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CONFIDENTIAL TREATMENT
EXHIBIT 10.17(b)
LICENSE AGREEMENT
This Agreement is effective May 2, 1997 ("the Effective Date") by and
between LeukoSite, Inc. ("LKS"). a Delaware corporation having an address at 000
Xxxxx Xxxxxx, Xxxxxxxxx, XX 00000, and L & I Partners, L.P., a Delaware Limited
Partnership having an address at 11550 1 H 00 Xxxx Xxxxx 000, Xxx Xxxxxxx, Xxxxx
00000 ("LICENSEE") .
WHEREAS, LICENSEE desires to obtain certain exclusive and non-exclusive
sub-licenses in and to certain patents and information which LKS has licensed
from the British Technology Group Ltd. ("BTG"); and
WHEREAS, LKS is willing to grant the sub-licenses desired by LICENSEE.
NOW THEREFORE in consideration of the mutual promises and other good
and valuable consideration, the parties agree as follows:
Section I - Definitions
1.1 IN this Agreement the following terms shall have the following meanings
(subject to subsequent amendment pursuant to this Agreement):-
1.1.1 "Campath I H" the anti-CD52 humanized monoclonal antibody
that is produced from the Cell Line and
derivatives of the antibody so-produced
including conjugates of the antibody with
other substances;
1.1.2 "Cell Culture Medium" the powdered CM5 cell culture medium more
particularly described and claimed in the
patent rights represented by WF code number
PA 1194 which forms part of the Know-how;
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1.1.3. "Cell Line" cell line obtained from the Chinese Hamster
Ovary (CHO) clone CIC2 derived from original
master cell bank CIM 3D44 10.8.90 and the
Master Cell Bank CHO IH 10.11.93 which forms
part of the Know-how;
1.1.4 "Chargeable
Transaction" the use sale or other disposal of a Product
by or on behalf of the LICENSEE, provided
that where such sale or other disposal is
made by or on behalf of the LICENSEE to
another company within its Group for further
sale or disposal then the Chargeable
Transaction shall be the first sale or other
disposal outside that Group provided further
that neither use of Product in clinical
trials nor distribution of Samples as part
of Product promotion shall be deemed
Chargeable Transactions as long as no
consideration is received by the LICENSEE or
any Group Company in relation thereto, and
provided always that if on the sale or
disposal of Product by or on behalf of the
LICENSEE or relevant Group company (as the
case may be) the Product is not in Final
Form then the Chargeable Transaction shall
be the first sale of Product which is in
Final Form;
1.1.5 "the Confidentiality
Undertaking" the written undertaking given by the
LICENSEE in Section 5.3 of this
Agreement;
1.1.6 "Connected Persons" the meaning ascribed by Section 839 of the
Income and Corporation Taxes Xxx 0000 of the
United Kingdom ("UK");
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1.1.7 "Deductions" quantity discounts and bona fide rebates as
part of managed care programs relating (in
both cases) specifically and solely to
Product trade discounts and (where such
items are specifically shown in the invoice)
purchase, sales, import or value Added taxes
and the costs of delivery and insurance, but
not commission or cash discounts;
1.1.8 "the Development Plan" the document set out in Schedule I below
together with each development plan
delivered to LKS pursuant to 4.2.2 below;
1.1.9 "Dollars" US dollars;
1.1.10 "the Effective Date" the date on which this Agreement is made;
1.1.11 "the Exercise Fee" * Dollars * for
exercise of each of the options except that
for exercise of Option I it shall be
* ;
1.1.12 "Final Form" fully formulated, in final form packaged for
ultimate consumer use and suitable for
purchase by a purchaser or distributor who
is not undertaking substantial product
support or marketing, (e.g., a drug
wholesaler, a pharmacist or a group of
pharmacists, a chain of drug retailers or a
hospital or central purchasing department
for a group of hospitals);
1.1.13 "Force Majeure"
1.1.13.1 civil commotion, riot, invasion,
war threat or-preparation for war;
* Confidential treatment requested: material has been omitted and filed
separately with the Commission
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1.1.13.2 fire, explosion, storm, flood,
earthquake, subsidence, epidemic or
other natural physical disaster;
1.1.13.3 impossibility of the use of
railways, shipping, aircraft, motor
transport or other means of public
or private transport;
1.1.13.4 political interference with the
normal operations of the LICENSEE.
