Exhibit 10.15


 


CONFIDENTIAL
TREATMENT REQUESTED:


 


Portions
of this Exhibit have been redacted pursuant to a request for confidential
treatment under Rule 24b-2 of the General Rules and Regulations under
the Securities Exchange Act of 1934, as amended.  Such redacted portions
have been replaced with “{***}” in this
Exhibit.  An unredacted version of this document has
been filed separately with the Securities and Exchange Commission along with
the request for confidential treatment.


 


PRODUCT DEVELOPMENT
and LICENSE AGREEMENT

(Diltiazem Bead Tablets)


 


THIS AGREEMENT IS
MADE EFFECTIVE THIS 31st DAY OF MAY 2000 BETWEEN:


 


BIOVAIL LABORATORIES
INCORPORATED a Barbados corporation incorporated under the International
Business Companies Act, 1991-24, whose head office is


 


Chelston Park


Building 2, Collymore
Rock


St. Michael BH1


Barbados, West
Indies,


 


(“Biovail”)


 


- and -


 


Universiteit Gent


a public law entity
having its offices at St. Pietersnieuwstraat 25


B-9000 Gent


Belgium


 


(the “University”)
and -


 


Professor Jean-Paul
Remon


acting as Director of
the Department of Pharmaceutical Technology of the University,


Harelbekestraat 72 B


B-9000 Gent


 


(“Remon”)


 


WHEREAS Biovail has
developed and is marketing a once-daily controlled release formulation of
diltiazem, in the form of capsules;


 


WHEREAS Remon has
developed a method of compressing of beads into tablets which was communicated
to Biovail under a secrecy agreement signed on August 21st, 1998;


 


WHEREAS Biovail has
expressed an interest in the commercial exploitation of this method;


 


WHEREAS Biovail is
interested in developing a controlled release formulation of diltiazem, in the
form of tablet;


 

















 


WHEREAS that
controlled release tablet formulation is intended to be bio-equivalent to
marketed controlled release Diltiazem in form of non compressed encapsulated
Beads according to FDA and TPP regulations.


 


WHEREAS the Licensors
have represented to Biovail that they have the capability of developing
controlled release formulations of various medicines;


 


WHEREAS Biovail is
interested in engaging the Licensors, and each of them, to perform specific
development services relating to the development of a controlled release
formulation of diltiazem for which Biovail may obtain marketing authorizations
in Canada, the United States of America and such other countries;


 


WHEREAS the Licensors
are willing to perform the development work specified in this Agreement to
apply their existing technology to the preparation of a controlled release
formulation of Diltiazem, subject to the terms and conditions hereinafter set
forth;


 


WHEREAS the Licensors
are willing to license to Biovail such application of this technology for the
controlled release formulation of Diltiazem, allowing Biovail inter alia to
obtain marketing authorizations in Canada, in the United States or in any other
countries.


 


IN CONSIDERATION OF
the mutual covenants and agreements contained in this Agreement and other good
and valuable consideration (the receipt and sufficiency of which are
acknowledged by each of the Parties), it is agreed by and between the Parties
as follows:


 


DEFINITIONS


 


As used in this
Agreement, the following terms shall have the meanings set forth in this
Article:


 


1.1                                 Additional Products means any controlled release formulations of any
pharmaceutically active compound in the form of tablets made by compressing
beads or pellets using any part or all of the University Technology, and which
are developed or to be developed pursuant to the terms of this Agreement,
excluding:


 


(a)                                  any such formulation in which the principal active ingredient is the
subject of any existing or future agreement relating to the Technology between
the University and any third party;


 


(b)                                 any such formulation which is primarily intended for agricultural use;


 


(c)                                  any such formulation which is primarily intended for veterinary use; and


 


(d)                                 any such formulation in which the principal active ingredient is the
subject of patent protection in the form of a product or product by process
claim which is in force for at least four more years.


 

















 


1.2                                 Affiliated Company means any company, partnership, joint venture or
subsidiary that is Controlled directly or indirectly by one of the Parties, or
any company that directly or indirectly Controls one of the Parties, or any
company that is directly or indirectly Controlled by a company which also
directly or indirectly Controls one of the Parties, so that Affiliated Company
shall include any parent or subsidiary of one of the Parties, or any direct or
indirectly held subsidiary of one of the Parties. Affiliate has a corresponding
meaning.


 


1.3                                 Agreement means this agreement, all schedules to this Agreement and all
instruments supplemental to this Agreement or in amendment or confirmation of
this Agreement; “hereof’, “hereto” and “hereunder” and similar expressions mean
and refer to this Agreement and not to any particular article, or paragraph;
and “article”, “paragraph”, or “schedule” mean and refer to the specified
article, paragraph, or schedule of this Agreement.


 


1.4                                 Application for Regulatory Approval means an application made to a
Regulatory Authority in the Territory for permission to Market and/or
Manufacture the Product in any country in the Territory.


 


1.5                                 Beads means Biovail’s formulation of extended release diltiazem, in the
form of generally spherical particles individually covered with an appropriate
extended release coating and used by Biovail, infer alia, in manufacturing a
controlled release formulation of diltiazem in the form of capsules marketed in
the USA and in Canada in association with the trade mark Tiazac.


 


1.6                                 Biovail Technology means any technology, information or data relating to
the Product or any Additional Product developed by or for Biovail by Persons
other than the Licensors.


 


1.7                                 Business Day means any day other than a Saturday, Sunday or statutory
holiday in the Territory.


 


1.8                                 Clinical Batches means commercial size batches of any product on which
the clinical studies and tests necessary to file an Application for Regulatory
Approval and for obtaining Regulatory Approval are to be performed.


 


1.9                                 CMC Section means the Chemistry, Manufacturing and Control data
section of an Application for Regulatory Approval filed in the USA or Canada.


 


1.10                           Control means the ownership, directly or indirectly, of more than fifty
percent (50%) of the voting rights attached to the issued voting shares of a
Party to this Agreement.


 


1.11                           Effective Date means the date on which this Agreement becomes effective
as set out on page 1.


 


1.12                           FDA means the Food and Drug Administration of the United States of
America.


 


1.13                           First Commercial Sale means the first arm’s length sale of the Product
by Biovail or an Affiliated Company to a Purchaser.


 

















 


1.14                           GCP means Good Clinical Practice, as prescribed from time to time by the
FDA, the TPP or other Regulatory Authority in the country in which the Product
is to be Marketed during the term of this Agreement.


 


1.15                           GLP means Good Laboratory Practice, as prescribed from time to time by
the FDA, the TPP or other Regulatory Authority in the country in which the
Product is to be Marketed during the term of this Agreement.


 


1.16                           GMP means the Good Manufacturing Practices, as prescribed from time to
time by the FDA, the TPP or other Regulatory Authority in the country in which
the Product is to be Marketed during the term of this Agreement.


 


1.17                           Improvement means an improvement to the Product for which Regulatory
Approval may be obtained by filing a supplement to the Regulatory Approval.


 


1.18                           Intellectual Property means all trademarks, patents, copyrights, industrial
designs (including applications for any of the foregoing, and any renewals,
divisions, extensions and reissues, where applicable, relating thereto), owned
by or licensed to the Licensors, or either of them, and relating to the Product
or any Additional Product.


 


1.19                           Invention means the technology involved in the compression of beads into
tablets, as invented by Professor Jean-Paul Remon and as communicated to
Biovail of Canada under a confidentiality agreement made in September, 1998 and
presently the subject of a Patent Application Nr. GB 992 1933.9.


 


1.20                           Know-How means any and all trade secrets, know-how, and other
non-publicly known inventions, discoveries, formulae, processes, and data
related to the technology used to formulate and Manufacture the Product or any
Additional Product owned by or licensed to the Licensors, or either of them,
and which relate to preparations or formulations of the Product or any
Additional Product, and includes all data and information relating to:


 


(a)                                  Any characteristics, selection, judgment of properties and data relating
to all materials used or useful in the processing, preparing, manufacturing,
making and testing of the Product or any Additional Product; and


 


(b)                                 All information and data concerning any processes, techniques, equipment
and methods used or useful in the processing, preparing, manufacturing, making
and testing of the Product or any Additional Product.


 


1.21                           Lab Batches means batches of a product manufactured using laboratory
size equipment for the purpose of developing and testing any formulation for
that product.


 


1.22                           Licensors means the University and Remon.


 


1.23                           Manufacture means to process, prepare, make, test, package or label the
Product, and Manufacturing and Manufactured have a corresponding meaning;


 

















 


1.24                           Market means to register, promote, distribute, test, market, advertise,
sell or offer to sell, and Marketing has a corresponding meaning.


