Exhibit 10.25
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May 5,1999
SUPPLY AGREEMENT
(ON CAMPATH-1H)
Supply Agreement.........................................................................................3
WITNESSETH...............................................................................................3
1. DEFINITIONS........................................................................................3
1.1 "L&I Partners, L.P.".........................................................................3
1.2 "Contract Research and Development Agreement"................................................4
1.3 "Product-price"..............................................................................4
1.4 "Capacity"...................................................................................4
1.5 "Product"....................................................................................4
1.6 "Bulk Product"...............................................................................4
1.7 "Final Product"..............................................................................4
1.8 "Finished Product"...........................................................................4
1.9 "Specifications".............................................................................4
1.10 "Process"....................................................................................4
1.11 "Certificate of Analysis"....................................................................5
1.12 "Certificate of Compliance"..................................................................5
1.13 All other terms..............................................................................5
2. SUPPLY.............................................................................................5
2.1 Exclusivity..................................................................................5
2.2 Capacity, Process and Specifications.........................................................5
2.3 Approved Facility............................................................................6
2.4 Subcontracting...............................................................................6
2.5 Rolling Forecasts............................................................................6
2.6 Quantities beyond the [**] forecasts.........................................................7
2.7 Delivery.....................................................................................7
2.8 Minimum quantities...........................................................................7
2.9 Exclusivity/Competition......................................................................7
3. QUALITY/WARRANTY/LIABILITY/INDEMNIFICATION.........................................................8
3.1 Warranty/Limitation..........................................................................8
3.2 Tests of the Product and agreed upon Audits..................................................8
3.3 Defective Product (including loss and inaccurate quantity)...................................8
3.4 Indemnification by L&I Partners, L.P.........................................................8
3.5 Infringement of intellectual property rights.................................................9
3.6 Limitation of Warranty/Liability/Maximum Amount..............................................9
3.7 Delivery/Risk of Loss........................................................................9
3.8 Documentation................................................................................9
3.9 Indemnification by BI Pharma KG.............................................................10
3.10 Superiority.................................................................................10
4. SUPPORT REGARDING POST LICENSING ISSUES...........................................................10
5. PRICE AND PAYMENT.................................................................................10
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5.1 Product-price...............................................................................10
5.2 Surcharge...................................................................................10
5.3 Payment Conditions..........................................................................10
(1) PREMARKETING PHASE:....................................................................10
(2) MARKETING PHASE:........................................................................10
(3) SURCHARGE: .............................................................................10
(4) INVOICE/TRANSFER OF PAYMENTS:...........................................................10
5.4 Currency/Conversion.........................................................................11
5.5 Prices Adjustments..........................................................................11
5.6 Introduction of the Euro....................................................................12
6. CONFIDENTIALITY...................................................................................13
6.1 BI Pharma KG................................................................................13
6.2 L&I Partners, L.P...........................................................................13
6.3 Exceptions..................................................................................13
7. LICENSE...........................................................................................14
7.1 Use of L&I Partners, L.P. Cell Line and Intellectual Property...............................14
7.2 No other Right or License...................................................................14
8. TERM AND TERMINATION..............................................................................14
8.1 Basic Term..................................................................................14
8.2 Automatic Extension.........................................................................14
8.3 Early Termination...........................................................................15
8.4 Termination in case of Breach of Agreement..................................................15
8.5 Premature Termination.......................................................................15
9. MISCELLANEOUS.....................................................................................15
9.1 Force Majeure...............................................................................15
9.2 Publicity...................................................................................16
9.3 Notices.....................................................................................16
9.4 Applicable Law/Jurisdiction.................................................................17
9.5 Compliance with Laws........................................................................17
9.6 Independent Contractors.....................................................................18
9.7 Waiver......................................................................................18
9.8 Severability................................................................................18
9.9 Entirety....................................................................................18
9.10 Assignment..................................................................................18
Appendices..............................................................................................20
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SUPPLY AGREEMENT
(ON CAMPATH-1H)
THIS SUPPLY-AGREEMENT ("Agreement") is made effective as of June 4, 1999
("Effective Date"), by and between
L&I PARTNERS, L.P.
a limited partnership of the State of Delaware, having its principal business
offices at 00000 XX 00 Xxxx, Xxxxx 000, Xxx Xxxxxxx, XX 00000, XXX
(hereinafter referred to as "L&I PARTNERS, L.P."),
and
BOEHRINGER INGELHEIM PHARMA KG,
whose registered office is at Xxxxxxxxxxxx XxxxXx 00, 00000 Xxxxxxxx an der
Riss, Federal Republic of Germany
(hereinafter referred to as "BI PHARMA KG").
WITNESSETH
WHEREAS Xx. Xxxx Xxxxxx GmbH and L&I Partners, L.P. have - among others -
concluded a Contract Research and Development Agreement regarding the research
and development of a method to produce CAMPATH-1H in a commercial scale, which
has been assigned to BI Pharma KG as of January 1, 1998; and
WHEREAS L&I Partners, L.P. has all rights to the Product and is the owner of the
Process and
WHEREAS L&I Partners, L.P. wishes BI Pharma KG, and BI Pharma KG accepts, to
manufacture and supply L&I Partners, L.P. with Product for commercial use,
manufactured in accordance with the Process.
