EXHIBIT 10.17
LICENSE AGREEMENT
This Agreement is made and entered into on this 18th day of January, 1994,
between
NOVO NORDISK A/S, with its place of business at Novo Alle, XX-0000
Xxxxxxxxx, Xxxxxxx, and
ZYMOGENETICS INC., with its place of business at 0000 Xxxxxxxxx Xxx
XX, Xxxxxxx, Xxxxxxxxxx 00000, XXX
(hereinafter collectively called NOVO NORDISK)
and XXXXXXX & XXXXXXX, with its place of business at Xxx Xxxxxxx & Xxxxxxx
Xxxxx, Xxx Xxxxxxxxx, X.X. 00000, XXX, (hereinafter called XXXXXXX &
XXXXXXX),
and CHIRON CORPORATION, with its place of business at 0000 Xxxxxx Xxxxxx,
Xxxxxxxxxx, Xxxxxxxxxx 00000, XXX, (hereinafter call CHIRON)
WITNESSETH:
WHEREAS, NOVO NORDISK is the owner of certain Patent Rights concerning platelet
derived growth factor ("PDGF"), its manufacture and use as a wound
healing agent, and
WHEREAS, XXXXXXX & XXXXXXX and CHIRON desire to obtain a license under such
Patent Rights,
NOW THEREFORE, the parties agree as follows:
1 DEFINITIONS
1.1 The term "Patent Rights", shall mean all the patents and the patent
applications owned, controlled or licensed to NOVO NORDISK concerning
PDGF, a partial listing of which is identified in Exhibit I attached
---------
hereto, any patents maturing from the said applications and their
parents, and any divisions, continuations, continuation in parts,
reissues, reexaminations, renewals, or extensions thereof.
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
1.2 The term "Licensed Product" shall mean any PDGF (including A chain or
B chain polypeptide, monomers or dimers thereof, or fragments,
modifications or derivatives thereof) containing agent for human use
to accelerate healing of soft tissue wounds, excluding ophthalmic
wounds, but including surgical incision healing unless used as a
component in a tissue glue, biologically derived for use in
controlling intense bleeding in surgery, the manufacture, use or sale
of which is covered by at least one valid and granted claim of Patent
Rights.
1.3 The term "Affiliate" shall mean a legal entity which owns or controls,
is owned or controlled by or is under common ownership or control with
a party to this Agreement. Ownership for purposes of this paragraph
shall mean ownership of at least 50% of the equity ownership to direct
or cause the direction of the management and policies of such legal
entity.
1.4 The term "Net Proceeds of Sales" shall mean XXXXXXX & JOHNSON's and
CHIRON's and/or their Affiliates' gross proceeds of sales to
independent third parties of Licensed Product less
a) Trade, cash and/or quantity discounts allowed, if any;
b) Commission and discounts which are in the nature of refunds,
rebates or allowances, which effectively reduce the selling
price;
c) Actual returns and allowances;
d) Credits, if any, to customers on account of retroactive price
reductions;
e) Value added taxes and sales taxes;
f) Duties; and
g) Freight charges paid for delivery.
Sales of Licensed Product between XXXXXXX & XXXXXXX or CHIRON and an
Affiliate of XXXXXXX & XXXXXXX or CHIRON, and between Affiliates of
XXXXXXX & XXXXXXX or CHIRON are not to be included within the Net
Proceeds of Sales.
In the event of commercial use of Licensed Product by XXXXXXX &
XXXXXXX or CHIRON and/or an Affiliate of XXXXXXX & XXXXXXX or CHIRON,
the Net Proceeds of Sales
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-2-
thereof shall be the comparable selling price of XXXXXXX & XXXXXXX or
CHIRON and/or Affiliate of XXXXXXX & XXXXXXX or CHIRON to independent
third parties for such Licensed Product so used.
If, in a market, XXXXXXX & XXXXXXX or CHIRON (or its Affiliates) sells
all or part of its sales to the trade through a marketing/business
partner, the royalty to be paid on such sales shall be calculated on
the basis of the price invoiced by such marketing/business partner
when selling to independent third parties. Should such invoice price
not be identifiable, the royalty shall instead be based on XXXXXXX &
JOHNSON's or CHIRON's average selling price in the same market or, if
XXXXXXX & XXXXXXX or CHIRON is not present in the relevant market, by
the average selling price obtainable in that market.