 


1.25                           NDA means a New Drug Application filed with FDA in connection with an
Application for Regulatory Approval in the United States.


 


1.26                           NDS means a New Drug Submission filed with TPP in connection with an
Application for Regulatory Approval of the Product by the TPP.


 


1.27                           Net Sales means the total of all amounts received in arm’s-length sales
made by Biovail or by any Affiliate of Biovail of the Product to arm’s length
purchasers, including Sub-Licensees and distributors, in the Territory,
(excluding sales made by Biovail to any Affiliate of Biovail) net of:


 


(a)                                  distributors’, wholesalers’ or trade discounts or rebates, and rebates
actually paid to customers for distribution services;


 


(b)                                 price adjustments to customers’ inventories to address market price
declines;


 


(c)                                  charge-backs or rebates actually allowed and taken on such sales in such
amounts as are customary in the trade and are specifically related to the
Product (excluding cash discounts, except for normal trade discounts for early
payment of invoices);


 


(d)                                 duties and taxes on any sale to the extent separately included in the
amount billed;


 


(e)                                  transportation charges separately itemized;


 


(f)                                    credits for product returns; and


 


(g)                                 other deductions mutually agreed on by the Licensors and Biovail.


 


1.28                           Party means any of Biovail, the University, or Remon, and Parties means
any two or more of them.


 


1.29                           Person means an individual, partnership, joint venture, trustee, trust,
corporation, unincorporated organization or other entity or a government, state
or agency or political subdivision thereof, and pronouns have a similarly
extended meaning.


 


1.30                           Pilot Batch means a batch of approximately 50,000 doses of a product
made on pilot size production equipment at Biovail’s manufacturing facility on
which in vitro studies or pilot bio studies may be performed.


 


I.31                             Pilot Bio Study means the development and conducting of comparative
bioavailability studies on a Lab Batch or a Pilot Batch of a Product to
determine whether that Product meets the applicable in vivo Product Standards.


 


1.32                           Product means the controlled release formulation of Diltiazem in the
form of a tablet which meets the Product Standards, which is made by
compressing Beads using any part or all of the


 

















 


University
Technology, and which is developed by the Licensors pursuant to their
obligations under this Agreement.


 


1.33                           Product Standards means the standards for the Product set out in
Schedule 1.33 to this Agreement, including the Target Profile, and the dosage
forms and strengths for the Product.


 


1.34                           Regulatory Approval means approval to Market pharmaceutical products
issued by government health authorities.


 


1.35                           Regulatory Authority means a government health authority or other body
having jurisdiction to grant Regulatory Approvals within the Territories.


 


1.36                           Royalty Bearing Product means the Product and any Additional Product.


 


1.37                           Sub-Licensee means any Person licensed or authorized by Biovail to
Market the Product or any Additional Product in any country in the Territory
and includes any Affiliate of Biovail, and any distributor appointed by Biovail
for the Product.


 


1.38                           Target Profile means the bioavailability profile for the Product to be
achieved by Biovail, as specified by Biovail.


 


1.39                           Term means the period of time that this Agreement will remain in force
unless earlier terminated in accordance with the provisions of Article 12.


 


I.40                             Territory means all countries of the world.


 


1.41                           TPP means the Therapeutic Products Program of Health Canada or any
successor agency having the administrative authority to regulate or approve the
testing or marketing of human pharmaceutical or biological therapeutic products
in Canada.


 


I.42                             University Technology means collectively, the Invention, the Know-How
and all Intellectual Property in existence at the Effective Date or developed
by or for the Licensors after the Effective Date.


 


I.43                             The following Schedules are attached to this Agreement:


 


(a)                                  Schedule 1.33                       Product
Standards


 


(b)                                 Schedule 2.1                             Product
Development Steps


 


(c)                                  Schedule 3.1                             Development
Fees


 


2                                          PRODUCT DEVELOPMENT SERVICES


 


2.1                                 Biovail hereby engages the Licensors, and each of them, to work in close
co-operation with Biovail to apply the University Technology to the development
of the Product in accordance with Schedule 2.1. Licensors shall diligently
pursue the development of the Product to enable Biovail to apply for and obtain
Regulatory Approval for the Product in Canada and the United


 

















 


States. In return,
Biovail agrees to pay to the Licensors the Fees set out in Article 3 of
this Agreement.


 


The Licensors shall
use their best efforts, in accordance with the highest professional standards
in performing the development services described in this section, and shall
diligently perform the development work. The Licensors shall incur no liability
for any damage, as specified in Article 16.5, caused to Biovail if the
development of the Product, or the Application for Regulatory Approval for the
Product, is not successful.


 


Review of Work done
to Date


 


2.2                                 The Licensors shall provide to Biovail, as soon as reasonably possible
after the Effective Date, the results of any in vitro or in vivo testing of any
formulation of the Product that is available to the Licensors at that time.


 


Formulation
Development


 


2.3                                 The Licensors shall perform all of the services specified in this Article 2,
in co-operation with Biovail, and shall assist Biovail:


 


(a)                                  in developing the Product to meet the Product Standards, and


 


(b)                                 in acquiring the ability to Manufacture the Product in full compliance
with the Product Standards.


 


2.4                                 Biovail shall supply to the Licensors, at the request of and at no cost
to the Licensors, such quantities of Beads as the Licensors may reasonably
require for the purposes of the development of the Product. The Licensors shall
as soon as reasonably possible after the execution of this Agreement provide to
Biovail a schedule with its estimated requirements, by quantity and time, for
the Beads. The Licensors shall keep full and accurate records of the quantities
of Beads received and used by them, for three (3) years following the
receipt of each shipment from Biovail. Such records shall be made available for
inspection by Biovail or an independent certified public or chartered
accountant of Biovail’s choice during normal business hours after reasonable
notice, up to two (2) years after the termination or expiration of this Agreement,
and at Biovail’s expense. Such inspection shall occur no more often than once a
year, except in the year following the discovery of any discrepancies, during
which quarterly inspections shall be permitted.


 


2.5                                 Biovail shall provide to the Licensors, at the request of the Licensors,
all data on Diltiazem, including chemistry and pharmacological data and
analytical and methodological data that, in the opinion of Biovail, the
Licensors may require to carry out their obligations under this Agreement.


 


Preparation of Lab
Batches


 


2.6                                 The Licensors shall develop, for and on behalf of Biovail, all
formulations for the Product, and prepare all Lab Batches of those
formulations, required for the purposes of this Agreement. The Licensors shall
conduct whatever analytical tests and studies are required to


 

















 


demonstrate that
those Lab Batches meet the applicable Product Standards in accordance with
protocols approved by Biovail.


 


2.7                                 The Licensors shall as soon as reasonably possible after the completion
of any test or study on any Lab Batch provide the results of that test or
study, together with all information relating to the formulation of the Lab
Batch tested, to Biovail for review.


 


Stability Protocols
and Analytical Methods


 


2.8                                 Biovail shall be responsible for developing all of the stability
protocols, including but not limited to those required for the CMC Section, and
all bioavailability protocols, required for the test and studies contemplated
by paragraph 2.22 of this Agreement.


 


2.9                                 The Licensors shall develop and validate all necessary analytical
methods and disclose those to Biovail for review and approval before use. Such
approval shall not be unreasonably delayed or withheld. Biovail shall, at the
request of the Licensors, provide to the Licensors any validated analytical
methods known to Biovail and useful in the development of the Product.


 


2.10                           Any report or protocol required by this Agreement to be delivered to
Biovail shall be deemed to be approved by Biovail upon the expiry of thirty
(30) working days from the date of delivery to Biovail unless Biovail has
within that thirty (30) days delivered to the Licensors a notice specifying all
of the defects or deficiencies in that report or protocol. Biovail may
designate any third person to inspect any such report or protocol.


 


Reporting by the
Licensors


 


2.11                           The Licensors shall deliver on oral report on the development of the
Product, by conference call, every two weeks. The Licensors shall deliver to
Biovail every sixty days during the development of the Product, written reports
setting out the steps taken by the Licensors to develop the Product, summaries
of any tests or studies conducted by the Licensors since the last such report
was delivered, and a comparison of the progress made in the development of the
Product against the Development Plan, and shall provide to Biovail on a monthly
basis an extract relating to the Product from Biovail’s internal monthly
R&D report.


