1
Exhibit 10.1
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
OPTION/LICENSE AGREEMENT
-------------------------
AGREEMENT ("Agreement") dated as of May 24, 1995 between XXXXXXX-XXXXX
SQUIBB COMPANY, a Delaware corporation having a principal place of business at
Xxxxx 000 xxx Xxxxxxxx Xxxx Xxxx, Xxxxxxxxx, XX 00000 ("BMS"), and GENETICS
INSTITUTE, INC., a Delaware corporation having its principal place of
business at 00 XxxxxxxxxXxxx Xxxxx, Xxxxxxxxx, XX 00000 ("GI").
WHEREAS, GI has invented a certain improved plasminogen activator
protein; and
WHEREAS, BMS is desirous of obtaining from GI, and GI is desirous of
granting to BMS, an exclusive license to such protein on the terms and
conditions set forth herein;
NOW, THEREFORE, in consideration of the mutual covenants and promises
contained in this Agreement and other good and valuable consideration, the
parties hereto agree as follows:
Article I. DEFINITIONS
-----------------------
As used in this Agreement, the following terms, whether used in the
singular or plural, shall have the following meanings:
1.1 "Confidential Information" means (a) all proprietary information
------------------------
and materials, patentable or otherwise, of a party which is disclosed by or on
behalf of such party to the other party, including DNA sequences, vectors,
cells, substances, formulations, techniques, methodology, equipment, data,
reports, know-how, preclinical and clinical trials and the results thereof,
patent positioning and business plans, including any negative developments, and
(b) any other information designated by the disclosing party to the other
party as confidential or proprietary, related to NPA or otherwise disclosed in
furtherance of the purposes of this Agreement.
1.2 "Effective Date" means May 15, 1995.
--------------
1.3 "Improvement" means any information, patentable or otherwise, of
-----------
BMS relating to the identification, characterization, expression, use or
production of NPA which is reasonably useful or necessary or is required to
develop, use, register, produce, formulate, fill and finish, distribute and/or
sell bulk NPA or products containing NPA as an ingredient, including, without
limitation, scientific discoveries, developments, preclinical data, clinical
data, and marketing approval and regulatory filings and records related
thereto.
1.4 "Know-How" means any information, patentable or otherwise, of GI
--------
(including that
2
licensed to GI by a third party as to which GI has the right to sublicense BMS)
relating to the identification, characterization, expression, use or
production of NPA which is reasonably useful or necessary or is required to
develop, use, register, produce, formulate, fill and finish, distribute
and/or sell bulk NPA or products containing NPA as an ingredient, including,
without limitation, scientific discoveries, developments, preclinical data,
clinical data, and marketing approval and regulatory filings and records
related thereto.
1.5 "Licensed Products" means any product containing NPA as an
-----------------
ingredient and any and all formulations, mixtures or compositions thereof
which, or the making, use or sale of which, is covered by a Valid Claim of any
of the Patent Rights and/or embodies any Know- How.
1.6 "Net Sales" means the aggregate United States Dollar equivalent of
---------
gross revenues derived by or payable to BMS, its affiliates and sublicensees
from or on account of the sale of Licensed Products to third parties, less (a)
credits, allowances, discounts, chargebacks or refunds, if any, actually
granted on account of quantity, cash or trade discounts, recalls, price
reductions, rejection or return of items previously sold, (b) excises, sales
taxes, value added taxes, consumption taxes, duties or other taxes imposed
upon and paid with respect to such sales (excluding income or franchise taxes
of any kind), (c) separately itemized insurance and transportation costs that
are incurred in shipping Licensed Products to such third parties and (d)
rebates or price reductions or adjustments required by law, regulation or
contract. Net Sales shall not include any transfer between BMS and any of its
affiliates or sublicensees for resale. In the event that BMS or any of its
affiliates or sublicensees shall make any transfer of Licensed Products to a
third party for other than monetary value, such transfer shall be considered a
sale for royalty purposes. Net Sales for any such transfers shall be the
average price of "arms length" sales in the relevant country during the
royalty reporting period in which such transfers occur. If no "arms length"
sales shall have occurred in the relevant country during such period, the
relevant reference factor shall be the last royalty reporting period in which
such "arms length" sales occurred. If no "arms length" sales shall have
occurred in the relevant country, the relevant reference factor shall be the
average price of "arms length" sales in all countries. Notwithstanding the
foregoing, no transfer of Licensed Products for test or developmental purposes
or as free samples shall be considered a sale for royalty purposes. In the
event that BMS or any of its affiliates or sublicensees shall sell Licensed
Products together with other products and the price attributable to Licensed
Products is less than the average price of "arms length" sales of Licensed
Products for the relevant country for the royalty reporting period in which
such sales occur (such sales to be excluded from the calculation of "arms
length" sales), Net Sales for any such sales shall be the average price of
"arms length" sales of Licensed Products in the relevant country during the
royalty reporting period in which such sales occur. If no "arms length" sales
shall have occurred in the relevant country during such period, the relevant
reference factor shall be the last royalty reporting period in which such "arms
length" sales occurred. If no "arms length" sales shall have occurred in the
relevant country, the relevant reference factor shall be the average price of
"arms length" sales in all countries.
1.7 "NPA" means the protein identified on Schedule A to this
---
Agreement.
1.8 "Patent Rights" means all patents and patent applications (which
-------------
for purposes of this
3
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Agreement shall be deemed to include certificates of invention and applications
for certificates of invention and priority rights), of GI (including those
licensed to GI by a third party as to which GI has the right to sublicense
BMS), including any reissues, extensions or other governmental acts which
effectively extend the period of exclusivity by the patent holder,
substitutions, confirmations, registrations, revalidations, additions,
continuations, continuations- in-part, or divisions of or to any of the
foregoing, which relate to NPA and are reasonably useful or necessary or are
required to develop, use, register, produce, formulate, fill and finish,
distribute and/or sell bulk NPA or products containing NPA as an ingredient.
