Document:

Exhibit 10.16

 

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.

 

First
Amendment to the Product Development and License Agreement

 

THE
PARTIES

 

Ghent
University, public institution with legal personality,
having its administrative offices in Belgium, B-9000 Gent,
Sint-Pietersnieuwstraat 25 and duly represented by Prof. dr. Luc Moens,
vice-rector (hereinafter referred to as “University”)

 

AND

 

Biovail
Laboratories International SRL (successor in interest to
Biovail Laboratories Incorporated), a society with restricted liability
organized under the laws of Barbados and having a principal place of business
at Welches Christ Church, Barbados, West Indies, BB17154 (hereinafter referred
to as “Biovail”)

 

AND

 

Professor
Jean-Paul Remon, living at John
Youngestraat 14 B-9090 Melle, Belgium (hereinafter referred to as “Remon”).

 

PREAMBLE

 

Whereas,
the parties have entered into a Product Development and License Agreement dd. May 31,
2000 (hereinafter the “Agreement”);

 

Whereas,
University has requested Biovail to make payment of future royalties due to
University in EURO;

 

Now,
therefor, it is agreed by and between the parties as
follows:

 

Article 1.                                            Subject

 

1.1                                 Article 8.4. of the
Agreement shall as of the date of this amendment be deleted and replaced by
following:

 

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. {***}† of
the royalties which in accordance with paragraph 8.10 are due to Remon or his
assigns shall be paid in U.S. dollars. {***}† of
the royalties which in accordance with paragraph 8.10 are due to University shall
be paid in EURO. The royalties payable to University shall be calculated in
U.S. dollars and be converted into EURO on the due date of payment (or the
earlier date on which payment is made) using the conversion rate listed on the
European Central Bank website. 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 quotations of the main banker of
Biovail on the currency rates in question and shall provide reasonable detail
on the U.S. dollar/EURO conversion of the royalties due to University.

 

Article 2.                                            Miscellaneous

 

2.1                                 All other provisions of the
Agreement remain unchanged and in full force and effect.

 

IN
WITNESS WHEREOF, THE PARTIES HAVE EXECUTED
THIS AGREEMENT IN THREE (3) ORIGINAL COPIES ON JULY 21, 2009

 

	
  For Ghent University

  	
   

  	
  GEZIEN EN GOEDGEKEURD ZIEN

  
	
   

  	
   

  	
   

  
	
  /s/ P. Van Cauwenberge

  	
   

  	
  /s/ Yannick de Clercq

  
	
   

  	
   

  	
  27 Aug 2009

  
	
   

  	
   

  	
  YANNICK DE CLERCQ

  
	
  Prof. dr.
  Luc Moens

  	
  Prof.
  Dr. P. Van Cauwenberge Rector

  	
   

  	
  REGERINGSCOMMISSARIS

  
	
  Vice-Rector of the University

  	
   

  	
   

  
				

 

	
   

  	
   

  	
   

  
	
  For Biovail Laboratories International SRL

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/ Fitzroy Bardouille

  	
   

  	
   

  
	
  Fitzroy
  Bardouille

  	
   

  	
   

  
	
  Vice-President,
  Finance

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  For Professor Jean-Paul Remon

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/ Jean-Paul Remon

  	
   

  	
   

  
	
  Jean-Paul
  Remon

  	
   

  	
   

  

 

† 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.Exhibit
10.17

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.

 

NON-EXCLUSIVE LICENSE AGREEMENT

 

This Agreement, effective as
of December 5, 1996, is between ETHYPHARM S.A., a French Corporation,
having offices at 21 rue Saint Mathieu, 78550 Houdan, France, (hereinafter
ETHYPHARM) and Hoechst Marion Roussel, Inc., a Delaware Corporation,
having offices at 10236 Marion Park Drive, Kansas City, Missouri 64137
(hereinafter HMRI).