1.1.14 "the Glaxo Group" Glaxo Wellcome plc (Co. no. in England
1047315) and, as from time to time, any
Holding Company and any subsidiary of Glaxo
Wellcome plc and any other Subsidiary of
Glaxo Wellcome plc,s Holding Company and
affiliates;
1.1.5 "Group" the LICENSEE (as appropriate in the context)
and, as from time to time, any Holding
Company and Subsidiary of the LICENSEE and
any other Subsidiary of the LICENSEE's
Holding Company and in the case of the
LICENSEE any company fifty per cent owned by
the LICENSEE;
1.1.16 "Holding Company"
and "Subsidiary" the meanings ascribed to them by section 736
of the Companies Xxx 0000 of the UK;
1.1.17 "The Index" the US All Urban Consumer Price Index or if
that Index shall cease to be published the
nearest index having like effect;
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1.1.18 "Inventors" Xxxxxxxxx Xxxxxx Xxxxxxxx, Xx Xxxxxxx Xxxxxx
Xxxxx, Xx. Xxxx Xxxxxxxxx and Xx Xxxxxxx
Xxxx Xxxxxx;
1.1.19 "the Know-how" the technical information and data and
biological materials specified in Schedule 2
and any other information disclosed to the
LICENSEE by LKS pursuant to the
Confidentiality Undertaking;
1.1.20 "Launch Date" the first arm's length sale of Product by
the LICENSEE in a Major Territory following
grant of Regulatory Approval in such Major
Territory;
1.1.21 "the Licenses" the licenses granted or to be granted under
this Agreement
1.1.22 "LICENSEE
Inventions" inventions arising from the LICENSEE's
development of the inventions which are the
subject matter of the Patents and inventions
arising from any such development carried
out for or with the LICENSEE;
1.1.23 "Major Territory" UK, France, Germany, Italy, USA and Japan;
1.1.24 "Net Sales" the aggregate Net Selling Prices of
Chargeable Transactions for a calendar year;
1.1.25 "Net Selling Price" the price of Products the subject of a
Chargeable Transaction calculated as
follows:-
1.1.25.1 in the case of an arm's length
sale the gross price as charged
or
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invoiced, less any Deductions;
1.1.25.2 in the case of a sale which is
not at arm's length or any
disposal other than by sale the
open market price in the country
where the transaction was
effected or the use occurred,
less any Deductions;
1.1.26 "the Options" Option 1, Option 2, Option 3 and Option 4.
1.1.27 "Option 1" the right to insert 'or for ex Vivo bone
marrow purging in humans' before 'which is
made or sold' in the definition of "the
Product" (as varied from time to time);
1.1.28 "Option 2" the right to replace 'propymphocytic
leukaemia or chronic lymphocytic leukaemia'
with 'cancer' in the definition of 'Product'
(as varied from time to time);
1.1.29 "Option 3" the right to insert 'or multiple sclerosis
in humans' before 'which is made or sold' in
the definition of 'Product' (as varied from
time to time);
1.1.30 "Option 4" the right to insert 'or rheumatoid arthritis
in humans' before 'which is made or sold' in
the definition of 'Product' (as varied from
time to time);
1.1.31 "the Option Period" three (3) year period provided for in the
license agreement between LKS and BTG (the
"BTG Agreement");
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1.1.32 "the Patents"
1.1.32.1 the patents and applications for
patents specified in Schedule 3;
and
1.1.32.2 any patent which may be granted
pursuant to any of the above
applications; and
1.1.32.3 any patents and applications
corresponding to such patents
and applications which may be
granted to or made by LKS in
other countries; and
1.1.32.4 any re-issues or extensions of
such patents and any
Supplementary Protection
Certificates in respect of such
patents and any divisions and
continuations of such
applications.
1.1.33. "Product" any product containing Campath I H antibody
for the treatment of propymphocytic
leukaemia or chronic lymphocytic leukaemia
in humans or for such other therapy for
which LICENSEE has exercised its option
under Clause 4.2.1 which is made or sold or
otherwise disposed of, in any country by, or
on behalf of, the LICENSEE, and which
1.1.33.1 falls within the scope of, or
utilizes any method or process
which falls
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within the scope of, any of the
Patents or which incorporates,
or is itself, the invention the
subject of any of the Patents of
that country, or
1.1.33.2 embodies or utilizes any of the
Know-how, or
1.1.33.3 infringes any copyright in the
Know-how.
1.1.34 "Regulatory Approval" full regulatory approval (i.e., marketing
authorization) for sale of Product;
1.1.35 "the Results" all technical data, Know-how, computer
software, notes, chemical compounds,
biological material, models, prototypes,
specimens, drawings, reports and information
arising from the LICENSEE's development of
the inventions which are the subject of the
Patents (and from others' development where
the same is carried out for or with the
LICENSEE) including in particular data
relevant to applications for Regulatory
Approvals, and including the copyright,
design rights and other intellectual
property rights arising therein;
1.1.36 "the Sub-License" a sub-license or any agreement or commitment
for the grant of a sub-license;
1.1.37 "the Sub-License
Terms" those terms set out in Schedule 4;
1.1.38 "Supplementary
Protection
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Certificates" supplementary protection certificates
granted "Certificates" pursuant to Council
regulation (EEC) Xx. 0000/00 ("xxx XXX
Xxxxxxxxxx") and any like certificates
granted by any government, authority or
agency;
1.1.39 "the Territory" the countries of the European Union, USA,
Canada and Japan;
1.1.40 "the Trade Marks" the trade marks specified in Schedule 5;
1.1.41 "WF" The Wellcome Foundation Limited (Co. no. in
England is 194814, registered office at
Glaxo Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx,
Xxxxxxxxx, Xxxxxxxxx XX0 XXX);
1.1.42 "the WF Patents Those of the Patents which have been
licensed (as opposed to assigned) to LKS by
WF;
1.1.43 "Year 1" the calendar year in which Product is first
launched by the LICENSEE, with Year 2 being
the next calendar year (and so on).
1.2 Some of the licenses granted by LKS hereunder are in fact sub-licenses (with
WF owning the relevant patent applications and patents).
