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EXHIBIT 10.1
CONFIDENTIAL PORTIONS OMITTED
TERMINATION AND TRANSFER AGREEMENT
This Termination and Transfer Agreement ("Agreement") is made and
entered into as of November 14, 1997 by and between TECHNICLONE CORPORATION, a
Delaware corporation having its principal place of business at 00000 Xxxxxxxx
Xxxxxx, Xxxxxx, Xxxxxxxxxx 00000, a successor in interest to Techniclone
International Corporation, a California corporation, (hereinafter "Techniclone")
and ALPHA THERAPEUTIC CORPORATION, a California corporation having its principal
place of business at 0000 Xxxxxx Xxxxxxxxx, Xxx Xxxxxxx, Xxxxxxxxxx 00000
(hereinafter "Alpha").
RECITALS
A. Techniclone and Alpha entered into an Agreement dated October 28,
1992, and such Agreement was amended on February 7, 1996, July 13, 1994, and on
July 23 1993 (hereinafter collectively referred to as the "Development
Agreement").
B. Techniclone and Alpha believe that it is in their respective best
interests to terminate the Development Agreement and enter into this Agreement
for the return to Techniclone of the rights described in the Development
Agreement and for the transfer to Techniclone of Alpha's know-how, proprietary
information and the tradename/trademark "Oncolym(TM)" all of which are further
described herein.
C. Techniclone intends to use its most reasonable business efforts
to obtain FDA approval and commercially market the Product as expeditiously as
possible.
NOW, THEREFORE, in consideration of the promises and covenants
herein contained, and other good and valuable consideration, the parties agree
as follows:
ARTICLE 1
DEFINITIONS
1.1 THE EFFECTIVE DATE means the date of full execution of this
Agreement in all its counterparts.
1.2 LICENSED ANTIBODIES means hybridomas designated LYM-1 (ATCC No.
HB 8612), LYM-2 (ATCC No. HB 8613), and other hybridomas, and antibodies
produced by or derived from such hybridomas, pursuant to a license agreement
dated June 12, 1985 between Northwestern University and Techniclone
International Corporation except for certain rights which may be held by the
United States Government.
1.3 BLA means any Biologics License Application for the Product
submitted to the FDA.
1.4 IND DOCUMENTS means the Investigational New Drug application and
any supplements, amendments or correspondence submitted by Alpha to the FDA or
any
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correspondence received by Alpha from the FDA in connection therewith.
1.5 THE PATENT means
a. U.S. patent 4,724,213 dated February 9, 1988, entitled
"Murine Hybridoma LYM-1 and Diagnostic Antibody Produced Thereby" and U.S.
patent 4,724,212 dated February 9, 1988, entitled "Murine, Hybridoma LYM- and
Diagnostic Antibody Produced Thereby" and any U.S. or foreign patents which may
issue therefrom; and
b. any re-issues or extensions of such patents and any division
and any like protection such as supplementary patent extension certificates or
anything else of similar effect.
1.6 PRODUCT means any products or process made, used, sold, hired
out or otherwise disposed of anywhere in the world, and which:
a. falls within the scope of any claim of Patent 4,724,213,
entitled "Murine Hybridoma LYM-1 and Diagnostic Antibody Produced Thereby" or
b. embodies or utilizes any of the claims of Patent 4,724,213
entitled "murine Hybridoma LYM-1 and Diagnostic Antibody Produced Thereby" or
c. falls within the scope of any other right pursuant to Patent
4,724,213, entitled "Murine Hybridoma LYM-1 and Diagnostic Antibody Produced
Thereby" including any product which, although not necessarily a Product at the
time of manufacture, sale, or other disposal, is capable, by its virtue of its
availability in the marketplace, of being administered or used for any
indication covered by Patent 4,724,213, entitled "Murine Hybridoma LYM-1 and
Diagnostic Antibody Produced Thereby" and whose labeling does not prohibit use
for such indication.
