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EXHIBIT 10.8
[CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE
BEEN REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION]
ANTIBODY LICENSE AGREEMENT
THIS AGREEMENT, dated September 22, 1995, is entered into by and
between SANDOZ PHARMA LTD., a Swiss Corporation with offices at Xxxxxxxxxxxx 00,
XX0000 Xxxxx/Xxxxxxxxxxx ("Sandoz"), and BIOSITE DIAGNOSTICS INCORPORATED, a
Delaware corporation with offices at 00000 Xxxxxxx Xxxxxx, Xxx Xxxxx, XX
92121/USA ("Licensee").
W I T N E S S E T H:
WHEREAS, Sandoz owns patents, patent applications, technical
information, data and know-how relating to cyclosporine, an immnunosuppressive
drug marketed under the trademarks Sandimmun(R) or Sandimmune(R) (or Neoral(R)
or Optoral(R) for Sandoz's patented microemulsion preconcentrate formulation of
cyclosporine), and to monoclonal antibodies capable of distinguishing between
cyclosporine and metabolites thereof which are suitable for use in diagnostic
assay kits and systems, and to assay kits or systems comprising such monoclonal
antibodies;
WHEREAS, Licensee has extensive know-how relating to the development
and marketing of diagnostic assays for the monitoring of drugs and other small
molecules;
WHEREAS, Sandoz, in order to xxxxxx the safety of patients all over the
world receiving cyclosporine, is interested that both in whole blood and plasma
analogous therapeutic windows are determined whatever assay system is used, and
is therefore interested to grant licenses on its patents, patent applications,
technical information, data and know-how to develop and commercialize such assay
systems and to supply companies manufacturing such assay kits with monoclonal
antibodies, cyclosporine and certain cyclosporine metabolites for cyclosporine
assays;
NOW, THEREFORE, Sandoz and Licensee agree as follows:
1. DEFINITIONS.
The following definitions shall control the construction of each of the
following terms wherever they appear in this Agreement:
1.1 "Affiliate" of a part shall mean a corporation or other business
entity controlled by, controlling or under common control with such party. For
this purpose, control of a corporation or other business entity shall mean
direct or indirect beneficial ownership of at least fifty percent (50%) of the
voting interest in, or a greater than fifty percent (50%)
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interest in the equity of, such corporation or other business entity.
1.2 "CyA" shall mean the immunosuppressive drug cyclosporine.
1.3 "Monoclonal Antibody(ies)" shall mean antibody(ies) to CyA, its
analogues, and/or to metabolites thereof whether or not derived from a Sandoz
cell line, and useful in measuring amounts of CyA, its analogues and/or
metabolites thereof.
1.4 "CyA Assay(s) (or Products or Kits)" shall mean those certain
testing devices, which are used with a testing device reader, which utilize in
vitro diagnostic assay(s) based on Monoclonal Antibodies and which are useful
for therapeutic drug level monitoring in patients treated with CyA; provided,
however, that the CyA Assay(s) (or Products or Kits) shall not include the
testing device reader.
1.5 "Sandoz Know-How" shall mean all biological, chemical, and
immunological materials, methods and other technical information, presently or
hereafter during the term of this Agreement in the possession or control or
Sandoz which relate to Monoclonal Antibodies or to CyA Assays conveyed to
Licensee in writing, orally or through other tangible materials.
1.6 "Sandoz Patent Rights" shall mean all patent applications
world-wide and patents granted thereon, and all extensions and supplemental
protection certificates based on such patents, now or hereafter during the term
of this Agreement owned or controlled by Sandoz, which incorporate a Valid Claim
covering Monoclonal Antibodies or CyA Assays; a listing of such subsisting
Sandoz Patent Rights being provided in the attached Schedule A, which will be
updated from time to time as appropriate.
1.7 "Effective Date" shall mean the date first written hereinabove.
1.8 "Non-exclusive License" shall mean a license under which Sandoz is
free to grant other licenses in the same field to other parties than Licensee.
