EXHIBIT 10.4
Agreement dated for reference the 23rd day of May, 2001.
COLLABORATIVE RESEARCH AGREEMENT
BETWEEN:
MIVI TECHNOLOGIES INC. , a company incorporated under
the laws of Yukon Territory and having its offices at
Xxxx 0, 0000 Xxx Xxxxxx, in the City of Vancouver, in
the Province of British Columbia, V6P 6T3.
(the "Sponsor")
AND:
THE UNIVERSITY OF BRITISH COLUMBIA, a corporation
continued under the University Act of British
Columbia and having its administrative offices at
0000 Xxxxxxxx Xxxx, in the City of Vancouver, in the
Province of British Columbia, V6T 1W5.
(the "Research Organization")
WHEREAS:
A. The Research Organization has invented and developed certain technology
relating to sol-gel hydroxyapatite ceramics and hydroxyapatite coatings
developed by Xx. Xxx Xxxxxxxxxx of the Department of Metal and Material
Engineering at the Research Organization; and
B. The research program contemplated by this Agreement is of mutual
interest and benefit to the Research Organization and to the Sponsor, will
further the instructional and research objectives of the Research Organization
in a manner consistent with its status as a non-profit, tax-exempt, educational
institution, and may derive benefits for both Sponsor and Research Organization
through inventions, improvements, and/or discoveries.
NOW THEREFORE THIS AGREEMENT WITNESSETH that in consideration of the premises
and of the mutual covenants herein set forth, the parties hereto have covenanted
and agreed as follows:
1. DEFINITIONS
1.1 In this Agreement, unless a contrary intention appears, the following
words and phrases shall mean:
(a) "Affiliate" of a party hereto shall mean an entity that
controls, is controlled by, or is under common control with such party.
For purposes of this definition, a party shall be
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deemed to control another entity if it owns or controls, directly or
indirectly, at least fifty percent (50%) of the voting power of the
other entity.
(b) "Confidential Information" shall mean any and all knowledge,
know-how, information, and/or techniques disclosed by the one party
(referred to in this capacity as the "Provider") to another (referred
to in this capacity as the "Recipient") relating to the Project,
including, without limiting the generality of the foregoing, all
research, data, specifications, plans, drawings, prototypes, models,
documents, records, instructions, manuals, papers, or other materials
of any nature whatsoever, whether written or otherwise, relating to
same. In order to constitute "Confidential Information" for the
purposes of this Agreement, the Provider must clearly identify it in
writing as being confidential, or if the disclosure takes place orally
or in some other non-tangible form, the Provider must summarize it in
writing and identify it as being confidential within thirty (30) days
of making the disclosure. Furthermore, such disclosures shall not be
considered "Confidential Information" for the purposes of this
Agreement if and when it:
(i) is made subject to an order by judicial or
administrative process requiring the Recipient to disclose any
or all of the Confidential Information disclosed to it by the
Provider, provided however that the Recipient shall promptly
notify the Provider and allow the Provider reasonable time to
oppose such process before disclosing any of the Confidential
Information disclosed to it by the Provider;
(ii) is published or becomes available to the general
public other than through a breach of this Agreement;
(iii) is obtained by the Recipient from a third party with
a valid right to disclose it, provided that said third party
is not under a confidentiality obligation to the Provider;
(iv) is independently developed by employees, agents or
consultants of the Recipient who had no knowledge of or access
to the Confidential Information disclosed to it by another
party to this Agreement as evidenced by the Recipient's
business records; or
(v) was possessed by the Recipient prior to receipt from
the Provider, other than through prior disclosure by the
Provider, as evidenced by the Recipient's business records.
(c) "Contract Period" shall mean June 1, 2001 through September
30, 2001.
(d) "Investigator" shall mean Xx. Xxx Xxxxxxxxxx of the Department
of Metals and Materials Engineering at the University of British
Columbia.
(e) "Joint Intellectual Property" shall mean, individually and
collectively, all inventions, improvements, and/or discoveries which
exclude the Technology and which are conceived and/or made jointly by
one or more employees of the Research Organization and by one or more
employees of the Sponsor during the Contract Period in the performance
of the Project.