 

ARTICLE I

BACKGROUND OF THE AGREEMENT

 

ETHYPHARM has developed
certain technology relating to diltiazem formulations for the North American
market that are bioequivalent to Cardizem CDÒ, but which may likely infringe HMRI’s PATENTS.  The ETHYPHARM formulations possess the
advantage that while being bioequivalent to Cardizem CDÒ, they are smaller than CD,
and thus easier for patients to swallow. 
HMRI is interested in obtaining rights to these formulations, so that
they may be marketed as line extensions to the current offering of CardizemÒ products. 
ETHYPHARM is interested in collaborating with HMRI so that its
technology may be rapidly commercialized in U.S.A. by the rights provided
herein.  Therefore the parties agree to
the following terms and conditions.

 

ARTICLE II

DEFINITIONS

 

2.01                           “ETHYPHARM TECHNOLOGY”  The term “ETHYPHARM TECHNOLOGY” refers
to:  a) the two formulations of diltiazem
HCL that ETHYPHARM has currently developed that are bioequivalent to HMRI’s
brand of Cardizem CDÒ; b) the know how and trade secrets
necessary or desirable to commercially manufacture these formulations; c) all
bioequivalence studies completed or underway with these formulations; d) all analytical
work carried out on these formulations; e) any data package assembled or
partially assembled that may be suitable for submission to the FDA; and e) all
other information, know how, processes etc., that are either necessary or
desirable, to receive approval by the FDA in the TERRITORY or is required for
commercial production.

 

2.02                           “TERRITORY”  The term “TERRITORY” refers to Australia, New
Zealand, the United States, its territories and possessions.  At the present time, ETHYPHARM cannot convey
a non-exclusive license to HMRI for Canada. 
If ETHYPHARM is able to so convey a license for the ETHYPHARM TECHNOLOGY
within sixty (60) days, the term TERRITORY shall include Canada.  ETHYPHARM will use its best efforts to issue
a non-exclusive license to HMRI for Canada.

 

 

2.03                           “NET SALES”  The term “NET SALES” shall mean the gross
invoice amount billed for the DOSAGE FORM by HMRI (or an affiliate of HMRI
or any licensee thereof) to customers (other than an affiliate of HMRI) in the
TERRITORY, less trade, cash or quantity discounts actually allowed and taken,
amounts repaid or credited by reasons of rejections, returns, or because of
retroactive price reductions (given in the normal course of business), freight,
insurance, and other transportation costs, rebates paid pursuant to
governmental regulation and taxes on such sales of the daily dosage product, as
normally deducted from sales by HMRI for financial reporting purposes.  The amount of NET SALES for any period shall
be determined on the basis of sales recorded in the ordinary course on the
books and records of HMRI (or an affiliate of HMRI) during such period
consistent with past practice.

 

2.04                           “DOSAGE FORM”  The term “DOSAGE FORM” shall refer to a
once-a-day diltiazem product which incorporates or utilizes the ETHYPHARM
TECHNOLOGY.

 

2.05                           “AFFILIATE”  The term “AFFILIATE” shall refer to any
entity which directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with one of the parties
to this agreement.  For the purpose of
the preceding sentence, the term control shall mean the possession, direct or
indirect, of the power to direct the management and policies of an entity,
whether through ownership of voting securities, by contract, or otherwise.

 

2.06                           FDA refers to the United States Food and
Drug Administration, or the equivalent Health Ministry Agency for Australia,
New Zealand or Canada.

 

2.07                           “HMRI PATENTS”  The term “HMRI PATENTS” refers to certain
patents that have issued in the United States to HMRI’s affiliate, Carderm
Capital, and that are directed to sustained release formulations of
diltiazem.  These include United States
Patent No. 5,286,497, No. 5,470,584, and No. 5,439,689.  Corresponding applications or patents exist
in Australia, Canada and New Zealand and are assigned to HMRI.

 

ARTICLE III

GRANT OF LICENSE

 

3.01                           ETHYPHARM hereby grants to HMRI, a
non-exclusive license on ETHYPHARM’s TECHNOLOGY in the TERRITORY.  This license includes the right to make, have
made, use, sell, offer for sale, export or import.

 

3.02                           ETHYPHARM has filed certain patent
applications directed to its TECHNOLOGY in the TERRITORY.  In the event that any patents issue in the
TERRITORY, then ETHYPHARM grants to HMRI a non-exclusive license under these patents.  This license shall include the right to make,
have made, use, sell, offer for sale, import or export.