 


Pilot Batches and
Pilot Bio Studies at Biovail


 


2.12                           As soon as possible after Biovail is satisfied that the Lab Batches of
the Product prepared and tested by the Licensors meet the Product Standards,
Biovail shall use its reasonable best efforts to manufacture one or more Pilot
Batches of the Product in all dosage strengths of the Product at a Biovail
facility. The Licensors shall at the request of Biovail, assist Biovail in the
manufacture of those Pilot Batches of the Product. Remon and any other
representatives of the Licensors reasonably required for that purpose shall at the
request of Biovail be present at the manufacture of each such Pilot Batch.
Biovail shall reimburse the Licensors for the reasonable out of pocket expenses
incurred by the Licensors for that purpose.


 


2.13                           Biovail may perform such Pilot Bio Studies on each Pilot Batch as
Biovail may reasonably require for the purposes of this Agreement, and shall
notify the Licensors of the successful 


 

















 


completion of each
such Pilot Study, or of the reasons why the results of any Pilot Bio Study was
not successful.


 


2.14                           In the event that Biovail determines from the results of any such Pilot
Bio Study that the Product studied does not meet the Product Standards, the
Licensors shall, at the request of Biovail, make any necessary modifications to
the formulation of the Product and prepare additional Lab Batches of the
Product, and shall assist in repeating the development, production and testing
of Pilot Batch until the deficiencies noted by Biovail are corrected..


 


Clinical Batches


 


2.15                           Biovail shall use its reasonable best efforts to manufacture one or more
Clinical Batches of the Product as soon as reasonably possible, after the
successful completion of the Pilot Bio Studies. The Licensors shall provide
whatever assistance is reasonably required by Biovail for that purpose.


 


2.16                           Biovail shall complete the Pivotal Bio Studies on the Product as soon as
reasonably possible after the manufacture of the Clinical Batch(es).


 


Scope of Assistance
by the Licensors


 


2.17                           The Licensors shall provide to Biovail, at no additional cost to Biovail
except as provided in this Agreement, such assistance in the Manufacture of any
Pilot Batches, Clinical Batches, validation batches and pre-approval batches,
in the Application for Regulatory Approval and in the Manufacture of the
Product, at Biovail’s manufacturing facility as Biovail may reasonably require.
Such assistance shall be sufficient to enable Biovail to Manufacture the
Product on a commercial scale so that the Product when manufactured will meet
the Product Standards.


 


2.18                           In fulfilment of the obligations of the Licensors:


 


(a)                                  technical personnel of Biovail shall, at Biovail’s expense, have the
right by prior arrangement to visit the relevant research and development
facilities of the Licensors to review, examine and acquire any formulations,
test results or other Know-How related to the use of the University Technology
to develop and manufacture the Product under this Agreement. The Licensors
shall co-operate fully with and assist Biovail’s personnel in order to
facilitate the review and examination of that Know-How; and


 


(b)                                 at the request of Biovail, Remon or any other employees of the Licensors
skilled in manufacturing the Product and acceptable to Biovail, shall visit
Biovail’s manufacturing facility to advise and assist Biovail’s personnel in
the use or application of the Know-How, including the Manufacture of that
Product, and in any relevant analytical and quality control procedures known to
the Licensors, and methods for such Manufacture. Dates and times for such
visits shall be arranged at the mutual convenience of Biovail and the
Licensors, but shall not be unreasonably delayed by the Licensors.


 


2.19                           Biovail shall be entitled to a maximum of twenty (20) man-days of such
visits for the Product, by Remon and/or employees of the Licensors skilled in
the Manufacture of the Product. Should Biovail required additional assistance,
the Licensors shall at the request of Biovail 


 

















 


provide such
assistance. Biovail shall reimburse the Licensors for the travel expenses
reasonably incurred by the Developer in providing such assistance to Biovail.


 


Information for the
Application for Regulatory Approval


 


2.20                           The Licensors shall provide to Biovail all information relating to the
Product as it may possess, which may be reasonably necessary to enable Biovail
to complete the CMC section of an Application for Regulatory Approval, within
twenty (20) working days of the acquisition or development of such information.


 


2.21                           The Licensors shall provide to Biovail such assistance as Biovail may reasonably
require to complete the product development report required for an Application
for Regulatory Approval. In accordance with its obligations, the Licensors
shall disclose Know-How to Biovail including:


 


(a)                                  all Manufacturing procedures and processes, raw material lists and
specifications, equipment lists and specifications;


 


(b)                                 Master formula describing quantitative composition of all active and
inactive components;


 


(c)                                  Manufacturing procedures for both Lab Batches as used by the Licensors;


 


(d)                                 all in vitro and in vivo test methodologies, test results and product
specifications generated by the Licensors; and,


 


(e)                                  all reports of stability studies conducted by the Licensors; and


 


(f)                                    all other data and information reasonably in the possession of or
available to the Licensors and reasonably required by or useful to Biovail in
the preparation of an Application for Regulatory Approval in any country in the
Territory.


 


Further Studies


 


2.22                           Biovail shall, perform at its own expense, any other tests or studies
required to obtain Regulatory Approval of the Product anywhere in the Territory
where Biovail may wish to apply for Regulatory Approval of the Product.


 


3                                          DEVELOPMENT FEES AND MILESTONES


 


3.1                                 In partial compensation for the costs incurred by University for the
development of the Product using the University Technology, and for developing
a successful Clinical Batch, and in consideration for the license given
hereafter in Article 5, Biovail shall pay to the Licensors, or to any
other person designated by the Licensors, development fees in the amount of
{***}† as specified in Schedule 3.1 to this Agreement, upon the completion
of the events specified in Schedule 3.1.


 






† Represents
material which has been redacted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 














 


3.2                                 The payments required by paragraph 3.1 of this Agreement shall be paid
to the University and to Remon or his assigns, as indicated in Schedule 3.1.


 


3.3                                 Each of the payments specified in Schedule 3.1 of this Agreement shall
be non-refundable, and fully earned by the Licensors upon completion of the
development work preceding the completion of the milestone in respect of which
the payment is made specified this Agreement. No such payment shall be credited
or debited against any other amount that may be payable to the Licensors by
Biovail under this Agreement.


 


3.4                                 None of the payments made to the Licensors, or either of them shall be
returned or repaid even if any subsequent milestones or standards are not met.


 


4                                          REGULATORY APPROVALS


 


4.1                                 Provided that there are no legal or regulatory impediments to such
applications, Biovail shall itself file, or have its Sub-Licensee file, an
Application for Regulatory Approval of the Product in Canada and in the United
States of America, as soon as reasonably possible after the completion of the
tests and studies considered necessary by Biovail for that purpose.


 


4.2                                 Provided that there are no legal or regulatory impediments to such
applications, Biovail shall itself file or have its Sub-Licensee file, an
Application for Regulatory Approval in such other countries in which Biovail
deems commercialization of the Product desirable, as soon as reasonably
possible after the completion of the tests and studies considered necessary by
Biovail for that purpose.


 


5                                          GRANT OF RIGHTS TO BIOVAIL


 


Transfer to Biovail


 


5.1                                 The Licensors, and each of them, hereby grant to Biovail an exclusive
license to Manufacture and Market the Product and subject to the provisions of
paragraphs 5.5 and 5.6, any Additional Product, for pharmaceutical use, in the
Territory, to use the Technology for those purposes and to authorize or
Sub-License others to do any of the things that Biovail has the right to do
under this Agreement.


 


5.2                                 Biovail shall have the exclusive right to negotiate, and shall be solely
responsible for the negotiation of, Sub-Licenses for the Manufacture or
Marketing of the Product and/or of any Additional Product.


 


5.3                                 All of the right, title and interest in and to any formulation of the
Product developed by Biovail, and in and to any Biovail Technology, or any
University Technology relating exclusively to the Product and developed or
applied by the Licensors pursuant to this Agreement, shall belong to and be
owned by Biovail. The Licensors shall retain all rights to any University Technology
not granted to Biovail by this Agreement, but grants to Biovail an exclusive
license under that University Technology to the full extent required to enable
Biovail to Manufacture and Market the Product and, subject to the provisions of
paragraphs 5.5 and 5.6, any Additional Product. Biovail shall own all data and
information relating to the Product, or to any Additional Product developed
from any tests or studies conducted by or for Biovail, including all clinical 


 

















 


information and all
data generated by any bioavailability studies or clinical studies conducted
pursuant to the provisions of this Agreement.