1.7 AFFILIATE means, with respect to any party, any person or entity
which, directly or indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with, such party. A person or entity
shall be deemed to control a corporation (or other entity) if such person or
entity 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.
1.8 NET SALES means the gross amount invoiced by Techniclone or its
Affiliates on all sales of Product to third parties less the following items to
the extent the amount of such item was included in such gross amount invoiced
(whether or not separately stated on such invoice): a. credits or allowances
granted upon returns, rejections or recalls; b. freight, shipping and insurance
costs; c. quantity and other trade discounts, credits or allowances actually
allowed and taken; d. customs duties, taxes and surcharges and other
governmental charges incurred in connection with exportation or importation; and
e. government mandated and other rebates.
ARTICLE 2
TERMINATION
2.1 TERMINATION OF DEVELOPMENT AGREEMENT. Alpha and Techniclone
hereby
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terminate the Development Agreement effective as of the date first set forth
above. Accordingly, Alpha's rights in the Licensed Antibodies, the Patent and
the Product are hereby terminated, and Techniclone accordingly shall resume
ownership and control of same.
2.2 EXPRESS WAIVER. Except as set forth in this Agreement,
notwithstanding anything to the contrary set forth in the Development Agreement,
including but not limited to Section 8.6 thereof, the parties agree that no
rights or obligations will survive the termination of the Development Agreement.
ARTICLE 3
TECHNOLOGY, TRANSFER AND ASSISTANCE
3.1 TRANSFER OF REGULATORY AFFAIRS. Alpha shall supply to
Techniclone all of its original IND Documents and shall retain one copy for its
records. Such copy shall only be used to comply with regulatory requirements.
Alpha hereby transfers all of its right, title and interest in such IND
Documents to Techniclone. Techniclone and Alpha shall jointly notify the FDA of
this transfer. Alpha shall also supply Techniclone with a copy of its file
concerning the Orphan Drug Application submitted for the Product. Alpha hereby
transfers all of its right, title and interest in the Orphan Drug Application
substituted for the Product and agrees to use its most reasonable business
efforts to have Techniclone recognized as the owner for all purposes of such
Orphan Drug Application.
3.2 TRANSFER OF CLINICAL PROGRAM. The parties shall cooperate and
assist each other in concluding the clinical research activities being conducted
by Alpha in furtherance of the Development Agreement and in transferring such
activities to Techniclone. Alpha and Techniclone shall jointly notify Alpha's
clinical investigators regarding the termination of Alpha's responsibility for
the clinical trials being conducted and that Techniclone will assume sponsorship
and control of the clinical trials. Techniclone shall, with Alpha's assistance
and full cooperation, establish its own relationship with Alpha's clinical sites
and investigators, and subject to a review of the obligations to be undertaken
by Techniclone, will assume full responsibility for any remaining activities
required to be performed in connection with the clinical trials. The orderly
transfer of the clinical trial responsibility shall occur as soon as possible
after the execution of the Agreement.
3.3 TRANSFER OF OTHER KNOW-HOW, PROPRIETARY INFORMATION AND
TRADEMARK/TRADENAME. Alpha shall physically transfer to Techniclone all data,
information it has developed or purchased concerning the research, development,
testing, and marketing activities conducted pursuant to the Development
Agreement. Alpha hereby transfers to Techniclone all of its right, title and
interest in the Know-How and Proprietary Information set forth as Exhibit A.
This right is exclusive, except for Alpha's rights to access the information as
set forth in Section 6.2 of this Agreement. The data and information to be so
transferred is further described on Exhibit "A" attached hereto (collectively
"Know How" and "Proprietary Information"). Further, Alpha hereby agrees to
transfer its Tradename/Trademark "Oncolym(TM)". Such transfer to be evidenced by
Alpha executing an Assignment of Tradename/Trademark in substantially the form
attached as Exhibit B to this Agreement.
3.4 TIMEFRAME FOR COMPLETION OF TRANSFER. Performance of the matters
set forth in 3.1, 3.2 and 3.3 above will be completed within 45 days of the
effective date.