 

2

 

ARTICLE IV

ROYALTIES

 

4.01                           LICENSE EXECUTION FEE

 

HMRI
shall pay to ETHYPHARM, the one time execution fee of {***}† for the exclusive
rights granted immediately above. This payment shall be made by December 20,
1996.

 

4.02                           ROYALTIES FOR NEW DOSAGE FORMS OF
CARDIZEM CDÒ

 

HMRI
will utilize the ETHYPHARM TECHNOLOGY in order to introduce a new DOSAGE FORM of
Cardizem CDÒ that it currently does not market. This new
DOSAGE FORM shall initially be a 360mg Cardizem CDÒ.  The royalty
rate for any new DOSAGE FORM, for a strength not currently on the market, shall
be {***}† of the net sales of the new DOSAGE FORM in the TERRITORY.

 

4.03                           ROYALTIES ON OTHER EXISTING DOSAGE FORMS

 

The
parties agree that HMRI shall be free, but not obligated, to use ETHYPHARM’s
TECHNOLOGY to produce its currently existing once-daily diltiazem products. If
HMRI shall use ETHYPHARM’s TECHNOLOGY to produce such DOSAGE FORMS, then the
royalty shall be {***}† of net sales.

 

4.04                           MINIMUM ROYALTIES

 

For
a period of 7 years, measured from the end of the quarter in which HMRI
receives final approval from the FDA for the 360mg DOSAGE FORM, HMRI agrees to
pay ETHYPHARM the following minimum royalties on this 360mg dosage form:

 

	
  Year

  	
   

  	
  Minimum Royalty (US$)

  
	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  {***}†

  
	
  2

  	
   

  	
  {***}†

  
	
  3

  	
   

  	
  {***}†

  
	
  4

  	
   

  	
  {***}†

  
	
  5

  	
   

  	
  {***}†

  
	
  6

  	
   

  	
  {***}†

  
	
  7

  	
   

  	
  {***}†

  

 

The
parties agree that after 7 years, all guarantees of a minimum royalty base
shall cease. The royalty on the 360mg dosage form shall remain at {***}† of net
sales. No minimum royalty shall be due on any other DOSAGE FORM OF
CARDIZEM CDÒ except the 360mg dosage form.

 

4.05                           PAYMENT OF ROYALTIES AND FEES

 

Royalty
payments to ETHYPHARM shall be made on a quarterly basis, and will be paid
within 30 days of the close of each quarter. Each royalty payment shall be
accompanied by a statement which shall set forth for each DOSAGE FORM: 1) the
amount of sales of that 

 

† 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

 

DOSAGE FORM; 2) the amount of royalty due thereon for that quarter,
and; 3) all deductions taken in computing to arrive at NET SALES.

 

4.06                           REDUCTION OF ROYALTY IN EVENT ETHYPHARM
GRANTS FURTHER LICENSES

 

The
minimum royalty schedule agreed to in Section 4.04 shall be revised in the
event that: 1) ETHYPHARM grants an additional license on the ETHYPHARM
technology in the TERRITORY; or 2) if ETHYPHARM or one of its affiliates sells
or offers for sale, a DOSAGE FORM in the TERRITORY.  This reduction in royalties shall apply to
the entire year in which such an event shall occur. The schedule below should
be interpreted such that the year refers to the number of years after launch
and the royalty reduction (as in the year relating to the scheduled payment in
4.04.). Illustratively, if a license is granted in the third year, minimum  royalties are called for, even if that year
is five years from the date of this Agreement, the royalty payment shall be on
reference to year 3 of the schedules set forth herein, or {***}†. The new
reduced minimum royalty schedule shall be:

 

	
  Year after Launch

  	
   

  	
  Minimum Royalty (US$)

  
	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  {***}†

  
	
  2

  	
   

  	
  {***}†

  
	
  3

  	
   

  	
  {***}†

  
	
  4

  	
   

  	
  {***}†

  
	
  5

  	
   

  	
  {***}†

  
	
  6

  	
   

  	
  {***}†

  
	
  7

  	
   

  	
  {***}†

  

 

4.07                           RECORDS

 

