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EXHIBIT 10.22
ALTANA, INC.
THERAPEUTIC ANTIBODIES INC
DISTRIBUTION AGREEMENT
October 2, 1997
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TABLE OF CONTENTS
PAGE
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1. RECITALS............................................................ 1
2. DEFINITIONS......................................................... 1
3. CLINICAL TRIALS..................................................... 4
4. REGISTRATION........................................................ 4
5. MANUFACTURING....................................................... 4
6. APPOINTMENT OF AUTHORIZED DISTRIBUTOR............................... 5
7. DISTRIBUTION OF PRODUCTS............................................ 5
8. PAYMENTS............................................................ 7
9. RECORDS AND REPORTING............................................... 7
10. ORDER PROCEDURE..................................................... 8
11. SHIPMENT, RISK OF LOSS, AND DELIVERY................................ 10
12. PRODUCT MANAGEMENT ASSISTANCE....................................... 10
13. COMPLIANCE.......................................................... 10
14. TRADEMARKS AND PROPRIETARY RIGHTS................................... 10
15. DURATION AND TERMINATION OF AGREEMENT............................... 12
16. INDEMNIFICATION..................................................... 14
17. REPRESENTATIONS AND WARRANTIES...................................... 15
18. DISCLAIMER OF WARRANTIES; LIMITED LIABILITY......................... 15
19. CONFIDENTIALITY..................................................... 16
20. ENFORCEMENT......................................................... 17
21. GENERAL............................................................. 17
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DISTRIBUTION AGREEMENT
This Distribution Agreement is made and entered into this ____ day of
October, 1997, by and between ALTANA, INC., a New York corporation located in
Melville, New York ("Altana") and THERAPEUTIC ANTIBODIES INC, a Delaware
corporation located in Nashville, Tennessee ("TAb").
W I T N E S S E T H:
1. Recitals.
1.1 TAb has developed and is the sole owner of all worldwide
right, title, and interest in and to certain antibody products.
1.2 TAb is seeking to obtain registration and marketing
approval for certain products from the United States Food and Drug
Administration so that such products may be distributed in the United States of
America and its territories and possessions.
1.3 Altana has agreed to distribute certain antibody products
of TAb on the terms and subject to the conditions set forth herein.
2. Definitions.
2.1 "Clinical Trials" shall mean any and all investigations,
evaluations, or experiments that are conducted on human beings in relation to
the potential use of each Product.
2.2 "Commencement Date" means, with respect to each Product
within the Territory, the date on which TAb receives Product Approval (as
defined herein).
2.3 "Confidential Information of TAb" means all information
obtained or developed by Altana which relates to TAb's business or the Products,
regardless of the form in which such information is transmitted, including,
without limitation, all such information previously obtained by Altana pursuant
to the Confidentiality Agreement dated April 1, 1995, between TAb and Altana
(the "Confidentiality Agreement"), all information furnished to Altana by TAb in
relation to the Products or to TAb, all Results, and all Trade Secrets. The
following shall not be considered Confidential Information of TAb for purposes
hereof:
(a) Information that is already in the possession of Altana at
the time it is received from TAb or developed on TAb's behalf, so long as Altana
can provide satisfactory written documentation of such;
(b) Information received by Altana from a Person which has the
right to disclose the same, so long as the receiving party promptly notifies TAb
of its belief that the information is excepted under the terms of this
subsection;
(c) Information that is or becomes publicly available without
the fault of Altana; or
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(d) Information that Altana is obligated to produce pursuant
to an order of a court of competent jurisdiction or a valid administrative
order; provided that if Altana is subject to such an order, it must promptly
notify TAb and cooperate with TAb's efforts to contest or limit the scope of
such order.
In the event of a dispute regarding the applicability of the above exceptions to
the definition of Confidential Information of TAb, Altana shall have the burden
of producing clear and convincing proof that the information should be excepted
from the definition of Confidential Information of TAb.
2.4 "Confidential Information of Altana" means all information
obtained by TAb which relates to Altana's business, existing or potential
customers of Altana, and product marketing data of Altana, regardless of the
form in which such information is transmitted. Neither the Confidential
Information of TAb nor the following shall be considered the Confidential
Information of Altana for purposes hereof:
(a) Information that is already in the possession of TAb at
the time it is received from Altana, so long as TAb can provide satisfactory
written documentation of such;
(b) Information received by TAb from a Person which has the
right to disclose the same, so long as the receiving party promptly notifies
Altana of its belief that the information is excepted under the terms of this
subsection;
(c) Information that is or becomes publicly available without
the fault of TAb; or
(d) Information that TAb is obligated to produce pursuant to
an order of a court of competent jurisdiction or a valid administrative order;
provided that if TAb is subject to such an order, it must promptly notify Altana
and cooperate with Altana's efforts to contest or limit the scope of such order.
In the event of a dispute regarding the applicability of the above exceptions to
the definition of Confidential Information of Altana, TAb shall have the burden
of producing clear and convincing proof that the information should be excepted
from the definition of Confidential Information of Altana.
2.5 "Confidential Information" means collectively Confidential
Information of TAb and Confidential Information of Altana.
2.6 "Documentation" means any and all labels, instructions
(including without limitation instructions for storage and handling), manuals,
specifications, warnings and similar documentation regarding the Products
prepared by or for TAb.
2.7 "End User" means a Person who purchases the Product for
such Person's own use or for administration to patients, and not for
redistribution.
2.8 "FDA" means the United States Food and Drug Administration
or any successor governmental agency performing similar functions.
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2.9 "Net Sales Revenue" means the aggregate amount billed by
Altana, directly or indirectly, for the sale of the Products, provided that Net
Sales Revenue shall not include cash discounts, allowances, sales tax (if any),
and returns actually credited. If, as a result of governmental action, customs
clearance costs should materially increase over levels as of the date of this
Agreement, then such customs clearance costs shall be included as a reduction of
Net Sales Revenue for purposes of determining the Altana purchase price of the
Products.
2.10 "Person" means an individual, corporation, company,
partnership, trust, association, governmental authority or other entity.
2.11 "Product" or "Products" means certain antibody products
that were developed and are owned by TAb, each of which is described in Schedule
1.1.
2.12 "Product Approval" means final FDA approval to market and
sell each Product commercially in the Territory for use in humans.
2.13 "Proprietary Rights" means the rights and properties
described in Section 14.9.
2.14 "Regulatory Filing" shall mean any filing of or
equivalent to Notice of Claimed Investigational Exemption for a New Drug
("IND"), Product License Application("PLA"), Establishment License Application
("ELA"), or New Drug Application ("NDA") in the United States pursuant to the
regulations and procedures required by any regulatory authority in the Territory
for the testing, manufacture, distribution, sale, or specific use of the
Products.
