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EXHIBIT 10.35
SECOND AMENDMENT TO COLLABORATION AGREEMENT
AMONG
COR THERAPEUTICS, INC.,
SCHERING CORPORATION
AND SCHERING-PLOUGH, LTD.
DATED APRIL 10, 1995
This second amendment ("Second Amendment") effective as of the last date set
forth below (the "Second Amendment Effective Date"), to the Collaboration
Agreement by and among COR Therapeutics, Inc., a Delaware corporation ("COR"),
Schering Corporation, a New Jersey corporation ("Schering Corporation") and
Schering-Plough, Ltd., a corporation organized under the laws of Switzerland
("Schering Ltd.") dated April 10, 1995, as amended on December 23, 1998 (as
amended, the "Agreement") is entered into by and between the parties hereto with
reference to the facts below. Schering Corporation and Schering Ltd. are
referred to herein collectively as "Schering". Terms with initial capitals,
which are not specifically defined in this Second Amendment, shall have the
defined meaning set forth in the Agreement.
WHEREAS, the Agreement does not specify to which country sales should be
attributed when a sale is made by a distributor in one country to a distributor
in another country;
WHEREAS, the Parties desire to modify their agreement to address such
issue of sales allocation, and also with respect to the allocation of regulatory
responsibilities in Canada, the manufacture and supply of Integrilin Product in
Canada, and to set forth certain understandings regarding a Phase III clinical
trial for Integrilin Product in the setting of acute myocardial infarction
("AMI"); and
WHEREAS, the Parties desire to make certain elements of this Second
Amendment conditional on the conduct of a Phase III clinical trial for AMI, and
have made provision herein for modification of this Second Amendment based upon
the conduct of such trial;
WHEREAS, Section 18.1 provides for amendment, change or addition to the
Agreement if reduced to writing and signed by an authorized officer of each
Party.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants and obligations below, the Parties agree as follows:
I. TREATMENT OF CROSS-BORDER SALES
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The Parties agree that Section 2.8, shall be amended by adding the following to
the end of the existing text:
"The sale of any unit of Integrilin Product shall be accounted for
either as Net Sales or as Royalty-Bearing Sales, depending on the
location of the final distributor in the chain of sales for such unit,
and in no event shall the proceeds of the sale of any single unit be
ultimately accounted for as both Net Sales and Royalty-Bearing Sales.
The method for attributing such sales shall be as follows: Sale of a
unit shall be attributed to the location of the first distributor to
whom the sale is made. If there is a subsequent sale of such unit to a
distributor in another country, the Parties shall re-attribute such sale
to the location of the final distributor to whom such unit was sold. The
Party selling the Co-Developed Product shall provide the other Party
with sales reports and distributor reports on a country-by-country basis
within [ * ] of the end of each calendar quarter. The reattribution of
sales from the location of the initial distributor to the location of
the final distributor shall be based on such distributor reports and
shall be made, together with any corresponding reconciliation payment or
credit, within [ * ] of the end of each calendar quarter."
The remainder of Section 2.8 shall remain unchanged.
II. COMMUNICATIONS WITH REGULATORS IN CANADA
The Parties agree that Section 3.4(a) shall be amended by adding the following
to the end of the existing text:
"Notwithstanding anything to the contrary in this Section 3.4(a), until
such time as COR commences Co-Promotion of a Co-Developed Product in
Canada, Schering shall have primary responsibility for communications
with Canadian regulatory authorities with respect to the review and
release of marketing promotional material, reporting of adverse events
for Integrilin Products sold in Canada and Schering shall be responsible
for QC testing/QA release activities in connection with Integrilin
Products in Canada and such other regulatory matters in connection with
Integrilin Products in Canada as the parties shall mutually agree upon.
However, COR shall retain ownership of all regulatory submissions in
Canada, and shall be responsible for any amendments thereof and for
communications with Canadian regulatory authorities regarding clinical
trials, adverse events in clinical trials, clinical data, manufacturing
process changes and such other matters as the parties shall mutually
agree upon."
