product set forth in Exhibit 1.1.3;
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 (including the raw materials
used in the manufacture thereof) in the Territory owned or possessed by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ 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 sixty (60) days thereafter;
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 Territory; and
1.1.6 Goodwill. All goodwill associated with the Product in
the Territory other than goodwill associated with any trademark. trade name,
service ▇▇▇▇, service name, slogan or logo used by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ 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.
1.2 EXCLUDED ASSETS. Notwithstanding anything in this Agreement to
the contrary, the following assets of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ (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 ▇▇▇▇▇▇-▇▇▇▇▇▇▇ 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
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1.2.4 Excluded Intellectual Property. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall
retain the right and title to any Intellectual Property (as defined herein) and
Information utilized in connection with the manufacture, packaging, testing,
development, distribution, marketing, use or sale of the Product outside of the
Territory and of any of ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ or its Affiliates' products, other than
the Product, including, but not limited to, those that are also used by
▇▇▇▇▇▇-▇▇▇▇▇▇▇ on the Product, such as the ▇▇▇▇▇-▇▇▇▇▇ trademark, logo and
designs. As used herein "Intellectual Property" means, with respect to the
Product, all of the following without limitation and whether registered, issued,
pending or in a draft form: all patents, trademarks and trademark rights,
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.
1.3 ASSUMED LIABILITIES. Horizon shall assume and agrees to pay,
perform and discharge when due the following liabilities and obligations of
▇▇▇▇▇▇-▇▇▇▇▇▇▇ arising in connection with the Product (the "Assumed
Liabilities"):
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 six
(6) months after the Closing Date and (ii) the returned units of the Product
during the first six (6) months following the Closing Date to the extent such
returns exceed 4.6% of the gross sales of the Product in the Territory in the
first six (6) months immediately preceding the Closing Date;
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
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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 NDA 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 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 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").
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 Nine Million
Five Hundred Thousand Dollars ($9,500,000) payable to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ on the
Closing Date, (ii) Three Million Five Hundred Thousand Dollars ($3,500,000)
payable to ▇▇▇▇▇▇-▇▇▇▇▇▇▇ on the earliest of (A) three (3) Business Days
following signing of a definitive asset purchase agreement by ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and
a party other than Horizon regarding ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ Cognex business, (B) three
(3) Business Days following the date on which Horizon notifies ▇▇▇▇▇▇-▇▇▇▇▇▇▇
that it does not intend to purchase ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ Cognex business, (C) June
1, 2000, in the event that Horizon has not purchased ▇▇▇▇▇▇-▇▇▇▇▇▇▇'▇ Cognex
business by such date, other than due to a delay in receiving clearance from the
Federal Trade Commission to proceed with the purchase of the Cognex business,
(D) three (3) Business Days following the date on which a definitive agreement
between Horizon and ▇▇▇▇▇▇-▇▇▇▇▇▇▇ for the Cognex Business is terminated, (E)
three (3) Business Days following the date of the initial public offering of
Horizon or (F) November 30, 2000, as evidenced by an interest-free promissory
note in the form of Exhibit 2.4.2 and (iii) an
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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) 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 portion of the
Purchase Price paid pursuant to Sections 2.1(a)(i) and 2.1(a)(ii) among the
Assets (other than Inventory) purchased hereunder. The allocation of the
Purchase Price to Inventory shall be the amount calculated as Closing Inventory
Value in accordance with Section 2.1(a)(iii).
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 to its knowledge: (i) it or its Affiliates has good and marketable title to
the Assets, free and clear of all liens; (ii) no sublicenses have been granted
to any third party with respect to the Assets; and (iii) there are no adverse
claims of ownership to the Assets.
3.4 INTELLECTUAL PROPERTY RIGHTS. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ 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.
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.
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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. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and Horizon each hereby
represents and warrants that it has obtained all third party consents and
government approvals, if any, required in connection with the assignment and
assumption of the Assets to and by Horizon. Notwithstanding the foregoing, the
parties acknowledge that transfer of the NDAs will not be completed until
receipt and acceptance by the United States Food and Drug Administration ("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 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 or entity 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 10, 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 10, 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).
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3.11 REGISTRATIONS. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ hereby represents and warrants
that, to its knowledge, (i) the Registrations are in good standing and (ii)
there is no pending or threatened action by the FDA which will have a material
adverse effect on the Registrations. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ has paid the NDA maintenance
fee for the Product for the year 2000. It is understood and agreed by the
parties that if USP publishes a monograph covering the Product, the Product may
not meet the new USP specifications. Under those circumstances, the Product must
be labeled accordingly.