2.15 "Results" means all technology, ideas (whether or not
copyrightable), know-how, data, improvements, modifications, innovations,
inventions, methodology, processes, techniques, and results, tangible and
intangible, developed or discovered by TAb or Altana in connection with the
clinical trials, registrations, and approvals contemplated by Sections 3 and 4,
or otherwise in connection with the Products or this Agreement.
2.16 "Territory" means the United States of America and its
territories and possessions.
2.17 "Trademarks" means all trademarks, trade names, and other
designations of origin used on or in connection with the Products, including,
without limitation, CroTAb(R), DigiTAb(TM), and TriTAb(TM).
2.18 "Trade Secrets" means all techniques, technology,
processes, and know-how related to production and purification of polyclonal
antibodies developed by or on behalf of TAb, including (a) the design and
syntheses of immunogens which can produce high affinity antibodies in large
quantities, (b) the selection, immunization, and handling of animals to produce
therapeutic polyclonal antibodies (including breed comparison studies), (c) the
aseptic collection and handling of antisera, and (d) closed systems for fully
processing and purifying antibodies; types and configuration of processing
equipment; lists of suppliers; development plans; methods of operation and
management; cost control methods; methods of setting prices; reporting methods;
quality assurance programs; information systems; training manuals; databases;
production solutions; financial information; customer and prospective customer
lists; and all other trade secrets of TAb.
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3. Clinical Trials.
3.1 TAb has completed Phase II/III Clinical Trials for its
antivenom product known as CroTAb(R). As of the date hereof, TAb is conducting
Phase II/III Clinical Trials for its digoxin antibody product known as
DigiTAb(TM) and is planning to conduct Clinical Trials for its tricyclic
antibody product known as TriTAb(TM). TAb is solely responsible for paying for,
conducting, monitoring and using commercially reasonable efforts to complete all
Clinical Trials necessary for Product Approval for each of the Products in the
Territory.
3.2 TAb shall at its cost promptly provide Altana with
relevant safety and efficacy information in relation to each Product, as it
becomes aware of the same from time to time, including information relating to
any adverse reactions to a Product.
4. Registration.
4.1 TAb shall use all commercially reasonable efforts to
obtain and maintain Product Approvals for each Product. TAb shall be responsible
for the preparation and filing with the FDA of all Regulatory Filings required
by the FDA for each Product at its own expense, including the payment of FDA
user fees. TAb shall provide Altana an opportunity to review the PLA for each
Product prior to submission thereof to the FDA. TAb shall provide Altana with
written certification that the Product has obtained Product Approval, promptly
upon receipt of the respective Product Approval. Altana agrees that it shall not
modify or alter the Products or their packaging and promotional materials in any
respect, whether in relation to design, content, manufacture, use or otherwise,
without the prior written consent of TAb.
4.2 All registrations and approvals obtained for the Products
hereunder shall be the sole and exclusive property of TAb. All registrations and
approvals shall be held in the name of TAb. All Results shall be the sole and
exclusive property of TAb, and Altana hereby assigns to TAb any and all right,
title, and interest it may now or in the future have in the Results.
5. Manufacturing.
5.1 At its own expense, TAb has developed production
facilities in the United Kingdom and Australia for the manufacture of the
Products.
5.2 The Products supplied by TAb to Altana shall not be
adulterated or misbranded within the meaning of the Federal Food, Drug, and
Cosmetic Act and shall be manufactured in compliance with (i) current Good
Manufacturing Practices as promulgated by the FDA under the Federal Food, Drug
and Cosmetic Act, as amended, (ii) specifications formulated by TAb and approved
by the FDA (the "Specifications") to be attached hereto as Schedule 5.2
following such approval, and (iii) the Product Approvals. The Product will be
manufactured, packaged, and labeled entirely by TAb and/or a third party
designated by TAb. TAb shall provide Altana an opportunity to review and advise
TAb in regard to the proposed package design for the Product prior to use of
such package design for sales pursuant to this Agreement.
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6. Appointment of Authorized Distributor.
6.1 TAb appoints Altana as an exclusive distributor for each
Product solely within the Territory and solely for human use so long as Altana
meets the minimum sales requirements set forth on Schedule 7.4; provided,
however, that TAb and its designees shall maintain the right to market and
distribute CroTAb(R) to zoos and military purchasers in the Territory. The
appointment shall be effective on the respective Commencement Dates, and shall
terminate in accordance with the provisions of Section 15 below. Subject to the
provisions of Section 14 below, Altana is authorized by TAb to use the Trademark
which corresponds to the approved Product following each Commencement Date and
for the term of this Agreement thereafter solely in connection with Altana's
advertisement, marketing, promotion, distribution and sale of such Product in
the Territory. No rights are granted to Altana with respect to non-human Product
applications; nothing herein shall restrict TAb's ability to develop,
manufacture, market, and sell Products for non-human applications.
6.2 The rights and licenses granted to Altana under this
Agreement are personal, non-transferable, non-assignable, are limited solely to
the Products, and in all cases are granted without the right to assign or
sublicense. Altana's appointment only grants to Altana a right to market,
advertise, promote, sell, and distribute Products in the Territory and does not
transfer any right, title, or interest in the Proprietary Rights to Altana.
6.3 Altana agrees that it shall not advertise, promote,
distribute, sell, or otherwise utilize the Products and/or Trademarks outside of
the Territory, and TAb agrees that it will not authorize any of its distributors
to supply the Products into the Territory; provided, however, that TAb and its
designees retain the right to market and distribute CroTAb(R) to zoos and
military purchasers in the Territory. Altana shall take such reasonable measures
as TAb requests to ensure that the customers of Altana do not sell CroTAb(R) to
zoos and military purchasers in the Territory, and TAb shall take such
reasonable measures as Altana requests to ensure that its designees and
customers do not sell Products within the Territory except for sales of
CroTAb(R) to zoos and the military.
6.4 Altana pricing practices for Products shall not include
lower prices or concessions designed to enhance sale of other Altana products.
Altana agrees that it shall not employ any of the Products as a premium or
give-away without the prior written consent of TAb. Any cash discount of greater
than two percent (2%) and/or any allowance other than initial stocking
allowances must be reviewed and approved by TAb.
7. Distribution of Products.
7.1 Altana agrees that, beginning on the respective
Commencement Dates for the Products in the Territory and continuing through the
term of this Agreement, it shall vigorously and diligently, advertise, market,
promote, sell and distribute the Products throughout the Territory in strict
accordance and conformity with the terms of this Agreement. Without limiting the
foregoing, the distribution efforts of Altana hereunder shall be at least as
great as the efforts exerted by Altana to distribute and sell its own products.