NOW THEREFORE, the parties hereto agree as follows:
1. DEFINITIONS
In this Agreement the following terms shall have the meanings indicated:
1.1 "L&I PARTNERS, L.P."
means L&I Partners, L.P., Inc. as laid down first above.
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1.2 "CONTRACT RESEARCH AND DEVELOPMENT AGREEMENT"
means the agreement on CAMPATH-1 H (the humanized IgG 1 monoclonal
antibody specifically directed against CD 52 between Xx. Xxxx Xxxxxx
GmbH and L&I Partners, L.P dated August 5,1997 regarding the
development of the Process and assigned to BI Pharma KG effective as of
January 1, 1998.
1.3 "PRODUCT-PRICE"
means BI Pharma KG's prices for Product, Bulk Product, Final Product
and/or Finished Product (as the case may be) to be calculated on the
basis of the assumptions set forth in Appendix 1.
1.4 "CAPACITY"
means BI Pharma KG's at a given time total production capacity per year
reserved for CAMPATH-1H in accordance with the Process. The maximum
Capacity shall be [**]kg/year of Product based on the assumptions set
forth in Appendix 1 unless otherwise agreed upon with a reasonable
leadtime.
1.5 "PRODUCT"
means any product containing CAMPATH-1H in Bulk Product or as Final
Product or as Finished Product its sole or combined active ingredient
and produced according to the Process.
1.6 "BULK PRODUCT"
means Product which has been purified to a concentrated form and can be
stored in a liquid or frozen form under appropriate conditions.
1.7 "FINAL PRODUCT"
means unlabelled final container containing liquid Product.
1.8 "FINISHED PRODUCT"
means Final Product and also labeled and packaged.
1.9 "SPECIFICATIONS"
mean the specifications to be enclosed hereto as Appendices 3 for
Product, Final Product and Finished Product produced and supplied
hereunder by BI Pharma KG. These Appendices will be agreed upon by the
parties after the finalization of the Process.
1.10 "PROCESS"
shall be the final Process for manufacturing Product developed and
agreed by the parties according to the Contract Research and
Development Agreement. The actual Process is laid down in documents
added hereto as Appendix 4. For the time being the Process is a
[****].
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1.11 "CERTIFICATE OF ANALYSIS"
shall mean a document describing testing methods and results, the
accuracy of which has been certified by the issuing party.
1.12 "CERTIFICATE OF COMPLIANCE"
shall mean a document (a) listing the expiration date and quantity of a
particular batch of Bulk Drug, Final Product and/or Finished Product,
(b) certifying that such batch was manufactured in accordance with all
Specifications, current cGMP, the BLA/EMEA dossier for the Product (as
applicable), and (c) certifying that such batch is acceptable for
manufacturer release. The agreed upon format is attached hereto as
Appendix 6.
1.13 ALL OTHER TERMS
used herein shall have the same meaning as defined in the Contract
Research and Development Agreement.
2. SUPPLY
2.1 EXCLUSIVITY
Subject to L&I Partners, L.P.'s right to manufacture or have
manufactured by a third party Bulk Product and/or Final Product and/or
to have a third party to produce Final Product and/or Finished Product
from Bulk Product produced by L&I Partners, L.P. as expressly stated in
this Agreement, BI Pharma KG will manufacture and supply Product to L&I
Partners, L.P. or its designee(s) exclusively throughout the world
during the full term of this Agreement and according to the provisions
of this Agreement (incl. rolling forecasts and minimum quantities). L&I
Partners, L.P. will purchase Product from BI Pharma KG throughout the
world for the period of this Agreement. This does not prevent L&I
Partners, L.P. to have Product in reasonable quantities manufactured
for clinical testing purposes solely elsewhere.
To minimize the theoretical risk of the exclusiveness the parties have
agreed on a stock policy as laid down in Appendix 5.
2.2 CAPACITY, PROCESS AND SPECIFICATIONS
Subject to Section 3 below BI Pharma KG undertakes to supply L&I
Partners, L.P. or its designee(s) with the quantities of Product
ordered by L&I Partners, L.P. within its Capacity. All manufacture of
Product hereunder will be made in accordance with the Process and will
be delivered in agreed form suitably packed as specified in the
Specifications.
In case BI Pharma KG cannot produce sufficient commercial quantities of
the Product (provided that L&I Partners, L.P. is adhering to the
provisions of this Agreement (e.g. the rolling forecast system) then
L&I Partners, L.P. shall have the right to manufacture or have
manufactured by a third party the missing quantities; only in this case
and if reasonably necessary, BI Pharma KG shall
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assist L&I Partners, L.P. in transfer of the Process for a limited time
not to exceed [**] skilled people and [**] L&I Partners, L.P.