1.9 "Territory" means all countries of the world other than Japan, the
---------
People's Republic of China (including Hong Kong once Hong Kong reverts to the
People's Republic of China in 0000), Xxxxx Xxxxx and Taiwan.
1.10 "Valid Claim" means (a) a claim of an unexpired patent which shall
-----------
not have been withdrawn, canceled or disclaimed, nor held invalid or
unenforceable by a court of competent jurisdiction in an unappealed or
unappealable decision or (b) a claim of a patent application which has not
been on file for more than seven years, provided that the foregoing seven-year
period shall be tolled during any period in which such claim is the subject of
a pending patent interference proceeding.
Article II. OPTION
-------------------
2.1 Grant of Option. GI hereby grants to BMS the option (the
---------------
"Option"), exercisable by written notice to GI at any time on or prior to
******************, subject to extension as set forth in Section 2.2 of this
Agreement (the "Option Period"), to enter into a definitive agreement (the
"License Agreement") in implementation of the licenses of the Patent Rights and
Know-How in the Territory granted to BMS in this Agreement.
2.2 Option/License Fee. In consideration of the Option and the
------------------
licenses granted to BMS in this Agreement, BMS shall make the following
payments to GI within thirty (30) days of the dates set forth below (the
"Option/License Fees"):
Date Payment
---- -------
Effective Date $*********
***************** or the date of $*********
completion of BMS's ************
*******************, whichever occurs first
******************, the date of $*********
commencement of BMS's *****************
or the effective date of the License Agreement,
whichever occurs first
3
4
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Notwithstanding the foregoing, in the event that BMS shall fail to receive, on
or before ******************, sufficient initial supply of bulk and formulated
and finished NPA to meet its reasonable requirements for the commencement of
its ***************************** in ****** or sufficient data as contemplated
by Section 3.1(b) of this Agreement and the last sentence of Section 3.1 of
this Agreement for the commencement of its ********************* *************
in ******, the foregoing payment dates and Option Period shall be extended as
follows, provided that BMS shall have specified its reasonable needs with
respect to such supply and data on or prior to *************:
Receipt Date Extended Payment Dates Extended Option Period
------------ ---------------------- ----------------------
After **************, but on **************** or the date Until ****************
or prior to **************** of completion of BMS's *****
*************************
whichever occurs first
****************, the date of
commencement of BMS's ******
******** or the effective date of
the License Agreement, whichever
occurs first
After ***************, but on ***************** or the date Until ************,
or prior to ***************** of completion of BMS's ***** ****
*************************,
whichever occurs first
*****************, the date of
commencement of BMS's ******
********* or the effective date of
the License Agreement, whichever
occurs first
After ***************** ***************** or the date Until ************,
of completion of BMS's ***** ****
**************************,
whichever occurs first
*****************, the date of
commencement of BMS's *******
********** or the effective date of
the License Agreement, whichever
occurs first
4
5
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Other than the three payments specified in this Section 2.2, there shall be no
license, milestone or other like fees payable by BMS to GI under this Agreement
or the License Agreement.
2.3 Refund. The Option/License Fees shall not be refundable except as
------
follows. BMS shall be entitled, by delivering written notice to GI at
any time on or prior to ***************, to receive from GI a refund of the
******************************* payment due on the Effective Date in the event
that, on or prior to *****************, (a) GI shall fail to have in place the
written agreement called for by Sections 3.1(a)-(d) of this Agreement, (b) BMS
shall fail to receive sufficient supply of bulk and formulated and finished
NPA to meet its reasonable requirements for its *****************************
in ******, provided that BMS shall have specified its reasonable needs with
respect to such supply on or prior to ************, (c) BMS shall fail to
receive the data called for by Section 3.1(b) of this Agreement, provided that
BMS shall have specified its reasonable needs with respect to such data on or
prior to *************, (d) BMS shall fail to receive the data in GI's
possession as of June 30, 1995 called for by the last sentence of Section 3.1
of this Agreement, provided that BMS shall have specified its reasonable needs
for such data on or prior to *************, (e) the data delivered to BMS in
accordance with the agreement contemplated by Section 3.1(b) of this Agreement
and in GI's possession as of June 30, 1995 in accordance with the last
sentence of Section 3.1 of this Agreement prove to be deficient in any
material respect for the ****** of ****** in the ************ covering the ***
of *** as a ****************, (f) the ********** that the ********* **********
contemplated by BMS as described in Section 3.2 of this Agreement is not
******* for ************, or (g) BMS reasonably determines that the
***************** used by GI's existing licensee of NPA, Suntory Limited
("Suntory"), to ********************** of *** or that proposed to be used to
************************* of *** (if a **************) is likely to ********
any ************************ not identified on ********* to this Agreement.
2.4 Agreement Not to License. For the avoidance of doubt, in
------------------------
consideration of the payment of the Option/License Fees to GI and in
recognition of BMS's exclusive rights under the licenses granted to BMS in
this Agreement, GI acknowledges that it has no right to enter into any license
agreement with any third party granting rights to market NPA in the Territory.
2.5 Option/License Termination. The failure of BMS to make any of the
--------------------------
payments set forth in Section 2.2 of this Agreement when due or to exercise the
Option within the Option Period in accordance with Section 2.1 of this
Agreement shall not be deemed to be a breach of this Agreement by BMS.
