EXTENSION AGREEMENT
BY AND BETWEEN
EISAI CO., LTD.
AND
IGEN INTERNATIONAL, INC.
JULY 11, 2002
EXTENSION AGREEMENT
THIS EXTENSION AGREEMENT is made this 11th day of July 2002, by and between IGEN
International Inc. ("IGEN"), a Delaware corporation, having a principal place of
business at 00000 Xxxxxxxxxx Xxxxx, Xxxxxxxxxxxx, Xxxxxxxx 00000 U.S.A., and
Eisai Co., Ltd. ("Eisai"), a Japanese corporation, having a principal place of
business at 6-10, Xxxxxxxxxx 0-xxxxx, Xxxxxx-xx, Xxxxx 000-0000 Xxxxx.
BACKGROUND
A. IGEN and Eisai entered into an agreement dated May 25, 1990 ("Eisai/IGEN
License Agreement") and a supplemental agreement dated July 23, 1997
("Supplemental Agreement") whereby Eisai obtained certain exclusive rights
relating to IGEN's proprietary electrochemiluminescence (ECL) technology in
Japan.
B. IGEN and Eisai wish to extend the licensing arrangement relating to IGEN's
ECL technology in Japan set forth therein under certain modified terms.
Now, therefore, IGEN and Eisai agree as follows:
1. DEFINITION
1.1 Capitalized terms used herein and not defined herein shall have meanings
ascribed to them in the Eisai/IGEN License Agreement and the Supplemental
Agreement. The Eisai/IGEN License Agreement, the Supplemental Agreement and this
Extension Agreement are collectively referred to as AGREEMENTS.
2. EXTENSION
2.1 The parties agree that the Eisai/IGEN License Agreement and the Supplemental
Agreement will be extended to an expiration date (hereinafter the "Expiration
Date") that is the later of: (i) May 25, 2010; and (ii) the date of expiration
of the last of expired Licensed Patents or Improved Patents in the Territory
under the same terms and conditions described therein except those set forth
herein.
3. INSTRUMENTS
3.1 Subsection 2(A) of the Supplemental Agreement shall be replaced with the
following sentences from one (1) year after the date of execution of this
Agreement or a later date that IGEN may designate by written notice to EISAI
before expiration of the one (1) year period:
(A) Eisai has the non-exclusive right to market and sell the Eisai
Instrument in the Clinical Diagnostic Market in Japan, except for
Point-of-Care use for which Eisai is not entitled to market and sell
the Eisai Instrument.
3.2 Subsection 2(B) of the Supplemental Agreement shall be replaced with the
following sentences from one (1) year after the date of execution of this
Agreement or a later date that IGEN may designate by written notice to EISAI
before expiration of the one (1) year period:
(B) Eisai has the non-exclusive right to market and sell in the Clinical
Diagnostic Market in Japan except for Point-of-Care use, any Enhanced
Eisai Instrument that Eisai may develop and obtain authority to sell,
provided that Eisai shall have complied with the procedure specified
in Section 5(B) below with respect to each such Enhanced Eisai
Instrument. For the avoidance of doubt, Eisai is not entitled to
market and sell the Point-of-Care use of Enhanced Eisai Instruments.
3.3 Subsection 2(C) of the Supplemental Agreement shall become no force or
effect from one (1) year after the date of execution of this Extension Agreement
or a later date that IGEN may designate by written notice to EISAI before
expiration of the one (1) year period.
3.4 Subsection 2(E) of the Supplemental Agreement shall be replaced with the
following sentences:
(E) Eisai has the right to manufacture or have manufactured Eisai
Instruments and Enhanced Eisai Instruments in Japan. In case of any
manufacturing by parties other than Eisai, Eisai shall obtain legally
binding contractual commitments from the manufacturer to the effect
that IGEN's patents and other proprietary or confidential information
will be protected against disclosure or unauthorized use, and that the
manufacturer will grant back to IGEN a non-exclusive, perpetual,
royalty-free license (with the right to grant sublicenses) covering
any improvements to IGEN technology that the manufacturer may make.