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(f) "Project" shall mean the project as described in Appendix "A"
hereof.
(g) "Research Organization Intellectual Property" shall mean,
individually and collectively, all inventions, improvements, and/or
discoveries which relate to the Technology and which are conceived
and/or made solely by the Research Organization, or solely by the
Sponsor, or jointly by the Research Organization and the Sponsor during
the Contract Period in the performance of the Project and all
inventions, improvements, and/or discoveries which exclude the
Technology and which are conceived and/or made solely by one or more
employees of the Research Organization during the Contract Period in
the performance of the Project.
(h) "Sponsor Intellectual Property" shall mean, individually and
collectively, all inventions, improvements, and/or discoveries which
exclude the Technology and which are conceived and/or made solely by
one or more employees of the Sponsor during the Contract Period in the
performance of the Project.
(i) "Technology" shall mean any and all knowledge, know-how,
technique or technology, improvement, variation, up-date, modification
or enhancement relating to "Low Temperature Sol-Gel Synthesis of
Hydroxyapatite Ceramics for Biomedical Applications" as disclosed in US
Patent application serial No. 09/563,231 filed April 2, 2000 and any
and all knowledge, know-how, technique or technology, improvement,
variation, up-date, modification or enhancement relating to
"Biofunctional Hydroxyapatite Coatings and Microspheres for In-Situ
Drug Encapsulation" as disclosed in US Provisional Patent application
filed April 20, 2001.
2. RESEARCH WORK
2.1 The Research Organization shall commence the performance of the Project
promptly after the effective date of this Agreement, and shall use reasonable
efforts to perform the Project substantially in accordance with the terms and
conditions of this Agreement. Notwithstanding anything to the contrary in this
Agreement, the Sponsor and the Research Organization may at any time amend the
Project by mutual written agreement.
2.2 In the event that the Investigator becomes unable or unwilling to
continue the Project, and a mutually acceptable substitute is not available, the
Research Organization and the Sponsor shall each have the option to terminate
the Project and this Agreement by providing the other party with written notice
of same.
2.3 In the performance of all services hereunder:
(a) the Research Organization shall be deemed to be and shall be
an independent contractor;
(b) neither party is authorized or empowered to act as agent for
the other for any purpose and shall not on behalf of the other enter
into any contract, warranty, or representation as to any matter; and
(c) neither party shall be bound with respect to third parties by
the acts or conduct of the other.
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3. REPORTS AND CONFERENCES
3.1 Interim written project reports shall be provided by the Research
Organization to the Sponsor regularly during the Contract Period, and a final
project report shall be submitted by the Research Organization to the Sponsor
within sixty (60) days after the conclusion of the Contract Period or early
termination of this Agreement, whichever is sooner.
3.2 A financial statement shall be submitted by the Research Organization
to the Sponsor within sixty (60) days after the conclusion of the Contract
Period or early termination of this Agreement, whichever is sooner.
3.3 During the term of this Agreement, representatives of the Research
Organization will meet with representatives of the Sponsor at times and places
mutually agreed upon to discuss the progress and results, as well as ongoing
plans, or changes therein, of the Project.
4. COSTS, XXXXXXXX, AND OTHER SUPPORT
4.1 It is agreed to and understood by all parties that, subject to Article
4.3, the total costs to the Sponsor hereunder shall be $20,459.00CDN. The
parties acknowledge that any budget categories that may be set forth in the
description of the Project are estimates only and that changes from category to
category may be made at the Research Organization's discretion. Invoices shall
be issued to the Sponsor by the Research Organization in accordance with the
following schedule:
1) Upon execution of this agreement.................. $15,000.00
2) Upon receipt of final report...................... $ 5,459.00
The Research Organization reserves the right to suspend work on the Project or
to terminate the Project and this Agreement by delivering written notice of same
to the Sponsor if the Sponsor fails to pay any invoiced amount within fifteen
(15) days after the invoice is issued.
4.2 The Research Organization shall retain title to any equipment purchased
with funds provided by the Sponsor under this Agreement.
