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USE AND LICENSE AGREEMENT

License Agreement

USE AND LICENSE AGREEMENT | Document Parties: HALSEY DRUG CO INC/NEW You are currently viewing:
This License Agreement involves

HALSEY DRUG CO INC/NEW

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Title: USE AND LICENSE AGREEMENT
Governing Law: Florida     Date: 3/25/2004
Industry: Biotechnology and Drugs     Law Firm: Reed Smith LLP     Sector: Healthcare

USE AND LICENSE AGREEMENT, Parties: halsey drug co inc/new
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                                                                    EXHIBIT 10.2

 

 

                            Use and License Agreement

                            -------------------------

 

     This Use and License Agreement (this "Agreement") is dated and entered into

on this the 19th day of March, 2004 (the "First Closing Date"), by and among

HALSEY DRUG CO., INC., a New York corporation with offices at 616 N. North

Court, Suite 120, Palatine, Illinois 60067 ("Halsey"), AXIOM PHARMACEUTICAL

CORPORATION, a Delaware corporation and wholly-owned direct subsidiary of Halsey

with offices at 616 N. North Court, Suite 120, Palatine, Illinois 60067 ("Axiom"

and, together with Halsey, collectively and individually, the "Seller"), and

IVAX PHARMACEUTICALS NEW YORK LLC, a New York limited liability company with

offices at 77 Brenner Drive, Congers, New York 10920 (the "Purchaser") (the

Seller and the Purchaser, collectively, the "Parties", and each individually, a

"Party").

 

                             PRELIMINARY STATEMENTS

                             ----------------------

 

     A. In connection with the assignment to the Purchaser of (i) all the

Seller's rights, title and interests in and to the Brenner Contract of Sale (as

defined in the Asset Purchase Agreement) relating to the Brenner Facility (as

hereinafter defined) and (ii) Seller's tenant interest in the Wells Avenue Lease

(as defined in the Asset Purchase Agreement) relating to the Wells Facility (as

hereinafter defined, collectively together with the Brenner Facility, the

"Facilities", and each individually, a "Facility"), each pursuant to the

transactions, documents and deliveries contemplated by the Asset Purchase

Agreement entered into by the Parties on this date (the "Asset Purchase

Agreement"), the Seller also desires to sell, and the Purchaser desires to

purchase, subject to the terms and conditions set forth therein, the Seller's

rights in the Products as well as the Halsey Equipment, Intellectual Property,

Product Registrations, Transferred Documentation and Manufacturing Information

(each, as defined in the Asset Purchase Agreement).

 

     B. The Parties have agreed that, pending Shareholder Approval of the

Transactions Requiring Shareholder Approval (as such terms are defined in the

Asset Purchase Agreement), the Seller shall grant to the Purchaser the exclusive

right and license to exploit the Second Closing Acquired Assets (as defined in

the Asset Purchase Agreement) for its own commercial purposes, as more

particularly set forth in this Agreement.

 

     C. The Purchaser and the Seller have entered into this Agreement to induce

the Purchaser to enter into the Asset Purchase Agreement which it would not do

but for the agreement of the Seller to enter into this Agreement.

 

     NOW, THEREFORE, in consideration of the foregoing preliminary statements

and the mutual agreements and covenants set forth herein, the Parties hereby

agree as follows:

 

 

 

1.        DEFINITIONS; INTERPRETATION

 

     1.1 Definitions. Capitalized terms not otherwise defined in this Agreement

shall have the meanings assigned to such terms in the Asset Purchase Agreement.

As used in this

 

 

 

 

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Agreement, the following terms shall have the respective meanings set forth in

this Section 1.1, unless otherwise specifically indicated.

 

          (a) "Affiliates" shall mean, with respect to any Person, any Persons

directly or indirectly controlling, controlled by, or under common control with,

such Person. For purposes hereof, the term "controlled" (including the terms

"controlling," "controlled by" and "under common control with"), as used with

respect to any Person, shall mean the direct or indirect ability or power to

direct or cause the direction of management policies of such Person or otherwise

direct the affairs of such Person, whether through ownership of voting

securities or otherwise.