The geographic scope of each such license shall be worldwide. Any
manufacturing of Eisai Instruments or Enhanced Eisai Instruments
outside Japan by Eisai or any other party under contact with Eisai
shall require the prior written consent of IGEN, which consent shall
not be unreasonably withheld. IGEN shall be entitled to withhold or
impose conditions on its consent to avoid conflict with exclusive
rights of other IGEN licensees or to protect IGEN technology or other
IGEN business interests reasonably implicated by the proposed
manufacturing outside Japan. In addition to seeking IGEN's consent for
such manufacturing, Eisai shall give IGEN a reasonable opportunity to
bid for the manufacturing work.
4. ASSAYS
4.1 From one year after the date of this Extension Agreement or a later date
that IGEN may designate by written notice to EISAI before expiration of the one
(1) year period, the final sentence of Subsection 3(A) of the Supplemental
Agreement shall be replaced with the following sentence:
The geographic scope of each such license shall be worldwide, each such
license shall be perpetual and IGEN shall have the right to grant
sublicenses thereunder.
4.2 Subsection 3(E) of the Supplemental Agreement shall be replaced with the
following sentence from one (1) year after the date of execution of this
Extension Agreement or a later date that IGEN may designate by written notice to
EISAI before expiration of the one (1) year period:
(E) IGEN may not sell in Japan, nor authorize or allow other parties to
sell in Japan, any Assays formatted for the Eisai Instrument or any
Enhanced Eisai Instrument, or any Assays produced from products or
material supplied by Eisai, except that IGEN shall be entitled to sell
or authorize others to sell such Assays (i) for markets other than the
Clinical Diagnostic Market in Japan, and/or (ii) for Point-of-Care use
in Japan.
4.3 From one year after the date of execution of this Extension Agreement or a
later date that IGEN may designate by written notice to EISAI before expiration
of the one (1) year period, Eisai shall take effective steps to ensure that its
Assays will not be compatible with instruments marketed by IGEN or its
sublicensees in the Territory.
5. IMPROVEMENTS
5.1 Attachment B lists the patents and patent applications issued to or filed by
Eisai or IGEN between the date of the Eisai/IGEN License Agreement and the date
of this Extension Agreement under which the other party is entitled to license
rights pursuant to Section 3.3. or Section 3.6. of the Eisai/IGEN License
Agreement, as the case may be.
6. ROYALTY
6.1 To reflect the value of unpatented know-how provided to or to be provided to
Eisai by IGEN in connection with the AGREEMENTS, notwithstanding Section 2.1. of
this Extension Agreement, for seven (7) years after the Expiration Date, Eisai
shall continue to pay royalties to IGEN with respect to Instruments and Assays
at one half (1/2) of the rate specified in the AGREEMENTS, on Net Sales as
defined in the Eisai/IGEN License Agreement.
Eisai and IGEN agree for the period of seven (7) years following the Expiration
Date of the AGREEMENTS that:
(i) Sections 4.4, 4.5, 5.4 (d), 7, 8 (except 8.2), 9, 13, 14 and 16 of the
Eisai/IGEN License Agreement (including the related definitions), and
(ii) Section 10 of the Supplemental Agreement (including the related
definitions),
shall remain in full force and effect between Eisai and IGEN.
Eisai and IGEN agree that the wording of the aforementioned sections shall be
deemed adjusted, as necessary, during such seven (7) year period to reflect the
royalty rate prescribed above to be paid to IGEN.