In the event that Licensed Product is sold in the form of a
combination product containing one or more growth factors, other than
the Licensed Product, Net Proceeds of Sales for such combination
product will be calculated by multiplying actual net Proceeds of Sales
of such combination product by the fraction A/(A+B) where A is the
invoice price of the Licensed Product if sold separately, and B is the
total invoice price of any other growth factor in the combination, if
sold separately by XXXXXXX & XXXXXXX or CHIRON or an Affiliate.
In no event will the royalty to be paid on a combination product be
less than [ * ] of the running royalty payments payable to NOVO
NORDISK on the Net Proceeds of Sales, if calculated for the entire
combination product.
1.5 The term "First Commercial Sale" shall mean the first sale or disposal
of a Licensed Product for a value in an arm's length transaction
following approval by the appropriate regulatory agency for the sale
of Licensed Product to the public.
2 LICENSING OF PATENT RIGHTS
2.1 NOVO NORDISK grants to XXXXXXX & XXXXXXX and CHIRON a worldwide
exclusive right and license under Patent Rights to make, have made,
use or sell Licensed Product during the term of this Agreement.
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-3-
2.2 Subject to such agreement as may exist between XXXXXXX & XXXXXXX and
CHIRON from time to time, each of XXXXXXX & XXXXXXX and CHIRON has the
right to sublicense their Affiliates to make, use or sell Licensed
Product -or a marketing/business partner as mentioned in Clause 1.4 to
sell Licensed Product - provided XXXXXXX & XXXXXXX and CHIRON will
separately guarantee payment to NOVO NORDISK of royalties under this
Agreement for their own sublicenses.
2.3 It is presently contemplated that CHIRON will manufacture PDGF for
XXXXXXX & XXXXXXX for use in Licensed Product under this Agreement. If
CHIRON products PDGF, CHIRON will supply NOVO NORDISK with PDGF for
NOVO NORDISK's requirements for development and manufacture of PDGF
products outside Licensed Product on reasonable terms to be agreed
upon between CHIRON and NOVO NORDISK. Failure of CHIRON and NOVO
NORDISK to agree on such reasonable terms will not constitute a breach
of this Agreement or in any way jeopardize XXXXXXX & JOHNSON's rights
under this Agreement.
XXXXXXX & XXXXXXX and CHIRON can have the Licensed Product made or
manufactured for it by another third party contract manufacturer,
provided that prior to contracting for such third party manufacture,
XXXXXXX & XXXXXXX and CHIRON will notify NOVO NORDISK in advance of
the chosen contract manufacturer for the purpose of approval by NOVO
NORDISK, which may only be withheld for reasonable cause.
2.4 In the event that XXXXXXX & XXXXXXX and CHIRON determine that the
commercialization of Licensed Product for the treatment of diabetic
ulcers is best achieved through a co-promotion arrangement with NOVO
NORDISK, XXXXXXX & XXXXXXX, CHIRON and NOVO NORDISK will consider the
utilization of the NOVO NORDISK sales and marketing organization via
separately negotiated co-promotion agreements on the basis of fair
compensation to each party.
3 ROYALTIES AND PAYMENT
3.1 In consideration of all the rights and licenses granted hereunder,
XXXXXXX & XXXXXXX and CHIRON shall jointly pay to NOVO NORDISK
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-4-
3.1.1. a license fee of [ * ] payable within 30 (thirty) days after
signature of this Agreement, which amount shall be non-refundable
and non-creditable.
3.1.2. a further license fee of [ * ], payable at the earliest of (i)
within 30 (thirty) days after the filing of a Product License
Application ("PLA") for Licensed Product with the U.S. Food and
Drug Administration, the filing of a similar application with the
CPMP in Europe, or the filing of a similar application in either of
the countries France, Germany, UK, Japan, or (ii) December 31,
1996. [ * ] shall be creditable against any future running
royalties.
3.1.3. a running royalty payable on a country by country basis on all
Licensed Products sold by XXXXXXX & XXXXXXX and CHIRON, its
Affiliates - or a marketing/business partner as mentioned in Clause
1.4 - at a rate of [ * ]% of Net Proceeds of Sales of Licensed
Product. XXXXXXX & XXXXXXX and CHIRON shall jointly pay this
running royalty quarterly within sixty (60) days after the end of
each calendar quarter.