Capacity may be increased by BI Pharma KG on the written request of L&I
Partners, L.P. with a reasonable leadtime, not to be less than [**],
if the requested increase requires major investment and/or
construction and if L&I Partners, L.P. commits itself to the taking
over of the expense of the increase of capacity to be reasonably agreed
upon by the Parties.
2.3 APPROVED FACILITY
All quantities of Product will be produced in a production facility
designated by BI Pharma KG which is approved by the FDA and/all of the
European Community regulatory authorities for commercial scale
production and deliveries.
To the extent that L&I Partners, L.P. requests that BI Pharma KG secure
regulatory approval of the manufactured Product in other countries,
then BI Pharma KG shall seek such regulatory approval of its production
facility unless such approval would require change in the production
facility.
L&I Partners, L.P. shall pay any additional costs for such approval.
If changes are required by the respective authority and if BI Pharma KG
does not agree to make such changes at L&I Partners, L.P.'s expense,
then L&I Partners, L.P. shall have the right to seek a third party
manufacturer for the respective country(ies).
BI Pharma KG shall take all commercially reasonable efforts to secure
approval of BI Pharma KG's manufacturing facility by the FDA and the
respective European regulatory authority and BI Pharma KG's obligations
under Section 2.1 above are subject to such approval as the case may
be.
2.4 SUBCONTRACTING
BI Pharma KG will not further contract out to a third party any part of
the manufacturing or release-testing of Product without prior written
approval from L&I Partners, L.P., which shall not be unreasonably
withheld.
2.5 ROLLING FORECASTS
(1) Beginning as of 10 September 1999 and by the 10th of the last
month of each quarter L&I Partners, L.P. will provide BI
Pharma KG with a [**] Product forecast planning horizon for
Final Product and Finished Product or an update thereof. The
planning horizon shall start the first day of the fourth month
after the first forecast which shall be January 2000 or an
update thereof.
The rolling forecasts are to be broken down to single months.
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(2) The forecast for the first year (months 1-12) are [**].
The forecast for the second year (months 13-24) is a [**]
forecast which means that the forecast can [**] within this
period as follows:
the forecast may be [**] within the Capacity, but is limited
to the following restrictions [**]:
months [**] the forecast can be [**]
months [**] the forecast can be [**]
months [**] the forecast can be [**]
months [**] the forecast can be [**]
The forecast for the third year (months 25-36) is a [**]
forecast. The rolling forecasts (including [**] orders) for
Final Product and Finished Product are laid down in Appendix
2.
(3) Whilst the rolling forecast system is not applicable (see
Article 2.5(1) above) L&I Partners, L.P. shall place all
requirements for Product and Final Product [**].
2.6 QUANTITIES BEYOND THE [**] FORECASTS
BI Pharma KG shall use reasonable efforts to manufacture and deliver to
L&I Partners, L.P. all quantities of the Product beyond the [**]
forecasts at L&I Partners, L.P.'s request within its Capacity.
2.7 DELIVERY
BI Pharma KG shall make deliveries by the 15th day of the month for
which [**] order is made.
2.8 MINIMUM QUANTITIES
Provided that the Product is approved in the USA, and starting as of
[**], the minimum quantity of Product to be bought by L&I
Partners, L.P. each calendar year is [**] based on the assumptions set
forth in Appendix 1.
If the quantity falls below the minimum quantity of [**] of Product
annually, BI Pharma KG will charge L&I Partners, L.P. an annual
surcharge according to Article 5.2 below.
2.9 EXCLUSIVITY/COMPETITION
During the term of this Agreement, BI Pharma KG agrees that it will not
supply Product to a third party nor shall BI Pharma KG assist any third
party with respect to development or manufacture of [**], except where
BI Pharma KG is granted marketing rights [**].
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3. QUALITY/WARRANTY/LIABILITY/INDEMNIFICATION
3.1 WARRANTY/LIMITATION
BI Pharma KG warrants that the Product to be supplied by BI Pharma KG
hereunder corresponds to the Specifications and shall be produced
according to current GMP standard as of the date and time of production
and in accordance with all applicable laws, rules and regulations in
the country where produced.
The Product shall be delivered free and clear of liens and claims which
affect title. BI Pharma KG makes no other warranty of any kind, express
or implied.
3.2 TESTS OF THE PRODUCT AND AGREED UPON AUDITS
L&I Partners, L.P. shall have the right to carry out agreed upon
customary tests of the Product and agreed upon audits at reasonable
times, of the premises and facilities where BI Pharma KG performs work
under this Agreement, and of the premises where it stores raw
materials, auxiliary materials, intermediates, packing materials for
the Product and the Product itself. The agreed upon tests of the
Product shall be included in Appendix 3 hereto.
3.3 DEFECTIVE PRODUCT (INCLUDING LOSS AND INACCURATE QUANTITY)
Claims on account of quantity, quality, loss or damages to the Product
shall be made by L&I Partners, L.P. in writing within [**] following
receipt thereof, and BI Pharma KG's liability for damages for such
claims shall in no event exceed the purchase price or replacement of
goods for the particular shipment with respect to which such claims are
made. No Product will be returned to BI Pharma KG without BI Pharma
KG's written permission.