 


Additional Products
and Other Uses of the Technology


 


5.4                                 Biovail shall not use the University Technology to develop any
Additional Product, or any other pharmaceutical product or formulation except
in accordance with this Agreement. Biovail shall not use the University
Technology to develop a generic version of the Product without the consent in
writing of the Licensors, or to develop an Additional Product except in
accordance with the terms of this Agreement. Biovail shall not use the Biovail
Technology, and the University shall not use the University Technology, to
develop any product containing the same active ingredient as the Product.


 


5.5                                 If at any time after the Effective Date Biovail wishes to use the
University Technology to develop any pharmaceutical product or formulation
other than the Product, Biovail shall notify the Licensors of that intention in
writing, and shall identify the active ingredient(s) and dosing strengths
of that proposed formulation, and shall confirm that the proposed formulation
meets the criteria for an Additional Product. The Licensors shall within
fourty-five (45) days of their receipt of that notice :


 


(a)                                  confirm to Biovail in writing that no agreement to develop or no license
has been granted to any third party for the use of the University Technology
with the active ingredient referred to in that notice; or


 


(b)                                 notify Biovail that such an agreement to develop or a license has been
granted; and


 


(c)                                  if such a license has not been granted, notify Biovail in writing
whether the Licensors wish to carry out the development activities set out in Article 2
of this Agreement for that Additional Product.


 


5.6                                 Upon the delivery of the confirmation of a notice by the Licensors
pursuant to paragraph 5.5(a), or the expiration of the time specified in
paragraph 5.5 without the delivery of a notice by the Licensors pursuant to
paragraph 5.5(b), the Licensors and Biovail shall enter into, and shall be
deemed to have entered into, a license agreement for that Additional Product on
the same terms as those of this Agreement. Biovail shall within sixty (60) days
of the delivery of that notice pay to the Licensors the sum of {***}† as
an advance on any royalties payable under this Agreement in respect of the Net
Sales of that Additional Product.


 


5.7                                 Biovail shall diligently pursue the development of any such Additional
Product. If that development has been suspended or discontinued for a period
longer than six (6) months, Biovail shall, at the request in writing of
the Licensors and upon repayment by the Licensors of the amounts paid pursuant
to this Agreement, surrender any rights granted to Biovail by this Agreement
and in respect of that Additional Product to the Licensors, if Biovail fails to
conduct or resume such development work within four (4) months of such a
request from the Licensors.


 






† Represents
material which has been redacted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 

















 


5.8                                 The Licensors may convert any license agreement in respect of that
Additional Product to a non-exclusive license agreement if Biovail has not
filed an Application for Regulatory Approval of that Additional Product within
three (3) years of the effective date of that license agreement. Biovail
shall, within 30 days after the request in writing from the Licensors, to be
made no more frequently than once every six months, report to the Licensors in
writing about all the steps taken by Biovail or its Affiliates to develop any
Additional Product identified in the request, and it shall advise the Licensors
whether or not it is continuing the research and development of that Additional
Product in accordance with the requirements of paragraph 5.7, and whether it
has filed an Application for Regulatory Approval of that Additional Product.


 


5.9                                 If the Licensors notify Biovail pursuant to paragraph 5.5(c) that
the Licensors do not wish to develop that Additional Product, Biovail itself
may develop that Additional Product and sub-license any rights in that
Additional Product to others.


 


Development by the
Licensors of Additional Products


 


5.10                           If the Licensors notify Biovail pursuant to paragraph 5.5(c) that
the Licensors wish to develop that Additional Product, each of the Licensors
shall, at the request of Biovail, work in close co-operation with Biovail to
apply the University Technology to the development of that Additional Product
on the same terms and conditions as those specified in this Agreement.
Licensors shall diligently pursue the development of any such Additional
Product to enable Biovail to apply for and obtain Regulatory Approval for that
Additional Product in Canada and the United States. In return, Biovail shall
pay to the Licensors the same Fees as those set out in Article 3 of this
Agreement.


 


Restriction on the
Developer’s Activities


 


5.11                           The Licensors shall not themselves Market the Product, or any other
modified, controlled or extended release form of Diltiazem, within the
Territory, and shall not assist, authorize or permit any other Person other
than Biovail to Manufacture or Market the Product, or any other modified,
controlled or extended release form of Diltiazem, within the Territory, except
as expressly permitted by this Agreement, or as otherwise expressly authorized
in writing by Biovail.


 


6                                          MARKETING OF THE PRODUCT


 


6.1                                 Provided that it is then commercially reasonable to Biovail to do so,
Biovail shall by itself or through a Sub-Licensee Market the Product in Canada,
the United States of America and in all other countries in which Regulatory
Approval has been granted for the Product in the name of Biovail or an
Affiliate within six (6) months of obtaining that Regulatory Approval for
the Product.


 


6.2                                 Provided that it is then commercially reasonable to Biovail to do so,
Biovail shall take all steps available to it to cause a Sub-Licensee to Market
the Product in any countries in which Regulatory Approval has been granted for
the Product in the name of that Sub-Licensee, within six (6) months of the
receipt of Regulatory Approval in that country.


 

















 


6.3                                 Biovail shall deliver to the Licensors at the end of each calendar
quarter a report setting the countries in which Applications for Regulatory
Approval for the Product have been filed, Sub-Licenses to Market the Product
have been entered into, and the Product is being Marketed.


 


6.4                                 The provisions of paragraphs 6.1 to 6.3 shall apply to any Additional
Product developed by Biovail.


 


7                                          INTELLECTUAL PROPERTY


 


Patent Review


 


7.1                                 The Licensors shall notify Biovail within ten (10) days after the
Effective Date of any patents or patent applications known to the Licensors, or
either of them, that may be infringed by any the Manufacture or Marketing of
the Product in the Territory. The Licensors shall modify or amend any
formulation of the Product to avoid any such infringement, or the infringement
of any other patents or patent applications that come to the attention of the
Licensors or either of them, and shall not be liable to Biovail for any delay
in the development of the Product resulting in any such modification or
amendment required by any patents issued or patent application published more
than sixty (60) days after the Effective Date.


 


7.2                                 Biovail may, from time to time during the development of the Product and
at its own expense, conduct any patent review deemed by Biovail to be necessary
or advisable to identify any patents that may be infringed by the Manufacture
or Marketing of the Product in the Territory. Biovail shall notify the
Licensors within ten (10) days of the completion of any such review of any
patents that may be infringed by any such Manufacture or Marketing. The
Licensors may modify or amend any formulation of the Product to avoid any such
infringement, and shall not be liable to Biovail for any delay in the
development of the Product resulting in any such modification or amendment
required by any patents issued or patent application published more than sixty
(60) days after the Effective Date.


 


Patent Applications


 


7.3                                 The Licensors shall file and diligently prosecute applications for
patents for the Invention, all countries of the Territory, including without
limitation in the United States, Canada and the European Patent Office,
provided that patent protection for the Invention in any such country is
reasonably available.. All such applications and all patents issuing from such
applications in the Territory shall be assigned to Biovail to the full extent
that such applications or patents cover the Product. If such a partial
assignment cannot reasonably be made the Licensors shall grant to Biovail an
exclusive license for the Product and any Additional Product under such
applications or patents for the Term of this Agreement at no further cost to
Biovail. Each of Biovail and the Licensors shall at no further cost to the
other execute any documents that may reasonably be required by the other to
fulfil its obligations to apply for and to obtain any such patents.


 


7.4                                 The Licensors shall advise Biovail in writing of its plans to file
patent applications for the Invention, and of the countries in the Territory in
which the Licensors intend to file such applications. Biovail may at its own
expense file an application for the Invention in any country in respect of
which the Licensors have not indicated that they will file an application. Any
such application filed by Biovail and any patent issuing therefrom shall be
filed in the name of the 


 

















 


inventors or of the
Licensors. All such applications filed by Biovail shall be assigned to the
Licensors to the full extent that such applications or patents cover any and
all technical application other than the Product or any Additional Product. If
such a partial assignment cannot reasonably be made, Biovail shall grant to the
Licensors an exclusive license, including the right to sublicense for any and
all technical application other than the Product or any Additional Product,
under such applications or patents for the duration of the patent. Subject to
the provisions of paragraph 7.7 of this Agreement, Biovail may deduct all of
the costs associated with or incurred in the filing, prosecution, issuing and
maintenance of any such patents and applications in any such country from the
royalties payable to the Licensors pursuant to Article 8 of this
Agreement.


