AMENDMENT TO REVISED LICENSE AGREEMENT
Under this Amendment, effective March 25, 1994 (the "Amendment
Effective Date"), Research Corporation Technologies, Inc., a Delaware nonprofit
corporation, with offices at 000 X. Xxxxxx Xxxx, Xxxxx 000, Xxxxxx, XX, ("RCT"
or "LICENSOR"), and Enzon, Inc., a Delaware corporation, with offices at 00
Xxxxxxxxxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx, ("Enzon" or "LICENSEE") agree as
follows:
ARTICLE I
BACKGROUND
SECTION 1.1. RCT and Enzon are parties to that certain license
agreement made effective August 25, 1985, and subsequently amended (the "Revised
License Agreement") under which Enzon was granted the right to make, use and
sell certain complexes of polyethylene glycol ("PEG") and polypeptides of
interest under the "PATENT RIGHTS," as such term is defined in the Revised
License Agreement, and which PATENT RIGHTS include United States Patent No.
4,179,337, issued December 18, 1979, (the "U.S. PEG Patent"). Enzon, the Xxxxxxx
Kodak Company ("Kodak") and Sterling Winthrop Inc., formerly Sterling Drug,
Inc., ("Sterling") are parties to that certain agreement made effective June 19,
1989 concerning the development of, inter alia, complexes of PEG and superoxide
dismutase ("SOD") and the granting of a sublicense to Sterling under the Revised
License Agreement to make, use and sell PEG-SOD (the "Sterling Agreement").
Under the Sterling Agreement, Enzon, Kodak, and Sterling have obligations to
cooperate with RCT in obtaining any patent extension of the U.S. PEG Patent that
may be obtained by RCT and that RCT may desire to obtain.
SECTION 1.2. Section 156 of Title 35 of the United States Code entitles
RCT to seek extension of the term of a United States patent for one product
covered by such patent.
SECTION 1.3. Enzon desires that RCT agree to seek extension of the term
of the U.S. PEG Patent, to the extent such extension becomes available for
PEG-SOD and that RCT agree not to seek any other extension of the U.S. PEG
Patent based on any other drug product.
RCT is willing to so agree under the following terms and conditions.
SECTION 1.4. RCT desires to confirm Enzon's continuing obligation to
pay earned royalties during the term of any extension of the PATENT RIGHTS.
ARTICLE II
AMENDMENT
SECTION 2.1. Amendment to Article 7(a) of the Revised License
Agreement. Article 7(a) of the Revise license Agreement is hereby amended by
adding the following paragraph after the second paragraph of Article 7(a):
This paragraph shall apply if the term of United States Patent
4,179,337, issued December 18, 1979, (the "U.S. PEG Patent") is
extended beyond December 18, 1996 pursuant to Section 156 of Title 35
of the United States Code and the rights derived from such extension
apply to LICENSED PRODUCTS in Field C (the "PEG-SOD Extension").
LICENSEE and LICENSOR agree and affirm that, during the period of the
PEG-SOD Extension, if any, the rights and duties of the parties under
this License Agreement, and the terms of this License Agreement, as
they pertain to LICENSED PRODUCTS in Field C ("PEG-SOD Products"),
shall continue in full force and effect unchanged, including without
limitation LICENSEE's obligations to pay royalties for the manufacture,
USE or SALE of any PEG-SOD Product, throughout the term of the PEG- SOD
Extension, and the parties' obligations under Articles 9 and 16(j).
Nothing in any agreement or this Amendment shall affect, change or
diminish LICENSEE's or any SUBLICENSEE's obligation to pay earned
royalties to LICENSOR under this License Agreement through the
expiration of the PEG-SOD Extension, or any party's obligations under
Articles 9 or 16(j).