Altana shall advertise, promote, sell and distribute the Products in the
Territory through all sales channels appropriate for pharmaceutical products as
chosen by Altana and reviewed by TAb in accordance with Section 7.3.
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7.2 Except as expressly set forth in this Agreement, TAb shall
not supply the Products to any Person located within the Territory other than
Altana for the term of this Agreement. Altana agrees that it shall not, within
the Territory, develop, manufacture, assemble, advertise, promote, sell or
distribute any products or goods competitive with any Product or which by reason
of their design, or packaging may be reasonably confused with any Product after
the corresponding Commencement Date.
7.3 Altana shall be solely responsible for its marketing plan,
but shall review the plan with TAb each calendar quarter. TAb acknowledges that
customer lists are Altana's property and are confidential except that TAb shall
have unrestricted use of the customer lists (without reference or liability to
Altana) in the event of uncured breach of this Agreement by Altana.
7.4 The annual minimum acceptable Net Sales Revenue for each
Product ("Minimums") shall be fifty percent (50%) of the Product sales estimates
agreed by TAb and Altana, as specified in Schedule 7.4. Failure to meet the
Minimums on any Product at any time after the second anniversary of the
Physicians Launch Date (defined herein) for such Product shall entitle TAb to
terminate this Agreement with respect to the Product for which the Minimums were
not met, following thirty (30) days' written notice, unless (a) Altana pays TAb,
within the notice period of thirty (30) days, the difference between (i) the
amount TAb would have received in royalty and other payments hereunder if the
Minimums for such period had been met, and (ii) the amount actually received by
TAb for such period, or (b) TAb fails to meet its supply obligations for the
Product at issue as set forth in Section 10 in the two successive Purchase
Periods (defined herein) preceding Altana's failure to meet the Minimums. The
Physicians Launch Date for each Product shall be three (3) months following the
initial receipt by Altana of stock of such Product that has received Product
Approval and that is supplied in accordance with Section 5.2. The Minimums for
the period that begins on the second anniversary of the Physicians Launch Date
and ends on the next anniversary of the Commencement Date shall be reduced pro
rata to reflect the proportionate amount of the year at issue. Thereafter, the
full Minimums shall apply. The parties hereto shall review and may modify the
Minimums on each anniversary of the Physicians Launch Date for a Product if
there is mutual agreement. Any modification of the Minimums must be in writing
and must be signed by an authorized representative of both parties. The parties
agree that the occurrence of any of the following events or conditions may
negatively affect the marketability of the Products: (1) the introduction of
directly competitive products, (2) final labeling for CroTAb(R) that does not
specifically allow for the promotion of an improved safety profile (but only if
the Wyeth Crotalid antivenom is commercially available in the Territory), and
(3) final labeling for DigiTAb(TM) that is not at least equal to the DigiBind
labeling regarding safety, efficacy, and indications. If any of these things
occur, the parties will promptly negotiate new Minimums which will become
effective on the date of the occurrence, provided, that the newly negotiated
Minimum for each Product shall not be less than twenty-five percent (25%) of the
Product sales estimates specified for such Product on Schedule 7.4.
7.5 Altana shall insure that its distribution of the Products
and its use of the Trademarks complies with all applicable laws and regulations
within the Territory.
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7.6 Altana shall provide its sales force with training,
technical support and other assistance appropriate in promoting the Products
based upon product management assistance provided by TAb including attendance by
at least one TAb representative at at least one Altana training meeting covering
each Product. TAb shall supply Altana with one (1) copy of Documentation and
other TAb literature so that Altana may carry out such training. Altana sales
representatives will be conversant with the technical language conventional to
the Products and similar products in general pursuant to documentation supplied
by TAb.
7.7 Altana shall not make representations, warranties, or
guarantees with respect to the specifications, features or efficacy of the
Products that are inconsistent with the literature distributed by TAb, including
all warranties and disclaimers contained in the Documentation.
7.8 TAb will advise Altana promptly concerning any market
information that comes to TAb's attention regarding the Products or the
continued competitiveness of the Products in the marketplace outside the
Territory. Altana will advise TAb promptly concerning any market information
that comes to Altana's attention regarding the Product, its market position or
the continued competitiveness of the Products within the Territory.
7.9 Altana shall transport and store the Products in
accordance with instructions provided by TAb and all applicable laws and
regulations.
7.10 Altana agrees not to promote, sell, distribute, or use
for any purpose whatsoever any Products which Altana knows are damaged or
spoiled. Altana shall not jeopardize the integrity of the container closure
system for the Products.
7.11 Altana shall assign responsibility for the promotion,
distribution, and sale of the Products to at least eighty-five percent (85%) of
its Savage Laboratories division sales representatives at all times following
the initial Commencement Date. From the initial Commencement Date until the
second anniversary of the initial Physicians Launch Date, each such sales
representative shall make sales calls to emergency rooms to promote and sell the
Products an average of at least four times per year and to poison control
centers to promote and sell the Products an average of at least six times per
year, and during such sales calls, the Products shall be the primary detail.
7.12 Altana shall store, handle, and use the Products in
accordance with the Documentation.
7.13 Altana shall be the primary contact for receipt of
post-marketing adverse event reports from the medical community. TAb and Altana
will jointly evaluate each such adverse event. TAb shall be responsible for
reporting such events to the FDA.
8. Payments.
Each party shall make payments as specified on Schedule 8.1.
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9. Records and Reporting.
9.1 Altana shall furnish TAb within thirty (30) days
following each March 31, June 30, September 30, and December 31 of each calendar
year, a complete and accurate statement for the immediately preceding quarterly
period, said statement to be certified as accurate by the Senior Financial
Officer of the division of Altana which manages distribution of the Products,
and to include the following information: (a) total Net Sales Revenue on an
aggregate basis; (b) number and gross selling price of Product sold; (c)
information as to returns actually credited; (d) current inventory levels for
Products; and (e) such other information as TAb reasonably may request. All
amounts shall be stated in U.S. dollars.
9.2 Altana agrees that at all times during the existence of
this Agreement, and for a period of seven (7) years thereafter, it will keep
accurate books of account and other records containing all details relating to
the distribution and sale of Products, and the calculation of Net Sales Revenue.
Altana agrees that these books of account and other records shall be kept in
accordance with the legal regulations in existence in the Territory and
carefully preserved for at least seven (7) years.