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3.5 ALPHA ASSISTANCE. During the nine (9) months following the
execution of this Agreement Alpha agrees to make available to Techniclone, for
up to two hundred (200) hours of consultation, the Alpha employees involved in
the development of the Product pursuant to the Development Agreement. Such
consultation shall be subject to the payments set forth in Section 5.5. Alpha
agrees to use its most reasonable business efforts to make the named, requested
personnel available, if they are still in its employ, to consult with
Techniclone at the earliest possible time, during normal business hours, but in
any event, not later than ten (10) working days after receiving notice from
Techniclone that such assistance will be required.
ARTICLE 4
TECHNICLONE DEVELOPMENT PROGRAM
4.1 DUE DILIGENCE. Techniclone shall promptly commence all remaining
development work and clinical studies necessary for submission of a BLA for the
Product to the FDA, and will pursue with reasonable business efforts all
activities necessary to obtain approval of the BLA as expeditiously as possible.
Techniclone will use reasonable business efforts to promptly file applications
with the appropriate regulatory authorities in Canada, Mexico and such other
countries in Central America, South America and Asia as Techniclone, in its sole
business judgment, designates to achieve approvals in those countries as soon as
is practicable.
4.2 MARKETING PROGRAM. Techniclone will use reasonable business
efforts to effect commercial sales of the Product as soon as possible. Following
the initial commercial launch of the Product and until the expiration of this
Agreement, Techniclone shall use reasonable business efforts to market and sell
the Product.
ARTICLE 5
PAYMENTS
5.1 PAYMENTS. For, and in consideration of, the termination of
Alpha's rights as described in Article 2 and of transfer of its entire right,
title and interest to the Know-How, Proprietary Information and
Tradename/Trademark, "Oncolym(TM)" all as described on Exhibit A, Techniclone
shall pay to Alpha the following fees and royalties set forth below.
5.2 FEES. Techniclone shall pay to Alpha the following amounts for
the termination of the Development Agreement and the transfer of the
Tradename/Trademark, "Oncolym(TM)". The amounts due and the events which make
such amounts due and payable are set forth below:
$ [*] Payable upon signing the Agreement
[*] When the first patient is enrolled, in a
Techniclone sponsored clinical trial or six months,
whichever is earlier
[*] Upon Techniclone's filing of the BLA for the
Product
[*] Upon FDA approval of the BLA for the Product
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$ [*]
=========
[*CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION]
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5.3 ROYALTIES. For five (5) years following BLA approval,
Techniclone shall pay Alpha a royalty of [*] of its Net Sales revenue of the
Product which is sold in the Xxxxxx Xxxxxx, Xxxxxx, Xxxxxx, Xxxxxxx Xxxxxxx,
Xxxxx Xxxxxxx and Asia. Royalty payments shall be made quarterly during the term
of this Agreement within 60 days of the close of each calendar quarter.
5.4 ROYALTY REPORTS AND AUDITS. Techniclone shall supply to Alpha a
written report for each six month period following approval of the BLA (or of
its equivalent in the other countries set forth in Section 2.1 of the
Development Agreement), showing (i) the Net Sales of all Products in each
country; (ii) the royalties, payable in U.S. Dollars, which shall have accrued
hereunder with respect to such sales; (iii) taxes, if any, required by law to be
deducted with respect to such sales; and (iv) the exchange rates used in
converting the royalties into dollars from the currencies in which the sales
were made. In addition, upon the written request of Alpha and at Alpha's cost,
Techniclone shall permit an independent public accountant, selected by Alpha and
acceptable to Techniclone, to have access during normal business hours to those
records of Techniclone as may be reasonably necessary to verify the accuracy of
the royalty reports furnished to Alpha pursuant to this Section.