4.3 Notwithstanding anything to the contrary in this Agreement, in the
event of early termination of this Agreement, the Sponsor shall pay all costs
and liabilities relating to the Project which have been incurred by the Research
Organization as of the date of receipt of notice of such termination. For
greater certainty, such costs and liabilities shall include all non-cancelable
obligations including payments in lieu of reasonable notice for technicians,
graduate students, and other staff assigned to the Project.
5. PUBLICITY
5.1 Notwithstanding anything to the contrary in this Agreement, the
Research Organization may disclose the identity of the Sponsor, the title of the
Project, the name of the Investigator, the Contract Period, and the amount of
funding being provided by the Sponsor in support of the Project. Except as
provided by the foregoing, neither party may use the name of the other, nor of
any member of the other's Project staff, in any publicity, advertising, or news
release without the prior written approval of an authorized representative of
the other.
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6. CONFIDENTIALITY
6.1 The Recipient shall not use the Confidential Information provided to it
by the Provider, directly or indirectly, for any purpose other than as
specifically set forth in this Agreement. Without limiting the generality of the
foregoing, the Recipient shall not use, manufacture, or sell the Provider's
Confidential Information or any device or means incorporating any of the
Provider's Confidential Information, and shall not use any of the Provider's
Confidential Information as the basis for the design or creation of any device
or means.
6.2 The Recipient shall keep and use all of the Provider's Confidential
Information in confidence and shall not disclose any part of the Provider's
Confidential Information to any person, firm, corporation, or other entity.
6.3 Subject to Article 5.1, the Sponsor requires of the Research
Organization, and the Research Organization agrees insofar as it may be
permitted to do so at law, that this Agreement, and each part of it, is
confidential and shall not be disclosed to third parties, as the Sponsor claims
that such disclosure would or could reveal commercial, scientific or technical
information and would significantly harm the Sponsor's competitive position.
6.4 Notwithstanding any termination or expiration of this Agreement, the
obligations of confidentiality set forth in this Article 6 shall survive and
continue to be binding upon the Recipient, its successors, and assigns until
three (3) years after such termination or expiration.
7. PUBLICATIONS
7.1 The Sponsor acknowledges that the policies of the Research Organization
require that the results of the Project be publishable, subject to Article 6.
The parties therefore agree that researchers engaged in the Project shall not be
restricted from presenting at symposia, national, or regional professional
meetings, or from publishing in abstracts, journals, theses, or dissertations,
or otherwise, whether in printed or in electronic media, methods and results of
the Project, provided however that:
(a) the Research Organization provides the Sponsor with copies of
any proposed publication or presentation at least forty-five (45) days
in advance of the submission of such proposed publication or
presentation to a journal, editor, or other third party; and
(b) the Sponsor has not, within thirty (30) days after receipt of
said copies, objected in writing to such proposed presentation or
proposed publication in accordance with Article 7.2 of this Agreement.
7.2 The Sponsor may object to a proposed presentation or proposed
publication on the grounds that it contains Confidential Information that was
disclosed to the Research Organization by the Sponsor or on the grounds that it
discloses patentable subject matter which needs protection. In the event that
the Sponsor makes such objection on the former ground, the Research Organization
shall ensure that its researchers remove such Confidential Information
immediately from the proposed presentation or publication, after which the
Research Organization and its researchers may proceed with said presentation or
publication. In the event that the Sponsor makes such an objection on the latter
ground, it shall be deemed to be a direction to the University to file a patent
application pursuant to Article 8.4, and the Research Organization shall ensure
that its researchers refrain from making such publication or presentation until
Research Organization has filed one or more patent applications with one or more
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patent offices directed to such patentable subject matter, or until three (3)
months have elapsed from date of receipt of such written objection from the
Sponsor by the Research Organization, whichever is sooner, after which the
Research Organization and its researchers may proceed with said presentation or
publication. For greater certainty, a provisional patent application shall be
considered to be a patent application in the United States of America for the
purposes of this Agreement.
8. INTELLECTUAL PROPERTY
8.1 The parties acknowledge and agree that all rights and title to the
Technology and Research Organization Intellectual Property shall belong to the
Research Organization.
