Contract Research and Development Agreement - MedImmune Inc. and Dr. Karl Thomae GmbH
CONTRACT RESEARCH AND DEVELOPMENT AGREEMENT
(MEDI-493)
THIS CONTRACT RESEARCH AND DEVELOPMENT AGREEMENT ("Agreement") is made
effective as of November 27, 1997 ("Effective Date"), by and among
MedImmune, Inc. ("MEDIMMUNE"), a corporation having a place of business
at 35 West Watkins Mill Road, Gaithersburg, Maryland 20878 U.S.A., and
Dr. Karl THOMAE GmbH ("THOMAE") a German corporation having its
principal place of business at Birkendorfer Strabe 65, 88397 Biberach
an der Riss, Federal Republic of Germany.
BACKGROUND
MEDIMMUNE has developed proprietary protein production technologies,
and has developed a proprietary cell line capable of expressing a
humanized monoclonal antibody against Respiratory Syncyital Virus (RSV)
and designated as MEDI-493.
THOMAE owns specialized cell culture, processing, protein purification
and lyophilization facilities that may be suitable for production of
MEDI-493, and employs personnel who have experience in production of
proteins by cell culture and purification processes as well as in
registration and marketing of biopharmaceuticals.
MEDIMMUNE desires to have THOMAE personnel evaluate the performance of
the MEDIMMUNE MEDI-493 production process, formulation and
lyophilization of the resulting product in THOMAE's facilities.
MEDIMMUNE and THOMAE have previously entered into an evaluation
agreement dated April 16, 1997 to evaluate the potential production and
supply of MEDI-493 (the "Evaluation Agreement"), and THOMAE has already
started the development work under an interim agreement dated August
15/21, 1997 with MEDIMMUNE covering all expenditures by THOMAE for the
interim period from May to December 1997 the "Interim Agreement"),
which shall be replaced by signing of this Agreement.
AGREEMENT
IN CONSIDERATION OF the mutual covenants set forth in this Agreement,
THOMAE, and MEDIMMUNE hereby agree as follows:
1. DEFINITIIONS.
1.1 "MEDIMMUNE" shall mean MEDIMMUNE Inc. as laid down first above.
(PAGE 1)
1.2 "MEDIMMUNE Confidential Information" shall mean the Cell Line,
Process, Product and all technical and other information relating
thereto that is disclosed or supplied to THOMAE by MEDIMMUNE
pursuant to this Agreement or the Evaluation Agreement whether
patented or unpatented, including, without limitation, trade
secrets, know-how, processes, concepts, experimental methods and
results and business and scientific plans.
1.3 "MEDI-493" shall mean the humanized IgG1 monoclonal antibody
specifically directed against RSV.
1.4 "Cell Line" shall mean the novel and proprietary cell line (Id.-No.
RSV-1129 a-6H3) developed by MEDIMMUNE and provided to THOMAE pur
suant to the terms of this Agreement or the Evaluation Agreement
including, without limitation, all modifications and derivatives of
such cell line.
1.5 "Certificate of Analysis" shall mean a document describing testing
methods and results, the accuracy of which has been certified by
the issuing party.
1.6 "Effective Date" shall mean the date first above written, which
shall be the effective date of this Agreement.
1.7 "GMP" shall mean the current regulatory requirements for good
manufacturing practices promulgated by the FDA under the Federal
Food, Drug and Cosmetic Act, as amended, 21 C.F.R. 210, 211 et
seq and 21 C.F.R. 600-610, as applicable.
1.8 "Master Cell Bank" shall mean MEDIMMUNE's reference deposit or
collection of vials of the Cell Line, from which the Working Cell
Bank is derived.
1.9 "Phase I" shall mean the activities and work to be performed as
laid down in the respective chapter of the Master Project plan
attached hereto as APPENDIX 1.
1.10 "Phase II" shall mean the activities and work to be performed as
laid down in the respective chapter of the Master Project plan
attached hereto as APPENDIX 1.
1.11 "Phase III" shall mean the activities and work to be performed as
laid down in the respective chapter of the Master Project plan
attached hereto as APPENDIX 1.
1.12 "Bulk Product" shall mean the Product which has been purified to a
concentrated form and can be stored in a liquid or frozen form
under appropriate conditions.
(PAGE 2)
1.13 "Final Product" shall mean unlabelled final container containing
lyophilized Product.
1.14 "Finished Product" shall mean Final Product and also labelled and
packaged.