The remainder of Section 3.4 shall remain unchanged.
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III. EXTENSION OF EXCLUSIVITY PERIOD IN CANADA AND EUROPE
The Parties agree that Section 4.1(a) shall be amended by deleting it in its
entirety and replacing Section 4.1(a) with the following:
"Subject to the terms and conditions of this Agreement, COR will have
the right to Co-Promote with Schering, on a country-by-country basis, in
each country in the Co-Promotion Territory each Co-Developed Product
following Regulatory Approval, provided, however, that the right of COR
to Co-Promote each Co-Developed Product in Canada shall commence on [ *
] (subject to COR complying with its contribution of Sales
Representative Efforts as set forth in [ * ]), or such earlier date as
may be provided for in Article IX of the Second Amendment to this
Agreement (the "Canadian Co-Promotion Date") and the right of COR to
Co-Promote each Co-Developed Product in any country of Europe shall
commence, on a country-by-country basis, on [ * ] (subject to COR
complying with its contribution of Sales Representative Efforts as set
forth in [ * ]), or such earlier date as may be provided for in Article
IX of the Second Amendment to this Agreement (the "European Co-Promotion
Date"). The JSC shall approve annual sales targets for Canada for each
year beginning with [ * ]. Notwithstanding anything to the contrary in
this Section 4.1(a), in the event that, for [ * ] years Schering shall
fail to achieve at least [ * ] of the year-end annual sales target for
Canada approved by the JSC, COR shall have the right to commence
Co-Promotion of each Co-Developed Product in Canada upon [ * ] written
notice. Schering shall provide COR with [ * ] reports on sales in Canada
to enable COR to monitor progress against such sales targets."
IV. NOTICE OF INTENT TO CO-PROMOTE IN CANADA
The Parties agree that Section 4.2 shall be amended by deleting the first
sentence and replacing it with the following:
"Within 60 days after the filing, and acceptance for review, of a Drug
Approval Application in the United States with respect to a Co-Developed
Product, which is the subject of such Drug Approval Application, COR
shall notify Schering whether or not it elects to Co-Promote such
Co-Developed Product in the United States. With respect to Co-Promotion
of each Co-Developed Product in Canada, such notice shall be delivered [
* ] to the [ * ] on which the right of COR to Co-Promote such
Co-Developed Product in Canada would commence under Section 4.1(a)."
V. MODIFICATION OF SALES REPRESENTATIVES' EFFORTS
The Parties agree that Section 5.5 shall be amended by deleting Section 5.5(a)
in its entirety and replacing Section 5.5(a) with the following:
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"(a) Subject to the terms and conditions of this Agreement, in each
calendar year, each Party will have the right to contribute [ * ] of the
overall level of Sales Representative Efforts for each Co-Promoted
Product in each country in which COR has elected to Co-Promote, provided
that, without the consent of the other Party, (i) in the United States,
[ * ] may not contribute [ * ] of such level, Schering may not
contribute [ * ] of such level in the [ * ] years following commercial
launch of such Co-Promoted Product and Schering may not contribute [ * ]
of such level thereafter; (ii) commencing on the Canadian Co-Promotion
Date, COR will have the right to contribute [ * ] of the overall level
of Sales Representative Efforts in Canada provided that COR may not
contribute [ * ] of the total level of Sales Representative Efforts in
Canada; and (iii) commencing on the European Co-Promotion Date, COR will
have the right to contribute [ * ] of the overall Sales Representative
Efforts in any country of Europe, provided that, without the consent of
Schering, COR may not contribute [ * ] of the total level of Sales
Representative Efforts in each country of Europe in which COR is
Co-Promoting and Schering may not contribute [ * ] of such total."
The remainder of Section 5.5 shall remain unchanged.