9.3 Where TAb is not satisfied that statements made to it by
Altana are accurate, TAb may give Altana written notice requesting Altana to
confirm the accuracy of the statements made to TAb by conducting an internal
review. Altana must provide a written response which confirms or corrects the
statements within thirty (30) days. If Altana fails to provide its response or
if TAb is still not satisfied, Altana agrees that TAb may inspect the books of
account of Altana for the purpose of ascertaining or confirming the accuracy of
the statements rendered hereunder. TAb shall also have the right to have an
independent audit conducted by any national firm of independent public
accountants ("Independent Auditors") of the books of account of Altana for the
purpose of ascertaining or confirming the accuracy of the statements rendered
hereunder. If an inspection by Independent Auditors reveals that Net Sales
Revenue and/or corresponding payments have been understated in any report, then
Altana shall pay to TAb the amount understated, immediately upon demand, plus
interest accrued thereon from the date due at a rate equal to the prime rate
announced by Citibank, N.A., New York, New York, on the date that the
Independent Auditors inform TAb the amount has been understated. The cost of
these inspections by the Independent Auditors shall be borne by TAb; provided,
however, that if an inspection reveals that a statement rendered hereunder has
understated Net Sales Revenue and/or corresponding payments by greater than five
percent (5%), then the costs of such inspection shall be borne by Altana.
10. Order Procedure.
10.1 Purchase Orders in the First Two Years of Distribution.
Within thirty (30) days of the Commencement Date for each Product, Altana shall
submit a written order for the amount of each corresponding Product that it
commits to purchase within one (1) year (a "Purchase Order in the First Two
Years") from each respective Commencement Date. Once during each calendar
quarter thereafter (each calendar quarter is herein referred to as a "Purchase
Period") until the second anniversary of each Commencement Date, Altana shall
provide TAb any additional Purchase Order in the First Two Years. Each Purchase
Order in the First Two Years shall be accompanied by a standard form of purchase
order indicating the quantity of each Product to be purchased, a non-refundable
payment of thirty-three percent (33%) of the Purchase Price (defined herein) for
the purchase order, and an estimated delivery schedule for such Product. TAb
shall use its best efforts to supply each Product in accordance with any
Purchase Order in the First Two Years made by Altana. Because of supply
variables, no Purchase Order in the First
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Two Years shall be binding upon TAb unless and until accepted by TAb in writing.
All orders shall be subject to delays in production or delays due to causes
beyond TAb's control. Should TAb not accept any one particular Purchase Order in
the First Two Years, TAb (a) shall credit the payment accompanying the purchase
order toward future orders, or (b) at the request of Altana, shall refund the
entire payment accompanying the purchase order or the proportionate part thereof
requested by Altana if Altana cancels a purchase order in its entirety or in
part due to such delays. Such purchase orders and any acknowledgment thereof,
whether printed, stamped, typed, or written shall be governed by the terms of
this Agreement, and none of the provisions of such purchase orders or
acknowledgments shall be enforceable except those specifying quantity ordered,
delivery dates, and invoice information, and only if such provisions do not
conflict with the terms hereof. All nonrefundable payments shall be credited in
full against the Purchase Price on the corresponding Purchase Order in the First
Two Years.
10.2 Preliminary Forecasts for Subsequent Purchase Orders.
Within thirty (30) days of each Commencement Date, Altana shall provide TAb with
a good-faith estimate of the amount of the corresponding Product which Altana
shall purchase from TAb in the first calendar quarter beginning after the second
anniversary of such Commencement Date (the "Preliminary Forecasts"). Within
ninety (90) days after each such forecast is given and on the first day of each
calendar quarter thereafter, Altana shall provide TAb with a forecast for the
quarter that follows the last quarter of the preceding forecast and shall,
within the limitations set forth herein, revise and update each quarterly
forecast provided earlier, and deliver such updated and revised forecast to TAb
prior to the start of each quarter during the term of this Agreement. Each such
revised and updated forecast shall include Altana's good-faith estimate of the
amount of each Product Altana shall purchase from TAb during each Purchase
Period beginning one (1) year from the date such forecast is due to TAb (each
quarterly forecast required by this Section 10.2, including all Preliminary
Forecasts, is herein referred to as a "Forecast").
10.3 Subsequent Purchase Orders. Altana may revise the amount
of Product estimated for purchase in any Preliminary Forecast, until one year
prior to the start of each Purchase Period. In the Forecast which is due to TAb
on or before one year prior to the start of a given Purchase Period, Altana
shall indicate the amount of each Product which it thereby commits to purchase
from TAb within one (1) year from the start of such Purchase Period (the
"Purchase Order"). The quantity of any Product to be ordered pursuant to a
Purchase Order shall not be less than seventy-five percent (75%), nor greater
than one hundred twenty-five percent (125%) of the quantity indicated in the
Preliminary Forecast for such Product; provided, however, that TAb shall use its
best efforts to supply the Products for orders by Altana in excess of such
amounts. Each Purchase Order shall be accompanied by a standard form of purchase
order indicating the quantity of each Product to be purchased, a nonrefundable
payment of thirty-three percent (33%) of the Purchase Price (defined herein) for
the Purchase Order, and an estimated delivery schedule for such Product, which
shall not commence sooner than one (1) year from the date of such Purchase
Order. Such purchase orders and any acknowledgment thereof, whether printed,
stamped, typed, or written shall be governed by the terms of this Agreement, and
none of the provisions of such purchase orders or acknowledgments shall be
enforceable except those specifying quantity ordered, delivery dates, and
invoice information, and only if such provisions do not conflict with the terms
hereof. Any nonrefundable payments shall be credited in full against the
Purchase Price on the corresponding Purchase Order.
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10.4 Delivery Instructions. On or before six (6) months prior
to the start of a given Purchase Period, Altana shall indicate the amount of
each Product which it requires to be delivered to Altana during the Purchase
Period (the "Initial Delivery Amount"). The Initial Delivery Amount shall not be
less than fifty percent (50%), nor greater than one hundred percent (100%), of
the quantity indicated in the Purchase Order in the First Two Years or Purchase
Order for such Product. Altana reserves the right to reject, in whole or in
part, any shipments of Products that have a shelf life of less than eighteen
(18) months (as indicated on the corresponding FDA-approved label). To the
extent that the Initial Delivery Amount is less than the amount indicated in the
Purchase Order in the First Two Years or Purchase Order (such difference being
the "Delayed Delivery Amount"), Altana hereby commits to accept delivery of the
Delayed Delivery Amount prior to the end of one (1) year from the start of the
Purchase Period to which such Delayed Delivery Amount pertains and to pay TAb
for such Delayed Delivery Amount in accordance with the terms hereof. Altana
shall indicate an acceptable delivery date for the Delayed Delivery Amount not
less than ninety (90) days prior to such delivery date.