HMRI
agrees to keep records showing sales of the DOSAGE FORMS under the license
granted herein in sufficient detail to enable royalties payable under sections
3.02 and 3.03 to be calculated. HMRI agrees to maintain these records for THREE
(3) years after payment of the royalty. HMRI has no obligation to
ETHYPHARM to maintain these records beyond this THREE (3) year period.
HMRI agrees to permit its records to be inspected from time to time to the
extent necessary to verify the accuracy of the reports specified in section
4.05. Such inspection shall be carried out at ETHYPHARM’s expense by an
independent certified public accountant acceptable to HMRI, during normal
business hours, at the location where HMRI routinely stores such records. The
certified public accountant shall only report to ETHYPHARM the amount of
royalties payable 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.

 

4

 

ARTICLE V

TERM

 

5.01                           The term of this Agreement shall run for
Ten (10) years from the date of the launch of the initial DOSAGE FORM. If
any patents issue on the ETHYPHARM TECHNOLOGY in the TERRITORY, then the life
of this Agreement shall run until the expiration of the patent in the
TERRITORY, provided that the DOSAGE FORM would literally infringe any
claim of the issued patent, absent the license granted under Section 3.02.
After the expiration of the Agreement, HMRI shall be free to use the ETHYPHARM
TECHNOLOGY.

 

5.02                           If either party shall be in default of
any obligation hereunder, or shall be adjudged bankrupt, or becomes insolvent,
or makes an assignment for the benefit of creditors, or is placed in the hands
of a receiver or a trustee in bankruptcy, the other party may terminate this
Agreement by giving sixty( 60) day’s notice to the other party, specifying the
basis for termination. If within sixty (60) days after receipt of such notice,
the party who received notice shall remedy the condition forming the basis for
termination, such notice shall cease to be operative, and this AGREEMENT shall
continue in full force.

 

5.03                           HMRI shall have the right to cancel this
AGREEMENT by December 20, 1996 on the basis of any information uncovered
in its due diligence review, or if sufficient information is not provided
during its due diligence review. If HMRI has paid the LICENSE EXECUTION FEE,
then ETHYPHARM agrees to return these moneys to HMRI within 14 days of
ETHYPHARM receiving notice of HMRI’s decision to cancel. ETHYPHARM shall not
owe HMRI any interest for the period in which it is in receipt of this LICENSE
EXECUTION FEE, provided it is returned within the 14 day period.

 

ARTICLE VI

TECHNOLOGY TRANSFER

 

6.01                           Within 60 days after the execution of
this Agreement, ETHYPHARM shall make available to HMRI all of the ETHYPHARM
TECHNOLOGY. The exact manner by which this disclosure shall occur will be
decided by the technical personnel of HMRI after consultation with the
technical personnel of ETHYPHARM. The goal of this disclosure shall be to
provide the information it requires in order to be able to receive rapid
approval of the DOSAGE FORM by the FDA. This disclosure will include, but
not be limited to, information regarding the composition of the formulation,
all biostudies carried out on the formulations including summaries as well as
raw data, methods of manufacture, quality control assays, methods of storing,
methods of packaging, etc. This disclosure will include written materials (in
English) prepared by ETHYPHARM personnel, visits by HMRI personnel to ETHYPHARM’s
facilities and visits by ETHYPHARM’s personnel to HMRI’s facilities in the.
United States.

 

6.02                           HMRI will reimburse ETHYPHARM for the
reasonable and customary expenses associated with the technology transfer.
These expenses include internal costs, such as employee salaries and external
costs, such as the travel expenses. 
ETHYPHARM will obtain HMRI’s approval prior to incurring any expenses
associated with the technology transfer. The technical personnel of HMRI will
determine the most appropriate mechanism for estimating and approving costs
associated with the technology transfer after consultation with ETHYPHARM.  

 

5

 

ETHYPHARM will submit
invoices to HMRI detailing its expenses for the technology transfer on a
monthly basis. HMRI will reimburse ETHYPHARM for its expenses  associated with the technology transfer
within 30 days of its receipt of the invoice.