However, in the event that BMS shall fail to make any of the payments set
forth in Section 2.2 of this Agreement when due or shall fail to exercise the
Option within the Option Period in accordance with Section 2.1 of this
Agreement, the Option, the licenses granted to BMS in this Agreement and this
Agreement shall terminate immediately. Further, in the event that BMS shall
exercise any of its rights to receive a refund of the
************************** payment due on the Effective Date in accordance with
the terms of Section 2.3 of this Agreement, the Option, the licenses granted
to BMS in this Agreement and this Agreement shall terminate immediately. In
the event of any termination of the Option, the licenses granted to BMS in
this Agreement and this Agreement, GI shall have no further obligation to
license the Patent Rights or Know-How to BMS in the Territory and GI shall be
5
6
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
free to license or otherwise utilize or dispose of the Patent Rights and
Know-How in the Territory in any manner it deems appropriate.
2.6 Exercise of Option. In the event that BMS exercises the Option,
------------------
the parties agree to negotiate in good faith the terms of the License
Agreement with the goal of executing such an agreement within one hundred
twenty (120) days of the exercise of the Option by BMS. The License Agreement
shall incorporate all of the terms and conditions provided herein for the
licenses granted in this Agreement, contain additional customary and
commercially reasonable terms and conditions and otherwise be consistent with
the intent and purpose of this Agreement. The parties further agree that any
failure to finalize the License Agreement shall not affect the continued
validity, effectiveness and enforceability of the licenses granted in this
Agreement.
Article III. RIGHTS AND OBLIGATIONS DURING OPTION PERIOD
---------------------------------------------------------
3.1 Obligations of GI. Upon execution of this Agreement, GI shall use
-----------------
commercially reasonable and diligent efforts to obtain from Suntory a
written agreement, in form and substance reasonably satisfactory to BMS,
to (a) supply BMS with its reasonable preclinical and clinical requirements
of bulk and formulated and finished NPA ******* the ******** of
***************** in ****** and ************************* to *****
the ********************* to ***********************, (b) grant BMS access to
such laboratory, preclinical, clinical, manufacturing and other scientific and
technical data in Suntory's possession as of June 30, 1995 and as shall be
reasonably useful or necessary or required in order for BMS to file an IND in
the United States covering the use of NPA as a thrombolytic agent or
otherwise, it being understood that such data shall be furnished to BMS in the
same form possessed by Suntory, (c) transfer and license to BMS all biological
materials and manufacturing technology of Suntory as shall be reasonably
useful or necessary or required in order for BMS to produce its further
preclinical and clinical and commercial requirements of bulk and formulated
and finished NPA and (d) exchange with BMS on a reciprocal basis future
scientific and technical data which BMS and Suntory may develop or acquire.
The terms of the agreement contemplated by the foregoing clauses shall include
financial and other terms reasonably acceptable to BMS, it being specifically
understood that *** will be ********** for ***************** with its
*****************, the ******************, and the ***************** of
*********, and that access to Suntory's data existing as of June 30, 1995 shall
be **** of ****** to ***. GI shall also furnish BMS with all laboratory,
preclinical, clinical, manufacturing and other scientific and technical data in
GI's possession from time to time and as shall be reasonably useful or
necessary or required in order for BMS to file an IND in the United States
covering NPA as a thrombolytic agent or otherwise, it being understood that
such data shall be furnished to BMS in the same form possessed by GI.
3.2 Obligations of BMS. As soon as practicable, BMS shall contact the
------------------
*** to determine whether the ************************ contemplated by BMS, a
**************** involving ************************************* and
*********************, will be ******** for *********. For purposes of
facilitating GI's meeting the time lines called for in this Agreement for the
entering into of the agreement with Suntory and the furnishing of BMS,
6
7
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
either directly or through Suntory, with supply and data, on or prior to
*************, BMS shall furnish GI with an estimate of its reasonable
preclinical and clinical requirements of bulk and formulated and finished NPA
******* the ********** of its ************************* ***** in ****** and
shall furnish GI with a written list of the data specifically requested by it
to be furnished for the commencement of its *************************** in
****** and for the ****** of its *** in the ***********. Upon receipt of the
data called for by Section 3.1(b) of this Agreement and the data in GI's
possession as of June 30, 1995 called for by the last sentence of Section 3.1
of this Agreement, BMS shall, as soon as practicable, use commercially
reasonable and diligent efforts to procure an *** and
********************************* and, in addition thereto, upon receipt of
sufficient initial supply of bulk and formulated and finished NPA, BMS shall,
as soon as practicable, use commercially reasonably and diligent efforts to
************************ in ****** and the *************.
3.3 License to BMS. Subject to the reservations set forth in this
--------------
Section 3.3, during the Option Period, BMS shall have the
exclusive right to practice the Patent Rights in the Territory and to use the
Know-How in the Territory for the sole and exclusive purpose of performing its
obligations under Section 3.2 of this Agreement and for the purpose of
developing a commercial manufacturing process for producing bulk NPA. GI
reserves the right to practice the Patent Rights in the Territory and to use
the Know-How in the Territory for the purpose of conducting research and
development to support either BMS or Suntory.
3.4 Patent Prosecution and Infringement. During the Option Period, GI
-----------------------------------
shall have the exclusive right, at its own expense, to seek, obtain and
maintain patents in the Territory and to initiate litigation against infringers
in the Territory. GI shall keep BMS informed of its activities in these areas.
3.5 License to Improvements. BMS hereby grants to GI a non-exclusive,
-----------------------
royalty-free license to all Improvements, including the right to grant
sublicenses, for the sole and exclusive purpose of (a) producing bulk NPA both
within and outside the Territory, but only for distribution and sale outside
the Territory, (b) developing, using, registering, formulating, filling and
finishing, distributing and/or selling Licensed Products outside the Territory
and (c) in the event that the Option, the licenses granted to BMS in this
Agreement and this Agreement expire or terminate for any reason without BMS
having exercised the Option, distributing and selling bulk NPA within the
Territory and developing, using, registering, formulating, filling and
finishing, distributing and/or selling Licensed Products within the Territory.