8.2 The parties acknowledge and agree that all rights and title to Sponsor
Intellectual Property shall belong to the Sponsor.
8.3 The parties acknowledge and agree that all rights and title to Joint
Intellectual Property shall belong jointly to the Research Organization and the
Sponsor. Notwithstanding the applicable patent or other intellectual property
laws in any jurisdiction, none of the parties may commercially exploit any Joint
Intellectual Property except as specifically provided for in Article 9.2.
8.4 The Research Organization will promptly notify Sponsor of any Research
Organization Intellectual Property. The parties will promptly notify one another
of any Joint Intellectual Property. The Sponsor may direct that one or more
patent applications be filed in respect of such Research Organization
Intellectual Property or Joint Intellectual Property, as the case may be, in
which case the Research Organization shall promptly prepare, file, and prosecute
such patent applications in such jurisdictions as the Sponsor directs in the
name of the Research Organization in the case of Research Organization
Intellectual Property and in the joint names of the Research Organization and
the Sponsor in the case of Joint Intellectual Property. The Sponsor shall bear
all costs incurred in connection with the preparation, filing, prosecution, and
maintenance of such patent applications and shall cooperate with the Research
Organization to assure that such patent applications cover, to the best of the
Sponsor's knowledge, all items of commercial interest and importance. While the
Research Organization shall be responsible for making final decisions regarding
the scope and content of such patent applications and the prosecution thereof,
the Sponsor shall be given an opportunity to review and provide input thereto.
The Research Organization shall keep the Sponsor advised as to all developments
with respect to such applications and shall promptly supply the Sponsor with
copies of all papers received and filed in connection with the prosecution
thereof in sufficient time for the Sponsor to comment thereon.
8.5 If the Research Organization wishes to obtain patent protection in
respect of Research Organization Intellectual Property and/or Joint Intellectual
Property over and above that for which the Sponsor wishes to provide its
financial support pursuant to Article 8.4, the Research Organization shall be
free to file or continue prosecution or maintain any such applications and to
maintain any protection issuing thereon at its own expense.
9. GRANT OF RIGHTS
9.1 The Research Organization grants the Sponsor and, at the Sponsor's
election its Affiliate, the option to obtain a royalty-bearing license to use or
otherwise exploit Research Organization Intellectual Property and / or the
Research Organization interest in the Joint Intellectual Property subject to
terms and conditions determined in accordance with Article 9.2. Said option
shall subsist with respect to each item
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of Research Organization Intellectual Property and/or Joint Intellectual
Property for a period of six (6) months after said item has been disclosed in
writing by the Research Organization to the Sponsor and may be exercised within
this period by the Sponsor delivering written notice of same to the Research
Organization.
9.2 If the Sponsor exercises its option pursuant to Article 9.1, the
parties shall negotiate in good faith to determine the specific terms and
conditions on which the license shall be granted by the Research Organization to
the Sponsor. If the parties are unable to agree upon such specific terms and
conditions within a period of six (6) months after the date when the Sponsor
exercised its option, either party shall have the right to have the terms and
conditions which are still in issue determined by an arbitrator in accordance
with Article 14. Said arbitrator shall be required to determine such outstanding
terms and conditions:
(a) in accordance with generally accepted industry standards where such
terms and conditions relate purely to financial matters such as minimum
annual royalty amounts, percentage royalty rates, and performance
requirements; and
(b) in accordance with the current licensing practices of the University
of British Columbia in all other matters including, without limiting the
generality of the foregoing, matters of indemnification, insurance,
confidentiality, use of trade-marks or names of Research Organization
personnel, and disclaimer of warranty.
9.3 The Sponsor hereby grants the Research Organization a non-exclusive,
royalty-free license in perpetuity to use or otherwise exploit Sponsor
Intellectual Property but only for academic and research purposes, and not for
any commercial purposes whatsoever.
10. TERM AND TERMINATION
10.1 This Agreement shall be deemed to have come into force upon the
beginning of the Contract Period and shall continue in effect for the full
duration of the Contract Period unless sooner terminated in accordance with the
provisions of this Article. The parties hereto may, however, extend the term of
this Agreement for additional periods as desired under mutually agreeable terms
and conditions which the parties reduce to writing and sign. Either party may
terminate this agreement upon thirty (30) days prior written notice to the
other.