 

6.03                           HMRI will be responsible for obtaining
the appropriate approvals by the FDA in the TERRITORY. HMRI will use its best
efforts to file the supplemental NDA on the initial DOSAGE FORM rapidly,
and will have the supplemental NDA filed by July 1, 1998. HMRI will also
be responsible for manufacturing the DOSAGE FORMS for sale in the TERRITORY.
After completion of the TECHNOLOGY TRANSFER, ETHYPHARM agrees to continue to
provide technical support to HMRI throughout the term of this agreement, when
requested by HMRI.

 

6.04                           During the period in which HMRI is
seeking FDA approval of the DOSAGE FORM, HMRI will keep ETHYPHARM advised of
the status of the regulatory submission. Once final approval of the FDA is
obtained for said DOSAGE FORM, HMRI will launch the product within 90 days of
receiving final approval.

 

6.05                           FUTURE IMPROVEMENTS

 

During
the term of this Agreement, ETHYPHARM will keep HMRI advised of any
improvements to the ETHYPHARM TECHNOLOGY. HMRI shall be free to use these
improvements for no additional consideration, Any improvement made to ETHYPHARM’s
TECHNOLOGY by HMRI shall be the property of HMRI.

 

ARTICLE VII

LITIGATION AND PATENTS

 

7.01                           ETHYPHARM agrees to keep HMRI informed if
it files patent applications on the ETHYPHARM TECHNOLOGY in the TERRITORY.
ETHYPHARM also agrees to keep HMRI advised of the status of the prosecution of
these patent applications in the TERRITORY.

 

7.02                           Each party shall notify the other party
of any suspected infringement of the patents and shall inform the other party
of any evidence of such infringement.

 

7.03                           In the event of an infringement, HMRI has
the first right to bring suit under the patents at its own expense in ETHYPHARM’S
name.  ETHYPHARM agrees to cooperate with
HMRI in any such litigation, including providing witnesses, documents or items
in response to discovery requests or to facilitate prosecution of the action.

 

If after One Hundred and
Twenty (120) days, HMRI has not brought suit, then ETHYPHARM is free to institute
suit at its own expense.  HMRI will
cooperate with ETHYPHARM in any such action if it has any documents, witnesses,
or items that are relevant to the action.

 

ARTICLE VIII

INDEMNIFICATION

 

8.01                           HMRI agrees to defend ETHYPHARM and hold
ETHYPHARM harmless from any loss incurred or suffered, arising out of, or in
connection with:

 

6

 

a)                                      the manufacture, sale, distribution, or
packaging of any DOSAGE FORMS produced pursuant to this agreement including,
without limitation, product liability claims;

 

b)                                     the filing, or the failure to file, any
report, application, document, or information required to be filed regarding
the DOSAGE FORM with the FDA, and;

 

c)                                      any claim, or related claim, based upon
entering into this agreement with HMRI, whether instituted by a third party, or
an agency of the United States government.

 

8.02                           In order for HMRI to incur this liability
under section 8.01, ETHYPHARM must promptly notify HMRI of any third party
claim or third party suit, which ETHYPHARM considers to fall within the
provisions of section 8.01.  ETHYPHARM
shall specify with particularity the basis of the claims or suit and provide
HMRI with any information requested so that it may assess the claim.

 

8.03                           HMRI shall at its own expense assume the
defense of such claim or suit, provided that ETHYPHARM, upon reasonable notice,
consults and cooperates with HMRI regarding the suit, and any discovery
requests.  ETHYPHARM agrees to provide witnesses,
documents or items requested by HMRI, whether to comply with a discovery
request, or to adequately defend the suit. 
Failure to cooperate will extinguish HMRI’s obligations under section
8.01.

 

8.04                           HMRI shall control any such litigation
and shall at its own sole discretion defend, settle or compromise the action.

 

ARTICLE IX

CONFIDENTIALITY

 

9.01                           HMRI is being provided with ETHYPHARM’s
TECHNOLOGY which contains valuable know how and trade secrets.  During the technology transfer described in Article VI,
ETHYPHARM will be exposed to valuable trade secrets and know how of HMRI’s
which are utilized in the manufacture of Cardizem CD®.  Each party recognizes the confidential and
proprietary nature of the others information and agrees to take the following
steps to protect it.