1.15 "Process" shall refer to a proprietary MEDIMMUNE process for using
the Cell Line, including defined procedures, equipment and
analytical methodologies for in-process control, release testing
and Product characterization, that has been used by MEDIMMUNE to
produce the Product at the (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) fermentation scale which has already partly been and
shall fully be disclosed by MEDIMMUNE to THOMAE to enable THOMAE to
carry out the Project or if and when applicable the modified
process after scale up by THOMAE to the (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED) fermentation scale. The current format of MedImmune
Process and of Thomae Process are set forth in APPENDIX 13.
1.16 "Product" shall mean the MEDI-493 produced by the Cell Line in
accordance with the Process.
1.17 "Project" shall mean the Phase I - III program described herein, in
which MEDIMMUNE shall transfer the Process to THOMAE to be
implemented upscaled and evaluated at the respective fermentation
scale in THOMAE's facility and equipment. The primary objectives of
the Project will be to establish or adapt and scale up the Process
in the THOMAE facility, successfully demonstrate that equivalent
Product can be reproducibly manufactured in THOMAE's facilities,
and generate a report compiling all relevant data generated in the
Project. A proposed timeline for the Project is included in
APPENDIX 1.
1.18 "Project Fee" shall have the meaning specified in Section 6 hereof.
1.19 "Project Manager" shall have the meaning specified in Section 2.1
hereof.
1.20 "Project Team" shall have the meaning specified in Section 2.2
hereof.
1.21 "Start Date" shall mean May 12, 1997.
1.22 "THOMAE Confidential Information" shall mean all technical and
other information relating to THOMAE's facilities and associated
technologies that is disclosed or supplied to, or used on behalf
of, MEDIMMUNE by THOMAE pursuant to this Agreement, whether
patented or unpatented, including, without limitation, trade
secrets, know-how, processes, concepts, experimental methods and
results and business and scientific plans.
(PAGE 3)
1.23 "Working Cell Bank" shall mean MEDIMMUNE's vialed collection
serially subcultivated cells that is derived from the Master Cell
Bank. The Working Cell Bank is used to establish seed cultures of
the Cell Line to initiate the Process.
1.24 "Specifications" shall mean the specifications for the Product and
the respective test methods attached hereto as APPENDIX 5 on the
basis of the specifications provided by MEDIMMUNE and as such
specifications may be amended from time to time by mutual agreement
of MEDIMMUNE and THOMAE according to further development of the
Process and Product.
1.25 "Product Characterization" shall mean the analytical
characterization of the Product performed at MEDIMMUNE as specified
in APPENDIX 10.
2. COOPERATION BETWEEN THE PARTIES IN THE COURSE OF THE PROJECT.
2.1 Designation of Project Manager.
THOMAE and MEDIMMUNE shall each identify a Project Manager who will
be responsible for communicating all instructions and information
concerning the Project to the other party. Each Project Manager
will be available on an agreed upon monthly basis for consultation
at prearranged times during the course of the Project. In the
absence of the Project Manager, a substitute shall be appointed.
Additional modes or methods of communication and decision making
may be implemented with the mutual consent of each party.
2.2 Project Team.
THOMAE and MEDIMMUNE shall each name representatives to a Project
Team, which shall consist of knowledgeable specialists in
appropriate disciplines who shall be responsible for planning and
executing the Project and any subsequent interactions between the
parties. At regular intervals, the Project Managers shall schedule
meetings between each company's representatives for the purpose of
communicating Project updates and providing a forum for strategic
decision making and rapid resolution of issues. Joint Project
meetings shall be conducted by telephone conference, video
conference and face to face meetings. Meeting minutes shall be
prepared jointly by the Project Managers to record all issues
discussed and decisions made.
The present list of the members of the Project Team is attached
hereto as APPENDIX 6.
2.3 Cooperation.
In the course of the Project, THOMAE will at all times take into
consideration and implement the recommendations of MEDIMMUNE as
long as they do not adversely affect other THOMAE biotech
(PAGE 4)
operations and are agreed upon by the Project Team; in the absence
of explicit instructions from MEDIMMUNE, THOMAE shall be entitled
to employ its reasonable judgment in carrying out the Project.
THOMAE shall be entitled to rely upon any instructions or
directives provided by any MEDIMMUNE representative and shall not
be responsible for failure to achieve any objective or the
inability to adhere to any guideline due to technical failures,
incomplete direction or documentation of Process variables, or
other causes beyond the control of THOMAE.