VI. SUPPLY OF FINAL INTEGRILIN PRODUCTS FOR CANADA
The Parties agree that Section 7.1(b) shall be amended by deleting the third and
fourth sentences and replacing them with the following:
"Unless otherwise directed by the JSC, COR shall use Diligent Efforts to
obtain from Third Party suppliers necessary quantities of bulk and final
Integrilin Product for supply in the United States and necessary
quantities of bulk Integrilin Product for supply in all other countries
of the world. Schering shall use Diligent Efforts to produce final
Integrilin Product for all countries of the world outside of the United
States unless Schering requests not to do so, in which case the JSC
shall make arrangements for Third Party suppliers to provide such
services."
VII. PROVISIONS RELATING TO CANADA
A. The Parties agree that the first sentence of Section 9.2 shall be
amended by deleting it in its entirety and replacing it with the following:
"Net Sales shall be allocated first to reimburse each Party for its
Allowable Expenses, on a country-by-country basis (excluding Canada
until COR begins to Co-Promote in Canada), for each Co-Developed
Product. Any
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remaining sums shall be Marketing Margin, which shall be determined on a
country-by-country basis (excluding Canada until COR begins to
Co-Promote in Canada) for each such Product, and shall be allocated as
follows:"
B. The Parties agree that the following shall be added as a new sentence at
the end of Section 9.2:
"Until COR begins to Co-Promote in Canada, in lieu of an allocation of
Marketing Margin for sales of Co-Developed Product in Canada, COR shall
receive a royalty as set forth in Section 9.7."
C. The Parties agree that the definition of Net Sales in Section 1.32 is
hereby amended to add, [ * ] immediately after the words [ * ] and immediately
prior to the commencement of the parenthetical in such line, the words: [ * ].
The remainder of Section 1.32 shall remain unchanged.
VIII. ROYALTIES
The Parties agree that Section 9.7 shall be amended by deleting the proviso
immediately after the table setting forth the dollar amounts and royalty rate
and replacing it with the following:
"provided, however, that the royalty rate in the Co-Promotion Territory
(except for the United States and Canada) shall be the sum of a Base
Royalty, a Sales Volume Royalty, and a Cost of Goods Royalty, as
follows, and provided further that in no calendar year will the
aggregate royalty in such territory exceed [ * ] of Net Sales in such
territory (except as provided below in the case that the Average Cost
Per Gram, as defined below, is [ * ] per gram):
- Base Royalty. During the period from the first commercial sales
of an Integrilin Product in a country of Europe through [ * ],
the "Base Royalty" shall be [ * ] of Net Sales in Europe.
Thereafter, the Base Royalty shall be [ * ] of Net Sales in
Europe, except in countries where COR is Co-Promoting the
Integrilin Product, in which case COR shall be compensated under
Section 9.2.
- Sales Volume Royalty. Through [ * ], the following additional
royalty (the "Sales Volume Royalty") shall be added to the Base
Royalty, as follows:
[ * ] if Net Sales in Europe are less than [ * ];
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[ * ] of all Net Sales in Europe if total annual Net Sales in
Europe are equal to or greater than [ * ] but less than [ * ];
[ * ] of all Net Sales in Europe if total annual Net Sales in
Europe are equal to or greater than [ * ] but less than [ * ];
[ * ] of all Net Sales in Europe if total annual Net Sales in
Europe are equal to or greater than [ * ] but less than [ * ];
and
[ * ] of all Net Sales in Europe if total annual Net Sales in
Europe are equal to or greater than [ * ].
At the end of each quarter of each [ * ], the Sales Volume
Royalty shall be determined on the basis of the above percentage
associated with actual Net Sales in Europe for the year through
such quarter, with any [ * ] as necessary to [ * ] the Sales
Volume Royalty for prior quarters of the year, e.g., if sales in
the fourth quarter bring total Net Sales to [ * ], then total
Sales Volume Royalty payments to COR for that year would equal [
* ].