2. Payments
2.1 THE LICENSEE shall pay to LKS:-
2.1.1 immediately upon the signing of this Agreement the sum of
* ; and
2.1.2 * on the first anniversary of
the Effective Date; and
2.1.3 * on the second anniversary of
the Effective Date; and
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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2.1.4 * on each subsequent anniversary of
the Effective Date which is prior to the Launch Date; and
2.1.5 * on the earlier of,
2.1.5.1 the date falling four years and six months after the
Effective Date, and
2.1.5.2 the date on which the LICENSEE (or any third party
on behalf of the LICENSEE) files its first
application for Regulatory Approval in a Major
Territory; and
2.1.6 the royalties specified in Clause 6;
2.1.7 the share of downpayments specified in Clause 7.
2.2 THE sums referred to in sub-clause 2.1 shall not be refundable.
2.3 WHEN making any payment under this Agreement the LICENSEE shall also pay any
Value Added Tax payable by LKS. Where the LICENSEE has to pay Value Added Tax
LKS shall provide the LICENSEE with a Value Added Tax invoice in respect of the
relevant payment.
3. Commencement and duration
3.1 THIS Agreement shall come into force on the Effective Date.
3.2 SUBJECT to Clauses 16 and 17:-
3.2.1 the Licenses under the Patents shall continue in force in each
country until all of the Patents of that country have expired;
3.2.2 the Agreement shall continue in force until all of the royalty
obligations have expired after which LICENSEE shall have a fully
paid up, non-cancelable license which is equivalent in scope to that
held by the LICENSEE immediately before the expiry of the said
royalty obligations.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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3.3 THE LICENSEE shall be responsible for obtaining any requisite registration
or governmental approval of this Agreement and of acts to be carried out
pursuant to or in connection with this Agreement (including in particular that
of transferring the Know-how (or part thereof) from the UK to the USA) and the
LICENSEE shall expeditiously take all necessary steps to obtain the same.
4. Licenses and Option Rights
4.1 LKS grants to the LICENSEE on and from the Effective Date:-
4.1.1 Licenses under the Patents to make, have made, use, sell and
otherwise dispose of Products;
4.1.2 licenses for the purposes set out in 4.1.1 above to use:-
4.1.2.1 the Know-how,
4.1.2.2 the copyright in the Know-how,
SUCH licenses are without geographical restriction and, subject to the
fact that the Patents only relate to some countries, are worldwide. Such
licenses are also subject to the terms set forth in Schedule 4 and to the terms
of the agreements between LKS and the Wellcome Foundation Limited set forth in
Schedule 6, attached hereto and made a part hereof and LICENSEE agrees to be
bound by such terms.
4.2 FOR the avoidance of doubt it is declared that the LICENSEE shall not use,
nor allow others to use the biological materials forming part of Schedule 2 for
human use but substances derived from the Cell Lines may be used in humans and
Cell Culture Medium may be used in connection with the preparation of substances
for human use.
4.2.1 LKS grants the LICENSEE the Options.
4.2.2 Subject to the following provisions of this Agreement the LICENSEE
may exercise each of the Options at any time during the Option
Period except when it is in breach of its obligations under this
Agreement by simultaneously:-
4.2.2.1 giving notice of exercise to LKS; and
4.2.2.2 making payment of the Exercise Fee to LKS; and
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4.2.2.3 delivering a development plan to LKS, with such
development plan to be for the relevant indication, to
be similar in form and detail to the document set out in
Schedule I and to contain development timescales
consistent with those set out in the said document; and
4.2.2.4 making payment of all outstanding sums (if any) due
to LKS under this Agreement.
4.2.3 In the exercise of each of the Options time shall be of the essence.
4.3 THE licenses under the Patents of Schedule 3 Part A (and under the related
applications and patents failing within 1.1.32.2, 1.1.32.3 and 1.1.32.4 of the
definition "the Patents") shall be exclusive. The rest of the Licenses shall be
non-exclusive. The exclusivity referred to above shall be qualified by (and
subject to):-
4.3.1 the right of each member of the Glaxo Group to use any stocks of
Campath IH remaining after the transfer of the Know-how to LKS for
general research and development purposes which shall exclude
clinical development and subsequent commercialization; and
4.3.2 the right of each member of the Glaxo Group to retain stocks of
Campath I H for supply of Carnpath I H to those patients to whom any
member of the Glaxo Group has obligations to under existing clinical
protocols; and
4.3.3 the right of the Inventors to carry out non-commercial work in
relation to that Campath I H which is produced by the cell line
which they originated and which is known as TF57:19; in the event
such research produces a cell line which produces a humanized
antibody with the same specificity as Campath IH, and such cell line
and the intellectual property rights related thereto are assigned to
LKS then LKS shall notify the LICENSEE of such assignment and (on
request by the LICENSEE) such cell line and intellectual property
right shall be licensed to the LICENSEE hereunder, (and form part of
the Patents or the Know-how as appropriate).
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4.4 WITHOUT prejudice to Clause 3.2 the Licenses are granted for the purpose
only of making, having made, using, selling and otherwise disposing of Products
during the life of this Agreement. These rights shall not be used thereafter or
otherwise unless and until the Know-how has come into the public domain
otherwise than through breach or default of the LICENSEE or the Copyright has
expired.
4.5 LKS shall, at the request and expense of the LICENSEE, execute any further
formal document which may be necessary to give effect to this Agreement in any
country. Until such license shall be granted formally, this Agreement shall take
effect as a license.