MEDIMMUNE must be informed of any changes that are expected to
change the Process or Product Specifications. Process format and
Process changes for Project Phase I, II and III will be mutually
agreed upon by the Project Team.
If THOMAE proposes a change of the Process, such a change must be
approved by MEDIMMUNE according to the procedure in APPENDIX 8 or
the change shall not be implemented. If MEDIMMUNE proposes a change
of the Process, see first paragraph of this Section 2.3 above.
The parties will inform each other within an appropriate time and
participate in all regulatory contacts and regulatory inspections
regarding MEDI-493 and each party may take part therein at its sole
discretion.
MEDIMMUNE will be provided an opportunity to review and comment on
all documents used for the registration of Product (CMC-Part of
BLA). However, this shall not include any and all ELA-documents of
THOMAE with respect to MEDI-493 and/or the Product. Basically
MEDIMMUNE will be provided with copies of all regulatory
submissions, submitted for MEDI-493. For those
documents/submissions not to be provided according to the exception
above, MEDIMMUNE will have the right to reference such
documents/submissions for regulatory purposes.
3. MEDIMMUNE'S TASKS AND RESPONSIBILITIES.
3.1 Use of MEDIMMUNE Cell Line and Intellectual Property.
MEDIMMUNE and THOMAE hereby acknowledge and agree that MEDIMMUNE is
providing Cell Line, Process and MEDIMMUNE Confidential Information
to THOMAE for use by THOMAE on behalf of and for the benefit of
MEDIMMUNE for the purposes of this Agreement, that THOMAE will make
use therof solely for such purposes and that MEDIMMUNE hereby
consents to such use.
3.2 Materials and Information to be Provided.
To enable THOMAE to begin and continue the Project, MEDIMMUNE shall
use commercially reasonable efforts to perform the work and tasks
(PAGE 5)
as set forth and detailed in APPENDIX 7 hereto and shall provide
all materials and information as set forth in APPENDIX 7 and
defined therein. In case MEDIMMUNE is not able to fulfill the
requirements mentioned above the parties shall discuss and
negotiate an alternative (including but not limited to timeline and
cost).
4. THOMAE'S TASKS AND RESPONSIBILITIES (PHASES I-III).
4.1 THOMAE's work and tasks
In the course of this Agreement THOMAE shall perform the work and
tasks as laid down and detailed in APPENDIX 8 hereto.
4.2 Documentation.
As soon as available THOMAE shall provide MEDIMMUNE with the CMC-
part of the BLA (all other parts of registration and the
registration itself being the task and responsibility of
MEDIMMUNE), in formats to be mutually agreed upon. Such CMC-part
shall be in English and shall contain all required portions of the
respective filing as laid down in APPENDIX 2 hereto.
4.3 Stability Program.
Notwithstanding its work described in Section 4.1 above, MEDIMMUNE
and THOMAE shall perform a stability program as laid down in
APPENDIX 4 hereto. The timeline for this work is laid down in the
Master Project plan including Project Timeline (APPENDIX 1). It is
planned that THOMAE will perform release testing for lots post
approval.
4.4 Additional Work
On request of MEDIMMUNE THOMAE shall perform additional work to
sustain the progress of the Project on conditions in terms of
money, time and scope to be subject to mutual agreement of the
parties hereto and defined in an amendment to the Master Project
plan (APPENDIX 1).
4.5 Exclusivity/Competition
During the term of this Agreement, THOMAE agrees that it will not
supply Product to a third party nor shall THOMAE assist any third
party with respect to development or manufacture of a monoclonal
antibody against RSV except where THOMAE is granted marketing
rights to such monoclonal antibody.
4.6 Project is experimental in Nature
MEDIMMUNE acknowledges that the Project is experimental in nature
and that no favorable or useful result can be assured by THOMAE.
Accordingly, THOMAE shall not be responsible to MEDIMMUNE for any
failure of fermentations or inability to obtain useful yields of
Product or keeping the intended timeline.
(PAGE 6)
4.7 GMP
THOMAE will perform the manufacturing operations at its facility in
accordance with GMP and compliance with all applicable local laws
and regulations. THOMAE will deliver Product based on the
Specifications defined in APPENDIX 5. If a run does not meet the
Specifications due to a THOMAE operation error or an equipment
failure, THOMAE will repeat the run at no cost to MEDIMMUNE as the
sole remedy.
