<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON JUNE 4, 1996
REGISTRATION NO. 333-3368
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
----------------
PRE-EFFECTIVE
AMENDMENT NO. 3
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
----------------
INNOVASIVE DEVICES, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
----------------
MASSACHUSETTS 3842 04-3132641
(PRIMARY STANDARD (I.R.S.
(STATE OR OTHER INDUSTRIAL EMPLOYERIDENTIFICATION
JURISDICTION OF CLASSIFICATION CODE NUMBER)
INCORPORATION OR NUMBER)
ORGANIZATION)
----------------
734 FOREST STREET,
MARLBOROUGH, MASSACHUSETTS 01752-3032
(508) 460-8229
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF
REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
----------------
RICHARD D. RANDALL PRESIDENT AND CHIEF EXECUTIVE OFFICER INNOVASIVE DEVICES,
INC. 734 FOREST STREET MARLBOROUGH, MASSACHUSETTS 01752-3032 (508) 460-8229
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE,
OF AGENT FOR SERVICE)
----------------
COPIES TO:
ROSLYN G. DAUM, ESQ.CHOATE, HALL & RUFUS C. KING, ESQ.TESTA, HURWITZ &
STEWARTEXCHANGE PLACE53 STATE THIBEAULT, LLP HIGH STREET TOWER125
STREETBOSTON, MASSACHUSETTS 02109- HIGH STREETBOSTON, MASSACHUSETTS
2891(617) 248-5000 02110(617) 248-7000
----------------
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: As soon as
practicable after this Registration Statement becomes effective.
If any of the securities being registered on this form are being offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box. [_]
If this form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective
registration statement for the same offering. [_]
If this form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
check the following box. [X]
----------------
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT
SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS
REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH
SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THIS REGISTRATION
STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE
COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
<PAGE>
EXPLANATORY NOTE
This Pre-Effective Amendment No 3 is being filed solely for the purpose of
filing Exhibit 10.9.
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
<TABLE>
<CAPTION>
Item 16. EXHIBITS
EXHIBIT
NO. DESCRIPTION
------- -----------
<C> <S>
*1.1 Form of Underwriting Agreement
*3.1 Second Restated Articles of Organization
*3.2 Articles of Amendment to Second Restated Articles of Organization,
to be effective prior to the effectiveness of this offering
*3.3 Third Restated Articles of Organization, to be effective upon the
closing of this offering
*3.4 Amended and Restated By-laws of the Registrant
*4.1 Specimen Certificate representing the Common Stock
*4.2 Amended and Restated Rights Agreement dated as of October 17, 1995
by and among the Company, the Founders (as defined therein), the
holders of the Series A Preferred Stock and the holders of the
Series B Preferred Stock.
*4.3 Amendment to Amended and Restated Rights Agreement dated as of
October 17, 1995 by and among the Company, the Founders (as defined
therein), the holders of the Series A Preferred Stock and the
holders of the Series B Preferred Stock
*4.4 Amended and Restated Stockholders' Voting Agreement dated as of
October 17, 1995 by and among the Company, the Founders (as defined
therein), the holders of the Series A Preferred Stock and the
holders of the Series B Preferred Stock
*4.5 Amendment to Amended and Restated Stockholders' Voting Agreement
dated as of October 17, 1995 by and among the Company, the founders
(as defined therein), the holders of the Series A Preferred Stock
and the holders of the Series B Preferred Stock
*5.1 Opinion of Choate, Hall & Stewart
*9.1 James E. Nicholson Voting Trust dated February 22, 1994
*9.2 Anthony J. May Voting Trust dated March 28, 1996
*10.1 1992 MinVasive Stock Option Plan
*10.2 1996 Omnibus Stock Option Plan
*10.3 1996 Non-Employee Director Stock Option Plan
*10.4 1996 Employee Stock Purchase Plan
*10.5 Form of Standard Non-qualified Stock Option Agreement
*10.6 Form of Standard Incentive Stock Option Agreement
*10.7 Form of Standard Stock Option Agreement for Sales and Marketing
Personnel
*10.8 Form of Standard Stock Option Agreement for Sales and Marketing
Personnel (with cliff vesting)
+10.9 Research and Development Agreement between the Registrant and
Collagen Corporation dated October 17, 1995
*+10.10 Distribution Agreement between the Registrant and Collagen
Corporation dated October 17, 1995
*10.11 Manufacturing and Supply Agreement between the Registrant and
Collagen Corporation dated October 17, 1995
*10.12 Lease dated March 12, 1996 between New Boston Wilmar Limited
Partnership and the Registrant for 28,657 square feet of space at
734 Forest Street, Marlborough, Massachusetts
*10.13 Lease dated April 29, 1994 between Thomas B. O'Brien as Trustee of
the Jelric Realty Trust u/d/t dated September 19, 1968 and the
Registrant for 6,000 square feet of space at 100 South Street,
Hopkinton, Massachusetts
*11.1 Statement regarding Computation of Net Loss per Common Share
*24.1 Consent of Price Waterhouse LLP
*24.2 Consent of Choate, Hall & Stewart (included in Exhibit 5.1)
*24.3 Consent of Pandiscio & Pandiscio, P.C.