3.6 Data Exchange. BMS acknowledges that GI has licensed, and may
-------------
further license, NPA outside the Territory. During the Option Period, BMS
agrees to provide GI with a summary of BMS's preclinical and clinical testing
results and other data related to the testing and approval of Licensed
Products which GI may provide to any GI licensee outside the Territory which
is under a similar contractual obligation to GI to provide summaries of such
licensee's corresponding results and data to BMS, either directly or through
GI. In the event that a licensee of GI does not provide to BMS such summaries
of preclinical and clinical testing results and other data, GI shall not make
BMS's summaries available to such licensee except to
7
8
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
the extent necessary to disclose any adverse effects of a Licensed Product or
as otherwise required by law. In the event that a licensee requests more
detailed information than that provided in a summary, but on which the summary
was based, BMS agrees to comply with such request, provided that such
licensee is under a similar contractual obligation to GI to provide such
information to BMS, either directly or through GI.
Article IV. TERMS OF LICENSE
-----------------------------
4.1 General. In the event that BMS exercises the Option, the License
-------
Agreement shall contain such terms and conditions as are described in this
Article IV and such other terms and conditions as are agreed upon by the
parties in accordance with Section 2.6 of this Agreement. In the event that
BMS shall fail to exercise the Option in accordance with the terms of Section
2.1 of this Agreement, the terms and conditions described in this Article IV
shall cease to be effective.
4.2 Exclusive License. GI hereby grants to BMS an exclusive license
-----------------
in the Territory under the Patent Rights and an exclusive license in the
Territory to use the Know-How, including the right to grant sublicenses, for
the sole and exclusive purpose of producing bulk NPA and developing, using,
registering, formulating, filling and finishing, distributing and/or selling
Licensed Products. The exclusive license under the Patent Rights shall be for
the life of the Patent Rights and the exclusive license to use the Know-How
shall be for a period of twelve (12) years from the first commercial sale in
each country of a Licensed Product. Thereafter, the license to use the
Know-How in the Territory shall become a perpetual, paid-up, non- exclusive
license.
4.3 License to Improvements. The License Agreement shall contain
-----------------------
provisions comparable to those set forth in Section 3.5 of this Agreement,
provided that the provisions of Section 3.5(c) of this Agreement shall apply
to any termination of the License Agreement not due to GI's breach of the
License Agreement.
4.4 Royalties. BMS shall pay GI earned royalties at the initial rate
---------
of ********************************** on Net Sales by BMS and its affiliates
and sublicensees of Licensed Products until such time as the Net Sales in the
Territory for any one calendar year exceed **** *************************.
Upon the attainment of such sales threshold, (a) two (2) royalty rates shall
apply with respect to the Net Sales during the calendar year in which the sales
threshold is met, namely, ******************************* for the first
*********************** of such Net Sales and fifteen percent (15%) for the
portion of such Net Sales in excess of ******************************* and (b)
the royalty rate shall be adjusted for all Net Sales in subsequent calendar
years to equal fifteen percent (15%) of Net Sales by BMS and its affiliates
and sublicensees of Licensed Products. Notwithstanding the foregoing, where
the manufacture, use or sale of a Licensed Product is not covered by a Valid
Claim of any Patent Right and where a generic form of NPA is being
commercially sold by a third party in a particular country in the Territory,
the earned royalties payable by BMS in respect of such Licensed Product in
such country in the Territory shall be reduced to *************** of the
8
9
amount that would otherwise be payable by BMS to GI. Royalties shall be
payable on a country-by-country basis in the Territory for the life of the
Patent Rights in the case of each Licensed Product the manufacture, use or
sale of which is covered by a Valid Claim of the Patent Rights, or, in the
absence of such Patent Rights, twelve (12) years from the first commercial
sale in each country of a Licensed Product embodying any Know-How. There shall
be no minimum or other unearned royalties due GI. BMS shall also be
responsible for and pay all license fees or royalties, should there be any,
which may be due third parties in connection with the production of bulk NPA,
the formulation of NPA and the filling and finishing of Licensed Products.
4.5 Other Terms. The License Agreement shall contain customary
-----------
diligence (namely, commercially reasonable and diligent efforts on BMS's part
to continue to develop NPA and to commercialize Licensed Products), royalty
reporting, patent prosecution, infringement and claimed infringement, adverse
event reporting, confidentiality, product liability indemnity and termination
(including BMS's right to terminate at will subject to transfer to GI of all
data, licenses and approvals, trademarks and similar items) provisions.
Article V. CONFIDENTIALITY
---------------------------
Each party agrees (a) to maintain the Confidential Information of the
other party and not to use it for any purpose except for the purposes set
forth in this Agreement and (b) not to disclose the Confidential Information
of the other party to others (except to employees and consultants of a party
who reasonably require the Confidential Information for the purposes of this
Agreement and who are bound by an obligation of confidentiality to the
receiving party) without the express written permission of the other party,
except that a party shall not be prevented from using or disclosing
Confidential Information which (i) was known or used by the receiving party
prior to its date of disclosure to the receiving party, as demonstrated by
legally admissible evidence available to the receiving party, (ii) either
before or after its date of disclosure to the receiving party is lawfully
disclosed to the receiving party by an independent, unaffiliated third party
rightfully in possession of the Confidential Information (but only to the
extent of the rights obtained from such third party), (iii) either before or
after its date of disclosure to the receiving party becomes published or
otherwise part of the public domain through no fault or omission on the part of
the receiving party or (iv) is required to be disclosed by the receiving party
to comply with applicable laws or regulations or to defend or prosecute
litigation, provided that the receiving party provides prior written notice of
such disclosure to the other party and takes all reasonable action s to avoid
and/or minimize the degree of such disclosure. In addition, nothing in this
Article V shall be construed as precluding BMS from disclosing or using the
Confidential Information of GI in connection with conducting preclinical and
clinical trials, pursuing product registrations, sublicensing its rights
hereunder or any other transaction contemplated by this Agreement.