3.12 CERTAIN FINANCIAL INFORMATION. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ represents and
warrants that certain 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 in the Territory were 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 in the Territory (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 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
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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 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.
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ARTICLE 5
ADDITIONAL AGREEMENTS
5.1 TERRITORIAL RESTRICTION. Horizon shall not directly or
indirectly sell the Product outside the Territory at any time. Horizon will use
its commercially reasonable efforts to prevent the Product from being resold for
use or sale outside the Territory. ▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall not directly or
indirectly sell the Product in the Territory at any time after the Closing Date.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ will use its commercially reasonable efforts to prevent the
Product from being resold for use or sale in the Territory. The restrictions set
forth in this Section 5.1 shall survive indefinitely.
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
purchased from ▇▇▇▇▇▇-▇▇▇▇▇▇▇ by Horizon hereunder bearing the ▇▇▇▇▇▇-▇▇▇▇▇▇▇
Name (including inventory purchased under the Supply Agreement) for ten (10)
months following the Closing Date or until such Inventory 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.
5.3 USE OF PROMOTIONAL MATERIALS. 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 containing the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name shall be destroyed at Horizon's
sole cost and expense. Use of the ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Name on 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 in the Territory with
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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 in the Territory, 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 in the Territory
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 concerning Product lots sold in the Territory. Each party shall
notify the other 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. On and after the Closing
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 arising in the Territory and all serious adverse
drug experience reports arising outside the Territory 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 arising in the Territory and for reporting such
reports to governmental and regulatory authorities in the Territory.
▇▇▇▇▇▇-▇▇▇▇▇▇▇ shall have sole responsibility for investigating such adverse
experience reports arising outside the Territory and for reporting such reports
to applicable governmental and regulatory authorities outside the Territory.
Except as otherwise stated above, the terms
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"adverse drug experience" and "serious adverse drug experience" used in this
paragraph shall have the meanings set forth in 21 CFR 314.80.
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.
5.5 PAYMENT OF TRANSACTION EXPENSES. All sales taxes, use 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 (5) 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, 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 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
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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 TECHNICAL TRANSFER. Subsequent to the Closing Date,
▇▇▇▇▇▇-▇▇▇▇▇▇▇ agrees to provide the technical support, to the extent possible,
set forth on Exhibit 5.9 attached hereto. Horizon shall pay to ▇▇▇▇▇▇-▇▇▇▇▇▇▇
the amounts set forth on Exhibit 5.9 for all technical support provided by
▇▇▇▇▇▇-▇▇▇▇▇▇▇. In addition, the parties agree to use their best efforts to
agree upon a systems transfer plan within thirty (30) days after the Closing
Date.
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 of the sale of the Product to
Horizon within three (3) Business Days after the Closing Date.
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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.
6.2 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.
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
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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").
7.2 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.
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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").
ARTICLE 8
GENERAL
8.1 ASSIGNMENT. Until such time as Horizon has discharged all its
payment obligations hereunder, 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 Section
8.1, 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 ▇▇▇▇▇▇-▇▇▇▇▇▇▇:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn: President, Pharmaceutical Sector
Fax: ▇▇▇-▇▇▇-▇▇▇▇
with a copy to:
▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
▇▇▇ ▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Senior Vice President and General Counsel
Fax: ▇▇▇-▇▇▇-▇▇▇▇
16
17
(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 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.
8.4 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.
8.5 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.
8.6 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.
8.7 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.
8.8 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.
17
18
8.9 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.
8.10 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.
8.11 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 or
entity.
8.12 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 or entities 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.