*25.1 Power of Attorney (See page II-4)
*27.1 Financial Data Schedule
</TABLE>
- --------
*Previously filed.
+Confidential Treatment requested as to certain portions
II-1
<PAGE>
SIGNATURES
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THE REGISTRANT
HAS DULY CAUSED THIS AMENDMENT NO. 3 TO REGISTRATION STATEMENT NO. 333-3368 TO
BE SIGNED ON ITS BEHALF BY THE UNDERSIGNED, THEREUNTO DULY AUTHORIZED, IN
MARLBOROUGH, MASSACHUSETTS ON JUNE 4TH, 1996.
Innovasive Devices, Inc.
/s/ Richard D. Randall
By: _________________________________
RICHARD D. RANDALLPRESIDENT AND
CHIEF EXECUTIVE OFFICER
PURSUANT TO THE REQUIREMENTS OF THE SECURITIES ACT OF 1933, THIS AMENDMENT
NO. 3 TO REGISTRATION STATEMENT NO. 333-3368 HAS BEEN SIGNED BELOW BY THE
FOLLOWING PERSONS IN THE CAPACITIES INDICATED ON JUNE 4TH, 1996
SIGNATURE TITLE(S)
/s/ Richard D. Randall President, Chief
- ------------------------------------- Executive Officer
RICHARD D. RANDALL and Director
(Principal
Executive Officer)
/s/ James V. Barrile Executive Vice
- ------------------------------------- President of
JAMES V. BARRILE Finance, Chief
Financial Officer
and Treasurer
(Principal
Financial and
Accounting Officer)
* Director
- -------------------------------------
JAMES E. NICHOLSON
* Director
- -------------------------------------
JOSEPH A. CIFFOLILLO
* Director
- -------------------------------------
THOMAS C. MCCONNELL
* Director
- -------------------------------------
ROBERT R. MOMSEN
* Director
- -------------------------------------
HOWARD D. PALEFSKY
/s/ Richard D. Randall
*By: ________________________________
RICHARD D. RANDALL, ASATTORNEY-IN-
FACT FOR EACH OFTHE PERSONS
INDICATED
II-2
<PAGE>
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT
NO. DESCRIPTION PAGE
------- ----------- ----
<C> <S> <C>
*1.1 Form of Underwriting Agreement
*3.1 Second Restated Articles of Organization
*3.2 Articles of Amendment to Second Restated Articles of
Organization, to be effective prior to the effectiveness of
this offering
*3.3 Third Restated Articles of Organization, to be effective upon
the closing of this offering
*3.4 Amended and Restated By-laws of the Registrant
*4.1 Specimen Certificate representing the Common Stock
*4.2 Amended and Restated Rights Agreement dated as of October 17,
1995 by and among the Company, the Founders (as defined
therein), the holders of the Series A Preferred Stock and the
holders of the Series B Preferred Stock.
*4.3 Amendment to Amended and Restated Rights Agreement dated as of
October 17, 1995 by and among the Company, the Founders (as
defined therein), the holders of the Series A Preferred Stock
and the holders of the Series B Preferred Stock
*4.4 Amended and Restated Stockholders' Voting Agreement dated as of
October 17, 1995 by and among the Company, the Founders (as
defined therein), the holders of the Series A Preferred Stock
and the holders of the Series B Preferred Stock
*4.5 Amendment to Amended and Restated Stockholders' Voting
Agreement dated as of October 17, 1995 by and among the
Company, the founders (as defined therein), the holders of the
Series A Preferred Stock and the holders of the Series B
Preferred Stock
*5.1 Opinion of Choate, Hall & Stewart
*9.1 James E. Nicholson Voting Trust dated February 22, 1994
*9.2 Anthony J. May Voting Trust dated March 28, 1996
*10.1 1992 MinVasive Stock Option Plan
*10.2 1996 Omnibus Stock Option Plan
*10.3 1996 Non-Employee Director Stock Option Plan
*10.4 1996 Employee Stock Purchase Plan
*10.5 Form of Standard Non-qualified Stock Option Agreement
*10.6 Form of Standard Incentive Stock Option Agreement
*10.7 Form of Standard Stock Option Agreement for Sales and Marketing
Personnel
*10.8 Form of Standard Stock Option Agreement for Sales and Marketing
Personnel (with cliff vesting)
+10.9 Research and Development Agreement between the Registrant and
Collagen Corporation dated October 17, 1995
*+10.10 Distribution Agreement between the Registrant and Collagen
Corporation dated October 17, 1995
*10.11 Manufacturing and Supply Agreement between the Registrant and
Collagen Corporation dated October 17, 1995
*10.12 Lease dated March 12, 1996 between New Boston Wilmar Limited
Partnership and the Registrant for 28,657 square feet of space
at 734 Forest Street, Marlborough, Massachusetts
*10.13 Lease dated April 29, 1994 between Thomas B. O'Brien as Trustee
of the Jelric Realty Trust u/d/t dated September 19, 1968 and
the Registrant for 6,000 square feet of space at 100 South
Street, Hopkinton, Massachusetts
*11.1 Statement regarding Computation of Net Loss per Common Share
*24.1 Consent of Price Waterhouse LLP
*24.2 Consent of Choate, Hall & Stewart (included in Exhibit 5.1)
*24.3 Consent of Pandiscio & Pandiscio, P.C.