Article VI. MISCELLANEOUS
--------------------------
6.1 Survival. The provisions of Section 3.5 of this Agreement shall
--------
survive any
9
10
expiration or termination of the Option and this Agreement without BMS having
exercised the Option. The provisions of Article V of this Agreement shall
survive for five (5) years following any expiration or termination of the
Option and this Agreement, provided that the provisions of Article V shall be
perpetual with respect to any and all data supplied by Suntory to BMS that is
conspicuously marked as "confidential."
6.2 Publicity. Except as is otherwise required by law, neither party
---------
shall originate any publicity, news release or public announcement, written or
oral, relating to this Agreement without the prior written approval of the
other party, which approval shall not be unreasonably withheld.
6.3 Notices. Any notice or other communication in connection with
-------
this Agreement must be in writing and if by mail, by certified mail,
return-receipt requested, and shall be effective when delivered to the
addressee at the address listed below or at such other address as the
addressee shall have specified in a notice sent in accordance with this Section
6.3. Notice by facsimile shall constitute valid notice if delivered to the
facsimile number listed below or at such other facsimile number as the
addressee shall have specified in a notice sent in accordance with this
Section 6.3, provided that the receipt of such facsimile is confirmed by the
addressee in writing and further provided that such notice shall be effective
only when receipt of such facsimile is confirmed.
BMS: Xxxxxxx-Xxxxx Squibb Company GI: Genetics Institute, Inc.
X.X. Xxx 0000 00 XxxxxxxxxXxxx Xxxxx
Xxxxx 000 and Province Line Road Cambridge, MA 02140
Xxxxxxxxx, XX 00000-0000 Attn: General Counsel
Attn: Xxxx X. Xxx, Vice President Fax: (000) 000-0000
Licensing
Fax: (000) 000-0000
6.4 Assignment. This Agreement, and the rights and obligations
----------
hereunder, may not be assigned or transferred by either party without the
prior written consent of the other party, except that a party may assign this
Agreement to an affiliated company or in connection with such party's merger,
consolidation or sale of all or substantially all of its assets.
6.5 Entire Agreement and Modification. This Agreement constitutes the
---------------------------------
entire agreement of the parties with regard to its subject matter and
supersedes all previous written or oral representations, agreements and
understandings between the parties. This Agreement may be amended only by a
writing signed by the parties.
6.6 Governing Law. This Agreement shall be governed by and
-------------
interpreted in accordance with the laws of the Commonwealth of Massachusetts.
6.7 Counterparts. This Agreement may be executed in any number of
------------
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same
10
11
instrument.
IN WITNESS WHEREOF, the parties hereto have set their hand and seal as
of the date first above written.
XXXXXXX-XXXXX SQUIBB COMPANY
By: /s/ Xxxxxxx Xxxxxxx
----------------------------------------
Name: Xxxxxxx Xxxxxxx
-----------------------------------------
Title: Vice President and Senior Counsel
---------------------------------
GENETICS INSTITUTE, INC.
By: /s/ Xxxx Xxxxxx
-----------------------------------
Name: Xxxx Xxxxxx
---------------------------------
Title: Vice President, Corporate
----------------------------------
Development
----------------------------------
11
12
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Schedule A
----------
NPA
---
NPA is a tissue plasminogen activator protein variant known at GI as
XXXX and defined as the plasminogen activating material produced by expression
in a mammalian host cell of a DNA sequence encoding the peptide sequence for
tPA (published Figure 1 of United States Patent 4,740,461 (Xxxxxxx)) modified
in the following respects: (1) delete codons Cys 6 through Ile 86; and (2)
replace the Asn codon at position 117 with a Gln codon, where the codons are
numbered with Ser-1 of the mature protein.
Third Party Patents
-------------------
************************ *************************
*************************
*************************
****************** *************************
*************** *************************
*************************
*************************
13
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Genetics Institute, Inc.
00 XxxxxxxxxXxxx Xxxxx
Xxxxxxxxx, XX 00000
September 21, 0000
Xxxxxxx-Xxxxx Xxxxxx Company
Xxxxx 000 xxx Xxxxxxxx Xxxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Re: Option/License Agreement between Xxxxxxx-Xxxxx Squibb Company
and Genetics Institute, Inc. dated May 24, 1995 and Supply, Data
Exchange and Manufacturing Technology License Agreement BETWEEN
Genetics Institute, Inc. and Suntory Limited dated September 21,1995
--------------------------------------------------------------------
Gentlemen:
Reference is made to the Option/License Agreement between Xxxxxxx-Xxxxx Squibb
Company ("BMS") and Genetics Institute, Inc. ("GI") dated May 24, 1995 (the
"Agreement") and the related Supply, Data Exchange and Manufacturing
Technology License Agreement between GI and Suntory Limited ("Suntory") of
even date herewith (the "Suntory Agreement"). The purpose of this letter is
to set forth certain supplemental terms to the Agreement which relate to the
Suntory Agreement. Capitalized terms used herein and not otherwise defined
shall have the meanings given them in the Agreement.
1. You hereby agree to purchase the quantities and form of NPA set
forth in Section 1.1 of the Suntory Agreement for the purchase price set
forth in Sections 1.4 and 1.5 of the Suntory Agreement, provided that the
condition under Section 1.6 of the Suntory Agreement has been met and the
NPA supplied by Suntory meets the specifications called for by Section 1.3
of the Suntory Agreement. This obligation shall survive any termination
of the Agreement. Further, for purposes of Section 1.3 of the Suntory
Agreement, we hereby agree that, as between BMS and GI, all discussions and
decisions pertaining to the specifications applicable to the NPA to be
supplied by Suntory shall be under your exclusive reasonable control.