10.2 In the event that either party hereto shall commit any breach of or
default in any of the terms or conditions of this Agreement, and also shall fail
to remedy such default or breach within fifteen (15) days after receipt of
written notice thereof from the other party hereto, the party giving notice may,
at its option and in addition to any other remedies which it may have at law or
in equity, terminate this Agreement by sending notice of termination in writing
to the other party to such effect and such termination shall be effective as of
the date of the receipt of such notice.
10.3 Termination of this Agreement by either party for any reason shall
not affect the rights and obligations of the parties accrued prior to the
effective date of termination of this Agreement pursuant to Articles 8 and 9. No
termination of this Agreement, however effectuated, shall release the parties
hereto from their rights and obligations under Articles 4.3, 5, 6, 10.4, or 12.
10.4 Forthwith upon the termination of this Agreement, the Recipient
shall cease to use the Provider's Confidential Information in any manner
whatsoever and upon the written request of the Provider shall
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forthwith deliver up to the Provider all of the Provider's Confidential
Information in the Recipient's possession or control, together with a
certificate certifying that no copies have been made or retained.
11. DISCLAIMER OF WARRANTY
11.1 The Research Organization makes no representations or warranties,
either express or implied, with respect to the data or other results arising
from the Project or with respect to any Confidential Information it may disclose
to the Sponsor. The Research Organization specifically disclaims any implied
warranty of non-infringement or merchantability or fitness for a particular
purpose and shall in no event be liable for any loss of profits, be they direct,
consequential, incidental, or special or other similar or like damages arising
from any defect, error or failure to perform, even if the Research Organization
has been advised of the possibility of such damages. The Sponsor hereby
acknowledges that the Project is of an experimental and exploratory nature, that
no particular results can be guaranteed, and that it has been advised by the
Research Organization to undertake its own due diligence with respect to all
matters arising from this Agreement.
12. INDEMNITY
12.1 The Sponsor hereby indemnifies, holds harmless and defends the
Research Organization, its Board of Governors, directors, officers, employees,
faculty, students, invitees, and agents against any and all claims (including
all legal fees and disbursements incurred in association therewith) arising out
of the receipt or use by the Sponsor of any of the Research Organization's
Confidential Information, the Research Organization Intellectual Property, the
Joint Intellectual Property, the Sponsor Intellectual Property, or any data or
other results arising from the Project including, without limiting the
generality of the foregoing, any damages or losses, consequential or otherwise,
arising from or out of same, howsoever the same may arise.
13. INSURANCE
13.1 The parties acknowledge that the Research Organization has adequate
liability insurance applicable to its officers, employees, and agents while
acting within the scope of their employment by the Research Organization, and
that the Research Organization has no liability insurance policy as such that
can extend protection to any other person. Therefore, subject to Article 12,
each party hereby assumes any risks of personal injury and property damage
attributable to the negligent acts or omissions of that party and its officers,
employees, and agents.
14. GOVERNING LAW AND ARBITRATION
14.1 This Agreement shall be governed by and construed in accordance with
the laws of the Province of British Columbia and the laws of Canada in force
therein without regard to its conflict of law rules. All parties agree that by
executing this Agreement they have attorned to the jurisdiction of the Supreme
Court of British Columbia. Subject to Article 14.2, the Supreme Court of British
Columbia shall have exclusive jurisdiction over this Agreement.
14.2 In the event of any dispute arising between the parties concerning
this Agreement, its enforceability, or its interpretation, said dispute shall be
settled by a single arbitrator appointed pursuant to the provisions of the
International Commercial Arbitration Act of British Columbia, or any successor
legislation then in force. The place of arbitration shall be Xxxxxxxxx, Xxxxxxx
Xxxxxxxx, Xxxxxx and the language to be used in the arbitration proceedings
shall be English. Notwithstanding the foregoing, either
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party may apply to a court of competent jurisdiction for interim protection such
as, by way of example, an interim injunction.