 


7.5                                 Biovail may, at its own expense, file applications for patent for any
new invention relating directly to the Product or to any Additional Product
(after a license has come into existence according to Sections 5.5 and 5.6) or
to the Biovail Technology in any countries or territories in which Biovail
intends to sell the Product or have the Product sold, and where such patent
protection is reasonably available.


 


7.6                                 The Licensors shall, at their own expense, file applications for patents
any new invention not relating directly to the Product or to any Additional
Product but otherwise relating to the University Technology in the United
States of America, Canada, and in Europe and in all other countries and
territories in which Biovail indicates, in writing to the University, its
intention to sell the Product or any Additional Product, or have the Product or
any Additional Product, sold and where such patent protection is reasonably
available, within the times prescribed by the applicable laws. The Licensors
shall advise Biovail in writing of their plans to file such patent applications
and of the countries in which the Licensors intends to file such applications.
Biovail may file any such application in any country in respect of which the
Licensors has not indicated it will file an application after notice from
Biovail stating its intention to sell in such a country, as is indicated in
section 7.3. All such applications filed by Biovail shall be assigned to the
Licensors to the full extent that such applications or patents cover any and
all technical application other than the Product or any Additional Product. If
such a partial assignment cannot reasonably be made, Biovail shall grant to the
Licensors an exclusive license, including the right to sublicense, for any and
all technical application other than the Product or any Additional Product,
under such applications or patents for the duration of the patent. Subject to
the provisions of paragraph 7.7 of this Agreement, Biovail may deduct all of
the costs associated with the filing, prosecution, issuing and maintenance of
any such patents and applications in any such country from the royalties
payable to the Licensors pursuant to Article 8 of this Agreement.


 


7.7                                 The deduction by Biovail of costs associated with the filing,
prosecution, issuing and maintenance of patents and applications permitted by paragraphs
7.4 and 7.6 in respect of any country in the Territory shall be limited to the
amount of royalties paid or payable in respect of sales of the Product or any
Additional Product in that country, except in the case of such costs incurred
in respect of costs incurred with respect to:


 


(a)                                  the international phase of a PCT application;


 


(b)                                 a European application prior to the entry of a national phase
application;


 

















 


(c)                                  national phase applications in the United States, Canada, Japan, the
United Kingdom, France and Germany


 


which may be deducted
from any royalties payable by Biovail to the Licensors under this Agreement.


 


Improvements


 


7.8                                 Any improvements to the University Technology made by the Licensors
shall be included within the scope of the Licenses granted by this Agreement
and shall be disclosed promptly by the Licensors to Biovail. No additional
royalty or other compensation shall be paid by Biovail to the Licensors in
respect of any improvement that does not allow Biovail to manufacture the Product
at a lower cost. Provided that any such improvement allows Biovail to
manufacture the Product at a lower cost, the Parties shall conduct good faith
negotiations regarding any additional compensation that Biovail should pay with
respect to such improvement.


 


7.9                                 All improvements in or to the Biovail Technology made or acquired by
Biovail shall remain the property of Biovail.. All improvements to the
University Technology made or acquired by Biovail may be used by the Licensors
and their licensees without compensation to Biovail. Biovail shall retain all
other rights in and to the Improvements not granted by this Article.


 


Enforcement of
Intellectual Property Rights


 


7.10                           Each of the Licensors and Biovail shall notify the other of any material
infringement of the University Technology or of the Biovail Technology of which
it becomes aware during the term of this Agreement. To the extent that it is
commercially feasible to do so Biovail shall institute patent infringement
actions against any controlled release product in tablet form made from
compressed active beads or active pellets containing Diltiazem, or any other
controlled release product in tablet form made from compressing active beads or
active-pellets containing the same active ingredient as contained in any
Additional Product, marketed by third parties in the United States of America,
Canada or Europe and having a material impact on the sales of the Product in
the Territory.


 


7.11                           The Licensors shall have the right, but not the duty, to institute an
action for any infringement of any University Technology hereby licensed to
Biovail. The costs and expenses of any such action shall be borne by the
Parties in such proportions as they may agree in writing. Each party shall
execute all necessary and proper documents and take such actions as shall be
appropriate to allow the other party to institute and prosecute such
infringement actions and render such assistance as reasonably required by the
party enforcing such patents. Any award paid by a third party as a result of
such an infringement action (whether by way of settlement or otherwise) shall
first be allocated among the Parties to reimburse each of them for their
respective contributions to the costs and expenses incurred in such action, and
then in proportion to their respective losses (namely, lost royalties for the
Licensors, and lost sales for Biovail) arising from such infringing acts.


 

















 


8                                          ROYALTIES ON SALES


 


8.1                                 Biovail shall pay to the Licensors or to their assigns, in accordance
with the provisions of paragraph 8.10 below, a royalty in the amount of {***}† of
the Net Sales of each Royalty Bearing Product in the Territory as well as of
any material value or reduction that Biovail may obtain from the purchasers of
the Product in compensation for the Product and of any payment or settlement
for disputes with third parties over the use or purchase of the Product.


 


8.2                                 Biovail’s obligations to pay the royalties required by paragraph 8.1
shall cease, in any particular country with respect to the Royalty Bearing
Product:


 


(a)                                  upon the expiry of the patent-protection for the University Technology
covering the Royalty Bearing Product in that country; or


 


(b)                                 on the 15th anniversary of the First Commercial Sale of the Royalty
Bearing Product in that country if no patent protection was applied for
obtained in that country,


 


and thereafter the
license granted to Biovail shall be a paid-up royalty-free license.


 


8.3                                 Biovail shall notify the Licensors of the date of the First Commercial
Sale of the Royalty Bearing Product by itself, its Affiliated Companies, or its
Licensees of the Royalty Bearing Product in the Territory within thirty (30)
days of that First Commercial Sale.


 


8.4                                 The royalties required by paragraph 8.1 shall be due and payable within
sixty (60) days of the end of March, June, September and December with
respect to sales of the Royalty Bearing Product in the three (3) month
periods ending on last days of March, June, September and December. Such
royalties shall be paid to the Licensors, to such bank account as the Licensors
may designate, in U.S. dollars. Biovail shall on payment of royalties submit a
written statement summarizing on a country by country basis the accrual of the
royalties in question together with a copy of the quotations of the main banker
of Biovail on the currency rates in question.


 


8.5                                 Upon expiry of Biovail’s obligation to pay royalties in respect of the
Net Sales of the Royalty Bearing Product in any particular country, Biovail and
its Affiliated Companies and its Sub-Licensees shall have a perpetual,
non-terminable paid-up license to use the Know-How for that Royalty Bearing
Product and to Manufacture and Market that Royalty Bearing Product in that
particular country without further obligation to the Licensors.


 


Marketing, Promotion
and Minimum Royalties


 


8.6                                 Biovail shall use, or shall cause a Sub-Licensee of Biovail to use,
commercially reasonable efforts to market, promote and sell the Royalty Bearing
Product in the Territory.


 


Reports


 


8.7                                 Within sixty (60) days of the end of each calendar quarter, Biovail
shall send to the Licensors a statement disclosing the Net Sales of each
Royalty Bearing Product for the just ended calendar 


 






† Represents
material which has been redacted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 

















 


quarter, and the
royalties due to the Licensors. The Licensors may disclose those reports to any
person entitled to receive that portion of the royalties attributable to Remon
or his assigns, as contemplated by paragraph 8.10 of this Agreement.


 


8.8                                 Biovail, if required so to do by any applicable tax law, may deduct any
governmental withholding tax required to be deducted by it on payment of
royalties hereunder or on payment of any of the development fees set out in Section 3,
but shall account to the relevant tax authorities for the sum so deducted and
provide the Licensors with proof of such payment from such authorities. Biovail
shall provide reasonable assistance to the Licensors in securing any benefits
available to the Licensors with respect to governmental tax withholdings by any
relevant law or double tax treaty.


 


8.9                                 Biovail shall keep at its registered office, and shall cause its
Affiliated Companies and its (sub-Licensees to keep, full and accurate records
of the sales of each Royalty Bearing Product for each country for purposes of
compliance with its obligations hereunder. Such records shall be made available
following the First Commercial Sale of each Royalty Bearing Product in the
Territory, for inspection by the Licensors or an independent certified public
or chartered accountant of the Licensors’ choice during normal business hours
after reasonable notice, up to two (2) years after the termination or
expiration of this Agreement, and at the Licensors’ expense. Such inspection
shall occur no more often than once a year, except in the year following the
discovery of any discrepancies, during which quarterly inspections shall be
permitted.