4.8 Special Problems
(CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
5. PHASES I-III TO BE CONDUCTED ON FIXED-FEE BASIS.
The Project shall be conducted by THOMAE for MEDIMMUNE on fixed fee
basis to be paid by MEDIMMUNE to THOMAE as set forth in Article 6
hereof (the "Project Fee"). The estimated duration of the Project
shall be 19 (nineteen) months from the Start Date as outlined in
APPENDIX 1 hereto.
As the Project is experimental in nature, the Project Fee shall be
payable in full when due regardless of result unless the Project is
terminated prior to its scheduled completion pursuant to Article 12
hereof.
6. PHASES I-III PAYMENTS
6.1 Fixed Project Fee MEDIMMUNE shall pay THOMAE a Project Fee
based on actual costs of (CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED) for the services provided in carrying out the Project.
This Project Fee includes the actual costs of THOMAE's work ac
cording to Article 4 hereof (for additional work if any see
Section 4.4 hereof), and insofar is all inclusive.
Disposal of organic and hazardous waste is included in the Project
Fee. The Project Fee shall be payable in installments, each non-
refundable when paid, (except for a breach of this Agreement by
THOMAE as provided herein), as provided for in the Master Project
plan (APPENDIX 1).
THOMAE shall receive installments according to the progress of the
Project pursuant to the agreed schedule set forth in APPENDIX 1.
Each invoice shall be payable within 30 days following receipt
thereof.
6.2 Success Fee
As a means to secure deliverables according to Specifications and
timelines, which would enable MEDIMMUNE to file a BLA amendment and
launch in the U.S. in 1998, MEDIMMUNE will make incentive payments
of up to (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED) to THOMAE as
follows:
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(i) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
(ii) (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
7. ORDERING INITIAL START-UP MATERIAL FOR (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED) SCALE
MEDIMMUNE and THOMAE expect that a raw material purchase for
Phase III will be necessary prior to the completion of Phase II
(February 1998).The purchase of such materials at the respective
date laid down in APPENDIX 1 hereto is covered by this Agreement
and is at the sole risk of MEDIMMUNE. The present cost estimate for
initial start-up material is outlined in APPENDIX 3 hereto.
8. OWNERSHIP OF PROJECT DATA / FUTURE ACTIVITIES / COMMERCIAL
PRODUCTION.
8.1 Ownership of Project Data.
In consideration of the Project Fee, THOMAE shall carry out the
Project and transfer all relevant information concerning the
process, and materials related to the Product and obtained in the
course of the Project to MEDIMMUNE. However, this shall not apply
to information regarding THOMAE's facility and technical equipment.
All transferred information - with the exception of THOMAE
Confidential Information - shall be the sole and exclusive property
of MEDIMMUNE and MEDIMMUNE shall have the right to use such
information for any purpose without further obligation to THOMAE.
After transfer of the information, THOMAE shall not be obliged to
provide technical assistance to MEDIMMUNE or a third party with re
spect to use of such information at a facility other than THOMAE's
facility. After termination of the intended supply agreement or as
provided in the supply agreement between the parties, MEDIMMUNE
shall have the right to transfer the modified and scaled-up Process
to third parties. Further such information and materials to be
transferred to MEDIMMUNE shall be MEDIMMUNE Confidential
Information subject to the provisions of Article 11.
THOMAE shall cooperate with MEDIMMUNE in taking all reasonable
steps, including execution of documents, which are commercially
necessary to enable MEDIMMUNE to protect its ownership interest.
8.2 Further Future Activities regarding Research and Development.
If the results of the Project are favorable, THOMAE and MEDIMMUNE
may confer to determine if additional work should be undertaken
pursuant to subsequent agreement between THOMAE and MEDIMMUNE.
Neither party shall be obligated to conduct any further
undertakings on behalf of the other except as provided for herein
or as may be mutually agreed and set forth in a subsequent written
agreement.
(PAGE 8)
Other then as provided in the manufacturing agreement, MEDIMMUNE
shall not assert any right to use THOMAE facilities at any future
date as a result of its use of THOMAE facilities pursuant to this
Agreement.
8.3 Thomae's Right and Obligation for Commercial Manufacture
The parties acknowledge and agree that, in case MEDIMMUNE decides
to commercialize the Product, THOMAE has the right and obligation
to produce commercial quantities of Product (Bulk Product, Final
Product and/or Finished Product form) for MEDIMMUNE within its
respective capacity which shall be exclusive but for MEDIMMUNE's
right to manufacture Bulk Product and/or Final Product and/or
Finished Product and/or to have a third party to produce Final
Product and or Finished Product from Bulk Product produced by
MEDIMMUNE and MEDIMMUNE will have the right and obligation to have
such commercial quantities of MEDI-493 manufactured by THOMAE and
the parties shall negotiate in good faith and consummate a
manufacturing agreement (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
at the earliest opportunity for the manufacturing by THOMAE of
commercial quantities of the respective Product, any prolongation
to be subject to separate agreement of the parties. Such agreement
shall contain terms and conditions customary for such a
manufacturing agreement.
During the term of the manufacturing agreement, if THOMAE cannot
produce sufficient commercial quantities of Product as outlined in
APPENDIX 9 for whatever reason, MEDIMMUNE will have the right to
have the missing quantities manufactured by a third party.
8.4 Terms and Conditions of Manufacturing Agreement
Such manufacturing agreement shall contain terms and conditions
customary for such a manufacturing agreement.
In particular, the parties hereby agree that the pricing from
THOMAE for the manufactured Product under such manufacturing
agreement shall be in accordance with a volume discount pricing
matrix and basic production assumptions, both set forth in APPENDIX
11 attached hereto, which pricing matrix will establish an absolute
initial price ceiling for Product under the manufacturing agreement
and will provide a framework to establish Product costs for
variable length production campaigns.
Moreover, such manufacturing agreement shall contain a "Rolling
Forecast Planning System for Product (Commercial Manufacture)"
attached hereto as APPENDIX 12.
In APPENDIX 9 MEDIMMUNE has set forth its present forecast
estimation of its latest requirements of the Product. This forecast
is non-binding; however, THOMAE's capacity planning for commercial
manufacture is based on and limited by MEDIMMUNE's forecast.
(PAGE 9)
9. REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION.
9.1 MEDIMMUNE.
MEDIMMUNE hereby represents, warrants and agrees that:
(a) MEDIMMUNE is free to supply the Cell Line and MEDIMMUNE Con
fidential Information to THOMAE;
(b) MEDIMMUNE is not aware of any special or unusual hazards in
volved in handling the Cell Line or Product;
(c) MEDIMMUNE has full corporate authority to enter into this
Agreement and this Agreement is binding upon MEDIMMUNE in
accordance with its terms; and
(d)MEDIMMUNE shall indemnify, defend and hold THOMAE, its affiliates, and
their respective officers, employees and agents harmless from and
against all third pary losses, damages, costs and expenses
(including, without limitatiion, reasonable attorneys' fees),
including injury to persons or damage to property resulting from
any breach of the representations and warranties made by MEDIMMUNE
under this Section, or as a result of any third party claim of
infringement of the intellectual property rights of a third party
based upon THOMAE's activities in implementing the Process or
producing the Product in accordance with the instructions and
documentation provided by MEDIMMUNE or developed in the course of
the Project, except those which result from the gross negligence
or willful misconduct of an indemnified person or entity.
9.2 THOMAE.
THOMAE hereby represents, warrants and agrees that:
(a) THOMAE is the owner of the facilities and THOMAE
Confidential Information to be used for purposes set forth
in this Agreement;
(b) THOMAE is not aware of any special or unusual hazards that
would arise as a result of its carrying out of the Project
as planned;
(c) THOMAE has full corporate authority to enter into this
Agreement and this Agreement is binding upon THOMAE in
accordance with its terms; and
(d)THOMAE shall indemnify, defend and hold MEDIMMUNE and its officers,
employees and agents harmless from and against all third party
losses, damages, costs and expenses (including,
(PAGE 10)
(e)without limitation, reasonable attorneys' fees), including injury to
persons or damage to property, resulting from any breach of the
representations and warranties made by THOMAE under this Section,
or as a result of any claim that THOMAE has violated any
applicable local law, regulation or ordinance in carrying out its
biotechnical manufacturing responsibilities under this Agreement
or as a result of willful breach or misconduct of THOMAE or its
officers, employees or agents, except those which result from
gross negligence or willful misconduct of an indemnified
person or entity.
9.3 Information
With respect to the indemnification mentioned above in this
section, each indemnified party will notify the indemnifying party
promptly of any claim or loss and the indemnifying party shall be
entitled to control the defense, settlement or compromise of any
such claim or loss.
10. LIABILITY.
10.1 No Warranty of Merchantability or Fitness.
THOMAE shall provide the results of the Project to MEDIMMUNE
without any warranty of any kind, express or implied, including,
without limitation, any warranties of merchantability or fitness
for a particular purpose. THOMAE warrants solely that the Project
shall be conducted as laid down in APPENDIX 1 of this Agreement,
and that any documentation of Project results or procedures
provided to MEDIMMUNE by THOMAE shall be accurate in all material
respects.
10.2 Limitation of Liability.
THOMAE has no knowledge or awareness of or control over the manner
in which MEDIMMUNE intends to use any Product or results obtained
in the Project.
THOMAE shall not be liable to MEDIMMUNE for any losses, damages,
costs or expenses of any nature incurred or suffered by MEDIMMUNE
or by a third party, arising out of any dispute or other claims or
proceedings made by or brought against MEDIMMUNE with respect to
use of the results of the Project, or the use of any Product by
MEDIMMUNE or by a third party (including, without limitation,
product liability claims and claims by a third party alleging
infringement of its intellectual property rights) except as to
those under Section 9.2 (d) above, nor shall THOMAE be responsible
in any way for dealing with any such disputes, claims or pro
ceedings.
(PAGE 11)
THOMAE will provide reasonable cooperation, if requested by
MEDIMMUNE, on matters relating to the Project in the event of such
claims.
MEDIMMUNE shall indemnify, defend and hold THOMAE, its affiliates
and their respective officers, employees and agents harmless from
and against all such third party losses, damages, costs and
expenses (including, without limitation, reasonable attorneys' fees
and infringement of the intellectual property rights of a third
party). This indemnification shall also be subject to the
provisions of Section 9.3 above.
10.3 Maximum Amount.
THOMAE undertakes to use its best efforts to perform the Project
under the Master Project plan and to meet the target dates set
forth in APPENDIX 1 hereto. However, due to the biological nature
of the work to be performed hereunder THOMAE's liability under this
Agreement and its indemnification and holdharmless obligations
shall in no event amount to more than (CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED) of the Project Fee. This limitation does not apply
in cases of willful breach or misconduct of THOMAE or its officers,
employees or agents.
11. CONFIDENTIALITY.
11.1 THOMAE shall not disclose MEDIMMUNE Confidential Information to any
person other than its employees or employees of affiliated
companies of the Boehringer Ingelheim group who have a need to know
such information in order to perform their duties in carrying out
the Project hereunder and who have an obligation to maintain the
confidentiality thereof as provided herein.
11.2 MEDIMMUNE shall not disclose any THOMAE Confidential Information to
any person other than
(a) its employees or consultants who are bound by similar
obligations of confidentiality and who have a need to know
such information in order to provide direction to THOMAE or
evaluate the results of the Project, or
(b)regulatory authorities, for example, the FDA, that require such infor
mation in order to review an IND, BLA or other regulatory filing.
THOMAE will be informed and must agree prior to filing of any
THOMAE confidential Information to regulatory authorities. In
these case where THOMAE restricts MEDIMMUNE's ability to file
(PAGE 12)
THOMAE Confidential Information, THOMAE agrees to provide
the Confidential Information directly to the regulatory
authorities and will provide a letter of authorization for
cross-reference to MEDIMMUNE.
(c) persons or entities that manufacture Product for MEDIMMUNE
after termination of the manufacturing agreement or during
the manufacturing agreement as permitted therein.
11.3 The obligations of confidentiality applicable to MEDIMMUNE
Confidential Information and THOMAE Confidential Information shall
not apply to any information that is:
(a) known publicly or becomes known publicly through no fault of
the recipient;
(b) learned by the recipient from a third party entitled to
disclose it;
(c) developed by the recipient independently of information
obtained from the disclosing party;
(d) already known to the recipient before receipt from the
disclosing party, as shown by its prior written records;
(e) required to be disclosed by law, regulation or the order of
a judicial or administrative authority; or
(f) released with the prior written consent of the disclosing
party.
11.4 Except as granted under this Agreement, no right or license, either
express or implied, under any patent or proprietary right is
granted hereunder by virtue of the disclosure of MEDIMMUNE
Confidential Information or THOMAE Confidential Information.
11.5 Either party shall be entitled to injunctive relief in the event of
a breach of this Agreement by the other party. The obligations of
both parties under this Article 11 shall survive the expiration or
termination of this Agreement. Both MEDIMMUNE and THOMAE shall use
reasonable and customary precautions to safeguard MEDIMMUNE
Confidential Information and THOMAE Confidential Information,
including ensuring that all employees or consultants who are pro
vided access to such information are informed of the confidential
and proprietary nature of such information and understand that all
such information is required to be maintained confidential.
(PAGE 13)
12. TERM AND TERMINATION.
12.1 Term.
This Agreement shall, unless terminated earlier, take effect as of
the Effective Date retroactive as of the Start Date and shall
terminate upon the date of payment of the last sum due hereunder,
or upon the date when the last services required to be performed
hereunder are performed, whichever date shall last occur.
12.2 Right to Terminate.
If it becomes apparent to either party at any stage of the Project
that it will not be possible to carry out the Project for
scientific or technical reasons or as a result of Force Majeure,
the parties shall permit 10 (ten) business days for discussion to
make a proposal to resolve, if possible, the scientific or
technical issue giving rise to the problem. If the parties fail to
resolve the problem within further 20 business days, either party
shall have the right to terminate this Agreement, effective upon
written notice to the other. MEDIMMUNE shall also have the right
to terminate this Agreement on ninety (90) days written notice in
the event, MEDIMMUNE determines to cease development and marketing
of the Product.
In the event of termination as set forth within Section 12.2, the
amount due to THOMAE hereunder shall include all expenses
reasonably incurred by THOMAE prior to such termination in respect
of the purchase of supplies or raw materials, and an allocation of
the balance of the Project Fee for the period prior to receipt of
such termination and for a period of 8 (eight) weeks thereafter.
Either party may terminate this Agreement effective upon written
notice if either of the following events occurs
(a) the other party commits a breach of this Agreement and the
breach is not remedied within 30 days after the receipt of
notice identifying the breach and requiring its remedy; or
(b) the other party (I) becomes unable to pay its debts as they
become due, (II) suspends payment of its debts, (III) enters
into or becomes subject to corporate rehabilitation or
bankruptcy proceedings or liquidation or dissolution, (IV)
makes an assignment for the benefit of its creditors or (V)
seeks relief under any similar laws for debtor's relief.
12.3 Effect of Termination.
Upon the expiration or termination of this Agreement:
(a)at the request of MEDIMMUNE, THOMAE shall destroy the Cell Line as
well as the material derived from its culture or deliver the same
at MEDIMMUNE's request to MEDIMMUNE or a
(PAGE 14)
(b)party nominated by MEDIMMUNE at MEDIMMUNE's cost and shall promptly
return all MEDIMMUNE Confidential Information to MEDIMMUNE; except
for a single copy and/or sample of each material for documentation
purposes only and except as required to meet THOMAE's obligations
under the manufacturing agreement. THOMAE's responsibility to keep
and store the Cell line and any other materials shall terminate 6
six months after expiration or termination of this Agreement, and
(b) MEDIMMUNE shall promptly return all THOMAE Confidential
Information to THOMAE, except for a single copy and/or
sample for documentation purposes only.
(c) The respective rights of THOMAE and MEDIMMUNE to indemnifi
cation as set forth in Article 9 and 10 hereof shall
survive termination of this Agreement with respect to any
claims that relate to or derive from the Project, or any
acts or failures to act, of either THOMAE or MEDIMMUNE in
connection with the Project that occur prior to termination.
(d) The rights and obligations of Sections 8.1 and 12.3 shall
also survive termination of this Agreement.
This also applies to Section 9 (d) as far as a breach occurs
prior to termination of this Agreement.
13. MISCELLANEOUS
13.1 Force Majeure.
Neither party shall be in breach of this Agreement if there is any
failure of performance under this Agreement (except for payment of
any amounts due hereunder) occasioned by any act of God, fire, act
of government or state, war, civil commotion, insurrection,
embargo, prevention from or hindrance in obtaining energy or other
utilities, labor disputes of whatever nature or any other reason
beyond the control of either party.
13.2 Publicity.
No press release or other form of publicity regarding the Project
or this Agreement shall be permitted by either party to be
published unless both parties have indicated their consent to the
form of the release in writing.
Nothing in this Article 13.2 shall prevent the parties from
disclosing this Agreement as required by applicable laws, rules or
regulations.
13.3 Notices.
Any notice required or permitted to be given hereunder by either
(PAGE 15)
party shall be in writing and shall be (i) delivered personally,
(ii) sent by registered mail, return receipt requested, postage
prepaid or (iii) delivered by facsimile with immediate telephonic
confirmation of receipt, to the addresses or facsimile numbers set
forth below:
<TABLE>
<S> <C>
If to THOMAE: Dr. Karl THOMAE GmbH
Birkendorfer Strabe 65
88397 Biberach an der Riss
Federal Republic of Germany
Attention: Prof. Dr. Rolf G. Werner
Fax: 0 73 51/54-51 31
Phone: 0 73 51/54-48 00
If to MEDIMMUNE: MEDIMMUNE Inc.
35 West Watkins Mill Road
Gaithersburg, Maryland 20878
U.S.A.,
Attention: President
Fax: 301/527-4201
Phone: 301/ 417-0770
</TABLE>
Each notice shall be deemed given (i) on the date it is received if
it is delivered personally, (ii) 3 days after the date it is sent
by Federal Express, UPS, DHL, MSAS, World Courier or similar
service if receipt is immediately confirmed in writing or (iii) on
the date it is received if it is sent by facsimile with immediate
telephonic confirmation of receipt.
13.4 Applicable Law/Jurisdiction.
This Agreement shall be governed by and construed in accordance
with the laws of Germany without regard to its choice of law
principles. The courts of the place of domicile of THOMAE shall
have exclusive jurisdiction over all legal matters and proceedings
hereunder.
13.5 Compliance with Laws.
THOMAE shall perform the work hereunder in conformance with GMP, as
applicable, and all German and/or EEC laws, ordinances and govern
mental rules or regulations pertaining thereto.
13.6 Relationship
THOMAE shall not incur any liabilities on behalf of MEDIMMUNE nor
pledge the credit of MEDIMMUNE nor make any representations, or war
ranties on behalf of MEDIMMUNE nor hold itself out to third parties
as having any such rights.
MEDIMMUNE shall not incur any liabilities on behalf of THOMAE nor
(PAGE 16)
pledge the credit of THOMAE nor make any representations, or
warranties on behalf of THOMAE nor hold itself out to third parties
as having any such rights.
13.7 Waiver.
No waiver of any term, provision or condition of this Agreement
whether by conduct or otherwise in any one or more instances shall
be deemed to be or construed as a further or continuing waiver of
any such term, provision or condition or of any other term,
provision or condition of this Agreement.
13.8 Severability.
If any provision of this Agreement is held to be invalid or
unenforceable by a court of competent jurisdiction all other
provisions shall continue in full force and effect. The parties
hereby agree to attempt to substitute for any
invalid or unenforceable provision a valid or enforceable provision
which achieves to the greatest extent possible the economic legal
and commercial objectives of the invalid or unenforceable
provision.
13.9 Entirety.
This Agreement, including any exhibits and appendices attached
hereto and referenced herein and the Evaluation Agreement and the
Interim Agreement, constitutes the full understanding of the
parties and a complete and exclusive statement of the terms of
their agreement, and no terms, conditions, understandings or
agreements purporting to modify or vary the terms thereof shall be
binding unless they are hereafter made in writing and signed by
both parties.
13.10 Assignment.
This Agreement shall be binding upon the successors and assigns of
the parties and the name of a party appearing herein shall be
deemed to include the names of its successors and assigns provided
always that nothing herein shall permit any assignment by either
party. However, THOMAE may assign this Agreement to an affiliated
company taking over the operative biotech business of THOMAE and
MEDIMMUNE may assign this Agreement in the case of a merger or
acqusition or transfer of its assets related to this Agreement to a
third party without the prior written consent of THOMAE.
(PAGE 17)
IN WITNESS WHEREOF, the parties have caused this Agreement to be exe
cuted as of the Effective Date.
<TABLE>
<S> <C> <C>
MEDIMMUNE Inc. DR. KARL THOMAE GMBH
ppa.
BY:/S/David M. Mott /s/Dr. Jacob /s/ Dr. Michelberger
Title: President Member of the Board Head of Legal Department
Date: November 27, 1997
</TABLE>
Appendices:
Appendix 1 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 2 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 3 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 4 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 5 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 6 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 7 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 8 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 9 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 10 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 11 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 12 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
Appendix 13 (CONFIDENTIAL TREATMENT HAS BEEN REQUESTED)
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