15. ASSIGNMENT
15.1 This Agreement shall not be assigned by any party without the prior
written consent of the others, which consent shall not be unreasonably withheld.
16. NOTICES
16.1 All notices or other documents that either of the parties hereto are
required or may desire to deliver to the other party hereto may be delivered
only by personal delivery or by registered or certified mail, telex or telecopy,
all postage and other charges prepaid, at the address for such party set forth
below or at such other address as that party may hereinafter designate in
writing to the other. Any notice personally delivered or sent by telex or
telecopy shall be deemed to have been given or received at the time of delivery,
telexing or telecopying.
Sponsor: Xx. Xxxx X. Xxxxxx
President
MIVI Technologies Inc.
Xxxx 0, 0000 Xxx Xxxxxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx
X0X 0X0
Telephone: (000) 000-0000 X00
Telecopier: (000) 000-0000
Research Organization: Xx. X. X. Xxxxxxxxxxx
Managing Director
University - Industry Liaison Office
I.R.C. Room 331
2194 Health Sciences Mall
University of British Columbia
Xxxxxxxxx, Xxxxxxx Xxxxxxxx
X0X 0X0
Telephone: (000) 000-0000
Telecopier: (000) 000-0000
16.2 Questions or queries of a scientific nature or regarding financial
matters may be directed by the Sponsor to the Research Organization through the
following contacts:
Technical Matters: Xx. Xxx Xxxxxxxxxx
Department of Metals & Materials Engineering
University of British Columbia
Xxxx 000 Xxxxxxx Xxxxxxxx
0000 Xxxxxx Xxxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx
X0X 0X0
Telephone: (000) 000-0000
Telecopier: (000) 000-0000
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Financial Matters: Xx. Xxxxxx Xxxxxxx
Office of Financial Services
University of British Columbia
General Services Administration Building
0000 Xxxxxxxx Xxxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx
X0X 0X0
Telephone: (000) 000-0000
Telecopier: (000) 000-0000
17. GENERAL
17.1 The appendices to this Agreement together with the terms and
conditions contained within this Agreement constitute the entire understanding
between the parties hereto and no modifications hereof shall be binding unless
executed in writing by the parties hereto. The appendices will be binding upon
the parties hereto except to the extent that they may conflict with the terms
and conditions contained within this Agreement itself, in which case the terms
and conditions of this Agreement shall govern.
17.2 In the event that any part, section, clause, paragraph or
subparagraph of this Agreement shall be held to be indefinite, invalid, illegal
or otherwise voidable or unenforceable, the entire agreement shall not fail on
account thereof, and the balance of the Agreement shall continue in full force
and effect.
17.3 No condoning, excusing or overlooking by either party of any default
or breach by the other party in respect of any terms of this Agreement shall
operate as a waiver of such party's rights under this Agreement in respect of
any continuing or subsequent default or breach, and no waiver shall be inferred
from or implied by anything done or omitted by such party, save only an express
waiver in writing.
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17.4 No exercise of a specific right or remedy by any party precludes it
from or prejudices it in exercising another right or pursuing another remedy or
maintaining an action to which it may otherwise be entitled either at law or in
equity.
IN WITNESS WHEREOF the parties hereto have hereunto executed this Agreement
effective as of the beginning of the Contract Period, regardless of the date of
execution.
Signed for and on behalf of
MIVI TECHNOLOGIES INC.