If L&I Partners, L.P. claims that any shipment of Product did not at
time of delivery meet the Specifications, BI Pharma KG shall conduct an
assay of its retained sample from such shipment. If BI Pharma KG agrees
with L&I Partners, L.P.'s claim, BI Pharma KG shall replace such
shipment of Product within [**] from existing stock of released Product
if available, and if not available, at L&I Partners, L.P.'s option, BI
Pharma KG shall either replace such shipment of Product within [**] or
give credit for such payment to L&I Partners, L.P. If the parties are
unable to resolve their differences, then either party may refer the
matter to an independent specialized firm of international reputation
agreeable to both parties for final analysis, which shall be binding on
both parties hereto.
3.4 INDEMNIFICATION BY L&I PARTNERS, L.P.
In accordance with all applicable laws L&I Partners, L.P. shall be
responsible for, and hold BI Pharma KG harmless from any damage, loss,
cost or expense relating to third party claims or suits arising from
the packaging, use, marketing or sale of the Product by L&I Partners,
L.P., or its licensee(s) or other authorized persons or entities, other
than those which arise out of a breach of warranty by BI Pharma KG and
those which arise out of gross negligence or willful misconduct of BI
Pharma KG or its officers, employees or agents, and provided that upon
receipt of
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notice by BI Pharma KG of any claims or suits relating to such use or
sale of the Product, BI Pharma KG shall notify L&I Partners, L.P.
thereof without delay and shall permit L&I Partners, L.P. to handle
such claims or suits at the cost and discretion of L&I Partners, L.P.
including but not limited to defense, settlement and compromise
thereof.
3.5 INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS
With respect to the Process, L&I Partners, L.P. shall be responsible
for and hold BI Pharma KG harmless from any third party claim of
infringement of its intellectual property rights from a third party
based upon BI Pharma KG's contractual activities hereunder.
3.6 LIMITATION OF WARRANTY/LIABILITY/MAXIMUM AMOUNT
Except as provided in Article 3.1 above, BI Pharma KG makes no warranty
of any kind, express or implied.
Except for willful misconduct BI Pharma KG shall not be liable for any
lost profits or any special, incidental or consequential damages.
BI Pharma KG's total liability under this Agreement shall in no event
exceed [**] of the sales of Product from BI Pharma KG to L&I Partners,
L.P. or L&I Partners, L.P.'s licensee(s) of the respective year.
3.7 DELIVERY/RISK OF LOSS
BI Pharma KG shall deliver or arrange for the delivery of the Product
purchased by L&I Partners, L.P. to a carrier designated by L&I
Partners, L.P. on the basis of EXW BI Pharma KG's plant in Biberach, in
accordance with Incoterms 1990 as published. Title to the Product sold
hereunder shall pass to L&I Partners, L.P. and BI Pharma KG's liability
as to risk of loss and/or damage during transportation thereof shall
cease upon delivery of the Product in good condition to the carrier at
BI Pharma KG's plant in Biberach designated by L&I Partners, L.P..
3.8 DOCUMENTATION
BI Pharma KG shall certify in writing, that each shipment lot of
Product, was produced and tested in compliance as of the time of
production with (i) the Specifications (including the respective test
methods), (ii) the current GMP requirements, (iii) all other applicable
regulatory documents, in accordance with procedures agreed between BI
Pharma KG and L&I Partners, L.P. BI Pharma KG shall provide L&I
Partners, L.P. with a Certificate of Analysis appropriately signed and
a Certificate of Compliance appropriately signed by BI Pharma KG's
quality assurance, as are necessary to demonstrate BI Pharma KG 's
compliance with this Article 3.8 for and with each shipment lot from BI
Pharma KG 's manufacture site.
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3.9 INDEMNIFICATION BY BI PHARMA KG
BI Pharma KG shall indemnify, defend and hold L&I Partners, L.P. and
its officers, employees and agents harmless from and against all third
party losses, damages, costs and expenses (including, without
limitation, reasonable attorneys' fees), including injury to persons or
damage to property, resulting from any breach of the warranties made by
BI Pharma KG under this Agreement or which arise out of and are proved
to be directly associated with the gross negligence or willful
misconduct of BI Pharma KG or its officers, employees or agents in
carrying the obligations under this Agreement and provided that upon
receipt of notice by L&I Partners, L.P. of any claims or suits relating
to such use or sale of the Product, L&I Partners, L.P. shall notify BI
Pharma KG thereof without delay and shall permit BI Pharma KG to handle
such claims or suits at the cost and discretion of BI Pharma KG
including but not limited to defense, settlement and compromise
thereof.
3.10 SUPERIORITY
No provision on L&I Partners, L.P.'s purchase order forms or in BI
Pharma KG's General Conditions of Sale which may purport to impose
different conditions upon L&I Partners, L.P. or BI Pharma KG, nor any
other modification of this Agreement, will be of any force and effect,
unless in writing and signed by both parties claimed to be bound
thereby. In the event of any inconsistencies the terms of this
Agreement shall govern.