- Cost of Goods Royalty. Through [ * ], an additional royalty (the
"Cost of Goods Royalty") shall be added to the Base Royalty and
any Sales Volume Royalty if the Average Cost Per Gram for
Integrilin Product sold in Europe is less than [ * ] per gram,
as follows:
Average Cost Per Gram
Below [ * ] but greater than or equal to [ * ] additional
royalty;
Below [ * ] but greater than or equal to [ * ] additional
royalty;
Below [ * ] but greater than or equal to [ * ] additional
royalty;
Below [ * ] but greater than or equal to [ * ] additional
royalty;
Below [ * ] additional royalty.
"Average Cost Per Gram" shall mean the average cost per gram of
[ * ], calculated in accordance with the Cost of Goods Shipped
definition but [ * ] to the [ * ] of any [ * ].
For each of the first three quarters of each [ * ], the Cost of
Goods Royalty shall be paid on the Net Sales in Europe during
such quarter at a royalty rate calculated on the basis of the
Average Cost Per Gram achieved in such year to date. At the end
of each calendar year, the Cost of Goods Royalty shall be
calculated for the year as a whole,
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based on the Net Sales in Europe during such year and the
Average Cost Per Gram during such year, with any reconciling
payment or credit as necessary to adjust for any different Cost
of Goods Royalty rate(s) which may have been applied for the
first three calendar quarters.
Notwithstanding the above references to a [ * ], in any year in which
the Average Cost Per Gram for Integrilin Product sold in Europe is equal
to or less than [ * ] per gram, an additional [ * ] royalty shall be
added to any other applicable royalties up to a [ * ].
In addition, COR shall receive a royalty on Royalty-Bearing Sales of all
Integrilin Products in Canada as follows:
[ * ] on Net Sales in Canada of Integrilin Products in [ * ];
[ * ] on Net Sales in Canada of Integrilin Products in [ * ].
Such royalty shall not be payable to COR after it has initiated
Co-Promotion of each Co-Developed Product in Canada."
The remainder of Section 9.7 shall remain unchanged.
IX. [ * ] TRIAL
A. At such time as the JSC votes to conduct a [ * ] study [ * ],
the Parties agree that the [ * ] shall be conducted as set forth
in the [ * ] attached hereto as Exhibit A [ * ]. The Parties
agree that the [ * ] may be amended only by vote of the JSC.
B. Schering shall continue to be the [ * ] for the [ * ] phase of
the development of Integrilin for the [ * ]. COR shall be the [
* ] (as that [ * ]) for the [ * ]. COR shall also be the [ * ]
for a [ * ] and the [ * ].
C. As set forth more fully in the [ * ], the Parties shall each
actively participate in a [ * ], which will have the [ * ] for
the [ * ], consistent with the principles of prompt and diligent
development of the Integrilin Products, as set forth in the
Agreement. However, notwithstanding the formation or [ * ] or
any other provision of this Second Amendment, the Parties
confirm that the JSC shall retain overall responsibility for the
clinical development of Integrilin Products, including without
limitation for the [ * ].
D. At such time as the JSC votes to conduct the [ * ], the Parties
agree that the [ * ] shall include the [ * ] as are deemed
necessary by the JSC to carry out the [ * ].
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E. The Parties recognize that the [ * ] of the [ * ] provided for
in [ * ] is intended to [ * ] to [ * ] for the substantial [ * ]
associated with a [ * ]. Accordingly, the Parties have provided
in [ * ] for the possible termination [ * ] prior to the [ * ],
and have further agreed that if for any reason the [ * ] but not
[ * ], then the [ * ] shall be [ * ] as follows:
1. If the [ * ] is [ * ] but is [ * ] at a time when the [ * ]
in [ * ] are [ * ], then the [ * ] shall be [ * ] and the [ * ]
shall be [ * ].
2. If the [ * ] is [ * ] but is [ * ] at a time when the [ * ]
in [ * ] have [ * ] but are [ * ], then the [ * ] shall be [ * ]
and the [ * ] shall be [ * ].