 

          (b) "ANDA" shall mean an abbreviated new drug application requesting

permission to place a drug on the market in accordance with 21 C.F.R. Part 314

Subpart C, and all supplements filed pursuant to the requirements of the FDA,

including all documents, data and other information concerning the applicable

drug which are necessary for FDA approval to market the drug in the United

States.

 

          (c) "Bankruptcy Code" shall have the meaning assigned to such term in

Section 4.1.

 

          (d) "Brenner Facility" shall mean the land, facilities and equipment

leased by the Seller at 77 Brenner Drive, Congers, New York, being formerly

known as Lot 22.02, Block A, Section 128 and being currently known as Lot 12,

Block 2, Section 44.7 on the tax map of the Town of Clarkstown, Rockland County,

New York.

 

          (e) "Confidential Asset Information" shall have the meaning assigned

to such term in the Asset Purchase Agreement.

 

           (f) "DEA" shall mean the United States Drug Enforcement Administration

and any successor agency or entity that may be established hereafter.

 

          (g) "FDA" shall mean the United States Food and Drug Administration

and any successor agency or entity that may be established hereafter.

 

          (h) "First Closing Date" shall have the meaning assigned to such term

in the Asset Purchase Agreement.

 

          (i) "First Refusal Period" shall have the meaning set forth in Section

3.3.

 

          (j) "Licensee" shall have the meaning set forth in Section 4.2.

 

          (k) "Licensor" shall have the meaning set forth in Section 4.2.

 

          (l) "Non-Packaging Assets" shall mean any and all Second Closing

Acquired Assets other than the Packaging Equipment.

 

          (m) "Notice" shall have the meaning set forth in Section 3.3.

        

                                       2

<PAGE>

 

 

          (n) "Packaging Equipment" shall mean any and all Halsey Equipment with

  application in the packaging of pharmaceutical products.

 

          (o) "Person" shall mean a natural person, a corporation, a

  partnership, a trust, a joint venture, a limited liability company, any

governmental authority or any other entity or organization.

 

          (p) "Refundable Amount" shall have the meaning assigned to such term

in the Asset Purchase Agreement.

 

          (q) "Related Agreement" shall have the meaning assigned to such term

  in the Asset Purchase Agreement.

 

          (r) "Retained Information" shall have the meaning assigned to such

term in the Asset Purchase Agreement.

 

          (s) "Second Closing Date" shall have the meaning assigned to such term

in the Asset Purchase Agreement.

 

          (t) "Term" shall have the meaning assigned to such term in Section

  3.1.

 

           (u) "Third Party" shall mean any person or entity who or which is

  neither a Party nor an Affiliate of a Party.

 

          (v) "Wells Facility" shall mean the land and facilities leased by the

Seller at 125 Wells Avenue, Congers, New York, being formerly known as Lot 26,

Block A, Section 128 and being currently known as Lot 3, Block 3, Section 44.11

on the tax maps of the Town of Clarkstown, New York.

 

 

2.        DELIVERY; USE AND OWNERSHIP; GRANT; RESERVATION OF RIGHTS

 

     2.1 Delivery; Use and Ownership. On or before the First Closing Date, the

Seller shall deliver to the Purchaser possession of all of the Second Closing

Acquired Assets and all information, records and materials contained therein

(e.g. full access to use, copies of documents etc.). All such information,

records and materials provided by the Seller shall be filed in files at the

Facilities or packaged, organized and listed in a commercially reasonable

manner, at the Seller's cost. While the Purchaser shall be permitted to exploit

and use the Second Closing Acquired Assets in accordance with this Agreement,

during the Term the Seller shall retain title and ownership to the Second

Closing Acquired Assets. During the Term prior to the effectiveness of the

termination of this Agreement with respect to the Non-Packaging Assets, the

Purchaser shall have the undisturbed quiet use and enjoyment of all of the

Non-Packaging Assets and the Seller shall not interfere in any way with the

Purchaser's quiet use and enjoyment of any of the Non-Packaging Assets. During

the Term, the Purchaser shall have the undisturbed quiet use and enjoyment of

all of the Packaging Equipment and the Seller shall not interfere in any way

with the Purchaser's quiet use and enjoyment of any of the Packaging Equipment.