18
19
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:
19
20
EXHIBIT A
PRODUCT
Ponstel
21
EXHIBIT 1.1.1
FINISHED PRODUCT INVENTORY
Item Quantity
-------------------------------------------------------------------------------
▇▇-▇▇▇-▇▇ Ponstel 250mg 100's 16,339 Bottles of 100's
22
EXHIBIT 1.1.2
TRADEMARKS
Registration Renewal
Trademarks Number Country Date Owner
---------- ------ ------- ---- -----
▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇ 11/07/2007 ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
Ponstel 25773 Puerto 9/06/2004 ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company
Rico
23
EXHIBIT 1.1.3
REGULATORY APPROVALS
The following NDA relating to the Product:
NDA # 15-034 Ponstel
24
EXHIBIT 2.4.2
PROMISSORY NOTE
US$3,500,000.00
April 14, ▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇
FOR VALUE RECEIVED, the undersigned, First Horizon
Pharmaceutical Corporation, a Delaware corporation (the "Borrower"), hereby
promises to pay to the order of ▇▇▇▇▇▇-▇▇▇▇▇▇▇ Company, a Delaware corporation
(the "Lender"), in accordance with the terms hereof, in lawful money of the
United States, the principal sum of Three Million Five Hundred Thousand Dollars
(US$3,500,000.00). The unpaid principal amount of this Note shall be payable by
the Borrower in full, on the earliest of (i) three (3) Business Days following
signing of a definitive asset purchase agreement by Lender and a party other
than Borrower regarding Lender's Cognex business, (ii) three (3) Business Days
following the date on which Borrower notifies Lender that it does not intend to
purchase Lender's Cognex business, (iii) June 1, 2000, in the event that
Borrower has not purchased Lender's Cognex business by such date, other than due
to a delay in receiving clearance from the Federal Trade Commission to proceed
with the purchase of the Cognex business, (iv) three (3) Business Days following
the date on which a definitive agreement between Borrower and Lender for the
Cognex Business is terminated, (v) three (3) Business Days following the date of
the initial public offering of the Borrower and (vi) November 30, 2000. As used
herein, "Business Day" means a day during which banks are generally open for
business in New York.
The outstanding principal of this Note, shall be payable by
wire transfer of funds, to the account of the holder of this Note at such
financial institution as such holder designates in writing or, if requested by
such holder, by check payable to the holder of this Note mailed to the address
of such holder as set forth on the records of the Borrower or such other address
as shall be designated in writing by the holder of this Note to the Borrower.
Notwithstanding the foregoing, in the event that (i) the
Borrower shall fail to pay any amount of principal when due hereunder, or (ii)
the Borrower shall become insolvent, or admit in writing its inability to pay
its debts as they mature, or make an assignment for the benefit of creditors, or
apply for or consent to the appointment of a trustee, examiner, liquidator or
receiver for the Borrower or for a substantial part of the Borrower's property
or business, or fail to obtain the discharge within thirty (30) days of a
trustee, examiner, liquidator or receiver appointed for the Borrower or for a
substantial part of Borrower's property or business, the Lender at its option
may declare the unpaid principal amount of this Note and any other amount due
hereunder, immediately due and payable.
Whenever any payment under this Note shall be due on a day
which is not a Business Day, such payment shall be due on the first Business Day
thereafter.
This Note may be paid or prepaid at any time in whole or in
part without premium or penalty.
No delay by the Lender in exercising any power or right in
connection herewith shall operate as a waiver of any power or right, nor shall
any single or partial exercise of any power
20
25
or right preclude other or further exercise thereof, or the exercise of any
other power or right in connection herewith or otherwise; and no waiver whatever
or modification of the terms hereof shall be valid unless set forth in writing
by the Lender and then only to the extent set forth therein.
The Borrower may not assign or otherwise transfer any of its
rights or obligations under this Note without the consent of the Lender, and
this Note shall be binding upon the Borrower and its successors and permitted
assigns. The Lender may assign or otherwise transfer all or any part of its
rights under this Note without the consent of the Borrower, and this Note shall
inure to the benefit of the Lender and its successors and assigns.
This Note shall be construed in accordance with and governed
by the laws of the State of New York.
IN WITNESS THEREOF, the undersigned has caused this Note to be
executed and delivered by a duly authorized officer as of the date first above
written.
FIRST HORIZON PHARMACEUTICAL
CORPORATION
By:
------------------------------
26
EXHIBIT 3.10
[****]-CONFIDENTIAL TREATMENT REQUESTED
MANAGED CARE CUSTOMERS
▇▇▇▇▇-▇▇▇▇▇
PONSTEL CONTRACTS
--------------------
ALPHA LISTING
----------------------------------------------------------------------------------------------------------------------------------
Renewal/ Current Rights to
Term. Rights Rebate/ Contract Change Assign. Primary Admin.
Name Contact Person Type Phone Number Term Both Parties Discount Price Price/Rebate Rights Wholesaler Fee Amend.