11. Shipment, Risk of Loss, and Delivery.
11.1 Altana shall take delivery of all Product C.I.F. the ▇▇▇▇
▇. ▇▇▇▇▇▇▇ Airport at New York, New York ("JFK") or C.I.F. such other location
as the parties may agree. TAb will be responsible for and pay all shipping,
freight, and insurance charges for delivery to JFK or such other agreed
location, and Altana will be responsible for and pay all customs clearance
costs.
11.2 All risk of loss, spoilage, or damage shall pass to
Altana upon delivery by TAb to JFK or to Altana, whichever first occurs. Unless
Altana advises TAb to the contrary in writing, TAb may make partial shipments of
Altana's orders, to be separately invoiced and paid for when due.
12. Product Management Assistance.
TAb shall provide Altana with reasonable product management
assistance based on TAb's experience with the Product, its business contacts,
and its relationships with opinion leaders, subject to availability of
appropriate personnel. Such assistance shall be for informational purposes only,
and Altana shall have sole responsibility for determining the adequacy of such
information.
13. Compliance.
13.1 TAb agrees that its conduct in performing its obligations
under this Agreement shall conform in all material respects to all applicable
laws and regulations of the U.S. and foreign governments (and political
subdivisions thereof).
13.2 Altana agrees that its conduct in performing its
obligations under this Agreement shall conform in all material respects to all
applicable laws and regulations of the U.S. and foreign governments (and
political subdivisions thereof).
14. Trademarks and Proprietary Rights.
14.1 "CroTAb(R)" is a registered trademark of TAb. TAb has
made application to register the trademarks, DigiTAb(TM) and TriTAb(TM) in the
United States.
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14.2 Altana shall not use any alternative trademark or other
designation of origin on or in connection with Products unless and until Altana
has given at least ninety (90) days' prior written notice to TAb and TAb has
approved the use of such trademark in writing.
14.3 For the purpose of protecting its trademark rights and
any registrations of the Trademarks, TAb shall have the right to supervise and
control Altana's use of TAb's Trademarks. Altana shall not have any right,
title, or interest, express or implied, in the Trademarks. Altana's right to use
any Trademarks developed by TAb for use with the Product shall be nonassignable
and nonexclusive as to distribution of CroTAb(R) to zoos and military purchasers
in the Territory and as to distribution of any Product outside of the Territory.
14.4 Altana agrees to use only those labels, imprints, and
other devices, and only the format or formats and design or designs of the
Trademarks which are approved by TAb in writing. TAb shall have the right to
restrict the use of a particular design or format of the Trademarks to a
particular use, within the scope of this Agreement, and require that said format
or design of the Trademarks be put to no other use.
14.5 Altana shall submit to TAb for its written approval,
which shall not be unreasonably withheld or delayed, prior to any use or
dissemination thereof, two (2) copies of all labels, designs, cartons,
containers, or other packaging or wrapping, and all related advertising,
promotional, and display material (collectively, "Packaging and Promotional
Material"). TAb's trade name and relevant Trademarks shall be prominently
displayed on all labels and other Packaging and Promotional Material. Altana
shall make no use whatsoever of any Packaging and Promotional Material prior to
receiving TAb's written approval pursuant hereto. After samples of Packaging and
Promotional Material have been approved as provided herein, Altana shall not
depart therefrom in any material respect without TAb's prior written consent.
14.6 TAb shall respond to all requests for approval required
by this Section 14 within fourteen (14) days of receipt of Altana's written
request and accompanying Product and/or accompanying materials. No approval
shall be effective unless in writing and signed by a TAb officer. If TAb has not
responded within fourteen (14) days, the material will be deemed to have been
approved.
14.7 Altana agrees that it shall not adopt or use for any
purpose any variation of the Trademarks or any word, design, or ▇▇▇▇ likely to
be confused with the Trademarks. Altana further agrees not to register during
the term of the Agreement and thereafter, in any country any name, word, design,
logo, or ▇▇▇▇ resembling or confusingly similar to any of the Trademarks.
14.8 Altana agrees not to advertise, promote, sell,
distribute, or use for any purpose whatsoever any Product or Packaging and
Promotional Material which Altana knows are damaged or spoiled. Altana shall not
jeopardize the integrity of the container closure system for the Products.
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14.9 Altana acknowledges that all Trademarks and all rights
and goodwill pertaining thereto are the exclusive property of TAb. Altana
further acknowledges that TAb is the sole and exclusive owner of all present and
future right, title, and interest in and to the Products, including, without
limitation, (a) all worldwide patent rights, including registrations and
applications, Product Approvals, Regulatory Filings, copyrights, and related
rights, in or related to the Products and any present and future renewals
thereof, (b) all rights (including copyrights) in the appearance, packaging,
design, trade dress, and other identifying features of the Products and the
Packaging and Promotional Materials, (c) the Trade Secrets and the Results, (d)
any adaptations, additions, derivatives, translations, and/or improvements to
any of the foregoing, and (e) all other intangible or intellectual property
rights in the Products. The Trademarks and other rights and properties described
in this Section 14.9 are referred to collectively as the "Proprietary Rights."
14.10 Altana agrees it will not challenge, oppose or cancel,
or permit any act or thing that would endanger any right of TAb in any Product
or the Proprietary Rights, nor will Altana claim any proprietary interest in any
Product or the Proprietary Rights. Altana agrees that its use of Trademarks
shall inure to the benefit of TAb, and that Altana shall not, at any time,
acquire any rights in Trademarks by virtue of any use it may make hereunder.
Altana shall not apply to register rights in the Product or the Proprietary
Rights with any governmental authority.
14.11 During the term of this Agreement, each party shall
promptly give the other notice of:
(a) any claim or allegation that the exercise of the rights
under this Agreement constitutes an infringement of the rights of any third
party; and
(b) any third party's infringement or threatened
infringement of any of the Proprietary Rights of which it becomes aware.
14.12 Altana will cooperate with TAb at TAb's expense in any
actions taken against any Person infringing any of TAb's patents and trademarks
related to the Products. TAb shall promptly enforce its rights against any
Person that is believed to be infringing TAb's patents and trademarks related to
the Products in a manner that has a substantial negative impact on Altana's
ability to market the Product. TAb shall have control over any related
prosecution or proceeding and shall bear all costs in connection with such
prosecution or proceeding.
