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EXHIBIT 10.13
MATERIAL RELEASE AGREEMENT
THIS AGREEMENT is made as of the 30th day of September 1996 BETWEEN THE WELLCOME
FOUNDATION LIMITED of Glaxo Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxxx XX0 ONN, England trading as GLAXO WELLCOME RESEARCH AND DEVELOPMENT
(hereinafter called "WELLCOME") and LEUKOSITE, INC. of 000 Xxxxx Xxxxxx, Xxxxxx,
XX 00000, XXX (hereinafter called "LEUKOSITE").
WHEREAS:
A. WELCOME has executed a Heads of Agreement with British Technology Group
Limited of even date hereof following its decision not to pursue its
further development of Campath 1H, concerning inter alia the transfer
of certain patents, cell culture medium, know how, cell line, drug
substance and drug product relating to an anti CD52 humanized
monoclonal antibody called Campath 1H which is produced from a cell
line obtained from the Chinese Hamster Ovary clone.
B. LEUKOSITE has executed a Heads of Agreement with British Technology
Group Limited of even dated hereof concerning its appointment as a
sublicensee of BTG in respect of the continued development and intended
commercialization of Campath 1H aforementioned in Recital A hereto.
C. Following signature of both the aforementioned Heads of Agreement and
conditional upon the Intended Agreements to be finally executed by both
Wellcome and Leukosite respectively with BTG, WELLCOME is agreeable to
releasing certain Critical Information to Leukosite in accordance with
the provisions of this Agreement.
D. LEUKOSITE intends to enter into an agreement with BTG relating to the
commercial exploitation of Campath 1H by LEUKOSITE and WELLCOME intends
to transfer Campath 1H to BTG who intend thereafter to sub-license the
rights to LEUKOSITE.
NOW THEREFORE, in consideration of the covenants and conditions herein
contained, THE PARTIES HEREBY AGREE AS FOLLOWS:
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1. DEFINITIONS AND INTERPRETATION
1.1 The following capitalized terms shall have the following
meanings in this Agreement unless the context required
otherwise.
1.1.1 "Agreement" means the Material Release Agreement
between The Wellcome Foundation Limited and Leukosite
Inc. respectively.
1.1.2 "Affiliate" means any company that is the holding
company, subsidiary or a subsidiary of the holding
company in question, as those term defined in Section
736 of the Companies Xxx 0000.
1.1.3 "Critical Information" means the material and
information listed in Annex I to this Agreement.
1.1.4 "Intended Agreements" means the sub-license agreement
between BTG and Leukosite and the agreement between
BTG and The Wellcome Foundation Limited concerning
the transfer to BTG of the Campath 1H Programme.
1.1.5 "Specified Purpose" means the evaluation of the
Critical Information by a sub-contractor of LEUKOSITE
of the sub-contractors manufacturing equipment and
techniques and which evaluation shall be limited to
assessment of cell growth productivity and stability
of expression, assessment of the purification system
and characterization of the antibody with a view to
the further development of Campath 1H.
1.2 The headings in this Agreement are inserted only for
convenience and shall not affect the construction hereof.
1.3 Where appropriate, words denoting a singular number only shall
include the plural and vice versa.
1.4 References to Sections, Clauses and Annexes are references to
Sections and Clauses of, and Annexes annexed to, this
Agreement;
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1.5 Annexed to this Agreement is Schedule 1: Critical Information.
2. RELEASE OF CRITICAL INFORMATION
2.1 Following execution of this Agreement by both parties hereto,
WELLCOME shall provide to LEUKOSITE, the Critical Information
and as soon as reasonably practicable.
2.2 The Critical Information is provided to LEUKOSITE strictly for
the Specified Purpose and subject to the conditions set forth
herein. Notwithstanding the foregoing, the Critical
Information shall at all times remain confidential.
3. CONFIDENTIALITY AND NON-USE
3.1 LEUKOSITE shall:
3.1.1 hold the Critical Information separately and securely
from other information and materials and in the
strictest of confidence at all times.
3.1.2 not disclose to, or allow any of its subsidiaries
affiliates, employees, subcontractors and/or agents
to use the Critical Information nor shall LEUKOSITE
allow any of its sublicensees, subsidiaries,
affiliates, employees, sub-contractors and/or agents
to use the Critical Information for any purpose other
than for the Specified Purpose.
3.2 Other than sublicensees and other than for the Specified
Purpose and provided that such sublicensee is bound by
confidentiality and non-use provisions at least as strict as
this Agreement, LEUKOSITE shall not disclose or cause or
authorize or permit the Critical Information to be disclosed
to any third party without first obtaining WELLCOME's prior
written consent.