 

9.02                           All written material transferred pursuant
to this Agreement will be labeled confidential, if the owner considers such
information confidential.  During any
visits to manufacturing facilities pursuant to the technology transfer, the
disclosing party will advise the recipient if it is being exposed to
confidential information and the nature of the confidential information .  Each party agrees that any confidential
information received from the other party will only be used for the transaction
described by this agreement and for no other purpose.  Each party agrees not to disclose the other
party’s confidential information to any third party.  The obligations of confidentiality do not
prohibit submitting any information to the FDA, or other governmental agency,
that is required for product approval or maintenance of such approval.

 

9.03                           The obligations of confidentiality and
non-use will not apply to information which:

 

7

 

a)                                      can be shown by the recipient to have
been in the public domain at the time of its receipt from the disclosor;

 

b)                                     subsequently comes into the public domain
through no fault of the recipient;

 

c)                                      the recipient can show information was
already in its possession prior to its disclosure hereunder, or;

 

d)                                     the information had previously been
received from a third party who had not received it in confidence from the
disclosor hereunder.

 

ARTICLE X

WARRANTIES AND REPRESENTATIONS

 

10.01                     ETHYPHARM represents and warrants that it has free,
clear, and good title to the ETHYPHARM TECHNOLOGY and its granting a license to
HMRI in the TERRITORY does not conflict with any previous or existing
agreement.

 

10.02                     Each party represents and warrants that it has the
power and authority to execute and deliver this agreement and to carry out its
obligations hereunder and to consummate the transactions contemplated hereby.

 

ARTICLE XI

MISCELLANEOUS

 

11.01                     Subject to any prior countervailing obligations for
the duration of this Agreement, HMRI shall have a right of first refusal on all
products and technology owned or acquired by ETHYPHARM for marketing in the
TERRITORY, insofar as such products relate to the slow release of diltiazem,
and its salts, esters and analogues. 
This right of first refusal shall be such that no subject product or
technology shall be offered for sale or distribution in the TERRITORY on terms
more favorable than terms first offered to HMRI, and shall not be offered on
terms equivalent to those first offered to HMRI, until HMRI has either failed
or refused, for a period of one hundred eighty (180) days from the date of
offer, to accept an offer to license, distribute or market in the
TERRITORY.  This right of first refusal
shall not apply to either Australia or Canada for the current Ethypharm
diltiazem formulations currently marketed in Europe by ETHYPHARM and its
licensees, which formulations are not bioequivalent to Cardizem CD.

 

11.02                     Neither party shall be liable for nonperformance or
delay in performance due to any Act of God; act, regulation or law of any
government; war; riot; civil commotion; destruction of production facilities or
materials by fire, earthquake or storm; strike; labor disturbances; epidemic;
failure of public utilities or common carriers; or any limitation requirement
or prohibition imposed or required by the United States Food and Drug
Administration or any other governmental agency having jurisdiction over the
subject matter of this agreement.

 

11.03                     A.                                   Any notice, consent, authorization,
communication of approval required to be given hereunder shall be effected
by:  (i) depositing it in writing in
Registered or Certified Mail, with the requisite postage affixed, addressed to
the party notified, or (ii) transmitting it by 

 

8

 

telefax, confirmed by letter addressed to the party or
notified; or (iii) personally delivering it in writing to the party
notified, at the address of such party herein below set forth or at such latest
address as may hereunder be given by such party in writing to the other for
notice:

 

To:                              ETHYPHARM

ETHYPHARM S.A.

21 rue Saint Mathieu,

78550 Houdan, France

Attention:                                         Patrice
Debregeas

President Directeur General

 

To:                              HMRI

Hoechst Marion Roussel, Inc.

10236 Marion Park Drive,

Kansas City, Missouri 64137

Attention:                                         Chief Legal
Counsel

 

B.                                     Unless
otherwise specified in this Agreement, the date of such deposit, transmission
or delivery, respectively, shall be the date of such notice, consent,
authorization, communication or approval.