XXXXXXX & XXXXXXX and CHIRON shall diligently pursue the
development, registration and product introduction into the market
and minimum royalties shall be payable after the earliest of (i)
the first twelve (12) months of sales of Licensed Product after the
First Commercial Sale or (ii) January 1st 1998 according to the
following schedule:
Year 1 [ * ]
Year 2 [ * ]
Year 3-6 [ * ]
In any year in which running royalties are less than the applicable
minimum royalty under this paragraph, then XXXXXXX & XXXXXXX and
CHIRON shall, within sixty (60) days after such year, pay to NOVO
NORDISK a sum equal to [ * ].
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-5-
3.2 XXXXXXX & XXXXXXX and CHIRON shall make all payments hereunder after
deducting or withholding all taxes as required by the laws of Denmark
or laws of any other country in which an Affiliate of XXXXXXX &
XXXXXXX or CHIRON is selling Licensed Product; and shall furnish NOVO
NORDISK as soon as practicable with proper evidence as to the payment
of such taxes.
3.3 XXXXXXX & XXXXXXX and CHIRON shall make all payments to NOVO NORDISK
under this Agreement in USD calculated on the rate of exchange quoted
by Xxxxxx'x at the end of the quarter for which payment is due and
such payment is made and shall make all payments by telegraphic
transfer to a bank account designated by NOVO NORDISK. If the transfer
or the conversion into USD equivalents in any country is not lawful or
possible, the payment as is necessary shall be made by the deposit
thereof, in the currency of the country where the sales were made on
which the royalty was based to the credit and account of NOVO NORDISK
or its nominees in any commercial bank or trust company of its choice
located in that country, notice of which shall be given to NOVO
NORDISK by XXXXXXX & XXXXXXX and CHIRON.
3.4 XXXXXXX & XXXXXXX and CHIRON shall pay only one royalty under this
Agreement for Net Proceeds of Sale of each Licensed Product,
regardless of the number of claims, patents or patent applications
applicable hereto.
4 LICENSES, PERMITS ETC.
4.1 XXXXXXX & XXXXXXX and CHIRON shall obtain and maintain at its sole
expense all clearances, permits, licenses, authorizations, and
registrations required by any nation, country, sovereignty,
commonwealth, possession, territory, state, county, parish,
municipality, local or similar government entity which are necessary
to manufacture, use and/or sell Licensed Product.
5 RECORD KEEPING, PAYMENT AND REPORTS
5.1 XXXXXXX & XXXXXXX and CHIRON shall keep, and cause its Affiliates and
as far as possible its marketing/business partners as mentioned in
Clause 1.4 to keep, complete and correct records concerning Net
Proceeds of Sales of Licensed Product. XXXXXXX &
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-6-
XXXXXXX and CHIRON shall be obliged to keep such records for three (3)
years after the making of a royalty payment as provided in Article 3.
5.2 XXXXXXX & XXXXXXX and CHIRON shall within sixty (60) days after the
end of each calendar quarter after the First Commercial Sale send to
NOVO NORDISK a written statement, certified by a responsible
representative of XXXXXXX & XXXXXXX and CHIRON, showing Net Proceeds
of Sales. Such statements shall be accompanied by a payment of the
total amount of royalty then due. After the First Commercial Sale,
XXXXXXX & XXXXXXX and CHIRON shall render a statement even if no
royalty is due.
5.3 Upon NOVO NORDISK's request, XXXXXXX & XXXXXXX and CHIRON shall
provide to NOVO NORDISK a statement from XXXXXXX & JOHNSON's and
CHIRON's outside auditors certifying the correctness of XXXXXXX &
JOHNSON's and CHIRON's royalty payments. The statement shall be
provided at NOVO NORDISK's request and expense, no more than once in a
calendar year.
5.4 XXXXXXX & XXXXXXX and CHIRON shall grant NOVO NORDISK the right to
have an independent certified public accountant to whom XXXXXXX &
XXXXXXX and CHIRON has no reasonable objection with access, during
ordinary business hours to such records of XXXXXXX & XXXXXXX, CHIRON
and their Affiliates as provided for in Section 5.1 in order to verify
the accuracy of royalty payments made or payable hereunder. Such
access shall be granted at NOVO NORDISK's request and expense, but no
more than once in a calendar year. Such accountant shall be under
confidentiality obligations to XXXXXXX & XXXXXXX and CHIRON to
disclose to NOVO NORDISK only the amount of royalties payable and the
accuracy of the royalty payments made hereunder.