4.6 THE LICENSEE acknowledges that LKS, BTG and WF have the right to review and
discontinue those of the Patents which they respectively own or beneficially own
provided that as regards those of the Patents owned/beneficially owned by LKS
for countries in the Territory LKS shall notify the LICENSEE prior to
discontinuance/ abandonment. After any such notification, and subject to the
existing rights of the Inventors and other prior owners of such of the Patents,
LKS shall allow the LICENSEE to continue the Patents the subject of the
discontinuance/notification notice, with such continuance to leave LKS as owner,
and to-be at the LICENSEE's cost.
5. Know-how
5.1 TO the extent to which it has not already done so, the LICENSEE shall
arrange, and pay the cost of and be responsible for, copying, shipment to the
LICENSEE and storage of the Know-how and such shipment shall be at the
LICENSEE's risk.
5.2 THE LICENSEE may, in appropriate circumstances, but in its sole discretion,
consult the Inventors regarding the design, conduct and results of clinical
trials and give due weight to their views.
5.3 THE LICENSEE shall keep the Know-how confidential to the LICENSEE, and to
such of its officers and employees as are bound by obligations of confidence and
need to be informed, and shall ensure that the Know-how is not disclosed to
others orally or in writing, save to the extent that the Know-how:-
5.3.1 as evidenced by the LICENSEE's written records, was lawfully known
to the LICENSEE prior to its communication by or through LKS, BTG or
WF and was not communicated
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to the LICENSEE subject to any restrictions on disclosure or use; or
5.3.2 is necessarily disclosed by the sale of Products embodying any of
the Know-how; or
5.3.3 is or becomes in the public domain, otherwise than by any default of
the LICENSEE, or persons acquiring the same from the LICENSEE; or
5.3.4 becomes known to the LICENSEE by the action of a third party not in
breach of any obligation of confidence.
6. Royalties
6.1 SUBJECT to clauses 6.2 and 6.3 below the LICENSEE shall pay to LKS in
respect of Products the subject of Chargeable Transactions and as provided in
Clause 17.2 on Products held on termination, a royalty at the rate of * on the
Net Selling Price.
6.2 IF, in transactions where the LICENSEE itself is making the Chargeable
Transaction, the following apply:
6.2.1 the LICENSEE is paying patent royalties to a third party/third
parties; and
6.2.2 that third party or those third parties (as the case may be) is
not/are not member(s) of the LICENSEE's Group, or a Connected
Person(s) of the LICENSEE; and
6.2.3 such patent royalties are paid under an arm's length bona fide
license; and
6.2.4 those patent royalties are for rights which are essential for the
exploitation of Product; and
6.2.5 the sum of such patent royalties with characteristics 6.2.1 to 6.2.4
above, ("Other Royalties") and the royalties payable to LKS under
clause 6.1 above would in total amount to more than * on the Net
Selling Price for that Chargeable Transaction
then the royalty to be paid to LKS on that Chargeable Transaction shall be
reduced by * of the amount that such Other Royalties are above
*Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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* provided that in no event shall the royalty rate payable to LKS be reduced
under this Clause 6.2 below * . (By way of illustration if Other Royalties
equal * then the royalty rate payable to LKS would be * , if Other Royalties
equal * then the royalty rate payable to LKS would be *.
6.3 ROYALTY shall be payable in each country for a period of twenty years from
the Effective Date. Thereafter royalty shall only be payable in respect of
Products (the subject of Chargeable Transactions) which are such by reference to
1.1.33.1 of the definition "Product" but not 1.1.33.2 or 1.1.33.3.
6.4 ROYALTY shall only be payable once in respect of the same Product.
6.5 THE LICENSEE shall at the request of LKS provide half-yearly forecasts of
the amount of royalties likely to be payable under this Agreement but whilst
such forecasts (or the like) may be adopted and utilized by LKS for the purposes
of Clause 16.5 the LICENSEE shall not be liable in damages to LKS for any
inaccuracies in such forecasts.
6.6 THE LICENSEE shall be entitled to credit against royalties the amount of the
royalty paid on any Products the subject of Chargeable Transactions which are:-
6.6.1 subsequently returned to the LICENSEE or Group Company (as the case
may be) in exchange for a refund or credit and not then re-sold or
disposed of again, (other than by destruction); or
6.6.2 destroyed after a refund or credit has been given.
6.7 IF in relation to any accounting period and in any country in which there is
no extant patent forming part of the Patents LICENSEE demonstrates to LKS's
reasonable satisfaction that a competitor or competitors, (i.e. a company which
is not part of LICENSEE's Group) is/are selling Campath IH products, (which
would fall within the definition PRODUCT but for-being sold by the competitor or
competitors), then the appropriate royalty rate on sales in the country in
question shall be reduced for that accounting period if the market share of the
competitor(s) amounts to more than * of the total market for PRODUCTS (and
exact equivalents) in that country. The reduced royalty shall be the appropriate
fraction shown in the second
*Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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column below of the royalty rate normally payable (but for the application of
this clause 6.8)
Market share of Competitor(s)
(based upon sales value in the
relevant accounting period) Fraction
* *
* *
* *
* *
Notwithstanding the above, in no case shall the royalty rate be less than *.