SECTION 2.2. Amendment to Add Article 17 to the Revised License
Agreement. The Revised License Agreement is hereby amended by adding the
following new Article 17 after Article 16:
17. The PEG-SOD Extension.
(a) Obligations of LICENSOR. Unless LICENSOR and LICENSEE
otherwise mutually agree, LICENSOR agrees to seek extension of the term
of U.S. PEG Patent, to the extent such extension is available, for
PEG-SOD and not to take any action or fail to take any action that
would preclude or delay such extension, or directly place the
availability of such extension in jeopardy. So long as the law of the
United States pertaining to extension of patents is understood or
interpreted to permit only one extension per patent under the
provisions of Section 156 of Title 35 of the United States Code (and
other corresponding sections of the law of the United States pertaining
to patent extension), LICENSOR agrees not to seek any extension of the
term of the U.S. PEG Patent for any other product covered by the U.S.
PEG Patent under the provisions of Section 156 of Title 35 of the
United States Code. The foregoing in no way prohibits LICENSOR from
seeking additional extensions by way of legislative or judicial means
and in no way prohibits LICENSOR from seeking other extensions under
Section 156 of Title 35 of the United States Code if such provision is
amended (or other provisions are added to the law of the United States)
to provide for multiple extensions or is interpreted in a final ruling
by a court of competent jurisdiction (from which no appeal can be or is
taken) to permit multiple extensions.
(b) Notice of PLA Filing for FDA Approval. If, on or before
December 18, 1996, LICENSEE or any SUBLICENSEE files with the FDA an
NDA or a Product License Application ("PLA") seeking FDA Approval to
market and sell a PEG-SOD Product, LICENSEE shall, immediately after it
is aware of such filing, notify
- 2 -
LICENSOR in writing of such filing. If LICENSOR becomes aware of such
filing, LICENSOR shall immediately notify LICENSEE in writing of such
filing. If neither LICENSEE nor LICENSOR has received notice by June
19, 1996 that the FDA has approved such NDA or PLA, the parties shall
confirm that fact in writing between themselves, the earliest dated
confirmation being hereafter referred to as the "Initiating Notice". If
LICENSEE or any SUBLICENSEE files with the FDA an NDA or PLA seeking
FDA approval to market and sell a PEG-SOD Product and such NDA or PLA
is approved by the FDA on or before December 18, 1996, LICENSEE shall,
immediately after it is aware of such approval, give LICENSOR written
notice (the "Initiating Notice") of such approval. If LICENSOR becomes
aware of such approval, LICENSOR shall immediately give LICENSEE
written notice (the "Initiating Notice") of such approval.
(c) Responsibility for PEG-SOD Extension; Periodic Reports. In
connection with filing for interim PEG-SOD Extensions (before FDA
approval of the PEG-SOD Product) and the final PEG-SOD Extension (after
such FDA approval) and any other PEG-SOD Extensions as may become
available for any reason, within ten days after LICENSOR's receipt or
issuance of any Initiating Notice, LICENSOR shall either: (i) file a
complete application with the United States Patent and Trademark Office
("USPTO") seeking the then-available PEG-SOD Extension; or (ii) subject
to Article 17(d) below, grant to LICENSEE the power of attorney,
substantially in the form of Exhibit A attached hereto, to seek the
then-available PEG-SOD Extension (and all subsequent PEG-SOD Extensions
available) on behalf of LICENSOR. Concurrently with the execution and
delivery of such power of attorney, LICENSOR shall execute and deliver
to LICENSEE the Right of Assignee, substantially in the form attached
to the power of attorney of Exhibit A. Every two weeks after the date
of each such Initiating Notice, through the date on which the PEG-SOD
Extension corresponding to such Initiating Notice is obtained or
finally denied, the party undertaking to obtain the PEG- SOD Extension
(the "Responsible Party") shall report to the other party in writing
regarding: (A) the status of the application; (B) the Responsible
Party's efforts to complete and file the application (including the
degree of cooperation received from any SUBLICENSEE, if such is
necessary); (C) any requests or inquiries received from the USPTO or
the FDA, and the Responsible Party's responses to such request or
inquiries; and (D) if applicable, the status of any administrative or
judicial proceedings concerning the PEG-SOD Extension, its preparation,
filing or prosecution. Although an extension may be in effect at the
time of a particular Initiating Notice, it is the intention of the
parties that all actions possible are taken to maximize and keep in
effect any PEG-SOD Extension.