4. SUPPORT REGARDING POST LICENSING ISSUES
BI Pharma KG is willing to support L&I Partners, L.P. with regard to
post licensing issues (e.g. possible registration-issues in the various
countries) on commercial conditions to be agreed upon separately.
5. PRICE AND PAYMENT
5.1 PRODUCT-PRICE
The Product-price for the Product shall be calculated according to the
scheme laid down in Appendix 1. The basic product assumptions of that
scheme as [**] will be reassessed after scale-up of the Process to
the commercial scale after the [**]manufacturing campaign successful
batches and then be valid for this Agreement.
5.2 SURCHARGE
If L&I Partners, L.P. doesn't purchase the minimum quantities of
Product in a given year (i.e. supplied quantities are below minimum
quantities), L&I Partners, L.P. shall pay a surcharge according to the
scheme in Appendix 1.
5.3 PAYMENT CONDITIONS
(1) Premarketing Phase:
The Product-price for Product ordered by L&I Partners, L.P. or
according to L&I Partners, L.P.'s instructions during the premarketing
phase shall be payable by
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L&I Partners, L.P. within 30 (thirty) days after receipt by L&I
Partners, L.P. of notification of release of the respective Bulk
Product.
(2) Marketing Phase:
Unless otherwise provided for in Article 5.3 (1) above, the
Product-price for Product delivered to L&I Partners, L.P. or according
to L&I Partners, L.P.'s instructions shall be payable by L&I Partners,
L.P. within 30 (thirty) days after receipt of Product by the respective
party.
(3) Surcharge:
The surcharge according to Article 5.2 above shall be payable within 30
(thirty) days after receipt of the respective invoice.
(4) Invoice/Transfer of Payments:
All invoices under this Agreement shall be made by BI Pharma KG in
Deutsche Xxxx and all payments under this Agreement shall be made by
L&I Partners, L.P. in DEM (Deutsche Xxxx) by wire transfer to an
account to be nominated by BI Pharma KG.
5.4 CURRENCY/CONVERSION
"Deutsche Xxxx" or "DEM" means the lawful currency for the time being
of Germany or, in case of the implementation of the European Monetary
Union, the "Euro" on the basis of the official conversion rate.
Currency conversions, if any, shall be made using the average quarterly
exchange rates published regularly by Deutsche Bank AG, Frankfurt, or
its successor. The average will be calculated by summing the exchange
rates for the final business day of each of the 3 (three) months in the
applicable calendar quarter and dividing by 3 (three). All currency
conversions will be calculated to an accuracy of at least 3 (three)
digits after the decimal point.
5.5 PRICES ADJUSTMENTS
(a) The Product-price mentioned in Article 5.1 above (basis
14.05.1998) may be increased by BI Pharma KG effective at the
beginning of a calendar year (for the first time effective
January 1, 2000) by [**] per year for [**].
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(b) In case any cost increases (in terms of [**] of [**]
for [**] and/or [**]) by more than [**] in a given
calendar year, which BI Pharma KG must demonstrate, the
parties shall agree upon the direct amount of such
increase based on good faith negotiations to be effective
on January 1st of the calendar year following the more than
[**] increase and the price for Product in such calendar year
shall be increased for such amount, provided that the price
increase taken by BI Pharma KG under Article 5.5 (a) shall be
[**] under this Article 5.5 (b).
(c) In case of any cost decrease (as defined in lit. (b) above) by
more than [**] in a given calendar year, the parties shall
agree upon the direct amount of such decrease based on good
faith negotiations to be effective on January 1st of the
calendar year following the more than [**] decrease and the
price for Product in such calendar year shall be decreased for
such amount.
(d) In case of a change of the Process which lasting influences
the basic assumptions, the price shall be recalculated
according to Appendix 1 after [**] and the parties shall agree
on a new price for Product on the basis of an [**] of the
[**] as an [**] and BI Pharma KG shall on an ongoing basis
intend to provide suggestions for such enhancements of the
Process. Such agreed new price will then be effective for
Product produced with the new Process from the next run on.
(e) L&I Partners, L.P. may elect whether the direct amount of an
increase according to (a) and (b) above is payable pursuant
to a separate invoice or by a proportional increase in the
price for Bulk Product, Final Product and/or Finished
Product. If L&I Partners, L.P. [**] BI Pharma KG that [**]
for [**] can be [**] a [**] and of [**] and [**] than [**]
of [**], then [**] for [**] Article 5.5 (b).
5.6 INTRODUCTION OF THE EURO
The introduction of the Euro as the legal currency or legal tender in
Germany (see Article 5.4 above) shall in no way affect the validity of
this Agreement and shall not entitle any party hereto to terminate, or
to require any amendment to this Agreement.