1.9 "Net Sales" shall mean the gross sales of CyA Assays by Licensee,
its Affiliates and its sublicensees (if any) billed to customers, less the
amount actually allowed to customers for (1) adjustments granted to customers,
including without limitation credits and allowances or on account of the
rejection or return of CyA Assays previously sold, (2) trade and cash discounts,
rebates and distributor fees, (3) transportation, insurance and handling charges
and (4) sales, excise, turnover and similar taxes and any duties and other
governmental charges imposed upon the production, importation, use or sale of
CyA Assays. Where the price of a CyA Assay includes the price of
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the device reader or the price of an assay for a compound other than CyA, Net
Sales shall be determined by a formula (to be agreed upon by the parties before
sales at such price are made) calculated to exclude that portion of sales of CyA
Assays reasonably attributable to such prices of the device reader and/or the
assay for a compound other than CyA.
1.10 "Valid Claim" shall mean one or more claims within Sandoz Patent
Rights which has not been declared to be invalid or unenforceable by the final
judgment of a court of competent jurisdiction from which no appeal can be or has
been taken.
1.11 "Patent Countries" shall mean countries in which Sandoz Patent
Rights subsist.
1.12 "First Commercial Sale" shall mean the first sale of CyA Assay
under this Agreement by Licensee or its Affiliates to a non-affiliated third
party, following approval of its marketing by the appropriate governmental
agency for the country in which the sale is to be made or, when governmental
approval is not required, the first sale in a country.
1.13 "1992-SFr" shall indicate a quoted price which may, at the option
of Sandoz, be adjusted yearly as of January 1 of each year to correspond to
changes in the Swiss Consumer Price Index of the Swiss Bundesamt fur Statistik
since December 31, 1992.
2. FEASIBILITY STUDY.
2.1(a) Within fifteen (15) working days after the Effective Date of
this Agreement, Sandoz will supply to Licensee [CONFIDENTIAL MATERIAL REDACTED
AND FILED SEPARATELY WITH THE COMMISSION] as reference compound and starting
material for tracer synthesis, respectively. Import regulations will be handled
by Sandoz upon receipt of the permit applied for by Licensee at the U.S.
Department of Agriculture, Xxxxxxxxxxx, Xxxxxxxx 00000. The permit forwarded by
Licensee to Sandoz will accompany the shipment of antibody to facilitate port of
entry clearance by USDA inspectors. During the Feasibility Period as set forth
in Sections 2.2 and 2.3, Sandoz warrants that it will satisfy all applicable
U.S. governmental import regulations regarding all materials required by
Licensee and supplied by Sandoz such evaluation.
To demonstrate feasibility using quality control samples of Cyclosporin
A in whole blood, Licensee's test will be required to have accuracy, precision
and reproducibility at least equivalent to (at a 95% confidence level) the
INCSTAR CycloTrac RIA assay for cyclosporine (or such other standard assay as is
acceptable to the US FDA as a reference for bioequivalence). INCSTAR CycloTrac
assays for comparison purposes are commercially distributed by INCSTAR Company,
Xxxxxxxxxx, Xxxxxxxxx 00000.
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(b) If Licensee demonstrates the above results to Sandoz, Licensee
shall have the right to enter the next stage of cooperation. Sandoz shall then
supply Licensee with [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH
THE COMMISSION]. For testing cross reactivity with the preliminary assay system,
Licensee will receive small quantities [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] of [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] and, in addition to that, Licensee shall analyze
several blood samples from various transplant patients from local hospitals with
both the INCSTAR CycloTrac assay (or such other standard assay as is acceptable
to the US FDA as a reference for bioequivalence) and the experimental test
design of Licensee. The performance requirements as set forth in 2.1(a) will
apply equally.
(c) Licensee will not use any materials supplied by Sandoz for any
other purpose than performing the feasibility phase investigations under this
Agreement and will not divulge the nature of or provide any such materials to
any third party.
(d) Prior to or during the investigations of Section 2.1, Sandoz shall
provide its Know-how to Licensee only as each portion is requested by Licensee.
2.2 Sandoz hereby grants Licensee the non-exclusive right to perform
feasibility investigations during a Feasibility Period of one year starting with
the Effective Date of this Agreement. Licensee shall inform Sandoz in quarterly
reports on progress and status of these investigations. At the end of the
Feasibility Period, if successful, Licensee shall provide a demonstration of
meeting the performance criteria set out in Section 2.1 with whole blood. Each
such report, and the information and data contained in each such report, shall
constitute Confidential Information of Licensee under Section 8 below.