2. You hereby acknowledge that, with respect to your reasonable requirements
for the commencement of your ***************************** in ******, you
have elected
14
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
to purchase from Suntory a custom filled and finished form of NPA that
cannot be delivered by Suntory on or before ******************.
Accordingly, the second sentence of Section 2.2 of the Agreement is hereby
amended to read in its entirety as follows:
"Notwithstanding the foregoing, in the event that BMS shall fail to
receive, on or before ****************** (the date of receipt being
referred to in the table below as the "Data Receipt Date"), sufficient
data as contemplated by Section 3.1(b) of this Agreement and the last
sentence of Section 3.1 of this Agreement for the commencement of its
******************************* in ******, the foregoing payment dates and
Option Period shall be extended as follows, provided that BMS shall have
specified its reasonable needs with respect to such data on or prior to
*************:
Data Extended Extended
Receipt Date Payment Dates Option Period
------------ ------------- -------------
After *********** ************** or the date Until *******
****, but on or of completion of BMS's ********
prior to *********, *********************
**** **************, whichever
occurs first
****************, the date of
commencement of BMS's *****
************** or the effective
date of the License Agreement,
which ever occurs first
After **********, ***************** or the date Until ********
****, but on or of completion of BMS's ***** ********
prior to ******** *************************
******** *****, whichever occurs first
*****************, the date
of commencement of BMS's
********************* or the
effective date of the License
Agreement, whichever
occurs first
After ******** ***************** or the date Until ********
******** of completion of BMS's ***** ********
*************************
2
15
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
*****, whichever occurs first
*****************, the date
of completion of BMS's
********************* or the
effective date of the License
Agreement, whichever
occurs first
As used in this Agreement, Suntory Agreement means the Supply, Data
Exchange and Manufacturing Technology License Agreement between GI and
Suntory dated September 21, 1995."
In addition, you hereby agree that the refund provisions of Section 2.3 of
the Agreement shall not apply with respect to clause (b) thereof unless you
shall fail to receive the supply of NPA called for by Section 1.1 of the
Suntory Agreement on or prior to *****************. If such failure
occurs, you shall be entitled, as otherwise provided in Section 2.3(b) of
the Agreement, by delivering written notice to GI at any time on or prior
to **************, to receive from GI a refund of the ******************
************ payment due on the Effective Date.
3. With respect to Section 1.1 of the Suntory Agreement, you agree to
advise us in writing as to the additional stability studies you desire to
have Suntory conduct. You further agree to pay the reasonable costs for
the additional stability tests requested by you.
4. With respect to Section 1.1 of the Suntory Agreement, you agree to pay
the costs for the preparation of the drug master file if required in
order for you to conduct your dose- ranging Phase II clinical trial or any
subsequent clinical trial involving NPA supplied by Suntory.
5. With respect to Section 1.2 of the Suntory Agreement, you agree to
advise us in writing on or before *************** as to any preclinical,
clinical and/or proof of equivalency requirements of NPA that you desire
to have Suntory supply in calendar years 1996 and 1997. You further
acknowledge that, ************** the ********************** of ***********
of the *****************, our ********** to you set forth in ******* of
*********** of the Agreement shall remain unaltered.
6. With respect to Sections 1.3 and 1.5 of the Suntory Agreement, you
agree that any rejection by you of any shipment of NPA as not meeting the
warranted specifications for such NPA shall be made by you within ** days
of your receipt of the applicable invoice; otherwise you shall be deemed
to have accepted the shipment for purposes of Section 1.5 of the Suntory
Agreement.
7. With respect to Section 1.5 of the Suntory Agreement, you agree to pay
us for each
3
16
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
accepted shipment of NPA within ** days of your receipt of the
applicable invoice. In addition, if we so request, in each case where the
related purchase order was submitted by you directly to Suntory, you agree
to make such payments directly to Suntory on behalf of us.
8. For purposes of Sections 1.3 and 1.5 of the Suntory Agreement, you
agree that the following notification procedures shall apply. Upon
receipt of the applicable invoice from Suntory, GI shall send a copy of
the applicable invoice to you by facsimile to facsimile number (908)
519-3962 to the attention of Alistar X. Xxxxxxx and shall send a
confirmatory copy of the applicable invoice to you by overnight express
mail to the attention of Alistar X. Xxxxxxx, Xxxxxxx-Xxxxx Squibb Company,
P. X. Xxx 000, Xxx Xxxxxxxxx, Xxx Xxxxxx 00000-0000. So long as GI
complies with the foregoing confirmatory notice procedure, the applicable
invoice shall be deemed to be received by you on the day the facsimile of
the applicable invoice is sent to you. In addition, if we so request, you
agree to confirm in writing your receipt of the applicable invoice within
two business days of your deemed receipt of the applicable invoice.
9. You agree to the use restrictions on the documentation furnished to GI
pursuant to Section 2.1 of the Suntory Agreement set forth in Section 2.2
of the Suntory Agreement. You further agree to the right of review and
consent granted to Suntory in Section 2.2 of the Suntory Agreement and
agree to comply with the provisions set forth in Section 2.2 of the
Suntory Agreement pertaining to the preparation and review of translations
and summaries.
10. With respect to Section 2.3 of the Suntory Agreement, you agree to
directly disclose to both us and Suntory all data and information regarding
the adverse effects and any other adverse events which occur in
association with any product (either for development or commercial use)
which contains NPA as an ingredient that you obtain subsequent to June 30,
1995. You further agree to enter into a separate written agreement with
Suntory under which the exchange of such data and information shall be
stipulated in reasonable detail.