6 TERM
6.1 Unless terminated according to Section 7 below, this Agreement shall
become effective on the day and year first written above and shall
continue to be in full force and effect on a country-by-country basis
until the expiration date of the last of Patent Rights to expire in
each such country.
6.2 Upon expiry of the Patent Rights in a country XXXXXXX & XXXXXXX and
CHIRON shall have the fully paid up license regarding such Patent
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-7-
Rights, provided XXXXXXX & XXXXXXX and CHIRON pays all royalties
accrued in relation to Licensed Products manufactured and/or sold in
that country before expiry of the Patent Rights.
7 TERMINATION
7.1 XXXXXXX & XXXXXXX and CHIRON may terminate this Agreement at any time
by providing NOVO NORDISK with sixty (60) days' advance notice. In
such case no refund of payments made according Article 3 shall take
place.
7.2 If XXXXXXX & XXXXXXX and CHIRON or NOVO NORDISK at any time materially
defaults i) in rendering any of the reports required under, ii) or
making the payment of any money due hereunder, iii) or in fulfilling
any of the other obligations or conditions hereunder, the other party
may in its sole discretion waive the default; if not electing to waive
the default, the other party shall notify the defaulting party in
writing of the default and allow the defaulting party sixty (60) days
from such notification to correct the default. If at the end of said
sixty (60) days the default remains uncorrected, the aggrieved party
may terminate this Agreement and also any licenses granted thereunder
by giving written notice of termination to the defaulting party.
7.3 XXXXXXX & XXXXXXX and CHIRON or NOVO NORDISK, in addition to any other
remedies available to it in law or equity, may terminate this
Agreement by written notice to the other party in the event the other
party shall:
a) become insolvent or bankrupt;
b) make an assignment for the benefit of its creditors;
c) appoint a trustee or receiver for itself for all or a substantial
part of its property;
d) have any case of proceeding commenced or other action taken by or
against itself in bankruptcy;
e) seek reorganization, liquidation, dissolution, a winding-up
arrangement, composition or readjustment of its debts;
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-8-
f) seek any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any jurisdiction,
now or hereafter in effect; or
g) have issued against itself a warrant of attachment, execution,
distraint or similar process against any substantial part of its
property of the other party.
7.4 Upon termination of this Agreement for any reason, except for the
expiration of the term of this Agreement, all rights and licenses
granted to XXXXXXX & XXXXXXX, CHIRON and their Affiliates hereunder
shall automatically terminate and revert to NOVO NORDISK. XXXXXXX &
XXXXXXX and CHIRON shall immediately discontinue and cause their
Affiliates to immediately discontinue any further use of Patent
Rights; and shall forthwith cease and desist from manufacturing,
having manufactured, using or selling Licensed Product under the
Patent Rights, except that each - for a period of 1 year after the
effective date of the termination - shall have the right to sell off
any existing inventory, subject to the royalty provisions herein.
8 LITIGATION
8.1 NOVO NORDISK agrees to notify XXXXXXX & XXXXXXX and CHIRON in writing
if the validity, infringement, or priority of invention of any Patent
Rights is made an issue by any person not a party hereto. XXXXXXX &
XXXXXXX and CHIRON agree to notify NOVO NORDISK in writing if any
dispute with a third party or parties arises out of or in relation to
or in connection with the manufacture, use and/or sale of Licensed
Product by XXXXXXX & XXXXXXX, CHIRON and/or their Affiliates.
8.2 In the event that there is infringement on a substantial commercial
scale by a third party of any patent licensed to XXXXXXX & XXXXXXX and
CHIRON hereunder, XXXXXXX & XXXXXXX and/or CHIRON shall notify NOVO
NORDISK in writing to that effect, including with said written notice
evidence establishing a prima facie case of infringement by such third
party. If, prior to the expiration of 120 days from the date of said
notice, NOVO NORDISK obtains a discontinuance of such infringement or
brings suit against the third party infringer, then the obligation of
XXXXXXX & XXXXXXX and CHIRON to pay royalties under such licensed
patent shall continue unabated. NOVO NORDISK
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-9-
shall bear all the expenses of any suit brought by it and shall retain
all damages or other monies awarded or received in settlement of such
suit. XXXXXXX & XXXXXXX and CHIRON will cooperate with NOVO NORDISK in
any such suit and shall have the right to be represented by their own
counsel at their own expense.