2.3 Licensee may elect to extend the duration of the Feasibility Period
for an additional period of time mutually to be agreed upon, if such extension
is deemed necessary by mutual agreement of SANDOZ and LICENSEE for the proper
performance and completion of the respective investigations. SANDOZ will not
unreasonably withhold agreement to any such extension which has been reasonably
requested by LICENSEE.
2.4 Upon receipt by Sandoz of written notification from Licensee prior
to expiry of the one year period referred to in Section 2.2 above or any
extended period agreed in accordance with Section 2.3 above, that Licensee has
successfully performed the feasibility investigations in whole blood and plasma
and wishes to enter into a Nonexclusive License under Sandoz Patent Rights and
Sandoz Know-How to make, have made, use and sell CyA Assays,
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Sandoz will in writing confirm the feasibility or object to it within thirty
(30) days. Upon confirmation, Section 3 through 16 of this Agreement shall
immediately become effective without further documentation between the parties.
2.5 In the absence of any notification by Licensee in accordance with
Section 2.4 above or in the event that Licensee notifies Sandoz during the
Feasibility Period pursuant to Sections 2.2 and 2.3 that it does not wish to
enter into a Nonexclusive License according to Section 2.4, this Agreement shall
terminate and the parties shall have no further liability or obligations to each
other concerning CyA Assays or Monoclonal Antibodies under this Agreement,
provided, however, that the materials and Sandoz Know-How provided to Licensee
pursuant to Section 2.1 hereof shall continue to be governed by the
Confidentiality Provision set out in Section 8. In such event, Licensee shall
immediately return to Sandoz all unused portions of Monoclonal Antibodies and
any other materials provided by Sandoz remaining in Licensee's possession and
any copies of tangible materials embodying Sandoz Know-How, except for one copy
which may be retained in Licensee's confidential legal files for use solely by
Licensee's counsel.
3. LICENSE.
Upon receipt of the notification referred to in Section 2.4, Sandoz
undertakes to grant to Licensee a Non-exclusive License with the right to
sublicense Affiliates under the Sandoz Patent Rights and Sandoz Know-How to
make, have made, use and sell CyA Assays worldwide.
4. SUPPLIES.
4.1 Cell Line Transfer and License.
(a) Sandoz grants Licensee a Non-exclusive License under Sandoz Patent
Rights and Sandoz Know-How to manufacture Monoclonal Antibodies and
shall--subject to the payment referred to in Section 5.2 below--make available
the Sandoz cell-lines and the necessary Know-How to Licensee within
one month after the grant of the Non-exclusive License in accordance with
Section 3 of this Agreement.
(b) The cell-lines shall remain the property of Sandoz. No further
transmission and no alternations or special manipulations by Licensee shall be
permitted.
Sandoz, at its discretion and its own costs, shall have the possibility
to test the integrity of the cell lines in order to assure presence of the
essential chromosomes to produce antibody of proper specificity.
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(c) Licensee agrees to supply Sandoz upon Sandoz Pharma's request, and
solely for Sandoz internal use, with Monoclonal Antibodies in accordance with
reasonable price, ordering and supply terms to be agreed upon.
4.2 CyA and CyA Metabolites.
(a) Sandoz shall supply Licensee and Licensee shall purchase from
Sandoz all requirements of [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
WITH THE COMMISSION] reasonably and justifiably needed for the purpose of
development after the work contemplated in Section 2 and production of CyA
Assays and available to Sandoz, in accordance with the provisions of this
Section 4. During the term of this Agreement, Sandoz shall continue to provide
such materials to Licensee pursuant to Section 4.2, even if the license is paid
up and royalties are no longer due under this Agreement.
SANDOZ, however, may terminate at its sole discretion by written
previous notice of one year, its obligation to provide such materials to
licensee, provided it makes available [CONFIDENTIAL MATERIAL REDACTED AND
FILED SEPARATELY WITH THE COMMISSION] or the know how to manufacture such
metabolites to LICENSEE within one (1) month after the date of such
notification. The Non-exclusive license granted to LICENSEE hereunder shall not
be affected thereby.