14.13 As both a covenant by Altana and a condition of TAb's
authorization of Altana's distribution, Altana will include on all Packaging and
Promotional Material, all patent, trademark, and other notices of proprietary
rights reasonably required by TAb. Altana, at all times when it uses a
Trademark, shall conspicuously note that the Trademark is used under license
from TAb, and shall indicate TAb's ownership of the Trademark along with the
registration symbol "(R)" for registered trademarks (or the designation TM where
applicable as specified by TAb). Altana agrees not to alter, erase, deface or
overprint any such notice on any item provided by TAb. Altana agrees that all
Packaging and Promotional Material shall identify TAb as the source of the
Product, and agrees to comply with TAb's reasonable instructions in this regard.
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15. Duration and Termination of Agreement.
15.1 This Agreement is effective on the date first written
above and, unless earlier terminated in accordance with the provisions hereof,
this Agreement shall terminate five (5) years from the last of the three (3)
Commencement Dates, but in any event, no later than September 30, 2005. On such
expiration date of the initial term, the term of this Agreement shall be
automatically continued for a successive period of five (5) additional years for
all Products except for any Product previously terminated by Altana pursuant to
Section (8) of Schedule 8.1; provided, if Altana has failed to meet the Minimums
for any Product pursuant to Section 7.4, this Agreement shall not be renewed if
either party provides sixty (60) days' notice prior to expiration of the term of
its intent not to renew.
15.2 If either party materially breaches any of its
obligations under this Agreement, the other party may give notice of such
material breach in accordance with the provisions of Section 21.2 hereof. If the
breaching party does not cure the material breach within thirty (30) days from
the date of receipt of the notice, then the notifying party may terminate this
Agreement.
15.3 Either party hereto shall have the right to terminate
this Agreement immediately and without prior notice in the event that the other
party files a petition for voluntary bankruptcy, has a petition for involuntary
bankruptcy filed against it (which petition is not withdrawn within sixty (60)
days of such filing), is adjudicated to be or becomes bankrupt, places any of
its property in liquidation for the purpose of meeting claims of its creditors,
is otherwise unable to pay its debts as such debts become due (including, but
not limited to, payments due hereunder), or ceases to function as a going
concern.
15.4 The obligations of both parties under Sections 8, 9, 11,
13, 14, 15, 16, 18, 19, 20 and 21 hereof shall survive the expiration or
termination of this Agreement.
15.5 Upon termination of this Agreement as a result of an
uncured breach by TAb of its obligations as set forth in Section 15.2, TAb shall
promptly reimburse Altana any payments by Altana of thirty-three percent (33%)
of the Purchase Price for any unfilled Purchase Orders. Upon termination or
expiration of this Agreement for any reason, TAb shall not have any liability
for actual or alleged loss of goodwill, or on account of any leases or overhead
allocated to any Product. Altana acknowledges and agrees that it has no
expectation and has received no assurances that its business relationship with
TAb will continue beyond the stated term of this Agreement or its earlier
termination in accordance with this Section 15.
15.6 Upon expiration or termination of this Agreement (a)
Altana may continue to sell and distribute the Products to the extent necessary
to fulfill all orders placed by End Users prior to the date of such termination,
and (b) if Altana has existing inventory of the Products in excess of orders
placed prior to the date of such termination, Altana shall have a period of six
(6) months from the date of such termination (in either case, the "Sell-Off
Period") to advertise, promote, sell and distribute such existing inventory. All
terms and conditions of this Agreement shall remain in full force and effect
during any such Sell-Off Period. Immediately upon such expiration or termination
or, if applicable, upon the expiration of the Sell-Off Period, (i) Altana shall
cease all use of the Products, the Packaging and Promotional Materials, the
Trademarks, and all other Proprietary Rights, including all advertisement,
promotion, sale, and distribution of the Products, (ii) all rights granted by
TAb herein shall revert to TAb, (iii) Altana shall destroy all Packaging and
Promotional Material and certify the same to TAb, and (iv) Altana shall prepare
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and deliver to TAb a final accounting. Any and all amounts shown on such
inventory statement and final accounting shall be due and payable no later than
thirty (30) days following the date of termination or expiration, or if
applicable, the expiration of the Sell-Off Period.
15.7 Notwithstanding the above, should TAb terminate this
Agreement pursuant to Section 15.2 or 15.3, Altana shall not be entitled to a
Sell-Off Period, the provisions of subparts (i)-(iv) of Section 15.6 shall be
effective immediately, and TAb shall have the right, in its sole discretion,
subject to applicable bankruptcy law in the event of termination pursuant to
Section 15.3, to either (a) purchase all or a portion of the Products in
Altana's possession at the Purchase Price paid by Altana, which inventory shall
be returned to TAb or destroyed by Altana at TAb's direction, or (b) permit
Altana to sell such Products in Altana's possession.
16. Indemnification.
16.1 Altana shall indemnify and hold harmless TAb, its
subsidiaries, and affiliates, and their officers, directors, employees, agents,
and shareholders, notwithstanding termination of this Agreement, against any
liability, damage, loss, cost, or expense (including reasonable attorneys' fees)
relating to any third party claims arising from:
(a) default under any provision of the Agreement by Altana;
(b) any alleged negligence, gross negligence, or intentional
misconduct of Altana; or
(c) promotion, distribution, and sale of the Products by
Altana;
provided that upon receipt of notice by TAb of any such claims, TAb shall
promptly notify Altana. TAb shall permit Altana to handle such claims at
Altana's sole cost, and TAb shall give Altana all reasonable assistance (except
financial assistance) in the conduct of any such claims. In no event is Altana
authorized to settle or compromise any claim, or to consent to the entry of any
order or judgment, without the prior written consent of TAb. Altana shall
maintain products liability insurance with limits of liability of not less than
$20,000,000 and naming TAb as additional insured under said policy from the
commencement of marketing through termination of this Agreement on an occurrence
basis. Altana shall provide a Certificate of Insurance to TAb evidencing said
coverage annually.
16.2 TAb shall indemnify and hold harmless Altana, its
subsidiaries and affiliates, and their officers, directors, employees, agents,
and shareholders, notwithstanding termination of this Agreement from all
liability, damage, cost, or expense (including reasonable attorneys' fees)
relating to any third party claims arising from:
(a) default under any provision of the Agreement by TAb; or
(b) any alleged negligence, gross negligence, or intentional
misconduct of TAb; or
(c) any claim of an inherent defect in a Product;
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(d) any alleged infringement of a third party patent or
trademark as a result of the manufacture, use, or sale of
a Product;
provided that upon receipt of notice by Altana of any such claims, Altana shall
promptly notify TAb. Altana shall permit TAb to handle such claims at TAb's sole
cost, and Altana shall give TAb all reasonable assistance (except financial
assistance) in the conduct of any such claims. In no event is TAb authorized to
settle or compromise any claim, or to consent to the entry of any order or
judgment, without the prior written consent of Altana. TAb shall maintain
products liability insurance with limits of liability of not less than
$20,000,000 and naming Altana as additional insured under said policy from the
commencement of marketing through termination of this Agreement on an occurrence
basis. TAb shall provide a Certificate of Insurance to Altana evidencing said
coverage annually.