3.3. LEUKOSITE shall ensure that all its employees, (including but
not limited to Xx. Xxx Xxxxxxxxx) consultants and experts
having access to the Critical Information shall be
individually bound in writing to an Agreement, of
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confidentiality and non-use at least as strict as this
Agreement.
3.4 LEUKOSITE shall not use, reproduce, transform or store any of
the Critical information on an externally accessible computer
or electronic information retrievable system or transmitting
it in any form or by any means whatsoever (with the exception
of facsimile where appropriate in the circumstances) outside
its place of business in USA.
3.5 LEUKOSITE shall only make copies of the Critical Information
to the extent that the same is strictly required for the
purposes hereof.
3.6 LEUKOSITE shall return or destroy and shall ensure its
sublicensees, sub-contractors, employees, consultants and
experts having access to the Critical Information return or
destroy to WELLCOME's complete satisfaction all Critical
Information and sub-unit derivative or product thereof within
thirty (30) days of termination of this Agreement.
3.7 In the event that LEUKOSITE or its employees make any
improvements, acquires or has access to or owns any
intellectual property rights relating to the Critical
Information ("the Rights") LEUKOSITE shall insofaras it can be
reasonably determined that LEUKOSITE is able to grant WELLCOME
a non-exclusive license under the Rights on reasonable terms
to be negotiated in good faith and reasonably agreed between
the parties.
3.8 The requirements and restrictions contained in this Clause
shall continue to apply after the termination or expiry of
this Agreement.
4. LIABILITY
4.1 No warranties or representations, expressed or implied, are
made by WELLCOME with regard to the Critical Information its
fitness for purpose, accuracy, completeness or its suitability
for any particular purpose. LEUKOSITE hereby accepts the
Critical Information on an "as is basis".
4.2 LEUKOSITE shall be fully responsible for the use of the
Critical Information for the Specified Purpose at all stages
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and for the results obtained therefrom. In no circumstances
will WELLCOME be held responsible or liable for the same.
LEUKOSITE shall indemnify and hold WELLCOME harmless against
all costs, claims, demands, loss, damage, liability or claims
by any person(s). WELLCOME shall give prompt notice to
LEUKOSITE of any such claim. LEUKOSITE shall control the
defense settlement or compromise of any such claim, unless the
parties mutually agree otherwise in writing.
5. TERM AND TERMINATION
5.1 This Agreement shall be effective from the date of signature
hereof and shall be coterminous with the Sublicense Agreement
between BTG and LEUKOSITE.
5.2 Following termination the provisions of Clause 3.7 shall
apply, unless the parties mutually agree otherwise in writing.
5.3 Termination of this Agreement shall not affect the obligations
concerning liability and confidentiality and non-use herein
contained.
6. ASSIGNMENT
LEUKOSITE may not assign its rights and obligations hereunder to any
third party who is not a party to this Agreement without the prior
written consent of WELLCOME, which consent shall not be unreasonably
withheld (it being understood that assignment to a competitor of
WELLCOME shall be a reasonable reason for withholding consent).
7. ACKNOWLEDGMENT
LEUKOSITE acknowledge hereunder that any breaches of its obligations
hereunder would cause irreparable damage to WELLCOME.
8. AMENDMENT
This Agreement may be only amended, extended or modified by written
agreement of the LEUKOSITE and WELLCOME authorized representatives.
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9. GOVERNING LAW
This Agreement shall be governed and construed in accordance with
English Law.
Accepted and Agreed
For and on behalf of
THE WELLCOME FOUNDATION LIMITED
Signed:[signature appears here]
Name(Print): ______________________
Position: _________________________
Accepted and Agreed
For and on behalf of
LEUKOSITE, INC.
Signed:[signature appears here]
Name(Print): ______________________
Position: _________________________
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ANNEX I
DETAILS OF THE CRITICAL INFORMATION BE RELEASED TO LEUKOSITE
1. Seven vials of Working Cell Bank derived from Master Cell Bank 2 and
known as CHO CIH 6.12.93.
2. Two grammes of MCB1 material in the form of filled quality assured
released vials together with quality control results, and a two gramme
sample of superdex monomer (the final stage before dilution and
filling) from MCB2 together with the provisional quality control
results for that batch.
3. One container of dry powdered medium.
4. Protocol(s) in respect of the Complement Mediated Cell Lysis (CMCL) and
the Antibody Dependent Cellular Cytoxicity (ADCC) tests.
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