3. If the [ * ] is [ * ] but is [ * ] at a time when the [ * ]
in [ * ] have [ * ] but are [ * ], then the [ * ] shall be [ * ]
and the [ * ] shall be [ * ].
4. If the [ * ] is [ * ] but is [ * ] before [ * ] at a time
when the [ * ] in [ * ] have [ * ], then the [ * ] shall be [ *
] and the [ * ] shall be [ * ].
X. TERMINATION RIGHTS
A. Certain provisions of this Second Amendment shall terminate if, for
any reason: (i) as of [ * ], the [ * ] to [ * ] the [ * ]; or (ii) as of [ * ]
the [ * ] has not [ * ]. If the [ * ] has not [ * ] by [ * ], the [ * ] will be
deemed [ * ]. The termination of certain provisions of this Second Amendment as
set forth above shall have the following consequences:
1. Articles [ * ] of this Second Amendment shall be deleted from
this Second Amendment and shall have no force or effect, except as provided in
paragraph 3 of this Article X.
2. Articles [ * ] of this Second Amendment shall continue in full
force and effect, but COR shall then have the right to give a notice of election
to Co-Promote Co-Developed Products in Canada at any time within [ * ] following
the effectiveness of termination under this Article X, which notice shall give
COR the right to commence such Co-Promotion in Canada [ * ] following such
notice. Should COR commence Co-Promotion in Canada before [ * ] will [ * ] to [
* ] any [ * ] for sales of Co-Developed Product in Canada [ * ] to [ * ] to the
[ * ] Co-Promotion in Canada.
3. In the event of any termination under this Article X, [ * ] in
accordance with Article [ * ] of this Second Amendment until the end of the [ *
] in which termination occurs under this Article X. At that point, Article [ * ]
shall have
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no further force or effect and [ * ] in accordance with the original Agreement
as amended by the First Amendment.
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XI. MISCELLANEOUS
A. Each Party agrees to act in good faith and do all other acts as may
be necessary or appropriate in order to carry out the purposes and intent of
this Second Amendment.
B. This Second Amendment has been prepared jointly and shall not be
strictly construed against either Party.
C. The terms, conditions and existence of this Agreement shall be
treated by the Parties on a confidential basis, subject to Section 13.3 of the
Agreement and subject further to appropriate disclosure to employees and
shareholder of Schering-Plough Corporation (the corporate parent of Schering)
and its Affiliates and/or COR, or as otherwise required by law. Each of Schering
and COR agrees to coordinate both the timing and content of any public
announcements relating to this Second Amendment and any such public
announcements shall be subject to the review and approval of the Parties prior
to public disclosure.
D. This Second Amendment to the extent set forth herein, amends,
modifies and supplements the Agreement. This Second Amendment contains the
entire agreement between the Parties hereto, and the terms of this Second
Amendment are contractual and not a mere recital. Except as expressly modified
herein, all of the terms and provisions of the Agreement remain in full force
and effect and cannot be amended, modified or changed in any way whatsoever
except by a written instrument duly executed by the Parties hereto.
IN WITNESS WHEREOF, the Parties have executed this Second Amendment by
their authorized officers effective as of the last date below.
SCHERING CORPORATION COR THERAPEUTICS, INC.
By: /s/ Xxxxxx X. Xxxxx By: /s/ Xxxxxx X. Xxxxxxx
------------------------------- -------------------------------
Xxxxxx X. Xxxxx Xxxxxx X. Xxxxxxx
Title: Executive Vice President Title: Chief Executive Officer
---------------------------- ----------------------------
Date: 11/1/99 Date: 11/5/99
----------------------------- -------------------------------
SCHERING-PLOUGH LTD.
By: /s/ Xxxxxx X. Xxxxx
-------------------------------
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Xxxxxx X. Xxxxx
Title: Manager (Director)
----------------------------
Date: 11/1/99
-----------------------------
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Confidential
Exhibit
[ * ]
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