5.5 PAYMENT FOR CONSULTATION. After the completion of the transfer
of the materials and the completion of the obligations set forth in Article 3,
then Techniclone shall pay Alpha [*] per hour for each hour that an employee of
Alpha consults with Techniclone. If such consulting is accomplished by
telephone, all time for such employee shall be billed to the nearest quarter
hour and if in person, at Techniclone's facility or at a place designated by
Techniclone, Alpha shall be entitled to xxxx the greater of a minimum of 8 hours
per day or the actual hours worked.
5.6 CESSATION OF PRODUCT DEVELOPMENT. The parties acknowledge that
the consideration tied to successful development of the Product that is, the
three fee payments in Section 5.2 above are only due upon the occurrence of the
respective event set forth in Section 5.2, as well as the royalty payments of
Section 5.3 - are a material inducement to Alpha in entering into this
Agreement. Accordingly, in the event Techniclone, in its sole judgment,
determines that further development of the Product is not feasible, Techniclone
shall, thirty (30) days prior to the cessation of the development, notify Alpha
in writing of its intent not to proceed.
ARTICLE 6
CONFIDENTIALITY
6.1 CONFIDENTIALITY. Except as required by the Securities Exchange Commission or
other regulatory agency, Techniclone and Alpha shall keep the contents of this
Agreement confidential and shall not disclose its terms to any third party.
Neither Techniclone nor Alpha shall use or disclose, directly or indirectly, any
of the information of the other party transferred during the term of the
Development Agreement or during this Agreement, except as may be necessary to
enable the parties to perform their obligations under this Agreement. The
parties may disclose such information to its officers, employees and agents, to
authorized licensees and sublicenses and to subcontractors to the extent
necessary to enable such parties to perform their obligations hereunder or under
the applicable agreement. The parties shall also comply with any existing
confidentiality
[*CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION]
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obligation with any third parties contained in any of the documents transferred
between Alpha and Techniclone. The provisions of this Section shall not apply to
any such information which (i) is known to the receiving party at the time of
disclosure or independently developed by the receiving party and documented by
written records; (ii) information disclosed to the receiving party by a third
party which has a right to make such disclosure; (iii) information which becomes
patents, published or otherwise part of the public domain as a result of acts by
the disclosing party.
6.2 ACCESS TO INFORMATION. Alpha shall have access to any of the
information referenced in Article 3 and wherever located until the expiration of
the 45 day period for transfer of the information to Techniclone.
6.3 RETURN OF INFORMATION BY TECHNICLONE. Notwithstanding Section
6.1 concerning Confidentiality, Techniclone may use the information and know how
contained in any internal Alpha documents provided during the term of the
Development Agreement describing Alpha's manufacturing and quality assurance
processes, including but not limited to Standard Operating Procedures (SOPs);
provided, however, that Techniclone shall remove the Alpha logo from any such
material and shall not use any such materials to which the Alpha logo is
affixed.
6.4 PUBLICATION. Techniclone shall have the right to publish or
publicly present the results of the clinical activities conducted pursuant to
the Development Agreement. Alpha agrees that neither it nor its personnel shall
have any right to publish or disclose any data or results relating to the
Development Agreement without the prior written consent of Techniclone.
Techniclone may, in its sole discretion, refuse to consent to any publication.
Techniclone acknowledges that the clinical investigators that Alpha contracted
for the trial have the right to publish data on the clinical trial conducted by
Alpha, and that Alpha's only right with respect to such publication is to
review, within thirty (30) days for all articles and seven (7) days for
abstracts, all publications for factual and confidential information. Alpha
shall, within two business days of the receipt of such potential publication,
deliver to Techniclone, for its review and comments, the article or abstract.
Techniclone shall use reasonable business efforts to assemble and publish the
data relating to the Phase II/III clinical trials of Oncolym.
6.5 PUBLICITY. The timing and content of any public communications
relating to the Development Agreement or this Agreement will be determined by
Techniclone. Alpha shall be entitled to review any press release or publicity
relating to this Agreement. If, after review, Alpha reasonably objects to the
contents of such press release or publicity, then Alpha and Techniclone shall
use their most reasonable business efforts to write and agree on a press
release.