(d) Best Effort Requirement. The Responsible Party covenants and
agrees to exercise its best efforts to obtain each such extension
until each PEG-SOD Extension is either obtained or it is finally
denied by a court of competent jurisdiction from which no appeal can
be taken. The other party shall fully and promptly cooperate with the
Responsible Party. "Best efforts" shall include, without limitation:
(i) timely preparing
- 3 -
and filing a complete application (subject to any delays that may arise
because a SUBLICENSEE does not cooperate with such preparation and
filing but further subject to the Responsible Party's obligation below
to pursue legal proceedings to cause any such SUBLICENSEE to provide
such information); (ii) timely and fully responding to any request by
the USPTO regarding the application; (iii) completely exhausting any
administrative proceedings, avenues or remedies that may be necessary
to obtain such extension; (iv) timely bringing any suit, appeal or
other legal proceeding in a court of competent jurisdiction to obtain
such extension or to obtain the information from any SUBLICENSEE
necessary to complete the application for the PEG-SOD Extension and to
cause such application to be timely filed; and (v) seeking extension by
virtue of action by any legislative or judicial authority. If, in the
reasonable opinion of the other party, the Responsible Party is failing
to exercise its best efforts to obtain the PEG-SOD Extension, the other
party may give the Responsible Party five days' written notice of such
opinion. If the Responsible Party fails, in the reasonable opinion of
the other party, to exercise its best efforts before the expiration of
such five day period to obtain the PEG-SOD Extension, the other party
may, in addition to any other remedies at law or equity, enforce the
requirements of this Article 17 through injunctive proceedings and an
action at law or equity. Additionally, if LICENSEE is the other party,
LICENSEE may request the court to order LICENSOR to grant LICENSEE the
power of attorney to prepare and file the application for any such
PEG-SOD Extension; if LICENSOR is the other party, LICENSOR may revoke
the power of attorney granted to LICENSEE to prepare and file such
application and may undertake to prepare and file such application on
LICENSOR's own behalf. The party from whom responsibility for seeking
the PEG-SOD Extension is taken pursuant to the preceding sentence shall
nonetheless cooperate with the efforts of the other party in seeking
each and every PEG- SOD Extension.
(e) Grant of Power of Attorney. If: (i) LICENSOR has not
previously granted LICENSEE a power of attorney to seek any PEG-SOD
Extension; (ii) a PLA or NDA before October 19, 1996; and (iii)
LICENSEE has provided LICENSOR with all information in its possession
that LICENSOR may desire for filing the interim PEG-SOD Extension but
LICENSOR has not filed for interim PEG-SOD Extension before October 19,
1996; then the power of attorney in the form attached to this Agreement
as Exhibit B shall become automatically effective on October 19, 1996
so as to enable LICENSEE to pursue the PEG-SOD Extension. The foregoing
provisions shall apply with equal force, and to the same effect and
extent, for any subsequent interim PEG-SOD Extension except that the
pertinent date on which such provision takes effect for any subsequent
interim PEG-SOD Extension shall be the date sixty days before the
expiration of the then-existing interim PEG-SOD Extension. If: (A)
LICENSOR has not previously granted LICENSEE a power of attorney to
seek any PEG-SOD Extension; (B) the FDA has approved an earlier-filed
PLA or NDA for a PEG-SOD Product; and (C) LICENSEE has provided
LICENSOR with all information in its possession that LICENSOR may
desire for filing the final PEG-SOD Extension but LICENSOR has not
filed for final PEG-SOD Extension on or before the later of the date
twenty days after the date of such
- 4 -
FDA approval or the date five days after LICENSOR's receipt of the