 


8.10                           All royalty payments made pursuant to the provisions of paragraph 8.1
shall be apportioned between the Licensors. {***}† of such royalties shall
be paid directly to the University (to the credit of account number {***}† of
the ASLK/CGER Bank in Brussels for “Universiteit Gent” and specifying the
Department of Remon as recipient). {***}† of such royalties and such milestones
as indicated shall be paid separately to Remon or his assigns. The University
and Remon acknowledge that a separate agreement shall be made for {***}† of the
compensation and that this provides full satisfaction of any claim Remon may
have for his rights in the Invention and the Know-How.


 


9                                          REPRESENTATIONS AND WARRANTIES


 


9.1                                 Unless specifically stated below, each Party hereby represents and
warrants to the other Party as follows:


 


(a)                                  Such Party is duly organized, validly existing and in good standing
under the laws of the jurisdiction in which it is organized; has the corporate
or other power and authority and the legal right to conduct its business as it
is now being conducted; and is in compliance with all requirements of
applicable law, except to the extent that any noncompliance would not have a
material adverse effect on the properties, business, or financial or other
condition of such Party and would not materially adversely affect such Party’s
ability to perform its obligations under this Agreement.


 






† Represents
material which has been redacted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 

















 


(b)                                 Such Party has the corporate or other power and authority and the legal
right to enter into this Agreement and to perform its obligations hereunder and
has taken or will take all necessary corporate or other action on its part to
authorize the execution and delivery of this Agreement and the performance of
its obligations hereunder. This Agreement has been duly executed and delivered
on behalf of such Party, and constitutes a legal, valid and binding obligation,
enforceable against such Party in accordance with its terms, except as such
enforcement may be limited by applicable bankruptcy, insolvency,
reorganization, moratorium, and other similar laws affecting the enforcement of
creditors’ rights generally from time to time in effect and general principles
of equity.


 


(c)                                  Each Party will comply with all applicable laws and regulations in the
Territory in connection with the performance of its duties hereunder.


 


(d)                                 All necessary consents, approvals and authorizations of all governmental
authorities and other Persons required to be obtained by such Party in
connection with this Agreement have been or will be obtained.


 


(e)                                  The execution and delivery of this Agreement and the performance of such
Party’s obligations hereunder will not conflict with, violate the provisions
of, constitute a default or give rise to rights of any entity under (a) the
Party’s Articles of Incorporation or Bylaws; (b) any requirement of
applicable laws or regulations; (c) any judgement, decree or order of any
court or governmental or regulatory agency applicable to the Party, its
subsidiaries, its Affiliates or their respective assets; or (d) any
agreement, commitment or contractual obligation of such Party or of any of its
subsidiaries or Affiliates is a party or by which they or their respective
assets are bound, except such conflicts that do not materially adversely affect
such Party’s ability to perform its obligations under this Agreement.


 


9.2                                 The Licensors warrant that they have not developed for themselves or any
other Person any controlled release formulation containing Diltiazem, and that
they have not granted licenses to, authorized, or permitted any Persons other
than Biovail to use the University Technology to Manufacture or to Market, any
controlled release formulation containing Diltiazem in any country within the
Territory.


 


9.3                                 The Licensors represent and warrant that:


 


(a)                                  they own, will own or will have the right to use all of the University
Technology and that they have or will have the right to transfer to Biovail the
rights transferred by this Agreement;


 


(b)                                 that all University Technology to be supplied to Biovail will, at the
time the information is disclosed, accurately reflect the results of the tests
and studies performed and all other information known to Biovail;


 


(c)                                  they are not aware of any actual or potential claims by any third
parties adverse to Biovail’s right to use the University Technology or to
authorize Biovail to use the University Technology;


 

















 


(d)                                 they are not aware of any third party rights that would be infringed in
the Territory by the use by Biovail or its Licensees of the University Technology,
or by the Manufacture or Marketing of the Product in the Territory; and


 


(e)                                  no information has been provided to third parties (apart from Affiliates
of Biovail) that would facilitate any such party in Manufacturing the Product
in the Territory.


 


10                                    CONFIDENTIALITY AND NON-DISCLOSURE


 


10.1                           Each of the Licensors and Biovail shall receive and maintain all
disclosures by the other Party hereunder, and any other information about the
businesses or affairs of the other relating to Biovail Technology, the
University Technology or to the Product in confidence, and shall not at any
time disclose any such received information to Persons other than their
Affiliated Companies, agents officers, employees, representatives, consultants
and advisors, and to licensees and potential licensees of Biovail, except where
permitted by this Agreement, and in any case only under confidentiality
agreements which are at least as restrictive as the provisions of this
Agreement. The Licensors and Biovail shall use such received information only
to the extent necessary or permitted by this Agreement, or required by law. The
Licensors and Biovail shall take all reasonable steps, including but not
limited to prosecution, to ensure that their respective Affiliated Companies,
agents, officers, employees, representatives, consultants, advisors and
licensees and potential licensees maintain the obligations of confidence
imposed on the Licensors and Biovail by this Agreement.


 


10.2                           Paragraph 10.1 shall not apply to any Biovail Technology or University
Technology which:


 


(a)                                  was already known to the receiving Party at the time of its disclosure
by the disclosing Party;


 


(b)                                 has been published or is otherwise within the public knowledge or is
generally known to the public;


 


(c)                                  has come into the public domain without any breach of this Agreement;


 


(d)                                 became known or available to the receiving Party from a source having
the right to make such disclosure to the receiving Party and without
restriction on such disclosure to the receiving Party;


 


(e)                                  is disclosed to the public and is generally available to the public as a
result of compliance with any applicable law or regulation; or


 


(f)                                    is disclosed as the result of any applications for patents relating to
the Product anywhere in the world.


 


10.3                           Any information or data relating to the Product and developed after the
Effective Date may be disclosed by the Party developing that information or
data, provided that such disclosure does not result in any disclosure contrary
to paragraph 10.1.


 

















 


11                                    ASSIGNMENT


 


11.1                           This Agreement may be assigned by Biovail or the Licensors only with the
prior written consent of the other, which consent shall not be unreasonably
withheld, subject to confirmation by any assignee of Biovail or the Licensors
to the other that such assignee agrees to be bound by the terms of this
Agreement. No such assignment shall relieve the assigning Party of its
obligations under this Agreement. Consent shall not be necessary for any
assignment of this Agreement, including both the rights and obligations
hereunder, to a company that is, an Affiliated Company of the assigning Party,
provided the assigning Party notifies the other Party promptly of such
assignment. Any such assignment may be on a country by country basis. No such
assignment shall relieve the assigning Party of its obligations under this
Agreement.


 


11.2                           The Licensors may assign their rights to receive the payments referred
to in Articles 3 and 8, in any one or more countries of the Territory, to any
other Person, on notice in writing to Biovail. Neither Party shall transfer,
assign or otherwise encumber the University Technology without taking all steps
necessary to preserve the rights granted to the other Party by this Agreement.


 


11.3                           Notwithstanding the provisions of paragraph 11.1, this Agreement and the
rights and obligations under it may be assigned by either Party to any
purchaser of that Party, subject to confirmation by the purchaser of that Party
to the other Party that it agrees to be bound by the terms of this Agreement.
No such assignment shall relieve the assigning Party of its obligations under
this Agreement. Neither Party shall transfer, assign or otherwise encumber the
University Technology without taking all steps necessary to preserve the rights
granted to the other Party by this Agreement.


 


12                                    TERM, TERMINATION AND OTHER REMEDIES


 


12.1                           This Agreement becomes effective on the date indicated on Page 1.


 


Termination During
Product Development


 


12.2                           Either Party may terminate this Agreement and the license(s) of the
University Technology herein contemplated forthwith by notice in writing to the
other Party, and without further liability to the other Party, with respect to
the Product if any patent evaluation for the Product discloses patent rights
which would prevent the Licensors from performing its obligations under this
Agreement, or which would prevent Biovail from Manufacturing or Marketing the
Product in any country in the Territory, and the attempts to modify the
formulation pursuant to paragraph 7.1 have been unsuccessful in avoiding any
potential infringement.


 


Termination — Non-Payment
of Fees


 


12.3                           If Biovail defaults in its obligation to pay any of the development fees
specified in paragraph 3.1, the Licensors may, by written notice, terminate all
rights and obligations of Biovail under this Agreement unless Biovail cures the
default in payment not later than thirty (30) days after Biovail receives
notification in writing of such default from Biovail.