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6. CONFIDENTIALITY
6.1 BI PHARMA KG
shall not disclose L&I Partners, L.P. Confidential Information to any
person other than its employees or employees of affiliated companies of
the Boehringer Ingelheim group who have a need to know such information
in order to perform their duties in carrying out the work hereunder and
who have an obligation to maintain the confidentiality thereof as
provided herein without the other party's written consent.
6.2 L&I PARTNERS, L.P.
shall not disclose any BI Pharma KG Confidential Information to any
person other than
(a) its employees or consultants who are bound by similar
obligations of confidentiality and who have a need to know
such information in order to provide direction to BI Pharma KG
or evaluate the results of the work, or
(b) regulatory authorities, for example, the FDA, that require
such information in order to review an IND, BLA or other
regulatory filing. BI Pharma KG will be informed and must
agree prior to filing of any BI Pharma KG Confidential
Information to regulatory authorities. In these cases where BI
Pharma KG restricts L&I Partners, L.P.'s ability to file BI
Pharma KG Confidential Information, BI Pharma KG agrees to
provide the Confidential Information directly to the
regulatory authorities and will provide a letter of
authorization for cross-reference to L&I Partners, L.P.
(c) persons or entities that manufacture Product for L&I Partners,
L.P. after termination of this Agreement or during this
Agreement as permitted herein without the other party's
written consent.
6.3 EXCEPTIONS
The obligations of confidentiality applicable to L&I Partners, L.P.
Confidential Information and BI Pharma KG Confidential Information
shall not apply to any information that is:
(a) known publicly or becomes known publicly through no fault of
the recipient;
(b) learned by the recipient from a third party entitled to
disclose it;
(c) developed by the recipient independently of information
obtained from the disclosing party;
(d) already known to the recipient before receipt from the
disclosing party, as shown by its prior written records;
L&I Partners, L.P./BI Pharma KG: Supply Agreement Page: 14
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(e) required to be disclosed by law, regulation (e.g. by
SEC-regulation) or the order of a judicial or administrative
authority; or
(f) released with the prior written consent of the disclosing
party.
(g) released to a potential marketing partner after written notice
thereof to BI Pharma KG and under secrecy obligations covering
at least the same extent as stated herein.
7. LICENSE
7.1 USE OF L&I PARTNERS, L.P. CELL LINE AND INTELLECTUAL PROPERTY
L&I Partners, L.P. and BI Pharma KG hereby acknowledge and agree that
L&I Partners, L.P. is providing Cell Line, Process and L&I Partners,
L.P. Confidential Information to BI Pharma KG for use by BI Pharma KG
on behalf of and for the benefit of L&I Partners, L.P. for the purposes
of this Agreement, that BI Pharma KG will make use thereof solely for
such purposes and that L&I Partners, L.P. hereby consents to such use.
BI Pharma KG agrees that L&I Partners is the owner of the Cell Line,
Process, and L&I Partners Confidential Information, and upon
termination of this Agreement such shall be returned to L&I Partners,
L.P., provided however, that BI Pharma KG shall have the right to
retain one copy/sample for documentation purposes solely or if and when
and to the extent required by law or regulation.
7.2 NO OTHER RIGHT OR LICENSE
Except as granted under this Agreement, no right or license, either
express or implied, under any patent or proprietary right is granted
hereunder by virtue of the disclosure of L&I Partners, L.P.
Confidential
Information or BI Pharma KG Confidential Information.
8. TERM AND TERMINATION
8.1 BASIC TERM
This Agreement will come into force and effect as of the date first
above written, and shall remain valid until December 31, 2006.
8.2 AUTOMATIC EXTENSION
This Agreement will automatically extend for additional 3 (three) year
periods in the absence of a written notice of termination by one of the
parties to the other and such written notice shall be given no later
than 2 (two) years prior to the end of the fix period and 3 (three)
years prior to the end of any extension period.
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
8.3 EARLY TERMINATION
To the extent permitted by law, if either party shall become insolvent
or shall make assignment for the benefit of creditors, or proceedings
in voluntary bankruptcy shall be instituted on behalf of or against a
party or a receiver or trustee of all, or substantially all of the
property of a party shall be appointed to a third party, the other
party shall be entitled to terminate this Agreement by giving written
notice to this effect to the first party whereupon this Agreement shall
so terminate, unless such situation is rectified within a period of 60
(sixty) days.
8.4 TERMINATION IN CASE OF BREACH OF AGREEMENT
Either party may terminate this Agreement for any material breach of
this Agreement, if such breach is not cured within 90 (ninety) days
following receipt by the party committing the breach of written notice
of the intent to terminate. Such termination shall become effective
immediately upon further notice to the defaulting party.
8.5 PREMATURE TERMINATION
8.5.1 This Agreement may be terminated by L&I Partners, L.P. at any time if
L&I Partners, L.P. shall withdraw the Product from all relevant markets
(US, Canadian and Europe).
8.5.2 In this case L&I Partners, L.P. will pay to BI Pharma KG the
Product-price for the [**]ordered quantities (see Article 2.5 above) of
the Product.