(b) At the latest three months before the beginning of any calendar
quarter Licensee shall place a firm order with Sandoz in writing for the first
quarter and indicate to Sandoz its estimated requirement for each of the
following three quarters and the subsequent 12 months. Sandoz has no commitment
to supply any quantities of Licensee's requirements exceeding by twenty-five
percent (25%) the last estimate given for such quarter. In the event that Sandoz
is unwilling or unable to supply any quantities of Licensee's requirements
exceeding by twenty-five percent (25%) the last estimate given for such quarter,
then Licensee shall have the right to purchase the [CONFIDENTIAL MATERIAL
REDACTED AND FILED SEPARATELY WITH THE COMMISSION] or CyA elsewhere or to
prepare these compounds internally.
(c) Freight, duty and associated taxes shall be paid by LICENSEE with
each element shown separately in invoices. Title shall pass to Licensee upon
transfer to the carrier by Sandoz for final shipment to Licensee. Delivery shall
be made to Licensee within forty five (45) working days of the date of
Licensee's order therefor.
4.3 The supply price for [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION], pursuant to Section 4.2, shall be Swiss Francs
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] per
gram FCA Basel. The supply price for [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION], pursuant to 4.2 shall be Swiss Francs
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] per
gram FCA Basel for [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY
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WITH THE COMMISSION] FCA Basle. Licensee may purchase less than one gram of such
materials at pro rata cost.
5. FEES AND ROYALTIES.
5.1 Upon execution of this Agreement, LICENSEE shall pay a
non-refundable lump sum payment of Swiss Francs 120,000. -- (one hundred twenty
thousand) to SANDOZ. [CONFIDENTIAL TREATMENT REDACTED AND FILED SEPARATELY WITH
THE COMMISSION] of this lump sum payment shall be creditable against future
royalties according to Article 5.3.
5.2 Upon transfer of the Monoclonal Antibody-producing cell-line to
Licensee pursuant to Section 4.1(a), Licensee shall pay a further,
non-refundable and non-creditable lump-sum payment of Swiss Francs 55,000.--
(fifty-five thousand) to Sandoz.
5.3 Licensee will pay a royalty of [CONFIDENTIAL MATERIAL REDACTED AND
FILED SEPARATELY WITH THE COMMISSION] in Patent Countries and [CONFIDENTIAL
MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] in all other
countries upon the Net Sales.
In Patent Countries, the period for payment of royalties in a given
country shall be extended so long as a Valid Claim of Sandoz Patent Rights
covers the sale by Licensee of CyA Assays in said country.
With respect to sale of CyA Assays in any Patent Country, the
obligation of Licensee to pay royalties as provided above shall be reduced by
[CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION] in the
event and for the period that an unlicensed third party or parties sell any
quantity of CyA Assays in excess of [CONFIDENTIAL MATERIAL REDACTED AND FILED
SEPARATELY WITH THE COMMISSION] of the total CyA Assay market in such Patent
Country, said market share percentage to be determined by an independent market
survey organization mutually agreed to by Sandoz and Licensee.
5.4 To ensure Sandoz' royalty income from the sale of CyA Assays,
absent prior written consent of Sandoz, Licensee shall not sell to any third
party any CyA Assays for a consideration other than that upon which Net Sales
can be determined for the purpose of payment of royalty to Sandoz.
5.5 There shall be no obligation to pay Sandoz under this Section 5 on
sales of CyA Assays between Licensee and its sublicenses (if any), but in such
instances the obligation to pay royalties shall arise upon the sale by Licensee
or its sublicensees to unrelated third parties. It is understood and agreed that
any payment under this Section 5 may be made on behalf of Licensee by any
sublicensee of Licensee, provided, however, that Licensee shall remain primarily
responsible therefor. Payments due under this Section 5 shall be deemed to
accrue when CyA Assays are sold to such unrelated third party.
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5.6 For purposes of this Agreement, a sale of a CyA Assay to an
unrelated third party shall be deemed to take place in the country of actual
sale to the final user.
5.7 Payments of royalties by Licensee to Sandoz shall occur half-yearly
to Sandoz' designated account within sixty (60) days after the end of the
respective calendar half-year.