 














 


Termination - General


 


12.4                           In the event of any default by the Licensors or Biovail in the
performance of its obligations under this Agreement not otherwise referred to
in this Agreement, the Party not in default may, by written notice to the Party
in default, terminate all rights and obligations of the Party in default under
this Agreement for the country or countries affected by that breach unless:


 


(a)                                  the Party in default cures the default within ninety (90) days after it
receives notification in writing of such default, if such default can be cured
within such ninety (90) days; or


 


(b)                                 the Party in default provides to the Party not in default, a reasonable
plan for curing such default as soon as reasonably possible if such cure will
take longer than such ninety (90) days.


 


12.5                           Upon any termination by the Licensors pursuant to paragraph 12.4:


 


(a)                                  Biovail shall return to the Licensors all documents and other materials
relating to the use of the University Technology in that countries or those
countries, except for one copy that may be retained by Biovail’s outside
counsel; and


 


(b)                                 Biovail shall cease all use of the University Technology, including any
sales of the Product in that country or those countries;


 


12.6                           Upon any termination by Biovail pursuant to paragraphs 12.4, the
Licensors shall return to Biovail all documents, all quantities of Diltiazem,
(including any in-process material containing Diltiazem), and all other
materials originating with Biovail and relating to the Manufacture of the Product
in that countries or those countries, except for one copy that may be retained
by the Licensors’ outside counsel.


 


Surviving Rights and
Obligations


 


12.7                           The Parties’ rights and obligations under Article 10 shall survive
any termination of this Agreement.


 


12.8                           Termination, relinquishment or expiration of this Agreement for any
reason shall be without prejudice to any rights which shall have accrued to the
benefit of either party prior to such termination, relinquishment or
expiration. Such termination, relinquishment or expiration shall not relieve
either party from obligations which are expressly indicated to survive
termination or expiration of this Agreement.


 


13                                    FORCE MAJEURE


 


I3.1                             In the event that either Party to this Agreement shall be rendered wholly
or partially unable to carry out its obligations under this Agreement, other
than obligations to render statements and make payments pursuant to the
provisions of the Agreement, by reason of causes beyond its control, including
but not restricted to acts of God, acts, omissions, or regulations of any
government or subdivision thereof, judicial action, fire, storm, accident, war,
riot, labour disputes, or transportation failure, then the performance of the
obligations of such party, in so far as it is affected by such cause, shall be
excused during the continuance of any inability so caused provided that the
Party affected advises the other Party of its inability within thirty (30) days
after such cause comes into existence.


 

















 


14                                    PROPER LAW


 


14.1                           Any action brought by Biovail or the Licensors, or their respective
assignees, to enforce any provision of this, or alleging any breach thereof
shall be brought before a court of competent jurisdiction in London, England.
This Agreement shall be governed and construed under and in accordance with the
laws of Great Britain. The Parties irrevocably submit and attorn to the
jurisdiction of the courts of Great Britain, without regard to their conflict
of law rules, with respect to all matters arising out of or in connection with
this Agreement and all matters, agreements or documents contemplated by this
Agreement. The Parties waive any objections they may have to venue being in
such courts, including, without limitation, any claim that such venue is an
inconvenient forum.


 


15                                    COMPLIANCE WITH LAWS AND CHANGES IN LEGISLATION


 


15.1                           If national, international and/or supranational legislation or rules necessitate
changes in the present Agreement or make it illegal for one or both of the
Parties to apply one or more of the provisions in the Agreement, it is the
intention that the Agreement shall continue to be applied by the Parties to the
extent it is legally possible. Changes in the provisions of this Agreement that
might be necessary due to the above-mentioned conditions shall be kept to the
minimum which is legally required and to the extent possible the changes shall
aim at maintaining the contents of this Agreement as much as possible in word
as well as in spirit, especially with respect to the financial balance between the
Parties established by paragraphs 3.1 and 3.2.


 


16                                    INDEMNIFICATION


 


I6.1                             Biovail shall indemnify the Licensors and hold the Licensors harmless
from and against any and all claims, damages, liabilities, costs and expenses,
including reasonable counsel fees, arising from:


 


(a)                                  any allegation of injury, damage or wrongdoing to third parties arising
out of the use by any person of the Product and any Additional Product anywhere
in the Territory, or out of Biovail’s breach of this Agreement;


 


(b)                                 any allegation of injury, damage or wrongdoing to any person arising out
of any use by that person of any Product or Additional Product Manufactured or
Marketed by Biovail;


 


(c)                                  any default, negligence or act of omission of Biovail, by an Affiliated
Company or by any Sub-Licensee;


 


(d)                                 any breach of this agreement or any covenant or warranty in it; and/or


 


(e)                                  any infringement or allegation of infringement of a third party’s
rights, including intellectual property rights, arising out of the Manufacture
or Marketing of the Product or of any Additional Product in the Territory.


 


16.2                           The Licensors shall indemnify Biovail and its Licensees and hold Biovail
and its Licensees harmless from and against any and all claims, damages,
liabilities, costs and expenses, including reasonable counsel fees, arising
from:


 

















 


(a)                                  any allegation of infringement of a third party’s rights resulting from
any breach by the Licensors of its obligations under this agreement, or from
the performance by the Licensors of any of the services specified in Article 2
of this Agreement; or


 


(b)                                 any allegation of injury, damage or wrongdoing to third parties arising
out of any breach of this Agreement, by the Licensors; or


 


(e)                                  any allegation of injury, damage or wrongdoing to third parties arising
out of the use of the University Technology to Manufacture the Product; or


 


(d)                                 any default, negligence or act of omission of the Licensors; or


 


(e)                                  any breach of this agreement or any covenant or warranty in it.


 


Notice


 


16.3                           In the event that either Party seeks indemnification under this Article 16,
such Party shall: i) promptly inform the indemnifying Party of any claim, suit
or demand threatened or filed, ii) permit the indemnifying Party to assume
direction and control of the defense of such claims, suit or demand resulting
therefrom (including the right to obtain a settlement thereof at the discretion
of the indemnifying Party with the reasonable consent of the other Party
hereto), and iii) co-operate as requested (at the expense of the indemnifying
Party) in the defense of such claims, suit or demand.


 


Limitations


 


16.4                           An indemnifying Party’s (including Biovail’s) obligations under this Article 16
shall not extend to any claims, suits or demands for liability, damages,
losses, costs or expenses arising from the indemnified Party’s failure to
comply with the terms and conditions of this Agreement, to the extent arising
from the negligence or wilful misconduct of the indemnified Party, its agents
or employees.


 


16.5                           Except as expressly provided herein, neither Party to this Agreement
shall be liable to the other for any consequential, special, incidental or
contingent damages or expenses, whether in contract (including patent
infringement), tort (including negligence) or otherwise arising out of,
connected with, or resulting from its performance under this Agreement or the
use or sale of the Product including, without limiting the foregoing, loss of
revenue, profit, property, opportunity or use of any kind, including without
limitation, damages for any loss of profits by the other Party hereto or
others, or for any other similar collateral or consequential damages which may
result from the use or sale of the Product.


 


17                                    GENERAL CONDITIONS AND PROVISIONS


 


17.1                           Article and paragraph titles used in this Agreement are for
convenience only and are not a part of the text hereof.


 


17.2                           This Agreement constitutes the entire agreement of the Parties with
respect to the subject matter hereof (and into which all prior negotiations,
commitments, representations and 


 

















 


undertakings of the
Parties are merged) and except as herein provided there are no other oral or
written understandings or agreements between the Parties hereto relating to the
subject matter hereof.


 


17.3                           No amendment or other modification of this Agreement shall be valid or
binding on either Party hereto, unless reduced to writing and executed by the
Parties hereto.


 


17.4                           The Parties hereto are independent and neither Party is the agent, joint
venturer, partner or employee of the other and, except as expressly provided
herein, Biovail shall not be obligated by any agreements, representations or
warranties made by the Licensors to any Person, nor with respect to any other
action of the Licensors.


 


17.5                           All terms used in any one number or gender shall extend to mean and
include any other number and gender as the facts, context, or sense of this
Agreement or any paragraph or Article hereof may require.


 


17.6                           No waiver by either Party of any breach or series of breaches or
defaults in performance by the other Party, and no failure, refusal or neglect
to exercise any right, power or option given to either Party hereunder or to
insist upon strict compliance with or performance of the obligations under this
Agreement, shall constitute a waiver of the provisions of this Agreement with
respect to any subsequent breach thereof or a waiver by such Party of its right
at any time thereafter to require exact and strict compliance with the
provisions thereof.