7. Downpayments from Third Parties
7.1 THE LICENSEE shall pay LKS fifty per cent (50%) of the following:-
7.1.1 each lump sum payment, (as opposed to royalties paid as a
consequence of actual sales), received by the LICENSEE (or by any
Connected Person of the LICENSEE or member of the LICENSEE's Group)
from a third party in connection with the grant of a distribution or
any other right under or in respect of Products; and
7.1.2 the cash equivalent of each non-cash benefit, (not in respect of
actual sales of Products), received by the LICENSEE or by any
Connected Person of the LICENSEE or member of the LICENSEE's Group
from a third party in connection with the grant of a distribution or
any other right under or in respect of Products.
Provided that the foregoing shall not apply to bona fide payments to the
LICENSEE which are solely for services provided by the LICENSEE or which are
solely for equity in the LICENSEE.
7.2 THE LICENSEE shall, within thirty(30) days of receipt by the LICENSEE (or by
the Connected Person or Group member) of each such lump sum payment, or non-cash
benefit, notify LKS of and provide full details of such lump sum payment,
(7.1.1)), and non-cash benefit, (7.1.2)). At the same time as the LICENSEE gives
LKS such notification the LICENSEE shall pay LKS the sum or sums due.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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7.3 WITH regard to non-cash benefits, the LICENSEE shall make its own valuation
but LKS may challenge such valuation in writing. Similarly, where a payment is
received by the LICENSEE (or by any Connected Person of the LICENSEE or member
of the LICENSEE's Group) from a third party, and such payment relates to equity
in the LICENSEE as well as rights under or in respect of Products, then the
LICENSEE shall apportion the payment between the two elements but LKS may
challenge the apportionment if it feels that the figure allocated to the equity
does not reflect the true open market value of the equity and includes a premium
above that ("Premium"). On receipt of either type of challenge the LICENSEE
shall promptly obtain an independent auditor's certificate specifying the
valuation made by the auditor. Both parties shall abide by the auditor's
certificate and shall rectify any overpayment or underpayment (as the case may
be). Where the auditor finds that there is a Premium the Premium (but not the
non-Premium payment for the equity) shall be subject to the above revenue
sharing arrangements.
8. Accounting for Royalties
8.1 THE LICENSEE shall:-
8.1.1 keep true and detailed accounts and records of all royalties and
other sums due under this Agreement:
8.1.2 within forty-five days after the last day of March, June, September,
and December in each year deliver to LKS a statement of all
royalties and other sums due for the three month period ending on
such date showing separately the Chargeable Transactions in each
country, credits under Clause 6.7 and (where relevant), the rate of
exchange used or, if it be the case, a statement that no royalties
are due;
8.1.3 send with the above statement the amount shown to be due;
8.1.4 immediately and without demand send to LKS the difference between an
amount already paid and the correct amount shown to be due and
payable as a result of verification under Clause 10.
8.2 ON termination or expiry, the final statement shall be delivered within
thirty days of termination or expiry and shall include details of royalties on
all Products being manufactured and all Products manufactured but not yet
disposed of.
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8.3 IF the LICENSEE defaults in payment of the royalties and other sums due
within the period stated above, the amount due shall bear interest, accruing
from day to day, at the rate per annum of Four per cent (4 %) above the Base
Rate for the time being of the National Westminster Bank p.l.c.
9. Currency and Taxes
9.1 ALL payments shall be made in Dollars in Cambridge, MA. Any necessary
currency conversion shall be at the rate at which English bank transfers are
made on the last business day of the period to which the relevant sales and
royalty statement relates.
9.2 PAYMENTS shall be made without deduction, other than such amount AS the
LICENSEE is required to deduct or withhold by law. In regard to any such
deduction, the LICENSEE shall use all reasonable endeavors to assist LKS to
claim recovery or exemption under any double taxation or similar agreement.
Evidence as to the payment of such tax or sum withheld shall, on request, be
given by the LICENSEE to LKS.
10. Verification
10.1 THE LICENSEE shall permit any authorized representative appointed by LKS,
upon reasonable notice, access to the premises of the LICENSEE and access to the
accounts, records and relevant documentation of the LICENSEE and shall provide
such information and explanations as the representative shall require to verify
the statements and to satisfy LKS that the financial and accounting provisions
of this Agreement are being complied with. The representative shall also be
permitted to take copies of extracts pertinent to the verification. If the
verification discloses an underpayment to LKS of more than 10% of the amount due
the LICENSEE shall promptly on demand reimburse LKS the fees and costs of the
representative, and the reasonable costs incurred by LKS in respect of the
verification.
10.2 LKS shall keep confidential any information which it may acquire in the
exercise of its rights under this Clause 10 with the exception of information
which was already lawfully known to it, or to which LKS is required to disclose
by law, or which is or becomes in the public domain otherwise than by any
default of LKS.
11. Suspension of royalties
IF any of the following events shall occur in respect of the Patents:-
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11.1 any patent application is finally refused so that the grant of a
patent thereon is unobtainable; or
11.2 any patent application is abandoned or withdrawn; or
11.3 any patent lapses; or
11.4 any patent is declared invalid or unenforceable by a court or
tribunal of competent jurisdiction;
then the royalties -payable solely in respect of such patent application or
patent shall cease after the date of the relevant event, but LKS shall be
entitled to all sums which shall have then already fallen due, and whether paid
or unpaid at such date. If such patent application is reinstated or such patent
is restored or is subsequently established as being valid and enforceable,
royalties shall again become payable, together with all royalties which would
have been payable if the relevant event had not occurred.