If, after the expiration of said 120 days from the date of said
notice, NOVO NORDISK has not overcome the prima facie case of
infringement, obtained a discontinuance of such infringement, or
brought suit against the third party infringer, then XXXXXXX & XXXXXXX
and CHIRON shall be relieved of all obligation to make payment of
further royalties hereunder until such time as either the third party
infringement has ceased or suit for infringement has been filed by
NOVO NORDISK. In addition, XXXXXXX & XXXXXXX and/or CHIRON shall have
the right after such 120 day notice period, but not the obligation, to
bring suit against such infringer and join NOVO NORDISK as a party
plaintiff, provided that XXXXXXX & XXXXXXX and/or CHIRON shall bear
all the expenses of such suit. NOVO NORDISK will cooperate with
XXXXXXX & XXXXXXX and/or CHIRON in any suit for infringement of a
licensed patent brought by XXXXXXX & XXXXXXX and/or CHIRON against a
third party, and shall have the right to consult with XXXXXXX &
XXXXXXX and/or CHIRON and to participate in and be represented by
independent counsel in such litigation at its own expense. XXXXXXX &
XXXXXXX and/or CHIRON shall incur no liability to NOVO NORDISK as a
consequence of such litigation or any unfavorable decision resulting
therefrom, including any decision holding NOVO NORDISK's patent
invalid or unenforceable.
Royalties which are based solely on the infringed licensed patent
which accrue during the pendency of any suit for infringement brought
by XXXXXXX & XXXXXXX and/or CHIRON shall be held in escrow by XXXXXXX
& XXXXXXX and/or CHIRON until a final decision is rendered by a court
of competent jurisdiction from which appeal can be or is taken. In the
event the patent under which such royalties are payable is held to be
invalid, the accrued royalty shall be retained by XXXXXXX & XXXXXXX
and/or CHIRON. In the event the validity of the patent is upheld, the
accrued royalty shall be paid to NOVO
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-10-
NORDISK, and any damages or other monies awarded or received in
settlement of such suit shall be retained by XXXXXXX & XXXXXXX
and/or CHIRON in satisfaction of its litigation expenses. If the
amount awarded exceeds such litigation expenses, the remaining
amount shall firstly be used for reimbursing NOVO NORDISK its
litigation expenses, if any. If the amount awarded further
exceeds NOVO NORDISK's litigation expenses, the remainder shall
be made payable to XXXXXXX & XXXXXXX and/or CHIRON.
9 PATENT RIGHTS
9.1 NOVO NORDISK shall, at its expense, make its best efforts to
obtain and maintain the Patent Rights.
9.2 In the event that any patent or any claim thereof included in the
Patent Rights shall be held invalid or unenforceable in any
country by a court of competent jurisdiction and last resort, or
by an inferior tribunal from which no appeal has or can be taken,
such invalid or unenforceable patent or claim in such country
shall be excluded from the definition of the Patent Rights.
10 INDEMNIFICATION
10.1 XXXXXXX & XXXXXXX and CHIRON shall indemnify and hold NOVO
NORDISK harmless from and against any and all claims, judgments,
costs, awards, expenses (including, but not limited to, any
attorney's fees) or liability of any kind arising out of injury
to a third party caused or alleged to be caused by the Licensed
Product. In addition, XXXXXXX & XXXXXXX and CHIRON hereby assume
all obligations for warranties that accompany the sale Licensed
Product; and indemnifies and holds NOVO NORDISK harmless from and
against any and all claims, judgments, costs, awards, expenses
(including, but not limited to, any attorney's fees) or liability
of any kind arising from such customers, relating to such
warranty obligations.
11 CONFIDENTIALITY
11.1 Subject to applicable law, the existence and contents of this
Agreement and the activities hereunder shall be kept strictly
secret by the parties unless otherwise agreed in writing by the
parties, except that each party
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-11-
may disclose the contents of this Agreement to its Affiliates and
sublicensees.
12 NOTICES
12.1 All notices required or provided for use in this Agreement shall
be in writing and shall be given by certified mail prepaid,
facsimile transmission or telex and properly addressed to the
address of the party to be served as shown below. Unless
otherwise provided for in this Agreement, notice shall be
effective seven (7) days after mailing or transmission. When a
facsimile transmission or telex is used, a confirmation letter
shall be dispatched thereafter. Reports under Secti on 5.2 shall
not be considered notices.