 

                                        3

 

<PAGE>

 

 

     2.2 Grant of License.

 

          (a) During the Term until the effectiveness of the termination of this

Agreement with respect to the Non-Packaging Assets, the Seller hereby grants to

the Purchaser and its Affiliates an exclusive, worldwide, royalty-free right and

license, together with the right to grant sublicenses, to (i) all of the

Seller's rights, as of the First Closing Date, to make, have made, use, offer

for sale, sell, import, develop and commercialize the Products, (ii) use and

operate for any purpose the Halsey Equipment which is not included in the

Packaging Equipment, (iii) utilize for any purpose the Manufacturing Information

relating to the Halsey Equipment which is not included in the Packaging

Equipment, (iv) utilize for any purpose the Intellectual Property relating to

the Halsey Equipment which is not included in the Packaging Equipment, (v)

utilize for any purpose the Product Registrations and the Transferred

Documentation, and (vi) to utilize the Retained Information in connection with

any of the foregoing.

 

          (b) In addition, during the Term, Seller hereby grants to the

Purchaser and its Affiliates an exclusive, worldwide, royalty-free right and

license, together with the right to grant sublicenses, to (i) use and operate

for any purpose the Packaging Equipment, (ii) utilize for any purpose the

Manufacturing Information relating to the Packaging Equipment, (iii) utilize for

any purpose the Intellectual Property relating to the Packaging Equipment, and

(iv) to utilize the Retained Information in connection with any of the

foregoing.

 

 

3.        TERM; TERMINATION

 

     3.1 Term; Termination. The term of this Agreement (the "Term") shall

commence on the First Closing Date and shall continue until the earlier of: (a)

the Second Closing Date, or (b) June 30, 2007, or (c) with respect to the

Non-Packaging Assets only, following termination of the Asset Purchase Agreement

and payment in full to the Purchaser by the Seller of the Refundable Amount as

well as any other amounts which are then due and payable by the Seller to the

Purchaser under the Asset Purchase Agreement or any Related Agreement in

accordance with Section 9.2 of the Asset Purchase Agreement, six (6) months

written notice to the Purchaser of the Seller's intention to remove the

Non-Packaging Assets from the Facilities (which notice may only be given after

payment of such amounts). Following such notice, during such six (6) month

period and thereafter until the obligations of the Seller described in Section

3.2 are fully performed, the Seller shall use its best efforts to cooperate with

the Purchaser in the unwinding of the relationship established herein with

respect to the Non-Packaging Assets in an orderly manner. The provisions of this

Section 3 shall survive any termination of this Agreement.

 

     3.2 Effect of Notice under Section 3.1(c). If and when the Seller gives

  notice in accordance with and as permitted under Section 3.1(c), then:

 

          (a) Except as otherwise agreed by the Parties, promptly, but in no

event less than 3 business days, following the end of the six (6) month period

described in Section 3.1(c), the Non-Packaging Assets shall be removed from the

Facilities by the Seller, at the Seller's cost, in a manner so as to be

minimally disruptive to the operations of the Purchaser and to the

 

                                       4

 

<PAGE>

 

 

 

Purchaser's use and enjoyment of the Facilities, the improvements thereon or the

other equipment located at the Facilities.

 

          (b) The Seller shall, at its expense, promptly restore the Facilities

to good condition and reimburse or pay the Purchaser for any and all reasonable

costs and expenses incurred or to be incurred by the Purchaser in connection

with the Seller's activities in removing the Non-Packaging Assets from the

Facilities, including (i) any damages sustained to the Facilities, the

improvements thereon or the other equipment located at the Facilities, and (ii)

repairing the Facilities and the improvements thereon such that they once again

can be used by the Purchaser for the purposes for which they were used by the

Purchaser prior to the removal of the Non-Packaging Assets.

 

          (c) On the first business day following the end of the six (6) month

period described in Section 3.1(c), the Seller shall post a performance bond in

the amount of One Hundred Fifty Thousand Dollars ($150,000) with a Third Party

bank or trust company, both the form of bond and institution being acceptable to

the Purchaser, to support payment and performance of the S


 
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