7. LICENSE REGISTRATION
7.1 Within thirty (30) days after one (1) year after the date of execution of
this Extension Agreement or a later date that IGEN may designate by written
notice to EISAI before expiration of the one (1) year period, Eisai and IGEN
shall jointly withdraw the senyo-jisshi xxx registrations which was filed
pursuant to Subsection 7(A) of the Supplemental Agreement,
and file an applications, in the form attached hereto as Attachment A for
registration covering non-exclusive license rights regarding Immunoassays under
the Japanese patent law in the governing patent office in Japan.
7.2 Subsection 7(B) of the Supplemental Agreement shall be deleted one (1) year
after the date of execution of this Extension Agreement or a later date that
IGEN may designate by written notice to EISAI before expiration of the one (1)
year period. On deletion of Subsection 7(B), any registration of non-exclusive
license rights for Eisai obtained pursuant to Section 7.1 of this Extension
Agreement shall terminate automatically upon the termination or expiration of
the AGREEMENTS, and shall thereafter be of no further force or effect.
7.3 From one (1) year after the date of execution of this Extension Agreement or
a later date that IGEN may designate by written notice to EISAI before
expiration of the one (1) year period, Eisai and IGEN and their respective
Affiliates shall each cooperate as needed in all actions with regard to
applications referred to in Section 7.1 above, and with regard to the resulting
registrations and enforcement of rights thereunder. Eisai and IGEN and their
respective Affiliates shall each cooperate as needed with regard to
deregistration in the event of termination or expiration of the AGREEMENTS.
8. ENFORCEMENT OF PATENT RIGHTS AGAINST THIRD PARTIES
8.1 The parties agree that Section 8 of the Supplemental Agreement shall become
no force and effect after one (1) year from the date of execution of this
Extension Agreement or a later date that IGEN may designate by written notice to
EISAI before expiration of the one (1) year period.
9. PUBLIC STATEMENTS
9.1 Section 10 of the Supplemental Agreement shall be replaced with the
following sentences:
In order to protect the integrity and confidentiality of the c commercial
relationship between Eisai and IGEN as reflected in the Eisai/IGEN
License Agreement, the Supplemental Agreement and the Extension
Agreement, each party and its officers and employees shall refrain
from issuing any press release, making any statement to any
third party, or otherwise disseminating any information or opinion that
might reasonably be interpreted as critical of the other party or its
performance pursuant to the agreements referred to above, except as
required by law or as part of the dispute resolution process set forth in
Section 7 of the Eisai/IGEN License Agreement. Each party shall also use
all reasonable efforts to ensure that its agent and other external
representatives comply with the terms of this Section 10.
10. EFFECTIVENESS
(A) This Extension Agreement shall become effective on the date as of which
authorized representatives of each of Eisai and IGEN shall have signed it below.
(B) At such time as this Extension Agreement may become effective, Eisai and
IGEN agree to be bound by the mutual promises and obligations herein.
(C) No parties shall be third party beneficiaries of this Extension Agreement,
or gain any rights directly by reason of it.
(D) Any dispute relating to the interpretation of this Extension Agreement or
performance according to its terms shall be resolved according to the provision
of Section 7 of the Eisai/IGEN License Agreement.
(E) It is agreed and acknowledged that, if there is inconsistency, contradiction
or discrepancy among paragraphs of this Extension Agreement and, those of the
Eisai/IGEN License Agreement and Supplemental Agreement, those of this Extension
Agreement shall control over those of the Eisai/IGEN License Agreement and
Supplemental Agreement.
It is further agreed and acknowledged that except as modified or nullified by
the terms and conditions of this Extension Agreement, all the provisions of the
Eisai/IGEN License Agreement and the Supplemental Agreement shall remain in full
force and effect between Eisai and IGEN until the AGREEMENTS are terminated or
expire.
Foregoing Agreed Upon:
IGEN International Inc.
By:
-------------------------------------------------
Name: Xxxxxx X. Xxxxxxxxxxx
Title: Chief Executive Officer
Eisai Co., Ltd.
By:
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Name: Xxxxxxxxx Xxxx
Title: Director of Diagnostic Division