5.8 Each payment paid hereunder shall be accompanied by a statement
which shall set forth, for sales subject to royalty under this Agreement, the
Net Sales of CyA Assays, the quantity of units of CyA Assays sold and the
royalty due thereon.
5.9 All amounts payable to Sandoz under this Agreement shall be made in
Swiss Francs, and shall be calculated in the currency of the sale and then
converted into Swiss Francs using the applicable exchange rate published in the
United States in "The Wall Street Journal" under the caption "Money Rates" (or
in the event "The Wall Street Journal" does not report the local currency, then
another reliable source which is mutually agreeable to Licensee and Sandoz)
using an average quarterly exchange rate determined as the average of the
exchange rates set forth in the first and last issue of The Wall Street Journal
published during (or average of the first and last business days of) the
applicable reporting calendar half-year.
5.10 The obligation to pay royalties to Sandoz under this Agreement is
imposed only once with respect to the same unit of CyA Assay regardless of the
number of claims of Sandoz Patent Rights or the amount of Sandoz Know-How
embodies in such CyA Assay.
5.11 If after the date of this Agreement, Sandoz grants to another
licensee a similar license of Sandoz Patent Rights and Sandoz Know-How, with
fees and royalties more favorable to such other licensee than as provided in
this Article 5, this Article 5 will be adapted prospectively to conform with
such more favorable terms.
5.12 Licensee shall be entitled to deduct from royalty payments to
Sandoz hereunder the amount of any taxes, levies or charges which Licensee, its
Affiliates or sublicensees are required by applicable law to withhold from such
royalty payments, to the extent that Licensee, its Affiliates or sublicensees
pay to the appropriate governmental authority on behalf of Sandoz such taxes,
levies or charges. Licensee shall use reasonable efforts to minimize any taxes,
levies or charges required to be withheld on behalf of Sandoz by Licensee, its
Affiliates or sublicensees. Licensee shall promptly deliver to Sandoz proof of
payment of all taxes, levies or charges, together with copies of all
communications from or with such governmental authority with respect thereto.
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6. VERIFICATION.
6.1 For a period of 2 (two years) from the date when each royalty
statement is due hereunder, Licensee agrees to keep records in sufficient detail
and to allow an independent certified public accounting firm of internationally
recognized standing appointed by Sandoz, and reasonably acceptable to Licensee,
to examine its books and records, at Sandoz' sole expense, upon reasonable
notice during business hours but not more than once a year, in order to verify
the payments due under this Agreement; provided, however, that such certified
public accounting firm shall not disclose any information to Sandoz except that
information which should properly have been contained in such royalty statement.
7. GOVERNMENT APPROVALS.
7.1 Licensee shall be solely responsible, at its expense, for all
required filings and all other proper action required to obtain all necessary
approvals to develop, promote, market and sell CyA Assays.
8. CONFIDENTIAL INFORMATION.
8.1 Any information which shall have been communicated in confidence
under this Agreement, whether in writing or orally and subsequently confirmed in
writing or in other tangible form, designated by the disclosing party to be
confidential (the "Confidential Information") shall be governed by the
provisions of this Article:
(a) Recipient shall not use the Confidential Information disclosed to
it for its own benefit except for the purpose of performing its obligations
under this Agreement.
(b) Recipient shall not disclose the Confidential Information disclosed
to it to any third party or to use such Confidential Information of the benefit
of any third party without the express written permission of the disclosing
party, except that the recipient shall not be prevented from using or disclosing
information disclosed to it hereunder:
(i) which recipient can demonstrate by written records was
known to the recipient prior to the date of disclosure by the
disclosing party, provided such information was not obtained by the
recipient through disclosure by a third party receiving such
information in confidence from the disclosing party;
(ii) which is now public knowledge, or becomes public
knowledge in the future other than by breach of this Agreement by the
recipient;
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(iii) which is independently developed by or for the recipient
without benefit of Confidential Information received from the
disclosing party;
(iv) which is disclosed to recipient, after the date of
disclosure by the disclosing party, by a third party having a right to
make such disclosure; or
(v) which is included in any filing or action taken by
Licensee to obtain governmental approval to develop, promote, market
and sell CyA Assays, provided, however, that when permitted by the
provisions of local law, Licensee will take reasonable steps to protect
the confidentiality of Confidential Information submitted to
governmental agencies or authorities pursuant to Section 7 hereof.