8.5.3 Moreover, L&I Partners, L.P. will pay to BI Pharma KG an amount to
cover the production loss caused by the premature termination as
follows:
for the 2 (two) years following the [**] order period (which is year 1)
L&I Partners, L.P. will pay the Product price for the minimum quantity
(according to Article 2.8 above) [**]
[**] for year 2
[**] for year 3.
8.5.4 Due Date
These payments shall be due within 1 (one) month after receipt by BI
Pharma KG of the notice of premature termination from L&I Partners,
L.P. and receipt by L&I Partners, L.P. of the respective invoice of BI
Pharma KG.
9. MISCELLANEOUS
9.1 FORCE MAJEURE
Neither party shall be in breach of this Agreement if there is any
failure of performance under this Agreement (except for payment of any
amounts due hereunder) occasioned by any act of God, fire, act of
government or state, war,
L&I Partners, L.P./BI Pharma KG: Supply Agreement Page: 16
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civil commotion, insurrection, embargo, prevention from or hindrance in
obtaining energy or other utilities, labor disputes of whatever nature
or any other reason beyond the control of either party; provided,
however, that if a party is not able to perform because of a force
majeure pursuant to this Article 8.1 for a period of 6 (six) months,
the other party may terminate this Agreement with immediate effect. In
this case the provisions of Article 8.5.3 shall not apply.
9.2 PUBLICITY
No press release or other form of publicity regarding the work
performed hereunder or this Agreement shall be permitted by either
party to be published unless both parties have indicated their consent
to the form of the release in writing.
Nothing in this Article 9.2 shall prevent the parties from disclosing
this Agreement as required by applicable laws, rules or regulations.
9.3 NOTICES
Any notice required or permitted to be given hereunder by either party
shall be in writing and shall be (i) delivered personally, (ii) sent by
registered mail, return receipt requested, postage prepaid, (iii)
delivered by facsimile with immediate telephonic confirmation of
receipt, to the addresses or facsimile numbers set forth below or (iv)
sent by overnight carrier (such as Federal Express, UPS, DHL, MSAS,
World Courier):
L&I Partners, L.P./BI Pharma KG: Supply Agreement Page: 17
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If to BI Pharma KG: Boehringer Ingelheim Pharma KG
Birkendorfer StraBe 65
D-88397 Biberach an der Riss
Federal Republic of Germany
Attention: Xx. Xxxxxxx Xxxxxx
Fax: 0 73 51/54 - 9 80 49
Phone: 0 73 51/54 - 94 21
If to L&I Partners, L.P.: LeukoSite Inc.
000 Xxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: President and CEO
Fax: 617/000 00 00
Phone: 617/000 00 00
with a copy to
Chief Financial Officer and/or
Vice President Manufacturing
at the same address
Each notice shall be deemed given (i) on the date it is received if it
is delivered personally, (ii) 3 (three) days after the date it is sent
by Federal Express, UPS, DHL, MSAS, World Courier or similar service if
receipt is immediately confirmed in writing (iii) on the date it is
received if it is sent by facsimile with immediate telephonic
confirmation of receipt.
9.4 APPLICABLE LAW/JURISDICTION
This Agreement shall be governed by and construed in accordance with
the laws of Germany without regard to its choice of law principles. The
courts of the place of domicile of BI Pharma KG shall have exclusive
jurisdiction over all legal matters and proceedings hereunder.
In case of any dispute, claim or controversy arising out of or relating
to the interpretation, execution or performance of this Agreement the
parties shall first try to settle the matter amicably, possibly by
having recourse to a neutral person acceptable to both parties.
9.5 COMPLIANCE WITH LAWS
BI Pharma KG shall perform the work hereunder in conformance with
current GMP, at the time of the respective production, as applicable,
and all German and/or EEC laws, ordinances and governmental rules or
regulations pertaining thereto.
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9.6 INDEPENDENT CONTRACTORS
Each of the parties hereto is an independent contractor and nothing
herein contained shall be deemed to constitute the relationship of
partners, joint ventures, nor of principal and agent between the
parties hereto. Neither party shall hold itself out to third persons as
purporting to act on behalf of, or serving as the agent of, the other
party.
9.7 WAIVER
No waiver of any term, provision or condition of this Agreement whether
by conduct or otherwise in any one or more instances shall be deemed to
be or construed as a further or continuing waiver of any such term,
provision or condition or of any other term, provision or condition of
this Agreement.
9.8 SEVERABILITY
If any provision of this Agreement is held to be invalid or
unenforceable by a court of competent jurisdiction all other provisions
shall continue in full force and effect. The parties hereby agree to
attempt to substitute for any invalid or unenforceable provision a
valid or enforceable provision which achieves to the greatest extent
possible the economic legal and commercial objectives of the invalid or
unenforceable provision.
9.9 ENTIRETY
This Agreement, including any exhibits and appendices attached hereto
and referenced herein, constitutes the full understanding of the
parties and a complete and exclusive statement of the terms of their
agreement, and no terms, conditions, understandings or agreements
purporting to modify or vary the terms thereof shall be binding unless
they are hereafter made in writing and signed by both parties.