17. Representations and Warranties.
17.1 TAb represents and warrants that to the best of its
knowledge as of the date hereof, the manufacture, use, or sale of the Products
do not infringe any patent, trademark, or other rights held in the Territory by
a third party.
17.2 Altana represents and warrants that (a) it is a company
duly organized and validly existing under the laws of New York; (b) the
execution and delivery by Altana of this Agreement, the performance by Altana of
all the terms and conditions thereof to be performed by it and the consummation
of the transactions contemplated hereby have been duly authorized by all
necessary action, and no other act or approval of any person or entity is
required to authorize such execution, delivery, and performance; (c) the
Agreement constitutes a valid and binding obligation of Altana, enforceable in
accordance with its terms; (d) this Agreement and the execution and delivery
thereof by Altana, does not, and the fulfillment and compliance with the terms
and conditions hereof and the consummation of the transactions contemplated
hereby will not, (i) conflict with any of, or require the consent of any person
or entity under, the terms, conditions, or provisions of the organizational
documents of Altana, (ii) violate any provision of, or require any consent,
authorization, or approval under, any law or administrative regulation or any
judicial, administrative, or arbitration order, award, judgment, writ,
injunction, or decree applicable to Altana, or (iii) conflict with, result in a
breach of, or constitute a default under, any material agreement or obligation
to which Altana is a party.
17.3 TAb represents and warrants that (a) it is a corporation
duly organized and validly existing under the laws of the State of Delaware; (b)
the execution and delivery by TAb of this Agreement, the performance by TAb of
all the terms and conditions thereof to be performed by it and the consummation
of the transactions contemplated hereby have been duly authorized by all
necessary action, and no other act or approval of any person or entity is
required to authorize such execution, delivery, and performance; (c) the
Agreement constitutes a valid and binding obligation by TAb, enforceable in
accordance with its terms; (d) this Agreement and the execution and delivery
thereof by TAb, does not, and the fulfillment and compliance with the terms and
conditions hereof and the consummation of the transactions contemplated hereby
will not (i) conflict with any of, or require the consent of any person or
entity under, the terms, conditions, or provisions of the organizational
documents of TAb, (ii) violate any provision of, or require any consent,
authorization, or approval under, any law or administrative regulation or any
judicial, administrative, or arbitration order, award, judgment, writ,
injunction, or decree applicable to TAb, or (iii) conflict with, result in a
breach of, or constitute a default under, any material
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agreement or obligation to which TAb is a party.
18. Disclaimer of Warranties; Limited Liability.
18.1 Under no circumstances shall either party be liable to
the other party on account of any claim (whether based upon principles of
contract, warranty, negligence or other tort, breach of any statutory duty,
principles of indemnity, the failure of any limited remedy to achieve its
essential purpose, or otherwise) for any special, consequential, incidental or
exemplary damages, including but not limited to lost profits, or for any damages
or sums paid by a party to third parties, even if the other party has been
advised of the possibility of such damages, except for breach by TAb of the
warranty in Section 17.1 above.
18.2 TAb disclaims all implied warranties, including, without
limitation, any warranty of merchantability or fitness for a particular purpose.
EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, TAB MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED. THERE ARE NOT EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
18.3 Except as expressly set forth in this Agreement, TAb's
sole liability to Altana for breach of warranty or for negligence or otherwise
shall be to replace promptly, free of charge, any nonconforming Products (i.e.
any Products that do not conform to the Specifications at the time of delivery
to Altana). Altana shall destroy or return to TAb all such nonconforming
Products, as instructed by TAb.
18.4 If either of the parties hereto is required by judicial
or administrative order to recall any Product, such party shall promptly notify
the other party. In such event, TAb shall develop a compliance plan for both
parties hereto, and at TAb's sole expense, TAb and Altana shall make best
efforts to comply with such compliance plan.
19. Confidentiality.
19.1 In consideration of the mutual exchange and disclosure of
Confidential Information, each party undertakes in relation to the other party's
Confidential Information:
(a) to treat the Confidential Information as strictly
confidential and not permit Confidential Information to be disclosed to third
persons;
(b) to use the Confidential Information only for the purpose
of this Agreement and not to use the Confidential Information for any commercial
purpose other than under a further agreement with the other party;
(c) not to copy or reduce to writing the Confidential
Information except as reasonably necessary for the purposes of this Agreement.
Any copies or reductions to writing so made and data storage media containing
Confidential Information shall be owned by the disclosing party;
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(d) to take all reasonable steps to insure that recipients of
Confidential Information comply with the terms of this Agreement, including all
restrictions on use, disclosure, and dissemination of Confidential Information.
Such steps shall include, without limitation, measures to insure that each
recipient has read, understands, and agrees to the provisions hereof. Each party
shall notify the other immediately upon becoming aware of any breach hereof and
shall take all reasonable steps to prevent any further disclosure or
unauthorized use;
(e) only to permit Confidential Information or any part
thereof to be disclosed to those of its employees and Third Parties authorized
by the disclosing party to whom it is strictly necessary to disclose
Confidential Information for the purpose of undertaking and satisfactorily
completing its obligations under this Agreement. The receiving party is
responsible for the performance of the obligations in this Agreement on the part
of its employees; and
(f) to maintain the Confidential Information in a way which
provides adequate protection of such information from unauthorized disclosure,
copying, or use.
19.2 Upon termination or expiration of this Agreement, TAb
shall deliver to Altana (a) all Confidential Information of Altana, all copies
thereof, and all documents and storage media containing Confidential Information
of Altana, (b) the names and addresses of all recipients of Confidential
Information of Altana, and (c) a written certification that TAb has complied
with its obligations under this Section 19.2.
19.3 Upon termination or expiration of this Agreement, Altana
shall deliver to TAb (a) all Confidential Information of TAb, all copies
thereof, and all documents and storage media containing Confidential Information
of TAb, (b) the names and addresses of all recipients of Confidential
Information of TAb, and (c) a written certification that Altana has complied
with its obligations under this Section 19.3.
19.4 Each recipient of Confidential Information shall keep
confidential and not use, except as provided herein, all Confidential
Information.