Each party shall use the same degree of care it uses to protect its own
confidential and proprietary technical information to prevent the unauthorized
disclosure to any third party of the Confidential Information.
(c) Each party agrees that the Confidential Information disclosed to it
will only be disclosed to such employees, officers, directors or consultants of
the recipient who reasonably require such disclosure for purposes of performing
the recipient's obligations under this Agreement. Such party shall cause each
such person to agree to keep confidential and not use the Confidential
Information disclosed to it to the same extent as such party is so obligated
under this Section 8.
Each party may disclose Confidential Information of the other party to
the extent that such disclosure is required by applicable law, regulation or
court order, provided that such party shall provide written notice to the other
party and sufficient opportunity to object to such disclosure or to request
confidential treatment thereof.
(d) Upon termination of this Agreement, each party shall return to the
other or destroy any tangible physical copies of any Confidential Information
provided to it hereunder and any notes taken or copies made by employees,
officers, directors or consultants of such party regarding Confidential
Information disclosed to it, provided, however, that each party may retain one
(1) copy of Confidential Information disclosed to it in its confidential legal
files for use solely by such party's counsel.
(e) The confidentiality obligations under the terms of this Agreement
shall remain in effect with respect to each portion of the Confidential
Information for a period of 5 (five) years after expiry of this Agreement but at
least 10 (ten) years from the Effective Date of this Agreement.
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8.2 Materials provided to or produced by Licensee under this Agreement,
including CyA, Monoclonal Antibodies, and CyA Derivatives, shall be used only
for the purposes contemplated by this Agreement and no other purposes. Upon
termination of this Agreement, all such materials in Licensee's possession
shall be returned to Sandoz.
9. PATENTS.
9.1 Sandoz warrants that at the time of execution of this Agreement it
knows of no third party patent rights which would impinge upon Licensee's
freedom to manufacture, use or sell CyA Assays in any country.
Should the existence of such third party patent rights become known to
either party subsequent to the execution of this Agreement, the parties shall
work together to ensure the continued exercise of the provisions of this
Agreement.
Should Licensee be required or if it is determined by mutual agreement
not to be withheld unreasonably that it needs to acquire a license under such
third party patent rights, Licensee shall be permitted to offset the cost of
such rights against royalties payable to Sandoz, such offset, however, shall not
exceed [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION]
of the royalties due and payable to Sandoz in any calendar half year.
10. TERM AND TERMINATION.
10.1 Unless earlier terminated in accordance with the terms hereof,
this Agreement shall remain in force until the later of the following dates:
(i) the date of expiration of the last-to-expire patent included in SANDOZ
Patent Rights; or (ii) the date of expiry of a ten (10) year period from the
date of First Commercial Sale in the last country in which CyA Assays are sold.
Upon termination of this Agreement pursuant to this Section 10.1, Licensee shall
have a fully-paid, worldwide, Non-exclusive License under the Sandoz Know-how to
make, have made, use and sell CyA Assays worldwide.
The parties will meet approximately two years before the latest such
date to determine whether and how Sandoz' supply to Licensee of CyA and CyA
metabolites [CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE
COMMISSION] under Section 4.2 hereof may be continued.
10.2 Licensee may terminate this Agreement at any time upon one year's
previous written notice.
10.3 If, at any time, Sandoz discovers that the performance of the CyA
Assay (or Product or Kit) of Licensee is no longer within the performance
criteria set out in Section 2.1 above, Sandoz shall notify Licensee accordingly.
Licensee shall
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have 90 days to rectify this deficiency, or if such deficiency is one which
requires more than ninety (90) to remedy, Licensee shall commence promptly and
thereafter diligently pursue to remedy such deficiency, failing which Sandoz
shall have the right to terminate the Agreement at any time upon the end of any
calendar-quarter by written notice.
10.4 Either party shall have the right to terminate this Agreement and
the license hereunder forthwith by notice in writing to the other party if the
other party fails to perform or observe any of the material terms hereof on its
part to be performed and observed, and fails to remedy such breach within
ninety (90) of a notice to remedy the same (such notice giving adequate
particulars of the alleged default and of the intention of the party serving the
notice to terminate this Agreement under this Section), or, if the breach is one
which requires more than ninety (90) to remedy, the remedying was not commenced
promptly and thereafter diligently pursued.