*25.1 Power of Attorney (See page II-4)
*27.1 Financial Data Schedule
</TABLE>
- --------
*Previously filed
+Confidential Treatment requested as to certain portions
<PAGE>
* As to asterisked portion, omitted and filed separately with the Securities
and Exchange Commission pursuant to Request for Confidential Treatment.
Exhibit 10.9
RESEARCH AND DEVELOPMENT AGREEMENT
This Research and Development Agreement ("Agreement") is entered into
effective as of October 17, 1995 (the "Effective Date"), by and between Collagen
Corporation, a Delaware corporation with offices at 2500 Faber Place, Palo Alto,
Ca 94303 ("Collagen"), and Innovasive Devices, Inc., a Massachusetts corporation
with offices at 100 South Street, Hopkinton, MA 01748 ("Innovasive").
WHEREAS, Innovasive is developing tissue and bone reattachment systems which are
particularly relevant to the sports medicine and arthroscopy segments of the
orthopedic surgery market;
WHEREAS, Collagen is a technology-based company that develops, manufactures and
markets biomedical devices for the treatment of defective, diseased, traumatized
or aging human tissues;
WHEREAS, the parties wish to collaborate to develop certain resorbable or
partially resorbable mechanical tissue-fixation devices utilizing collagen-based
biomaterials;
NOW THEREFORE, in consideration of the mutual covenants set forth herein,
Collagen and Innovasive agree as follows:
1. Definitions.
-----------
1.1 "Distribution Agreement" shall mean the Distribution Agreement
governing the distribution of Products which is entered into by the parties
effective on even date herewith.
1.2 "Investment Agreements" shall mean the Series B Preferred Stock
Purchase Agreement and the agreements attached as exhibits thereto, which are
entered into by the parties effective on even date herewith.
1.3 "Jointly Owned Technology" shall have the meaning set forth in Section
5.2.
1.4 "Listed Countries" shall mean the countries listed in Exhibit B, as
amended from time to time by mutual written agreement.
1.5 "Product One" shall mean a product which will serve as a mechanical
tissue-to-bone suture fastener of bone anchor, which consists of (i) a
resorbable or partially resorbable bone insert consisting of material which
contains collagen, and (ii) an attached suture.
1.6 "Product Two" shall mean a mechanical *
<PAGE>
* As to asterisked portion, omitted and filed separately with the
Securities and Exchange Commission pursuant to Request for Confidential
Treatment.
1.7 "Product Three" shall mean a fully or partially resorbable
mechanical *
1.8 "Orthopedic" shall mean musculoskeletal tissue below the first
cervical vertebrae, including bone, cartilage, tendon, ligament and muscle, and
excluding nervous tissue.
1.9 "Products" shall mean fully or partially resorbable mechanical *
devices and mechanical tissue-to-bone fixation devices which:
(i) are intended for use in the human body;
(ii) are labeled for Orthopedic, dermatology or facial plastic
surgery applications;
(iii) incorporate collagen;
(iv) *
(v) *
Products are expected to include Product One, Product Two, and Product Three.
1.10 "Project Plan" shall have the meaning set forth in Section 2.1
1.11 "Project Team" shall have the meaning set forth in Section 3.1.
1.12 "Research Project" shall mean the program of Product-related
research and development to be undertaken by the parties pursuant to this
Agreement.
1.13 "Supply Agreement" shall mean the Manufacturing and Supply
Agreement entered into by and between the parties effective on even date
herewith, which governs the manufacturing and supply of Products or other
products distributed by the parties pursuant to the Distribution Agreement.
2. The Research Project.
--------------------
2.1 The Project Plan. The project plan for the Research Project
----------------
("Project Plan") shall contain a plan for research and development efforts, and
a mutually acceptable budget for such efforts ("Project Budget"). The Project
Plan, as revised from time to time by mutual agreement of the parties, shall be
attached hereto as Exhibit A. The parties
-2-
<PAGE>
shall mutually assess the Project Budget on an ongoing basis, and shall agree
upon and update the Project Budget quarterly.
2.2 Initial Development. The initial development effort under the Research
-------------------
Project shall focus on Product One; provided, that Collagen shall, at its
discretion, apply resources covered by the initial Project Budget to Product Two
as such resources become available.
As of the Effective Date, the parties have agreed upon an initial Project Plan
and Project Budget which covers Product One.
2.3 Compliance With Applicable Laws and Regulations. Each party shall
-----------------------------------------------
fulfill its obligations under the Research Project in a manner which complies
with all applicable laws and regulations and applicable good laboratory,
clinical and manufacturing practices. Each party shall provide reasonably
sufficient time, equipment, facilities, personnel and other resources to the
Research Project to fulfill such obligations. Each party may subcontract any
portion of its obligations hereunder with the prior written consent of the other
party, which shall not be unreasonably withheld; provided, that the
subcontractor shall be bound by the terms and conditions of this Agreement.