9.10 ASSIGNMENT
This Agreement shall be binding upon the successors and assigns of the
parties and the name of a party appearing herein shall be deemed to
include the names of its successors and assigns provided always that
nothing herein shall permit any assignment by either party.
However, BI Pharma KG may assign this Agreement to an affiliated
company taking over the operative biotech business of BI Pharma KG and
L&I Partners, L.P. may assign this Agreement in the case of a merger or
acquisition or transfer of its assets related to this Agreement to a
third party without the prior written consent of BI Pharma KG.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their duly authorized representatives on the day and year first above
written.
Cambridge JUNE 4, 1999 Biberach, MAY 5TH, 1999
------------ -------------
L&I PARTNERS, L.P., INC. BOEHRINGER INGELHEIM PHARMA KG
ppa.
[Illegible] /s/ Dr. Xxxxx Xxxxx /s/ Prof. Xx. Xxxx X. Xxxxxx
------------------------------------ ------------------- ----------------------------
Dr. Xxxxx Xxxxx Prof. Xx. Xxxx X. Xxxxxx
(Member of the Board) (Head of Biotech worldwide)
L&I Partners, L.P./BI Pharma KG: Supply Agreement Page: 20
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APPENDICES
Appendix 1: Product-price and basic product assumptions
Appendix 2: Rolling forecast for Final Product and Finished Product
Appendix 3: Specifications for Product including tests
Appendix 4: Process Description
Appendix 5: Agreed upon stock policy of the Parties
Appendix 6: Agreed upon format of "Certificate of Compliance"
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX 1
MASTER PROJECTPLAN : CAMPATH-1H
L & I PARTNERS / BI PHARMA KG
Basic Production Assumptions and Pricing System for Commercial Supply
PRODUCTION ASSUMPTIONS:
[**]
Total material amount [**]
SUPPLY QUANTITY PER YEAR PRICE PER GRAM
[**] [**]
PRICE FOR STERILE LIQUID FILLING FOR COMMERCIAL SUPPLY
BATCH SIZE [**] [**]
[**]
BATCH SIZE [**]
[**] [**]
PRICE FOR LABELING AND PACKAGING FOR COMMERCIAL SUPPLY
[**] [**]
*)S = SURCHARGE
The surcharge system is effective, [**]
PRICE CALCULATION FINISHED PRODUCT
[**]
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX 2a
Example for firm order in pre approval phase
ORDER PLANNING SYSTEM OF CAMPATH-1H FINAL PRODUCT
COMMERCIAL SUPPLY PRE FDA APPROVAL
[**]
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX 2b
ROLLING FORECAST PLANNING SYSTEM OF FINAL PRODUCT
CAMPATH-1H (COMMERCIAL SUPPLY)
POST FDA APPROVAL
[**]
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX 3
(Page 1 of 2)
SPECIFICATIONS FOR PRODUCT CAMPATH 1H
INCLUDING TESTS
TABLE 1 SPECIFICATIONS FOR BULK DRUG SUBSTANCE**
[**]
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX 3
(Page 2 of 2)
TABLE 2 SPECIFICATIONS FOR DRUG PRODUCT RELEASE
[**]
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX 4
DESCRIPTION OF THE PROCESS
The Process for manufacturing Product as agreed upon by the Parties is described
in detail in Section 4.2.3.3., "Description of the Manufacturing Process" of the
BLA (Biologics License Application) as first submitted to the FDA.
APPENDIX 5
(Section 2.1 of the Supply Agreement on Campath-1H)
SAFETY STOCK POLICY
Drug Product, Finished Product [**]
Bulk Drug Substance [**]
Raw material [**]
The safety stock quantity is calculated based on the given [**] product
request and should ensure a high service level
The safety stocks are built up [**] with respect to the shelf life of
the product and manufacturing flexibility.
APPENDIX 6
Agreed upon format of "Certificate of Compliance"
See Attachment
XXXXXXXX 0
Xxxxxxxxxx
Xxxxxxxxx CERTIFICATE OF COMPLIANCE
_______________________________________________________________________________
Product:
_______________________________________________________________________________
Lot No.:
_______________________________________________________________________________
Manufacturing Date:
Expiration Date: ___________________
Number of ampoules:
--------------------------------------------------------------------------------
It is hereby certified that all manufacturing documents including batch
manufacturing records and in-process control sheets have been inspected and
found to be in compliance with current specifications and that the analyses
carried out in our control laboratory have revealed the results of the
attached analytical certificates and are in compliance with current
specifications.
If occurred, deviations during manufacturing and testing of the product are
documented in the batch manufacturing and testing records and have been
assessed and found to be acceptable.
The batch was manufactured in accordance with cGMP's and with the product's
BLA.
The lot is approved and released.
BOEHRINGER INGELHEIM PHARMA KG
QUALITY ASSURANCE
Signature:
--------------------------------
Date:
--------------------------------
(day/month/year)