11. With respect to Article III of the Suntory Agreement, you agree to
advise us in writing on or before **************** as to the manufacturing
improvements made by Suntory that you desire to have transferred and
licensed to you, if any. In addition, you agree to negotiate in good
faith the terms of any such transfer and license with the goal of GI's
reaching a final agreement with Suntory as soon as practicable.
Recognizing the fact that you will not be obligated to notify GI until
***************** as to the manufacturing improvements that you desire to
have transferred and licensed to you, with respect to the requirements of
Section 3.1(c) of the Agreement (but not the requirements of Sections 3.1
(a), (b) and (d) of the Agreement), you hereby agree that the refund
provisions of Section 2.3 of the Agreement shall not apply with respect to
clause (a) thereof unless GI shall fail to have in place the written
agreement called for by Section 3.1(c) of the Agreement on or prior to
*****************. If such failure occurs, you shall be
4
17
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
entitled, as otherwise provided in Section 2.3(a) of the Agreement, by
delivering written notice to GI at any time on or prior to **************,
to receive from GI a refund of the ****************************** payment
due on the Effective Date. You further agree that any failure by you to
so notify us by ***************** shall release us from our foregoing
***************** obligation to you. Lastly, anything to the contrary
notwithstanding, in the event that Suntory agrees to enter into a two-way
agreement with you regarding the transfer and license of its manufacturing
improvements and, in connection therewith, directly deal with you without
substantial involvement of GI as intermediary, you agree to release us
from our foregoing ***************** obligation to you.
12. With respect to Article III of the Suntory Agreement, you agree to
make all payments related to any transfer and license of biological
materials and manufacturing technology directly to Suntory if so requested
by GI or if you enter into a two-way agreement with Suntory. You further
agree to cooperate in any direct payment arrangement between you and
Suntory in order to assist Suntory in obtaining a foreign tax credit in
Japan against any tax withholding required to be made by you or your
affiliates or sublicensees. For the avoidance of doubt, any other payments
to Suntory related to any such transfer and license will be for your sole
account. Notwithstanding the contemplation under Article III of the
Suntory Agreement of an agreement between GI and Suntory, both BMS and GI
hereby agree to use commercially reasonable and diligent efforts to seek to
replace such agreement with a direct agreement between BMS and Suntory in
implementation of such transfer and license. In any event, we hereby agree
that, as between BMS and GI, all discussions and decisions pertaining to
such transfer and license shall be under your exclusive reasonable control.
13. You agree that the License Agreement shall contain provisions
sufficient in order for us to meet our obligations to Suntory set forth in
Sections 4.2, 4.3, 4.4 and 4.5 of the Suntory Agreement.
14. You agree to the warranty limitations set forth in Article V of the
Suntory Agreement.
15. You agree that the License Agreement shall contain appropriate
provisions for effecting the assumption by BMS of (a) GI's indemnification
obligations to Suntory under Section 6.1 of the Suntory Agreement to the
extent that such obligations arise out of the development, manufacture,
commercialization, marketing, sale or use by BMS and its affiliates and
sublicensees and (b) the benefit of Suntory's indemnification
obligations to GI under Section 6.2 of the Suntory Agreement.
16. You agree to the confidentiality provisions set forth in Article VII of the
Suntory Agreement.
17. In the event of any termination of the Agreement, you agree to cease
use of all data obtained by you from Suntory. In the event of a
termination of the Suntory Agreement
5
18
by Suntory, you agree to cease use of the data obtained by you from Suntory
unless you shall have assumed GI's obligations under the Suntory
Agreement in accordance with the terms of the Suntory Agreement.
18. With respect to each Option/License Fee, you hereby agree that, upon
written inquiry from us within 10 business days of the putative payment
due date (as provided in Section 2.2 of the Agreement), you will send us a
written notice on or prior to the business day immediately preceding
such payment due date as to your conclusive determination of whether to pay
such Option/License Fee.
If the foregoing is in conformity with your understanding of the supplemental
terms to the Agreement, please indicate your acceptance below.
Very truly yours,
GENETICS INSTITUTE, INC.
By: /s/ Xxxx Xxxxxx
------------------------------
Agreed and accepted:
XXXXXXX-XXXXX SQUIBB COMPANY
By: /s/ Sol I. Rajfer
---------------------------------
6
19
Genetics Institute, Inc.
00 XxxxxxxxxXxxx Xxxxx
Xxxxxxxxx, XX 00000
October 5, 0000
Xxxxxxx-Xxxxx Xxxxxx Company
Xxxxx 000 xxx Xxxxxxxx Xxxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Re: Option/License Agreement between Xxxxxxx-Xxxxx Squibb Company
and Genetics Institute, Inc. dated May 24, 1995 and Letter Agreement
between Xxxxxxx-Xxxxx Squibb Company and Genetics Institute, Inc.
dated September 21, 1995
--------------------------------------------------------------------
Gentlemen:
Reference is made to the Option/License Agreement between Xxxxxxx-Xxxxx Squibb
Company ("BMS") and Genetics Institute, Inc. ("GI") dated May 24, 1995 (the
"Agreement") and the Letter Agreement between BMS and GI dated September 21,
1995 (the "Letter Agreement"). The purpose of this letter is to set forth
certain amendments to the Agreement and the Letter Agreement. Capitalized
terms used herein and not otherwise defined shall have the meanings given them
in the Agreement.
1. BMS and GI agree that, notwithstanding the definition of the term
Improvements set forth in Section 1.3 of the Agreement, the term Improvements
shall not include any biological materials or manufacturing technology owned,
developed or acquired (other than from GI) by BMS relating to the production of
bulk NPA or the formulation, filling or finishing of Licensed Products.