If to NOVO NORDISK: NOVO NORDISK A/S
Novo Alle
XX-0000 Xxxxxxxxx
Xxxxxxx
Att.: President, Health Care
Group
with a copy to: Legal Department
NOVO NORDISK A/S
Novo Alle
XX-0000 Xxxxxxxxx
Xxxxxxx
If to XXXXXXX & XXXXXXX: XXXXXXX & XXXXXXX
Xxx Xxxxxxx & Xxxxxxx Xxxxx,
Xxx Xxxxxxxxx,
X.X. 00000, XXX
Att.: Xxxxx X. Tattle
with a copy to: Chief Patent Counsel
XXXXXXX & XXXXXXX
Xxx Xxxxxxx & Xxxxxxx Xxxxx,
Xxx Xxxxxxxxx,
X.X. 00000, XXX
If to CHIRON: CHIRON CORPORATION
0000 Xxxxxx Xxxxxx
Xxxxxxxxxx
Xxxxxxxxxx 00000, XXX
Att.: General Counsel
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.n.
-12-
13 FORCE MAJEURE
13.1 Each of the parties hereto shall be excused from the performance of
its obligations and shall not be liable for damages to the other in
the event that such performance is prevented by circumstances beyond
its effective control. Such excuse from performance shall continue
so long as the condition responsible for such excuse continues and
for a thirty (30) day period thereafter.
For the purposes of this Agreement, circumstances beyond the control
of the party which excuse that party from performance shall include,
but shall not be limited to, acts of God, acts, regulations or laws
of war, civil commotion, destruction of facility or materials by
fire, earthquake, storm or other casualty, labour disturbances,
epidemic and failure of public utilities or common carrier.
14 WARRANTIES AND REPRESENTATIONS
14.1 NOVO NORDISK expressly warrants and represents that it owns all of
the rights, title and interest in and to the Patent Rights and that
it has the full right and authority to grant the rights granted to
XXXXXXX & XXXXXXX and CHIRON hereunder.
14.2 NOVO NORDISK expressly warrants and represents that it has no
outstanding encumbrances or agreements, either written, oral or
implied, in connection with the Licensed Product, and that it has
not granted and will not grant during the term of this Agreement or
any renewal thereof, any similar rights, license, consent or
privilege with respect to the rights granted herein.
14.3 NOVO NORDISK expressly warrants and represents that during the term
of this Agreement it will not commercialize any Licensed Product.
15 MISCELLANEOUS
15.1 This Agreement shall be construed in accordance with English law. In
the event of any controversy or claim arising out of or in relation
to or in connection with any provision of this Agreement, including
breach
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.n.
-13-
hereof, the parties hereto shall try to settle the problem amicably
between themselves. Should the parties hereto fail to agree, the
matter in dispute may be finally settled by arbitration in London,
in accordance with the arbitration rules of the International
Chamber of Commerce, unless otherwise can be agreed to by the
parties. In the event that the parties hereto cannot agree to final
settlement by arbitration, the dispute shall be referred to the
court of London, England.
15.2 Each party hereto agrees that it does not intend to violate any
public policy, statutory or common laws:
However, if any sentence, paragraph, clause or combination of the
same is in violation of any state or federal law or is found to be
otherwise unenforceable by a court from which there is no appeal, or
no appeal is taken, such sentences, paragraphs, clauses or
combinations of the same shall be deleted and the remainder of this
Agreement shall remain binding.
Furthermore, in lieu of each such illegal, invalid or unenforceable
sentences, paragraphs, clauses or combinations of the same there
shall be added after consultation between the parties hereto as part
of this Agreement sentences, paragraphs, clauses, or combinations
which are as similar in terms to such illegal, invalid, or
unenforceable sentences, paragraphs, clauses, or combinations of the
same as may be possible and be legal, valid, and enforceable.
15.3 This Agreement and the covenants herein contained shall be binding
and inure to the benefit of the parties hereto and their heirs,
assigns, successors and legal representatives. This Agreement shall
not be assignable by either party without the other party's prior
written consent.
15.4 This Agreement constitutes the entire understanding between the
parties with respect to the subject matter hereof and shall
supersede all previous communications, representations,
understandings and agreements, either oral or written, between the
parties with respect to the subject matter of this Agreement;
amendments or modifications of this Agreement may be made only by a
written instrument executed by all of the parties hereto.
15.5 The paragraph headings contained herein are for reference only; they
are not a part of this Agreement nor shall they in any way affect
the interpretation thereof.
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.n.