12. Undertakings by the LICENSEE
THE LICENSEE:-
12.1 shall not use the Campath lH transferred pursuant to this Agreement
for human therapeutic administration;
12.2 shall not at any time make any use of the Know-how other than for
the purposes of the Licenses-,
12.3 shall have full control, authority and responsibility for
development, registration and commercialization of Products and
shall use all reasonable efforts and diligence in development
registration and commercialization of Products (and the efforts of
sub-licensees, members of the LICENSEE's Group and collaborators
shall be considered as efforts of the LICENSEE in this regard);
12.4 shall deliver to LKS at intervals of six months short summary
written reports on the development and regulatory work carried out
by and for the LICENSEE in relation to Products during the preceding
six months, and the LICENSEE shall arrange for its staff to answer
any reasonable questions LKS may raise on such reports with such
question and answer
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sessions to be either on the telephone or at a meeting (as
reasonably requested by LKS);
12.5 shall use all reasonable endeavors to promote the distribution and
sale of Products and will use all reasonable endeavors to procure or
make available necessary selling and manufacturing facilities to
meet demands for Products;
12.6 shall use all reasonable endeavors to maximize the demand for
Products;
12.7 undertakes to LKS that when selling Product as part of a package
with other products the LICENSEE shall ensure that it does not favor
the other products, or discriminate against Product, in terms of
pricing, discounts, or in any other way which would adversely affect
the royalties due to LKS under this Agreement.
13. Marking
THE LICENSEE shall legibly xxxx the Products or, if not practicable, then
any associated packaging or literature, with the relevant patent or application
number.
14. Supplementary Protection Certificates
14.1 THE LICENSEE shall use its reasonable endeavors to promptly take all
necessary steps to facilitate LKS's application for a Supplementary
Protection Certificate or Certificates and patent
extensions in respect of Products.
14.2 IN particular, but without limitation, the LICENSEE shall:-
14.2.1 promptly notify LKS of the number and date of the first
and any subsequent authorization to place Products on the
market;
14.2.2 promptly and free of charge provide to LKS:-
14.2.2.1 a copy of every authorization fulfilling the
requirements of Article 8.1(b) of the SPC
Regulation (and of any additional applicable
requirements imposed by
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relevant national law) in respect of all Products;
14.2.2.2 additional information fulfilling the requirements
of Article 8.l(c) of the SPC Regulation and a copy
of the notice publishing the authorization in the
appropriate official publication (and information
and documents fulfilling any additional
requirements imposed by relevant national law)
14.2.3 permit use of documents and information provided pursuant
to this clause for the purpose of such application for a
Supplementary Protection Certificate or Certificates
14.3 LKS shall notify the LICENSEE of the application for and grant of every
Supplementary Protection Certificate in respect of Products.
14.4 LKS shall not be obliged to apply for grant of any Supplementary
Protection Certificates.
14.5 FOR the avoidance of doubt the LICENSEE shall not be entitled to make an
application for or participate in negotiations for grant of any Supplementary
Protection Certificate.
15. Exclusion of liability; Indemnity
15.1 LKS warrants and represents that it has the full right and authority to
enter into this Agreement and is not aware of any impediment which would inhibit
its ability to perform the terms and conditions imposed on it by this Agreement.
15.2 SAVE as expressly stated herein, no representation condition made or
given by or on behalf of LKS. All conditions and warranties, arising by
opinion of law or otherwise:-
15.2.1 to the effect that any of the Patents or copyright in the
Know-how, are valid or enforceable, or
15.2.2 to the effect that any of the acts hereby licensed or agreed to be
licensed by LKS will not infringe the rights of third parties; or
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15.2.3 in relation to the provision or use of the Know-how or its
fitness for purpose, accuracy or completeness;
are hereby expressly excluded.
15.3 LKS shall be under no liability whatsoever to the LICENSEE (whether in
negligence or otherwise, in contract or in tort) for any expense, loss, death,
damage or injury of any kind (including any loss of profit or consequential
damage) sustained by the LICENSEE or any third party which arises directly or
indirectly from any cause or circumstance referred to in Clause 15.4 below.
15.4 THE LICENSEE shall indemnify LKS and its licensors, including BTG and WF,
against all claims and actions by and all damages awarded to any third person
against LKS (and any related costs and expenses) which arise directly or
indirectly from:-
15.4.1 the development, manufacture, use, storage, sale or disposal of
Products; or
15.4.2 the use of the Patents or the said Copyright; or
15.4.3 the provision, evaluation or use of the Know-how; or
15.4.4 any technical or other advice given by LKS or any of its officers,
employees or agents to the LICENSEE or from any reliance by the
LICENSEE or any third party thereon.
LICENSEE's indemnification hereunder shall not apply to any damages that are
directly attributable to the intentional misconduct or negligence of LKS.
LICENSEE shall have the right to control the defense, settlement or compromise
of any action to which this indemnity applies, but shall not act in any way
which may or does do material adverse damage to LKS's or BTG's name or
reputation. LKS shall notify LICENSEE promptly of any claim or threatened claim
and shall cooperate with all reasonable requests of LICENSEE with respect
thereto.