10.5 Any termination of this Agreement prior to the expiration of term
pursuant to Paragraph 10.1: (a) shall automatically cancel the license granted
to Licensee hereunder; (b) shall be without prejudice to the rights of either
party against the other party which may have accrued up to the date of such
termination (including Sandoz' right to be paid any amounts due and payable
hereunder); and (c) shall be without prejudice to the rights of Licensee to
dispose of quantities of CyA Assays in its possession, subject to the payment of
any amounts due thereon to Sandoz as provided herein.
11. GOVERNING LAW AND JURISDICTION.
11.1 This Agreement shall be governed by, interpreted and enforced in
accordance with the substantive laws of Switzerland.
11.2 All disputes arising out of this Agreement shall be finally
decided under the Rules of Conciliation and Arbitration of the International
Chamber of Commerce in Paris. The arbitration shall take place in Basle,
Switzerland if brought by Licensee or in San Diego, USA if brought by Xxxxxx.
00. NOTICES.
12.1 Any notice required or permitted to be given hereunder shall be in
writing and shall be deemed sufficient if sent by registered or certified mail,
telefax or air express or delivered by hand to the respective party at the
address stated below:
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If to Sandoz: Sandoz Pharma Ltd.
X.X. Xxx
XX-0000 Xxxxx, Xxxxxxxxxxx
Attention: Legal Department
Fax: x00 00 000-0000
If to Licensee: Biosite Diagnostics, Incorporated
00000 Xxxxxxx Xxxxxx
Xxx Xxxxx, XX 00000
Attention: President
Fax: x0 000 000-0000
Any such notice mailed by registered or certified mail, telefax or air
express shall be deemed to have been given when mailed, as evidenced by the date
on the receipt retained by the sender. Either party may change the address to
which notice to it is to be given by notice as provided herein.
13. ASSIGNABILITY.
13.1 This Agreement shall not be assignable without the prior written
consent of the other party hereto other than to an entity acquiring all or
substantially all of the stock of assets of the assignor by merger,
consolidation, purchase or similar transaction. All reference to a party in this
Agreement shall, to the extent reasonably necessary to carry out the purpose of
this Section 14 be considered references to each permitted transferee or
assignee of such party.
13.2 This Agreement shall be binding upon and inure to the benefit of
the successor or permitted assigns of Licensee and Sandoz, respectively.
14. EXCUSED NON-PERFORMANCE.
14.1 Each of the parties hereto shall be excused from the performance
of its obligations hereunder in the event such performance is prevented by a
cause beyond the reasonable control of such party, including, without
limitation, any act, regulation or law of any government, war, civil commotion,
destruction of production facilities or materials by fire, earthquake or storm
and failure of public utilities.
15. SEVERABILITY.
15.1 Should any part of this Agreement be held unenforceable or in
conflict with the applicable laws or regulations of any applicable jurisdiction,
the invalid or unenforceable part or provision shall be replaced with a
provision which accomplishes, to the extent possible, the original business
purpose of the invalid or unenforceable part or provision in a valid and
enforceable manner, and the remainder of this Agreement shall remain binding
upon the parties hereto.
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16. PUBLICITY AND PROMOTIONAL ACTIVITIES.
16.1 Neither Sandoz nor Licensee will issue any news releases or make
any public statements regarding this Agreement without the prior written
consultation at least 14 days in advance of the other party, giving such other
party reasonable opportunity of prior comment.
16.2 Licensee is entitled to use in its promotion a mention of "In
cooperation with Sandoz Pharma LTD., the producer of Sandimmun(R) [or
Sandimmune(R); or if referring to Sandoz's microemulsion preconcentrate
formulation of cyclosporine, then Sandimmun(e) Neoral(R), Neoral(R), or
Optoral(R)] (Cyclosporine)" after having submitted the relevant promotion
material to Sandoz for approval and not having received Sandoz's objection
within one month after such submission.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized representatives as of the date first written
above.