2.4 Regulatory Issues. The parties' obligations in connection with
-----------------
regulatory requirements are set forth in Section 8 of the Distribution
Agreement.
2.5 Exclusivity. Until the fifth (5th) anniversary of the Effective Date,
-----------
neither party shall develop or commence the development of any Products
(i) independently, or (ii) in collaboration with, or purchase any Products
from, any third party. With respect to any specific Product for which the
parties approve a revised Project Plan covering such Product prior to the
fifth (5th) anniversary of the Effective Date and for which the parties, after
the fifth (5th) anniversary of the Effective Date, actively fund development in
accordance with the Project Budget for such Product until completion of such
Product, neither party shall develop or commence the development of any Product
that would compete with such product, (a) independently, or (b) in
collaboration with, or purchase such Product from, any third party, until the
second (2nd) anniversary of the first commercial sale of such Product.
3. Management of the Research Project.
----------------------------------
3.1 Project Team. The day-to-day management of the Research Project will
------------
be the responsibility of a team (the "Project Team") led by a Collagen employee.
The Project Team will conduct regular meetings, at which representatives of each
party shall report on the progress made by such party in implementing the
Project Plan. Minutes of such meetings will be kept and distributed to members
of the Project Team and the Vice President of Scientific Affairs of Collagen and
the Director of Research & Development of Innovasive.
-3-
<PAGE>
3.2 Oversight. The Vice President of Scientific Affairs of Collagen and
---------
the Director of Research & Development of Innovasive shall be responsible for
overseeing the activities of the Project Team. In the event that members of the
Project Team are unable to agree on any issue in connection with the
implementation of the Project Plan, the Vice President of Scientific Affairs of
Collagen and the Director of Research & Development of Innovasive shall
negotiate in good faith to resolve such disagreement.
3.3 Management Reviews. The Project Team shall present quarterly reviews,
------------------
in a mutually acceptable format, to senior management of both parties which
shall cover progress on the Research Project, performance to budget, and planned
activities and expenses in connection with the Research Project.
3.4 Additional Administrative Matters. Collagen shall provide Innovasive
---------------------------------
with monthly reports containing project hours for each individual working on the
Research Project and itemized actual expenditures (including total salary cost
based upon actual, not average, salary of such individuals). Out-of-pocket
expenditures exceeding ten thousand dollars ($10,000) shall be approved by both
parties prior to funds being committed for such expenditures. The parties will
use commercially reasonable efforts to use both parties' internal facilities
(e.g. machine shop facilities or animal facilities) prior to engaging outside
contractors.
4. Payments.
--------
4.1. Invoices. Within thirty (30) days after the end of any calendar
--------
quarter during the term of this Agreement, Collagen shall send Innovasive an
invoice for the actual expenses (including previously agreed upon overhead)
incurred by Collagen in the course of implementing the Project Plan in
accordance with the Project Budget.
4.2 Payment. Innovasive shall pay amounts invoiced by Collagen pursuant to
-------
Section 4.1 above within thirty (30) days after receiving such invoice.
4.3 Audit. An independent certified public accountant selected by
-----
Innovasive may, upon reasonable notice and during normal business hours, and no
more than once in any twelve (12) month period, inspect the records of Collagen
on which the invoices referred to in Section 4.1 are based. If, upon performing
such audit, it is determined that Collagen has invoiced Innovasive an amount
which exceeds the amount that Collagen should have invoiced Innovasive for the
period being audited by more than ten percent (10%), Collagen will bear all
reasonable expenses and costs of such audit. Collagen shall promptly refund any
overpayment by Innovasive. In the event that such audit reveals that Collagen
invoiced Innovasive less than the amount that Collagen should have invoiced
Innovasive for the period being audited, Collagen shall invoice Innovasive for
the amount underpaid, and Innovasive shall promptly pay such invoiced amount.
5. Ownership of Inventions.
-----------------------
-4-
<PAGE>
5.1 Solely Developed Inventions. Each party shall own all rights,
---------------------------
title and interest in any technology which it develops independently.
5.2 Jointly Developed Inventions. The parties shall jointly own all
----------------------------
rights, title and interest in any technology which they jointly develop
("Jointly Owned Technology").
6. Cross-Licenses.
--------------
Subject to the terms and conditions of this Agreement, each party (the
"Licensing Party") hereby grants the other party a worldwide, nonexclusive,
royalty-free, nontransferable, nonsublicensable license under the Licensing
Party's patents, copyrights, trade secrets and other intellectual property
rights to (i) develop Products solely in accordance with this Agreement, and
(ii) distribute Products or Other Innovasive Products solely in accordance with
the Distribution Agreement, and (iii) manufacture Products and Other Innovasive
Products solely in accordance with the Supply Agreement. Licenses set forth in
Section 6(i) shall be effective during the term of this Agreement. Licenses set
forth in Section 6(ii) for any Product or Other Innovasive Product shall be
effective for so long as the Distribution Agreement remains effective for such
Product or Other Innovasive Product. Licenses set forth in Section 6(iii) for
any Product or Other Innovasive Product shall be effective for so long as the
Supply Agreement remains effective for such Product or Other Innovasive Product.