Further, BMS and GI agree that the license set forth in Section 3.5 of the
Agreement and the license called for by Section 4.3 of the Agreement shall not
include any license to any of such biological materials or manufacturing
technology of BMS relating to the production of bulk NPA or the formulation,
filling or finishing of Licensed Products.
2. Section 2.2 of the Agreement, as amended by Paragraph 2 of the
Letter Agreement, is hereby amended to read in its entirety as follows:
"2.2 Option/License Fee. In consideration of the Option and the
------------------
licenses granted to BMS in this Agreement, BMS shall make the following
payments to GI within thirty (30) days
20
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Xxxxxxx-Xxxxx Squibb Company
October 5, 1995
Page 2
of the dates set forth below (the "Option/License Fees"):
Payment
Number Date Amount
------ ---- ------
1 Effective Date $*********
2 ****************** or the date of $*********
completion of BMS's ************
****************, whichever occurs first
3 ****************** or the date of $*********
completion of BMS's ************
****************, whichever occurs first
4 ********************, the date of $*********
commencement of BMS's ***************
or the effective date of the License Agreement,
whichever occurs first
Notwithstanding the foregoing, in the event that BMS shall fail to receive, on
or before **************** (the date of receipt being referred to in the table
below as the "Data Receipt Date"), sufficient data as contemplated by Section
3.1(b) of this Agreement and the last sentence of Section 3.1 of this Agreement
for the commencement of its ************************** in ******, the foregoing
payment dates and Option Period shall be extended as follows, provided that
BMS shall have specified its reasonable needs with respect to such data on or
prior to ************:
Data Payment Extended Extended
Receipt Date Number Payment Dates Option Period
------------ ------ ------------- -------------
After ************ 2 ************** or the date Until *******
****, but on or of completion of BMS's ********
prior to ********** *********************
**** **************, whichever
occurs first
3 ************** or the date
of completion of BMS's
21
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Xxxxxxx-Xxxxx Squibb Company
October 5, 1995
Page 3
Data Payment Extended Extended
Receipt Date Number Payment Dates Option Period
------------ ------ ------------- -------------
*********************
clinical trial, whichever
occurs first
4 ****************, the date of
commencement of BMS's *****
************** or the effective
date of the License Agreement,
which ever occurs first
After **********, 2 ***************** or the date Until ********
****, but on or of completion of BMS's ***** ********
prior to ******** *************************
******** *****, whichever occurs first
3 ***************** or the date
of completion of BMS's *****
*************************
*****, whichever occurs first
4 *****************, the date
of commencement of BMS's
******************** or the
effective date of the License
Agreement, whichever
occurs first
After ******** 2 *************** or the date Until ********
******** of completion of BMS's ***** ********
*************************
*****, whichever occurs first
3 ***************** or the date
of completion of BMS's *****
*************************
*****, whichever occurs first
22
Confidential Material Omitted and Filed Separately with the Securities and
Exchange Commission. Asterisks denote such omissions.
Xxxxxxx-Xxxxx Squibb Company
October 5, 1995
Page 4
Data Payment Extended Extended
Receipt Date Number Payment Dates Option Period
------------ ------ ------------- -------------
4 ****************, the date
of completion of BMS's
****************** or the
effective date of the License
Agreement, whichever
occurs first
Other than the four payments specified in this Section 2.2, there shall be no
license, milestone or other like fees payable by BMS to GI under this Agreement
or the License Agreement."
3. BMS and GI agree that the obligation of BMS to make Payment Number
2 set forth in Section 2.2 of the Agreement, as amended by this Letter
Agreement ("Payment 2"), shall become guaranteed upon the occurrence of either
of the following situations on the following dates:
(a) in the event that all of the conditions set forth in Section 2.3
of the Agreement, as supplemented by Paragraphs 2 and 11 of the
Letter Agreement, shall have been met such that BMS shall have no
right to receive a refund from GI of Payment Number 1 set forth in
Section 2.2 of the Agreement ("Payment 1"), on ****************; or
(b) in the event that BMS shall have the right to receive a refund
from GI of Payment 1 as a result of the conditions set forth in
Section 2.3 of the Agreement, as supplemented by Paragraphs 2 and
11 of the Letter Agreement, not being satisfied, but BMS shall not
have delivered written notice to GI of its election to receive
such refund on or prior to **************, on **************.
Once either of the situations described in foregoing clauses (a) or (b) shall
have occurred, BMS and GI agree that Payment 2 shall become a guaranteed
payment to GI on the date set forth in the applicable clause, payable in
accordance with the provisions of Section 2.2 of the Agreement, as amended by
this Letter Agreement, and BMS's obligation to make Payment 2 shall survive
any termination of the Agreement in the interim.
4. BMS and GI agree that, unless BMS shall have been entitled to and
shall have duly elected to receive a refund of Payment 1 as a result of the
conditions set forth in Section 2.3 of the Agreement, as supplemented by
Paragraphs 2 and 11 of the Letter Agreement, not being
23
Xxxxxxx-Xxxxx Squibb Company
October 5, 1995
Page 5
satisfied, the first sentence of Section 2.5 of the Agreement shall not apply
to Payment 2 and that the failure of BMS to make Payment 2 when due shall be
deemed to be a breach of the Agreement by BMS.
5. BMS and GI agree that Paragraph 18 of the Letter Agreement shall
not apply to Payment 2.
If the foregoing is in conformity with your understanding of the
amendments to the Agreement and the Letter Agreement, please indicate your
acceptance below.
Very truly yours,
GENETICS INSTITUTE, INC.
By: /s/ Xxxx Xxxxxx
-----------------------------
Agreed and accepted:
XXXXXXX-XXXXX SQUIBB COMPANY
By: /s/ Xxxxx X. XxXxxxx
------------------------------