SANDOZ PHARMA LTD. BIOSITE DIAGNOSTICS,
INCORPORATED
By /s/ D. Vasella By /s/ Xxx X. Xxxxxxxxxxxx
-------------------------------- ------------------------------
/s/ X.X. Xxxxxx Names: Xxx X. Xxxxxxxxxxxx
-------------------------------- ---------------------------
Title: President & CEO
Names: D. Vasella
-----------------------------
X.X. Xxxxxx
-----------------------------
Title: CEO V.P.
-----------------------------
-14-
15
Schedule A
Listing of SANDOZ Patent Rights
As of 15 September 1995, SANDOZ has been granted the following patents covering
monoclonal antibodies to Cyclosporin A.
==========================================================================
Country Patent Numbers* Expiry date**
--------------------------------------------------------------------------
Australia 589917 27/09/01
--------------------------------------------------------------------------
Austria 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Belgium 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Canada 1309671 03/11/09
--------------------------------------------------------------------------
Denmark 2613/86*** 27/09/05
--------------------------------------------------------------------------
England 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Finland 93965 27/09/05
--------------------------------------------------------------------------
France 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Germany P3587505.4, 27/09/05
P3587342.6
--------------------------------------------------------------------------
Holland 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Italy 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Luxembourg 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Xxx Xxxxxxx 000000 02/10/01
--------------------------------------------------------------------------
Xxxxxx 000000 27/09/05
--------------------------------------------------------------------------
Japan 504679/85**** 27/09/05
--------------------------------------------------------------------------
South Africa 85/7684 04/10/05
--------------------------------------------------------------------------
Xxxxx Xxxxx 000000 27/09/00
--------------------------------------------------------------------------
Spain 547495-7 19/11/06
--------------------------------------------------------------------------
Sweden 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Switzerland 0198026, 0290762 27/09/05
--------------------------------------------------------------------------
Xxxxxx Xxxxxx 0000000 08/12/09
==========================================================================
* Where more than one patent number appears for a country, this reflects
divisional applications.
** The expiry date is calculated without considering the possibility of
patent term extension, which may be available in some cases.
*** Danish application pending; not yet granted.
**** Japanese application granted, but grant number not yet available.
-15-
16
[LETTERHEAD OF SANDOZ]
CORPORATE DEVELOPMENT
PROJECT MANAGEMENT
X. XXXXXXX
TEL: 000-0000
TELEFAX: 324-9145
Xx. Xxx Xxxxxxxx
BIOSITE DIAGNOSTICS
00000 Xxxxxxx Xxxxxx
XXX XXXXX, XX 00000
X.X.X.
Basle, July 26, 1996
Dear Xxx,
Following discussion with yourself, I would like to acknowledge the need to
extend the Feasibility Period (detailed in sect. 2.3. of the Sandoz/Biosite
Antibody Agreement) due mainly to the additional requests made by Sandoz in late
1996, and confirm the new mutually agreeable expiry date of November 30, 1996
(extended from September 22, 1996).
Best wishes
/s/ Xxxxxx
Xxxxxx Xxxxxxx, Ph.D.
International Project Manager for Neoral
cc: Messrs. B. Glass, X. Xxxxx, X. Xxxxx
17
[LETTERHEAD OF SANDOZ]
CORPORATE DEVELOPMENT
PROJECT MANAGEMENT
X. XXXXXXX
TEL: x00 00 000-0000
TELEFAX: x00 00 000-0000
Xx. Xxx Xxxxxxxx
BIOSITE DIAGNOSTICS
00000 Xxxxxxx Xxxxxx
XXX XXXXX, XX 00000
X.X.X.
Basle, December 3, 1996
RE: BIOSITE PROJECT - EXTENSION TO FEASIBILITY PERIOD
Dear Xxx,
Thank you for your fax messages of November 27 and December 2, 1996.
Following discussion with yourself, I would like to acknowledge the need to
further extend the Feasibility Period (detailed in sect. 2.3, of the
Sandoz/Biosite Antibody Agreement) and confirm the new mutually agreeable expiry
date of March 15, 1997 (extended from November 30, 1996).
Best wishes
/s/ Xxxxxx Xxxxxxx
Xxxxxx Xxxxxxx, Ph.D.
cc: Messrs. X. Xxxxxxx, X. Xxxxx, X. Xxxxx
