1
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"
1.1.2 "Cell Culture Medium"
2
-2-
1.1.3. "Cell Line" cell line obtained from the *******
***********************************
***********************************
***********************************
***********************************
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");
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
3
-3-
1.1.7 "Deductions" ***********************************
***********************************
******** relating (in both cases)
specifically and solely to Product
***********************************
***********************************
***********************************
***********************************
**********************, but not
***********************************;
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 ***************
***********************************
***********************************
**********;
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.
4
-4-
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;
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
5
-5-
1.1.18 "Inventors" Xxxxxxxxx Xxxxxx Xxxxxxxx,
Dr Michael Xxxxxx Xxxxx, Xx. Xxxx
Riechmann 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 *********
********************
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
6
-6-
********, 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
*************************
*************************
*************************
*******************, 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 '**************
***********************************'
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
'**********************************
******************************' with
******** in the definition of
'Product' (as varied from time to
time);
1.1.29 "Option 3" the right to insert '***********
*******************' 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 '*************
*******************' before 'which
is made or sold' in the definition
of 'Product' (as varied from time
to time);
1.1.31 "the Option Period" ************** period provided for
in the license agreement between
LKS and BTG (the "BTG Agreement");
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
7
-7-
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
correspon-ding 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 **************
********* or *******************
********* 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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
8
-8-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
9
-9-
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.
10
-10-
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 ************************* 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 *************** payable by LKS. Where the LICENSEE has to pay *****
********** LKS shall provide the LICENSEE with a *************** 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 *******
************************************************ have expired;
3.2.2 the Agreement shall continue in force until ******************
************************ after which LICENSEE shall have *
************************************* which is equivalent in
scope to that held by the LICENSEE immediately before the
****************************************.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
11
-11-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
12
-12-
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 *******; 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).
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
13
-13-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
14
-14-
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.
15
-15-
******************* 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 ********************** 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 ************
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.
16
-16-
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 ******************** 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.
17
-17-
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.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
18
-18-
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 ******************* 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 *** 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:-
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
19
-19-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
20
-20-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
21
-21-
by 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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
22
-22-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
23
-23-
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 ***
***************************************. 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.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
24
-24-
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 ********************
***** 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 ******
************** of the aggregate Net Sales forecasts for the
two Years in question.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
25
-25-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
26
-26-
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 ***********************
***************************************************, and in the case of the
Results until *********************************************** (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.
27
-27-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
28
-28-
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.
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
29
-29-
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
* Confidential treatment requested: material has been omitted and filed
separately with the Commission.
30
BDG LLP DRAFT
6/25/97
ACQUISITION AND DEVELOPMENT
CLOSING AGENDA
WINTER STREET OPCO, L.L.C.
MASSACHUSETTS MEDICAL SOCIETY
CLOSING DATE: JUNE 26, 1997
DOCUMENT RESPONSIBILITY STATUS
-------- -------------- ------
(1) Property Acquisition and BDG In Progress
Development Agreement
Exhibit A: Legal Description of BDG Copy from P+S
--------- Land
Exhibit B: Development Approvals BDG Copy from P+S
---------
Exhibit C: ANR Plan BDG Received
---------
Exhibit D: Form of Winter Street BDG Done
--------- Realty Trust Declaration
of Trust
Exhibit E: XXXXX Term Sheet LM In Progress
---------
Exhibit F: Form of Rights of First R&G Done
--------- Offer Agreement
Exhibit G: Form of Site LM In Progress
--------- Development
Management Agreement
Exhibit H: Form of Building LM In Progress
--------- Development
Management Agreement
Exhibit I: Designated LM Need MMS Reps
--------- Representatives
Exhibit J: Purchase Xxxxx XX In Progress
--------- Adjustment
31
DOCUMENT RESPONSIBILITY STATUS
-------- -------------- ------
Exhibit K: Polaroid Siting Plan BDG Received
---------
Schedule 3.2: Schedule of Third XX Xxxx Xxxxx is
------------ Party, Out of Pocket preparing
Due Diligence
Expenses
Schedule 8.4: Illustration of EYKL Xxxx Xxxxx is
------------ Sitework preparing
Savings/Building
Costs and Building
Savings/Sitework
Costs
Schedule 8.5: Illustration of "Truing EYKL Xxxx Xxxxx is
------------ Up" Concept preparing
(2) Rights of First Offer Agreement R&G Done
(a) Xxx 0
(x) Xxx 0
(x) Xxx 0
(x) Xxx 0
(3) Site Development LM Post-Closing
Management Agreement
(4) Building Develop ment LM Post-Closing
Management Agreement
(5) Development Rights Owners BDG Post-Closing
Agreement
(6) XXXXX BDG Post-Closing
32
DOCUMENT RESPONSIBILITY STATUS
-------- -------------- ------
(7) Winter Street Realty Trust BDG Draft of each done
(a) Declaration of Trust
(b) Schedule of
Beneficiaries
(c) Trustee Certificates (2)
(d) Designation of
Beneficiaries (2)
(8) Winter Street Realty Trust BDG Not yet done
(a) Declaration of Trust
(b) Schedule of
Beneficiaries
(c) Trustee Certificate
(d) Designation of
Beneficiaries
(9) MMS Real Estate Trusts A + B R&G In progress
(a) Declaration of Trust
(b) Schedule of
Beneficiaries
(c) Trustee Certificate
(d) Designation of
Beneficiaries
(10) No Consideration Quitclaim R&G Done
Deeds
(i) Lots 1 & 2 = (MMS or
Nominees)
(ii) Xxxx 0 & 0 x (XXX xx
Xxxxxxxx)
(11) Winter Street OpCo, L.L.C. BDG/Xxxxxx Xxxx In progress
Creation/Authority Documents
(12) MMS Winter Street, L.L.C. R&G In progress
33
DOCUMENT RESPONSIBILITY STATUS
-------- -------------- ------
(13) Title Insurance BDG/R&G Commitments
Received
(i) Parcel B
(ii) Lots 1 & 2
(iii) Lots 3 & 4
(14) Title Insurance Affidavits BDG Circulated to
Polaroid
(i) Mechanics Lien
(ii) PIP
(iii) Gap
(15) Survey BDG/R&G Draft Received
(16) Escrow Instruction Letter BDG/R&G Not yet done
(17) Settlement Statement BDG/R&G Not yet done
(18) Wire Instructions BDG Received
(19) Overnight Investment BDG/R&G Not yet done
Instructions
34
BDG LLP DRAFT
6/25/97
RECORDING ORDER
(1) ANR Plans
(2) Easement Plan
(3) MLCs
(4) Declaration of Trust
(5) Authority Documents
(6) Quitclaim Deed
(7) Easement
(7.5) [Rights of First Offer]
(8.) MMS Authority Documents
(9.) MMS Deed
(10.) New Trust/Declaration of Trust
(11.) New Trust Deed