by its duly authorized officer:
Per: /Xxxx X. Xxxxxx/
----------------------------------
Xx. Xxxx X. Xxxxxx
President
Date:
Signed for and on behalf of the
UNIVERSITY OF BRITISH COLUMBIA
by its duly authorized officer:
Per: /Xxxxx X. Xxxxx/
----------------------------------
Xx. Xxxxx Xxxxxxxxxxx
Managing Director
Date: June 27, 2001
I have read and understood the foregoing
Agreement and understand my responsibilities
as the Principal Investigator:
Per: /Xxx Xxxxxxxxxx/
----------------------------------
Xx. Xxx Xxxxxxxxxx
Department of Metals & Materials Engineering
Date:
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APPENDIX "A"
STATEMENT OF WORK
PROPOSAL TO MIVI TECHNOLOGIES
Term: 4 months (June 1, 2001 - September 30 / 2001)
Functionally Gradient Calcium Phosphate Coatings for Stents
Proof-of-Concept Proposal
by Xxx Xxxxxxxxxx
UBCeram - Ceramics Group at Metals and Materials Engineering of UBC - May 2001
This is proposal for a short-term (3m) proof-of-concept exploratory program
of deposition of thin hydroxyapatite (HA) films through sol-gel on 316 stainless
steel wires simulating the coronary stent substrate. The related background data
have been submitted to MIVI in the form of longer-term (3 years) collaborative
research and development CRD program co-supported by NSERC. Although both
proposals are to be submitted in May, 2001, engagement in NSERC-CRD will depend
on the outcome of the current 3m project. The goal of this program is to deposit
the thin film and characterize their behaviour after substrate deformation up to
20% strain. The HA film should remain attached to the strained substrate.
Deposition process modifications will be done to improve film retention on the
substrate.
The coatings will be thin films (0.2-0.5 [micron]m) of highly crystalline
hydroxyapatite (HA) produced through sol-gel (SG) technology. A novel sol-gel
process will be used (US patent pending) which allows the calcium phosphate to
be obtained in a well crystallized form, at relatively low temperatures, i.e.
approximately 400[degrees]C. The sol-gel process comprises: (a) hydrolysing a
phosphor precursor in a water based medium; (b) adding a calcium salt precursor
to obtain a calcium phosphate gel; (c) depositing the gel on the substrate,
typically through dip coating, and (c) calcining the calcium phosphate at a
suitable elevated temperature.
The coatings will be deposited on thin (75[micron]m) 316L stainless steel
wires resembling the actual coronary stent surface. Stress-strain
characteristics of the coated wires will be determined for three levels of
strain: low (5%), medium (10%) and high (20%), in tension and bending. These
strains are expected in the deformed stents, according to the FEM analysis by
InSitu Technologies Inc. Alternatively, the wires will be bent, coated, and then
un-bent. Structural damage to the coatings and interface will be assessed at
different strain values and straining procedures. The coatings will be evaluated
through optical and electron microscopy. Retention of the coatings after
multiple deformations of the coronary stent will be monitored. Samples of coated
wires will be SEM examined for evidence of HA coating failure and delamination.
The coating deposition and heat treatment process will be modified to
increase coating retention (and decrease structural damage) of the strained
coated wires. For example, introducing fraction of residual nanoporosity to the
SG-HA films by modifying the sol ageing process and coating heat treatment
schedules may increase the strain tolerance of the films (additionally, it may
be later used for enhanced adsorption of therapeutic agents, in the continued
CRD project). Bonding strength between HA and stainless steel substrate wire
will be changed by SG process modification, and strain testing repeated.
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In the last stage of the program several samples of the MIVIs coronary
stents will be coated according to the best accumulated practice. The coatings
will be SEM evaluated before and after deformation. The program findings will be
summarized in the final report to be delivered to MIVI by Sept. 30, 2001.
Budget
We plan to involve one research engineer (Xxxxx Xxxxxx, @ $2,375/month) and
50% of one summer student (Xxxxx Xx @ $1,000/month) in this program. Supervising
fee ($1,000/month) will also be paid to Xxxx. Xxxxxxxxxx. Additional costs will
include the Metals and Materials Eng. Departmental fees for use of all the
equipment within the department (shared services scheme, @ $200/month per
researcher, excluding the supervisor), and small M&S costs ($500). All these
costs will carry 38% university overhead.
THE BUDGET ITEMS FOR THE 3-MONTH PROGRAM ARE AS FOLLOWS:
Student Stipend $ 3,000
RE salary $ 7,125
Materials and Supplies $ 500
Shared Services (MMAT) $ 1,200
Supervising Fee (X. Xxxxxxxxxx) $ 3,000
-------------------------------------------------------
Subtotal $14,825
University Overheads (38%) $ 5,634
TOTAL PROJECT $20,459
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