15.5 UPON the initiation of Clinical trials with Products and for two (2) years
after termination of this Agreement the LICENSEE shall, at its own cost effect
and maintain in force with reputable insurers, adequate insurance in respect of
the development, storage, manufacture, use and supply of Products and shall
provide evidence of such insurance to LKS on request. Any consequent policy
shall name LKS as additional insured; waive any right of subrogation of the
insurers against LKS; be primary
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and without right of contribution from other insurance which may be available to
LKS; prohibit any alteration adversely affecting LKS's interest in the insurance
(or any alteration inconsistent with the requirements of Clause 15); prohibit
the lapse of or any cancellation or non-renewal of such insurance, without the
prior consent in writing of LKS. In the event a court determines that the
LICENSEE has failed to meet its obligation to obtain or maintain adequate
insurance, LKS may terminate this Agreement provided however that this Agreement
may not be terminated on this ground unless the LICENSEE has been given at least
ninety (90) days to cure such failure and has failed to do so.
16. Termination
16.1 THE LICENSEE may, at any time, terminate this Agreement, by giving not less
than 120 days notice to that effect. In such notice the LICENSEE must specify
whether it is terminating on account of breach by LKS, and, if it is, must give
details of that breach.
16.2 LKS may terminate this Agreement, or any of the Licenses forthwith, by
notice to the LICENSEE, upon the happening of any of the following events:-
16.2.1 if any royalties or other sums payable remain unpaid for thirty
days after the due date, or
16.2.2 if the LICENSEE is in breach of any of the other terms or
obligations of this Agreement, and such breach is not capable of
remedy;
16.2.3 if the LICENSEE is in breach of any of the terms or obligations
of any of LKS agreements with WF and BTG;
16.2.4 if in the United Kingdom the LICENSEE has a Receiver or an
Administrative Receiver or Administrator appointed of the whole,
or any part, of its undertaking or assets, or in any other
country has an officer appointed to perform a function analogous
to that of a Receiver, Administrative Receiver or Administrator;
16.2.5 if an order is made, or a resolution passed, for winding-up or
administering the LICENSEE, unless such order or resolution is
part of a scheme of solvent reconstruction of the LICENSEE.
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16.2.6 if LICENSEE is dissolved or otherwise ceases to do business.
16.3 IF the LICENSEE is six months or more behind schedule on any milestone (for
any indication) as per the Development Plan then LKS as its sole and exclusive
remedy for such delay may serve on the LICENSEE a notice of termination of this
Agreement and that notice shall have automatic effect six months after the date
of service, unless within that period the LICENSEE shall have achieved the
relevant milestone, provided that LKS shall not unreasonably refuse a request
for the remedy period to be extended beyond six months where the delay is due
(wholly or partly) to an event of Force Majeure, or for other reasons beyond the
control of the LICENSEE.
16.4 IF the LICENSEE is in breach of any of the terms or obligations of this
Agreement, other than the cases referred to in sub-clauses 15.4, 16.2 and 16.3,
and such breach is capable of remedy. LKS may serve on the LICENSEE a notice of
termination of the Agreement and that notice shall have automatic effect thirty
days after the date of service, unless within that period the LICENSEE shall
have remedied the breach.
16.4.1 LICENSEE shall, no later than 15th June of Year 3 produce Net
Sales forecasts for Years 3 to 5 inclusive: and thereafter
LICENSEE shall no later than 15th December of Year 5 and then
no later than 15th December of each subsequent third Year
produce Net Sales forecasts for the following three Years (so
that an uninterrupted stream of Net Sales forecasts are
produced). The LICENSEE shall deliver each three Year set of
Net Sales forecasts co LKS within one week of them being
produced.
16.4.2 LKS shall have the right to terminate this Agreement forthwith
on notice to the LICENSEE if the aggregate Net Sales for Years
3 to 5 inclusive do not match or exceed twenty five per cent
(25%) of the aggregate Net Sales forecasts for those Years.
Thereafter LKS shall have the right to terminate this
Agreement forthwith on notice to the LICENSEE if the aggregate
Net Sales for any two years, (the first two being Years 5 and
6, and the next Years 6 and 7), do not match or exceed forty
per cent (40%) of the aggregate Net Sales forecasts for the
two Years in question.
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16.4.3 IF LKS believes, in good faith, that any such forecast does
not represent a reasonable assessment of the likely future
sales, the parties shall endeavor to find a mutually
acceptable revision of the forecast. If the parties cannot
determine such mutually acceptable resolution, LKS shall
submit the dispute to a mutually acceptable third party expert
for a final and binding forecast, and the cost of such expert
shall be equally shared by the parties.
17. Rights on termination
17.1 TERMINATION (or expiry) of this Agreement shall be without prejudice to any
rights of either party against the other which may have accrued up to the date
of termination.
17.2 ON termination (or expiry) of this Agreement for whatever cause, the
LICENSEE shall pay to LKS royalty in respect of all Products being manufactured
at the date of termination and all Products manufactured and not yet sold. The
LICENSEE shall then be free to sell or dispose of Products on which royalty has
been paid.
17.3 TERMINATION (or expiry) of this Agreement for any reason shall not bring to
an end:-
17.3.1 the confidentiality obligations of Clause 5.3 until the Know-how
shall have come into the public domain otherwise than through the
breach or default of the LICENSEE;
17.3.2 the obligations of the LICENSEE in respect of the accounting for,
payment of and verification of royalties and other payments under
Clauses 6, 7, 8, 9, 10 and 17.2 until the settlement of all claims
of LKS;
17.3.3 the provisions of Clause 15.