7. Patent Applications and Enforcement.
-----------------------------------
7.1 Joint Patenting. The parties shall jointly patent Jointly Owned
---------------
Technology, and shall jointly maintain issued patents claiming Jointly Owned
Technology, in Listed Countries. The parties shall jointly agree upon their
respective responsibilities in connection with the patenting and/or maintenance
of Jointly Owned Technology in Listed Countries (and any other countries of
mutual interest), and shall (i) cooperate and provide reasonable assistance to
each other to facilitate such patenting or patent maintenance, and (ii) share
equally all out-of-pocket expenses associated with such patenting or patent
maintenance. For all patent applications on which the parties are cooperating
in such fashion, the filing party shall provide the non-filing party with copies
of all documents and correspondence associated with such filing at least thirty
(30) days prior to such filing to enable the non-filing party to provide
comments thereon.
7.2 Independent Patenting of Jointly Owned Technology.
-------------------------------------------------
Notwithstanding Section 7.1 above, if one party does not wish to jointly file
and bear the expense of a patent application, or maintain an issued patent,
covering Jointly Owned Technology in any country other than the Listed
Countries, the other party may file and prosecute such patent application or
maintain such issued patent in such country, at its sole expense. The rights of
the non-filing party in such patent application and any patents issuing
therefrom, or in such maintained patent, shall not be affected by the preceding
sentence.
-5-
<PAGE>
7.3 Infringement Actions Against Third Parties. Each party shall
------------------------------------------
notify the other party in writing if it becomes aware of any material
infringement by a third party of the intellectual property rights of both
parties in the Jointly Owned Technology. The parties shall collaborate to abate
any infringement by a third party of their rights in the Jointly Owned
Technology; provided, that (i) the parties shall share the cost of any mutually
agreed upon actions to abate such infringement, and (ii) if one party declines
to participate in a lawsuit against the alleged third party infringer, then the
other party may undertake such lawsuit at its own expense on behalf of both
Collagen and Innovasive. Proceeds from any actions described in Section 7.3(i)
should be shared equally. Proceeds from any actions described in Section 7.3
(ii) shall be allocated between the parties in accordance with their respective
mutually agreed upon contributions to the cost of such actions.
8. Trademarks.
----------
Neither party grants under this Agreement any actual or implied license
to use its trademarks, trade names or service marks to the other party.
9. Representations and Warranties.
------------------------------
9.1 By Both Parties. Collagen and Innovasive each individually
---------------
warrants that it (i) has all right, power and authority necessary to enter into
this Agreement and to grant the rights granted herein; (ii) has obtained all
approvals and authorizations that it is required to obtain in connection with
this Agreement; (iii) has not entered, and will not enter, into any arrangements
or agreements inconsistent with this Agreement; (iv) is not aware of any pending
or actual litigation which is likely to have a material adverse effect on the
rights or obligations of any party under this Agreement; and (v) as of the
Effective Date, is not aware of any claim or any basis for any claim that its
performance of its obligations hereunder will infringe any patents, trade
secrets or other intellectual property rights belonging to any third party.
9.2 Disclaimer of Other Warranties. THE REPRESENTATIONS AND
------------------------------
WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT, THE DISTRIBUTION AGREEMENT,
THE SUPPLY AGREEMENT AND THE INVESTMENT AGREEMENTS ARE EXCLUSIVE AND ARE IN LIEU
OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF
LAW, STATUTORY OR OTHERWISE, INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS
FOR A PARTICULAR PURPOSE FOR ANY PRODUCTS PRODUCED IN THE COURSE OF THE RESEARCH
PROJECT.
10. Term and Termination.
--------------------
10.1 Term. This Agreement shall become effective on the Effective
----
Date and shall continue in effect for an initial term of five (5) years.
Thereafter, this Agreement may
-6-
<PAGE>
* As to asterisked portion, omitted and filed separately with the
Securities and Exchange Commission pursuant to Request for Confidential
Treatment.
be renewed by mutual written agreement of the parties. This Agreement may be
terminated at any time after the Effective Date in accordance with the
provisions of this Section 10.
10.2 Termination of Product Development.
----------------------------------
(i) In the event that Innovasive believes that progress on the
development of Product One is unsatisfactory, Innovasive shall have the right to
terminate development of Product One upon ninety (90) days written notice after
the earlier to occur of (a) the second anniversary of the Effective Date, or (b)
the expenditure by Innovasive of $1.2 million on the development of Product One.
During such ninety (90) day notice period, Collagen shall not incur any
commitments or expenses with respect to Product One which will be funded by
Innovasive, other than commitments or expenses entered into or committed to
prior to the date of such written notice from Innovasive. The parties will
negotiate comparable provisions as part of the negotiation of extensions of the
Project Plan to cover additional Products. If the parties are unable to agree
upon an extension of the Project Plan to cover any Product within a period of
six (6) months of good faith discussions concerning such extension of the
Project Plan, either party may terminate the development of such Product upon
thirty (30) days written notice. The provisions of Section 2.5 shall not apply
to any Product for which development has been terminated by either party
pursuant to this Section 10.2.