 


17.7                           All provisions of this Agreement shall be severable and no such
provision shall be affected by the invalidity of any other such provision to
the extent that such invalidity does not also render such other provision
invalid, always provided that the balance anticipated between the Parties
relating to the payment and transfer of title to the University Technology, is
not materially affected. In the event of the invalidity of any provision of
this Agreement, it shall be interpreted and enforced as if all remaining
provisions of the Agreement were valid and enforceable. If any provision of
this Agreement shall be susceptible of two interpretations, one of which would
render the provisions invalid and the other of which would cause the provision
to be valid, such provision shall be deemed to have the meaning which would cause
it to be valid.


 


17.8                           The Parties agree that time is of the essence. If any item that is
contemplated by this Agreement shall not be done as provided herein then the
defaulting Party shall be subject to the termination provisions contained
herein. However, such termination shall not limit any other remedies at law or
in equity which may be available to the non-defaulting Party.


 


17.9                           All information, data, reports, studies and results required to be
provided to the Licensors or to Biovail by the terms of this Agreement shall,
if necessary, be translated into the English language, at no expense to the
Party receiving the information, data, reports, studies or results.


 


18                                    NOTICE


 


18.1                           Any notice or other communication required or permitted to be given pursuant
to the provisions of this Agreement shall be in writing and shall be given by
prepaid first class mail, by facsimile or by other means of electronic
communications, or by hand delivery as hereinafter provided. Any such notice if
mailed by prepaid first-class mail at any time other than during a 


 

















 


general
discontinuance of postal service due to a strike, lockout or otherwise shall be
deemed to have been received on the fourth Business Day after the post-marked
date thereof, or if sent by facsimile or other means of electronic
communication shall be deemed to have been received on the Business Day
following the sending, or if hand-delivered shall be deemed to have been
received at the time it is delivered to the applicable address noted below
either to the individual noted below or to an individual at such address having
apparent authority to accept deliveries on behalf of the addressee. Notice of
change of address shall be governed by this paragraph. In the event of a
general discontinuance of postal service due to a strike, lockout or otherwise,
notices or other communications shall be delivered by hand or sent by facsimile
or other means of electronic communication and shall be deemed to have been
received in accordance with this paragraph. Notices and other communications
shall be addressed as follows: :


 


Biovail Laboratories
Incorporated


Chelston Park


Building 2, Collymore
Rock


St Michael, BH1


Barbados


Attention: Mr. Eugene
Melnyk, President


Facsimile: + 1 246
437 7085


 


With a copy to:


 


Biovail Corporation
International


2488 Dunwin Drive


Mississauga, Ontario


L5L 1J9


Attention: Mr. Ken
Cancellara


Facsimile: +1 416 285
6499


 


AND TO:


 


Universiteit de Gent


Department of
Research Policy


Sint
Pietersnieuwstraat 25


B-9000 Gent, Belgium


Facsimile: 011-3 29-264
35 83


 


With a copy to:


 


Prof. Dr. J.
Erauw


Law School


Universiteitstraat 4


B-9000 Gent, Belgium


 


AND TO:


 


To Prof. Dr. Jean-Paul
Remon


Department of
Pharmaceutical Technology


 

















 


Harelbekestraat 72 B


B-9000 Gent, Belgium


 


18.2                           Notwithstanding the foregoing, any notice or other communication
required or permitted to be given by any Party pursuant to or in connection
with any court procedures contained herein or in any Schedule hereto may only
be delivered by hand. The failure to send or deliver a copy of a notice to
counsel for the Licensors or Biovail shall not invalidate any notice given
under this Article 18.


 


19                                    COPIES, ETC.


 


19.1                           This Agreement may be executed in any number of counterparts, each of
which will be deemed to be an original and all of which taken together will be
deemed to constitute one and the same instrument. Counterparts may be executed
either in original or faxed form and the parties adopt any signatures received
by a receiving fax machine as original signatures of the parties. Any Party
providing its signature in faxed form will promptly forward to the other Party
an original of the signed copy of this Agreement that was so faxed. The failure
of either Party to forward that original shall not affect the enforceability of
this Agreement.


 


In Witness Whereof
the Parties hereto have executed this Agreement.


 


On this Effective
Date, 5 March 2000


 


	
  BIOVAIL
  LABORATORIES INCORPORATED

  	
   

  
	
  Per:

  	
  /s/
  Eugene Melnyk

  	
   

  
	
  Eugene
  Melnyk, President and Chief Executive Officer

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  UNIVERSITEIT
  GENT

  	
   

  
	
  Per:

  	
  /s/
  J. Willems

  	
   

  
	
  Prof.
  Dr. J. Willems, Rector of the University

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  JEAN-PAUL
  REMON

  	
   

  
	
  /s/
  Jean-Paul Remon 31 May 2000

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  GEZIEN
  EN GOEDGEKEURD

  	
   

  
	
  /s/
  Yannick de Clercq

  	
   

  
	
  YANNICK
  DE CLERCQ

  	
   

  
	
  REGERINGSCOMMISSARIS

  	
   

  



 

















 


Schedule
2.1


 


	
  Diltiazem
  Bead Tablets

  	
   

  	
  Dates

  	
   

  	
  Responsibility

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Formulation
  Development

  	
   

  	
  Completed

  	
   

  	
  University
  of Gent

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Transfer
  of Formula

  	
   

  	
  Completed

  	
   

  	
  University
  of Gent

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Transfer
  of the Validated Methods

  	
   

  	
  Completed

  	
   

  	
  University
  of Gent

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Technology
  Transfer

  	
   

  	
  Completed

  	
   

  	
  University
  of Gent

  



 

















 


SCHEDULE
3.1


 


Services
Contracted by Biovail

and Fees to be paid to

the Licensors by Biovail


 


The fees specified in
this Schedule 3.1 shall be paid by Biovail to the Licensors for the services
performed by the Licensors and included in each of the events specified below:


 


	
  Payment Number and Event:

  	
   

  	
  Amount*

  payable to the

  University

  	
   

  	
  Amount

  payable to

  Remon

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  1.               Upon
  execution of this Agreement:

  	
   

  	
  {***}

  	
  †

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  2.               Upon
  the manufacture to the satisfaction of Biovail of the Pilot Batch of the
  Product

  	
   

  	
  {***}

  	
  †

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  3.               On the completion to the satisfaction of Biovail of the Pilot Bio
  Study performed on the Pilot Batches

  	
   

  	
  {***}

  	
  †

  	
  {***}

  	
  †

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  4.               On
  the completion to the satisfaction of Biovail of the Clinical Batch

  	
   

  	
  {***}

  	
  †

  	
  {***}

  	
  †

  



 






*                                         All amounts in this Schedule are expressed in US dollars.


 


† Represents
material which has been redacted and filed separately with the Securities and
Exchange Commission pursuant to a request for confidential treatment pursuant
to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 

















 


SCHEDULE
1.32


 


Product
Standards


 


Dosage
Form


 


The Product will be
in form of a marketable tablet prepared from Beads. The Product will have
physical characteristics, including friability and hardness, sufficient to
permit handling, packaging and Marketing of the Product in plastic bottles of
the type commonly used for the distribution and sale of pharmaceuticals in
North America


 


Dosage
Strengths


 


The Product shall be
developed in 4 dosages strengths: 120 mg; 180 mg; 240 mg and 360 mg 420 mg of
diltiazem per tablet, and in any other strengths than can be compressed on
conventional tablet presses.


 


Dissolution
and Bioavailability


 


The Product shall
provide a dissolution profile obtained according to FDA standards and test
conditions, that does not differ from the one obtained from Beads by more than
ten percent (10%) at any point in time on the profile.


 


The Product tested in
vivo in healthy volunteers shall meet the criteria for Bioequivalence according
to both FDA and TPP regulations.


 


Product
Composition


 


The Product shall
contain at least 34% active diltiazem, in amounts sufficient to comply with the
FDA standards and regulations for the dosage strengths specified above.


 


Each tablet shall have
a Capsule shape defined by a format design proposed by the Licensors and
approved and adapted to Biovail’s tabletting machine, (The upper punch may have
a secability bar).


 


The Product will
contain only approvable excipients that are listed in the Inactive Ingredient
Guide as issued and upgraded periodically by the FDA, in amounts that do not
exceed the amounts permitted by such Inactive Ingredient Guide(s), that are
approved by the FDA for use in pharmaceutical preparations intended for oral
administration to humans, and for which there is a Drug Master File available
in all countries in the Territory where Drug Master Files are required.