6.6 INJUNCTIVE RELIEF. The parties agree that they would be severely
and irreparably injured by a breach of this Article 6 and that the full amount
of injury resulting from any such breach would be difficult to estimate. In the
event of any breach of this Article, the non-breaching party shall be entitled,
without posting bond or proving damages, to equitable relief, including
injunctive relief and specific performance. Such remedy shall not be deemed to
be the exclusive remedy for breach of this Agreement, but shall be in addition
to all other remedies available at law or in equity.
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ARTICLE 7
INDEMNITY
7.1 INDEMNITY. The parties will indemnify, defend and hold each
other harmless against any and all losses, damages, liabilities, including
reasonable attorney's fees, and costs which arise out of claims concerning the
performance of their respective obligations under this Agreement. Techniclone's
indemnity obligation is deemed to include claims in the nature of product
liability or patent or trade secret infringement arising out of the manufacture,
sale or use of the Product.
7.2 INDEMNIFICATION PROCEDURE. The party seeking indemnity shall
promptly notify the indemnifying party, and the indemnifying party shall assume
its defense and settlement at its sole cost and expense.
ARTICLE 8
TERM AND TERMINATION
8.1 TERMINATION AND CAUSE. Either party may terminate this Agreement
upon sixty (60) days prior written notice to the other party upon the material
breach by such other party of any of its obligations under this Agreement,
provided that such termination shall become effective only if the breaching
party fails to remedy or cure the breach within such sixty day period.
8.2 EFFECT OF TERMINATION. Termination of this Agreement shall not
relieve or release either party from obligations which have accrued as of the
date of termination, or from making any payments which may otherwise be owing to
the other party under the terms of this Agreement.
ARTICLE 9
MISCELLANEOUS
9.1 NO WAIVER. The failure by either party to exercise or enforce
any rights under this Agreement shall not be deemed to be a waiver of any such
rights, nor shall any single or partial exercise of any right, power, or
privilege, or further exercise thereof, operate so as to bar the exercise ore
enforcement thereof at any later time. The waiver by either party of any breach
of any of the terms of this Agreement by the other shall not be deemed to be a
waiver of any other breach of the Agreement.
9.2 ENFORCEABILITY. If any part or provision of this Agreement is
prohibited, or rendered void or unenforceable, the validity or enforceability of
the Agreement as a whole or of any part of this Agreement shall not hereby be
affected; however, if this results in a material alteration to the terms and
conditions of this Agreement, the parties will renegotiate the terms and
conditions thereof to resolve any inequities.
9.3 NOTICES. Any payment, notice, consent or other communication
required or permitted to be made shall be deemed to be duly given on the date
personally delivered or mailed, if sent to the receive party by hand delivery,
facsimile (receipt verified), overnight courier (receipt verified), or certified
or registered mail, postage prepaid, addressed to:
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Alpha Therapeutic Corporation
0000 Xxxxxx Xxxxxxxxx
Xxx Xxxxxxx, XX 00000
Attn: Legal Department
Techniclone Corporation
00000 Xxxxxxxx Xxxxxx
Xxxxxx, XX 00000
or at such other address designated by the party after the Effective Date, by
written notice to the other party.
9.4 ASSIGNMENT. This Agreement may not be assigned or otherwise
transferred by either party without the written consent of the other party. This
Section 9.4 shall not be interpreted to preclude Techniclone from entering into
any transaction concerning the Licensed Antibodies, the Product, the Know-How,
Proprietary Information or the Trademark/Tradename as long as it retains the
obligation to pay Alpha.
9.5 INDEPENDENCE OF THE PARTIES. Alpha and Techniclone are
independent parties, and nothing herein shall be construed to deem them partners
or joint venturers, or to make either party liable for any of the debts or
obligations of the other party. Neither party shall have the right to bind the
other with respect to any contract or any other obligation whatsoever.