-14-
15.6 The express or implied waiver by a party of a breach of any
provision of this Agreement shall not constitute a continuing waiver
of other breaches of the same or other provisions of this Agreement.
IN WITNESS WHEREOF, the parties hereto have affixed their authorized signatures
as of the date first above written.
New Jersey, 1994 - 2/19 - Bagsvaerd, 0000 - 00-00
XXXXXXX & XXXXXXX XXXX XXXXXXX A/S
/s/ XXXXX X. TATTLE /s/ XXXX XXXXXXXX
-------------------------------------- -----------------------------------
By: Xxxxx X. Tattle By: Xxxx Xxxxxxxx
Xxxxxxxxxx, XX 0000- - Seattle, 1994- 01-19
CHIRON CORPORATION ZYMOGENETICS INC.
/s/ ILLEGIBLE /s/ XXXXX XXXXXX
-------------------------------------- -----------------------------------
By: By: Xxxxx Xxxxxx
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.n.
-15-
EXHIBIT I
Existing Patent List - PDGF
As of January 11, 1994
ISSUED PATENTS:
--------------
Country Patent Number Date of Issue
[*]
PENDING APPLICATIONS:
--------------------
Country Serial Number Filing Date
[*]
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
First Amendment to the License Agreement between
------------------------------------------------
NOVO NORDISK A/S, ZYMOGENETICS INC., XXXXXX & XXXXXXX,
------------------------------------------------------
and CHIRON CORP. dated 18 January 1994
--------------------------------------
THIS FIRST AMENDMENT is made this 1st day of January, 1997, by and
---------
between:
NOVO NORDISK A/S with its place of business at Novo Alle, XX-0000 Xxxxxxxxx,
Xxxxxxx, and ZYMOGENETICS INC., with its place of business at 0000 Xxxxxxxxx Xxx
XX, Xxxxxxx, Xxxxxxxxxx 00000 X.X.X. (hereinafter collectively referred to as
"NOVO NORDISK"); and
XXXXXXX & XXXXXXX with its place of business at Xxx Xxxxxxx & Xxxxxxx Xxxxx, Xxx
Xxxxxxxxx, Xxx Xxxxxx 00000 X.X.X. (hereinafter referred to as "XXXXXXX &
XXXXXXX"); and
CHIRON CORPORATION, with its place of business at 0000 Xxxxxx Xxxxxx,
Xxxxxxxxxx, Xxxxxxxxxx 00000 X.X.X. (hereinafter referred to as "CHIRON").
NOVO NORDISK, XXXXXXX & XXXXXXX, AND CHIRON are collectively referred to below
as "THE PARTIES".
WITNESSETH:
WHEREAS, THE PARTIES wish to amend in certain respects the License
Agreement between them dated as of the 18th day of January 1994, a copy of which
is attached hereto (hereinafter referred to as "THE AGREEMENT").
NOW, THEREFORE, in consideration of the mutual covenants and provisions set
forth herein, THE PARTIES agree as follows:
1.) In Article 3.1.3 of THE AGREEMENT the first paragraph of Article
3.1.3 is deleted in its entirety, and is replaced by the following new
paragraph:
"a running royalty payable on a country by country basis on all Licensed
Products sold by XXXXXXX & XXXXXXX and CHIRON, its Affiliates - or a
marketing/business partner as mentioned in Clause 1.4 - at the following rate
schedule:
i) a [*] royalty on the annual Net Proceeds of Sales up to and including
[*];
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-2-
ii) a [*] royalty on the annual Net Proceeds of Sales over [*] up to
and including [*]; and
iii) an [*] royalty on the annual Net Proceeds of Sales over [*].
For example, if the annual Net Proceeds of Sales is [*] then the royalty
would be[*]; [*]; and [*]. XXXXXXX & XXXXXXX and CHIRON shall jointly pay this
running royalty on annual Net Proceeds of Sales quarterly within sixty (60) days
after the end of each calendar quarter."
IN WITNESS WHEREOF, THE PARTIES have executed this First Amendment to be
effective as of the date written above.