 

11.04                     While the limitations and restrictions imposed by the
parties herein upon each other are considered by the parties to be reasonable
in all the circumstances, it is recognized that restrictions of the nature in
question may fail for technical reasons unforeseen, and, accordingly, if any such
restrictions shall be adjudged to be void, but would be valid if part of the
wording thereof were deleted or the period, if any thereof, reduced or the
range of said restriction shall apply with such modifications as may be
necessary to make it valid and effective, then the said Agreement shall be
modified to make it valid; provided, however, that this agreement is not
thereby rendered fundamentally different in its content or effect.

 

11.05                     All money amounts referred to in this Agreement are in
U.S. Dollars, and payments may be made in U.S. Dollars.

 

11.06                     The parties hereto shall not assign or transfer,
partially or entirely, any of their rights or interests or obligations under
this Agreement without the prior written consent of the other party, which
consent shall not be unreasonably withheld. 
However, either party to this Agreement may transfer this agreement to
the surviving corporation resulting from either a corporate merger, corporate
acquisition, or corporate reorganization. 
This transfer shall have no effect upon any of the rights and
obligations created under this Agreement, and the surviving corporation shall
assume all of the rights and obligations of the entity it acquires.

 

11.07                     This Agreement shall be interpreted in accordance with
and governed by the laws of the State of Missouri, U.S.A.

 

11.08                     The headings for the Paragraphs of this agreement are
to facilitate reference only, do not form a part of this Agreement and shall
not in any way affect the interpretation hereof.

 

9

 

11.09                     Upon execution of this Agreement, neither party shall
give any public notice or make any press announcement regarding this Agreement
except such notice as may have been jointly developed and agreed upon by the parties.  Either party is free to refer to this
Agreement in any regulatory filing required to be submitted to the SEC or any
equivalent government agency.

 

IN WITNESS WHEREOF, each of the parties hereto, through their
duly-authorized representative, has executed this Agreement on the day and year
first above written.

 

	
   

  	
  HOECHST MARION ROUSSEL, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By

  	
  (Signed)

  
	
   

  	
   

  	
   

  
	
   

  	
  Title

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  ETHYPHARM S.A.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By

  	
  (Signed)

  
	
   

  	
   

  	
   

  
	
   

  	
  Title

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  By

  	
  (Signed)

  
	
   

  	
   

  	
   

  
	
   

  	
  Title

  	
   

  

 

10

 

éthypharm

Direction Générala et Médicale

194, Bureaux de la Colline

S2213 SAINT-CLOUD — FRANCE

Visioconference (33) 01 41 12 00 75

Tél. (33) 01 41 12 17 20

Fax (33) 01 41 12 17 30

 

HAND DELIVERED

Mr. Charles R. Struby

Director,

U.S. Commercial Development

Hoechst Marion Roussel, Inc.

10236 Marion Park Drive

Kansas City, MO  64134-0627

U.S.A.

 

Dear Charley:

 

This letter is given in
reference to the Non-Exclusive License Agreement executed December 5,
1996.  As the Agreement specifies, Ethypharm
is committed to using our best efforts to eliminate any contractual impediments
to including Canada within the Territory as defined in Paragraph 2.02 of
the Non-Exclusive License Agreement.  In
the event that Ethypharm cannot accomplish this objective notwithstanding its
best efforts, then the Minimum Royalties provided in Paragraph 4.04 shall be
reduced to the following amounts:

 

	
  Year

  	
   

  	
  Minimum Royalty

  
	
  1

  	
   

  	
  {***}†

  
	
  2

  	
   

  	
  {***}†

  
	
  3

  	
   

  	
  {***}†

  
	
  4

  	
   

  	
  {***}†

  
	
  5

  	
   

  	
  {***}†

  
	
  6

  	
   

  	
  {***}†

  
	
  7

  	
   

  	
  {***}†

  

 

Dated this 5th day of December, 1996.

 

	
   

  	
  ETHYPHARM

  
	
   

  	
  /s/
  Patrice Debrégeas

  
	
   

  	
  Patrice
  Debrégeas

  
	
   

  	
   

  
	
   

  	
  /s/
  Gérard Leduc

  
	
   

  	
  Gérard
  Leduc

  

 

† 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.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00169-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00169-of-00352.parquet"}]]