9.6 ARBITRATION. Alpha and Techniclone agree that except for
disputes or claims which involve a question of infringement of any of the
Patents, any disputes or claims arising under or in connection with this
Agreement, including the interpretation or application of this Agreement, shall
be settled by arbitration in accordance with the rules of the American
Arbitration Association then in force. If the parties cannot agree upon a single
arbitrator within ten (10) days after demand by either of them for arbitration,
then each arty shall select one arbitrator from a list of arbitrators supplied
by the American Arbitration Association. The two arbitrators so selected shall
then choose a third arbitrator in order that the dispute may be finally resolved
by a majority of the panel of three arbitrators so selected. The decision of the
arbitrator or arbitrators shall be final and binding upon the parties both as to
law and fact. The expense of the arbitration shall be shared equally by the
parties, unless the arbitration award states that the expense shall be otherwise
assessed. Any such arbitration shall take place in Los Angeles, California.
9.7 CHOICE OF LAW. This Agreement is to be read and construed in
accordance with, and governed by, California law.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be duly executed as of the date first above written.
ALPHA THERAPEUTIC CORPORATION
By: /s/ H. Xxxxxx Xxxxxxx
----------------------------------------------
H. Xxxxxx Xxxxxxx, President & CEO
Date: November 14, 1997
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TECHNICLONE CORPORATION
By: /s/ Xxxx X. Xxxxxxxxx
----------------------------------------------
Xxxx X. Xxxxxxxxx, Vice President - Business Development
Date: November 14, 1997
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EXHIBIT "A"
Case Report Forms
Investigator Brochures
Investigator Correspondence Files
Nonstatutory SOPs
Protocols
SOPs
Marketing Research
Marketing Plans
The worldwide rights to the Tradename/Trademark "Oncolym(TM)", including all
applications and approvals thereof and all files related thereto. Techniclone
shall be responsible for all notifications and filing fees associated with such
transfer. Alpha agrees to cooperate with the prompt execution of all necessary
documentation.
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EXHIBIT "B"
ASSIGNMENT OF TRADEMARK
WHEREAS, Alpha Therapeutic Corporation, a California corporation
("Alpha"), of 0000 Xxxxxx Xxxxxxxxx, Xxx Xxxxxxx, Xxxxxxxxxx 00000, has adopted,
is using and is the owner of the following trademark, which is registered in the
United States Patent and Trademark Office:
REGISTERED TRADEMARKS
REGISTRATION
TRADEMARK REGISTRATION NO. DATE
--------- ---------------- ----
Oncolym 2,031,214 1/14/97
WHEREAS, Techniclone Corporation, a Delaware corporation
("Techniclone"), of 00000 Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxx 00000, is desirous
of acquiring all right, title and interest of Alpha in the trademark and the
registration thereof, together with the goodwill of the business symbolized by
the trademark;
NOW, THEREFORE, for good and valuable consideration, the receipt of
which is hereby acknowledged, said Alpha does hereby sell, assign and transfer
unto Techniclone all of its right, title and interest in and to the trademark,
together with the goodwill of the business symbolized by the trademark and the
above identified registration.
IN WITNESS WHEREOF, Alpha Therapeutic Corporation has caused this
Assignment to be signed its duly authorized officer this ______ day of November
1997.
ALPHA THERAPEUTIC CORPORATION,
a California corporation
By:____________________________
Its:___________________________
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STATE OF CALIFORNIA )
) SS.
COUNTY OF _________________)
On November ______, 1997, before me,_________________________________
(name, title of officer, e.g., Xxxx Xxx, Notary Public")
personally appeared____________________________________________________________
(name(s) of signer(s))
[ ] personally known to me -- OR --
[ ] proved to me on the basis of satisfactory evidence
to be the person whose name is subscribed to the within instrument and
acknowledged to me that he executed the same in his authorized capacity, and
that by his signature on the instrument the person, or the entity upon behalf of
which person acted, executed the instrument.
Witness my hand and official seal.
__________________________________
(Signature of Notary)
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