NOVO NORDISK A/S XXXXXXX & XXXXXXX
By: /s/ Xxxxx Xxxxxx By: /s/ Xxxxx X. Tattle
----------------------------------- --------------------------------
Name: Xxxxx Xxxxxx Name: Xxxxx X. Tattle
--------------------------------- ------------------------------
Title: Chief Scientific Officer Title: Company Group Chairman
-------------------------------- -----------------------------
Date: 1 May 97 Date:
--------------------------------- ------------------------------
ZYMOGENETICS INC. CHIRON CORPORATION
By: /s/ Xxxxx Xxxx By: /s/ Xxxxxx X. Xxxxxxx
----------------------------------- --------------------------------
Name: Xxxxx Xxxx Name: Xxxxxx X. Xxxxxxx
--------------------------------- -----------------------------
Title: President Title: CEO
-------------------------------- -----------------------------
Date: 5/1/97 Date: 5/9/97
--------------------------------- -----------------------------
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-3-
Second Amendment to the License Agreement between
-------------------------------------------------
NOVO NORDISK A/S, ZYMOGENETICS, INC., XXXXXXX & XXXXXXX
-------------------------------------------------------
and CHIRON CORP. dated 18 January 1994
--------------------------------------
THIS SECOND AMENDMENT is made this 5th day of June, 2000, by and between:
NOVO NORDISK A/S, with its place of business at Xxxx Xxxx, XX-0000, Xxxxxxxxx,
Xxxxxxx (hereinafter referred to as "NOVO NORDISK"); and
ZYMOGENETICS, INC., with its place of business at 0000 Xxxxxxxx Xxxxxx Xxxx,
Xxxxxxx, Xxxxxxxxxx 00000 U.S.A (hereinafter referred to as "ZYMOGENETICS); and
XXXXXXX & XXXXXXX, with its place of business at Xxx Xxxxxxx & Xxxxxxx Xxxxx,
Xxx Xxxxxxxxx, Xxx Xxxxxx 00000 X.X.X. (hereinafter referred to as "XXXXXXX &
XXXXXXX"); and
CHIRON CORPORATION, with its place of business at 0000 Xxxxxx Xxxxxx,
Xxxxxxxxxx, Xxxxxxxxxx 00000 X.X.X. (hereinafter referred to as "CHIRON").
NOVO NORDISK, ZYMOGENETICS XXXXXXX & XXXXXXX and CHIRON are collectively
referred to below as "THE PARTIES".
WITNESSETH:
WHEREAS, ZYMOGENETICS has been presented with an opportunity to pursue
commercialization of platelet-derived growth factor (PDGF) in the fields of
periodontal disease and cranio-maxillofacial osseous defects; and
WHEREAS, THE PARTIES wish to amend in certain respects THE AGREEMENT.
NOW, THEREFORE, in consideration of the mutual covenants and provisions set
forth herein, THE PARTIES agree as follows:
In Article 1.2 of THE AGREEMENT the paragraph is deleted in its entirety,
and is replaced by the following new paragraph:
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
"The term "Licensed Product" shall mean any PDGF (including A chain or B
chain polypeptide, monomers or dimers thereof, or fragments, modifications or
derivatives thereof) containing agent for human use to accelerate healing of
soft tissue wounds, excluding ophthalmic wounds and the treatment or diagnosis
of periodontal disease and/or the repair, restoration and reconstruction of
cranio-maxillofacial osseous defects, but including surgical incision healing
unless used as a component in a tissue glue, biologically derived for use in
controlling intense bleeding in surgery, in the manufacture, use or sale of
which is covered by at least one valid and granted claim of Patent Rights."
The remainder of THE AGREEMENT remains unchanged.
IN WITNESS WHEREOF, THE PARTIES have executed this SECOND AMENDMENT to be
effective as of the date written above.
NOVO NORDISK A/S XXXXXXX & XXXXXXX
By: /s/ XXXXX XXXXXX By: /s/ XXXXX X. TATTLE
--------------------------------- ------------------------------
Name: Xxxxx Xxxxxx Name: Xxxxx X. Tattle
------------------------------- ----------------------------
Title: CSO Title: C.G.C.
------------------------------ ---------------------------
Date: 7 June 00 Date: 6/20/00
------------------------------- ----------------------------
ZYMOGENETICS CHIRON CORPORATION
By: /s/ XXXXX XXXXXX By: /s/ XXXXXXX XXXXX
--------------------------------- -----------------------------
Name: Xxxxx Xxxxxx Name: Xxxxxx Xxxxx
------------------------------- ----------------------------
Title: CEO Title: Vice President, Finance &
------------------------------ ---------------------------
Operations
---------------------------
Date: 7 June 00 Chiron BioPharmaceuticals
------------------------------- ---------------------------
Date: 7/11/00
----------------------------
[*] designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the Commission.
-2-