information from LICENSEE; then the power of attorney in the form
attached to the Agreement as Exhibit B shall become automatically
effective on the 21st day after the date of such FDA approval so as to
enable LICENSEE to pursue the PEG-SOD Extension. Concurrently with the
execution of this amendment to the Revised License Agreement, LICENSOR
shall execute and deliver to LICENSEE (or its designated
representative) the sole and exclusive power of attorney to seek any
and all available PEG-SOD Extension, which power of attorney shall take
the form of Exhibit B. Concurrently with the execution and delivery of
such power of attorney, LICENSOR shall execute and deliver to LICENSEE
the Right of Assignee, substantially in the form attached to the power
of attorney of Exhibit B. The effectiveness and validity of such power
of attorney shall be subject to, and contingent upon, the satisfaction
of the conditions specified in this Article 17(e)). LICENSEE shall hold
such power of attorney in escrow until such time as the conditions of
this Article 17(e) are, in the reasonable opinion of LICENSEE,
satisfied, at which time, and only at which time, such power of
attorney shall be filed with the United States Patent and Trademark
Office. LICENSEE acknowledges and agrees that if it files such power of
attorney with the USPTO at a time in which the foregoing conditions
have not been fully satisfied, such power of attorney shall be revoked
ab initio and shall have no further force and effect. LICENSOR may seek
any remedy at law or equity for LICENSEE's violation of the provisions
of this Article 17(e).
(f) No Conflicting Agreements. Each party represents and
warrants to the other party that the provisions of this Article 17 do
not violate, and are not inconsistent with or contrary to, any other
agreement, contract or understanding to which the representing party is
presently a party. Each party represents and warrants to the other
party that the representing party shall not enter into any agreement,
contract or understanding that would be violated by, inconsistent with,
or contrary to, the representing party's fulfillment of the
representing party's duties under this Article 17.
SECTION 2.3. Amendment to Article 1(e)(viii) of the Revised License
Agreement. Article 1(e)(viii) of the Revised License Agreement is hereby changed
to read as follows:
(viii) "LICENSED FIELD" shall mean Fields A, B, C, D, E, F, G, H and
I taken collectively, and, from and after the date of
extension of the license granted in ARTICLE 2 hereof to any
NEW FIELD, as defined in clause (x) of this ARTICLE 1(e),
shall also include each such NEW FIELD so added, but in no
event shall the LICENSED FIELD include the EXCLUDED FIELD.
SECTION 2.4. Amendment to Article 1(e) of the Revised License
Agreement. Article 1(e) often Revised License Agreement is hereby amended by
adding the following subparagraph (xi) after subparagraph (x) of Article 1(e):
- 5 -
(xi) "Field I" shall mean the making, Using and Selling of
PEG-polypeptide complexes, the polypeptide portion of which is
the enzyme glucocerebrosidase, hereinafter
"PEG-Glucocerebrosidase."
SECTION 2.5. Amendment to Article 6 of the Revised Licensed Agreement.
Article 6 of the Revised License Agreement is hereby amended by adding the
following Paragraph (e) to the end of Article 6:
(e) Notwithstanding the foregoing, no License Issue Fee, no
Annual License Maintenance Fee and no Annual Minimum Royalty shall be
due or payable by LICENSEE for Field I.
SECTION 2.6 Continued Effect. The Revised License Agreement shall
continue in force and effect unchanged, except as specifically set forth in this
document.
IN WITNESS WHEREOF, the parties have each caused a duly authorized
officer to sign this Amendment Agreement on the date(s) indicated below, to be
effective the Amendment Effective Date.
ENZON, INC. RESEARCH CORPORATION
TECHNOLOGIES, INC.
By:/S/XXXXXXX XXXXXXXXXX By:/S/XXXX X. XXXXXXXXX
------------------------ -----------------------
Title: President
Date:March 24, 1994 Date:March 24, 1994
- 6 -