20. Enforcement.
Each party acknowledges that in the event of breach of its covenants
under this Agreement, actual damages will be impossible to calculate, the other
party's remedies at law will be inadequate, and the other party will suffer
irreparable harm. Therefore, each party agrees that any of the covenants
contained in this Agreement may be specifically enforced through injunctive
relief, but such right to injunctive relief shall not preclude the other party
from other remedies which may be available to it.
21. General.
21.1 No waiver or modification of the Agreement shall be
effective unless in writing and signed by the party against whom such waiver or
modification is asserted. Waiver by either party in any instance of any breach
of any term or condition of this Agreement shall not be construed as a waiver of
any subsequent breach of the same or of any other term or condition hereof. None
of the terms or conditions of this Agreement shall be deemed to have been waived
by course of dealing or trade
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usage.
21.2 All notices and demands hereunder shall be in writing and
shall be served by personal delivery, by registered mail, by recognized national
courier, or by facsimile transmission at the address of the receiving party set
forth below (or at such different address as may be designated by such party by
written notice to the other party).
TAb: Altana:
Therapeutic Antibodies Inc. Altana, Inc.
▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attention: President Attention: President
Fax: ▇-▇▇▇-▇▇▇-▇▇▇▇ Fax: ▇-▇▇▇-▇▇▇-▇▇▇▇
All notices or demands shall be deemed received on the earlier of actual receipt
or seven (7) days after posting if sent by mail, three days after delivery to
national courier, or upon receipt of fax-back confirmation if sent by facsimile.
21.3 (a) If any dispute arising out of the subject matter of
this Agreement cannot be resolved by discussion between the parties, the parties
agree first to try in good faith to settle the dispute by mediation administered
by the American Arbitration Association under its Commercial Mediation Rules
before resorting to arbitration or any other dispute resolution procedure.
(b) Any dispute not resolved in accordance with Section (a) above
shall be settled by arbitration proceedings administered in accordance with
Section (c) below, and judgment on the award rendered by the arbitrator(s) shall
be entered in any court having jurisdiction thereof. The parties shall jointly
select an arbitrator. In the event the parties fail to agree upon an arbitrator
within ten (10) days, then each party shall select an arbitrator, and such
arbitrator shall then select a third arbitrator to serve as the sole arbitrator;
provided, that if either party, in such event, fails to select an arbitrator
within seven (7) days, such arbitrator shall be selected by the American
Arbitration Association, as applicable, upon application of either party.
(c) Arbitration shall be administered in Atlanta, Georgia, by the
American Arbitration Association in accordance with its Commercial Arbitration
Rules. Notwithstanding the foregoing, this agreement to arbitrate shall not bar
TAb and/or Altana from seeking temporary, provisional, or injunctive relief
against conduct or threatened conduct that will cause it loss or damages, under
the usual equity rules, including the applicable rules for obtaining restraining
orders and preliminary injunctions. In any such action, suit, or proceeding,
both parties hereby consent to the jurisdiction of any state or federal court in
Nashville, Tennessee, for each of them personally in connection with such
litigation, and waive any objection to venue in such courts and any claim that
such forum is an inconvenient forum.
21.4 This Agreement shall be governed by and construed in
accordance with the laws of the State of Tennessee.
21.5 In the event that any provision of this Agreement shall
be held by a court or other
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tribunal of competent jurisdiction to be unenforceable, such provision will be
enforced to the maximum extent permissible and the remaining portions of this
Agreement shall remain in full force and effect.
21.6 Neither party shall be responsible for any failure or
delay in performing its obligations under this Agreement due to unforeseen
circumstances or to causes beyond such party's control, including but not
limited to acts of God, war, riot, embargoes, acts of civil or military
authorities, governmental decrees or regulations, fire, floods, accidents, or
strikes.
21.7 This Agreement and the Schedules hereto constitute the
entire agreement between the parties pertaining to the subject matter hereof,
and supersedes in their entirety and any and all written or oral agreements
previously existing between the parties with respect to such subject matter. The
terms of this Agreement may be modified only by a writing which is signed by
both parties.
21.8 The terms of this Agreement are intended solely for the
benefit of the parties hereto. They are not intended to confer upon any Person
the status of a third party beneficiary. Except as otherwise provided for by
this Agreement, the terms hereto shall inure to the benefit of, and be binding
upon, the respective successors and assigns of the parties hereto.
21.9 This Agreement shall not be assigned by either party
without the prior written consent of the other party, and the performance of its
duties shall not be delegated; provided, however, that either party may assign
this Agreement to any entity which acquires substantially all of its assets and
business.
21.10 Neither party hereto shall issue a press release or
otherwise make a public statement with respect to the subject matter hereof
without the prior consent of the other party, except as may be required by law.
21.11 The parties expressly acknowledge and agree that Altana
shall act only as an independent contractor of TAb and that this Agreement shall
not be deemed to create an agency, partnership, employment, or joint venture
relationship between TAb and Altana. Nothing in this Agreement shall be
construed as a grant of authority to Altana to accept any order, waive any
right, incur any obligation or liability, enter into any agreement, grant any
release or otherwise purport to act in the name of TAb. Nothing in this
Agreement shall be construed as a grant of authority to TAb to accept any order,
waive any right, incur any obligation or liability, enter into any agreement,
grant any release or otherwise purport to act in the name of Altana. Except as
expressly set forth herein, the parties agree that TAb shall neither exercise
control over Altana's method of operations nor provide assistance to Altana.
21.12 Neither party hereto shall solicit or hire any employee
or agent of the other party hereto without the prior written consent of the
other party for a period of at least one year after termination of such
employee's employment or agent's agreement with the other party.
21.13 The operations, policies and procedures of TAb,
including those related to TAb's performance of this Agreement, are subject to
the sole management and control of TAb. The operations, policies, and procedures
of Altana, including those related to Altana's performance of this Agreement,
are subject to the sole management and control of Altana.
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21.14 This Agreement may be executed in one or more
counterparts, each of which shall constitute an original.
21.15 Nothing contained herein shall be construed as
conferring by implication, estoppel, or otherwise any license or right under any
patent, whether or not the exercise of any right herein granted necessarily
employs an invention or any existing or later issued patent.
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IN WITNESS WHEREOF, each of the parties has caused this Agreement to be
executed in duplicate originals by its duly authorized representative effective
on the date first set forth above.
Altana, Inc. Therapeutic Antibodies Inc
By: By:
---------------------------------- ----------------------------------
Name: Name:
-------------------------------- --------------------------------
Title: Title:
------------------------------- -------------------------------
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