(ii) Innovasive hereby agrees that if Innovasive terminates
collaborative development of a Product pursuant to Section 10.2(i) above,
Collagen shall thereafter have the worldwide, sublicensable, perpetual and
irrevocable right under Innovasive's solely owned technology to use, reproduce
or have reproduced and modify such technology, and to use, manufacture or have
manufactured, market, promote and otherwise commercialize, and sell or otherwise
distribute such technology incorporated in such Product (as modified and/or
improved by Collagen after Innovasive terminates development of such
Product). It is the parties' intention that the foregoing license shall be
construed broadly enough to permit Collagen to continue or commence the
development, modification and distribution of such Product in a commercially
reasonable fashion. Collagen shall pay Innovasive a royalty on its Net Sales
(as defined in the Distribution Agreement) of such Product which shall
be mutually agreed upon, or if the parties are unable to agree, shall be set by
a mutually acceptable third party. Such royalty shall not exceed * percent
(*%). Such royalty shall be subject to Sections 6.3 through 6.8 inclusive of the
Distribution Agreement, after substitution of (a) such Product in place of
Reverted Products, (b) Innovasive in place of the Distributing Party, and (c)
Collagen in place of the Other Party ("Reverted Products", "Distributing Party"
and "Other Party" are terms defined in the Distribution Agreement).
Notwithstanding the foregoing, the parties agree that the distribution of any
Product shall be in Collagen's sole discretion and shall be outside the scope of
the Distribution Agreement if the collaborative development of such Product is
terminated by Innovasive and such Product is subsequently completed and
commercialized by Collagen pursuant to this Section 10.2(ii).
-7-
<PAGE>
10.3 Default.
-------
(i) If either party defaults in the performance of any of its
material obligations hereunder and if such default is not corrected within
ninety (90) days after written notice thereof by the other party, then the
nondefaulting party, at its option, may, in addition to any other remedies it
may have, terminate this Agreement by giving written notice of termination to
the defaulting party.
(ii) The parties expressly agree that any material default by a
party in the performance of such party's obligations under the Project Plan
shall constitute a default in such party's material obligations hereunder for
purposes of Section 10.3(i) above.
10.4 Insolvency. This Agreement may be terminated by either party,
----------
on written notice, (i) if the other party becomes insolvent, (ii) upon the
institution by the other party of insolvency, receivership or bankruptcy
proceedings or any other proceedings for the settlement of its debts, (iii) upon
the institution of such proceedings against the other party, which are not
dismissed or otherwise resolved in its favor within sixty (60) days thereafter,
(iv) upon the other party's making a general assignment for the benefit of
creditors, or (v) upon the other party's dissolution or ceasing to conduct
business in the normal course.
10.5 Survival. Sections 5, 6 (with respect to any Products for
--------
which the parties have approved a revised Project Plan covering such Product
prior to the fifth (5th) anniversary of the Effective Date), 7, 8, 9, 10.2(ii),
10.5, 11, 12, 13 (for the period set forth in Section 13.5), 14 and 15 shall
survive any termination or expiration of this Agreement.
11. Indemnities.
-----------
Each party (the "Indemnifying Party") shall defend, indemnify and hold
the other party (the "Indemnified Party") harmless against all damages, costs
(including attorneys' fees) or other liability actually incurred by the
Indemnified Party or assessed against the Indemnified Party by a court of
competent jurisdiction, arising from any claim, suit or proceeding brought
individually or severally against the Indemnified Party resulting from any
fraudulent or negligent act or omission by the Indemnifying Party, or the
Indemnifying Party's employees, agents or other representatives, in the course
of performing the Indemnifying Party's obligations hereunder. The Indemnified
Party shall provide the Indemnifying Party with prompt notification of any such
claim, suit or proceeding, and shall provide the Indemnifying Party with
reasonable assistance, at the Indemnifying Party's expense, in connection with
the defence or settlement thereof. The Indemnifying Party shall have sole
control of the defense or settlement of any such claim, suit or proceeding. The
Indemnified Party may retain counsel of its own choosing at its own expense.
-8-
<PAGE>
12. Limitation of Liability.
-----------------------
EXCEPT AS SET FORTH IN SECTION 11, IN NO EVENT SHALL ANY PARTY BE LIABLE
TO ANY OTHER PARTY FOR LOST PROFITS OR ANY CONSEQUENTIAL, SPECIAL, INCIDENTAL,
OR INDIRECT DAMAGES OF SUCH OTHER PARTY, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY, ARISING OUT OF THIS AGREEMENT. THESE LIMITATIONS SHALL APPLY
NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
13. Confidentiality.
---------------
13.1 Confidential Information. As used in this Agreement, the term
------------------------
"Confidential Information" shall mean any information disclosed by one party to
another pursuant to this Agreement which the recipient knows or has reason to
know is deemed confidential or proprietary by the disclosing party.