----------------------------------------------------------------------------------------------------------------------------------
[****]
**[****]
27
EXHIBIT 5.9
[****]-CONFIDENTIAL TREATMENT REQUESTED
TECHNICAL TRANSFER
MEFENAMIC ACID--API PROCESS
▇▇▇▇▇-▇▇▇▇▇, HOLLAND, MI PLANT
The follow list details the level of support that ▇▇▇▇▇-▇▇▇▇▇, ▇▇▇▇▇▇▇ staff
would provide for the technical transfer of the process used to manufacture this
active pharmaceutical ingredient.
1. A secrecy agreement would have to be in effect for all parties (including
Horizon and any third party manufacturer of Horizon) prior to the visit to
the Holland Plant site.
2. All technical transfer meetings and process observation would take place at
the Holland, Michigan plant site during the full scale production batch. It
will not be possible to provide any support at the customer's facility.
3. Since equipment availability is quite limited, the production batch would
be run around the clock in a manner which most efficiently utilizes plant
resources. The entire effort is expected to take between 1 1/2, and 3 weeks
to complete.
4. A production Area Manager and a Chemical Services Chemist will be assigned
to the customer's team during the technical transfer batch.
5. One eight hour day will be devoted to a process review with the
Manufacturing Area Manager and the Chemical Services Chemist the day before
the Q1 2000 batch is started.
6. No ▇▇▇▇▇-▇▇▇▇▇ documents may be copied/scanned for this transfer, but batch
records, analytical workcards and raw material specifications will be
available to the customer team for reading. The customer will of course be
allowed to take as many notes as needed while on site.
7. An analyst experienced in this product testing will be made available for a
separate eight-hour meeting to review testing procedures and experience for
this product.
8. Actual in-process and final testing of this product may be observed by the
customer in ▇▇▇▇▇-▇▇▇▇▇' laboratory. This testing will take place at
varying times of the day or night to accommodate other production schedules
at the plant.
9. The technology transfer would not include any validation work in
Manufacturing, Quality Assurance or Quality Control, just one production
batch from start to finish.
10. The standard yield of a Mefenamic Acid USP lot is [****]. Customer agrees
to purchase all of the approved Mefenamic Acid in ▇▇▇▇▇-▇▇▇▇▇, ▇▇▇▇▇▇▇'▇
inventory after the demonstration lot is complete, at a price of $[****].
11. The cost for technical support from Manufacturing, Chemical Services and
Analytical would come to $[****] for on-site support during the
demonstration batch.
SOLID DOSAGE PROCESS
▇▇▇▇▇-▇▇▇▇▇, LITITZ, PA PLANT
The follow list details the level of support that ▇▇▇▇▇-▇▇▇▇▇, Lititz staff
would provide for the technical transfer of the process used to manufacture this
solid dosage of Ponstel.
1. Horizon, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ and any third party manufacturer of Horizon
shall execute a Nondisclosure Agreement prior to visiting the Lititz
Plant.
28
2. All technical transfer meetings will take place in Lititz at the
▇▇▇▇▇-▇▇▇▇▇ production facility. No support shall be provided at the
purchaser's facility or any other facility designated by Purchaser.
3. Lititz Materials Management will provide dates when production can be
observed.
4. One man week of Pharm Tech transfer service will be provided at the
Lititz manufacturing site.
5. Validation reports for process, packaging and cleaning will be made
available when the production process is observed.
6. Analytical Procedures will be provided for all raw materials and the
finished product.
7. Material specifications will be provided for all raw materials and
packaging supplies.
8. Provision of the technical transfer service outlined above will be
subject to a schedule prepared by ▇▇▇▇▇▇-▇▇▇▇▇▇▇.
9. The cost for technical support provided by Lititz as outlined above
will be $12,000.
29
EXHIBIT 7.1.4(A)
ASSIGNMENT, ASSUMPTION AND ▇▇▇▇ OF SALE
THIS GENERAL ASSIGNMENT, ASSUMPTION AND ▇▇▇▇ OF SALE is
entered into this 14th day of April, 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 10, 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 ▇▇▇▇▇▇-▇▇▇▇▇▇▇
30
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:
31
EXHIBIT 7.1.4(B)
TRADEMARK ASSIGNMENT
WHEREAS, ▇▇▇▇▇▇-▇▇▇▇▇▇▇ COMPANY, a corporation organized and existing under the
laws of the state of Delaware, with an office and place of business at ▇▇▇ ▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, is the owner of the trademark Ponstel
with Registration Numbers _______ (the "Trademark"), 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 __, 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:
Title:
Date: