EXHIBIT 10.3
TECHNOLOGY TRANSFER AND CUSTOM SERVICES AGREEMENT
THIS AGREEMENT made as of the 23 day of March, 2001.
BETWEEN: MOLICHEM MEDICINES, INC., a corporation incorporated
under the laws of the North Carolina, USA and having a place
of business at:
000 Xxxxx Xxxxxxx Xxxx
PMB#231
Chapel Hill, NC
USA 27514
(hereinafter referred to as "MMI"
OF THE FIRST PART
- and -
APOTEX FERMENTATION INC., a corporation incorporated
under the laws of Manitoba, Canada and having a place of
business at:
00 Xxxxxxxxx Xxxxxxxxx
Xxxxxxxx, Xxxxxxxx
Xxxxxx X0X 0X0
(hereinafter referred to as "AFI")
OF THE SECOND PART
WHEREAS AFI is engaged in the business of development and production of active
pharmaceutical raw materials and intermediates and possesses the necessary
know-how in research, development, scale up and manufacturing to provide
Services in respect of the Product to MMI (as described in Schedule "A" hereto);
AND WHEREAS MMI is the owner of or represents to have the appropriate license
and/or authority for the transfer of the necessary engineering, design, process
and operating information, technical data and other scientific and technical
information required to produce the Product;
E-15
AND WHEREAS MMI wishes to engage AFI and AFI wishes to accept such engagement to
provide the Services in respect of the Product at AFI's manufacturing facility
at 00 Xxxxxxxxx Xxxxxxxxx, Xxxxxxxx, Xxxxxxxx (the '"Manufacturing Premises").
AND THEREFORE THIS INDENTURE WITNESSETH that in consideration of the payment
of two dollars ($2.00) by each of the parties hereto to the other party hereto,
the execution of this Agreement by the parties hereto, the mutual covenants and
conditions herein contained and other good and valuable consideration (the
receipt and sufficiency of which is hereby acknowledged by the parties), the
parties hereto do hereby covenant and agree as follows:
1.0 Upon the terms and conditions herein set forth, MMI hereby engages AFI
(and AFI hereby accepts such engagement) to provide the Services in
respect of the Product at the Manufacturing Premises in accordance with
the Proposal attached as Schedule "A". MMI confirms that AFI is to
proceed in accordance with Option #2 of the milestone payments program
(Annex D of the Proposal). MMI shall have the exclusive right to
acquire all the Product from AFI in accordance with the terms and
conditions set out in Schedule "A".
2.0 Subject to paragraph 13 herein, the term of this Agreement shall be
effective as of the date hereof and shall continue for the period until
the Services in respect of the Product are fully delivered.
3.0 In consideration of the aforesaid services in Respect of the Product,
MMI shall pay to AFI, the amounts set forth in Schedule "A" hereto upon
the terms and conditions set out therein.
4.0 MMI shall provide to AFI all technical information and specifications
on the Product required for manufacturing purposes as set out in
Schedule "A" hereto at no cost to AFI. Nothing on this agreement shall
be construed as a license to AFI for Moli1901 or the Product for any
purpose other than as specifically set forth in this Agreement.
4.1 AFI shall supply raw materials for the manufacture of the Product as
set out in Schedule "A" hereto.
5.0 AFI shall provide the Services in respect of the Product in compliance
with MMI's Specifications and Methods as described in Schedule "A"
hereto. Any changes to these Specifications and Methods must be
notified to and approved by MMI in writing, prior to implementation.
5.1 AFI shall provide the Services in respect of the Product in accordance
with the Good Laboratory Practice and Good Manufacturing Practices as
commonly known and referred to in the industry.
6.0 In respect of delivery of the Product to MMI's premises (or to such
other mutually agreed location) and by transportation mode mutually
agreed between the parties, shipments will be made at the sole risk if
AFI. Upon delivery by AFI of all or any part of the ordered Product to
MMI's premises, the risk of loss or damage will pass from AFI to MMI.
In the event of loss or damage to the Product during shipment, making
the Product unusable for the intended
E-16
purpose, AFI is responsible on a timely basis for the replacement of
the Product only and not for any financial or other damages which may
be suffered by MMI. MMI may at its option, arrange for its own
insurance protection against loss or damage during shipment in which
case MMI is to advise AFI of such an intention and AFI is to provide
the necessary shipment information to allow the MMI insurance
protection to be put in place.
7.0 MMI represents, warrants and covenants to AFI as follows and hereby
acknowledges and agrees with AFI that AFI is relying on such
representations, warranties and covenants in connection with the
entering into by AFI of this Agreement:
(a) MMI is a subsisting corporation duly and validly incorporated
under the laws of the State of North Carolina, USA;
(b) the execution and delivery of this Agreement by MMI has been
duly authorized by all necessary corporate action and MMI has
all requisite corporate power and authority to enter into this
Agreement and to carry out the terms herein;
(c) this Agreement has been duly and validly executed and
delivered by MMI and constitutes a valid and legally binding
Agreement, enforceable against MMI;
(d) to the best of MMI's knowledge, the Services provided in
respect of the Product by AFI will not infringe upon the
intellectual property rights (i.e. patents and trademarks) of
any other parties.
(e) MMI is the legal and beneficial owner of the technical
specifications documented in Schedule "A" hereto, free and
clear of any claims of any nature or kind whatsoever of third
parties and has the absolute right, power and authority to
enter into this Agreement and to engage AFI for the Services
in respect of the Product as is contemplated herein;
(f) to do all things and cause all things to be done to ensure
that all of the representations, warranties and covenants of
MMI contained in this Agreement remain true and correct
throughout the term as if such representations and warranties
and covenants were continuously made throughout the term.
8.0 AFI represents, warrants and covenants as follows to MMI and hereby
acknowledges and agrees that MMI is relying upon such representations,
warranties and covenants in connection with the entering into by MMI of
this Agreement;
(a) AFI is a subsisting corporation duly and validly incorporated
under the laws of the Province of Manitoba, Canada;
(b) the execution and delivery of this Agreement by AFI has been
duly authorized by all necessary corporate action and AFI has
all requisite corporate power and authority to enter this
Agreement and to carry out the terms herein;
E-17
(c) this Agreement has been duly and validly executed and
delivered by AFI and constitutes a valid and legally binding
agreement enforceable against AFI;
(d) the Product will be manufactured in compliance with and
meeting MMI's specifications as provided in Schedule "A"
hereto;
(e) AFI has the capability and capacity to provide the Services in
respect of the Product in accordance with MMI's specifications
as provided in Schedule "A" hereto;
(g) to do all things and cause all things to be done to ensure
that all of the representations, warranties and covenants of
AFI contained in this Agreement shall remain true and correct
throughout the terms as if such representations, warranties
and covenants were continuously made throughout the term.
9.0 AFI recognizes and acknowledges MMI's ownership and title to MMI's
proprietary information and specifications and agrees to co-operate
fully and in good faith with MMI and to execute such documents as MMI
may reasonably request for the purposes of securing and preserving the
rights of MMI in and to MMI's proprietary information as disclosed
pursuant to this Agreement including, without limitation, MMI's
specifications.
10.0 All copyrights, patents, trade secrets, or other intellectual property
rights associated with any ideas, concepts, techniques, inventions,
processes, or works of authorship developed or created by AFI during
the course of performing the Services and related to Moli1901
(collectively, the "Work Product") shall belong exclusively to MMI and
shall, to the extent possible, be considered "works made for hire" for
MMI. To the extent such work is determined not to constitute "works
made for hire" as a matter of law, AFI hereby irrevocably assigns and
transfers to MMI, as of the time of creation of the Work Product, any
and all right, title, or interest it may have in such Work Product.
Upon request of MMI and at MMI's expense, AFI shall take such further
actions, including execution and delivery of instruments of conveyance
necessary to obtain legal protection in the United States and foreign
countries for such Work Product and for the purpose of vesting title
thereto in MMI, or its nominee, as may be appropriate to give full and
proper effect to such assignment and to vest in MMI complete title and
ownership to such Work Product.
Notwithstanding anything to the contrary herein, AFI shall be free to
use and employ its general skills, know-how, and expertise, and to use,
disclose, and employ any generalized ideas, concepts, know-how,
methods, techniques or skills gained or learned during the course of
this Agreement, so long as it acquires and applies such information
without disclosure of any Confidential Information of MMI and without
any unauthorized use of disclosure of Work Product.
11.0 All confidential records, material and information and copies thereof,
and all trade secrets (and without restricting the generality of the
foregoing any inventions, discoveries and methods of processing and
production) concerning the business or affairs of obtained by MMI or of
MMI obtained by AFI including, without limitation, MMI specifications
and the
E-18
terms and conditions of this Agreement, as a result of the entering
into of this Agreement shall remain the exclusive property of the
respective owner thereof. In order to preserve and protect the
proprietary rights and any confidential information belonging to each
of the parties thereto ("Confidential Information"), MMI and AFI agree
that they will:
i. treat and maintain the Confidential Information as
confidential both during the term, any renewal term
and thereafter;
ii. use the Confidential Information only to fulfill its
obligations under this Agreement;
iii. disclose the Confidential Information only as
necessary to its employees or agents who have a
demonstrable and valid "need to know" the
Confidential Information and not to anyone else;
iv. disclose only so much of the Confidential Information
as is required to enable those employees or agents to
carry our their assigned duties; and
v. advise its employees, agents or independent
contractors of the confidential nature of such
information and the requirements of non-disclosure.
except if compelled to do so under Court Order of a competent authority
(in such circumstance the party receiving the order will inform the
other party prior to responding to the order).
11.1 For the purposes hereof, the Confidential Information includes
information known or used by MMI or AFI in connection with their
respective business, including, but not limited to any formula, design,
prototype, compilation of information, data, program, code, method,
technique or process, information relating to the Product or any other
products, device, equipment or machine, information about or relating
to MMI's or AFI's customers and MMI's or AFI's potential business
ventures, financial information of all kinds relating to MMI or AFI and
their respective activities, all inventions, ideas and related
material, but does not include any of the foregoing which was known to
MMI or AFI, as the case may be, prior to the entering into of this
Agreement or which is or becomes a matter of public knowledge.
12.0 This Agreement is strictly personal to MMI and AFI. Neither this
Agreement nor any of the rights granted hereunder including, without
limitation, the right to use MMI'S specifications and the right to
manufacture the Product shall be assignable or sub-licensed by MMI or
AFI, by operation of law or otherwise.
13.0 If any one or more of the following events shall occur, AFI shall have
the right to terminate this Agreement forthwith:
(a) MMI shall fail to pay any amounts payable hereunder within
thirty (30) days after the payment due date;
E-19
(b) MMI shall file a petition of bankruptcy, or shall be adjudged
a bankrupt, or a petition in bankruptcy shall be filed against
MMI and shall not be dismissed within thirty (30) days, or if
MMI shall become insolvent or shall discontinue its business;
(c) MMI shall disclose any information in respect to the
confidential information of AFI to any other party or shall
use any confidential information of AFI for any purpose other
than in relation to the provision of Services related to the
Product at the Premises; and
(d) MMI shall violate or fail to perform any of its other
undertakings, agreements, obligations, representations or
warranties under the terms of this Agreement and shall fail to
remedy any such breach within ten (10) days after AFI's notice
thereof.
13.1 If any one or more of the following events shall occur, MMI shall have
the right to terminate this Agreement forthwith:
(a) AFI shall fail to pay any amounts payable hereunder within
thirty (30) days after the payment due date;
(b) AFI shall file a petition of bankruptcy, or shall be adjudged
a bankrupt, or a petition in bankruptcy shall be filed against
AFI and shall not be dismissed within thirty (30) days, or if
AFI shall become insolvent or shall discontinue its business;
(c) AFI shall disclose any information in respect to the
confidential information of MMI to any other party or shall
use any confidential information of MMI for any purpose other
than for the provision of Services related to the Product at
the Manufacturing Premises; and
(d) AFI shall violate or fail to perform any of its other
undertakings, agreements, obligations, representations or
warranties under the terms of this Agreement and shall fail to
remedy any such breach within ten (10) days after MMI's notice
thereof.
(e) MMI shall have the right to terminate the contract at the
completion of any milestone defined in Annex C (Schedule) of
the Proposal for the Production of Clinical Batches of
Moli1901. AFI shall not proceed to perform any work on the
milestone listed in Annex C without written authorization from
MMI and MMI shall have no financial obligation beyond approved
current milestones. In the event that MMI chooses to terminate
the contract at any time, AFI shall complete the work assigned
to the current milestone and shall be paid in full for the
milestone upon its completion. Termination of the contact or
authority to proceed shall be provided in writing within
fifteen (15) days of notification in writing by AFI of the
completion of a milestone.
13.2 Upon termination of this Agreement for cause, (a) AFI agrees to
transfer and deliver to MMI immediately following the termination of
this Agreement all documents, notebooks, charts, files and records
containing or referencing MMI's Confidential Information (all
confidential information) including copies, summaries, and notes in its
possession or control and MMI
E-20
Product and (b) MMI agrees to transfer and deliver to AFI immediately
following the termination of this Agreement all documentation belonging
to AFI in its possession.
13.3 The termination or expiration of this Agreement shall not relieve MMI
or AFI from, or discharge, any obligations which accrued prior to such
termination or expiration and shall not destroy or diminish the binding
force and effect of any of the terms and conditions of this Agreement
that expressly or by implication come into or continue in effect on or
after termination or expiration.
13.4 Each of MMI and AFI acknowledge that the release or use of any of the
Confidential Information other than as set out herein would be highly
detrimental to the best interests of MMI or AFI, as the case may be,
and that the right to maintain the confidentiality and ownership of the
Confidential Information constitutes a proprietary right which MMI and
AFI is entitled to protect. Any use of or any disclosure of the
Confidential Information by MMI or AFI other than set out herein shall
be deemed for all purposes to have caused the damaged party irreparable
harm for which damages alone will not be adequate remedy and for which
the damaged party shall be entitled to injunctive relief in addition to
any other available remedies and MMI or AFI, as the case may be, hereby
consents to the granting of an injunction to enforce the provisions of
this Agreement and hereby waives any defenses AFI or MMI, as the case
may be, may have in respect thereto.
14.0 Miscellaneous.
14.1 This Agreement (including the attached Schedule(s)) constitutes the
entire Agreement between the parties with representations, warranties,
covenants, agreements, or understanding relative thereto which are not
set forth herein. No provision of this Agreement shall be effectively
amended or waived except in writing signed by the party against whom
the amendment or waiver is sought to be enforced.
14.2 Any notice or other communication required or permitted under this
Agreement shall be in writing and may be given by personal delivery to
the party for whom it is intended or by facsimile, or prepaid
registered mail addressed:-
in the case of MMI:
MOLICHEM MEDICINES INC.
000 Xxxxx Xxxxxx Xxxx
XXX#000
Xxxxxx Xxxx, XX
XXX 00000
Attn: Dr. Xxxx Xxxxxx, President and CEO
Fax No: 000-000-0000
E-21
and in the case of AFI:
APOTEX FERMENTATION INC.
00 Xxxxxxxxx Xxxxxxxxx
Xxxxxxxx, Xxxxxxxx
Xxxxxx X0X 0X0
Attn: Xxxx Xxxxx, General Manager and CEO
Fax No: 000-000-0000
In the event of a mail strike or other interruption of postal
deliveries, all notices, directions or other instruments required or
permitted to be given to the parties hereto shall be delivered or shall
be sent by facsimile (receipt confirmed) to such parties.
Any such notice or other communication given by delivery or facsimile
shall be deemed to have been given on the day of delivery or facsimile
or by prepaid mail twenty (20) days after mailing in Canada or the USA.
Each party may at any time change its address for the purposes hereof
by giving notice of such change to the others in accordance with the
foregoing provisions.
14.3 Matters in dispute under this Agreement may, as agreed by the parties
hereto, be referred to the arbitration.
14.4 Each of the parties hereto may extend the time for performance and
waive non-performance by any of the other party hereto of its
respective obligations and Agreements under this Agreement, but no act
and/or failure to act by any of the parties shall be deemed to be an
extension or waiver of timely and strict performance by the other
parties to this Agreement of such obligations and Agreements, except to
the extent notice is given to such of the other parties.
14.5 This agreement shall be governed by the laws of the state in the United
States or the province of Canada of the defending party. Any provision
herein which, in any way contravenes the laws of any jurisdiction or
which is void, shall be deemed not to be part of this Agreement and
shall be severable therefrom, and the remainder of the Agreement shall
remain in full force and effect.
14.6 Article and Section headings contained in this Agreement are included
solely for convenience, are not intended to be full or accurate
descriptions of content thereof and shall not be considered part of
this Agreement.
14.7 This Agreement shall extend to bind and enure to the benefit of the
heirs, executors, administrators, successors and permitted assigns of
the parties.
14.8 Nothing in this Agreement shall be deemed in any way or for any purpose
to constitute any party a partner of the other party to the Agreement
in the conduct of any business or
E-22
otherwise or a member of a joint venture or joint enterprise with the
other party to the Agreement.
14.9 AFI and MMI shall in a timely manner and as required from time to time
take all such actions as may be necessary to give full effect to the
provisions of this Agreement and abstain from taking any actions which
would contravene the intent of the provisions of this Agreement and
shall take all such actions, as may be necessary or appropriate to
implement the transaction contemplated by this Agreement, including
executing any appropriate documents or agreements.
14.10 AFI shall be excused for failure to perform any part of this Agreement
due to events beyond its control. These events shall include but not be
limited to fire, storm, flood, earthquake, explosions, embargoes, act
of God and enactments of any acts or regulations or any priorities of
any governmental authority.
14.11 This Agreement may be executed in counterpart.
14.12 Time shall be of the essence of this Agreement and every part hereof.
IN WITNESS WHEREOF the corporate parties hereto have set their hands and affixed
their corporate seals under the hands of their proper officers as of the date
first above written.
SIGNED, SEALED AND DELIVERED
In the presence of: MOLICHEM MEDICINES INC.
Per: _______________________
Name: Dr. Xxxx Xxxxxx
Title: President and EO
APOTEX FERMENTATION INC.
Per: __________________________
Name: Xxxx Xxxxx
Title: General Manager and CEO
E-23