13.2 Confidentiality. Each party shall treat as confidential all
---------------
Confidential Information of any other party, shall not use such Confidential
Information except as set forth herein, and shall use reasonable efforts not to
disclose such Confidential Information to any third party. Without limiting the
foregoing, each of the parties shall use at least the same degree of care which
it uses to prevent the disclosure of its own confidential information of like
importance to prevent the disclosure of Confidential Information disclosed to it
by the other parties under this Agreement. Each party shall promptly notify the
other party of any actual or suspected misuse or unauthorized disclosure of such
other party's Confidential Information.
13.3 Exceptions. Notwithstanding the above, neither party shall have
----------
liability to the other party with regard to any Confidential Information of such
other party which the receiving party can demonstrate:
(i) was in the public domain at the time it was disclosed or
has entered the public domain through no fault of the receiving party;
(ii) was known to the receiving party, at the time of
disclosure, as demonstrated by files in existence at the time of disclosure;
(iii) was disclosed with the prior written approval of the
disclosing party;
(iv) was independently developed by the receiving party
without any use of the Confidential Information of any other party, as
demonstrated by files created at the time of such independent development;
-9-
<PAGE>
(v) became known to the receiving party, without restriction, from
a source other than the disclosing party without breach of this Agreement by the
receiving party and otherwise not in violation of the disclosing party's rights;
(vi) has been disclosed to third parties by the disclosing party
without restrictions similar to those contained in this Agreement; or
(vii) is disclosed pursuant to the order or requirement of a court,
administrative agency, or other governmental body; provided, however, that the
receiving party shall provide prompt written notice thereof to the disclosing
party to enable the disclosing party to seek a protective order or otherwise
prevent or restrict such disclosure.
13.4 Return of Confidential Information. Upon expiration or termination of
----------------------------------
this Agreement each party shall upon request promptly return all tangible
Confidential Information received from the other party.
13.5 Survival of Confidentiality Obligations. This Section 13 will
---------------------------------------
survive, for any item of Confidential Information, for five (5) years after the
disclosure of such Confidential Information to the receiving party.
14. Confidentiality of Agreement.
----------------------------
Collagen and Innovasive agree that the terms and conditions of this
Agreement shall be treated as Confidential Information and shall not be
disclosed to any third party without the prior written consent of the other
party. Notwithstanding the statements above in this Section 14, any party may
disclose any of the terms and conditions of this Agreement:
(i) as required by any court or other governmental body;
(ii) as otherwise required by law (including without limitation with
regard to any registration statement filed by a party with the Securities and
Exchange Commission);
(iii) to legal counsel of the parties;
(iv) in confidence, to accountants, banks, and financing sources,
and other advisors or consultants of the parties;
(v) in connection with the enforcement of this Agreement or rights
under this Agreement;
(vi) in confidence, in connection with an actual or proposed
license, merger, acquisition, or similar transaction;
-10-
<PAGE>
(vii) which have been previously disclosed in a joint press release
by the parties hereto; or
(viii) in confidence, to a third party to the extent reasonably
necessary to permit the consideration of a bona fide collaboration which would
involve rights, obligations or limitations arising under this Agreement,
provided that such collaboration is not prohibited under this Agreement.
In the event of any disclosure pursuant to (i) or (ii) above, the
disclosing party shall use all reasonable efforts to obtain confidential
treatment of materials so disclosed. The parties shall in good faith consult
regarding the text of any proposed public announcement regarding this Agreement
or the terms and conditions hereof before such announcement is actually made.
Any press release to be issued in connection with the terms and conditions of
this Agreement must be approved in advance by both Collagen and Innovasive.
15. General.
-------
15.1 Governing Law. This Agreement shall be governed by and
-------------
interpreted in accordance with the laws of the State of California, without
reference to conflicts of laws provisions.
15.2 Partial Invalidity. If any provision in this Agreement shall be
------------------
found or be held to be invalid or unenforceable in any jurisdiction in which
this Agreement is being performed, then the meaning of said provision shall be
construed, to the extent feasible, so as to render the provision enforceable,
and if no feasible interpretation would save such provision, it shall be
severed, solely in such jurisdiction, from the remainder of this Agreement,
which shall remain in full force and effect. In such event, the parties shall
negotiate, in good faith, a substitute, valid and enforceable provision,
effective solely in such jurisdiction, which most nearly effects the parties'
intent in entering into this Agreement.
15.3 Relationship of the Parties. Collagen and Innovasive are independent
---------------------------
contractors under this Agreement. Nothing contained in this Agreement is
intended nor is it to be construed so as to constitute Collagen and Innovasive
as partners or joint venturers with respect to this Agreement. Employees of any
party remain employees of said party and shall at no time be considered agents
of or to be obligated to render a fiduciary duty to the other party.
15.4 Modification. No alteration, amendment, waiver, cancellation or
------------
other change in any term or condition of this Agreement shall be valid or
binding on any other party unless the same shall have been mutually assented to
in writing by both parties.