17.4 ON early termination the LICENSEE:-
17.4.1 shall/shall procure transfer to LKS or destruction (at LKS's
option, and in the former case at LKS's expense) of the Know-how
(and all copies and derivatives) in the possession of the
LICENSEE's Group; and
17.4.2 shall (at LKS's request) assign the Trade Marks to LKS; and
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17.4.3 except where the termination is for breach by LKS grant to LKS or
where necessary procure that others grant to LKS irrevocable
non-exclusive licenses under:-
17.4.3.1 each of those LICENSEE Inventions which is an
improvement invention to one or more of the
inventions the subject of the Patents, and all
patent applications and patents relating thereto
for which the LICENSEE has the benefit; and
17.4.3.2 the Results.
The license in respect of the Results shall permit use of the Results in
applications for regulatory clearance and such licenses (generally) shall be to
make, use, sell and otherwise dispose of products failing within the scope of
the claims of any of the applications or patents for the LICENSEE Inventions, or
which utilize the Results, and shall include full Sub-licensing rights and shall
continue, in the case of the LICENSEE Inventions until all of the applications
and patents relating thereto have ceased to subsist, and in the case of the
Results until all the same have fallen into the public domain (other than
through the LICENSEE's default). The license in respect of the Results shall
include the physical transfer of the Results (or copies) by the LICENSEE to LKS,
at LKS's expense.
17.5 IF the Agreement is terminated by the LICENSEE then, unless the LICENSEE
can prove to LKS's satisfaction (considered in good faith by LKS) that
termination was on the grounds of efficacy or safety, (and here LKS will
consider the LICENSEE's results from trials and studies), then the LICENSEE
shall pay LKS the next two annual payments (under 2.1.2 to 2.1.4) which would
have been payable but for termination (and any such payments already outstanding
on the date of termination shall be disregarded for these purposes).
18. Indexation
THE sums referred to in Clause 2.1.2 to 2.1.4 (inclusive) shall be adjusted
to account for increases in the Index which are above * in any calendar year.
Each tine there is an annual increase above * the sums shall be increased by the
percentage increase above * (such increase being in addition to any previous
increase hereunder).
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
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19. Legal Proceedings
If the LICENSEE contemplates legal proceedings against a third party under
one or more of the WF Patents, it shall first give reasonable notice to LKS and
WF. The LICENSEE shall take reasonable account of any concerns that WF and the
Glaxo Group have where such concerns are notified in writing to the LICENSEE
(whether directly or through LKS) and the LICENSEE shall give reasonable
consideration to any alternative strategies that WF or any member of the Glaxo
Group may propose in writing prior to commencement of the relevant action. WF
and the members of the Glaxo Group shall have the right: but not the obligation
to join the LICENSEE in any such legal proceedings.
20. Miscellaneous
20.1 THE LICENSEE shall not assign, charge or otherwise dispose of any of its
rights or obligations under this Agreement, or any of the Licenses.
20.2 Pursuant to the terms and conditions set forth in Schedule 4, the LICENSEE
may grant sub-licenses with the consent of LKS which consent shall not be
unreasonably withheld.
20.3 THE failure by either party to exercise or enforce any rights under this
Agreement shall not be deemed to be a waiver of any such rights, nor shall any
single or partial exercise of any right, power, or privilege, or further
exercise thereof, operate so as to bar the exercise or enforcement thereof at
any later time.
20.4 THE waiver by either party of any breach of any of the terms of this
Agreement by the other shall not be deemed to be a waiver of any other breach of
the Agreement.
20.5 IF any part or provision of this Agreement is prohibited, or rendered void
or unenforceable, by any legislation, the validity or enforceability of the
Agreement as a whole or of any other part of this Agreement shall not be
affected.
20.6 SUBJECT to Clause 16.3 the rights and remedies provided in this Agreement
are cumulative and not exclusive of any rights or remedies provided by law or in
equity.
20.7 FOR the avoidance of doubt it is declared that it is understood that the
Trade Marks will be assigned to the LICENSEE as of the Effective
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Date; it being further understood that it is entirely the LICENSEE's
responsibility to obtain the documentation necessary to accomplish such
assignment directly from LKS and/or WF and affiliates.
21. Notices
21.1 ANY notice authorized or required to be given by either party under
this Agreement to the other party, shall be in writing. and shall be
deemed to be duly given if left at, or sent by recorded delivery or
registered post addressed to:-
21.1.1 in the case of LKS, the address of LKS at the head of the
Agreement, unless notice of change has been given to
LICENSEE, in writing; and
21.1.2 in the case of the LICENSEE the address of the LICENSEE at
the head of this Agreement, unless notice of change has been
given to LKS, in writing.
21.2 ANY notice, if sent by post, shall be deemed to have been served at the
expiration of three days after posting.
22. Law and Jurisdiction
22.1 THIS Agreement is to be read and construed in accordance with. and
governed by, English law.
22.2 THE LICENSEE submits to the jurisdiction of the English Courts and to the
Courts of the Commonwealth of Massachusetts, USA.
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I N W I T N E S S whereof this document has been executed as a Deed,
pursuant to English law, the day and year first above written.
LEUKOSITE, INC. L & I PARTNERS, L.P.
By: L & I, L.L.C.
General Partner
_______________________________ ______________________________
, President , President
_______________________________ ______________________________
, Secretary , Secretary