15.5 Waiver. The failure of any party to enforce at any time any of the
------
provisions of this Agreement, or the failure to require at any time performance
by the
-11-
<PAGE>
other parties of any of the provisions of this Agreement, shall in no way be
construed to be a present or future waiver of such provisions, nor in any way
affect the right of any party to enforce each and every such provision
thereafter. The express waiver by any party of any provision, condition or
requirement of this Agreement shall not constitute a waiver of any future
obligation to comply with such provision, condition or requirement.
15.6 Assignment. This Agreement shall be binding upon and shall
----------
inure to the benefit of the parties hereto and their respective successors and
assigns. No party may assign any of its rights, obligations or privileges (by
operation of law or otherwise) hereunder without the prior written consent of
the other party, which shall not be unreasonably withheld, provided, that any
party shall have the right to assign its rights, obligations and privileges
hereunder to a successor in business or an acquirer of all or substantially all
of its business or assets to which this Agreement pertains without obtaining the
consent of the other party.
15.7 Notices. Any notice required or permitted to be given by any
-------
party under this Agreement shall be in writing, shall be addressed to the Chief
Financial Officer of Innovasive, with a copy to Roslyn G. Daum, Esq. Choate,
Hall & Stewart, Exchange Place, Boston, MA 02109 or to the Vice President of
Scientific Affairs of Collagen, and shall be personally delivered or sent by
certified or registered letter, or by telecopy confirmed by registered or
certified letter, to the receiving party at its address first set forth above,
or such new address as may from time to time be supplied hereunder by the
receiving party. Notices will be deemed effective upon receipt.
15.8 Force Majeure. Notwithstanding anything else in this Agreement,
-------------
no default, delay or failure to perform on the part of any party shall be
considered a breach of this Agreement if such default, delay or failure to
perform is shown to be due to causes beyond the reasonable control of the party
charged with a default, including, but not limited to, causes such as strikes,
lockouts or other labor disputes, riots, civil disturbances, actions or
inactions of governmental authorities or suppliers, epidemics, war, embargoes,
severe weather, fire, earthquakes, acts of God or other deities, acts of the
public enemy, nuclear disasters, or default of a common carrier; provided, that
for the duration of such force majeure the party charged with such default must
continue to use all reasonable efforts to overcome such force majeure.
15.9 Dispute Resolution. In the event of any disagreement arising
------------------
hereunder or with respect to this Agreement which the Vice President of
Scientific Affairs of Collagen and the Director of Research & Development of
Innovasive are unable to resolve, the matter shall be referred to qualified
designated representatives of both parties. Such individuals shall negotiate in
good faith to resolve such dispute for thirty (30) days, or for such longer
period of time as such individuals may agree upon. If such negotiations do not
result in a mutually satisfactory resolution of the issue in question, then the
matter shall be resolved by any procedure agreed to by such individuals or, in
the absence of such an agreed procedure, by a court of competent jurisdiction.
-12-
<PAGE>
15.10 Entire Agreement. The terms and conditions contained in this
----------------
Agreement, the Distribution Agreement, the Supply Agreement and the Investment
Agreements constitute the entire agreement between the parties and supersede all
previous agreements and understandings, whether oral or written, between the
parties hereto with respect to the subject matter hereof and thereof.
15.11 License of Intellectual Property. All rights and licenses
--------------------------------
granted under this Agreement by one party ("Licensor") to another party
("Licensee") are, and shall be deemed to be, for purposes of Section 365(n) of
the U.S. Bankruptcy Code, licenses of rights to "intellectual property" as
defined under Section 101 of the U.S. Bankruptcy Code. The parties agree that
Licensee, as the licensee of such rights under this Agreement, may fully
exercise all of its rights and elections under the Bankruptcy Code. The parties
further agree that, in the event Licensee elects to retain its rights as a
licensee in Licensor's bankruptcy proceedings, Licensee shall be entitled to a
complete duplicate of (or complete access to, as appropriate) any technology
licensed to Licensee by Licensor hereunder, and all embodiments of such
technology, and such embodiments of such technology, if not already in its
possession, shall be promptly delivered to Licensee (i) upon any such
commencement of a bankruptcy proceeding upon written request therefor by
Licensee unless Licensor elects to continue to perform all of its obligations
under this Agreement, or (ii) if not delivered under (i) above, upon the
rejection of this Agreement by or on behalf of Licensor upon written request for
such embodiments by Licensee.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
signed by duly authorized officers or representatives as of the date first above
written.
COLLAGEN CORPORATION INNOVASIVE DEVICES, INC.
BY: /s/ Frank DeLustre BY: /s/ James V. Barrile
------------------------ --------------------
PRINT NAME: Frank DeLustre PRINT NAME: James V. Barrile
---------------- ----------------
TITLE: Senior Vice President TITLE: Vice President, CFO
--------------------- -------------------
-13-
<PAGE>
* As to asterisked portion, omitted and filed separately with the Securities
and Exchange Commission pursuant to Request for Confidential Treatment.
EXHIBIT A
PROJECT PLAN
*
<PAGE>
EXHIBIT B
LISTED COUNTRIES
